EPA-815-Z-00-002
Wednesday,

May 10, 2000
Part H



Environmental

Protection Agency

40 CFR Parts 141 and 142
National Primary Drinking Water
Regulations: Ground Water Rule;
Proposed Rules

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Federal Register/Vol. 65, No.  91/Wednesday, May  10,  2000/Proposed  Rules
ENVIRONMENTAL PROTECTION
AGENCY

40 CFR Parts 141 and 142
[WH-FRL-6584-4]
RIN2040-AA97

National Primary Drinking Water
Regulations: Ground Water Rule

AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice of proposed rulemaking.

SUMMARY: EPA is proposing to require a
targeted risk-based regulatory strategy
for all ground water systems. The
proposed requirements provide a
meaningful opportunity to reduce
public health risk associated with the
consumption of waterborne pathogens
from fecal contamination for a
substantial number of people served by
ground water sources.
  The proposed strategy addresses risks
through a multiple-barrier approach that
relies on five major components:
periodic sanitary surveys of ground
water systems requiring the evaluation
of eight elements and the identification
of significant deficiencies;
hydrogeologic assessments to identify
wells sensitive to fecal contamination;
source water monitoring for systems
drawing from sensitive wells without
treatment or with other indications of
risk; a requirement for correction of
significant deficiencies and fecal
contamination {by eliminating the
source of contamination, correcting the
significant deficiency, providing an
alternative source water, or providing a
treatment which achieves  at least 99.99
percent (4-log) inactivation or removal
of viruses), and compliance monitoring
to insure disinfection treatment is
reliably operated where it is used.
  EPA believes that the combination of
these components strikes an appropriate
regulatory balance which tailors the
intensity or burden of protective
measures and follow-up actions with
the risk being addressed. In addition to
proposing requirements for ground
water systems, EPA requests comment
on ways 'to address the problem of
transient providers of water who furnish
drinking water to large numbers of
people for a limited period of time. One
possible solution is to adopt alternative
definitions for "public water systems"
which is currently defined as  "one that
serves 25 or more people or has 15 or
more service connections and operates
at least 60 days per year. EPA is only
requesting comment on this issue. The
Agency is not today proposing to change
the definition of "public water system ,"
                      or modify related provisions. If EPA ,
                      decides to take action on this issue, EPA
                      will publish a proposal at a later date.'
                      DATES: The EPA must receive comments
                      on or before July 10, 2000.
                      ADDRESSES: References, supporting
                      documents and public comments (and
                      additional comments as they are
                      provided) are available for review at
                      EPA's Drinking Water Docket #W-98-
                      23: 401 M Street, SW, Washington, DC
                      20460 from 9 a.m. to 4 p.m., Eastern
                      Time, Monday through Friday,
                      excluding Federal holidays.
                        You may submit comments by mail to
                      the docket at: 1200 Pennsylvania Ave.,
                      NW, Washington, DC 20460 or by
                      sending electronic mail (e-mail) to ow-
                      docket@epa.gov. Hand deliveries should
                      be delivered to: EPA's Drinking Water
                      Docket at 401 M Street, SW,
                      Washington, DC 20460.
                        For access to docket materials, please
                      call 202/260-3027 to schedule an
                      appointment and obtain the room
                      number.                          :
                      FOR FURTHER INFORMATION CONTACT: For
                      general information, contact the Safe
                      Drinking Water Hotline, telephone (800)
                      426-4791. The Safe Drinking Water
                      Hotline is open Monday through Friday,
                      excluding Federal holidays, from 9 a.m.
                      to 5:30 p.m. Eastern Time. For technical
                      inquiries, contact the Office of Ground
                      Water and Drinking Water (MC 4607),
                      U.S. Environmental Protection Agency,
                      1200 Pennsylvania Ave.,  N.W.
                      Washington, DC 20460; telephone (202)
                      260-3309.                         :
                      SUPPLEMENTARY INFORMATION:

                      Regulated Entities
                        Entities potentially regulated by the
                      Ground Water Rule are public water
                      systems using ground water. Regulated  •
                      categories and entities  include:
Category
Industry 	 	 .. ..
State, Local, Tribal, or
Federal Govern-
ments.
Examples of regu-
lated entities
Public ground water
systems.
Public ground water
systems.
                        This table is not intended to be
                      exhaustive, but rather provides a guide
                      for readers regarding entities likely to be
                      regulated by this action. This table lists
                      the types of entities that EPA is now
                      aware could potentially be regulated by
                      this action. Other types of entities not
                      listed in this table could also be
                      regulated. To determine whether your
                      facility is regulated by this action, you
                      should carefully examine the
                      applicability criteria in § 141.400(b) of
                      this proposed rule. If you have
questions regarding the applicability of
this action to a particular entity, consult
the person listed in the preceding
section entitled FOR FURTHER
INFORMATION CONTACT.

Abbreviations Used in This Notice
AWWA: American Water Works Association
ASDWA: Association of State Drinking Water
  Administrators
AWWARF: American Water Works
  Association Research Foundation
BMP: Best Management Practice
CDC: Centers for Disease Control and
  Prevention
CT: The residual concentration of
  disinfectant multiplied by the contact time
CWS: community water system
CWSS: Community Water System Survey
DBF: disinfection byproducts
ELR: Environmental Law Reporter
EPA: Environmental Protection Agency
FR: Federal Register
GAO: Government Accounting Office
GWR: Ground Water Rule
GWS: ground water system
HAAS: Haloacetic acids consisting of the sum
  of mono-, di-, and trichloroacetic acids,
  and mono-and dibromoacetic acids
HAV: Hepatitis A Virus              : '
ICR: Information Collection Rule
IESWTR: Interim Enhanced Surface Water
  Treatment Rule
IT: UV irradiance multiplied by the contact  :
  time
m: meter
ml: milliliters        .   ..  • •
MCL: maximum contaminant level
MCLG: maximum contaminant level goal
mg/L: milligrams per liter
MPN: most probable number
MWCO: molecular weight cut-off
NCWS: non-community water system
NTNCWS: non-transient non-community
  water system
PCR: polymerase chain reaction
PWS: public water system
RO: reverse osmosis
RT-PCR: reverse-transcriptase, polymerase
  chain reaction
SBREFA: Small Business Regulatory
  Enforcement Fairness Act
SDWA: Safe Drinking Water Act
SDWIS: Safe Drinking Water Information
  System
Stage 1 DBPR: Stage 1 Disinfectants/
  Disinfection Byproducts Rule
Stage 2 DBPR: Stage 2 Disinfectants/
  Disinfection Byproducts Rule
SWAPP: Source Water Assessment and
  Protection Program
SWTR:  Surface Water Treatment Rule
TCR: Total Coliform Rule
TNCWS: transient non-community water
  system
TTHM: total trihalomethanes
UIC: Underground Injection Control
USGS: United States Geological Survey
US EPA: United States Environmental
  Protection Agency
UV: ultraviolet radiation
WHP: Wellhead Protection

Table of Contents
I. Introduction and Background
A. Statutory Authority

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                                                                         30195
B. Existing Regulations
  l.TolalColiformRule
  2, Surface Water Treatment Rule and
    Interim Enhanced Surface Water
    Treatment Rule
  3, Information Collection Rule
  4. Stage 1 Disinfectants/Disinfection
    Byproducts Rule
  5. Underground Injection Control Program
  6, Source Water Assessment and Protection
    Program (SWAPP) and the Wellhead
    Protection (WHP) Program
C. Industry Profile—Baseline Information
  1, Definitions and Data Sources
  2. Alternate Definition of "Public Water
    System" and the Problem of Short-term
    Water Providers
  3, Number and Size of Ground Water
    Systems
  4. Location of Ground Water Systems
  S. Ownership of Ground Water Systems
D, Effectiveness of Various Best Management
    Practices in Ground Water Systems
  1. EPA Report on State Ground Water
    Management Practices
  2, ASDWA Analysis of BMPs  for
    Community Ground Water Systems
  3, EPA Report on Ground Water
    Disinfection and Protective Practices
E, Outreach Activities
  1. Public Meetings
  2, Review and Comment of Preliminary
    Draft GWR Preamble
It, Public Health Risk
A. Introduction
B, Wdtotborne Disease Outbreak Data
C. Ground Water Occurrence Studies
  1. Abbusisadegan et al. (1999)  (AWWARF
    Study)
  2. Lieberman et al. (1994,1999) (EPA/
    AWWARF Study)
  3. Missouri Ozark Aquifer Study #1
  4. Missouri Ozark Aquifer Study #2
  S. Missouri Alluvial Aquifer Study
  0. Wisconsin Migrant Worker Camp Study
  7. EPA Vulnerability Study
  8, US-Mexico Border Study
  9, Whittier, California, Coliphage Study
  10, Othu, Hawaii Study
  11. New England Study
  12, California Study
  13. Three State PWS Study (Wisconsin,
    Maryland and Minnesota)
D, Health Effects of Waterborne Viral and
    Bacterial Pathogens
E, Risk Estimate
  1. Baseline Risk Characterization
  2. Summary of Basic Assumptions
  3. Population Served by Untreated Ground
    Water Systems
  4. Pathogens Modeled
  S. Microbial Occurrence and
    Concentrations
  6. Exposure to Potentially Contaminated
    Ground Water
  7. Pathogenicily
  8. Potential Illnesses
  10, Request for Comments
F. Conclusion
HI, Discussion of Proposed GWR
Requirements
A. Sanitary Surveys
  1. Overview ana Purpose
  2. General Accounting Office  Sanitary
    Survey Investigation
  3. ASDWA/EPA Guidance on Sanitary
    Surveys
  4. Other Studies
  5. Proposed Requirements
  6. Reporting and Record Keeping
    Requirements
  7. Request for Comments
B. Hydrogeologic Sensitivity Assessment
  1. Overview and Purpose
  2. Hydrogeologic Sensitivity
  3. Hydrogeologic Barrier
  4. Alternative Approaches to
    Hydrogeologic Sensitivity Assessment
  5. Proposed Requirements
  6. Request for Comments
C. Cross Connection Control
D. Source Water Monitoring
  1. Overview and Purpose
  2. Indicators of Fecal Contamination
  3. Proposed Requirements
  4. Analytical Methods
  5. Request for Comments
E. Treatment Techniques for Systems with
    Fecally Contaminated Source Water or
    Uncorrected Significant Deficiencies
  1. Overview and Purpose
  2. Proposed Requirements
  3. Public Notification
  4. Request for Comments
IV. Implementation

V. Economic Analysis (Health Risk
Reduction and Cost Analysis)
A. Overview
B. Quantifiable and Non-Quantifiable Costs
  1. Total Annual Costs
  2. System Costs
  3. State costs
  4. Non-Quantifiable Costs
C. Quantifiable and Non-Quantifiable Health
    and Non-Health Related Benefits
  1. Quantifiable Health Benefits
  2. Non-quantifiable Health and Non-Health
    Related Benefits
D. Incremental Costs  and Benefits
E. Impacts on Households
F. Cost Savings from  Simultaneous
    Reduction of Co-Occurring Contaminants
G. Risk Increases From Other Contaminants
H. Other Factors: Uncertainty in Risk,
    Benefits, and Cost Estimates
I. Benefit Cost Determination
J. Request for Comment
  1. NTNC and TNC  Flow Estimates
  2. Mixed Systems
VI. Other Requirements
A. Regulatory Flexibility Act (RFA)
  1. Background
  2. Use of Alternative Definition
  3. Initial Regulatory Flexibility Analysis
  4. Small Entity Outreach and Small
    Business Advocacy Review Panel
B. Paperwork Reduction Act
C. Unfunded Mandates Reform Act
  1. Summary of UMRA Requirements
  2. Written Statement for Rules With
    Federal Mandates of $100 Million or
    More
  3. Impacts on Small Governments
D. National Technology Transfer and
    Advancement Act
  1. Microbial Monitoring Methods
  E. Executive Order 12866: Regulatory
    Planning and Review
  F. Executive Order 12898: Environmental
    Justice
  G. Executive Order 13045: Protection of
    Children from Environmental Health
    Risks and Safety Risks
  1. Risk of Viral Illness to Children and
    Pregnant Women
  2. Full Analysis of the Microbial Risk
    Assessment
H. Consultations with the Science Advisory
    Board, National Drinking Water Avisory
    Council, and the Secretary of Health and
    Human Services
I. Executive Orders on Federalism
J. Executive Order 13084: Consultation and
    Coordination With Indian Tribal
    Governments
K. Plain Language
VII. Public Comment Procedures
A. Deadlines for Comment
B. Where to Send Comment
C. Guidelines for Commenting
VIII. References

I. Introduction and Background
  The purpose of this section is to
provide background on existing
regulations that affect ground water
systems and current state practices.

A. Statutory Authority
  This section discusses the Safe
Drinking Water Act (SDWA)
requirements which EPA must meet in
developing the Ground Water Rule
(GWR).
  EPA has the responsibility to develop
a GWR which not only specifies the
appropriate use of disinfection but, just
as important, addresses other
components of ground water systems to
ensure public health protection. Section
1412(b)(8) states that EPA develop
regulations specifying the use of
disinfectants for ground water systems
"as necessary." Under these provisions,
EPA has the  responsibility to develop a
ground water rule which specifies the
appropriate use of disinfection, and,  in
addition, addresses other components of
ground water systems to ensure public
health protection.

B. Existing Regulations
  This section briefly describes the
existing regulations that apply to ground
water systems. These rules are the
baseline for developing the GWR. The
regulations that will be discussed
include the Total Coliform Rule
(TCRKUS EPA, 1989a), Surface Water
Treatment Rule (SWTR)(US EPA,
1989b), Interim Enhanced Surface Water
Treatment Rule (IESWTR)(US EPA
1998d), Information Collection Rule
(ICRKUS EPA, 1996b), Stage 1
Disinfectant/Disinfection Byproducts
Rule  (Stage 1 DBPR)(US EPA, 1998e),
Underground Injection Control Program
(US EPA, 1999g) and the  Source Water
Assessment and Protection Program/
Wellhead Protection Program.

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1. Total Coliform Rule
  The Total Coliform Rule (TCR),
promulgated on June 29,1989 (54 FR
27544)(US EPA,1989a) covers all public
water systems. The rule protects public
water supplies from disease-causing
organisms (pathogens), and it is the
most important regulation applicable to
drinking water from ground water
systems.
  Total coliforms are a group of closely
related bacteria that are generally free-
living in the environment, but are also
normally present in water contaminated
with human and animal feces. They
generally do not cause disease (there are
some exceptions). Specifically,
coliforms are used as a screen for fecal
contamination, as well as to determine
the efficiency of treatment and the
integrity of the water distribution
system. The presence of total coliforms
in drinking water indicates that the
system is either fecally contaminated or
vulnerable to fecal contamination.
  The TCR requires systems to monitor
their distribution system for total
coliforms at a frequency that depends
upon the number of people served and
whether the system is a community
water system (CWS) 'or non-community
water system (NCWS). The monitoring
frequency ranges from 480 samples per
month for the largest systems to once
annually for some of the smallest
systems. If a system has a total coliform-
positive sample, it must (1) test that
sample for the presence of fecal coliform
or E. coli, (2) collect three repeat
samples (four, if the system collects one
routine sample or fewer per month)
within 24 hours and analyze them for
total coliforms (and then fecal coliform
or E. coli, if positive), and (3) collect at
least five routine samples in the next
month of sampling regardless of system
size.
  Under the TCR, a system that collects
40 or more  samples per month
(generally systems that serve more than '
33,000 people) violates the maximum
contaminant level (MCL) for total
coliforms if more than 5.0% of the
samples (routine + repeat) it collects per
month are total coliform-positive. A
system that collects fewer than 40
samples per month violates the MCL if
two samples (routine or repeat samples)
during the month are total coliform-
positive. For any size system, if two
consecutive total coliform-positive
samples occur at a site during a month,
and one is also fecal coliform/£  coli-
positive, the system has an acute
violation of the MCL, and must provide
public notification immediately. The
presence of fecal coliforms or E.  coli
indicates that recent fecal,
                      contamination is present in the drinking
                      water.
                        The TCR also requires a sanitary
                      survey every five years (ten years for a
                      protected, disinfected, ground water
                      system) for every system that takes
                      fewer than five samples per month (the
                      monitoring frequency for systems
                      serving 4,100 people or fewer, which is
                      approximately 97%  of GWS). Other
                      provisions of the TCR include criteria
                      for invalidating a positive or negative
                      sample and a sample siting plan to
                      ensure that all parts  of the distribution
                      system are monitored over time.
                      2. Surface Water Treatment Rule and :
                      Interim Enhanced Surface Water
                      Treatment Rule
                        The Surface Water Treatment Rule,
                      promulgated in June 29, 1989 (54 FR
                      27486)(40 CFR Part 141, Subpart H)(US
                      EPA 1989b), covers all systems that use
                      surface water or ground water under the
                      direct influence of surface water. It is
                      intended to protect against exposure to
                      Giardia lamblia, viruses, and Legionella,
                      as well as many other pathogens. The
                      rule requires all such systems to reduce
                      the level of Giardia by 99.9% (3-log
                      reduction) and viruses by 99.99% (4-log
                      reduction). Under this rule, all surface ,
                      water systems  must disinfect. The vast
                      majority must also filter, unless they
                      meet certain EPA-specified filter
                      avoidance criteria that define high
                      source water quality. More specifically,
                      the SWTR requires: (1) A 0.2 mg/L
                      disinfectant residual entering the
                      distribution system,  (2)  maintenance of
                      a detectable disinfectant residual in all
                      parts of the distribution system; (3)
                      compliance with a combined filter
                      effluent performance standard for
                      turbidity (i.e., for rapid granular filters,
                      5 nephelometric turbidity units (NTU)
                      maximum; 0.5 NTU  maximum for 95%
                      of measurements (taken every 4 hours)
                      during a month); and 4) watershed
                      protection and other requirements for
                      unfiltered systems. The SWTR set a
                      maximum contaminant level  goal
                      (MCLG) of zero for Giardia, viruses, and
                      Legionella. The MCLG is a non-
                      enforceable level based  only on health
                      effects.
                        On December 16,1998, EPA
                      promulgated the Interim Enhanced
                      Surface Water Treatment Rule (IESWTR)
                      (63 FR 69478)(US EPA,  1998d). The
                      IESWTR covers all systems that use
                      surface water, or ground water under
                      the direct influence of surface water,
                      that serve 10,000 people or greater. Key
                      provisions include: a 2-log
                      Cryptosporidium removal requirement
                      for filtered systems; strengthened
                      combined filter effluent turbidity
                      performance standards (1 NTU
maximum; 0.3 NTU maximum for 95%
of measurements during a month);
individual filter turbidity provisions;
disinfection benchmark provisions to
ensure continued levels of microbial
protection while facilities take the
necessary steps to comply with new
disinfection byproduct (DBF) standards;
inclusion of Cryptosporidium in the
definition of ground water under the
direct influence of surface water and in
the watershed control requirements for
unfiltered public water systems;
requirements for covers on new finished
water reservoirs; sanitary surveys for all
surface water systems regardless of size;
and an MCLG of zero for
Cryptosporidium. In a parallel
rulemaking, EPA has proposed a
companion microbial regulation for
surface water systems serving less than
10,000 people, the Long Term 1
Enhanced Surface Water Treatment
Rule.

3. Information Collection Rule
  The Information Collection Rule,
promulgated on May 14, 1996 (61 FR
24368)(40 CFR part 141, Subpart M)(US
EPA, 1996b),  is a monitoring and data
reporting rule. The data and information
provided by this rule will support
development of the Stage 2 Disinfection
Byproducts Rule and a related microbial
rule, the Long Term 2 Enhanced SWTR,
scheduled for promulgation in May
2002.
  The ICR applied to large water
systems serving at least 100,000 people,
and ground water systems serving at
least 50,000 people. About 300 systems
operating 500 treatment plants were
involved. The ICR required systems to
collect source water samples, and in
some cases finished water samples,
monthly for 18 months, and test them
for Giardia, Cryptosporidium, viruses,
total coliforms, and either fecal
coliforms or E. coli. The ICR also
required systems to determine the
concentrations of a range of disinfectant
and disinfection byproducts in different
parts of the system. These disinfection
byproducts form when disinfectants
used for pathogen control react with
naturally occurring total organic
compounds (TOG) already present in
source  water. Some of these byproducts
are toxic or carcinogenic. The rule also
required systems to provide specified
operating and engineering data to EPA.
The required 18 months of monitoring
under the ICR ended in December 1998.
  As noted earlier, the only ground
water systems affected by the ICR were
those that served at least 50,000 people.
These systems had to conduct treatment
study applicability monitoring (by
measuring TOC levels) and, in some

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cases, studies to assess the effectiveness
of granular activated carbon or
membranes to remove DBF precursors.
In addition, ground water systems
serving at least 100,000 people had to
obtain disinfectant and DBF occurrence
and treatment data. EPA is still
processing the ICR data, and has not
used this information in developing the
GWR.
4. Stage 1 Disinfectants/Disinfection
Byproducts Rule
  The Stage 1 Disinfectants/Disinfection
Byproducts Rule (Stage 1 DBPR) (63 FR
69389; December 16,1998) (US EPA,
1998e) sets maximum residual
disinfection level limits for chlorine,
chloramines, and chlorine dioxide, and
MCLs for chlorite, bromate, and two
groups of disinfection byproducts: total
trihalomethanes (TTHMs) and
haloacetic acids (HAAS). TTHMs
consist of die sum of chloroform,
bromodichloromethane,
dibromochloromethane, and
bromoform. HAAS consist of the sum of
mono-, di-, and trichloroacetic acids,
and mono- and dibromoacetic acids.
The rule requires water systems that use
surface water or ground water to remove
specified percentages of organic
materials, measured as total organic
carbon (TOC), that may react with
disinfectants to form DBFs. Under the
rule, precursor removal will be achieved
through a treatment technique
(enhanced coagulation or enhanced
softening) unless a system meets
alternative criteria.
  The Stage 1 DBPR applies to all CWSs
and non-transient NCWSs, both surface
water systems and ground water
systems, that treat their water with a
chemical disinfectant for either primary
or residual treatment. In addition,
certain requirements for chlorine
dioxide apply to transient water
systems.
  A ground water system that  disinfects
with chlorine or other chemical
disinfectant must comply with the Stage
1 DBPR by December 2003. Sampling
frequency will depend upon the number
of people served. Ground water systems
not under the direct influence of surface
water that serve 10,000 people or greater
must take one sample per quarter per
treatment plant, and analyze for TTHMs
and HAAS; systems that serve fewer
than 10,000 people must take one
sample per year per treatment plant
during the month of warmest water
temperature, and analyze for the same
chemicals. Systems must monitor for
chlorine or chloramines at the same
location and time that they monitor for
total coliforms. Additional monitoring
for other chemicals is required for
systems that use ozone or chlorine
dioxide.
  5. Underground Injection Control
Program
  In 1980, EPA established an
Underground Injection Control (UIC)
Program (US EPA, 1999g) to prevent
injection practices which contaminate
sources of drinking water. The UIC
Program protects both underground
sources of drinking water and ground
water under the direct influence of
surface water, which includes at least 41
percent of the streams and rivers in the
U.S. during dry periods. Injection is a
common and long-standing method of
placing fluids underground for disposal,
storage, replenishment of ground water,
enhanced recovery of oil and gas, and
mineral recovery. These fluids often
contain contaminants. The EPA sets
minimum requirements for effective
State programs to ensure that injection
practices, or "injection wells" as they
are called in the UIC Program, are
operated safely. EPA or the appropriate
State regulatory agency may impose on
any injection well, requirements for
siting, construction, corrective action,
operation, maintenance, monitoring,
reporting, plugging and abandonment,
and impose penalties on violators. The
UIC Program regulations are designed to
recognize varying geologic, hydrologic
or historic conditions among different
States or areas within a State.
  The UIC Program regulations are
found under Title 40 of the Code of
Federal Regulations  (CFR), Parts 124,
and 144-148. Section 144.6 divides
injection practices into five categories or
classes of wells. Classes I, II, and in  are
wells  which inject fluids beneath and
away  from aquifers used by ground
water systems into confined geologic
formations. These wells are associated
with municipal or industrial waste
disposal, hazardous  waste or radioactive
waste sites, oil and gas production, and
extraction of minerals. Class IV and
most of Class V are wells which inject
contaminants, into or above aquifers
which may be used by ground water
systems. Class IV wells inject hazardous
or highly radioactive wastes and are
banned by all States and EPA. Class V
wells  include storm  water and
agricultural drainage wells, dry wells,
floor drains and similar types of shallow
disposal systems which discharge
directly or indirectly to ground water,
but in any case, must not endanger the
ground water resources. However, Class
V wells which may pose the greatest
potential threat to ground water systems
include poorly-designed or
malfunctioning large-capacity septic
tanks, leach fields and cesspools
associated with solely sanitary
wastewater disposal. Malfunctioning
septic systems can result in the release
of disease-causing microorganisms
including enteric viral and bacterial
pathogens to surface and ground water.
Multi-family, commercial,
manufacturing, recreational, and
municipal facilities, particularly those
located in unsewered areas sometimes
dispose both sanitary waste and process
wastewater containing harmful
chemicals in Class V wells. This
combination can increase the risk of
contamination to aquifers used by
ground water systems. Approximately
half of the States have adopted primary
enforcement authority for the regulation
in whole or part and, therefore, have
primary enforcement responsibility
(primacy). State enforcement activities
range from notices of improper activities
to penalties and well closures. For those
States which do not have primacy, the
EPA Regional Offices perform the
enforcement duties. (Note: the UIC
Program does not regulate individual or
single family residential septic systems
and cesspools which inject solely
sanitary wastewater) (40 CFR
144.1(g)(l)(2)). EPA has finalized
banning large capacity cesspools in
ground water source water protection
areas (64 FR 234, December 7,
1999)(USEPA, 1999g).
6. Source Water Assessment and
Protection Program (SWAPP) and the
Wellhead Protection (WHP) Program
  The Wellhead Protection Program
(WHP Program) in SDWA section 1428
requires every State to develop a
program that protects ground water
sources of public drinking water. The
intended result of the WHP Program are
local pollution prevention programs that
reduce or eliminate the threats of
contamination to ground water sources
of drinking water. To do this, States
delineate wellhead protection areas
(WHPA) in which sources of
contamination are managed to minimize
ground water contamination. WHPA
boundaries are determined based on
factors such as well pumping rates,
time-of-travel of ground water flowing
to the well, aquifer boundaries, and
degree  of aquifer protection by the
overlying geology. These hydrogeologic
characteristics have a direct effect on
the likelihood and extent of
contamination. Currently, 48 States and
two territories have a WHP Program in
place.
  A new Source Water Assessment and
Protection Program (SWAPP) was
incorporated into SDWA section 1453
and requires each State to establish a
SWAPP that describes how the State
will: (l) Delineate source water

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protection areas; '(2) inventory
significant contaminants in these areas;
and (3) determine the susceptibility of
each public water supply to
contamination. This program builds
upon the WHP Program; however, it
addresses both ground water and
surface water sources of public drinking
water. The States' SWAPP were
approved by EPA by November,  1999.
Under the SWAPP, the State must
complete source water assessments for
all PWSs by November 6, 2Q01,
although EPA may grant an extension to
May 6, 2003. A summary of the results
of the source water assessments must
then be made available to the public in
CWSs' Consumer Confidence Reports.
The 1996 Amendments to the SDWA do
not require States to protect water
sources after the assessments are
completed.
  EPA seeks, in today's proposed GWR,
to incorporate the States' SWAPP and
WHP Programs into an overall Agency
program for protecting ground water
sources of public drinking water by
encouraging States to use information
gathered through these programs in site-
specific sanitary surveys and
hydrogeologic sensitivity assessments
where appropriate.

C. Industry Profile—Baseline
Information

1. Definitions and Data Sources
  Outlined in the following section are
data sources relied upon by the Agency
to develop baseline information  for the
GWR. The baseline information  is
important to understanding how various
regulatory options might affect risk
reduction and the cost to small public
water systems. The information  shows
that there is a large number of systems
which solely utilize ground water, over
156,000. In addition, most of the ground
water systems are small, with 97%
serving 3,300 or fewer people. However,
55% of the people served by ground
water sources get their drinking  water
from systems which serve 10,000 or
more persons (one percent of the
systems).
  A public water system (PWS)  is one
that serves 25 or more people or has 15
or more service connections and
operates at least 60 days per year. The
following discussion of PWSs is based
on the current definition of PWS (i.e.,
operating at least 60 days a year). A
PWS can be publicly owned or privately
owned. EPA classifies PWSs as
community water systems (CWSs) or
non-community water systems
(NCWSs). CWSs are those that serve at
least 15 service connections used by
year-round residents or regularly serves
                      at least 25 year-round residents. NCWSs
                      do not have year-round residents, but
                      serve at least 15 service connections
                      used by travelers or intermittent users
                      for at least 60 days each year, or serving
                      an average of 25 individuals for at least
                      60 days a year. NCWSs are further
                      classified as either transient or non-
                      transient. A non-transient non-
                      community water system (NTNCWS)
                      serves at least 25 of the same persons
                      over six months per year (e.g., factories
                      and schools with their own water
                      source). Transient non-community'
                      water systems (TNCWS) do not serve at
                      least 25 of the same persons over six
                      months per year (e.g., many restaurants,
                      rest stops, parks). The majority of
                      ground water systems are NCWSs, with
                      60% (93,618) transient and 12%
                      (19,322) non-transient; CWSs make up
                      the remaining 28% (44,910) of all
                      ground water systems. Although there
                      are far more NCWSs, CWSs serve a far
                      larger number of people.
                        Over 88 million people are served by
                      CWSs that use ground water and 20
                      million people are served by NCWSs
                      that use ground water. An overlap
                      occurs because most people are served
                      by both types of systems which may
                      also include a combination of ground
                      and surface water. For example, a     ;
                      person may be served by a surface water
                      community water system (CWS) at
                      home and by a ground water non-
                      community water system (NCWS) at
                      work.
                        EPA uses two primary sources of
                      information to characterize the universe
                      of ground water systems: the Safe
                      Drinking Water Information System
                      (SDWIS) and the Community Water
                      System Survey (CWSS) (US EPA,
                      1997c). EPA's SDWIS contains data on
                      all PWSs as reported by States and EPA
                      Regions. This data reflects both
                      mandatory and optional reporting
                      components^ States must report the
                      location of, the system, system type
                      (CWS, TNCWS, or NTNCWS), primary
                      raw water source (ground water, surface
                      water or ground water under the direct
                      influence of surface water), and
                      violations. States may also report, at
                      their option, type of treatment and
                      ownership type. EPA does not have
                      complete data on the discretionary
                      items (such as treatment) in SDWIS for'
                      every system; this is especially common
                      for NCWSs.               - -    '
                        The second source of information,   ;
                      CWSS, is a detailed survey of surface
                      and ground water CWSs conducted by
                      EPA in 1995 (US EPA, 1997c). The
                      CWSS includes information such as the
                      number of system operators,, revenues,
                      expenses, treatment practices, source
                      water protection measures, and capacity
(i.e., the amount of water the system is
designed to deliver). The CWSS
contains data from 1,980 water systems,
and is stratified to represent CWSs
across the U.S. Of the 1,980 water
systems that were surveyed by CWSS,
1,020 are ground water systems; 510 are
surface water systems; and 450
represent purchased water systems.
Among the ground water systems
represented, approximately 17% were
from systems serving 100 persons or
less; 20% were from systems serving
101-500 persons; 13% were from
systems serving 501-1,000 persons;
14% were from systems serving 1,001—
3,300 persons; 15% were from systems
serving 3,301-10,000 persons; 10%
•were from systems serving 10,001—
50,000 persons; and 11% were from
systems serving 50,001 or more persons.
  Baseline profile data for ground water
systems from SDWIS and CWSS are
summarized later. The data on system
ownership, treatment,  and operator
information is from the CWSS.
2. Alternate Definition of "Public Water
System" and the Problem of Short-Term
Water Providers
  EPA is not today proposing to change
the definition of "public water supply,"
nor proposing additional requirements
for short-term water providers. If EPA
decides to take either action, EPA will
publish a proposal at a later date.
However, EPA requests comment on the
following issues.
  A PWS is one that serves 25 or more
people or has 15 or more service
connections and operates at least 60
days per year. EPA requests comment
on the definition of "public water
system" specifically, shortening the
time period within the regulatory
definition (§ 141.2). Section 140l(4)(A)
of the SDWA defines public water
system as one that "regularly serves at
least twenty-five individuals." EPA by
regulation defined the minimum time
period that a system "regularly" serves
as 60 days. See 40 FR 59566, December
24, 1975 for a discussion of the
definition. The current definition
applies after a minimum of 1,500
consumer servings (60 days multiplied
by 25 individuals). However, some
drinking water providers serve far more
people during just a few events. For
example, out-door public events may
occur at a site just a few days a year but
may draw thousands of people to each
event. Such drinking water providers
thus can affect the public health of a
similar number of persons in a short
period of time as a system that serves
fewer people for a longer period. EPA
•wants to provide the same public health
protection in these situations. Only

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                 Federal  Register/Vol. 65, No. 91/Wednesday, May 10, 2000/Proposed Rules
                                                                    30199
contaminants that cause adverse health
effects through small volumes or short
exposure (e.g., acute contaminants such
as microbes, nitrate and nitrite) are of
concern at these short term events.
Therefore, EPA is considering changing
the definition of "public water system"
by reducing the 60 day time frame to 30
days and including events drawing
many people on one or just a few days,
specifically by adding the phrase, "or
serves at least 750 people  for one or
more days" to the end of the current
definition of "public water system." In
other words, for short-term providers,
the term "regularly serves" would be
defined in terms of the number of
persons served rather than days of
service, but the minimum number of
persons served would be equivalent to
the number of servings for longer-term
systems. EPA requests comment on this
issue. Rather than the simple total of
750 (30 days times 25 people), should
EPA include a minimum of persons
served days (calculated by multiplying
the average number of individuals
served by the number of days the system
serves water)? What should that number
be? Should there be a sliding scale (e.g.,
for a system operating one day and
serving more than 10,000 consumers,
and systems operating more  than 30
days and serving 2,000 consumers)?
EPA requests comments on defining/
identifying systems, implementation,
public notice, training, monitoring and
record keeping and reporting issues for
these systems if they were included.
  As an alternate to changing the
definition EPA is also considering and
requesting comments on requiring
under section 1431 of the SDWA or
other appropriate authorities that
transient water providers or other types
of drinking water systems  (including
those not currently defined as public
water systems) monitor for acute
contaminants prior to providing water
to the public and requiring that any
such provider that finds acute
contaminants at a level above the MCL
not be allowed to serve drinking water
until it is corrected. Currently, transient
public water systems must currently
monitor for total coliforms, nitrate and
nitrite. In addition, transient public
water systems using surface water or
ground water under the direct influence
of surface water must comply with the
treatment technique requirements of the
SWTR. EPA is also considering
proposing requiring any non-
community water system that is not
operated year round monitor for: fecal
coliforms, nitrate and nitrate, and that
monitoring required fo show treatment
technique compliance (e.g.,
Cryptosporidium) no more than 30 days
prior to beginning operation for that
season. EPA requests comment on what
time frame the monitoring should be
completed prior to beginning operation
(i.e., 10 or 15 days).

3. Number and Size of Ground Water
Systems
  Nationally, SDWIS indicates that
there are approximately!57,000 public
water systems that use ground water
solely (SDWIS, 1997). Slightly more
than 13,000 additional systems use
surface water. SDWIS only describes
any system that uses any amount of
surface water as a surface water system.
SDWIS therefore, does not have
information on the number of systems
that mix ground water and surface
water. Under the SDWA and for
purposes of the Regulatory Flexibility
Act (RFA) analysis, EPA defines a small
system as serving fewer than 10,000
people. According to SDWIS (1997),
96.6% of the 42,413 CWSs and virtually
all of the NCWSs that use ground water
serve fewer than 10,000 persons and
thus are "small." Collectively, 99% of
systems serve fewer than 10,000 people.
About 97% of the systems (152,555)
serve 3,300 people or fewer (totaling
over 31 million people nationally). The
purpose of these requirements would be
to prevent any endangerment to public
health that might occur if these short-
term, high volume providers dispense
drinking water that is untested and
potentially contaminated.

4. Location of Ground Water Systems
   Ground water systems are located in
all 50 States, many tribal lands and most
United States territories. The number of
ground water systems varies
substantially by State. The largest
numbers of ground water systems are in
the States of Wisconsin, Michigan,
Pennsylvania, New York and
Minnesota. These five States, each with
over 8,000 ground water systems,
account for over 50,698 ground water
systems—one third of the total number
in the U.S. By contrast, Hawaii (126),
Kentucky (287), Rhode Island (430), and
the United States territories (<254) have
the fewest ground water systems  (See
Table 1-1).

5. Ownership of Ground Water Systems
  For ground water CWSs, 36% are
publicly operated, 35%  are owned and
operated by private entities whose
primary business is providing drinking
water, and 29% are ancillary water
systems which are operated by entities
whose primary business is not
providing drinking water, but do so to
support their primary business (e.g.,
mobile home park operators). The
distribution of ownership type,
however, varies significantly with the
size of the system. For example, over
90% of the ground water systems
serving less than 100 people are
privately owned or are ancillary
systems. For systems serving over
100,000 people, only 16% are privately
owned and none are ancillary systems.
     TABLE i-1.—NUMBER OF GROUND WATER SYSTEMS AND POPULATIONS SERVED BY STATE AND SYSTEM TYPE
State/territory
Alabama 	 	 	 	
Alaska 	 	 	 	 	
American Samoa 	 	 	
Arizona ,..,.,... 	 	 	
Arkansas 	 , 	 	
California 	 	 	 	 	 	
Colorado .,., 	
Commonwealth of the Northern Marianas
Connecticut 	 	
Delaware „.....„. 	 , 	 	 	
DisWet of Columbia 	
Florida 	 	 	 	 	 	 	 	
Georgia 	 	 	 	 	 	 	 	
Guam 	 	 	 	 	 	 	 	
CWSs
Number of
systems
345
511
10
783
480
2,831
548
30
537
225
0
2,019
1,465
6
Population
served
1,283,469
342,722
48,692
1,308,843
1,003,145
14,223,977
927,917
50,769
311,771
173,460
0
13,132,468
1,484,860
20.220
TNCWSs
Number of
systems
123
906
0
602
442
3,698
1,061
7
3,360
215
0
3,660
663
0
Population
served
11,170
97,647
120,126
22,521
1,301,671
153,454
620
2,98b,i'81
57,634
0
304,865
127,661
0
NTNCWSs
Number of
systems
46
0
0
216
57
1,018
133
6
641
86
0
1,119
291
2
Population
served
21,182
io,
100,317
13,528
359,096
34,884
3,039
121,664
24,840
,0
286 055
80,240
770

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Federal Register/Vol. 65,  No. 91/Wednesday, May  10,  2000/Proposed  Rules
     TABLE 1-1.—NUMBER OF GROUND WATER SYSTEMS AND POPULATIONS SERVED BY STATE AND SYSTEM TYPE—
                                                      Continued
              State/territory
                                                   CWSs
                                           Number of
                                           systems
                                      Population
                                        served
                                                                            TNCWSs
           Number of
            systems
        Population
          served
                                                                                                     NTNCWSs
           Number of
            systems
        Population
          served
Hawaii  	
Idaho 	
Illinois 	
Indiana	
Iowa	
Kansas 	
Kentucky  	....
Louisiana	
Maryland  	
Massachusetts 	
Michigan 	
Minnesota	
Mississippi 	
Missouri	
Montana 	
Nebraska	
Nevada 	
New Hampshire ....
New Jersey 	
New Mexico 	
New York 	
North Carolina	
North Dakota	
Ohio	
Oklahoma	
Oregon	
Pennsylvania	
Puerto Rico 	
Rhode Island 	
South Carolina 	
South Dakota 	
Tennessee 	
Texas 	
Tribes 	
Utah	
U.S. Virgin Islands
Vermont	
Virginia 	
Washington 	
West Virginia	
Wisconsin	
                                109
                                658
                              1,255
                                806
                              1,033
                                601
                                124
                              1,211
                                448
                                360
                              1,185
                                919
                              1,253
                              1,194
                                554
                                616
                                250
                                621
                                516
                                600
                              1,940
                              1,900
                                258
                              1,129
                                556
                                677
                              1,788
                                207
                                 59
                                550
                                367
                                193
                              3,613
                                685
                                335
                                  0
                                346
                              1,199
                              2,092
                                297
                              1,117
1,247,315
 579,778
2,606,104
1,826,820
1,239,902
 747,169
 271,630
2,707,805
 519,289
1,396,430
1,602,792
2,074,843
2,586,680
1,638,152
 267,597
 811,112
 187,509
 262,371
2,339,500
1,235,920
4,396,557
1,271,804
 239,874
3,555,876
 671,287
 622,157
1,567,696
 623,958
 127,854
 671,878
 250,742
1,312,996
6,150,001
 330,466
 583,506
       0
 154,521
 584,779
2,299,340
 304,888
1,947,016
   3
1,033
3.71S
2,984
 639
 11'0
   8|3
 482
2,509
 86|3
8,930
6,963
 169
1,040
1,011
 584
 27|3
1,012
2,955
 50|6
5,742
5,373
 215
3,545
 302
1,390
7,017
   '4
 30'0
 57,7
 243
 50'3
1,378
   0
 439
   >0
 718
1,911
1.49J8
 644
9,704
   1,125
 125,873
 413,000
 327,229
  78,653
   4,481
   9,374
 115,804
  93,757
 209,476
1,187,331
 252,602
  28,006
 138,894
 140,745
  22,241
  55,792
 181,949
 346,484
  74,256
 853,533
 542,400
  16,910
 533,921
  34,172
 233,477
 922,336
     765
  48,875
  54,837
  42,949
  61,504
 245,171
       0
  79,371
       0
 523,079
 443,920
 283,735
  47,313
 731,781
  14
 265
 446
 693
 133
  67
  80
 234
 495
 229
1,718
 672
 126
 227
 215
 189
  91
 421
1,009
 149
 693
 655
  22
1,116
 123
 332
1,251
  43
  71
 248
  25
  58
 748
  82
  52
   0
   1
 772
 287
 182
1,049
  7,437
 68,195
142,655
158,102
 35,715
 23,602
 21,620
 88,070
142,171
 67,650
344,654
 49,514
 89,416
 76,360
 38,504
 26,219
 28,497
 77,505
274,758
 38,101
248,223
198,136
  2,349
276,441
 20,419
 67,531
480,328
 36,426
 25,246
 71,239
  3,072
 11,010
253,468
 20,833
 20,969
      0
     25
312,422
 70,009
 39,318
214,561
D. Effectiveness of Various Best
Management Practices in Ground Water
Systems

  There are numerous sanitation
practices, called best management
practices (BMPs), to prevent, identify
and correct contamination in a water
supply. These practices relate to well
siting, well construction, distribution
system design and operations. Examples
of BMPs that form a barrier to ground
water contamination include drilling
into a protected aquifer;  siting a well
away from sources of contamination;
identifying and controlling
contamination sources; and
disinfection. BMPs that form a barrier to
well contamination include well casing,
well seals, and grouting the well.
Distribution system BMPs include
disinfection; maintaining positive
                       pressure; flushing water mains; and
                       adopting cross connection control
                       programs. Surveillance BMPs such as
                       sanitary surveys are conducted to
                       identify weaknesses in the barriers.
                         EPA recognizes that BMPs can and do
                       contribute significantly to the safety  of
                       drinking water; however, the          :
                       effectiveness of each individual practice
                       can be difficult to measure. Two studies,
                       State Ground Water Management
                       Practices—Which Practices are Linked
                       to Significantly Lower Rates of Total
                       Coliform Rule Violations? (US EPA,
                       1997d) and the Analysis of Best
                       Management Practices for Community
                       Ground Water Systems (Association  of,
                       State Drinking Water Administrators, or
                       ASDWA, 1998), were conducted to     '.
                       examine the relative effectiveness of
                       BMPs in reducing microbial
                      contamination of ground water systems.
                      The EPA study compared BMP
                      implementation at the State level to
                      total coliform MCL violation rates of
                      community ground water systems over
                      a four year period. The ASDWA study
                      compared BMP implementation to
                      detections of both total and fecal
                      coliform in community ground water
                      systems over a two year period.
                        A third study was conducted by EPA,
                      Ground Water Disinfection and
                      Protective Practices in the United States,
                      (US EPA, 1996a) to review State
                      practices and requirements for the
                      protection of drinking water that has
                      ground water as its source.
                      1. EPA Report on State Ground Water
                      Management Practices
                        In the EPA study, State Ground Water
                      Management Practices—Which

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                                                                      30201
Practices are Linked to Significantly
Lower Rates of Total Coliform Rule
Violations? (US EPA, 1997d), 12 BMPs
were compared to the MCL violation
rate for total coliform in community
water systems by State. The 12 State
BMPs were taken from the EPA report
Ground Water Disinfection and
Protective Practices in the United States
(US EPA, 1996a). The study used total
coliform MCL violation data in SDWIS
for community water systems for Fiscal
Years 1993 through 1996. In the study,
pairwise and stepwise linear regression
analyses were used to determine if there
was a statistically significant difference
in the TCR MCL violation rates between
those States that practice a particular
BMP and those that do not. From this
perspective, BMPs associated with
lower violation rates are considered
effective. The 12 BMPs included in the
study were well construction codes,
well/pump disinfection requirements,
sanitary surveys, disinfection of new/
repaired mains, cross connection
controls, operator certification,
minimum setback distances, EPA
approved State Wellhead Protection
Programs, periodic flushing of mains,
\veHhead monitoring, hydrogeologic
criteria, and disinfection.
  Six of the 12 State management
practices were unsuitable for pairwise
analysis because these practices were
present in nearly all States. Therefore, a
comparison of TCR MCL violation rates
in States with and without these
practices could not be made. The BMPs
for which analysis were not done were:
well construction codes, well/pump
disinfection requirements, sanitary
surveys, disinfection of new/required
mains, cross connection controls, and
operator certification. However, these
six management practices were
evaluated as part of the 1998 Best
Management Practices Survey
conducted by ASDWA,
  Using a pairwise statistical analysis,
two of the remaining six practices,
disinfection and hydrogeologic criteria,
showed a significant statistical
relationship (at a .01 and a .05 level of
confidence, respectively) in lowering
the statewide median TCR violation
rates, with disinfection showing the
strongest relationship. In this analysis,
disinfection is defined as the
maintenance of at least a chlorine
residual or its equivalent at the entry
point or in the distribution system. The
report focused its analysis on
disinfection practices among 20 States,
comparing the 10 highest disinfecting
States \vith the 10 lowest disinfection
States, Specifically, the 10 States with
the highest percentage of disinfected
CWSs had an average MCL violation
rate of 16% over the four year period,
versus a 33% violation rate for the ten
States with the lowest disinfection rates.
States that require hydrogeologic criteria
for well siting and construction
decisions had significantly lower
median MCL violation rates than States
that do not use these criteria (15.4% vs.
24.6%). The other four practices,
minimum setback distances from
pollution sources, EPA approved
Wellhead Protection Programs, periodic
flushing of the distribution system, and
wellhead monitoring, did not show a
significant relationship in  lowering TCR
violation rates at the State  level. The
report does not provide information on
the statistical significance  of these
results.
  The four year time frame for the
statistical analyses was chosen as a
more accurate reflection of the
effectiveness of statewide management
practices given the high degree of
variability in the TCR violation rate
from year to year. Different trends
emerge when annual rates  are
compared. There is not enough data to
determine if the year to year variability,
shown in the FY 96  data, correlates to
a change in State management practices.
  In a second analysis, stepwise linear
regression was used on the six best
management practices to further explain
the variability among States in their
reported TCR MCL violation rates. This
analysis examines both the
simultaneous effect  of several BMPs on
the State TCR MCL violation rate and
evaluates which of the practices may
explain the variability in the TCR
violation rate among States.
Ascertaining how much of the State-to-
State variability can be explained by
each of the practices is an important
question given that the TCR
requirements are the same  for all States.
The results of dais analysis indicate that
disinfection is the single largest factor in
explaining the difference in the TCR
violation rate among States. In general,
the higher the rate of disinfection, the
lower the rate of TCR MCL violations.
  Uncertainties associated with this
analysis were: (1) Whether a State's
BMP requirements are fully
implemented at the system level; (2)
what effect the six State BMPs not
analyzed had on violation  rates; (3) the
degree of voluntary implementation of
BMPs; and (4) the effect of not including
State practices required only under
certain circumstances. Nonetheless,  this
data on State management  practices
indicates that there is a significant
association between disinfection and a
lower TCR MCL violation rate.
2. ASDWA Analysis of BMPs for
Community Ground Water Systems
  In the ASDWA study, The Analysis of
Best Management Practices for
Community Ground Water Systems
(ASDWA, 1998), a working group
selected 28 BMPs that represent four
major areas of plant operations and
developed and distributed a survey to
all 50 State drinking water programs.
Each State was asked to select eight
systems in each of the three following
categories: (1) Systems with no
detections of total coliform; (2) systems
with total coliform detections only; and
(3) systems with both total coliform and
fecal coliform (or E. coll) detections. For
each system, the State was asked to
report which of 28 BMPs listed were
used by the system during a two year
period (1995 and 1996). Thirty-six
States responded to the survey, each
completing up to 24 individual system
surveys, providing data for 812 systems.
  The survey results were analyzed
using both descriptive statistics and two
statistical models—pairwise and
logistical regression. The descriptive
statistics illustrate the characteristics of
a system but cannot isolate the effect of
a particular BMP from the effects of
other BMPs. The statistical  models were
used to describe the relationship
between implementation of individual
or a group of BMPs and a reduction in
total or fecal coliform detections.
  A pairwise association analysis (i.e.,
comparing a system that implements a
particular BMP to one that does not)
was used to determine if the use of a
BMP reduced the percentage of positive
total coliform samples. The analysis
determined that a significant association
was found between 21 of the 28 BMPs
and systems with no total coliform
detections. The two BMPs with the
strongest correlation to fewer total
coliform detections were correction of
deficiencies identified by the sanitary
survey and operator certification
(ASDWA, 1998).
  Using pairwise analysis for systems
with fecal coliform (based only on those
systems with at least one positive total
coliform sample), the study found a
significant association for eight of the
twenty-eight BMPs. These eight BMPs
include: system wells constructed
according to State regulations, routine
disinfection after well or pump repair,
treatment for purposes other than
disinfection, system maintaining
acceptable pressure at all times, water
distribution tanks are designed
according to State requirements,
systems are in compliance with State
permitting requirements, systems have
corrected deficiencies noted by the State

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and system and operators receive
routine training and education.
According to the results,.fewer BMPs
are found to be significant in this
analysis than the total coliform analysis.
These results are expected given that the
analysis of fecal coliform and E. coli
only evaluate systems with at least one
total coliform positive detection. Fecal
coliform and E. coli tests are more
specific to organisms found in human
and animal feces, whereas total coliform
tests indicate the presence of a broader
class of enteric organisms. For this
reason, there are fewer data points to
model the association of BMPs with
fecal coliform. Therefore, this analysis
sets apart only the BMPs significant in
preventing or eliminating fecal
contamination.
  Using the logistical regression
technique, three BMPs were associated
with a significant reduction of total
coliform-positive samples: (1)
Maintaining a disinfectant residual; (2)
operator training; and (3) correcting
deficiencies identified by the State as
part of a sanitary survey. The two BMPs
associated with a significant reduction
of fecal coliform/£. co//-positive
samples  were treatment for purposes
other than disinfection, e.g., iron
removal, and operator training. Another
analysis  was constructed using Logit
models for four categories of BMPs to
consider the effects of BMPs in groups
rather than individually. Out of the four
categories (Source Protection/
Construction, Treatment, Distribution
System, and Management and
Oversight), the Management and
Oversight category showed the most
significant association with reduced
coliform detections.
  The ASDWA survey also evaluated
the effectiveness of BMPs with regard to
system size. For systems serving less
than 500 persons, correction of
deficiencies identified by the State, and
regular training and education of
operators were the most significant in   •
reducing microbial contamination.  '
Routine  disinfection after well or pump
repair had the greatest significance
among systems serving between 501 and
3,300 persons, while maintaining a
disinfection residual had the greatest
significance among systems serving
between 3301 and 10,000 persons.
   Overall, this study found that the
percentage of systems implementing
BMPs is highest among systems with no
total coliform  detections. In addition,
systems  that routinely educate and train
their operators were more likely to
implement other BMPs than systems
with no regular training. Similarly,
those systems that practice disinfection
(contact time or maintain disinfection
                      residual) were more likely to implement
                      other BMPs than systems that do not
                      disinfect. Observations about the
                      implementation of BMPs suggests that
                      many BMPs are interrelated, therefore, 'it
                      is difficult to isolate the effect of an
                      individual BMP.

                      3. EPA Report on Ground Water
                      Disinfection and Protective Practices
                        The purpose of the EPA study,
                      Ground Water Disinfection and       '
                      Protective Practices in the United States,
                      (US EPA, 1996a) was to compile and
                      assess State regulations, guidance,
                      codes, and other materials pertaining to
                      protection of public health from
                      microbial contamination in public water
                      systems using ground water.
                        The information compiled included .
                      the following:
                        • Wellhead/ground water protection
                      information;                         :
                        • Ground water disinfection
                      requirements;
                        • Well siting and construction
                      requirements/guidelines;             ;
                        • Sanitary survey requirements/
                      guidelines;
                        • Distribution system protection
                      requirements/guidelines; and
                        • Operator certification requirements.
                        The study found that there are
                      widespread, but diverse requirements
                      for the protection of drinking water that
                      has ground water as its source. Few of
                      these protective practices are used by all
                      States and there is a variety of
                      interpretations of the same practice. For
                      example, 47 States specify minimum  '
                      setback distances from sources of.
                      microbial contamination but show a
                      wide range of setback distances for the
                      same type of contaminant source; 49   i
                      States drinking water programs require
                      disinfection of some sort, but when and
                      where disinfection is required varies   :
                      considerably;  and of the 48 States that :
                      have well construction codes, 21 States
                      do not require consideration of
                      hydrogeological criteria in the approval
                      of the siting of a well.
                        Overall, the study found that although
                      many States appear to require similar
                      BMPs, the nature, scope, and detail of
                      these requirements varies considerably
                      at the national level.

                      E. Outreach Activities

                      1. Public Meetings                   :
                        As part of the 1986 amendments to
                      the Safe Drinking Water Act (SOWA)
                      Section 1412(b)(8), Congress directed
                      EPA to promulgate a national primary
                      drinking water regulation (NPDWR)   ;
                      requiring disinfection as a treatment
                      technique for all public water systems,
                      including those served by surface water
and ground water. In 1987, EPA began
developing a rule to cover ground water
systems. This effort included a
preliminary public meeting on the
issues in 1990 (see 55 FR 21093, May
22, 1990, US EPA, 1990a). In 1992, EPA
circulated a strawman draft for
comment (see 57 FR 33960, July 31,
1992) (US EPA, 1992a).
  From 1990 to 1997, EPA conducted
technical discussions on a number of
issues, primarily to establish a
reasonable means of establishing
whether a ground water source was
vulnerable to fecal contamination and
thus pathogens. This effort was
accomplished through 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
addition, technical meetings were held
in Irvine, California in July 1996, (US
EPA, 1996c) and in Austin, Texas in
March 1997 (US EPA, 1997e).
  The SDWA was amended in August
1996, and as a result, several statutory
provisions were added establishing new
drinking water requirements.
Specifically, Congress required under
section 1412(b)(8) that EPA develop
regulations specifying the use of
disinfectants for ground water systems
"as necessary." These amendments
established a new regulatory framework
that required EPA to  set criteria for
States to determine whether ground
water systems need to disinfect. In
December 1997, EPA held its first of a
series of stakeholder meetings to present
a summary of the findings resulting both
from technical discussions held since
1990 and from information generated by
internal EPA working groups with the
intention of developing disinfection
criteria for ground water systems.
  EPA held a preliminary Ground Water
Rule meeting on December 18 and 19,
1997, in Washington, DC for the
purpose of engaging all interested
stakeholders in the analysis of data to .
support the GWR. The two day meeting
covered discussions on the implications
of the data, solicited  further data from
stakeholders, and reviewed EPA's next
steps for rule development, data
analysis and stakeholder involvement.
  Since December 1997, EPA has held
GWR stakeholder meetings in Portland,
OR, Madison, WI, Dallas, TX, Lincoln,
NE, and Washington, DC along with
three early involvement meetings with
State representatives. In addition, EPA
has received valuable input from small
system operators as part of an Agency
outreach initiative under the Small
Business Regulatory Enforcement
Fairness Act. See section VI for more

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                                                                    30203
information on the SBREFA process.
Taken together, these stakeholder
meetings have been crucial both in
obtaining feedback and getting
additional information as well as in
guiding the Agency's consideration and
development of different regulatory
components.
  The Agency's goal in developing the
GWR is to reduce the risk of illness
caused by microbial contamination in
public water systems relying on ground
water. The series of GWR stakeholder
meetings were beneficial in assisting
EPA in understanding how State
strategies  fit together as part of a
national strategy. For more information
sea the (Stakeholders Meeting
Summary, Resolve, July 27,1998).
Portland,  OR, GWR Stakeholder Meeting
  There were four different regulatory
approaches presented in the first of a
series of stakeholder meetings held in
Portland,  OR, in May 1998: the Barrier
Assessment Approach, the Existing
State Practices Approach, the Setback
Approach, and the Checklist Approach
(Stakeholder Meetings Summary,
Resolve, July 27,1998). All approaches
address, to varying degrees, three main
areas: minimum program requirements
or baseline measures, identification of
high risk wells, and corrective action.
Discussions on the potential approaches
centered around determining triggers
that could place a well in a high priority
category and which minimum set of
BMPs should be implemented at high
risk wells.
Madison,  WI GWR Stakeholder Meeting
  There were three approaches
presented in a June 9,1998, GWR
stakeholder meeting held in Madison,
WI: Status Quo Approach, Baseline
Approach, and Disinfection Approach.
Regulatory approaches were revised in
response to stakeholder input from the
earlier GWR stakeholder meetings,
representing a continuum of
requirements, from Existing Status Quo
to mandatory disinfection for all ground
water systems. EPA emphasized that
existing occurrence data does not
appear to  support mandatory
disinfection across the board, but that
the Agency would still appreciate
stakeholder input on a range of options.
The approaches presented were based
on monitoring, inspections, BMPs and
disinfection.
Dallas, TX GWR Stakeholder Meeting
  A third  GWR meeting on June 25,
1998 in Dallas, TX, provided slight
modifications to the regulatory
approaches, but for the most part  the
regulatory approach remained
unchanged from the Madison meeting
held in early June. EPA continued to
emphasize the need to identify and
strengthen the potential barriers to
contamination. Among the three
approaches, (Status Quo, Progressive
and Universal Disinfection) the
Progressive approach was considered
the more viable regulatory option to
ensure public health protection among
public water systems.
Early Involvement Meetings
  ASDWA held three early involvement
meetings (EIMs) on the GWR. The first
EIM followed the May 5, 1998
stakeholder meeting,in Portland, OR.
The second EIM meeting was held in
Washington, DC on July 14 and 15, 1998
and the third meeting was held in
Chicago, IL on April 7 and 8,1999.
Representatives from 12 States, four
EPA Regions, ASDWA and EPA
Headquarters participated in the May 6
and 7,1998 meeting in Portland, OR.
The second EIM involved 10 State
representatives, ASDWA, and EPA
Headquarters. The third EIM included
one Region, seven State representatives,
ASDWA and EPA Headquarters. The
purpose of the meetings was to review
the findings and comments from the
stakeholder meetings and to work
together to further refine GWR
regulatory options. EPA and States
discussed a range of issues including
risk, exposure, strategies for identifying
high risk systems, occurrence data, and
regulatory implementation barriers.

2. Review and Comment of Preliminary
Draft GWR Preamble
  EPA developed a preliminary draft
preamble reflecting a wide range of
input from numerous stakeholders
across the country including four public
meetings, three EIMs with State
representatives, in addition to valuable
input received from small system
operators as part of the outreach process
established by SBREFA.
  To facilitate the rule development
process, the preliminary draft preamble
was made available to the public via the
Internet through EPA's website site on
February 3, 1999. Approximately 300
copies were mailed to participants of
the public meetings or to those who
requested a copy. EPA welcomed any
comments, suggestions, or concerns
reviewers had on either the general
direction or the technical basis of the
proposal. EPA closed the email box on
February 23,1999 and continued to
receive written comments through the
mail through March 17, 1999. Because
this was an informal process, EPA did
not prepare a formal response to the
comments. Nonetheless, the Agency
carefully reviewed and evaluated all
comments and technical suggestions
and greatly appreciated the input and
feedback provided by these outreach
efforts.    ,             I'1
  Eighty individual comment letters
were received. Commenters included:
State and local government
representatives, trade associations,
academic institutions, businesses and
other Federal agencies. Microbial
monitoring received the most individual
comments. Sanitary survey, sensitivity
assessment and treatment issues were
next, respectively.
II. Public Health Risk
  The purpose of this section is to
discuss the health risk associated with
pathogens in ground waters. More
detailed information about pathogens
may be found in three EPA drinking
water criteria documents for viruses (US
EPA 1985a; 1999b; 1999c), three EPA
criteria documents for bacteria (US EPA
1984a, b; 1985b) and the GWR
Occurrence and Monitoring Document
(US EPA, 1999d).  EPA requests
comment on all the information
presented in this section, and the
potential impact of proposed regulatory
provisions on public health risk.
A. Introduction
  Enteric viral and bacterial pathogens
are excreted in the feces of infected
individuals. Many bacterial pathogens
can infect both humans and animals.
Bacterial pathogens that infect humans
can also be found in animal feces. In
contrast, enteric viruses that are human
pathogens generally only infect humans,
and thus are only  found in human feces.
These organisms are able to survive  in
sewage and leachate derived from septic
tanks (septage) and sewer lines. When
sewage and septage are released into the
environment, they are a source of fecal
contamination. Fecal contamination is a
very general term  that includes all of the
organisms found in feces, both
pathogenic and non-pathogenic, as well
as chemicals.
  Fecal contamination of ground water
can occur by several routes. First, fecal
contamination can reach the ground
water source from failed septic systems,
leaking sewer lines, and from land
discharge by passage through soils and
fissures. Twenty-five million
households in the United States use
conventional onsite wastewater
treatment systems, according to the
1990 Census. These systems include
systems with septic systems and leach
fields. A national estimate for failure
rates of these systems is not available;
however, a National Small Flows
Clearinghouse survey reports that in

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1993 alone, 90,632 failures were
reported. (USEPA, 1997f). 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.
Third, fecal contamination may also
enter the distribution system when cross
connection controls fail or when  ,
negative pressure in a leaking pipe
allows contaminant infiltration.
  Biofilms in distribution systems may
harbor bacterial pathogens, especially
the opportunistic pathogens that  cause
illness primarily in individuals with
weakened immune systems. These
bacterial pathogens may have entered
the distribution system as part of fecal
matter from humans or other animals.
Biofilms may also harbor viral
pathogens (Quignon et al., 1997), but,
unlike some bacterial pathogens,  viruses
do not grow in the biofilm. However,  a
biofilm may protect the viruses against
disinfectants and help them survive
longer.
  Although not the basis for today's
proposed rule, there are additional
waterborne pathogens that EPA is
currently evaluating. These include
bacterial pathogens that may be free-
living in the environment, and thus not
necessarily associated with fecal
contamination. These  pathogens  include
Legionella (causes Legionnaires Disease
and Pontiac Fever), Pseudomonas
aeruginosa, and Mycobacterium avium-
intracellulare. Many of these bacteria
can colonize pipes of the distribution
system and plumbing systems and may
play a role in causing waterborne
disease that is currently under study.
EPA recognizes the potential risk of
such organisms, but believes that more
research needs to be conducted before
they can be considered for regulation.
Also, the Agency is aware that Giardia
and Cryptosporidium have occurred in
ground water systems (GWSs) (Hancock
et al., 1998), causing outbreaks in such
systems (Solo-Gabriele and Neumeister,
1996). However, by definition under
§ 141.2 ground waters with significant
occurrence of large diameter pathogens
such as Giardia or Cryptosporidium are
considered ground water under the
direct influence of surface water  and are
already subject to the SWTR and
IESWTR. The Agency  is also not
addressing in the GWR the important
issue of toxic or carcinogenic chemicals
in the GWR. This issue is instead
                      covered in other regulations that
                      address chemicals.
                        In order to assess the public health
                      risk associated with drinking ground
                      water, EPA has evaluated information  '.
                      and conducted analysis in a number of:
                      important areas discussed in more detail
                      later. These include: (l) Recent
                      waterborne disease outbreak data; (2)
                      dose-response data and other health
                      effects data from a range of pathogens;  ,
                      (3) occurrence data from ground water
                      studies and surveys; (4) an assessment!.
                      of the current baseline ground water   '.
                      protection provided by existing       ;
                      regulations; and (5) an analysis of risk.:

                      B. Waterborne Disease Outbreak Data
                        The purpose of this section is to
                      present a detailed review of waterborne
                      disease  outbreaks associated with
                      ground waters. Outbreak
                      characterization is useful for indicating
                      relative degrees of risk associated with.
                      different types of source water and
                      systems.
                        The Centers for Disease Control and
                      Prevention (CDC) maintains a database;
                      of information on waterborne disease
                      outbreaks in the United States. The
                      database is based upon responses to a
                      voluntary and confidential survey form
                      that is completed by State and local
                      public health officials. CDC defines a
                      waterborne disease outbreak as
                      occurring when at least two persons   -
                      experience a similar illness after
                      ingesting a specific drinking water     :
                      (Kramer et al., 1996). Data from the CDC
                      database appears in Tables II-l, II-2, II-
                      3, and II-4.
                        The National Research  Council
                      strongly suggests that the number of
                      identified and reported outbreaks in the
                      CDC database (both for surface and    :
                      ground waters) represents a small
                      percentage of actual waterborne disease
                      outbreaks (Safe Water From Every Tap,1
                      National Research Council, 1997;
                      Bennett et al., 1987; Hopkins et. al.,
                      1985 for Colorado data). In practice,
                      most waterborne outbreaks in
                      community water systems are not
                      recognized until a sizable proportion of
                      the population is ill (Perz et al., 1998;  ;
                      Craun 1996), perhaps 1% to 2% of the
                      population (Craun, 1996). Some of the
                      reasons for the lack of recognition and
                      reporting of outbreaks, most of which
                      were noted by the National Research
                      Council (1997), are as follows:
                        • Some States do not have active
                      disease  surveillance systems. Thus,
                      States that report the most outbreaks
                      may not be those in which the most
                      outbreaks occur.                     ,
                        • Even in States with effective disease
                      surveillance systems, health officials
                      may not recognize the occurrence of   ;
small outbreaks. In cities, large
outbreaks are more likely to be
'recognized than sporadic cases or small
outbreaks in which ill persons may
consult different physicians. Even so,
health authorities did not recognize the
massive outbreak (403,000 illnesses) of
waterborne cryptosporidiosis that
occurred in Milwaukee, WI, in 1993,
until the disease incidence was near or
at its peak (MacKenzie et al., 1994). The
outbreak was recognized when a
pharmacist noticed that the sale of over-
the-counter diarrheal medicine was very
high and consequently notified health
authorities.
   •  Most cases of waterborne disease
are characterized by general symptoms
(diarrhea, vomiting, etc.) that cannot be
distinguished from other sources (e.g.,
food).
   •  Only a small fraction of people who
develop diarrheal illness seek medical
assistance.
   •  Many public health care providers
may not have sufficient information to
request the appropriate clinical test.
   •  If a clinical test is ordered, the
patient must comply, a laboratory must
be available and proficient, and a
positive result must be reported in a
timely manner to the health agency.
   •  Not all outbreaks are effectively
investigated. Outbreaks are included in
the CDC database only if water quality
and/or epidemiological data are
collected to document that drinking
water was the route of disease
transmission. Monitoring after the
recognition of an outbreak may be too
late in detecting intermittent or a one-
time contamination event.
   •  Some States do not always report
identified waterborne disease outbreaks
to the CDC. Reporting outbreaks is
voluntary.
   •  The vast majority of ground water
systems are non-community water
systems (NCWSs). Outbreaks associated
with NCWSs are less likely to be
recognized than those in community
water systems because NCWSs generally
serve nonresidential areas and transient
populations.
   There is also the issue of endemic
waterborne disease. Endemic
waterborne disease may be defined as
any waterborne disease not associated
with an outbreak. A more precise
definition is the normal level  of
waterborne disease in a community.
Under this definition, an outbreak
would represent a spike in the
incidence of disease. Based on this
definition, the level of endemic
waterborne disease in a community may
be quite high. For example, 14%-40% of
the normal gastrointestinal illness in a
community in Quebec was associated

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                                                                    30205
with drinking treated water from a
surface water source (Payment et al.,
1997). Significant levels of endemic
disease could also be associated with
ground waters. Because endemic
waterborne disease may be a significant
and substantially preventable source of
health risk, under the directive of the
1996 SDVVA Amendments, EPA is
jointly pursuing with CDC a multi-city
study of waterborne disease occurrence
in an effort to provide greater
understanding of this risk. EPA believes
that some meaningful percentage of the
nationwide occurrence of endemic
waterborne disease is in ground water
systems (GWSs). EPA believes that the
prudent policy of prevention embodied
in this proposal with regard to
identified sources of substantial
microbial risk to GWSs gains further
justification as a counter to the endemic
occurrence of waterborne  disease. EPA
solicits comment and any data that can
increase knowledge of these endemic
risks, in particular any studies on such
risk in GWSs.
CDC Waterborne Disease Outbreak Data
  Outbreak data collected by CDC are
presented in Tables II-l, II-2 , II-3, and
II-4. Table II-l provides outbreak data
for all public water systems (surface and
ground water). Table 11-2 shows sources
of waterborne disease outbreaks for
GWSs. Table II-3 identifies the etiology
of waterborne outbreaks in GWSs. Table
II-4 shows causes associated with
waterborne disease outbreaks and
illnesses  in GWSs.
  According to CDC, between 1971 and
199S a total of 643 outbreaks and
571,161 cases of illnesses  were reported
(see Table II-l); however,  the total
includes  403,000 cases from a single
surface water outbreak caused by
Cryptosporidium in Milwaukee, WI in
1993, Excluding the Milwaukee
outbreak  from the data set, 642
outbreaks and 168,161 cases of illness
were reported during the same period  of
time. Ground water sources were
associated with 371 (58%) of the total
outbreaks and 16% of the  associated
illness (54% of the illness if the
Milwaukee outbreak is excluded). In
comparison, surface water sources were
associated with 216 (33%) of the total
outbreaks and 82% of the associated
illness (40% of the illness if the
Milwaukee outbreak is excluded).
Although the data in Table II-l indicate
that NCWSs using ground water had
twice as many outbreaks as CWSs using
ground water, this may reflect the fact
that there are over twice as many
NCWSs as CWSs.
  The outbreak data indicate that the
major deficiency in ground water
systems was source water
contamination—either untreated or
inadequately treated ground water (see
Table II-2). Contaminated source water
was the cause of 86% of the outbreaks
in ground water systems. Contamination
due to source water was the cause of
68% of the outbreaks for CWSs, while
for NCWSs it was 92%. Distribution
system deficiencies were associated
with 29% of the outbreaks in CWSs and
in five percent of the NCWSs.
  Of the 371 outbreaks in ground water
systems, 91 (25%) were associated with
specific viral or bacterial pathogens,
while 22 (6%) were associated with
chemicals (see Table II-3). Etiologic
agents were not identified in 232 (63%)
outbreaks. The diversity of disease
agents is similar to that of surface water,
with a variety of protozoa, viruses, and
bacteria. As stated previously, a ground
water with Cryptosporidium or Giardia
is, by definition, a "ground water under
the direct influence of surface water",
and is thus subject to the microbial
treatment requirements of a surface
water system (i.e., SWTR or IESWTR).
According to CDC's data, bacterial
pathogens were responsible for more
outbreaks (57) than were viral pathogens
(34). However, EPA suspects that many,
perhaps a majority, of the outbreaks
where an agent was not determined
(232) were virus-caused, given the  fact
that it is generally more difficult to
analyze for viral pathogens than
bacterial pathogens. The fecal bacterial
pathogen, Shigella, caused far more
reported outbreaks (eight percent) than
any other single agent.
  Table II-4 shows outbreak data since
1991, the year in which the TCR became
effective. Untreated ground water and
inadequate treatment were collectively
associated with 73% of the outbreaks in
ground water systems between 1991- :
1996.
  Large outbreaks are rarely associated
with ground water systems because
most ground water systems are small.
However, one large outbreak occurred in
Georgetown, TX, in 1980 (Hejkal et al,,
1982) where 7,900 people became ill.
Coxsackievirus and hepatitis A virus
were found in the raw well water in a
karst hydrogeologic setting; the outbreak
was the result of sourqe water
contamination. Another occurred in
1965, in Riverside, CA,  where  about
16,000 illnesses resulted from  exposure
to Salmonella typhimurium in the
source water (Boring, 1971).
  Most of the outbreaks were caused by
agents of gastrointestinal illness.
Normally, the disease is self-limiting
and the patient is well within  one week
or less. However, in some cases, deaths
have occurred. In 1989, four deaths (243
illnesses) occurred in Cabool,  MO, as a
result of distribution system
contamination by E. coli 0157:H7
(Swerdlow et al., 1992;  Geldreich et al.,
1992). In 1993, seven deaths (650
illnesses) occurred in Gideon,  MO, as a
result of distribution system
contamination by Salmonella
typhimurium (Angulo, 1997).  Both cases
involved ground water systems.
Waterborne disease in ground  water
systems has also caused serious illness
such as hemolytic uremic syndrome (six
reported cases in two outbreaks), which
includes kidney failure, especially in
children and the elderly. Two  cases of
hemolytic uremic syndrome were
reported during the Cabool outbreak, the
affected individuals being three and 79
years  of age. Deep wells are not immune
from contamination; for example, an
outbreak of gastroenteritis caused by  the
Norwalk virus (900 illnesses) was
associated with a 600-foot well (Lawson
etal., 1991).
  Collectively, the data indicate that
outbreaks in ground water systems are
a problem and that source
contamination and inadequate treatment
(or treatment failures) are responsible
for the great majority of outbreaks. The
outbreaks are caused by a variety of
pathogens, most of which cause short
term gastrointestinal disease.
 TABLE 11-1.—COMPARISON OF OUTBREAKS AND OUTBREAK-RELATED ILLNESSES FROM GROUND WATER AND SURFACE
                                      WATER FOR THE PERIOD 1971-199612                                 ""   ,
Water source
Ground 	 	 .....,..., 	 	 	
Surface .. . . ...... 	 	 	 	
Other 	 	 	 	
Total outbreaks1
371 (58%)
216 (33%)
56 (9%)
Cases of
illnesses
90,815 (16%)
469.7212 (82%)
10,625(2%)
Outbreaks In
CWSs
113
142
29
Outbreaks in
NCWSs
2581
43
19
Total CWS4
43,908
10,760

Total NCWSf
112,940
2,848


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Federal Register/Vol. 65, No. 91/Wednesday,  May 10,  2000/Proposed Rules
 TABLE 11-1.—COMPARISON OF OUTBREAKS AND OUTBREAK-RELATED ILLNESSES FROM GROUND WATER AND SURFACE
                       .  .      WATER FOR THE PERIOD 1971-199612—Continued
Water source
All Systems3 	
Total outbreaks1
643 (100%) ,
Cases of
illnesses
571,161 (100%)
Outbreaks in
CWSs
284
Outbreaks in
NCWSs
•320
Total CWS4
54,668
Total NCWS4
115,788
  1 Modified from Craun and Calderon, 1994, plus 1995-1996 data.
  2 Includes 403,000 cases of illness from a single outbreak in Milwaukee, Wisconsin, 1993.
  3 Includes outbreaks in CWSs + NCWSs + Private wells.
  4 Safe Drinking Water Information System, 1998.

   TABLE H-2.—SOURCES OF WATERBORNE DISEASE OUTBREAKS, PUBLIC GROUND WATER SYSTEMS, 1971-1996l-2.
Type of contamination
Source 	
Untreated 	

Filtered 	
Distribution System 	
Unknown Cause 	
Total 	
Total
274
150
122
2
35
9
318
Percent of
total
86
47
38
1
.11
3
100
CWSs
53
20
3i
2
23
2
78
Percent of
total
68
26
40
3
29
3
100
NCWSs
221
130
91
0
12
7
240
Percent of
total
92
54
38
0
. 5
3
100
  1 Source water could not be identified for 29 CWSs and 19 NCWSs with outbreaks, and thus these systems are not included in the table.
  2 Excludes outbreaks caused by protozoa and chemicals.                         •.

         TABLE II-3.—ETIOLOGY OF OUTBREAKS IN GROUND WATER SYSTEMS, 1971-96, CWSs AND NCWSs
Causative agent






Hepatitis A 	

Total Virus 	 • 	 • 	 '• 	
Shigella •• ..' 	 	 • 	


E coli 	 	 	
S typhi 	 < 	



Total Bacteria 	 	 	
Total 	 	 	
Outbreaks
232
22
121
14
1
26
18
16
34
30
10
10
4
1
1
1

57
371
Percent
63
6
6
1
<1
7
5
5
9
8
3
3
1
<1
<1
<1

15
100
  1 Ground waters with Giardia and Cryptosporidium are regulated under the SWTR and lES'WTR. These systems would likely not be considered
ground water systems for purposes of this rule.                                  :

                  TABLE I\-4.—CAUSES OF OUTBREAKS IN GROUND WATER SYSTEMS, 1991-1996
Cause

Distribution System Deficiency 	 	 	 	 	 	 	 ••

Miscellaneous, Unknown Cause 	 	 	
Total ..: 	 , 	 ;. 	 	 	
Number of
outbreaks
18
6
17
3
44
Cases of
illness
2924
944
1260
568
5696
Percent of out-
break-related
illnesses
51
17
22
10
100
  ' Excludes protozoa and chemicals.

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                 Federal Register/Vol.  65, No. 91/Wednesday, May 10, 2000/Proposed  Rules
                                                                     30207
C. Ground Water Occurrence Studies
  The purpose of this section is to
present data on the occurrence of
waterborne pathogens and indicators of
fecal contamination in ground water
supplying PWS wells. These data are
important to GWR development because
they provide insight on: (1) The extent
to which ground water may be
contaminated; (2) possible fecal
indicators for source water monitoring
under the GWR; and (3) a national
estimate of ground water pathogen
occurrence. In addition, determining the
occurrence of microbial contaminants in
ground water sources of drinking water
is necessary to yield a quantified
national estimate of public health risk.
  EPA has reviewed data fromlS recent
or on-going studies of pathogen and/or
fecal indicator occurrence in ground
waters that supply PWSs. While most of
these studies were not designed to yield
a nationally representative sample of
ground water systems, one of the studies
(Abbaszadegan et al., 1999, or the
"AWWARF study") was later expanded
to include a nationally representative
range of hydrogeologic settings. This
study was used as the basis of EPA's
quantitative assessment of baseline risk
from viral contamination of ground
water, which is also a component of the
quantitative benefits assessment for the
proposed rule. Short narratives on each
of the studies are provided in the next
sections. The study design and results
for each study are summarized in Table
II-6, at the end of the narratives. The
Agency decided not to combine the data
from these studies, because of the
different method protocols and scopes.
  Each occurrence study investigated a
combination of different pathogenic
and/or indicator viruses and bacteria.
Indicator viruses and bacteria may be
non-pathogenic but are associated with
fecal contamination and are transmitted
through the same pathways as
pathogenic viruses and bacteria. The
samples analyzed in each study were
tested for viral pathogens such as
enteroviruses (a group of human viruses
also referred to as "total cultureable
viruses") and/or bacterial pathogens
such as Legionella and Aeromonas.
Several studies used the polymerase
chain reaction (PCR) as part of the
method for determining the presence of
pathogenic viruses. Bacterial indicators
of fecal contamination tested included
enterococci (or fecal streptococci, which
are closely related), and fecal coliforms
(or E. coli, which is closely related), and
Clostridium perfringens. Most studies
tested for total coliforms, which are not
considered a direct fecal indicator since
they also include coliforms that live in
soil. Viral indicators of fecal
contamination were all bacteriophage,
which are viruses that infect bacteria.
Among the bacteriophage tested were
somatic coliphage and/or male-specific
coliphage, both of which infect the
bacterium E. coli. Bacteroides phage
were tested in two studies and
Salmonella phage in one study.
  While this section presents a
summary of each study, a more detailed
explanation of one study (Abbaszadegan
et al., 1999) (AWWARF Study) is
provided, as it is the broadest study in
scope. The hydrogeology of individual
wells is mentioned in addition to the
microbial results, because EPA
considers hydrogeology an important
factor in source water contamination.
Hydrogeology is discussed in greater
detail in section IK.B.
1. Abbaszadegan et al. (1999)
(AWWARF Study)
  Of the 13 studies, the AWWARF
study sampled the largest number of
wells, examined the widest array of well
and system characteristics, and tested
sites in 35 States across the U.S., located
in hydrogeologic settings representative
of national hydrogeology. The objectives
of the AWWARF study were to: (1)
Determine the occurrence of virus
contamination in source water of public
ground water systems; (2) investigate
water quality parameters and
occurrence of microbial indicators in
ground water and possible correlation
with human viruses; and (3) develop a
statistically-based screening method to
identify wells at risk of fecal
contamination. A summary of
AWWARF results are presented in
Tables II-5 and II-6.
  Many of the initial sites were selected
to evaluate the effectiveness of a method
based on the reverse-transcriptase,
polymerase chain reaction (RT—PCR)
technique to detect pathogenic viruses
in ground water. Sites for this portion of
the study were selected based on the
following criteria: (1) Ground water sites
with high concentrations of minerals,
metals, or TOC; (2) sites with a previous
detection of any virus or bacteria in the
ground water source; (3) sites with
potential exposure to contaminants due
to agricultural activities near the well,
industrial activities near the well, or
septic tanks near the well; and (4) sites
with different pH values, temperatures,
depths, production capacities and
aquifer types. Sites were selected for the
virus occurrence project based upon
their geological characteristics to
balance out the range of geologies so
that the sites in aggregate more closely
matched the national geologic profile of
ground water sources. Sites for the virus
occurrence study were selected from an
initial mailing to 500 utilities that
currently disinfect their water; 160
utilities with 750 wells volunteered to
be included in the study. In total, 448
wells were sampled for the study.
AWWARF excluded sites from the
investigation if: (l) It was known to be
under the influence of surface water; (2)
the well log records were not available;
or (3) it was considered poorly
constructed.
  EPA subsequently compared nitrate
concentrations from a national database
of nitrate concentrations in ground
water (Lanfear, 1992) with nitrate data
measured in the AWWARF study wells.
The purpose of the comparison was to
determine if there was any statistically
significant difference between the
nitrate levels in the AWWARF wells as
compared with the national distribution
of nitrate concentration data. Nitrate
was chosen for this comparison because
there is a large, national database
available. Each data set contained 216
samples selected so that
proportionately, wells of equal depth
were analyzed in each comparison. The
national data were selected randomly
from a database of more than 100,000
wells; all available AWWARF data were
used. In analyzing the data, EPA noted
that the national data is biased by
multiple sampling of many shallow
monitoring wells in farming regions
leading to a few wells having
exceptionally high nitrate levels.  In
order to minimize the impact of these
wells on the analysis, EPA chose  a small
random subset comparable in size to the
sample in the AWWARF study. Thus,
the data are not directly comparable
with PWS wells. Census data were used
to divide the national nitrate database
into 'urban and rural components. The
analysis showed that the AWWARF
wells had nitrate concentrations that
were not significantly different from the
national data or from the urban and
rural components. Thus, using nitrate :
concentration as a surrogate, EPA
concludes that, by this measure, the
AWWARF wells are nationally
representative.
  All samples were collected by the
systems. AWWARF provided a sample
kit containing all needed equipment and
a video illustrating the details of
appropriate sampling and storage .
procedures. A total of 539 samples were
collected from 448 sites in 35 States.
The preliminary results indicate that of
the 448 wells sampled, about 64% were
located in unconsolidated aquifers, 27%
in consolidated aquifers including
consolidated sedimentary strata, and
9% in unknown geology.
Unconsolidated aquifers are made of

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Federal Register/Vol.  65,  No. 91/Wednesday, May 10, 2000/Proposed  Rules
loosely packed (uncemented) particles,
such as sand grains or gravel, while
consolidated aquifers are comprised of
compacted (cemented) particles or
crystalline rock (e.g., granite, limestone).
As discussed further in section III.B.,
the degree and type of consolidation
may affect the transport of pathogens
from a source of fecal contamination to
the well. The percentages of sites
sampled from these geologic settings are
similar to those of national ground
water production from unconsolidated
and consolidated hydrogeologic settings
(modified by AWWARF, from United
States Geological Survey (USGS)
Circular 1081,1990). The data indicate
that 174 sites (39%) were within 150
feet of a known sewage source, and an
additional 127 sites (28%) were within
550 feet of a known sewage source.
There is no comparable data on the
distribution nationally of wells relative
                      to sewage sources. EPA notes however,
                      that the proximity to these sources is  '•
                      not inconsistent with State standards  ;
                      across the country. For example, 41
                      States have setback distances (the
                      minimum distance between a source of
                      contamination and a well) that are less
                      than or equal to 100 feet for sources of,
                      microbial contaminants. Only five
                      States appear to require setback from all
                      sewage sources of more than 200 feet.
                      The preliminary results also indicated.
                      that a total of 25 sites were sampled
                      more than once. Most sites were from
                      systems that serve greater than 3,300  :
                      people, and almost all systems maintain
                      a disinfectant residual.              :
                        In the study,  systems collected at least
                      400 gallons (1,512 liters) of water and
                      concentrated it using a filter-adsorptioti
                      and elution method. The concentrated
                      samples were then sent to the
                      researchers for  analysis. The presence .of
enterovirii'ses was determined by two
procedures: a cell culture assay and a.
procedure using the RT-PCR technique.
The RT-PCR technique was also used to
determine the presence of hepatitis A
virus, rotavirus, and Norwalk virus. The
researchers also tested each well for ..
total coliforms, enterococci, Clostridium
perfringens, somatic coliphage, and
male-specific coliphage to establish
their relationship with enteroviriis and
to get a better indication of the
percentage of fecally contaminated
wells.
  Preliminary results indicated that
fecal contamination occurs in a subset
of PWS wells (see Table 11-5). The
investigators detected pathogenic
viruses, either by cell culture or RT—
PCR analyses, in a significant
percentage of samples.
                              TABLE 11-5.—PRELIMINARY RESULTS OF AWWARF STUDY
Assay ;









PCR 	
Norwalk viruses (PCR) 	
Enteroviruses (PCR) . 	 - 	 	
Rotaviruses (PCR) 	 	
Hepatitis A viruses (PCR) 	 	 	 •'••• 	

Percent of wells
positive (number
positive/samples
analyzed)
4.8% (21/442)
15.1%
9.9% (44/445)
8.7% (31/355)
1.8% (1/57)
20.7%
9.5% (42/440)
4.1% (18/444)
10.8% (48/444)
31.5% .
0.96% (3/312)
15.9% (68/427)
14.6% (62/425)
7.2% (31/429)

 2. Lieberman et al., (1994, 1999) (EPA/
 AWWARF Study)
   The study objectives included the
 following: (1) develop and evaluate a
 molecular biology (PCR) monitoring
 method; (2) obtain occurrence data for
 human enteric viruses and Legionella  (a
 bacterial pathogen) in ground water; and
 (3) assess the microbial indicators of
 fecal contamination. These objectives
 were accomplished by sampling
 vulnerable wells nominated by States  to
 confirm the presence of fecal indicators
 (Phase I) and then choosing a subset of
 these for monthly sampling for one year
 (Phase II).
   In Phase I, well vulnerability was
 established using historical microbial
 occurrence data and waterborne disease
 outbreak history, known sources of
 human fecal contamination in close
 proximity to the well, and sensitive
 hydrogeologic  features (e.g., karst).
                      Ninety-six of the 180 potentially
                      vulnerable wells were selected for    ;
                      additional consideration. Selected wells
                      were located in 22 States and 2 US
                      territories. Additional water quality
                      information was then successfully
                      obtained for 94 of the wells through use
                      of a single one liter grab sample which
                      was subsequently tested for several   .
                      microbial indicators (see Table II-6). .
                      The wells from Phase I served as the \
                      well selection pool for Phase II
                      sampling.
                        In Phase II, 23 of the Phase I wells
                      were selected for monthly sampling for
                      one year. Seven additional wells were
                      selected from a list of state-nominated
                      wells for a total  of 30 wells, located in
                      17  States and 2 US territories. The    ;
                      additional seven wells were based on
                      other criteria, including historical water
                      quality data, known contaminant    ;
                      sources in proximity to the well,
hydrogeologic character or to replace
wells that were no longer available for
sampling. Samples were analyzed for
enteroviruses, Legionella, enterococci,
E. coli, Clostridium perfringens, total
coliforms, somatic coliphage, male-
specific coliphage and Bacteroides
phage. For each sample analyzed for
enteric viruses and bacteriophages, an
average of approximately 6,000 liters of
water were filtered and analyzed by cell
culture.
   Twenty samples from seven  wells.
were enterovirus positive and were.
speciated by serotyping. Coxsackievirus
and echovirus, as well as reovirus, were
identified. The range in virus
concentration in enterovirus-positive
samples was 0.9-212 MPN/100 liters ,
(MPN, or most probable number, is an
estimate of concentration).
   The hydrogeologic settings for the
seven enterovirus-positive wells were

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                 Federal Register/Vol. 65, No.  91 / Wednesday,  May 10, 2000/Proposed Rules
                                                                     30209
 karst (3), a gravel aquifer (1), fractured
 bedrock (2), and a sandy soil and
 alluvial aquifer (1). The karst wells were
 all positive more than once. The gravel
 aquifer was also enterovirus-positive
 more than once, with 4 of 12 monthly
 samples positive.

 3. Missouri Ozark Aquifer Study #1

   The purpose of this study was to
 determine the water quality in recently
 constructed community public water
 system \vells in the Ozark Plateau region
 of Missouri. This largely rural region is
 characterized by carbonate  aquifers,
 both confined and unconfined, with
 numerous karst features throughout. A
 confining layer is defined in this study
 as a layer of material that is not very
 permeable to ground water  flow and
 that overlays an aquifer and acts to
 prevent water movement into the
 aquifer.
   The US Geological Survey, working
 with the Missouri Department of
 Natural Resources, selected a total of
 109 wells, in both unconfined and
 confined aquifers (Davis and Witt, 1998,
 1999). In order to eliminate poorly
 constructed wells from the  study, most
 of the selected wells had been
 constructed within the last  15 years.
 Wells were also selected to  obtain good
 coverage of the aquifer and  to reflect the
 variability in land use. All wells were
 sampled twice, in summer and winter.
 Evidence of fecal contamination was
 found in a number of wells. Thirteen
 wells had samples that were PCR-
 positive for enterovirus.

 4. Missouri Ozark Aquifer Study #2

  The purpose of this study is to
 determine the water quality in older
 (pre-1970) CWS wells in the Ozark
 Plateau region of Missouri to
 supplement the Missouri Ozark Aquifer
 Study #1, by Davis and Witt (1998,
 1999). This largely rural region is
 characterized by carbonate aquifers,
 both confined and unconfined, with
 numerous karst features throughout.
  The US Geological Survey, working
 with the Missouri Department of
 Natural Resources, sampled a total of
 106 wells  (Femmer, 1999), in both
 unconfined and confined aquifers.
 Wells (all of which were constructed
 before 1970) were selected for
 monitoring to obtain good coverage of
 the aquifer, and to reflect the variability
 in land use. Priority was given to wells
that had completion records, well
operation and maintenance  history and
wells currently being used. Each well
was sampled once (during the spring).
No wells were enterovirus-positive by
cell culture.
 5. Missouri Alluvial Aquifer Study
   The purpose of this study was to
 determine water quality in wells located
 in areas that were subjected to recent
 flooding. The wells are located .
 primarily in the thick, wide alluvium of
 the Missouri and Mississippi rivers.
 Sampling (117 samples) occurred during
 the period of March through June 1996.
 Twelve wells served as control wells
 (uncontaminated) and were sited in
 "deep rock" aquifers or upland areas. A
 total of 64 wells were sampled.
   Many of the wells had been flooded.
 Fifty-five were affected by a flood in
 1995. In addition, some of the wells
 sampled had been flooded around the
 surface well casing prior to the sampling
 event, and several were flooded at the
 time of sampling (Vaughn, 1996).

 6. Wisconsin Migrant Worker Camp
 Study
   The purpose of this study was to
 determine the quality of drinking water
 in the 21 public ground water systems
 serving migrant worker camps in
 Wisconsin (US EPA, 1998a). These
 transient, non-community water
 systems are located in three geographic
 locations across the State. Each well was
 sampled monthly for six months, from
 May through November, 1997. The
 study conducted sampling for male-
 specific coliphage, total coliforms and E.
 coli. When detections of coliforms
 occurred, the specific type of coliform
 was further identified (speciated). One
 total coliform positive sample was
 identified to contain Klebsiella
 pneumoniae. Along with the microbial
 indicators, nitrate and pesticides were
 also measured.
  Other factors were compared to the
 microbial and chemical sampling results
 of the study. Well construction records
 were available for 14 of the wells. The
 mean casing depth was 109 feet (range
 40 to 282 feet) and the mean total well
 depth was 155 feet (range 44 to 414
 feet). Most of these 14 wells are also
 reported to terminate in a sand or
 sandstone formation.
  Investigators detected male-specific
 coliphage in 20 of 21 wells during the
 six-month sampling period, but never
 detected E. coli. In addition, four wells
had nitrate levels that exceeded the EPA
 MCL for nitrate.

 7. EPA Vulnerability Study
  The purpose of this study was to
conduct a pilot test of a new
vulnerability assessment method by
determining whether it could predict
microbial monitoring results (U.S. EPA
 1998b). The vulnerability assessment
assigned low or high vulnerability to
 wells according to their hydrogeologic
 settings, well construction and age, and
 distances from contaminant sources. A
 total of 30 wells in eight States were
 selected to represent ten hydrogeologic
 settings. Selection was based on the
 following criteria: (1) Wells representing
 a variety of conditions relevant to the
 vulnerability predictions; (2) wells with
 nearby sources of potential fecal
 contamination; and (3) wells with
 sufficient well and hydrogeologic
 information available.
   Samples were taken and tested for
 enteroviruses (both by cell culture and
 PCR), hepatitis A virus (HAV) (by PCR),
 rotavirus (by PCR), Norwalk virus (by
 PCR), and several indicators (total
 coliforms, enterococci, male-specific
 coliphage, and somatic coliphage). The
 only positive result was one PCR sample
 positive for HAV.

 8. US-Mexico Border Study
   The purpose of this study was to
 determine water quality in wells sited in
 alluvium along the Rio Grande River
 between El Paso,  Texas and the New
 Mexico border (U.S. EPA, in
 preparation). The 17 wells selected were
 perceived to be the most vulnerable,
 based on well depth, chloride
 concentration and proximity to
 contamination sources, especially the
 Rio Grande River.
   The wells tested are relatively shallow
 and  all serve less  than 10,000 people.
 One well serves 8,000 people, while
 seven wells serve fewer than 100
 people. Well depths range from 65 feet
 to 261 feet, but most are about 150 feet
 deep. This signifies that water was
 collected from the middle aquifer, a
 shallow but potable aquifer. Wells
 shallower than 65 feet contain chloride
 concentrations prohibitively high for
 drinking water.
  Samples were collected from each
 well and tested for enteroviruses (by cell
 culture), somatic coliphage, and male-
 specific coliphage. None of the sites
 were positive for any of the viruses
 tested.

 9. Whittier, CA, Coliphage Study
  The purpose of  this study was to
 determine the presence of fecal
 contamination in  all wells located
 within 500 feet down-gradient of a
 water recharge infiltration basin (Yanko
 et al., 1999). The 23 wells were sampled
 once per month for six months.
  The wells are sited in similar
hydrogeologic settings,  although they
vary in age and depth. The
hydrogeologic setting is primarily a
thick layer of unconsolidated sand, with
 lesser amounts of  other sized grains.
About 30% of the  recharge volume to

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Federal Register/Vol. 65, No. 91/Wednesday, May ,10, 2000/Proposed Rules
the wells is reclaimed water. Wells were
all constructed between .1919 and 1989
and produce water from depths ranging
from 60-888 feet.
  The wells were sampled monthly for
a six month period. The samples were
tested for total coliforms and indicators
of fecal contamination, including male
specific coliphage, somatic coliphage,
and E. coli. Coliphage were found in all
wells, and repeatedly in 20 of the 23
wells.
10. Oahu, HI Study
  The purpose of this study was to
establish a water quality monitoring
program to assess the microbial quality
of deep ground water used to supply
Honolulu (Fujioka and Yoneyama, ,
1997). A total of 71 wells were sampled,
32 of which were sampled for viruses
and 39 of which were sampled for
bacteria. The wells are located in
carbonate or basalt aquifers.
  Each of the wells was tested for   •
several pathogens and indicators of fecal
contamination. Bacterial samples taken
from  39 wells  (79 samples) were tested
for total coliforms, fecal streptococci,
Clostridium perfringens, heterotrophic
bacteria (by m-HPC), and Legionellq (by
PCR). Sample volumes were 100 mL for
C. perfringens and heterotrophic
bacteria, and both 100 mL and 500 mL
for coliforms and fecal streptococci. For
FRNA coliphage (male-specific
coliphage), one liter samples from 32
wells (35 samples) were tested by
membrane adsorption-elution method,
while 24 wells (24 samples) were tested
by an enrichment technique developed
by Yanko. None of the wells were
coliphage-positive, and only one sample
each was positive for E. coli and fecal
streptococci.
                       11. New England Study
                        The purpose of this study was to: (l)
                       Determine the prevalence of enteric   :
                       pathogens hi New England's public
                       water supply walls; (2) assess the
                       vulnerability of different systems; and
                       (3) evaluate yarious'fecal indicators.
                        Wells were selected based on the   ,
                       following criteria: (1) Must have
                       constant withdrawal throughout the  ;
                       year; (2) must be near septic systems, (3)
                       should have, if possible, a history of
                       violations of the MCL for total coliforms
                       or, elevated nitrate levels;1 and (4) must
                       not have direct infiltration by surface
                       water (Doherty, 1998).
                        Wells were nominated, characterized,
                       selected and sampled by regulatory staff
                       of Connecticut, Maine, Massachusetts,
                       New Hampshire, Rhode Island, and  ••
                       Vermont. The selection process      ;
                       considered wells in different
                       hydrogeologic settings. Of the 124 total
                       wells, 69 (56%) .were located in
                       unconfined aquifers, 31 (25%)  were
                       located in bedrock aquifers, 10 (8%)  ',
                       were located in confined aquifer      .
                       hydrogeologic settings, and 14  (11%)
                       were located in unknown aquifer
                       settings. Each well was sampled      ;
                       quarterly for one year. Enterococci were
                       identified in 20 of 124 wells (16%) and
                       in 6 of 31 (19%) bedrock aquifer wells.
                       Two wells were enterovirus-positive  ,
                       using cell culture methods, both in
                       unconsolidated aquifers. One of these:
                       two wells is 38 feet deep and the other
                       well is 60 feet deep. Final results from
                       this study are not yet available.
                       12. California Study
                        The purpose of this research is two-
                       fold: (1) To assess the vulnerability of,
                       ground water to viral contamination  :
                                               through repeated monitoring, and (2) to
                                               assess the potential for bacteria and
                                               coliphages to serve as indicators of the
                                               vulnerability of ground water to viral
                                               contamination (Yates 1999).
                                                 Eighteen wells were tested monthly
                                               for human enteroviruses (by cell culture
                                               (direct RT—PCR, Immunomagnetic
                                               separation reverse transcriptase (IMS—
                                               RT-PCR) and integrated cell culture
                                               RT-PCR) and PCR), HAV (by PCR),
                                               rotaviruses (by PCR), somatic and male-
                                               specific coliphage, and total coliforms
                                               and fecal streptococci. The depth of the
                                               wells is variable, but is on the order of
                                               about 200 feet (the deeper the well, the
                                               less likely contamination). There are
                                               some intermittent confining layers.
                                                 Of the 23'0 "samples tested for
                                               enteroviruses, 6 samples from 6 of the
                                               18 wells were cell culture positive for
                                               enteroviruses. Final results from this
                                               study are not yet available.

                                               13. Three State PWS Study (Wisconsin,
                                               Maryland and Minnesota)

                                                 The purpose of the three-state study is
                                               to characterize the extent of viral
                                               contamination in PWS wells by testing
                                               wells in differing hydrogeologic regions
                                               and considering contamination over
                                               time (Battigelli, 1999). Wells were
                                               sampled quarterly for one year in
                                               Wisconsin (25. wells), Minnesota (25
                                               wells), and will be sampled in Maryland
                                               (up to 35 wells).
                                                 Three wells in Wisconsin were
                                               positive for enteroviruses by cell
                                               culture. Final results for this study are
                                               not yet available.
                       TABLE 11-6.—GROUND WATER MICROBIAL OCCURRENCE STUDIES/SURVEYS
      Study
Number of PWS
 wells sampled
  and location
  Sampling frequency/volume
 Indicators monitored (number of
POS. wells/number of wells total,
   unless otherwise indicated)
 Pathogenic viruses, Legionella
(number of POS. wells/number of
  wells total, unless otherwise
         indicated)
 1. AWWARF
   Study.
448 wells; 35
  States.
2a. EPA/
  AWWARF
  Phase I Study.
94 wells; 22  .
  States plus
  PR and USVI.
Sampled once (25 wells sampled
  twice); 539 samples total, not
  all  analyses  conducted on all
.  samples.  Sampling volumes:
  1512L eluated for virus anal-
  yses (5 liter equivalent for RT-
  PCR,  600L  for cell culture),
  Coliphage 15L, Bacteria  200
 •mL.
One sample, 1 L	
Male-sp.  coliphage,  host  Sal-
  monella WG-49 (42/440); So-
  matic coliphage, host £ coli C
  (18/444); Coliphage, host £
  coli C-3000  (48/444);  Total
  coliform (44/445);  enterococci
  (31/355); C. perfringens (1/57).
Somatic coliphage 5/94; 1*; Total
  coliform 31/94; 9*; £ coli 18/
  94; 5*;  enterococci 17/94; 3*;
  C.   perfringens   4/94;   0*;
  'indicates  number of  wells
  positive in Phase 1 which were
  not positive or not sampled in
  Phase II.
Cell  Culture:  Enterovirus  (21/
  442); PCR: Rotavirus (62/425),
  Hepatitis A virus (31/429), Nor-
  walk virus (3/312), Enterovirus
  (68/427).

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                    Federal Register/Vol. 65,  No.  91/Wednesday, May 10,  2000/Proposed  Rules
                                                                                                        30211
                  TABLE 11-6.—GROUND WATER MICROBIAL OCCURRENCE STUDIES/SURVEYS—Continued
      Study
 Number of PWS
  wells sampled
   and location
   Sampling frequency/volume
 Indicators monitored (number of
 POS. wells/number of wells total,
   unless otherwise indicated)
  Pathogenic viruses, Legionella
 (number of POS. wells/number of
   wells total, unless otherwise
           indicated)
2b. EPA/
  AWWARF—
  Phase II Study.
3. Missouri Ozark
   Plateau Study
   #1 (Davis and
   Witt, 1999).

4. Missouri Ozark
   Plateau Studies
   #2 (Fammer,
   1999) (pre-1970
   weils).
5, Missouri AHu-
   vtel Study.
6. Wisconsin Mi-
  grant Worker
  Camp Study.
7. EPA Vulner-
  ability Study.
8. US-Mexico Bor-
  der Study (TX
  and NM).
9. Whittier, CA.
  Coliphago
  Study.

10, Oahu, Hawaii
  Study.
11. New England
  Study.
12. California
  Study.
13. Three-State
  Study (Wis-
  consin, Mary-
  land, Min-
  nesota),
 30. of which 23
   were from
   Phase I; 17
   States plus
   PR and USVI.
 109 wells
 106 wells
64 wells
21 wells
30 wells in 8
  States.
17 wells
23 wells
Virus—32 wells
  Bacteria—39
  wells.
124 wells; 6
  States.
18 wells
50 wells (25
  from MN, 25
  from Wl, addi-
  tional wells
  from MD).
 Monthly  for one year;  Average
  volume filtered: 6,037  L; Micro-
  scopic   Particulate   Analysis
  (MPA) data  available  for each
  well.
Two samples/well, 25 wells sam-
  pled once for tritium, 200-300
  L ground water filtered  at the
  well head.

One sample, 200-300 L filtered
  at the well head.
                  Sampling occurred during a four
                   month period. Some sampling
                   done during flooding.
Monthly:   Bacteria—6   mos.;
  Phage—5 mos.; Bacteria—100
  mL; Phage—1L.
Each well visited once. Two 1L
  grab  samples  and  1500-L
  sample  Equiv. vol.  650L  for
  enterovirus,  100 mL for bac-
  teria,   10  mL  to  100L  for
  coliphage, PCR?.
3 (300-1000 gallon) samples/well
                 Once a month for 6 months; 4L
                   samples.
Each well  sampled  1-4  times;
  total 79  samples, Virus—1-L;
  C.  perfringens,  HPC—0.1L;
  Conforms,  fecal  strep—0.1L
  and 0.5L.
Each well  sampled  four times
  over one year; Up to 1500-L
  sample for virus.
14 of 18 wells sampled 12 to 22
  times (monthly); Average sam-
  ple  volume  1784  L  (range
  240-3331  L) 1  I grab sample
  for indicators; (Coliphage -ana-
  lyzed using  10  mL grab sam-
  ples, 1-L enrichment samples,
  IMDS filter  eluates and  filter
  concentrates).
Each well  sampled  four  times
  over one year.
 Somatic coliphage (16/30); Male
  specific    coliphage    (6/30);
  Bacteroides bacterlophage (61
  30);    Somatic    Salmonella
  bacteriophage   (6/30);   Total
  coliform  (24/30);  enterococci
  (21/30);  C. perfringensC\0/30);
  E. co//(15/30); E. co//H7:O157
  (0/7).
 Somatic coliphage (1/109); Male
  specific  coliphage  (10/109);
  Fecal   streptococci  (1/109);
  Fecal coliform (2/109);  E. coli
  (0/109).
 Somatic coliphage (3/106); Male
  specific   coliphage   (3/106);
  Fecal   streptococci  (8/106);
  Fecal coliform (8/106);  E. coli
  (9/106).
 Somatic coliphage  (1/81); Male
  specific    coliphage    (1/81);
  Bacteroides bacteriophage (1/
  81);  Total  coliform  (33/81);
  Fecal  coliform  (5/81);  Fecal
  streptococci (12/81).
 Male  specific coliphage (20/21);
  Total coliform (14/21);  E. coli
  (0/21); K. pneumoniae (1/21).
 Male  specific coliphage  (0/30);
  Somatic  coliphage (2/24; large
  volume); Total coliform  (4/30);
  enterococci (0/30).
Male  specific coliphage (0/17);
  Somatic coliphage (0/17).

Male  specific  coliphage (18/23);
  Somatic   coliphage   (23/23);
  Total coliform (4/23);  E. coli (O/
  23).
Male  specific coliphage (0/32);
  Somatic coliphage (0/32); Total
  Coliform  (3/39); E. coli (1/39);
  Fecal Streptococci  (1/39);  C.
  perfringens (0/39).
Study in progress; Male specific
  coliphage   (4/79);    Somatic
  coliphage (1/70); Total coliform
  (27/124);          Aeromonas
  hydrophila     (19/122);     C.
  perfringens (6/119); E. coli (O/
  124); enterococci (20/124).
Study in progress; Male specific
  coliphage:   (hosts   E.   coli
  FAMP, S.  typhimurium  WG-
  49) (4/18);  Somatic coliphage:
  host  E.  coli  13706 (13/18);
  Total  coliform  (7/18);  Fecal
  streptococci (0/18).
Study   in   progress;   Somatic
  coliphage;    Male    specific
  coliphage;   Total   coliform;
  enterococci;  C.  perfringens; E.
  coli.
 Cell Culture: Enterovirus  (7/30);
   PCR: polio, entero, Hepatitis A,
   Norwalk, rota (results not avail-
   able),  (300+  samples from 30
   wells; several wells cell  culture
   positive    multiple     times);
   Legionella    sp.    (14/30),
   Legionella pneumophila  (6/30).

 Cell Culture: Enterovirus (0/109);
   PCR: Enterovirus (13/109).
                                                                                 Study  in progress;  Cell Culture:
                                                                                   Enterovirus (0/106).
                                                                Cell Culture: Enterovirus (1//81).
 Cell Culture: enterovirus  (0/30);
  PCR: HAV (1/30),  Rota  (0/30),
  Norwalk (0/30), enterovirus (Q/
  30).
                                                                                 Cell Culture: Enterovirus (0/17).
Legionella  sp.  (PCR;   15/26),
  Legionella pneumophila (PCR;
  1/27).
Study in progress;  Cell Culture:
  Enterovirus   (2/122);   PCR:
  Enterovirus (results not avail-
  able).
                                                                                 Study in progress; Cell Culture:
                                                                                   enterovirus (6/18);  PCR:  HAV
                                                                                   (0/18), Rota (0/18), enterovirus
                                                                                   (direct RT-PCR) (6/18), IMS-
                                                                                   RT-PCR  (10/18),   Integrated
                                                                                   Cell  Culture PCR  enterovirus
                                                                                   (4/18)).                     :
Study in progress; Cell Culture:
  enterovirus (3/25).

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Federal Register/Vol. 65,  No. 91/Wednesday, May 10,  2000/Proposed Rules
D. Health Effects of Waterborne Viral
and Bacterial Pathogens
  To assess the public health, risk
associated with a waterborne pathogen,
or group of pathogens, both occurrence
data and health effects data are needed.
The previous section discussed the
occurrence in ground water of
pathogens and indicators of fecal
contamination. This section discusses
the health effects associated with
waterborne pathogens, first viral agents
and then bacterial.
Viral Pathogens
   Table II-7  and II-8 list viral and
bacterial pathogens that have  caused
waterborne disease in ground waters.
Unlike some bacterial pathogens,
viruses cannot reproduce or proliferate
                       outside a host cell. Viruses that infect
                       cells lining the human gut are enteric
                       viruses. With a few exceptions, viruses
                       that can infect human cells typically
                       cannot infect the cells of other animals
                       and vice versa. This contrasts with   ;
                       many bacterial pathogens, which often
                       have a broader host range. Some enteric
                       viral pathogens associated with water
                       may infect cells in addition to those in
                       the gut, thereby causing mild or serious
                       secondary effects such as myocarditis,
                       conjunctivitis, meningitis or hepatitis.
                       There is also increasing evidence that
                       the human body reacts to foreign
                       invasion by viruses in ways that may!
                       also be detrimental. For example, one
                       hypothesis for the cause of adult onset
                       diabetes is that the human body,
                       responding to coxsackie B5 virus
 infection, attacks pancreatic cells in an
 auto-immune reaction as a result of
 similarities between certain pancreas
 cells and the viruses (Solimena and De
 Camilli, 1995).
   When humans are infected by a virus
 that infects gut cells, the virus becomes
 capable of reproducing. As a result,
 humans shed viruses in stool, typically
 for only a short period (weeks to a few
 months). Shedding often occurs in the
 absence of any signs of clinical illness.
 Regardless of whether the virus causes
 clinical illness, the viruses being shed
• may infect other people directly (by
 person-to-person spread, contact with
 infected surfaces, etc.) and is referred to
 as secondary spread. Waterborne viral
 pathogens thus may infect others via a
 variety of routes.
                          TABLE il-7.—SOME ILLNESSES CAUSED BY FECAL VIRAL PATHOGENS
                         Enteric virus
                                                                                       Illness
 Poliovirus 	
 Coxsackievirus A
 Coxsackievirus B
 Echovirus 	
 Norwalk virus and other caliciviruses	
 Hepatitis A virus 	
 Hepatitis E virus 	
 Small round structured viruses (probably caliciviruses)
 Rotavirus	
 Enteric Adenovirus 	:.	'•	
 Astrovirus	
                                           Paralysis.
                                           Meningitis, fever, respiratory disease.
                                           Myocarditis, congenital heart disease, rash, fever, meningitis, encepha-
                                             litis, pleurodynia, diabetes melitis, eye infections.
                                           Meningitis, encephalitis, rash, fever, gastroenteritis.
                                           Gastroenteritis.   ,
                                           Hepatitis.                         ,.                     '
                                           Hepatitis.       •                                •
                                           Gastroenteritis.
                                           Gastroenteritis.
                                           Respiratory disease, eye infections, gastroenteritis.
                                           Gastroenteritis.
   (Data from the 1994 Encyclopedia of Microbiology, Underf/neindicates disease causality rather than association)(Lederberg, 1992).
 Bacterial Pathogens
   Bacterial pathogens may be primary
 pathogens (those that can cause illness
 in most individuals)  or secondary or
 opportunistic pathogens (those that
 primarily cause illness only in sensitive
 sub-populations). Unlike most primary
 pathogens, some opportunistic bacterial
 pathogens can colonize and grow in the
 biofilm in water system distribution
 lines. Some waterborne bacterial agents
 cause disease by rapid growth and
 dissemination (e.g., Salmonella) while
 others primarily cause disease via toxin
 production (e.g., Shigella, E. coliOl57,
 Campylobacter jejuni). Campylobacter,
 E. coli and Salmonella have a host range
 that includes both animals and humans;
                       Shigella is associated with humans and
                       some other primates (Geldreich, 1996).
                       As noted previously, some waterborne
                       bacterial pathogens can survive a long
                       time outside their hosts.
                          Most of the waterborne bacterial
                       pathogens cause gastrointestinal illness,
                       but some can cause severe illness too.
                       For example, Legionella causes
                       Legionnaires Disease, a form of
                       pneumonia that has a fatality rate of
                       about 15%. It can also cause Pontiac,
                       Fever, which is much less severe than
                       Legionnaires Disease, but causes illness
                       in almost everyone exposed. A few
                       strains of E.  coli can cause severe    j
                       disease, including kidney failure. One
                       strain, E. coli O157:H7 has caused
  several waterborne disease outbreaks
  since 1990. It is a prime cause of bloody
  diarrhea in infants, and can cause
  hemorrhagic colitis (severe abdominal
  cramping and bloody diarrhea). In a
  small percentage of cases, hemorrhagic
  colitis can lead to a life-threatening
  complication known as hemolytic
  uremic syndrome (HUS), which
  involves destruction of red blood cells
  and acute kidney failure. From  3% to
  5% of HUS cases are fatal (CDC, 1999),
  and most commonly found in young
  children and the elderly. Some  of the
  opportunistic pathogens can also cause
  a variety of illnesses including
  meningitis, septicemia, and pneumonia
  (Rusinef al, 1997).
                 TABLE 11-8.—SOME ILLNESSES CAUSED BY MAJOR WATERBORNE BACTERIAL PATHOGENS
                       Bacterial pathogen
                                                                                       Illnesses
 Campylobacter jejuni.

 Shigella species	
 Salmonella species .
                                            Gastroenteritis,  meningitis,  associated  with  reactive  arthritis  and
                                              Guillain-Barre paralysis.
                                            Gastroenteritis, dysentery, hemolytic uremic syndrome, convulsions in
                                              young children, associated with Reiters Disease (reactive arthrop-
                                              athy).
                                            Gastroenteritis, septicemia, anorexia, arthritis, cholecystitis, meningitis,
                                              pericarditis, pneumonia, typhoid fever.

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                  Federal Register/Vol. 65, No.  91/Wednesday, May 10,  2000/Proposed Rules
                                                                     30213
          TABLE 11-8.—SOME ILLNESSES CAUSED BY MAJOR WATERBORNE BACTERIAL PATHOGENS—Continued
Bacterial pathogen
Vibrio cfcoterae ..„.,..„ 	
Eschcnch',3 co// (several species) 	
Yorslnlfi entercoKtlca , 	 	 	
Legtonetla species 	 	 	
Illnesses
Cholera (dehydration and kidney failure)


Legionnaires Disease, Pontiac Fever
   (Data from the 1994 Encyclopedia of Microbiology, Underline indicates disease causality rather than association)(Lederberg, 1992).
 E. Risk Estimate
 1. Baseline Risk Characterization
   This section provides an estimate of
 the number of people that may be at risk
 of microbial illness associated with
 consumption of fecally contaminated
 drinking water in populations served by
 ground water systems. EPA has
 prepared estimates of the numbers  of
 people at risk  of viral illness (and
 possibly death) from three conditions in
 which fecal contamination may be
 introduced to  ground water systems:
 fecal contamination in the source water
 of systems without disinfection; fecal
 contamination in the source water of
 systems with inadequate (less than 4-log
 as discussed later) or failed disinfection;
 and fecal contamination of the
 distribution system.
  The first condition in which EPA
 characterizes the baseline risk is for
 source contaminated ground water
 systems which do not have disinfection
 treatment. EPA characterizes the risk to
 consumers in these systems in five
 steps: (1) Calculating the population
 served by undisinfected systems using
 ground water sources; (2) determining
 the occurrence of the pathogens of
 concern in these systems; (3) assessing
 the exposure to the pathogens of
 concern; (4) determining the
 pathogenicity (likelihood of infection)
 based on dose-response information for
 each of the pathogens characterized; and
 (5) calculating the number of illnesses
 among the population served resulting
 from consumption of water containing
 the pathogens.
  EPA then estimates additional
 illnesses resulting from systems with
 inadequate or failed disinfection
 treatment and fecally contaminated
 source water, and systems in which
 fecal contamination is introduced into
 the distribution system. These
 additional illnesses are estimated based
 on the causes of contamination which
 lead to waterborne disease outbreaks
reported to the CDC in ground water
systems from 1991 to 1996. To estimate
these additional illnesses, EPA
calculated the ratio of the outbreak
illnesses in systems with inadequate or
 failed disinfection treatment to outbreak
illnesses in systems without any
 disinfection, and the ratio ofputbreak
 illnesses in systems with distribution
 system contamination to outbreak
 illnesses in systems without any
 disinfection.

 2. Summary of Basic Assumptions
   This risk assessment uses a number of
 assumptions to arrive at an estimate of
 the number of people at risk of illness
 or death due to consumption of water
 from systems with fecal contamination.
 Some of these assumptions are
 necessary because data in these areas
 simply does not exist.
   The feasibility of performing a risk
 analysis on each and every microbial
 contaminant is diminished when
 considering the wide range of different
 microbial contaminants that exist, and
 that detection methods for all of these
 contaminants do not exist. Therefore,
 the risk assessment assumes that the
 only people exposed to viral
 contamination are the people served by
 those wells which test positive for the
 two viruses used in the risk assessment
 model, and the exposed population will
 be exposed to the virus concentration
 throughout the entire year. The
 assumption that the population is
 exposed only to viruses which are
 accurately described by the model
 viruses may lead to an underestimation
 of exposure.  .
  The model viruses which were chosen
 to act as surrogates for all viruses fall
 into two categories; those viruses which
 have low-to-moderate, infectivity but
 relatively severe health effects, and
 those viruses which have high
 infectivity but relatively mild health
 effects. Exposure to viruses that do not
 fall into these categories may result in
 an underestimate or overestimate of
 risk. Risks are not directly quantified for
 bacterial contaminants because EPA
 does not have sufficient data to directly
 model bacterial risk. However, EPA has
 adjusted its risk estimate for viral illness
 to approximate for the risk of bacterial
 illness.
  The simplifying assumptions used in
this risk assessment, as well as assessing
the exposure in only the positive wells,
yields an estimated average risk that
EPA assumes is a best estimate of the
actual risk given available data.
 3. Population Served by Untreated
 Ground Water Systems
   EPA estimates there are 44,000
 community ground water systems
 (CWS) serving 88 million people; 19,000
 non-transient, non-community ground
 water systems (NTNCWS) serving five
 million people; and 93,000 transient
 non-community ground water systems
 (TNCWS) serving 15 million people
 (SDWIS, 1997a). Of these systems, EPA
 estimates that 68% percent of CWSs are
 disinfected (CWSS, 1997) (US EPA,
 1997c). Larger CWSs are more likely to
 practice disinfection than are smaller
 CWSs (e.g., 81% of CWSs serving more
 than 100,000 people are disinfected
 while 45% of systems serving less than
 100 people disinfect. Estimates of
 treatment for noncpmmunity water
 systems are not as detailed. However,
 based upon information from State
 drinking water programs, EPA estimates
 28% of NTNCWS and 18% of TNCWS
 disinfect (US EPA, 1996a).
  Based upon the number of people
 served by ground  water systems, and the
 percentage of systems which disinfect,
 EPA estimates that 18 million people
 are served untreated ground water from
 CWSs, four million people are served
 untreated water from NTNCWSs, and  13
 million people are served untreated
 water from TNCWSs. There is a
 potential for double or triple  counting of
 the same people within these estimates
 since a number of people may be served
 ground water from more than one of the
 system type categories. For example, a
 person may consume water from a CWS
 at home, and  a NTNCWS at work or a
 TNCS while on vacation. EPA has
 addressed the potential for double
 counting in the analysis by assuming
 that individuals do not consume water
 from each system type every day (see
 section V).

 4. Pathogens Modeled
  EPA is concerned about ground water
 systems which are fecally contaminated
 since drinking water in these systems   i
 may contain pathogenic viruses and/or
bacteria. A wide number of viral and
bacterial pathogens have been
associated with waterborne disease in
ground water systems. However, there
are inadequate data for EPA to

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30214
Federal  Register /Vol. 65,  No. 91/Wednesday, May  10,  2000/Proposed Rules
characterize the risk attributable to each
pathogen because detection methods are
not available for all pathogens.
Additionally, detection methods which
are available may be insensitive and
incapable of detecting the presence of
viruses at very low concentrations.
However, even at low concentrations,
viruses in drinking water can result in
infection. To the extent that detection
methods do not exist for a particular
pathogen, there may be a resultant
underestimation of the risk of illness
and death.
  In this analysis, EPA estimates the
number of illnesses annually associated
with two types of pathogenic viruses
found in fecally contaminated ground
water. These two types of viruses are    '
designated as Type A and Type B
viruses for this analysis. Type A viruses
represent those viruses which are highly
infective, yet have relatively mild
symptoms (e.g., gastroenteritis). For this
analysis, rotavirus is used as a surrogate
for all Type A viruses because rotavirus
has been detected in drinking water
sources, dose-response data have been
prepared for rotavirus and rotavirus has
been implicated as the etiologic agent in
incidents of waterborne disease. Type B
viruses represent those viruses which
have low-to-moderate infectivity, yet
have potentially more severe symptoms
(e.g., myocarditis), and are represented
by echovirus. Echovirus also has
available dose-response data (Regli et al,
1991) and has been implicated in a
waterborne disease outbreak (Haefliger
et al, 1998).
   The risk assessment used model
viruses as surrogates of the actual
viruses present. As a result, the risk
assessment provides an estimation of
risks. The additional risks from other
viruses may be higher or lower
depending on their occurrence or
pathogenicity. For example, if the risk
assessment estimated the risks from
exposure to Norwalk virus (a Type A
virus), using rotavirus as a surrogate, the
morbidity rate may be higher for adults
than the rate assumed in the model. An
 outbreak in an Arizona resort in 1989
was believed to be caused by a Norwalk-
 like virus. This agent may have been
 responsible for an outbreak which
 caused illness in 110 out of 240 guests
 of all ages (Lawson et al, 1991), a 46%
 morbidity rate. This is much higher than
 the morbidity rate of 10% for Type A
 virus among people older than two.
 National occurrence data do not exist
 for many of the other pathogens that
 may occur in drinking water; therefore,
 EPA has  limited its estimation of risk to
 only those viral pathogens for which
 occurrence data and dose response data
 are available.
                        Occurrence studies show a significant
                      occurrence of bacterial indicators in
                      ground water wells; for example, almost
                      9% percent of the wells sampled in the
                      AWWARF study tested positive for the
                      presence of enterococci (Abbaszadegan
                      et al., 1999). However, EPA cannot
                      directly estimate national illnesses from
                      bacterial pathogens such as Salmonella,
                      due to a lack of occurrence data for
                      those pathogens. EPA believes that the'
                      majority of waterborne illnesses due to
                      unknown etiological agents are caused
                      by viruses because viruses move more
                      readily in the ground, remain viable
                      longer and are more infectious than
                      bacteria. Also, more methodologies exist
                      for the identification of bacterial
                      pathogens than for viral pathogens and
                      therefore bacterial pathogens are more
                      likely to be identifiable. The CDC data
                      shows that for every 100 viral or
                      unknown etiological agent illness.es
                      there were 20 bacterial illnesses.
                      Therefore, EPA estimates that the
                      number of viral illnesses can be
                      increased by 20% to account for
                      bacterial illnesses in ground water
                      systems.

                      5. Microbial Occurrence and
                      Concentrations
                        EPA reviewed the ground water viral
                      occurrence data  (see discussion of
                      occurrence studies in section II. C.) to
                      develop estimates of: the portion of
                      ground water sources which are
                      contaminated with viruses, the period of
                      time in •which the wells are
                      contaminated, and the concentration of
                      viruses within the contaminated wells.
                      EPA believes'feat improperly
                      constructed wells may have
                      significantly higher virus occurrence
                      and concentrations than properly
                      constructed wells (wells which do not
                      comply with State well construction
                      codes). Improperly constructed wells
                      are likely to have more pathways for the
                      introduction of viruses and less natural
                      filtration by the  overlying hydrogeologic
                      material. Therefore, the exposure and
                      risks from consumption of water from;
                      improperly constructed wells will most
                      likely be higher. As a result, the
                      exposure and risks should be assessed
                      separately for properly and improperly
                      constructed wells in order to develop a
                      range reflecting  national conditions.
                         EPA determined that the study
                      conducted by AWWARF represents
                      conditions in properly constructed
                      wells and the EPA/AWWARF
                       (Lieberman et al., 1994,1999) study
                      represents conditions in improperly  •
                       constructed wells. EPA selected the
                      AWWARF study as representative of
                       properly constructed wells (e.g., wells
                       with casing and grout to confining
layers, sanitary seals,'etc.) because it
excluded wells of improper
construction and the wells sampled
were representative of hydrogeologic
conditions for water supply wells in the
United States. However, the wells
selected may not have been
representative of the probability of fecal
contamination in ground water wells
nationally. As noted in section II.C.l.,
one-third of the wells in this study were
originally selected for the purpose of
evaluating the effectiveness of the  PCR
method based on criteria that may over
represent high risk wells. The remaining
two-thirds were selected to balance the
sample with wells that were
representative of hydrogeologic
conditions for drinking water wells
nationally. EPA requests comment and
data which would help assess the
representativeness of the wells in the
AWWARF study sample. However, EPA
believes that the AWWARF study  data
represents the best currently available
data on occurrence of viral pathogens in
properly constructed wells and has thus
used it as the basis of baseline incidence
estimates.
  EPA selected the EPA/AWWARF
study to be representative  of wells of
improper construction because it
sampled wells which were determined
to be vulnerable to contamination. The
EPA/AWWARF study considered  wells
as vulnerable based on one "or more of
the following considerations:
hydrogeology, well construction, State
nominations, micrbbial sampling
results, close proximity to known
sources of fecal contamination, and
water quality history. For the purposes
of the risk assessment, all wells
determined to be vulnerable were used
as surrogates for improperly constructed
wells. The results from this study  may
over estimate the risks from improperly-
constructed wells generally, since it
included  only wells that were
deliberately selected through a several
step process to be highly vulnerable to
contamination (see section H.C.2.). EPA
estimated that 83% of systems have
properly constructed wells based  upon
data from ASDWA's Survey of Best .  •
Management Practices for Community
Ground Water Systems (ASDWA,  1998).
   The AWWARF study data include
viral cell  culture assay results which
detect the presence of viable enterovirus
 (including echovirus and other Type B
viruses) in the samples. Twenty-one of
the 442 wells sampled (4.8%) tested
positive for the Type B viral cell culture.
EPA determined that this  data can be
 used to estimate the percentage of
 properly constructed wells which are
 contaminated at a given point in time   .
 with Type B viruses. The AWWARF

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                 Federal Register/Vol. 65, No.  91/Wednesday, May  10,  2000/Proposed Rules
                                                                    30215
study data also include rotavirus PCR
results which indicate that 62 of the 425
(14.6%) wells sampled contained
rotavirus genetic material. EPA
determined that the PCR results may be
an overestimation of the portion of wells
with viable Type A viruses since PCR
methods do not distinguish between
viable and non-viable viruses. To
calculate the portion of PCR positive
wells which contain viable viruses EPA
compared the enterovirus (Type B) cell
culture results to the enterovirus (Type
B) PCR analysis and found that for every
enterovirus cell culture positive well,
there were 3.3 PCR enterovirus positive
wells. EPA estimated that the 1/3.3
rotavirus PCR wells contained viable
virus, and therefore 4.4% (l4.6%/3.3) of
all properly constructed wells were
contaminated with Type B viruses at
any one time. Viral and bacterial
indicator data indicate there are a
greater percentage of wells in the study
which were fecally contaminated than
contained the viral pathogens at the
time of sampling. For example, almost
16% of all wells tested positive for viral
cell culture, male specific coliphage or
enterococci.
  The EPA/AWWARF study sampled
wells vulnerable to contamination
monthly for a one year period and found
that 6.0% of the samples tested positive
for enterovirus (Type B) cell culture.
Since cell culture methods are not
available for rotavirus (the
representative of Type A viruses), the
EPA/A WWARF study tested samples
using PCR methods for the presence of
rotavirus to estimate the occurrence of
Typo A viruses in improperly
constructed wells. However, the PCR
data is still under review by researchers
and unavailable for consideration in this
analysis. EPA therefore based the
estimate of occurrence of viable Type A
viruses in improperly constructed wells
on the ratio of viable Type A  virus in
the A WWARF study (4.4%) to Type B
viruses in the AWWARF study (4.7%).
Applying this ratio (4.4%/4.7%) to the
percentage of improperly constructed
wells containing Type B viruses (6.0%),
EPA estimates the percentage of
improperly constructed wells with Type
A virus contamination is 5.5%.
  EPA estimated Type A and Type B
virus concentrations are 0.36 viruses/
100L for properly constructed wells
based on the mean enterovirus
concentration in the AWWARF study.
EPA also estimated Type A and Type B
virus concentrations to be 29 viruses/
100L for improperly constructed wells
based on the mean enterovirus
concentration in EPA/A WWARF study.
Although these studies determined the
concentrations of enteroviruses (Type B
viruses) only, for the purposes of this
analysis EPA assumed the
concentrations of Type A viruses and
Type B viruses were equivalent.

6. Exposure to Potentially Contaminated
Ground Water
  EPA developed estimates of the
population potentially exposed to viral
pathogens based upon the estimates of
population served by undisinfected
systems and the portions of those
systems which are estimated to be
virally contaminated. In CWS, 18
million people are served undisinfected
ground water. Assuming 17% of wells
serving these people'are improperly
constructed (and 83% are properly
constructed) from the results of the
ASDWA BMP Survey (ASDWA, 1997),
and Type A viruses occur in 4.4% of
properly constructed wells and 5.5% of
improperly constructed wells, the
population potentially exposed to Type
A viruses in CWS is 842,000. Similar
calculations can be conducted to obtain
the population exposed to Type A
viruses in NTNCWS, as well as Type B
viruses in all ground water systems.
EPA's estimates of the population
potentially exposed to the viruses are
presented in Table II-9. Many of the
people exposed to the Type A viruses
are also exposed to the Type B viruses,
therefore these number cannot be
added.

TABLE   M-9.—POPULATION    POTEN-
  TIALLY EXPOSED TO VIRALLY CON-
  TAMINATED   DRINKING  WATER   IN
  UNDISINFECTED   GROUND   WATER
  SYSTEMS
System
type
CWS
NTNCWS ..
TNCWS 	
Population po-
tentially ex-
posed to type
A virus
842 000
175,000
567,000
Population po-
tentially ex-
posed to type
B virus
918 000
191,000
619,000
  To estimate the risk of illness from
consumption of undisinfected ground
water, EPA estimated people consume
an average 1.2 liters of water per day
based upon the 1994-1996 USDA
Continuing Survey of Food Intakes by
Individuals (US EPA, 2000a). EPA
accounted for the variability in
consumption by modeling consumption
as a custom distribution fit to age groups
in the survey data. EPA also assumed
that people consume water from CWSs
350 days per year; from NTNCWSs 250
days per year; and from TNCWSs 15
days per year. EPA notes that these
assumptions may allow for some double
counting of exposure, but EPA is not
aware of data to allow a more refined
breakdown of consumption. EPA
requests comment on these
assumptions.

7. Pathogenicity
  After estimating the population
potentially exposed to untreated (i.e.,
not disinfected) contaminated ground
water and the amount of water
consumed, the next step is to assess the
pathogenicity of the viruses. Once
viruses are consumed, the likelihood of
infection and illness varies depending
on the virus.
  For this analysis, the likelihood of
infection from ingestion of one or more
Type A or Type B viruses are estimated
based on dose response equations
developed for rotavirus (Ward et al.,
1986) and echovirus (Schiff et al., 1984),
respectively. These equations estimate
the annual probability of infection
following consumption of a specified
virus and are based on studies of
healthy volunteers. The volunteers for
these studies are typically between the
ages of 20 and 50, and therefore, may
underestimate the probability of
infection in sensitive subpopulations
(e.g., children and elderly) and the
immunocompromised (e.g., nursing
home residents and AIDS patients).
Rotavirus dose-response information
was used to represent Type A viruses,
while echovirus dose-response
information was used to represent Type
B viruses.
  Once a person becomes infected, the
likelihood of illness (morbidity) varies,
depending on the pathogen and the
sensitivity of the consumer. For Type A
viruses, EPA assumed the percent of
people becoming ill once infected is
88% for children under the age of two
(Kapikian and Chanock, 1996). EPA
assumed a morbidity rate of 10% for all
other populations based upon a study of
a rotavirus outbreak (Foster et al., 1980)
and incidents of rotavirus in families
with infants ill with rotavirus (Wenman
et al., 1979).
  EPA assumed the percent of people
infected with Type B viruses who
become ill also varies with age: 50% for
children five years of age and less, 57%
for individuals between 5 and 16 years
of age, and 33% for people older than
16. EPA estimated these age-specific
morbidity values based on data from a
community-wide echovirus type 30
epidemic (Hall et al.,  1970) and from the
New York Viral Watch (Kogon et al.,
1969).
  Secondary illnesses result from
individuals being exposed to
individuals who contracted the illness
from drinking water. For this analysis,
EPA estimates the additional number of

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people who become ill as a result of
secondary spread. For Type A viruses,
EPA assumed that an additional 0.55
people will become ill from every child
that becomes ill through consumption of
drinking water. This assumption is
based on a study of children under five
years old,  ill with rotavirus, who spread
the illness to others in their households
(Kapikian and Chanock, 1996). For Type
B viruses EPA assumed that 0.35
additional people will become ill
through secondary spread. This
assumption was based on a  review of
various epidemiological studies for
echovirus (Morens etal., 1991). There is
some uncertainty as to the exact rate of
secondary spread for Type B viruses, so
EPA has assumed that the secondary
spread rates range from 0.11 to 0.55.
  The probability that an ill person will
die as a result of an illness is referred
to as mortality. EPA expects Type A
viruses to result in far fewer deaths than
Type B viruses. EPA assumed a
mortality rate for all age groups of
0.00073 percent. This assumption was
based on an estimate of 20 rotavirus
deaths per year out of 2,730,000 cases of
rotavirus diarrhea in children 0-4 years
old (Tucker et al, 1998). EPA assumed
the mortality rate for Type B viruses be
0.92 percent for infants one month or
less. This  assumption was based upon
studies of hospitalized infants (Kaplan
                      and Klein, 1983). For the rest of the   !
                      population, EPA assumed that 0.04
                      percent of people ill from Type B     ;
                      viruses will die. These estimates may
                      underestimate the number of infant
                      deaths due to Type B viral illnesses,   '
                      since Jenista et al. (1984) and Modlin
                      (1986) reported a three percent case
                      fatality rate for infants (one month or ,
                      less) which is three times the value used
                      in the model.                       \
                      8. Potential Illnesses
                        EPA estimates, based upon the
                      assumptions described earlier, that
                      98,000 viral illnesses each year are
                      caused by consuming drinking water in
                      undisinfected public ground water
                      systems. EPA further estimates that nine
                      of these people die each year.
                        EPA believes there are additional   ,
                      waterborne illnesses and deaths among
                      consumers of drinking water from
                      public ground water systems beyond •
                      those estimated due to contaminated :
                      source waters in undisinfected systems.
                      Between 1991 and 1996 there were
                      1,260 waterborne outbreak illnesses   ;
                      reported to CDC which were attributed
                      to microbial contamination of the source
                      and inadequate or interrupted
                      disinfection, and 944 waterborne
                      illnesses reported to CDC which were
                      attributed to distribution system
                      contamination in ground water systems.
In that same period there were 2,924
reported outbreak illnesses in source
contaminated undisinfected system.
This results in 0.43 (1,260/2,924)
additional illnesses in source
contaminated, ground water systems
with failed disinfection for every illness
from undisinfected, fecally
contaminated ground water. Based on
similar analysis, there are also 0.32
(944/2,924) additional illnesses due to
distribution system contamination for
every one illness due to source
contamination in undisinfected ground
water systems. (This ratio does not
apply to transient noncommunity water
systems, because they do not have
distribution systems.) EPA assumed the
ratios of the causes of reported outbreak
illnesses is equal to the ratio  of the
causes of all waterborne illnesses.
Therefore, EPA estimates, based upon
these ratios, that an average of 42,000
additional illnesses and four additional
deaths occur each year as a result of
source contamination and inadequate or
interrupted disinfection. EPA also
estimates that an average of 28,000   .
additional illnesses and three additional
deaths are caused each year by
distribution system contamination.
Table 11—10 presents the estimates of
viral illness and death under current
conditions.
 TABLE 11-10.—ESTIMATES OF BASELINE VIRAL ILLNESS AND DEATH DUE TO CONTAMINATION OF PUBLIC GROUND WATER
                                                     SYSTEMS
Cause of contamination
Source contamination/undisinfected sys-
tem 	



All Causes 	

No. of type A
virus illnesses
78,000
34 000
22000

134,000

No. of type A
virus deaths
1



1

No. of type B
virus illnesses
20.0001
8000:
6,000

34,000

No. of type B
virus deaths
8
4
3

14

total illnesses
types A & B
98,000
42,000
28,000

168,000

Total deaths
types A & B
9
4
3

16

  Because of a lack of occurrence data
for bacterial pathogens in ground water,
risks from bacterial contamination of
ground water sources and distribution
systems are not quantified in this
assessment. Although it is believed that
viruses are more readily transported
through the subsurface than bacteria
(Sinton et al., 1997), ground water
system disease outbreaks caused by
bacterial pathogens such as Shigella,
Salmonella spp., and Campylobacter
spp. and E. coli O157:H7 have been
reported. For the period 1971-1996, 56
outbreaks, resulting in more than 10,000
illnesses and 11 deaths, were attributed
to bacterial pathogen contamination of
public ground water systems. More than
20% of these bacterial outbreaks
                      occurred since 1991, and several     !
                      outbreaks were attributed to gross fecal
                      contamination of distribution lines.
                        As previously stated, there may be an
                      additional 20% of illnesses caused by
                      bacterial pathogens (in the absence of
                      viral pathogens) in fecally contaminated
                      ground water. Therefore, the numbers of
                      illnesses and deaths presented in Table
                      11-10 may underestimate the true
                      numbers of annual illnesses and deaths
                      by 20% (an estimated  34,000 additional
                      illnesses and three additional deaths).
                      9. Summary of Key Observations

                        In conclusion, EPA believes that at
                      any one point in time  (most
                      approximately 90 percent) ground water
                      systems provide uncontaminated water.
However, the risk characterization
described herein indicates that a subset
of ground water systems represent a
potential risk to public health, which
clearly supports the need to proceed
with regulation of these systems.
According to the assessment, EPA
estimates that approximately 168,000
people are at risk to viral illness and 16
people are at risk of death, annually. It
is noted that this analysis focuses
primarily on the potential of
gastrointestinal illness caused by
exposure to viruses, therefore; the
potential for additional illnesses from
ground water contaminated only by
pathogenic bacteria also exists and may
account for an additional 34,000
illnesses and three deaths annually.

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                                                                     30217
Therefore, the estimate of illnesses
represents a potential underestimate of
the actual illnesses attributed to
consumption of water from ground
water systems. Based on this analysis
EPA believes that risk of microbial
illness exists for a substantial number of
people served by ground water systems.
Consequently, EPA believes that the
proposed regulatory provisions
discussed later provide a meaningful
opportunity for public health risk
reduction.
10. Request for Comments
  EPA seeks comment on the data,
criteria and methodology used in the
risk assessment, and where any different
approaches may be appropriate. EPA
also seeks comment on the assumptions
used in this assessment, as well as the
conclusions reached, and any additional
data that commenters may be able to
provide on occurrence, exposure,
infectivity, morbidity, or mortality
associated with microbial pathogens in
ground water.
F. Conclusion
  In EPA's judgment, the data and
information presented in  previous
sections relating to outbreaks,
occurrence, adverse microbial health
effects, exposure, and risk
characterization demonstrate that there
are contaminants of concerns that exist
in ground water at levels and at
frequencies of public health concern.
Moreover, as discussed in detail later,
the Agency believes there are targeted
risk-based regulatory strategies that
provide a meaningful opportunity to
reduce public health risk for a
substantial number of people served by
ground water sources.
  EPA recognizes that there are
particular challenges associated with
developing an effective regulatory
approach for ground water systems.
These include first, the large number of
ground water systems; second, the fact
that only a subset of these systems
appear to have microbial contamination
(although a larger number are likely to
be vulnerable); and third, that most
ground water systems range from being
small to very small in terms of
population served. These factors
combine  to underscore the fact that a
one-size-fits-all approach cannot work.
This point was made repeatedly by
participants in public stakeholder
meetings across the country, and EPA
agrees. The task therefore is to develop
a protective public health approach
which ensures a baseline of protection
for all consumers of ground water and
sots in place an increasingly targeted
strategy to identify high risk or high
priority systems that require greater
scrutiny or further action.
HI. Discussion of Proposed GWR
Requirements
  The information outlined earlier
indicates that the primary causes of
waterborne related illnesses are
associated with source water
contamination and untreated ground
water, source water contamination and
unreliable treatment, water system
deficiencies, and a subset of waterborne
disease outbreaks of unknown causes.
The requirements and options proposed
today address each of these areas
through a multiple-barrier approach
which relies upon five major
components: periodic sanitary surveys
of ground water systems requiring the
evaluation of eight elements and the
identification of significant deficiencies;
hydrogeologic assessments to identify
wells sensitive to fecal contamination;
source water monitoring for systems
drawing from sensitive wells without
treatment or with other indications of
risk; a requirement for correction of
significant deficiencies and fecal
contamination through the following
actions: eliminate the source of
contamination, correct the significant
deficiency, provide an alternative
source water, or provide a treatment
•which achieves at least 99.99 percent (4-
log) inactivation or removal of viruses,
and compliance monitoring to insure
disinfection treatment is reliably
operated where it is used.
A. Sanitary Surveys
1. Overview and Purpose
  A key element of the multiple-barrier
approach is periodic inspection of
ground water systems through sanitary
surveys. According to the Total
Coliform Rule (TCR), a sanitary survey
is an onsite review of the water source,
facilities, equipment, operation and
maintenance of a public water system
for the purpose of evaluating the
adequacy of such source, facilities,
equipment, operation and maintenance
for producing and distributing safe
drinking water (40 CFR 141.2). The
Agency believes that periodic sanitary
surveys, along with appropriate
corrective actions, are indispensable for
assuring the long-term quality and
safety of drinking water. When properly
conducted, sanitary surveys can provide
important information on a water
system's design and operations and can
identify minor and significant
deficiencies for correction before they
become major problems. By taking steps
to correct deficiencies exposed by a
sanitary survey, the system provides an
additional barrier to microbial
contamination of drinking water.
  The Agency proposes the following
sanitary survey requirements: (1) States,
or authorized agents, conduct sanitary
surveys for all ground water systems at
least once every three years for CWSs   ,
and at least once every five years for
NCWSs; (2) sanitary surveys address all
eight elements set out in the EPA/State
Joint Guidance on sanitary surveys
(outlined later in this section); (3) States
provide systems with written
notification which describes and
identifies all significant deficiencies no
later than 30 days of the on-site survey;
and (4) systems consult with the State
and take corrective action for any
significant deficiencies no later than 90
days of receiving written  notification of
such deficiencies, or submit a schedule
and plan to the State for correcting these
deficiencies within the same 90 day
period; and (5) States must confirm that
the deficiencies have been addressed
within 30 days after the scheduled
correction of the deficiencies.
  A ground water system that has been
identified as having significant
deficiencies must do one  or more of the
following: eliminate the source of
contamination, correct the significant
deficiency, provide an alternate source '
water, or provide a treatment which
reliably achieves at least 99.99 percent
(4-log) inactivation or removal of viruses
before or at the first customer. Ground
water systems which provide 4-log
inactivation or removal of viruses will
be required to conduct compliance
monitoring to demonstrate treatment
effectiveness. The ground water system
must consult with the State to
determine which of the approaches, or
combination of approaches, are
appropriate for meeting the treatment
technique requirement. Ground water
systems unable to address the
significant deficiencies in 90 days, must
develop a specific plan and schedule for
meeting this treatment technique
requirement, submit them to the State,
and receive State approval before the
end of the same 90-day period. For the
purposes of this paragraph, a
"significant deficiency" includes,: 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.
  Sanitary surveys provide a
comprehensive and accurate record of
the components of water systems, assess
the operating conditions and adequacy
of the water system, and determine if

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Federal  Register/Vol. 65, No. 91 •/Wednesday, May  10,  2000/Proposed Rules
past recommendations have been
implemented effectively. The purpose of
the survey is to evaluate and document
the capabilities of the water system's
sources, treatment, storage, distribution '
network, operation and maintenance,
and overall management in order to
ensure the provision of safe drinking
water. In addition, sanitary surveys
provide an opportunity for State
drinking water officials or approved
third party inspectors to visit the water
system and educate operators about
proper monitoring and sampling
procedures, provide technical
assistance, and inform them of any
changes in regulations.
  Sanitary surveys have historically
been conducted by State drinking water
programs as a preventative tool to
identify water system deficiencies that
could pose a threat to public health. In
1976, EPA regulations established, as a
condition of primacy, that States
develop a systematic program for
conducting sanitary surveys, with
priority given to public water systems
not in compliance with drinking water
regulations (40 CFR 142.10 (b)(2)). This
primacy requirement did not define the
scope of sanitary surveys or specify
minimum criteria.
  In 1989, the TCR included a provision
that requires systems that serve 4,100
people or less and collecting fewer than
five routine total coliform samples per
month to conduct a periodic sanitary
survey every five years, with an
exception made for NCWS that use
protected and disinfected ground water
to conduct the survey every ten years.
The TCR, however, does not establish
what must be addressed in a sanitary
survey or how such a survey should be
conducted. The responsibility is on the
system rather than the State for
completing the sanitary survey (40 CFR
141.21(d)(2)). The TCR requires systems
to use either a State official or an agent
approved by the State to conduct the
sanitary survey.
  The IESWTR (63 FR 69478, December
16, 1998), established requirements for
primacy States to conduct sanitary
surveys for all systems using surface
water or ground water under the direct
influence of surface water. The rule also
requires States to have the appropriate
authority for ensuring that systems
address significant deficiencies. The
State must perform a survey at least
once every three years for CWSs and
every five years for NCWSs. These
surveys must encompass the eight major
areas defined by the EPA/State Joint
Guidance (discussed in section 3).'
  This GWR proposal and the IESWTR
differ in the requirements for a system
to correct any significant deficiency. In
                      the IESWTR, States are specifically  •  :
                      required to have the appropriate rules or
                      other authority to require systems to ,
                      respond in writing to significant     ;
                      deficiencies outlined in a sanitary
                      survey report within at least 45 days. :A
                      system, under this 45-day time frame, is
                      required to notify the State in writing,
                      how and on what schedule it will
                      address significant deficiencies noted in
                      the survey. This GWR proposal differs
                      from the IESWTR by proposing to
                      require ground water systems to correct
                      significant deficiencies and to do so
                      within 90  days or seek a State approved
                      schedule for plans requiring longer than
                      90 days.

                      2. General Accounting Office Sanitary
                      Survey Investigation
                        In 1993, the US General Accounting
                      Office (US GAO) investigated State
                      sanitary survey practices. The  US GAO
                      found that many sanitary surveys were
                      deficient, and that follow-up on major
                      problems was often lacking. This
                      investigation, which is described next,
                      was published as a report, Key Quality
                      Assurance Program is Flawed and
                      Underfunded (US GAO 199,3). .  .   ''
                        US GAO was directed by Congress to
                      review State, sanitary survey programs
                      due to congressional concern that many
                      States were cutting back on these
                      programs, and thus undermining public
                      health. Congress asked US  GAO to
                      determine in its report whether sanitary
                      surveys are comprehensive enough to
                      determine if a •water system is providing
                      safe drinking water and what the results
                      indicate about water systems
                      nationwide.
                        As part of this effort, GAO sent a  \
                      detailed questionnaire to 49 States to
                      attain a nationwide perspective on
                      whether the States were conducting
                      sanitary surveys, the frequency and
                      comprehensiveness  of the surveys, and
                      what the survey results indicate about
                      the operation and condition of water
                      systems. To obtain more detailed
                      information, the GAO also  focused on
                      200 specific sanitary surveys conducted
                      on CWSs in four States (Illinois,
                      Montana, New Hampshire  and
                      Tennessee). This information was
                      summarized in the GAO's report (US
                      GAO 1993). The GAO report presented
                      a number  of key concerns,  as discussed
                      next.
                        Frequency Varies  Among States and is
                      Declining Overall. At least 36 States had
                      a policy to conduct surveys of CWSs at
                      intervals of three years or less; however,
                      only 21 of these States were conducting
                      surveys at this frequency. The
                      remaining 15 States reported they were
                      unable to implement this policy because
                      their inspectors had other competing
responsibilities that often took       - • :
precedence over non-mandated
requirements (e.g., sanitary surveys).
Overall, the frequencies of the surveys
vary from quarterly to 10 years.
According to the report, States have
reduced the frequency of surveys since i
1988, a downward trend that is
expected to continue.
  Comprehensiveness of Sanitary
Surveys is Inconsistent. The report
indicates that a comprehensive sanitary
survey, as recommended in Appendix K
of EPA's SWTR Guidance Manual (US
EPA, 1990b), is frequently not
conducted. Forty-five out of 48 States
omitted one or more key elements
defined in the 1990 guidance manual.
The GAO noted wide variation among
States in the comprehensiveness of their
sanitary surveys. Some States, for
example, omit inspections of water
distribution systems arid/or other key
components or operations of water
systems, others do not provide complete
documentation of sanitary survey
results. Based on a review of the 200
sanitary surveys, survey results which
identify deficiencies were found to be
inconsistently interpreted from one
surveyor to another. In some cases,
systems' deficiencies that could have -
been detected during a comprehensive
survey may not be found until after
water quality is affected and the root
caiise(s) investigated. By that time,'
however, consumers may already have
ingeste'd contaminated water (US GAO,
1993).
  Limited Efforts to Ensure that
Deficiencies are Corrected. The GAO
found that follow-up procedures for
deficiencies were  weak. The detailed
review of the four States' sanitary
surveys indicated that deficiencies
frequently go uncorrected. Of the 200
surveys examined, about 80% .disclosed
deficiencies and 60% cited deficiencies
that had already been identified in
previous surveys.  Of particular concern
was the GAO finding that smaller
systems (serving 3,300 or less) are in
greatest need of improvements. Small
systems compose  a significant majority
of all ground water systems. Ninety-nine'
percent (approximately 154,000) of
ground water systems serve fewer than
10,000 people and ninetyjseven percent-
(approximately 151,000) Serve 3,300 or
fewer people.
  Results Poorly Documented. The GAO
also found variation in how States
document and interpret survey results.
Proper documentation would facilitate
follow-up on the problems detected.
  GAO recommended EPA work with
States to establish minimum criteria on
how surveys should be conducted and
documented and to develop procedures

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                 Federal Register/Vol.  65,  No. 91/Wednesday, May  10,  2000/Proposed Rules
                                                                     30219
to ensure deficiencies are corrected.
This proposal addresses these
recommendations.
3. ASDWA/EPA Guidance on Sanitary
Surveys
  Recognizing the essential role of
sanitary surveys and the need to define
the broad areas that all sanitary surveys
should cover, EPA and ASDWA
prepared a joint guidance on sanitary
surveys entitled EPA/State Joint
Guidance on Sanitary Surveys (1995).
The guidance identified the following
eight broad components that should be
covered in a sanitary survey: source,
treatment, distribution system, finished
water storage, pumps and pump
facilities and controls, monitoring/
reporting/data verification, water system
management and operations, and
operator compliance with State
requirements. The EPA/State Joint
Guidance does not provide detailed
instructions on evaluating criteria under
the eight elements; however, EPA has
recently issued detailed supplementary
information as technical assistance
(April 1999, Guidance Manual for
Conducting Sanitary Surveys of Public
Water Systems)(US EPA, 1999e).
—Source. The water supply source is
  the first opportunity for controlling
  contaminants. The reliability, quality,
  and quantity of the source should be
  evaluated during the sanitary survey
  using available information including
  results of source water assessments or
  other relevant information. A survey
  should assess the potential for
  contamination from activities within
  the watershed as well as from the
  physical components and condition of
  the source facility.
—Treatment. The treatment phase
  should consider evaluation of the
  handling, storage, use and application
  of treatment chemicals if the system
  includes application of any
  chemicals. A review of the treatment
  process should include assessment of
  the operation, maintenance, record
  keeping and management practices of
  the treatment system.
—Distribution System. Given the
  potential for contamination to spread
  throughout the distribution system, a
  thorough inspection of the
  distribution network is important.
  Review of leakage that could result in
  entrance of contaminants, monitoring
  of disinfection residual, installation
  and repair procedures of mains and
  services, as well as an assessment of
  the conditions of all piping and
  associated Fixtures are necessary to
  maintain distribution system
  integrity.
—Finished Water Storage. A survey of
  the storage facilities is critical to
  ensuring the availability of safe water,
  and the adequacy of construction and
  maintenance of the facilities.
—Pumps/Pump Facilities and Controls.
  Pumps and pump facilities are
  essential components of all water
  systems. A survey should verify that
  the pump and its facilities are of
  appropriate design and properly
  operated and maintained.
—Monitoring/Reporting/Data
  Verification. Monitoring and reporting
  are needed to determine compliance
  with drinking water provisions, as
  well as to verify the effectiveness of
  source protection, preventative
  maintenance, treatment, and other
  compliance-related issues regarding
  water quality or quantity.
—Water System Management/
  Operations. The operation and
  maintenance of any water system is
  dependent on effective oversight and
  management. A review of the
  management process should ensure
  continued and reliable operation is
  being met through adequate staffing,
  operating supplies, and equipment
  repair and replacement. Effective
  management also includes ensuring
  the system's long-term financial
  viability.
—Operator compliance with State
  requirements. A system operator plays
  a critical role in the reliable delivery
  of safe drinking water. Operator
  compliance with State requirements
  includes state-specific operation and
  maintenance requirements, training
  and certification requirements, and
  overall competency wiftron-site
  observations of system performance.
  4. Other Studies
  As previously described (see section
I.D.2.), ASDWA examined 28 different
BMPs to determine the  effectiveness of
each BMP in controlling microbial
contamination. Within this study,
91.4% of systems surveyed had
implemented a sanitary survey within
the previous five years. The ASDWA
survey found no significant association
with systems that conducted sanitary
surveys and no total coliform
detections. The insignificance of the
association between sanitary surveys
and the detection of bacteria may be due
to the fact that State sanitary surveys are
designed to identify problems (ASDWA,
1998). However, correction of sanitary
survey deficiencies was correlated with
lower levels of total coliform, fecal
coliform, and E. coli.
  EPA conducted a survey published in
Ground Water Disinfection and
Protective Practices in the United States
(US EPA 1996a), which confirmed the
GAO finding that considerable
variability among States exists with
regard to the scope and
comprehensiveness of sanitary surveys.
  The Environmental Law Reporter
(ELR), a private database of State and
Federal statutes and regulations,
provides some information on current
State regulations for ground water
systems. According to the ELR, only the
State of Washington does not require
sanitary surveys under the TCR
requirement at 40 CFR 141.21(d).
However, most State regulations found
in the ELR are general in nature and do
not specifically address the eight EPA/
State Joint Guidance sanitary survey
components. State.regulations vary
considerably in terms of types of
systems surveyed, the content of the
survey,  and who is designated to
conduct the surveys (e.g., a sanitarian).
The database indicates that the majority
of States (46 out of 50) do not
specifically require systems to correct
deficiencies. Significantly, a number of
States do not appear to have legal
authority to require correction of
deficiencies. The ELR findings
contained in the Baseline Profile
Document for the Ground Water Rule
(US EPA, 1999f) indicate that  many
sanitary survey provisions do  not
appear in State regulations. The GAO
report confirmed that many States
incorporated sanitary survey
requirements into policy, thereby
undercutting their legal enforceability.

5. Proposed Requirements
  EPA proposes to require periodic
State sanitary surveys for all ground
water systems specifically addressing all
of the applicable sanitary survey
elements noted earlier, regardless of
population size served.
  With regard to the frequency of
sanitary surveys, EPA proposes to
require the State or a state-authorized
third party to conduct sanitary surveys
for all ground water systems at least
once every three years for CWSs and at
least once every five years for  NCWSs.
This approach would be consistent with
the requirements of the IESWTR. CWSs
would be allowed to follow a five-year
frequency if the system either  treats to
4-log inactivation or removal of viruses
or has an outstanding performance
record in each of the applicable eight
areas documented in previous
inspections and has no history of TCR
MCL or monitoring violations  since the
last sanitary survey. A State must, as
part of its primacy application, include
how it will decide whether a system has
outstanding performance and  is thus
eligible for sanitary surveys at a reduced
frequency.

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  The Agency believes that periodic
sanitary surveys, along with appropriate
corrective measures, are indispensable
for ensuring the long-term safety of
drinking water. By taking steps to
correct deficiencies exposed by a
sanitary survey, the system provides an
additional barrier to pathogens entering
the drinking water.
  The definition of a sanitary survey
used in the GWR differs from the
definition of a sanitary survey in 40 CFR
141.2 by a parenthetical clause. For the
purpose of Subpart S, a sanitary survey
is "an onsite review of the water source
(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." This reflects a recommendation
by the 1997 M/DBP Federal Advisory
Committee Act that sanitary inspectors
should use source water assessments
and other information where available
as part of the overall evaluation of
systems.  This change in definition
reflects the value of Source Water
Assessment and Protection Programs
(SWAPPs) required by Congress in the
1996 SDWA amendments and the
importance of utilizing information
generated as a result of that activity.
  EPA is also proposing to require that
State inspectors, as part of each sanitary
survey, evaluate all applicable
components defined in the EPA/State
Joint Guidance on Sanitary Surveys and
identify any significant deficiencies.
Some stakeholders have suggested the
comprehensiveness of sanitary surveys
be tailored based upon system size and
type. EPA requests comment on whether
this would be an appropriate approach
and if so, what factors or criteria  should
be considered in tailoring the scope or
complexity of the sanitary survey.
  Individual components of a sanitary
survey may be separately completed as
part of a staged or phased State review
process as part of ongoing  State
inspection programs within the
established frequency interval. In its
primacy package, a State which plans to
complete the sanitary survey in such a
staged or phased review process must
indicate which approach it will take and
provide the rationale for the specified
time frames for sanitary surveys
conducted on a staged or phased
approach basis.
  EPA proposes to regard the
requirements for sanitary surveys under
the GWR as meeting the requirements
for sanitary surveys under the TCR (40
                      CFR 141.21). The reason for this is that
                      the frequency and criteria of a sanitary
                      survey under the GWR is more stringent
                      than that for the TCR. For example, the
                      TCR does not define a sanitary survey
                      as precisely as the GWR, which requires
                      an evaluation of eight elements. In
                      addition, the frequency of the sanitary
                      survey under the TCR for CWSs is every
                      five years, compared to three years (at
                      least initially) under the GWR. Also, the
                      TCR requires a survey every ten years  .
                      for disinfected NCWSs using protected
                      ground waters, as compared to every
                      five years under the GWR. The scope of
                      the systems that must conduct a sanitary
                      survey also differs; under the TCR only
                      systems that collect fewer than five ,
                      routine samples per month  and serve
                      less than 4,100 persons are required to
                      undergo a sanitary survey, compared to
                      all ground water systems under the :
                      GWR. Given that the proposed sanitary
                      survey requirements under  the GWR are
                      more stringent than those under the
                      TCR, EPA notes that a survey under;the
                      TCR cannot replace one conducted
                      under the GWR, unless that survey
                      meets the criteria specified  in the GWR.
                        As part of today's rule, a "significant
                      deficiency" as identified by a sanitary
                      survey includes: 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. This is a
                      working definition developed by the
                      EPA GWR workgroup.
                        The Agency proposes to require the
                      State to provide the system  with written
                      notification which identifies and
                      describes any significant deficiencies
                      found in a sanitary survey no later than
                      30 days after completing the on-site
                      survey. States would not be required, in
                      this rule, to provide the system with a
                      complete sanitary survey report within
                      the 30 days of completing the on-site
                      survey. Rather, this rule requires that, at
                      a minimum, the State provide the
                      system a written list which clearly
                      identifies and describes all significant
                      deficiencies as identified during the on-
                      site survey.
                        EPA proposes to require a system to:
                      (1) Correct any significant deficiencies
                      identified in a sanitary survey as soon
                      as possible, but no later than 90 days of
                      receiving State written notification of
                      such deficiencies, or (2) to submit a
                      specific schedule and receive State
                      approval on the schedule for correcting
                      the deficiencies within the same 90-day
                      period. The system must consult the
                      State within this 90-day period to
                      determine the corrective action
approach appropriate for that system,
consistent with the State's.general
approach outlined in their primacy
package. In performing a corrective
action, the system must eliminate the
source of contamination, correct the
significant deficiency, provide an
alternate source water, or provide a
treatment which reliably achieves at
least 99.99 percent (4-log) inactivation
or removal of viruses before or at the
first customer. Ground water systems
which provide 4-log inactivation or
removal of viruses will be required to
conduct compliance monitoring to
demonstrate treatment effectiveness.
There are cases in which one or more
of the corrective actions listed
previously may be inappropriate for the
nature of the problem, and in these
cases only appropriate corrective
actions  must be taken. For example, a
system with a significant deficiency in
the distribution system should not
install treatment at the source water as
the corrective action; that system should
correct the problem in the distribution
system. There may also be fecal sources
that a State does not identify as a
significant deficiency, however the State
may choose to use their authority to
require  source water monitoring to
monitor the influence of that fecal
source.  Ground water systems which
provide 4-log inactivation or removal of
viruses will be required to conduct
compliance monitoring to demonstrate
treatment effectiveness. States must
confirm that the deficiency has been
corrected, either through written
confirmation from systems or a site visit
by the State, within 30 days after the 90-
day or scheduled correction of the
deficiency. Systems providing 4-log
inactivation or removal of viruses need
not undergo a hydrogeologic sensitivity
assessment or monitor their source
water for fecal indicators.
  As noted earlier, States would be
required to have the appropriate rules or
other authority to: (l) Ensure that public
ground water systems correct any
significant deficiencies identified in the
written notification provided by the
State (including providing an alternative
source or 4-log inactivation or removal
of viruses); and (2) ensure that a public
ground water system confirm in writing
any significant deficiency corrections
made as a result of sanitary survey
findings.
  The requirements in today's rule do
not preclude a State from enforcing
corrective action on any significant
deficiencies whether or not they are
identified through a sanitary survey.
  EPA is also proposing to require
States, as part of their primacy
application, to indicate how they will

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                                                                    30221
define what constitutes a significant
deficiency found in a sanitary survey for
purposes of this rule. EPA believes that
this requirement would provide the
State sufficient latitude to work within
their existing programs in addressing
significant deficiencies yet provide
facilities and the public with clear
notice as to what kinds of system
conditions constitute a significant
deficiency. EPA recognizes the
importance of enabling States the
flexibility to identify and define sanitary
survey deficiencies in broad categories
under this requirement (e.g., unsafe
source, improper well construction,
etc.).
  Also, in its primacy application,
States must specify if and how they will
integrate SWAPP susceptibility
determinations into the sanitary survey
or the definition of significant
deficiencies.
  Based upon input from a number of
State and EPA Regional office experts,
significant deficiencies of ground water
systems may include but are not
limited, to the following types of
deficiencies:
—Unsafe source (e.g., septic systems,
  sewer lines, feed lots nearby);
—Wells of improper construction;
—Presence of fecal indicators in raw
  water samples;
—Lack of proper cross connection
  control for treatment chemicals;
—Lack of redundant mechanical
  components where chlorination is
  required for disinfection;
—-Improper venting of storage tank;
—Lack of proper screening of overflow
  pipe and drain;
—'Inadequate roofing (e.g., holes in the
  storage tank, improper hatch
  construction);
—Inadequate internal cleaning and
  maintenance of storage tank;
—Unprotected cross connection (e.g.,
  hose bibs without vacuum breakers);
—Unacceptable system leakage that
  could result in entrance of
  contaminants;
—Inadequate monitoring of disinfectant
  residual and TCR MCL or monitoring
  violations.
6. Reporting and Record Keeping
Requirements
  The GWR does not change the
requirements on the system and the
State to maintain reports and records of
sanitary survey information as specified
In 40 CFR 141.33(c) and 142.14(d)(l).
7. Request for Comments
  EPA requests comment on all the
information presented earlier and the
potential impacts on public health and
regulatory provisions of the GWR. In
addition, EPA specifically requests
comments on alternative approaches.

Alternative Approaches
a. Content of a Sanitary Survey
i. Grandfathering and Scope of Sanitary
Survey

  EPA requests comment on
"grandfathering" of surveys conducted,
under the TCR if those surveys
addressed all eight EPA/State Joint
Guidance on Sanitary Surveys
components. Under what circumstances
should grandfathering be allowed? Are
there circumstances under which
grandfathering should be allowed even
if the survey,did not address all eight
components?
  EPA is seeking comment on the level
of detail EPA should use in establishing
the sanitary survey requirement which
addresses the eight sanitary survey
components.

ii. Definition of Significant Deficiency

  EPA is also seeking comment on the
proposed definition of "significant
deficiencies." In this regard, EPA is
requesting comment on whether or not
the Agency should promulgate a
minimum list of specific significant
deficiencies for all States to use in their
programs.

iii. Well Construction and Age

  EPA considered specifying, in
addition to sanitary survey elements,
well construction deficiencies and well
age as surrogate measures of well
performance as part of the
hydrogeologic sensitivity assessment
(HSA) or as an independent component
from the sanitary survey or HSA. EPA
considered identifying older wells as
those more likely to be contaminated
because of degradation to the
construction materials over time. EPA
concluded that wells may have been
constructed adequately to protect public
health, but records to document such
construction may no longer be available.
Given these circumstances, EPA
recognizes that down-hole test methods
to evaluate well construction, as
required for some hazardous waste
disposal methods, is neither desirable
nor feasible for PWS wells. In addition,
EPA found that there were few data to
support the concept that older wells
were more likely to be contaminated. In
fact, data from two studies
encompassing more than 200 wells in
Missouri suggest that newer wells were
more likely to be contaminated than
older wells (Davis and Witt, 1998,1999
and Femmer, 1999). Thus, EPA decided
not to include well construction and age
as measures of the potential fecal hazard
to PWS wells.
  Almost all States have well
construction standards, and trade
associations, such as the American
Water Works Association and the
National Ground Water Association,
have also provided recommendations
for well construction. EPA recognizes
the importance of designing,
constructing and maintaining wells so
as to maximize well life and yield and
to minimize potential harmful
contamination. Therefore, the Agency
requests comment on whether well
construction and age should be
considered as a required element within
a sanitary survey or specifically
identified by States as a significant
deficiency. EPA also requests comment
on criteria for evaluating well
construction and age.

b. Frequency
  EPA believes that a sanitary survey
cycle of at least once every three years
for CWSs (with certain exceptions
discussed previously) and at least once
every five years for NCWSs most
properly balances public health
protection and State burden issues and
is consistent with the frequency
required for surface water systems.
However, the Agency seeks comment on
whether other alternative time cycles
might be appropriate together with any
applicable rationale that supports that
alternative frequency cycle.  Specifically,
EPA requests comment on requiring
States to conduct sanitary surveys for all
ground water systems every five years.
EPA also requests comment on allowing
States to conduct sanitary surveys less
often than once every 5 years if the
system provides 4-log inactivation or
removal. The Agency requests comment
on the resource implications for  States
and small systems to perform these
surveys with a frequency of 3—5 years.
  In addition, the Agency seeks
comment on requiring the State to
conduct a sanitary survey for new
systems prior to the system serving
water to the public. This requirement
would serve as an added public health
measure to ensure new  systems are in
compliance with the GWR sanitary
survey provisions.

c. Follow-Up Requirements
  EPA requests comment on requiring
States to schedule an on-site inspection
as follow-up to verify correction of
significant deficiencies, rather than
allowing States to accept written
certification from systems to verify the
correction. EPA requests comment on
alternative approaches for a  State to
verify that a significant  deficiency has

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been corrected. EPA notes that follow-
up in this context only applies to
significant deficiencies. .

d. Public Involvement
  EPA requests comment on including
public involvement and/or meetings for
certain systems to discuss the results of
sanitary surveys. Congress wrote
requirements for extensive public
information and involvement in
programs and decisions affecting
drinking water safety throughout the
1996 amendments to SDWA. For
example, in addition to the new
requirement for CWSs to produce and
distribute annually a Consumer
Confidence Report, the public notice
requirements for PWSs regarding
violations of a national drinking water
standard were made more effective, and
States were required to "make readily
available to the public" an annual report
to the Administrator on the statewide
record of PWS violations, see (SDWA
1414(c)(lM3)). Each State's triennial
report to the Governor on the
effectiveness  of and progress under the
capacity development strategy must  also
be available to the public. (See SDWA
section 1420(c)(3)). EPA must make the
information from the occurrence
database "available to the public in
readily accessible form." (See SDWA
section 1445(g)(5)). The public must be
provided with notice and an
opportunity to comment on the annual
priority list of projects eligible for State
Revolving Fund (SRF) assistance that
States "will publish as a part of their SRF
intended use plans (See SDWA section
1452(b)(3)(B)). States "shall make the
results of the source water assessments
* * * available to the public." (See
SDWA section 1453(a)(7)). And, under
several specific provisions of the SDWA
as well as the Administrative Procedure
Act, EPA generally must publish and
make regulations, and a number of
guidance and information documents,
available for public notice and
comment.
  These requirements, and others like
them, are integral to both the
philosophy and operation of the
amended SDWA. They reflect Congress"
view that public confidence in drinking
water safety and informed support for
any needed improvements must rest on
full disclosure of all significant
information about water system
conditions and quality, from source to
tap.
  The 1996 SDWA Amendments, and
EPA's implementation of them,
consistently provide for such disclosure
and involvement by means that are
informative, timely, understandable,
and practicable for each size group of
                      PWSs subject to them. EPA believes that
                      the principles of public information and
                      involvement must apply with equal
                      validity to the GWR, and is considering
                      including in the final rule provisions to
                      apply these principles, for disclosure
                      and involvement. EPA believes that the
                      following approach meets both tests and
                      principles, but solicits comment on
                      alternative means of doing so.
                        EPA requests comment on what
                      approaches might be practicable, not
                      burdensome and workable to involve
                      the public in working with their system
                      to address the results of their system's
                      sanitary survey. Specifically, EPA
                      requests comment on requiring ground
                      water CWSs to notify their consumers,
                      as part of the next billing cycle, of the
                      completion of any sanitary survey, and
                      any significant deficiency(s) and
                      corrective action(s) identified. The
                      system would also have to make
                      information concerning the sanitary
                      survey available to  the public upon
                      request. Alternatively, the system might
                      be required to notify customers of the
                      availability of the survey only, and
                      provide copies on request, or include
                      information about the survey in the
                      annual Consumer Confidence Report
                      (CCR). EPA requests comment on
                      whether this approach should be
                      extended to transient and nontransient
                      NCWSs as well. EPA also requests
                      comment on what approaches might be
                      practicable, not burdensome and
                      workable to involve the public in
                      working with their  system  to address
                      the results of their system's sanitary
                      survey.
                      B. Hydrogeologic Sensitivity Assessment
                      1. Overview and Purpose
                        Occurrence data collected at the
                      source from public  ground water
                      systems suggest that a small percentage
                      of all ground water systems are fecally
                      contaminated. Because of the large
                      number of ground water systems
                      (156,000), the GWR carefully targets the
                      high priority systems and has minimal
                      regulatory burden for the remaining low
                      priority systems. The GWR screens all
                      systems for priority and only requires
                      corrective action for fecally
                      contaminated systems and systems with
                      significant deficiencies. Thus, the
                      challenge of the hydrogeologic
                      sensitivity assessment is to identify
                      ground water wells sensitive to fecal
                      contamination. The assessment
                      supplements the sanitary survey by
                      evaluating the risk factors associated
                      with the hydrogeologic setting of the
                      system. EPA believes requiring
                      hydrogeologic sensitivity analysis for all
                      non-disinfecting ground water systems
will reduce risk of waterborne disease
by identifying systems with incomplete
natural attenuation of fecal
contamination. EPA bases the following
requirements oni CDC outbreak case
studies, USGS studies of ground water.
flow, State vulnerability maps, and US '
National Research Council reports on
predicting ground water vulnerability.
  For the purposes of this rulemaking,
EPA intends the term "well" to include
any method or device that conveys
ground water to the ground water
system. The term "well" include
springs, springboxes, vertical and
horizontal wells and infiltration
galleries  so long as they meet the
general applicability of the GWR (see
section 141.400). The GWR does not
apply to PWSs that are designated
ground water under the direct influence
of surface water; such systems are
subject to the SWTR and IESWTR. EPA
requests comment on this definition of
"well."
  The hydrogeologic sensitivity
assessment is a simple, low burden, •
cost-effective approach that will allow
States to  screen for high priority
systems.  Systems that are situated in
certain hydrogeologic settings are more
likely to become contaminated. EPA
believes that a well obtaining water
from a karst, fractured bedrock or gravel
hydrogeologic setting is sensitive to
fecal contamination unless the well is
protected by a hydrogeologic barrier. A
State may add additional sensitive
hydrogeologic settings (e.g., volcanic
aquifers) if it believes that it is necessary
to do so to protect public health. A
hydrogeologic barrier is defined as the
physical, biological and chemical
factors, singularly or in combination,
that prevent the movement of viable
pathogens from a contaminant source to
a public supply well. In this proposal,
a confining layer is one example of a
hydrogeologic barrier. The strategy is for
a State to consider hydrogeologic
sensitivity first. If ground water systems
not treating to 4-log inactivation of
viruses are located in sensitive
hydrogeologic settings, then the strategy
allows the State to consider the
presence of any existing hydrogeologic
barriers that act to protect public health.
If a hydrogeologic barrier is present,
then the State can nullify the
determination that a system is located in
a sensitive hydrogeologic setting. If no
suitable hydrogeologic barrier exists,
then the GWR requires the system to
conduct monthly fecal indicator source
water monitoring. Finally, for those
systems where monitoring results are
positive for the presence of fecal
indicators, under the proposed GWR,
States may require systems to eliminate

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                                                                     30223
the source of contamination, correct the
significant deficiency, provide an
alternate source water, or provide a
treatment which reliably achieves at
least 99.99 percent (4-log) inactivation
or removal of viruses before or at the
first customer. GWSs which provide 4-
log inactivation or removal of viruses
will be required to conduct compliance
monitoring to demonstrate treatment
effectiveness.
  The States have experience
implementing a wide variety of methods
suitable for identifying
hydrogeologicaHy sensitive systems.
Also, the States may collect
hydrogeologic information through their
SWAPP (see section I.B.) that is useful
for the hydrogeologic sensitivity
assessments under the GWR. EPA
believes that it would be beneficial if
the States coordinate their SWAPP
analysis with the GWR. By using the
information generated in the SWAPP for
the GWR hydrogeologic sensitivity
assessment, States can effectively
reduce the burden associated with this
requirement.
  EPA-approved vulnerability
assessments conducted for the purpose
of granting waivers under the Phase II
and Phase V Rules may also serve as
sources of hydrogeologic information
useful to the State in assessing the
hydrogeologic sensitivity of its GWSs
under the GWR. Under toe Phase II (56
FR 30268, July  1,1991d)(US EPA.1991)
and Phase V (57 FR 31821, July 17,
1992)(US EPA,1992b) Rules, monitoring
waivers may be granted to individual
systems for specific regulated chemicals
(e,g,, PCBs and  cyanide). Monitoring
frequencies may be reduced or
eliminated by the State if the system
obtains a waiver based on previous
sampling results and/or an assessment
of the system's  vulnerability to each
Phase II and V contaminant. This
evaluation must include the sampling
results of neighboring systems, the
environmental  persistence and transport
of the contaminant(s) under review,
how well the source is protected by
geology and well design, Wellhead
Protection Assessments, and proximity
of potential contamination sites and
activities.
2. Hydrogeologic Sensitivity
  Sensitive hydrogeologic settings occur
in aquifer types that are characterized
by large interconnected openings (void
space) and, therefore, may transmit
ground water at rapid velocities with
virtually no removal of pathogens.
Sensitive aquifers may be present at or
near the ground surface or they may be
covered by overlying aquifers or soils.
An aquifer is sensitive, independent of
its depth or the nature of the overlying
material, because average water
velocities within that aquifer are rapid.
This allows microbial contaminants to
be transported long distances from their
source at or near the surface and
especially in the absence of a
hydrogeologic barrier. In the following
paragraphs, each sensitive aquifer type
is briefly characterized. It is often
difficult to determine the actual
contaminant removal capabilities of an
aquifer and the and ground water
velocities within an aquifer.
Consequently, the aquifer rock type can
be a surrogate measure in the
hydrogeologic sensitivity assessment.
All soil and rocks have void space, but
aquifers have the largest interconnected
void space. The voids are filled with
water that is tapped by a well. Without
these interconnections, the water could
not flow to a well. In those aquifers with
the largest interconnected void space,
ground water velocities can be
comparable to the velocity of a river,
and the rate of travel can be measured
in kilometers per day (US EPA, 1997b).
Compared to velocities in fine-grained
granular aquifers (aquifers that are not
considered sensitive under the GWR),
ground water velocities in fractured
media are large (Freeze and Cherry,
1979).  Sensitive aquifers allow fecal
contaminants to travel rapidly to a well,
with little loss in number due to
inactivation or removal.
  In the GWR, three aquifer types are
identified as sensitive: (1) Karst
aquifers, (2) fractured bedrock aquifers,
and (3) gravel aquifers. Each aquifer
type is characterized by the differing
nature and origin of the interconnected
void space. These distinctions are
important to hydrogeologists identifying
these aquifer types. To meet the
requirements of the hydrogeologic
sensitivity assessment of the GWR, it is
sufficient for States to identify the
aquifer type supplying a system. Karst,
fractured bedrock and gravel aquifer
types are at high risk to fecal
contamination by virtue of their
capability to rapidly transmit fecal
contamination long distances over short
time periods.
  Several means can be used to evaluate
wells to determine if they are located in
one of the three sensitive hydrogeologic
settings proposed under the GWR. For
example, hydrogeologic  data are
available from published and
unpublished materials such as maps,
reports, and well logs. The United States
Geologic Service (USGS), U.S.
Department of Agriculture's Natural
Resource Conservation Service, USGS
Earth Resources Observation System
Data Center, the EPA Source Water
Assessment and Protection Program and
Wellhead Protection Program, State
geological surveys, and universities
have substantial amounts of regional
and site-specific information. The USGS
has published a national karst map
(USGS, 1984) on which States can locate
karst settings. Karst and other aquifers
may also be identified on finer scale
maps published by States or counties.
For example, the State of Kentucky
contains  substantial karst terrain,
documented in complete geologic maps
at the scale of one inch: 2000 feet (7.5
minute quadrangles).
  States can base assessments on
available information about the age and
character of the regional geology,
regional maps and rock outcrop
locations. For example, in a karst
setting, the State may have some
additional information such as: (1)
Observations of typical karst features
such as sinkholes and disappearing
streams; (2) well driller logs which
noted the presence of limestone or
crystalline calcite (a mineral that grows
into openings in rock) or a drop in the
drill string  as it penetrated a karst
opening; or (3) geologic reports (or
unpublished geological observations)
which  identify the presence of
limestone in rock outcrops in the
vicinity of the well.
(a) Karst Aquifers

  Karst aquifers are aquifers formed in
soluble materials (limestone, dolomite,
marble and bedded gypsum) that have
openings at least as large as a few
millimeters in radius (EPA 1997b). Over
geologic time periods, infiltrating
precipitation (especially acid rain)
moving through the aquifer has
enlarged, by dissolution, the small
openings that existed when the rock was
formed. In mature karst terrain,
characterized by relatively pure
limestone located in regions with high
precipitation, caves or caverns are
formed in the subsurface, often large
enough for human passage. Ground
water has the potential to flow rapidly
through karst because the void spaces
are large  and have a high degree of
interconnection. In addition to the
openings created by solution removal,
karst aquifers, like all consolidated
geologic formations, also contain
fractures that transmit ground water.
The size of these fractures may be small,
but the fractures may also be more
numerous than solution-enhanced
openings. The fractures may or may not
have a  high degree of interconnection,
and the degree of interconnection is a
primary factor that controls the velocity
of the ground water.

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Federal Register/Vol.  65,  No. 91/Wednesday,  May .10, 2000/Proposed Rules
  Quinlan (1989) suggests that about 20
percent of the U.S. is underlain by
limestone or dolomite which may be
karst aquifers. East of the Mississippi
River, almost forty percent of the U.S. is
underlain by limestone, dolomite or
marble that may be karst aquifers
(Quinlan, 1989). Karst areas are often
identified by the formation of sinkholes
at the ground surface. A sinkhole forms
when the roof of a cave collapses and
the material that was overlying the cave
is dissolved or otherwise carried away
by streams flowing through the cave.
Sinkholes may also form or become
enlarged as the direct result of vertical
ground water flow dissolving the rock
material to form a vertical passageway.
Sinkholes represent direct pathways for
fecal contamination to enter the aquifer
from the surface. The surface
topography may also be characterized
by dry stream valleys in regions of high
rainfall, by streams that flow on the
ground surface but suddenly sink below
ground to flow within a cave and by
large springs where underground
streams return to the surface. The degree
of karst development in Missouri has
been defined by Davis and Witt (1998)
as primary and secondary karst: primary
containing more than ten sinkholes per
100 square miles and secondary karst
containing between one and ten
sinkholes per 100 square miles. Other
features suitable for identifying karst
aquifers are described in EPA (1997b).
  The most direct method for ground
water velocity determinations  consists
of introducing a tracer substance at one
point in the ground water flow path and
observing its arrival at other points in
the path, usually at monitoring wells
(Freeze and Cherry, 1979). Using tracer
studies, ground water velocities in karst
aquifers have been measured as high as
0.5 kilometers (km) per hour (US EPA,
1997b). In Florida, ground water
velocities surrounding a well have been
measured at several hundred meters (m)
per hour (US EPA, 1997b). At Mammoth
Cave, Kentucky, ground water velocities
have been measured at more than 300 m
per hour (US EPA, 1997b). In a confined
karst aquifer in Germany, ground water
traveled  200 in in less than 4 days (Orth
et al., 1997). In the Edwards Aquifer,
Texas, Slade et al., (1986) reported that
dye traveled 200 feet in ten minutes.
The water level in one well (582 feet
deep with a water table 240 feet deep)
began rising within one hour after a
rainfall (Slade et al., 1986). These data
suggest that ground water flows
extremely rapidly through karst
aquifers. Because ground water flows
rapidly through karst aquifers, these
aquifers  are considered to be
                      hydrogeologically sensitive aquifers
                      under the GWR.

                      (b) Fractured Bedrock             '
                        Bouchier (1998) characterizes a
                      fractured bedrock aquifer as an aquifer
                      which has fractures that provide the
                      dominant flow-path. Although all rock
                      types have fractures, the rock types most
                      susceptible to fracturing are igneous and
                      metamorphic rock types (US EPA,
                      1991c).
                        Freeze and Cherry (1979) report void
                      space as high as 10 percent of total
                      volume in igneous and metamorphic
                      rock. These rock types readily become
                      fractured in the shallow subsurface .as a
                      result of shifts in the Earth's crust. Most
                      fractures are smaller than one
                      millimeter (mm) in width but each
                      fracture's capability to transmit ground
                      water varies significantly with the width
                      of the fracture. A one mm fracture will
                      transmit 1,000 times more water than a
                      0.1 mm fracture, provided that other
                      factors are constant (e.g., hydraulic
                      gradient) (Freeze and Cherry, 1979).
                      Data presented in Freeze and Cherry
                      (1979) suggest that the first 200 feet
                      beneath the ground surface produces the
                      highest water yields to wells. These data
                      suggest that the fractures are both more
                      numerous and more interconnected in
                      the first 200 feet interval. The rate of
                      ground  water travel in fractured rock
                      can be estimated through the results of
                      tracer tests. Malard et al., (1994) report
                      that  dye traveled 43 m in a fractured
                      aquifer  in two hours. Becker et. al.,
                      (1998) report that water traveled 36m
                      in about 30 minutes. Therefore, ground
                      water may travel as quickly as several
                      hundreds of meters per day in fractured
                      bedrock, comparable to travel times in
                      karst aquifers.
                        Aquifers that are comprised of
                      igneous or metamorphic rock are often
                      fractured bedrock aquifers, and their
                      size  is typically larger than a few tens
                      or hundreds of square miles in area,
                      EPA (I991c) has compiled a map
                      showing the distribution of fractured
                      bedrock aquifers in the U.S. Because
                      ground  water flows rapidly through
                      fractured bedrock aquifers, these   ;
                      aquifers are considered to be
                      hydrogeologically sensitive aquifers
                      under the GWR.

                      (cj Gravel Hydrogeology
                        Gravel aquifers are deposits of
                      unconsolidated gravel, cobbles and
                      boulders (material larger in size than
                      pebbles). Due to the large grain sizes of
                      gravel aquifers, ground water travels
                      rapidly within these aquifers with little
                      to no removal or filtration of
                      contaminants from the ground water.
                      Such gravel aquifers are typically
produced by catastrophic floods,
physical weathering by glaciers, flash-
floods at the periphery of mountainous
terrain or at fault-basin boundaries. For
example, glacial flooding has produced
the Spokane-Rathdrum Prairie aquifer
which extends from Spokane,
Washington to Coeur d'Alene, Idaho.
Another gravel aquifer is associated
with glacial flooding along the Umatilla
River in Milton-Freewater, Oregon. The
boulder zone in the Jacobs Sandstone
and Baraboo Quartzite near Baraboo,
Wisconsin may represent another
example. Typically, these aquifers are
small.
  Gravel aquifers are generally not
alluvial aquifers. Alluvial aquifers,
associated with typical river processes,
normally have high proportions of sand
mixed with the gravel. Sand or finer
materials provide a higher probability of
microorganism removal by the aquifer
particles (Freeze and Cherry, 1979), and,
therefore, greater public health
protection. Because ground water flows
rapidly through gravel aquifers, these
aquifers are considered to be
hydrogeologically sensitive aquifers
under the GWR.

3. Hydrogeologic Barrier
  The second part of the hydrogeologic
sensitivity assessment is determining
the presence of a hydrogeologic barrier.
Under the .GWR, the States perform an
initial screen for hydrogeologic
sensitivity by determining whether a
PWS utilizes a fractured bedrock, karst
or gravel aquifer. States would then
examine systems located in these
sensitive aquifers and determine
whether a hydrogeologic barrier is
present. A hydrogeologic barrier
consists of physical, chemical, and
biological factors that, singularly or in
combination, prevent the movement of
viable pathogens from a contaminant
source to a public water supply well. If
the State determines that a
hydrogeologic barrier is present, the
hydrogeologic setting is no longer
considered sensitive to fecal
contamination. If no such barrier is
present or if insufficient information is
available to make such a determination,
the system would be identified as a
sensitive system.
  It is difficult to describe a single,
detailed methodology for identifying a
hydrogeologic barrier that can be used
on a national basis. Geological and
geochemical conditions, climate, and
land uses are highly variable throughout
the United States. In its primacy
application, each State seeking
consideration of a proposed
hydrogeologic barrier under the rule
may identify an approach for

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                                                                      30225
 determining the presence of a
 hydrogoologic barrier that addresses its
 own unique set of these variables (e.g.,
 geological and geochemical conditions,
 climate, and land uses). In determining
 the presence of a hydrogeologic barrier,
 the State should evaluate specific
 characteristics  of the hydrogeologic
 setting, discussed in more detail in the
 following paragraphs.
   Examples of  characteristics to be
 considered  in determining the presence
 of a hydrogeologic barrier include, but
 are not limited to: (1) Subsurface
 vertical and horizontal ground water
 travel times or distances sufficiently
 large so that pathogens become
 inactivated  as they travel from a source
 to a public water supply well, or (2)
 unsaturated geological materials
 sufficiently  thick so that infiltrating
 precipitation mixed with fecal
 contaminants is effectively filtered
 during downward flow to the water
 table.
   A confining layer is one type of
 hydrogeologic barrier EPA has
 identified which can result in sufficient
 protection in many settings. A confining
 layer may protect sensitive aquifers
 from fecal contamination. It is defined
 as a layer of material that is not very
 permeable to ground water flow which
 overlies an aquifer and acts to prevent
 water movement into the aquifer (US
 EPA, 199lb). Confined aquifers are
 bounded by confining layers and,
 therefore, generally occur at depth,
 separated from  the water table aquifer at
 the surface.  Confining layers are
 typically identified by the high water
 pressures In the underlying aquifer.
 Where present, a confining layer will
 separate an  aquifer of high pressure
 from an overlying aquifer of lower
 pressure. The high water pressure in a
 confined aquifer can force water to flow
 naturally (without pumping) to heights
 greater than  the ground surface, as in an
 artesian well. The confining layer is
 comprised of fine-grained materials
 such as clay particles, either as an
 unconsolldated layer or as a
 consolidated rock (e.g., shale). The
small size of clay particles restricts the
 movement of water across or through
 the clay layer. Freeze and Cherry (1979)
 determined  that water would take
almost 10,000 years to pass through  a 10
meters-thick unfractured layer of silt
and clay deposited at the bottom of a
glacial lake,  such as the layers present
in the northern  part of the United States
and the southern part of Canada.
Therefore, the presence of a confining
layer can provide public health
protection.
  However,  confining layers may be
breached and, therefore, unprotective.
 Breaches may be natural (e.g., partly
 removed by erosion, sinkholes, faults,
 and fractures) or caused by humans
 (e.g., wells, mines, and boreholes). For
 example, an unplugged, abandoned well
 that breaches the confining layer is
 capable of providing a pathway through
 the confining layer, allowing water and
 contaminant infiltration into ground
 water. A thicker, unpunctured confining
 layer is considered most protective of
 the underlying aquifer. The State should
 consider such confined aquifer
 characteristics in determining the
 adequacy of a confining layer as a
 hydrogeologic barrier.
  EPA proposes to use the presence of
 a confining layer that is protective of the
 aquifer to act as a hydrogeologic barrier
 and nullify a sensitivity determination.
 Where the confining layer integrity is
 compromised by breaches or if the
 aquifer appears at the surface near the
 water supply well, the State shall
 determine if the layer is performing
 adequately to protect the well, and,
 therefore, public health. EPA estimates
 approximately 15 percent of
 undisinfected ground water system
 sources will be determined to be
 hydrogeologically sensitive (see RIA
 section 6.2.1.1).
 4. Alternative Approaches to
 Hydrogeologic Sensitivity Assessment
  EPA recognizes that the States have
 substantial experience characterizing
 hydrogeology. Most States require some
 hydrogeologic information for reasons
 such as to delineate wellhead protection
 areas, manage ground water extraction
 or assess ground water contamination.
 EPA recognizes that there is no single
 approach for identifying systems at risk
 from source water contamination.  In the
 GWR, a selected subset of hydrogeologic
 settings (karst, fractured bedrock and
 gravel aquifers) is hydrogeologically
 sensitive. These hydrogeologic settings
 are identified through regional and local
 maps that show the general distribution
 of these settings. Other approaches
 considered by EPA to identify sensitive
 systems, but not selected, require
 additional data that may not be
 available to all States. In the following
 paragraphs, alternative methods to
 identify sensitive systems are discussed,
 including the data requirements for
 implementing  each approach.

 (a) Horizontal Ground Water Travel
Time
  Horizontal ground water travel time is
the time that a water volume requires to
travel through an aquifer from a fecal
 contamination source to a well. Viruses
are longer lived than bacteria. Therefore,
the ground water travel time should
 allow sufficient virus die-off to take
 place such that the concentration of
 viruses in the well water would be at or
 below a 1 in 10,000 annual risk level
 (Regli et. al., 1991). However, travel
 time determinations are site specific,
 and some methods are expensive and/or
 difficult to perform. Therefore, EPA is
 not prescribing a particular travel time
 as a hydrogeologic sensitivity
 assessment criterion under the GWR.
 Travel time information may be useful
 for evaluating hydrogeologic barrier
 performance, and States may make use
 of this information where available.
  Ground water travel time
 measurement methods include
 conservative tracer tests (e.g., dyes,
 stable isotopes), and travel time
 calculations. Conservative tracer tests
 may be used in all aquifer types
 including karst and fractured bedrock,
 as well as porous media aquifers. Tracer
 tests are expensive and difficult to
 perform. Ground water travel time
 calculations are only suitable for porous
 media aquifers. Because travel time
 methods are site-specific and their
 associated levels of uncertainty vary,
 EPA is not prescribing one travel time
 number or method to be used
 nationally.
  In evaluating whether to require a
 specific ground water travel time, EPA
 recognized that there are three problems
 with requiring this method for all States.
 First, all ground water travel time
 calculations require measurement of the
 aquifer porosity (void space). Aquifer
 porosity data are rare and usually must
 be estimated based .on the aquifer
 character (e.g., sand, or sand and
 gravel). Second, ground water travel
 time calculations require knowledge of
 the distance traveled and water velocity;
 however, calculating travel time is
 complicated because ground water  does
 not travel in a straight line. The ground
 water's flow path can be nearly straight,
 as in the case of cavernous karst or it
 can be very convoluted as found in
 fractured media. Third, the ground
 water travel time value represents the
 average travel time of a large water
 volume moving toward a well. Some
 water arrives more quickly than the
 average. Because viruses and bacteria
 are small in size their charge effects
 become important. As a result, some
 fecal contaminants may take the fastest
 path from source to well and arrive
 faster than the average water volume.
 Fecal contaminants introduced into an
 aquifer may or may not be channeled
 into flow paths that move faster than the
 average water volume. Thus, a
 calculation of the average ground water
travel time is not as protective as the
calculation of the first arrival time of the

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Federal Register/Vol. 65, No.  917Wednesday, May 10,  2000/Proposed Rules
ground water volume. Because of the
additional uncertainty in calculating
first arrival times, average travel times
must be augmented with a safety factor.
Travel time data, where available, may
assist States in evaluating hydrogeologic
barriers for localities where all sources
of fecal contamination have been
identified.

(b) Setback Distance
  A setback distance is the distance
between a well and a potential
contamination source. Many States
already use setback distances around a
well as exclusion zones in which septic
tanks are prohibited.
  EPA compiled data on State sanitary
setback distances for PWS wells. EPA
found that there is little uniformity
among the States. State setback
distances from septic tanks or drain
fields for new PWS wells range from 50
to 500 feet. Moreover, some States have
differing setback distances depending
on the well type (e.g., CWS versus
NTNCWS and TNCWS ), the well
pumping rate (e.g., greater or less than
50 gallons per minute) or the microbial
contaminant source type (e.g., 50 feet
from a septic tank and 10 feet from a
sewer line).
  EPA considered using a strategy that
included the setback distance as an
element in determining the potential
fecal hazard to systems. In this strategy,
wells located near contamination
sources are at risk. EPA concluded that
it would be difficult to implement this
strategy on a national scale for two
reasons. First, the differing State setback
distance requirements suggests that
there is substantial disagreement among
the States about an appropriate setback
distance. Second, any setback distance
selected for use in the GWR must be
sufficiently large so as to protect a well
from fecal contamination. The
complexity of the processes that govern
virus and bacterial transport in ground
water and the variability of ground
water velocity in sensitive
hydrogeologic settings make it difficult,
if not impossible, for EPA to specify
setback distances that will be protective
of public health for all hydrogeologic
settings. Thus, EPA concluded that
there was insufficient scientific data to
mandate national setback distances in
the GWR.

(c) Well and Water Table Depth
  Well depth is the vertical distance
between the ground surface and the well
intake interval or the bottom of the  well.
Water table depth is the vertical
distance between the ground surface
and the water table. Infiltrating ground
water can require substantial time to
                      reach a deep well, or a deep water table
                      because precipitation infiltrating
                      downward to the water table and
                      vertical ground water flow within an
                      aquifer are typically slow, and thus the
                      long infiltration path to a deep well or
                      water table provides opportunities for
                      inactivation or removal of pathogens
                      and is protective against source water
                      contamination.
                         EPA considered identifying well
                      depth and water table depth as
                      alternative hydrogeologic sensitivity,
                      methods. Two key pieces of information
                      would then be needed for each well: (1)
                      Aquifer measurements that describe its
                      capability to vertically transmit ground
                      water  and (2) measurements from the
                      soil and other material overlying the
                      water  table that describe its capability to
                      transmit infiltrating precipitation mixed
                      with fecal contamination. EPA believes
                      that few data are available to describe
                      vertical ground water flow or infiltration
                      on a national level. Thus, EPA
                      concluded that there was insufficient
                      data available to determine a well depth
                      at which there exists a fecal
                      contamination risk for all systems on a
                      national scale.

                      5. Proposed Requirements

                      (a) Assessment Criteria
                         Today's proposal provides that States
                      shall identify high priority systems
                      through a hydrogeolpgic sensitivity
                      assessment. In this assessment, wells
                      located in karst, fractured bedrock or
                      gravel hydrogeologic settings are
                      determined to be sensitive. The
                      information provided in previous
                      paragraphs shows that the wells located
                      in these hydrogeologic settings are
                      potentially at risk of fecal contamination
                      because ground water velocities are high
                      and fecal contamination can travel long
                       distances over a short time. A
                      hydrogeologic barrier can protect a
                       sensitive aquifer, and if present, can
                       nullify the sensitivity determination. In
                       its primacy application, a State shall
                       identify its approach to determine the
                       presence of a hydrogeologic barrier. For
                       example, a State may choose to consider
                       a specific depth, hydraulic conductivity,
                       and the presence of improperly
                       abandoned wells. For systems with one
                       or more wells that potentially produce
                       ground water from'multiple aquifers,
                       the State shall identify its approach to
                       making separate hydrogeologic
                       sensitivity determinations and, if
                       appropriate, hydrogeologic barriers
                       identifications, for each well. For
                       example, a State may choose to consider
                       a specific depth and hydraulic
                       conductivity, improperly abandoned
                       wells. The system shall provide to the
State or EPA, at its request, any
pertinent existing information that
would allow the State to perform a
hydrogeologic sensitivity analysis. The
hydrogeologic sensitivity assessment
does not necessarily require an on-site
visit by the State, provided the State has
adequate information (geologic surveys,
etc.) to make the assessment without a
site visit.
  Discussions of proposed monitoring"
requirements for hydrogeologically
sensitive systems are found in section
III.D., and corrective action
requirements are found in section III.E,

(b) Frequency of Assessment
  The States, or their authorized agent,
shall conduct one hydrogeologic
sensitivity assessments for each GWS
that does not provide treatment to 4-log
inactivation or removal of viruses.
States shall conduct the hydrogeologic
sensitivity assessment for all existing
CWSs no later than three years after
publication of the final rule in the
Federal Register and for all existing
NCWSs no' later than five years after
publication of the final rule in the
Federal Register. States shall complete
the hydrogeologic sensitivity assessment
prior to a new ground water system
providing drinking water for public
consumption. EPA requests comment on
these time frames. Some stakeholders
have indicated that an assessment for
hydrogeologically sensitive areas (karst,
gravel, fractured rock) of a State can be
quickly performed at the State level. If
such data can be quickly gathered and
an assessment easily performed, EPA
questions putting off the routine
monitoring requirements and public
health protection that it would bring for
three or five years. EPA requests
comment on requiring the State to
perform the hydrogeologic sensitivity
assessment within one year .of the
effective date of the final GWR.

(c) Reporting and Record Keeping
Requirements
  The State shall keep records of the
supporting information and explanation
of the technical basis for determinations
of hydrogeologic sensitivity and of the
presence of hydrogeologic barriers. The
State shall keep a list of ground water
systems which have had a sensitivity
assessment completed during the
previous year, a list of those systems
which are sensitive, a list of those
systems that are sensitive, but for which
the State has determined a
hydrogeologic barrier exists at the site
sufficient for protecting public health,
and a record of an annual evaluation of
the State's program for conducting
hydrogeologic sensitivity assessments.

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                  Federal Register/Vol. 65, No.  91/Wednesday, May 10, 2000/Proposed Rules
                                                                     30227
 6. Request for Comments
   EPA requests comments on all the
 information presented earlier and the
 potential impacts on public health and
 the regulatory provisions of the GWR.
 a. Routine Monitoring Without State
 Assessment
   EPA requests comment on requiring
 systems to perform routine monitoring if
 the State fails to conduct a
 hydrogeologic sensitivity assessment.
 Under this provision, if the State fails to
 conduct a hydrogeologic sensitivity
 assessment within the time frame
 specified by the GWR, the systems
 would conduct fecal indicator
 monitoring once per month for every
 month they serve water to the public
 (see section § 141.403(d), microbial
 analytical methods). The time frame for
 completing sensitivity assessments for
 all existing CWSs is no later than three
 years after the date of publication of the
 final rule in the Federal Register, and
 the time frame  for all existing NCWSs is
 no later than Eve years after the date of
 publication of the final rule in the
 Federal Register. The systems could
 discontinue monitoring only after the
 State conducts  a hydrogeologic
 sensitivity assessment and determines
 that the systems are not sensitive, or if
 tho systems initiate and continue
 treatment to achieve 4-log inactivation
 or removal of viruses.
 b. Vulnerability Assessment
  EPA requests comment on a detailed,
 on-site vulnerability investigation as an
 alternative to the Hydrogeologic
 Sensitivity Assessment. The alternative
 hydrogeologic investigation will assess
 tho performance of all existing
 hydrogeologic barriers such as
 unsaturated zone thickness and
 composition (including the soil), the
 saturated zone thickness and
 composition above the well, intake
 interval, the frequency, duration and
 intensity of precipitation for all aquifer
 types,  and will  also require a detailed
 investigation of the well construction
 conditions by a certified well technician
 and a review of the well construction-
 related documentation from the sanitary
 survey and SWAPP assessment. The
 results of the detailed investigation
 must demonstrate that the existing
 hydrogeologic barriers, aquifer type and
 the well construction function to
 prevent the movement of viable
pathogens from a contaminant source to
a public water supply well. The
 demonstration may include ground
water age dating, natural or artificial
tracer test data, or ground water
modeling results. See EPA 1998b for
 more information on vulnerability
 assessments.

 c. Sandy Aquifers
   EPA is proposing to require States to
 identify systems in karst, gravel and
 fractured rock aquifer settings as
 sensitive and these systems must
 perform routine source water
 monitoring. On March 13, 2000, the
 Drinking Water Committee of the
 Science Advisory Board (DWCSAB)
 reviewed this issue and made several
 recommendations to EPA concerning a
 draft of this proposal. EPA requests
 comment on two DWCSAB
 recommendations concerning the
 hydrogeologic sensitivity assessment.
 The committee recommended that all
 ground water sources be required to
 monitor for bacterial indicators and
 coliphage for at least one year—
 regardless of sensitivity determination.
 As an alternative approach, the
 committee recommended sand aquifers
 be included as sensitive settings. This
 recommendations was based on column
 studies of virus transport in soils that
 showed that viruses move rapidly
 through sandy soils and field studies of
 virus transport from septic tanks
 showing rapid movement into ground
 water from sandy coastal plains.
 C. Cross Connection Control
   EPA is concerned about introduction
 of fecal contamination through
 distribution systems; however, EPA has
 not proposed cross connection control
 requirements in the GWR. EPA will
 work with the Microbial/DBP FACA to
 consider whether cross connection
 control should be required in future
 microbial regulations, particularly
 during the development of the Long
 Term 2 ESWTR, in the context of a
 broad range of issues related to
 distribution systems. EPA will also
 request input from the FACA on
 whether to require systems to maintain
 disinfection residual throughout the
 distribution system. EPA seeks
 comments or additional supporting data
 related to cross connection control or
 other distribution system issues. In
 particular to cross connections, the
 Agency requests public comment on: (1)
 Whether EPA should require States and/
 or systems to have a cross connection
 control program, (2) what specific
 criteria, if any, should be included in
 such a requirement, (3) how often a
program should be evaluated, (4) and
whether EPA should limit any
requirement to only those connections
identified as a cross connection by the
public water system or the State. The
Agency also requests comment on what
otter regulatory measures EPA should
 consider to prevent contamination of
 drinking water in the distribution
 system.

 D. Source Water Monitoring

 1. Overview and Purpose
  As previously stated, EPA recognizes
 that there are particular challenges
 associated with, developing an effective
 regulatory approach for ground water
 systems. These include the large
 number of ground water systems that
 would be regulated, the fact that only a
 subset of these systems appear to have
 fecal contamination (although a larger
 number are likely to be sensitive), and
 that most ground water systems range
 from small to very small in terms of the
 population served. These factors
 combine to underscore the limitations of
 an across-the-board disinfection
 approach to regulation.
  As part of the multiple-barrier
 approach, EPA proposes source water
 monitoring requirements that fulfill the
 need for a targeted risk-based regulatory
 strategy by identifying those systems
 with source water contamination and
 systems with high sensitivity to possible
 fecal contamination—specifically
 undisinfected  systems located in
 hydrogeologically sensitive aquifers.
 EPA believes that the proposed
 requirements provide a meaningful
 opportunity to reduce public health risk
 for a substantial number of people
 served by ground water sources. This
 section provides detailed information
 on current monitoring requirements,
 monitoring data, indicators of fecal
 contamination, co-occurrence issues,
 and describes the proposed
 requirements,
  EPA proposes the following source
 water monitoring requirements for
 systems that do not treat 4-log removal
 and/or inactivation of viruses: (1) A
 system must collect a source water
 sample within 24 hours of receiving
 notification of a total coliform-positive
 sample taken in compliance with the
 TCR, and test for the presence of E. coli,
 enterococci or  coliphage; and (2) any
 system identified by the State as
 hydrogeologically sensitive through a
 sensitivity assessment (see § 141.403)
 must conduct routine monthly
 monitoring, during the months the
 system supplies water to the public, and
 analyze for E. coli, enterococci or
coliphage. In either case, if any sample
is fecal indicator-positive, the system
would have to  notify the State
immediately and then the system must
take corrective action.
  Currently, all systems must comply
with the TCR (see section I.B.I.) and the
MCL for nitrates and nitrites. In

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Federal Register/Vol.  65,  No. 91/Wednesday, May  10,  2000/Proposed Rules
addition, CWSs and NTNCWSs must
monitor at the entrance of the
distribution system for 15 additional
inorganic chemicals associated with an
MCL (e.g., antimony, arsenic) and
sometimes other inorganic chemicals
not associated with an MCL (calcium,
orthophosphate, silica, sodium,
sulphate; 40 CFR 141.23(b) and (c)).
Systems will also have to comply with
the Stage 1 DBPR, if they use a chemical
disinfectant. CWSs must additionally
monitor for certain organic chemicals
and certain radionuclides. Ground water
systems under the  direct influence of
surface water must satisfy the
requirements of the SWTR and IESWTR.
  Microbial monitoring plays an
important role in detecting fecal
contamination in source waters, as well
as in assessing best management
practices, including in-place
disinfection adequacy and distribution
system integrity. It is the most direct
way to determine the presence of fecal
contamination. However, because of
limitations on sample volume,
monitoring frequency, and the species
of microorganisms that can reasonably
be monitored, non-detection of a fecal
indicator does not necessarily mean
fecal contamination is absent (see
Tables III-2 and 3).
2. Indicators of Fecal Contamination
  Two approaches for determining
whether a well is contaminated are to
monitor for the presence of either
specific pathogens or more general
indicators of fecal contamination.
Monitoring for individual pathogens,
however, is impractical because the
large number and  variety of pathogens
require extensive sampling and
numerous analytical methods. This is a
process which is extremely time-
 consuming, expensive, and also
technically demanding. Moreover,
 methods are not available for some
 pathogens and pathogen concentrations
 in water are usually sufficiently small so
 as to require analysis of large-volume
 samples, which significantly increases
 analytical costs. For these reasons, EPA
 is focusing on indicators of fecal
 contamination as  a screening tool rather
 than on individual pathogens
 themselves. The Agency is considering
 several promising fecal indicators: E.
 coli, enterococci,  somatic coliphage, and
 male-specific coliphage. Because these
 indicators are closely associated with
 fecal contamination, EPA believes that
 even a single positive sample should
 require urgent State notification and
 other follow-up activities.
   EPA considered three bacterial
 microorganisms as indicators of fecal
 contamination: E. coli,  enterococci, and
                      C. perfringens. E. coli and enterococpi
                      are both closely associated with fresh
                      fecal contamination and are found iri
                      high concentrations in sewage and
                      septage. Analytical methods are
                      commercially available, simple, reliable,
                      and inexpensive. E. coli is monitored
                      under the TCR, and E. coli and     |
                      enterococci are recommended by EPA as
                      indicators for fecally contaminated ;
                      recreational waters. A drawback is that
                      these two groups may die out more
                      quickly or be less mobile in the    •
                      subsurface environment than some '
                      waterborne pathogens.
                        As with E.  coli and enterococci, C.
                      perfringens is common in sewage (about
                      10 6 organisms per liter) and is     :
                      associated with fecal contamination.
                      Methods of detection are commercially
                      available, simple, reliable, and relatively
                      inexpensive. C. perfringens forms  .
                      protective spores (endospores), and
                      these spores survive much longer in
                      some environments than most
                      pathogens. Thus, these spores may be
                      present in old fecal contamination •
                      where fecal pathogens are no longer
                      viable. EPA rejected C. perfringens as an
                      indicator of fecal contamination for;
                      GWSs based  on co-occurrence data ,
                      showing that the organism is seldom .
                      present in ground water when other
                      fecal indicators are present (Lieberman
                      et. al, 1999).
                        Enteric viruses, much smaller in size
                      than bacteria such as E. coli, may be
                      more mobile than bacteria because they
                      can slip through small soil pores more
                      rapidly. Thus, viral pathogens may
                      sometimes be present in ground water
                      in the absence of bacterial indicators of
                      fecal contamination. However, other
                      factors such as sorption to soil and
                      aquifer particles are also important in
                      affecting the relative transport of viruses
                      and bacteria in ground water.
                         The coliphage are viruses that infect
                      the bacterium E. coli. Because they do
                      not often infect other bacteria, they (like
                      E. coli) are closely associated with
                      recent fecal contamination. Because
                      they are viruses, their stability and'
                       transport within soil and under aquifer
                       environmental conditions may be
                       similar to the fate and transport of
                       pathogenic viruses. There are two
                       categories of coliphage—somatic
                       coliphage and male-specific coliphage.
                       The somatic coliphage are a
                       heterpgenous group that enters the cell
                       wall of E. coli. The male-specific (also
                       called the F-specific) phage are those
                       that only enter through tiny hair-like
                       appendages  (pili) to the cell wall.
                         There are  issues about using
                       coliphage as an indicator of fecal
                       contamination in small communities.
                       Individuals  do not consistently shed
coliphage. For example, Osawa et al.
(1981) found that only 2.3% of infected
individuals shed male-specific phage.
Thus, the occurrence of these viruses in
small septic tanks, which is an
important source of fecal contamination
in ground water wells, is uncertain. The
issue of frequency and abundance is
important because a primary source of
fecal contamination in wells is thought
to be nearby leaking septic tanks.
  To answer this question, EPA funded
a study to determine (Deborde, 1998,
1999) the frequency and density of
coliphage occurrence in household
septic tanks. Deborde (1998) collected
and analyzed a sample from each of 100
sites in the Northwest and from each of
12 sites in the Midwest (3), Southwest
(3), Northeast  (3), and Southeast (3). All
112 samples were analyzed for male-
specific coliphage, while  33 were also
analyzed for somatic coliphage. Table
III-l shows that male-specific coliphage
are present in about one-third of the
septic tank samples, while somatic
coliphage are present in two thirds of
the samples tested. However, when
found, the male-specific coliphage are
present at a slightly higher level. The
number of possible people per
household (and therefore the number of
virus sources) varied from one to seven,
with an average of 2.8. In the next phase
of the study, Deborde (1999), selected
ten of the 112 sites (five coliphage-
positive, five coliphage-negative) and
collected three quarterly samples from
each. The data indicate that significant
changes in density occur over time. For
the male-specific phage, the number of
positive sites was 40%, 60% and 40%
for quarter 2, 3, and 4, respectively. For
the somatic phage, the number of
positive sites was 70%, 80% and 50%
during these same three quarters. As in
the first phase, somatic phage were
detected more frequently and the male-
specific phage were (when detected)
more abundant.
   The data indicate that household
 septic tanks often (50-80%) contain
 measurable levels of somatic coliphage,
 suggesting that the somatic coliphage
 may be an appropriate indicator of fecal
 contamination in nearby source waters.
 However, the male-specific coliphage
 were present in the septic tanks in
.slightly less than half the sites at any
 one time. Based on these data, male-
 specific phage may not be suitable for
 detecting fecal contamination in source
 waters if the most likely contamination
 source is a household septic tank.

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                                                                                        I
                  Federal Register/Vol. 65, No.  91/Wednesday, May  10,  2000/Proposed Rules
                                                                                                      30229
 TABLE IIt-1.—FREQUENCY  AND  DEN-
   SITY OF COLIPHAGE IN HOUSEHOLD
   SEPTIC  TANKS,  PRELIMINARY  RE-
   SULTS (DEBORDE, 1998)
Coliphage
Male-spe-
dfic.
Somatic ....
Presence
36% (44/1 12)
67% (22/33)
Density1
9.7x105PFUV
L
1.3 x 10s
PFU1/L
   1 Plaque-Forming Units (PFU).

   Analytical methods for coliphage are
 available and are far less expensive than
 methods for pathogenic virus detection.
 However, the coliphage detection
 methods are still somewhat more
 expensive than those for the common
 indicator bacteria. EPA is in the process
 of funding the development of more
                                   sensitive, less expensive analytical
                                   methods for the somatic and male-
                                   specific coliphage.
                                     EPA also considered methods using
                                   polymerase chain reaction (PCR) for
                                   identifying specific viruses. PCR
                                   amplifies the nucleic acid of the
                                   targeted virus, which then can be
                                   detected and identified by various
                                   procedures. An advantage of this
                                   method over those for coliphage is that
                                   it can identify the presence of specific
                                   viruses pathogenic to humans. Methods
                                   using PCR may be specific, sensitive,
                                   and much more rapid than other
                                   methods for pathogenic virus. However,
                                   current PCR technology cannot yet
                                   determine whether a virus is viable or
                                   infectious and is significantly more
                                   expensive than the culture methods for
                                   the above fecal indicators (currently
 about $250-300 per sample). EPA
 expects substantial reductions in this
 cost as the method is further developed.
 Nevertheless, in spite of the current
 limitations of PCR, a positive result in
 a ground water sample would strongly
 imply that a pathway exists for virus
 contamination of ground water.
   EPA did not consider total coliform
 bacteria or heterotrophic bacteria as
 fecal indicators because both groups
 grow naturally in soil and water, arid
 thus are not specific indicators of fecal
 contamination.
   According to a survey of ground water
 data by the AWWARF study (see Table
 II-6), C. perfringens was only detected
 in one of 57 samples (1.8%). Thus, EPA
 eliminated this organism from
 consideration. See Tables III-2 and 3 for
 occurrence data on candidate indicators.
   TABLE 111-2.—PRESENCE/ABSENCE OF INDICATORS AT ENTEROVIRUS-POSITIVE SITES (GENERALLY, ONE SAMPLE/SITE)
Study
AWWARF Study 	 	 	 	
Missouri Alluvial Study 	
Missouri Ozark Plateau 	 	 	

Number of
positive
enterovirus
sites
22
11
10

Total coliforms
(100 mL)
4
5
o

£. coli or fecal
coliforms
MA
3


Enterococoi or
fecal
streptococci
(100 mL)




Somatic phage
(100 L)




F-specific
phage
(100L)

2 2 (3)


   10nly 11 enterovirus-positive sites tested
   215fitei-i
 nter samples.
                                                                                   i
TABLE III-3.—DATA FROM EPA/AWWARF STUDY. NUMBER OF TIMES INDICATOR WAS POSITIVE IN 12 MONTHLY
                             SAMPLES AT ENTEROVIRUS-CONTAMINATED SITES 1
Entcfovirus-posilive site (2 Viz pas)
029 „„.,..„.„... ....
031 	 ..,....,..,..
047 	 	
061 „„„„.,.„..,. 	
091 	 „. 	 	 	
097 	 , 	 	 	
099 	 	 .. ..

Total 	 	 	 	 	
Total
coliform-positive
12
12
12
11
10
5
2

64
E. coli
positive
19

m
1 1
3
0


42
Enterococci-
positive








46
Somatic
coliphage-
positive 2
1







60
F-specific
coliphage
positive2
• . 	 i.. • 	 i
11
3
4
8
0

1 ,
27
  1 Sample volume: bacteria 300 mL; coliphage most between 10-100L; enterovirus: average of 6 037 L
  'Host for somatic coliphage: £ coliC; host for F-specific coliphage: WG49.
  The data strongly shows that a single
negative sample is usually not sufficient
to demonstrate the absence of fecal
contamination, and that repeated
sampling is necessary. Based on the
data, EPA does not believe that one fecal
indicator is clearly superior to the
others.
  The coliphage sample volume in the
studies in Table III-3 ranged from 10L
to 100L (compared to 100-300 mL for
the bacterial indicators). EPA believes
that it would be unreasonable to expect
systems to collect and transport these
high water volumes. However, as stated
earlier, several sensitive coliphage
                                  methods have been developed that can
                                  be used with a more reasonable volume
                                  (100-1,000 mL).
                                    Thus, for the reasons indicated
                                  earlier, EPA is proposing E. coli,
                                  coliphage and enterococci as
                                  appropriate monitoring tools for source
                                  water. Because these three fecal
                                  indicators are closely associated with
                                  fecal contamination, the Agency
                                  believes that a single source water
                                  positive E. coli, coliphage or enterococci
                                  sample is sufficient to consider the
                                  source water as fecally contaminated.
                                  Repeated sampling is proposed for
                                  routine monitoring (described in the
next section) since it may take more
than one sample to identify intermittent
contamination. Additional support for
this approach is provided by Christian
and Pipes (Christian and Pipes, 1983),
who found that coliforms follow a
lognormal distribution pattern in small
distribution systems (i.e., coliforms are
not uniformly distributed). EPA has no
reason to suspect that this non-uniform
pattern should be different in source
waters. Only one additional sample is
proposed after triggered monitoring
(described in the next section) since the

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30230
Federal Register/Vol.  65,  No. 91/Wednesday, May 10, 2000/Proposed  Rules
sample is taken immediately after an
indication of contamination.
  The Agency recognizes that errors in
sample collection and testing may
contaminate a sample, and therefore
would allow the State to invalidate such
samples, on a case-by-case basis, in the
same manner required under the TCR
(141.21(c)(l)(i) and (iii) for invalidating
total coliform samples. However, EPA
believes that  errors in sample collection
rarely lead to contamination. This is
based on a study by Pipes and Christian
(Pipes and Christian, 1982), where water
samplers and other individuals tried to
contaminate 111 sample bottles
containing 100-mL of sterile
dechlorinated tap water by placing a
finger into the mouth of each bottle and
shaking the bottle vigorously for about
5 seconds. Only 5.4% of the samples
were found to contain total coliforms.
  Thus, the Agency believes that States
should invalidate positive samples
sparingly. Under the GWR, the State
would be allowed to invalidate a
positive source water sample if.(l) the
laboratory establishes that improper
sample analysis caused the positive
result or (2) the State has substantial
grounds to believe that a positive result
is due to a circumstance or condition
which does not reflect source water
quality, documents this in writing, and
signs the document. In this case,
another source water sample must be
taken within 24 hours of receiving
notice from the State.
3. Proposed Requirements

a. Routine Source Water Monitoring •
   EPA stated in the previous section on
hydrogeology that a State  would be
, required to determine the
hydrogeological sensitivity of each
system not treating to 4-log inactivation
or removal of viruses. If the State
determines that the well(s) serving such
a system draws water from a sensitive
aquifer, that system would be required
to collect a source water sample each
month that it provides water to the
public and test the sample for the fecal
indicator specified. If any sample
contains a fecal indicator, the system
would be required to notify the State
immediately and address the
contamination within 90 days unless
the State has approved a longer
schedule (see § 141.404).
   Under the  GWR, if a system detects no
fecal indicator-positive samples after 12
monthly samples, the State would be
allowed to reduce routine source water
monitoring to quarterly. The State
would be allowed, after the first year of
monthly samples, to waive source water
monitoring altogether for  a system if the
                      State determines that fecal         :
                      contamination of the well(s) is highly •
                      unlikely, based on sampling history,
                      land use pattern, disposal practices in
                      the recharge area, and proximity of
                      septic tanks and other fecal
                      contamination sources. PWSs that do
                      not operate year-round  would need to
                      conduct monthly sampling for more
                      than one year to collect the twelve
                      monthly samples. EPA  requests
                      comment on allowing such systems to
                      monitor monthly for only one.seasonal
                      period when the system is in operation.

                      b. Source Water Sample After a Total
                      Coliform-Positive Under the TCR
                        EPA proposes that when a non-
                      disinfecting ground water system is
                      notified that a sample is total coliform-
                      positive under the TCR, that system
                      would have to collect, within 24 hours
                      of being notified, at least one source  .
                      water sample. This requirement would
                      be in addition to all monitoring and
                      testing requirements under the TCR,
                      The source water sample would be
                      tested for either E. coli, coliphage or
                      enterococci, as  determined by the State.
                      A system that chooses to first test for
                      total coliforms in the source water, and
                      then test any total coliform-positive
                      culture for E. coli would meet the
                      requirement.
                        If any sample is E. coL'-positive,
                      coliphage-positive or enterococci-
                      positive, the system would be required
                      to meet § 141.404. EPA believes that a
                      total coliform-positive sample in the
                      distribution system, followed by a fecal
                      indicator-positive sample in the source
                      water, indicates a serious contamination
                      problem.
                        The Agency would allow the State to
                      waive source water monitoring for any
                      system, on a case-by-case basis, if the
                      State determines that the total coliform-
                      positive is associated solely with a
                      distribution system problem. In this
                      case, a State official would be required
                      to document the decision, including the
                      rationale for this decision, in writing,
                      and sign the document.
                      c. Confirmation of Positive Source  ,
                      Water Sample
                        The Agency recognizes that false-
                      positive results may occasionally occur
                      with most microbial methods (i.e., a
                      non-target microbe  is identified by the
                      method as a target microbe). For
                      example, the false-positive rate for E.
                      coli is 7.2% for the E*Colite Test, 2.5%
                      for the ColiBlue24 Test, and 4.3% for
                      the membrane filter test using MI Agar.
                        Therefore, EPA would allow the State
                      to invalidate a positive source water
                      sample where a laboratory establishes
                      that improper sample analyses caused
the positive result or if the State has
substantial grounds to believe that a
positive result was due to a
circumstance or condition that did not
reflect source water quality and
documents this in writing. For example,
a State may invalidate a positive source
water sample if a subsequent validation
step for the same sample fails to confirm
the presence of the fecal indicator being
used. These provisions are consistent
with the invalidation criteria under the
TCR (40 CFR 141.2l(c)).
  EPA believes that, in the interest of
public health, a positive sample by any
of the methods listed in Table III-4
should be regarded as a fecal indicator-
positive source water sample. This   .
assumption is supported by the Pipes
and Christian study (Pipes and
Christian, 1982) study mentioned
previously, which shows that sample
collector handling error is rarely a cause
of fecal contamination. Nevertheless,
the Agency recognizes that
contamination during sampling and
analysis may occur, albeit rarely, and is
proposing to allow the State to
invalidate a fecal indicator-positive in  a
routine monitoring sample under
certain circumstances in the manner
described in this section. EPA is also
proposing to allow confirmation of a
fecal indicator-positive routine source
water sample. Specifically, the rule
would permit the State to allow a
system to waive compliance with the
treatment technique in § 141.404, after a
single fecal indicator-positive source
water sample on a case-by-case basis,
if—-
  (1) The system collects five repeat
source water samples within 24 hours
after being notified of a source water-
positive result;
  (2) The system has the samples
analyzed for the same fecal indicator as
the original sample;
  (3) All the repeat samples are fecal
indicator-negative; and
  (4) All required source water samples
(routine and triggered) during the past
five years were fecal indicator-negative.
  Under this approach, a system would
not necessarily have to comply with the
specified treatment requirements on the
basis of a single, isolated fecal indicator-
positive sample if all additional
monitoring showed that no problem
exists. The Agency believes that this
limited level of confirmation would not
undermine public health protection.
Conversely, the Agency believes that
two fecal indicator-positive source
water samples at a site provides strong
evidence that the source water has been
fecally contaminated.
  The Agency is also proposing that a
total coliform-positive sample in the

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                 Federal Register/Vol.  65,  No. 91/Wednesday, May 10, 2000/Proposed  Rules
                                                                     30231
 distribution system accompanied by a
 fecal indicator-positive source water
 sample be sufficient grounds for
 requiring compliance with the treatment
 requirements. The Agency argues that it
 would be unreasonable to expect a
 sample collector to accidently
 contaminate two samples taken at least
 one day apart, and also contends that
 the likelihood of a false-positive result
 occurring in both of two samples is
 much lower than in a single sample.
 Thus, the Agency believes that, in this
 circumstance, there is a significant
 probability that the source water is
 indeed fecally contaminated. Moreover,
 the Agency notes that, under the TCR,
 two consecutive total coliform-positive
 samples, one of which is E. coli-
 positive, is sufficient grounds for an
 acute violation of the MCL for total
 coliforms. For these reasons, EPA
 balieves that it is reasonable to require
 a system with a total coliform-positive
 sample in the distribution system
 followed by a fecal indicator-positive
 source water sample to comply with the
 treatment requirements. However, EPA
 also recognizes that, by itself,  a positive
 total coliform result is not always an
 indication of fecal contamination (even
 if the sample result is not a false
 positive). EPA requests comment on
 waiving compliance of the treatment
 techniques after a single positive
 triggered monitoring source water
 sample based upon five negative repeat
 samples as described previously in this
 section.
 4, Analytical Methods
  EPA proposes to approve the
 following methods (listed in 141.403),
 with the sample volume of 100 mL,  for
 source water monitoring of E.  coli,
 enterococci and coliphage. A system
 would have  to use one of these methods.
 Most of the proposed analytical
 methods for E. coli for source water
 monitoring are consensus methods
 described in Standard Methods for the
 Examination of Water and Wastewater
 (19th and 20th ed.). 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. Information about these methods
 is available in the Federal Register (63
FR 41134-41143, July 31, 1998; 64 FR
2538-2544, January 14,1999) and in the
EPA Water Docket. Of the three
enterococci methods, two are consensus
methods in Standard Methods; while
the third (Enterolert) was described in a
 peer-reviewed journal article (Budnick
 et al., 1996). The description for each of
 the proposed E. coli and enterococci
 methods state explicitly that the method
 is appropriate for fresh waters or
 drinking waters.
   EPA is proposing the approval of two
 newly developed coliphage methods for
 detecting fecal contamination.
   The Agency has conducted
 performance studies on the two
 proposed methods, using ten
 laboratories: a new two-step enrichment
 method and a single-agar layer method
 used for decades, but recently optimized
 for ground water samples. For the two-
 step enrichment method, using 100-mL
 spiked water samples (reagent water and
 ground water) and two" E. coli hosts
 (CN-13 and Famp), laboratories  detected
 one plaque-forming unit (PFU) 60-90%
 of the time. For the optimized single-
 agar layer method, using the same water
 type and volume (but higher coliphage
 spike) and same two E. coli hosts,
 recoveries ranged from 61% to 178%,
 based upon a coliphage spike level
 determined by a standard double-agar
 layer test.
  Based upon the results  of performance
 testing, EPA believes that these two
 coliphage tests are satisfactory for
 monitoring ground water in compliance
 with this rule. The two test protocols
 and study results are available for
 review in EPA's Water Docket.
  EPA is proposing requiring that
 systems collect and test at least a 100-
 mL sample volume. The Agency
 recognizes that a 1-L sample volume
 will provide ten times more sensitivity
 than a 100-mL sample. However, the
 Agency also understands that the greater
 sample volume would also weigh ten
 times more, and thus cost more to ship
 to a laboratory. Data exists that indicate
 more frequent smaller-volume samples
 are better in detecting fecal
 contamination than a smaller number of
 high volume samples (Haas,1993).
 AWWARF is funding a study on this
 issue, and data should be  available
 shortly. The Agency requests comment
 on the most appropriate sample volume.
  For any of the methods  described
 previously, the maximum allowable
 time between ground water sample
 collection and the initiation of analysis
 in the certified laboratory, is 30 hours.
This would be consistent with the TCR.
The Agency would prefer a shorter time,
but believes that a sizable percentage of
small systems have difficulty getting
then- samples to a certified laboratory
within 30 hours. In addition, unlike the
SWTR where the density is measured,
EPA is proposing in the GWR to require
analysis for microorganism detection
alone. The Agency believes that the
 detection of an organism is less
 sensitive to change than measurement of
 density, and thus a 30-hour transit time
 would be reasonable.

 5. Request for Comments
   EPA requests comments on proposed
 indicators of fecal contamination and
 analytical methods. In addition, EPA
 requests comments on the following
 alternative approaches.
 (a) Source Water Samples after an MCL
 Violation of the TCR
   EPA requests comment on requiring a
 system that violates the MCL for total
 coliforms, or detects a single fecal
 coliforin/E1. co//-positive sample under
 the TCR, to collect five source water
 samples, rather than a single source
 water sample as proposed. The Agency
 believes this alternative approach would
 be reasonable, given that both events are
 sufficiently important to require the
 system to notify the State (and, for a
 MCL violation, the public) as opposed
 to a single total coliform-positive
 sample which does not require
 notification. Under this approach,
 systems would be required to collect
 five source water samples within 24
 hours for every MCL violation or
 positive E. coli or fecal coliform sample
 in the distribution system and test them
 for one of the EPA-specified fecal
 indicators. If any source  water sample
 were positive, the system would have to
 treat or otherwise protect the drinking
 water. This monitoring requirement
 would be in addition to requirements
 under die TCR.

 (b) Sampling of Representative Wells
  EPA recognizes that most CWSs have
 more than one well, raising the question
 about whether the system would need to
 monitor all wells or just one
 representative well.  One approach
 would be to require a system to sample
 all wells because this approach provides
 more reliable public health protection.
 However, the Agency notes that wells
 belonging to a system may vary in their
 sensitivity to fecal contamination.
  If a system is drawing water from
 more than one well in a
 hydrogeologically sensitive aquifer, EPA
 believes that all such wells should be
 sampled routinely, unless the State can
 identify a single representative well or,
 the well (or subset of wells) sensitive to
 fecal contamination. If a system is
 required to collect a  source water
 sample as  a result of a total coliform-
 positive sample in the distribution
 system (triggered monitoring), EPA
believes that all wells should be
 sampled, unless the State can identify a
 single representative well or the well (or

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Federal  Register/Vol. 65,  No. 91/Wednesday, May 10,  2000/Proposed Rules
subset of wells) most vulnerable to fecal
contamination. Alternatively, if the total
coliform-positive sample was found in a
part of the distribution system supplied
by a single well, then it might be
acceptable to sample that specific well
alone. The Agency seeks comment on
these alternatives and other approaches.
  EPA recognizes that systems may
have storage tanks  or other water
holding tanks between the wellhead and
the distribution system. Therefore the
Agency also requests comment on
whether further definition is needed for
exactly where source water samples
should be taken; e.g., at the well, the
tank, or at any point before the water
enters the distribution system. The
Agency seeks comment on where source
water samples should be collected.

(c) Distribution System Monitoring for
Fecal Indicators
  One alternative approach for
distribution system monitoring is to
augment total coliform/£ coli testing in
the distribution system with one or
more additional fecal indicators. For
example, under this approach, a system
would be required to monitor coliphage
or enterococci at the same frequency as
it monitors for total coliforms. This
approach recognizes that fecal
indicators differ in their effectiveness in
detecting fecal contamination, and that
this effectiveness may vary with
environmental conditions. Thus, more
than one fecal indicator should stand a
greater likelihood  of detecting fecal
contamination' than a single indicator
(i.e., E.  coli under the TCR). This
approach would be more expensive for
systems, but may be counterbalanced by
the greater likelihood of detecting fecal
contamination. EPA seeks comment on
this monitoring approach.
(d) Persistent Monitoring Non-
Compliers
   EPA requests  comment on defining a
persistent non-complier of monitoring
requirements and, specifically what any
additional monitoring, public
notification or treatment requirements
should pertain to them.

 (e) Monitoring of Disinfecting Systems
   Some States currently require
 disinfected systems to monitor their
 source water to  ensure that the system
 would be protected against the potential
risk of fecal contamination in the event
 of a disinfectant failure. The Agency
 requests comment on requiring a
 disinfected system to test its source
 water periodically.
   The Agency also requests comment on
 requiring all ground water systems
 (including those that disinfect to 4-log
                      removal/ inactivation of viruses) to
                      collect a source water sample after a,
                      total coliform-positive in the       ;
                      distribution system (triggered
                      monitoring). Systems may want or need
                      to change their disinfection practices or
                      take other source water protection  ;
                      actions based on discovering 'that their
                      source water is contaminated.

                      (f) Multiple Fecal Indicators        !
                        EPA is proposing to require ground
                      water systems to monitor coliphage, E.
                      coli, or enterococci, as determined by
                      the State, in the source water. On March
                      13,  2000, the Drinking Water Committee
                      of the Science Advisory Board
                      (DWCSAB) made a few            :
                      recommendations to EPA concerning a
                      draft of this proposal.              '.
                        The DWCSAB recommended
                      unanimously, and the Agency is    ;
                      requesting comment on, requiring
                      monitoring for both bacterial and viral
                      indicators for both routine and triggered
                      monitoring. Specifically, EPA is    ;
                      requesting comment on whether
                      systems that must monitor their source
                      water be required to monitor for both a
                      bacterium (E.coli or enterococci) and
                      virus (male specific and somatic
                      coliphage). As discussed earlier,
                      occurrence data show that fecal
                      indicators differ in their scope and  this
                      may vary with environmental
                      conditions. The DWCSAB noted that the
                      scientific literature documents
                      significant differences between    :
                      transport and survival of bacteria and
                      viruses. Coliphage and human viruses
                      are smaller than bacterial indicators and
                      thus under certain conditions may
                      travel faster through the ground than
                      bacteria; alternately, bacterial indicators
                      are often at much higher concentrations
                      in fecal matter than coliphage, and  thus
                      may be a more sensitive indicator than
                      coliphage relatively near the
                      contamination source. The use of both
                      bacteria and coliphage indicators could
                      provide better ability to detect fecal
                      contamination and greater protection of
                      human health. However it would also
                      entail a higher probability of false  ,
                      positive results, and higher sampling
                      costs to the systems.
                        The DWCSAB believed that the
                      proposed indicators (E.coli, enterococci,
                      and coliphage) are appropriate. The
                      DWCSAB noted that both E. coli and
                      enterococci are effective bacterial
                      indicators. E. coli methods may be  more
                      familiar to many laboratories which may
                      be  advantageous. The enterococci may
                      be  somewhat hardier in terms  of
                      environmental persistence and perhaps
                      more fecal specific/The media for
                      enterococci is more selective and less
                      subject to background growth with
regards to the viral indicators. The
DWCSAB recommended both somatic
and male-specific coliphage be required
when viral monitoring of the source
water is conducted because they will
detect a larger population of coliphage.
The DWCSAB stated that laboratory
methods are available to detect both
coliphages and that they believe that a
method can be made available to detect
both coliphages on a single host (using
a single host such as E. coli C3000) so
that it would not be  necessary to collect
and test two samples for coliphage.

(g) Monitoring Frequency and Number
of Samples To Identify Fecal
Contamination
  As stated previously, the proposed
rule  would require systems with
sensitive wells to conduct monthly
routine monitoring.  The Agency
believes that monitoring more
frequently than monthly would increase
the probability for detecting fecal
indicator organisms sooner in a fecally
contaminated well. However, the
Agency also recognizes that more
intensive monitoring could be overly
burdensome to many small systems.
Less than monthly monitoring would
likely delay fecal contamination
detection, and thus continue a possible
health risk for a longer time. EPA
concludes that monthly monitoring is
the most appropriate balance between
monitoring costs and prompt fecal
contamination detection.
  The total number of samples needed
to determine" whether a ground water is
fecally contaminated depends on the
fecal indicator used, the sample volume,
and  the level and duration of fecal
contamination in the source water.
Because the EPA/AWWARF study
described in section II.C.2. monitored
contaminated wells repeatedly, the
results of this study were used to assess
the likelihood (95%, 99%, 99.9%
confidence) of detecting fecal
contamination with different indicators,
number of samples and level of fecal
contamination actually in the ground
water. The Agency then determined the
minimum number of samples necessary
to detect contamination, allowing for a
small percentage of samples where fecal
contamination is not detected. The EPA/
AWWARF study operated in two
phases. In Phase I, the EPA/AWWARF
researchers identified a set of 93 wells
thought to be vulnerable to fecal
contamination. In Phase II, the
researchers conducted further analysis,
including monthly monitoring for virus
and bacteria, on a subset of 23 of the
Phase I wells which demonstrated total
coliform and/or fecal bacteria
contamination and  on an additional 7

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                  Federal Register/Vol.  65, No. 91/Wednesday,  May 10, 2000/Proposed Rules
                                                                    30233
 wells chosen for their unique physical
 or chemical characteristics.
   From the wells tested in Phase n of
 the EPA/AWWARF study, seven sites
 tested positive for enterovirus in at least
 one sample of the twelve collected
 during the year. These seven waters are
 considered to be representative of
 ground water that are highly fecally
 contaminated at least part of the year. In
 such waters, a good indicator should he
 present in almost every sample,
 therefore, the number of non-detects
 should be very low. Combining the
 monthly results for these seven waters,
 there are 84 results for each indicator.
 Table III-5 shows the proportion of
 positives among the 84 results for each
 of four indicators.

 TABLE  111-5.—INDICATOR   PERFORM-
   ANCE IN  SEVEN  HIGHLY-CONTAMI-
   NATED WATERS
Indicator
E. coli 	
Enterococci 	
Somatic Coliphage 	
F-Specific Coliohage 	
Samples
positive
(percent)
(N=84)
50
548
71 4
32.1
   If P is the probability of a positive
 sampling result (a detect) for a single
 indicator sample assay, then the
 probability of at least one positive result
 for N repeated independent samples is
 1-(1-P)N- The probability of "N" non-
 detects is (1-P)N-. Table III-6 shows the
 probabilities of "N" non-detects for the
 same indicators as a function of the
 number of independent sample assays
 (N).
   N = number of samples.
   TABLE III-6.—PROBABILITY OF NON-DETECTS IN GROUND WATER THAT is HIGHLY FECALLY CONTAMINATED AT LEAST
                      PART OF THE YEAR (WHERE 'N1 Is THE NUMBER OF  INDEPENDENT ASSAYS)
Indicator '
EooH 	 	
Enterococci 	 ., 	 .....
Somatic Coliphage 	 	 	
F-Spociffc Coliphage 	 	 	
Number of samples (N)
N = 1
(percent)
50
45.2
28.6
67.9
N = 2
(percent)
25
20.5
8.2
46
N = 4
(percent)
6.3
4.2
0.7
21.2
N = 6
(percent)
1.6
0.9
0.1
9.8
N = 12
(percent)
-U1
<0.1
<0.1
<1.0
N = 24
(percent)
0.1
<0.1
<0.1
<0.1
N*
5
percent
5
4
3
8
N*1
1
percent
7
6
4
12
N*
0.1
percent
10
9
6
18
  Sample volume was 300 ml for E. col! and enterococci, 10-100L for coliphage
  N* » Smallest number of samples for which the error rate is less than or equal to the specified percentage (5%, 1%, 0.1%).
  Table HI-6 shows that six to!8 source
 water samples are needed, depending
 on the fecal indicator (and sample
 volume used), to determine with a
 99.9% probability that a fecal indicator
 positive will be detected in ground
water that is highly contaminated at
least part of the year.
  A similar analysis was conducted
using the results for the 10 waters that
tested positive for E. coli at least once
(N=12), but negative for enterovirus.
These waters were defined as
moderately contaminated during at least
 part of the year. Because these waters
 probably do not contain enterovirases at
 easily detectable levels, the incidence of
 waterborne disease is probably less.
 Table III-7 shows the probabilities of
 "N" non-detects for different numbers
 of independent sample assays (N).
                                                                                       i  i
   TABLE 111-7.—PROBABILITY OF NON-DETECTS IN GROUND WATER THAT is MODERATELY FECALLY CONTAMINATED AT
                   LEAST PART OF THE YEAR (WHERE'N'is THE NUMBER OF INDEPENDENT ASSAYS)
Indicator
E.coK 	 ,....„...„ 	 	 	
Enterococci ,......,.,.,, 	 	 	
Somatic ..,„„.„.„.,...., 	
F-SpecJffc 	 	 	 	
Number of samples (N)
N = 1
(percent)
71.7
67.5
72.5
96.7
N = 2
(percent)
51.4
45.6
52.6
93.4
N = 4
(percent)
26.4
20.8
27.6
87.3
N = 6
(percent)
13.5
9.55
14.5
81.6
N = 12
(percent)
1.8
0.9
2.1
66.6
N = 24
(percent)
<0.1
<0.1
<0.1
44.3
N*
5
percent
9
8
10
89
N*
1
percent
14
12
15
136
N*
0.1
percent
21
18
22
204
  Sample volume was 300 ml for E coli and enterococci, 10-100L for coliphage
  N* = Smallest number of samples for which the error rate is less than or equal to 5.0%, 1 % and 0.1 %.
  Table III-7, shows that 8 to 89
samples are needed, depending on the
indicator selected, to determine with a
95% probability that a fecal indicator
positive will be detected in a well that
is moderately contaminated at least part
of the year.
  Based on the data described
previously and statistics, EPA concludes
that, given a margin of safety for the
analysis, 12 samples would be sufficient
for determining the presence of fecal
contamination in sensitive wells. For
systems operating year round, 12
monthly samples will provide data
throughout the year, increasing the
likelihood of detecting the seasonal
presence of fecal contamination.
  EPA requests comment on the
monitoring approach discussed
previously and the analysis and the
assumptions used.

(h) Triggered Monitoring in Systems
Without a Distribution System

  EPA believes that circumstances exist
that might not require the collection of
a source water sample after a total
coliform-positive sample in the
distribution system. For example, if an

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30234
Federal Register/Vol. 65, No. 91/Wednesday, May  10,  2000/Proposed Rules
undisinfected system does not have a
distribution system, any sample taken
for compliance with the TCR is
essentially a source •water sample.
Therefore, the Agency is requesting
comment on whether to allow States to
waive "triggered" source water
sampling for systems without
distribution systems if the system is also
taking TCR samples at least quarterly. If
the total coliform-positive sample from
the distribution system is fecal coliform-
or E. co]i-positive, the system would be
required to meet the treatment
technique. There might also be
provisions for repeat sampling in this
case.
(i) Routine Monitoring in Systems
Without a Distribution System.
  EPA requests comment on whether to,
allow States to substitute  TCR
monitoring for routine monitoring in
hydrogeologically sensitive systems if
the system does not have  a distribution
system and takes at least one total
coliform sample per month under the
TCR for every month it provides water
to the public. Such a system would be
monitoring source water under the TCR.
The State would be allowed to reduce
or waive monthly monitoring after
twelve negative monthly samples. The
rule would require a system that has a
total coliform-positive sample that is
also E. coli (or fecal coliform)-positive to
meet the treatment requirements  in
§ 141.404.
(j) Source Water Monitoring for All
Systems
  EPA is proposing to require source
water monitoring requirements for
systems that do not treat to 4-log
inactivation or removal of viruses and
have either a total coliform-positive
sample taken in compliance with the
TCR, or any system identified by the
State as hydrogeologically sensitive. On
March 13, 2000 the Drinking Water
Committee of the Science Advisory
Board  (DWCSAB) reviewed this issue
and made several recommendations to
EPA concerning a draft of this proposal.
The DWCSAB raised concerns that
under this approach many untreated
ground water systems will not be
monitored at the source, particularly in
light of available  occurrence data
indicating contamination between 4 and
31 percent of ground water systems, a
number of which many riot be located
in hydrogeologically sensitive areas.
DWCSAB unanimously recommended
that all ground water systems monitor
for both bacterial and viral indicators.
EPA requests comment on whether
routine source water samples should be
required for all ground water systems
                      that do not notify the State that they
                      achieved 4-log inactivation or removal
                      of virus. EPA also requests comment
                      upon the appropriate frequency .>
                      (monthly or quarterly) for routine
                      monitoring if it were required for all
                      systems. EPA also requests comment
                      upon whether this monitoring should be
                      performed in conjunction with sanitary
                      surveys so as to provide data for the
                      sanitary survey and to reduce the
                      capacity burden on laboratories by
                      taking advantage of the phased timing of
                      sanitary surveys (every 3 years  for CWSs
                      and every 5 years for NCWs).

                      E. Treatment Techniques for Systems
                      With Fecally Contaminated Source
                      Water or Uncorrected Significant
                      Deficiencies

                      1. Overview and Purpose       ,
                        EPA proposes that a public ground
                      water system with unconnected
                      significant deficiencies or fecally
                      contaminated source water must apply
                      a treatment technique or develop
                      application for a longer State-approved
                      treatment technique within 90  days of
                      notification of the problem. Under the
                      SDWA, the State may extend the 90 day
                      deadline up to two additional years if
                      the State determines that additional
                      time is necessary for capital
                      improvements (SDWA, 1412(b)(10)). As
                      part of this requirement and in
                      consultation with the State, systems
                      must eliminate the source of
                      contamination, correct the significant
                      deficiency, provide an alternate source
                      water, or provide a treatment which
                      reliably achieves at least 99.99  percent
                      (4-log) inactivation or removal  of viruses
                      before or at the first customer. Ground
                      water systems which provide 4-log
                      inactivation or removal of viruses will
                      be required to conduct compliance
                      monitoring to demonstrate treatment
                      effectiveness.
                        EPA is proposing 99.99% (4-log)  virus
                      inactivation or removal as the mnaimum
                      level of treatment since it is the level
                      required of surface water system? under
                      . the SWTR and because, the World
                      Health Organization (WHO) states that
                      disinfection processes must achieve at
                      least 4-log reduction of enteric viruses
                      (WHO, 1996). Which treatment
                      technique approach is chosen will
                      depend on existing State programs,
                      policies or regulations. States must
                      describe in their primacy application
                      the treatment technique they will
                      require and under what circumstances.
                      If the treatment technique is not,
                      provided within 90 days, or if it is not
                      implemented by the system in
                      accordance with schedule requirements,
                      the system is in violation of the
treatment technique requirements of the
GWR.                     .
  States and systems can select a
number of treatment technologies to
achieve 4-log virus inactivation or
removal. The treatment technologies
which have demonstrated the ability to
achieve 4-log virus inactivation are
chlorine, chlorine followed by ammonia
(chloramines), chlorine dioxide, ozone,
ultraviolet radiation (UV) and anodic
oxidation. Reverse osmosis (RO) and
nanofiltration (NF) have demonstrated
the ability to achieve 4-log removal of
viruses.                      ,
  •The Agency is also proposing
requirements for systems that treat to
monitor the disinfection and State
notification requirements any time a
system fails to disinfect to  4-log
inactivation or removal of viruses. As
part of this proposal, systems serving
3,300 or more people per day must
monitor the disinfection continuously.
Systems serving fewer than 3,300
people per day must monitor the
disinfection by taking daily grab
samples. When a system continuously
monitors chemical disinfection, the
system must notify the State  any  time
the residual disinfectant concentration
falls below the State-determined
residual disinfectant concentration and
is not restored within four hours. When
a system monitors chemical disinfection
by taking daily grab samples the system
must  maintain the State-determined
residual disinfectant concentration in
all samples taken. If any sample does
not contain the required concentration,
the system must take follow-up samples
every four hours until the required
residual disinfectant concentration is
restored. The system must notify the
State  any time the system does not
restore die disinfectant concentration to
the required level within 4 hours.

a. Background
  A key element of the multiple-barrier
approach is disinfection where fecal
contamination or significant-
deficiencies are not or cannot be
corrected. EPA recognizes that the GWR
must provide system-specific flexibility
due to the diverse configuration and
variability of the numerous public
ground water systems in operation and
allow for State-specific flexibility.
Therefore, the proposed treatment
technique requirements are designed to
support the multiple-barrier approach,
yet provide flexibility to meet system-
specific concerns.
  EPA recognizes that States use
varying approaches and that a State's
preferred approach comes from
extensive experience in dealing with
uncorrected significant deficiencies and

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                 Federal Register/Vol. 65, No.  91/Wednesday,  May 10, 2000/Proposed  Rules
                                                                     30235
contaminated source water. States may
require systems to take differing
approaches to providing treatment
techniques, depending upon many
factors, including the system's
configuration, or State policies or
regulations. Therefore, the proposed
GWR attempts to build on the strengths
of existing State programs, yet provide
requirements which ensure safe
drinking water for all consumers. Under
the proposed GWR, States may require
systems to eliminate the source of
contamination, correct the significant
deficiency, provide an alternate source
water, or provide a treatment which
reliably achieves at least 99.99 percent
(4-log) inactivation or removal of viruses
before or at the first customer. Ground
water systems which provide 4-log
inactivation or removal of viruses will
ba required to conduct compliance
monitoring to demonstrate treatment
effectiveness. For example, a State may
have a policy or regulation requiring a
system to consider an alternative source
of safe drinking water before
considering the use of disinfection.
Alternatively, the State may require the
system to disinfect to 4-log virus
inactivation without first considering
the use of corrective BMPs or alternative
sources of safe drinking water. The
approach the State will use to require a
treatment technique for uncorrected
significant deficiencies or fecally
contaminated source water must  be
described in the State's primary
enforcement application (primacy). EPA
expects a State to build upon existing
ground water programs to meet today's
proposed regulations. In any case,
systems which do not provide the
appropriate State-determined treatment
technique within the 90 day deadline,
and do not have a State-approved plan
in place for complying with the
treatment technique requirement within
90 days, are in violation of the treatment
technique requirements of the GWR.
b. Corrective Action Background
Information

  This section presents background
information used by EPA to develop the
proposed treatment technique
requirements for ground water systems
with uncorrected sanitary survey
significant deficiencies or fecally
contaminated source water. Specifically
discussed is information related to
current State treatment technique
requirements, and the protectiveness of
treatment techniques, as well as a
discussion of disinfection as it relates to
uncorrected significant deficiencies and
fecally contaminated source water.
i. Alternative Sources of Safe Drinking
Water
  Limited data exists on the
effectiveness of systems using an
alternative source as a treatment
technique against uncorrected
significant deficiencies or fecally
contaminated source water. However,
since many States require a wide range
of BMPs to be followed prior to placing
an alternative source into service, it is
believed that this treatment technique
would be effective. In addition, some
States require the local hydrogeology or
sources of contamination to be
considered for all new sources of
drinking water, and would, therefore,
provide some assurance that an
alternative source as a treatment
technique is effective. Several States
require systems with source water
contamination to provide an alternative
source, if possible.

ii. Background Information on
Eliminating the Source of
Contamination
  As with the effectiveness of providing
alternative source water as a treatment
technique for uncorrected significant
deficiencies or fecally contaminated
source water, limited data exists on the
effectiveness  of eliminating the source
of contamination as a treatment
technique. The report on  the Analysis of
Best Management Practices for
Community Ground Water Systems
Survey Data Collected by the
Association of State Drinking Water
Administrators (ASDWA, 1998)
provides information on the
effectiveness  of BMPs in reducing total
coliform positives, however, it  does not
address those BMPs used in response to
a source water fecal contamination
event. The report does show that when
correcting significant deficiencies, a
significant pairwise association exists in
reducing both total and fecal coliform
positive samples. A wide range of State
requirements exist for the use of BMPs,
with some States requiring the  use of
one or more BMPs in response  to
contamination events.

iii. Disinfection
  Under today's  proposal, disinfection
is defined as the inactivation or removal
of fecal microbial contamination. As
noted earlier, corrective actions to met
the GWR treatment technique includes
disinfection. Chemical disinfection  of
viruses involves  providing a dosage of a
disinfectant for a period of time for the
purposes of inactivating the viruses. For
most treatment strategies, the level of
inactivation achieved varies depending
on the target microorganism, residual
disinfectant concentration, ground
water temperature and pH, water quality
and the contact time. The CT value is
the residual disinfectant concentration
multiplied by the contact time.
Specifically, the contact time is the time
in minutes it takes the water to move
between the point of disinfectant
application and a point before or at the
first customer during peak hourly flow.
The concentration is the residual
disinfectant concentration in mg/L
before or at the first customer, but at or
after the point the contact time is
measured. A system compares the CT
value achieved to the published CT
value for a given level of treatment (e.g.,
4-log inactivation of viruses) to
determine the level  of treatment
attained. As long as the CT value
achieved by the system meets or
exceeds the CT value needed to
inactivate viruses to 4-log, the system
meets the treatment technique
requirement.
  Four-log virus inactivation can also be
achieved by UV disinfection, which
differs from some other treatment
technologies, in that providing a
residual concentration is not possible.
When using UV disinfection, a light
dosage is applied to the water to target
the attainment of IT values (measured in
mWs/cm2). IT is the light irradiance
(measured in mW/cm2) to which the
target organisms are exposed, multiplied
by the time for which the irradiance is
applied (measured in seconds). A
system compares the IT value achieved
to the published IT value for a given
level of treatment (e.g., 4-log
inactivation  of viruses) to determine the
level of treatment attained. Systems
required to disinfect with UV
disinfection  under the GWR must
provide 4-log inactivation of viruses at
a minimum.  As long as the system
attains IT values necessary for 4-log
virus inactivation, the system meets the
treatment technique requirement.
  Removal, in the context of treatment
of microbially contaminated ground
water, is the physical straining  of the
microbial contamination, and is usually
accomplished through filtration. For the
purposes of disinfection of microbially
contaminated ground water, removal is
accomplished by membrane processes.
Membrane processes physically remove
viruses from the water based on the size
of the virus and the size of the
membrane's  pores. When the absolute
size of the membrane's pores (the
molecular weight cut-off, or MWCO) are
substantially smaller than the diameter
of the virus, removal of the virus can be
achieved. Therefore, membrane
filtration technologies with MWCO
substantially less than the diameter of

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Federal  Register/Vol.  65,  No. 91/Wednesday, May  10,  2000/Proposed Rules
viruses can be effective treatment
technologies for 4-log virus removal.

iv. State Requirements

  EPA used the Baseline Profile
Document for the Ground Water Rule
(USEPA, 1999f) to assess current State
treatment technique requirements. The
EPA survey Ground Water Disinfection
and Protective Practices in the United
States (US EPA, 1996a) was used where
the Baseline Profile Document for the
Ground Water Rule (USEPA, 1999f)
lacked certain information. These data
are important in illustrating the wide
range of State requirements that exists
in ground water systems. The GWR
attempts to build on existing State
practices and provide State flexibility to
address system-specific concerns.
  Based on an analysis of information in
the Baseline Profile Document for the
Ground Water Rule (USEPA, 1999f),
there is great variability nationwide in
State statutes, regulations, and policies
for when and how systems must apply
treatment techniques. The variability
ranges from 11 States requiring across-
the-board disinfection, several other
States requiring systems to attempt to
eliminate the real or potential source of
fecal contamination before considering
disinfection, to some States requiring
systems with fecally contaminated
source water to provide an alternative
source of safe drinking water. Almost all
of the States have statutes, regulations,
or policies for treatment techniques that
define under what circumstances
treatment techniques are necessary.
Twenty-eight of the 39 States which do
not require across-the-board  disinfection
require application of treatment
techniques based on the microbial
quality of the water and 12 of the 39
require application of treatment
techniques based on the sanitary quality
of the system.
   How a system applies treatment
techniques also varies considerably
from State to State. For example, 36  of
the 50 States specify requirements on
the use of disinfectant residuals in the
distribution system, while five States
require 4-log inactivation of viruses  at
the source.
                      v. Disinfection Technologies
                        In ground water systems, 4-log
                      inactivation of viruses can be
                      accomplished by disinfection with free
                      chlorine, chloramines, chlorine dioxide,
                      ozone, on-site oxidant generation
                      (anodic oxidation) or ultraviolet     '
                      radiation (UV). Reverse osmosis (RO)
                      and nanofiltration (NF) can achieve 4-
                      log removal of viruses. Chlorine,
                      chloramines, chlorine dioxide, ozone,
                      UV, RO and NF are all listed as small
                      system compliance technologies for the
                      SWTR. EPA also suggests that small
                      systems consider on-site oxidant
                      generation for SWTR compliance
                      purposes (US EPA, 1998c).
                        Chemical disinfection technologies
                      are commonly used to provide
                      disinfection prior to distribution, and
                      must attain specific CT values (which
                      vary depending on the technology) to
                      achieve 4-log virus inactivation. Free
                      chlorine disinfection is the most
                      commonly practiced chemical
                      disinfection technology, and requires a
                      CT value of four to provide 4-log
                      inactivation of viruses at a water
                      temperature of 15°C, and a pH of 6-9
                      (USEPA, 1991a).
                        The required CT values for 4-log virus
                      inactivation when using chloramines or
                      chlorine dioxide are higher than when
                      using free chlorine (Table III-8). The CT
                      values for 4-log inactivation of viruses at
                      a pH of 6—9 and a temperature of 15°C
                      are 16.7 mg-min/L for chlorine dioxide
                      and 994 mg-min/L for chloramines (US
                      EPA,  1991a). The CT value for
                      chloramines applies to systems which
                      generate chloramines by the addition of
                      free chlorine, followed by the addition
                      of ammonia. This chloramine CT value
                      for 15°C was obtained by extrapolating
                      CT values from a study performed by
                      Sobsey, et al, (1988) at 5°C. These CT
                      values for chlorine and chloramines
                      studied HAV, which, compared to other
                      viruses which occur in fecally
                      contaminated ground water, is relatively
                      resistant to chlorine disinfection. The
                      CT value for chlorine dioxide was
                      obtained from a study of chlorine
                      dioxide inactivation of HAV by chlorine
                      dioxide at 5°C (Sobsey, et al.,  1988). The
                      CT value obtained in this study was '
                      adjusted to 15°C, and had a safety factor
                      of two applied. Considering that
chlorine dioxide has a higher CT value
than chlorine and due to site specific
situations, chlorine dioxide may not be
a feasible disinfection technology for all
systems. Additional studies have been
conducted using free chlorine on
Coxsackie virus B5 and poliovirus 1
(Kelly and Sanderson, 195'8), and
information on these studies is provided
in Table III-8. Although the CT values
for HAV were included in the guidance
manual to the SWTR intended for
surface water systems, the CT values are
applicable to ground water systems,
since they are based on disinfectant
'residual (i.e., after demand)
concentrations.
  Many systems apply free chlorine
disinfection in a contact basin prior to
distribution for virus inactivation,
followed by ammonia addition prior to
distribution (to form chloramines) to
protect the water as it travels through
the distribution system, since
chloramines provide a longer lasting
residual than free chlorine. Due to the
high CT value for chloramines, some
additional disinfection prior to
distribution would probably be needed.
  A system that must disinfect may also
need to increase the CT value attained
if the CT value attained does not
achieve the 4-log inactivation of viruses.
Under some circumstances, this can be
accomplished by providing a higher
disinfectant dosage (and hence, a higher
disinfectant residual), or a longer
contact time (by providing additional
storage). Data from the CWSS (1995)
suggests that many CWSs (and some
NCWSs) served by ground water may
already have storage in place and may
be able to achieve 4-log virus
inactivation without additional storage.
According to the CWSS, 59% of
community ground water systems have
distribution system storage tanks,
including 34% of systems serving less
than  100 people (CWSS, 1995). This
number increases to 95% for systems
serving 10,001-100,000 people. Twenty-
eight percent of ancillary community
ground water systems were found to
have storage. According to the CWSS,
ancillary systems are those systems for
which providing drinking water is not
their primary business (e.g.,
restaurants).
       TABLE 111-8.   DISINFECTION STUDIES USING CHLORINE, CHLORINE DIOXIDE AND CHLORAMINES ON VIRUSES
Studies conducted
Disinfectant


Virus studied
HAV 	
Coxsackie B5 :. 	
Reference & date
Sobsey ef al., 1988 	
Sobsey et al., 1988 	
Kelly & Sanderson, 1958
Effectiveness
Log '
removal
4
4
4
CT
14
130
-1.07
Additional notes
Residual
Y
Y
Y
Comments
safety factor = 3
PH = 10 safety factor = 3
JH = 6, T = 28°C

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                 Federal Register/Vol.  65,  No. 91/Wednesday, May  10,  2000/Proposed Rules
                                                                     30237
 TABLE 111-8.  DISINFECTION STUDIES USING CHLORINE, CHLORINE DIOXIDE AND CHLORAMINES ON VIRUSES—Continued
Studies conducted
Disinfectant
Chloramino .....................
zChlorlne dioxide 	 	 	
Virus studied
'Poliovirus 	
HAV 	
HAV 	
Reference & date
Kelly & Sanderson, 1958
Sobsey era/., 1988 	
Sobsev etal.. 1988 	
Effectiveness
Log
removal
4
4
4
CT
-7.8
1994
116.7
Additional notes
Residual
• I
,?:
V
Comments
4-log at 5°C
safetv factor = 2
  1 CT values are for 15°C and a PH of 6-9, unless otherwise noted.
  afab!e adapted from Technologies and Costs for Ground Water Disinfection (USEPA, 1993).
  Ozone, unlike chlorine dioxide and
chloramines, is a stronger disinfectant
than chlorine and would require less
contact time (and less storage) at a
similar dosage (Table III-9) to inactivate
viruses. The CT value for 4-log
inactivation of HAV using ozone is 0.6
mg-min/L at a pH of 6-9 and a
temperature of 15°C (US EPA, 1991a).
The CT data for ozone were obtained
from a study by Roy et al., (1982). This
study obtained data for 2-log
inactivation of poliovirus 1 at 5°C. The
CT value for 4-log virus inactivation
listed in Table III-8 is an extrapolation
of the 2-log inactivation value assuming
first-order kinetics, as well as an
adjustment for inactivation at 15°C. In
addition, a safety factor of three was
applied to the CT values. However, the
CT value required for 4-log virus
inactivation may depend on the virus.
Poliovirus 1 (Kaneko, 1989) and enteric
viruses (Finch et al.,  1992) have
demonstrated other CT requirements in
studies; however, it is uncertain
whether or not all other experimental
conditions were the same (e.g.,
temperature) .
  Numerous studies on viral
inactivation using UV have been
conducted, with Table III-9 presenting
some of the findings. According to these
studies, 4-log UV disinfection of HAV
requires an IT of between 16 mWs/cm2
(Battigelli et. al., 1993) and 39.4 mWs/
cm2 (Wilson et al., 1992). IT is the UV
light irradiance multiplied by the
contact time. Other studies have shown
variable IT values, depending on the
virus studied (Table III-9). Harris et al.
(1987)  found that an IT of 120 mWs/
cm 2 (including a safety factor of 3) was
required for 4-log inactivation of
poliovirus. Unlike many of the other
alternative treatment technologies, the
efficacy of UV disinfection is not
dependent on the temperature and PH.
             TABLE III-9.—DISINFECTION STUDIES USING OZONE, MEMBRANE FILTERS AND UV ON VIRUSES
Studies conducted
Disinfectant
•"Ozone ,.,., 	 	 	
RO 	 	
NF 	 	 	 	
UV3 * 	 	
34 UV continued 	
Virus studied
Poliovirus 	
Poliovirus 	
enterics 	 , 	
HAV 	
MS2 	
<0.5 nm 	
MS2 	
-0.5—13 nm
MS2 	
HAV 	
Rotavirus 	
Poliovirus 	
Rotavirus SA1 1 	
Coxsackie B5 	

Reference E & date
Roy efa/.,1982 	
Herbold efa/.,1989
Kaneko, 1989 	
Finch et a/.,1992 ....
Hall & Sobsey,
1993.
Herbold efa/.,1989
Vaughn et a/,1990
Finch et a/., 1992
Finch efa/.,1992 ....
Jacangelo ef
a/.,1995.
Adham efa/.,1998
US EPA, 1993 	
Snicer et a/.,1996 ...
Roessler & Severin,
1996.
Wiedenmann et
a/.,1993.
Battigelli era/., 1993
Wilson et a/.,1992 ..
Roessler & Severin,
1996.
Harris efa/.,1987 ...
Chang et a/.,1985 ..
Battigelli efa/.,1993
Chang ef a/., 1985 ..
Battigelli efa/.,1993
Effectiveness
Log removal
4-6
4 	
4 	
3.9-6.0
4-6 	
4 	
27-7
4 	
2 100% removal 	
1.4-7.4 	
2 100% removal 	
4
4
4 	
4 	
4 	
4
4 	
3-4 	
4 ....
3-4 	
4

CT
10.6 	
008
5 •
3
0 167
022 .
0.40 	
72
.013 	 , 	 	
50-70%"" recovery '...
N/A
60-80% recovery ...
87 4-93
-63
-20
16 	
39.4 	 	
r'-s 	 !i'i.;;l: - ? :,i-1d
• 	 , i 	 , 	 ,: i' n| i
25
120 	
-30 	
42
-30
29

Additional notes
Residual
N
N
N, . .,'"
N
N
N
N
N
N
N
N
N
pi.
N
N , ..
N
N
N
N
N
N
N
N
N
Comments
,i
safety factor = 3.
T= iobc. 	
Also MS2.
T=10°C.
T = 4°C.
T - 22°C
T = 22°C.
MWCO<0.5 nm.
MWCO 200-400
Daltons.
Ground water.
, )
Also Rota SA11,
Poliovirus 1 .
Safety factor — 3
Approximately 4-
log.
Approximately 4-
log.
 1 CT values are values for 15 °C and a pH of 6-9, unless otherwise noted.
 3 Removal based on pore size.
 3 Inactivation measured by IT, rather than CT. IT is the UV irradiance multiplied by the contact time.
 4 Table adapted from Technologies and Costs for Ground Water Disinfection (USEPA, 1993)

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30238
Federal Register/Vol.  65,  No. 91/Wednesday,  May 10, 2000/Proposed Rules
  When systems use anodic oxidation
the primary disinfectant generated is
free chlorine. Therefore, the CT value
for anodic oxidation is the same as free
chlorine (Table III—8). However, when
using anodic oxidation other
disinfectants are also generated, and
data suggests that the combined effects
of these disinfectants are stronger than
that of free chlorine alone; however, this
effect has not been substantiated.
  Removal as a ground water treatment
technique provides public health
protection through physical filtering of
water using membrane  processes. The
effectiveness of a particular membrane
technology depends on the size of the
target organism and the size of the
membrane's pores (Table III-9).
Membrane filters achieve removals
when the MWCO of the filter is
significantly smaller than the diameter
of the target organism. Viruses range in
diameter from approximately 20-900
nm and may be effectively removed
using reverse osmosis (RO) and
nanofiltration (NF), having MWCOs of
approximately 5 nm and 30 nm,
respectively. Those technologies which
provide removal of microbial
contamination cannot provide a
disinfectant residual, and must be
applied prior to the distribution of the
water.
vi. Free Chlorine in the Distribution
System
   Chlorine disinfection is the most
commonly practiced disinfection
technology for microbial contamination
of ground water. Many ground water
systems which practice chlorine
disinfection do so by providing a free
chlorine residual at the entry point to
the distribution system. In general, the
level of inactivation achieved using
disinfectants such as chlorine increases
the longer the disinfectant is in contact
with the water (i.e., contact time). This
is true only when there is an available
supply of chlorine. When the chlorine
dissipates there is no further increase in
the inactivation level. Therefore, when
systems use a chlorine residual at the
entry point to the distribution system,
microbes (including viruses) are
inactivated at varying levels through the
length of the distribution system, and
the risk of illness from  pathogens
originating in the source water
decreases with increased travel time
through a well-maintained distribution
system if there is sufficient residual. For
example, if customers at the first service
connection in the water main receive
•water disinfected to 4-log virus
inactivation, those customers  farther
along the distribution main would
receive •water disinfected to levels
                      greater than 4-logs as long as
                      disinfectant remains, and no additional
                      contamination has entered the
                      distribution system.
                        EPA conducted analyses to evaluate
                      the potential effectiveness of a free
                      chlorine distribution system residual to
                      provide 4-log inactivation of viruses
                      originating in the source water. It was
                      assumed that the customer at the first
                      service connection received water
                      disinfected to 4-log virus inactivation.
                      Preliminary analysis indicates that a
                      number of ground •water systems can
                      achieve at least 4-log virus inactivation
                      throughout the distribution system.
                      Some systems can provide this log
                      inactivation by maintaining a 0.2 mg/1
                      free chlorine residual at the entry point
                      to the distribution system (as  required
                      by the SWTR) and a contact time of 20
                      minutes prior to the first customer. Data
                      suggests that as many as 77% of small
                      community ground water systems (i.e.,
                      serving less than 10,000 customers) may
                      achieve 4-log virus inactivation prior to
                      the first customer during maximum flow
                      conditions (AWWA, unpublished data
                      1998). When a ground water system
                      uses a free chlorine distribution system
                      residual to disinfect contaminated
                      source water, the level of virus
                      inactivation is likely well in excess of 4-
                      log, especially when taking into account
                      the time the •water awaits usage in the
                      customers' piping beyond the service
                      connection. This extra holding time in
                      the distribution system increases the :CT
                      value achieved and therefore  increases
                      the log inactivation level achieved. A
                      system may also need to apply a free
                      chlorine residual at the entry point to
                      the distribution system that is higher
                      than 0.2 mg/L to maintain a detectable
                      residual throughout the distribution
                      system, which may lead to higher levels
                      of virus inactivation. In these instances,
                      increased levels of protection would be
                      provided for customers served by all
                      service connections along the
                      distribution main. Assuming 4-log virus
                      inactivation at the first customer, it
                      could also be assumed that customers at
                      service connections at later points in the
                      distribution system would receive water
                      disinfected to higher levels of
                      inactivation, in many cases much
                      higher.
                        For some systems application of a 0.2
                      mg/L free chlorine residual at the entry
                      point to the distribution system and a
                      detectable free chlorine residual
                      throughout the distribution system will
                      not achieve 4-log virus inactivation. In
                      some cases this will be because the  ;
                      system does not achieve adequate
                      contact time, and these systems may'
                      have to increase the contact time by
                      installing extra distribution system
storage, increasing the free chlorine
residual concentration, adding
supplemental disinfection (such as
disinfection in a contact basin) or
reconfiguring the system. However,
based on 1998 AWWA data, EPA
believes that most ground water CWSs
will have sufficient contact time.
  EPA considered requiring systems to
apply a disinfectant residual at the entry
point to the distribution system and
maintain a detectable disinfectant
residual throughout the distribution
system. However, EPA decided against
including it in the proposed GWR since
a disinfectant residual is more accepted
as a distribution system tool than for
controlling source •water contamination.
EPA will address the issue of
maintaining a residual in future
rulemaking efforts  (e.g. long term 2
ESWTR) as part of a broad discussion on
distribution system issues for all PWSs.

2. Proposed Requirements
  EPA proposes  the following
requirements for ground water systems
with an uncorrected significant
deficiency or fecally contaminated
source water. The requirements for
treatment techniques, disinfection
monitoring, and  notification to ensure
public health protection are addressed.
  EPA proposes  treatment technique
requirements as  one barrier in the
multiple barrier  approach. Treatment
techniques contribute to public health
protection by eliminating public
exposure to the source of pathogens,
through eliminating the source of
contamination, requiring the system to
provide an alternative source as the
State deems appropriate, correcting
significant deficiencies that can act as a
potential pathway for contamination, or
disinfection to remove, or inactivate the
microbial contaminants. Information
related to the effectiveness of these
treatment techniques can be found in
the ASDWA BMP study Results and
Analysis of ASDWA Survey of BMPs in
Community Ground Water Systems
(ASDWA, 1998), as well as the SWTR.
a. Treatment Technique Requirements
for Systems With Uncorrected
Significant Deficiencies or Source Water
Contamination
  EPA proposes  requiring ground water
systems with an  uncorrected significant
deficiency or source water
contamination to apply an appropriate
treatment technique, as determined by
the State, within 90 days of detection of
the significant deficiency or source
water contamination. If they cannot
apply an appropriate treatment
technique within that time frame, they
must at a minimum have a State-

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                 Federal  Register/Vol. 65, No. 91/Wednesday, May 10, 2000/Proposed Rules
                                                                     30239
approved plan and specific schedule for
doing so. Treatment techniques include:
eliminate the source of contamination,
correct the significant deficiency,
provide an alternate source water, or
provide a treatment which reliably
achieves at least 99.99 percent (4-log)
inactivation  or removal of viruses before
or at the first customer. Some treatment
techniques are inappropriate solutions
for the nature of the problem. For
example, a system with contamination
entering the  distribution system must
not address the problem by providing
treatment at  the source.
  Ground water systems which provide
4-log Jnactivation or removal of viruses
will be required to conduct compliance
monitoring to demonstrate treatment
effectiveness. If a system is unable to
address the significant deficiency
within 90 days, the system must
develop a specific plan and schedule for
providing a treatment technique, submit
the plan and schedule to the  State and
receive State approval on the plan and
schedule within the same 90 days. EPA
expects the system to consult with the
State on interim measures to ensure safe
water is provided during the 90 day
correction time frame. During this 90
day period the State and system must
identify and apply a permanent
treatment technique appropriate for that
system, consistent with the State's
general approach outlined in their
primacy package. If the treatment
technique is not complete within 90
days (or the deadline specified in the
State-approved plan), the system is in
violation of the treatment technique
requirements of the GWR.
b. Disinfection Options

  EPA proposes requiring systems that
disinfect due to uncorrected significant
deficiencies  or fecally contaminated
source water to provide disinfection
adequate to achieve at least 4-log
inactivation  or removal of viruses as
determined by the State. When a system
provides disinfection for uncorrected
significant deficiencies or fecally
contaminated source water, EPA
recommends that the State use EPA-
published CT tables to determine what
treatment technologies and what
disinfection  parameters are appropriate
for  the system. If a system is currently
providing 4-log disinfection and
therefore does not monitor the source
water for fecal indicators, per § 140.403,
then that system must meet the
definition and requirements of
disinfection as described in this section.
c. Monitoring the Effectiveness and
Reliability of Treatment
  EPA proposes requiring systems with
uncorrected significant deficiencies or
fecally contaminated source water
under this proposal to monitor the
effectiveness and reliability of
disinfection as follows. This monitoring
must be conducted following the last
point of treatment, but prior to each
point of entry to the distribution system.
  Systems serving 3,300 or more people
that chemically disinfect must monitor
(using continuous monitoring
equipment fitted with an alarm)  and
maintain the required residual
disinfectant concentration continuously
to ensure that 4-log virus inactivation is
provided every day the system serves
water to the public. EPA recommends
that the State use EPA-developed CT
tables to determine if the system meets
the residual concentration and contact
time requirements necessary to achieve
4-log virus inactivation. As a point of
comparison, the surface water system
size cutoff for systems to measure the
residual disinfectant four or fewer times
per day is 3,300 people served.
  Systems serving 3,300 or fewer people
that chemically disinfect must monitor
and maintain the residual disinfectant
concentration every day the system
serves water to the public. The system
will monitor by taking daily grab
samples and measuring for the State-
determined concentration of
disinfectant to ensure that 4-log virus
inactivation is provided. EPA
recommends that the State use EPA-
developed CT tables to determine if the
system meets the residual concentration
and contact time requirements
necessary to achieve 4-log virus
inactivation. If the daily grab
measurement falls below the State-
determined value, the system must take
follow-up samples every four hours
until the required residual disinfectant
concentration is restored.
  Systems using UV disinfection must
monitor for and maintain the State-
prescribed UV irradiance level
continuously to ensure that 4-log virus
inactivation is provided  every day the
system serves water to the public. EPA
recommends that the State use EPA-
developed IT tables to determine if the
system meets the irradiance and contact
time requirements necessary to achieve
4-log virus inactivation.
  Systems that use membrane filtration
as a treatment technology are assumed
to achieve at least 4-log removal of
viruses when the membrane process is
operated in accordance with State-
specified compliance criteria, or as
provided by EPA, and the integrity of
the membrane is intact. Applicable
membrane filtration technologies are
RO, NF and any membrane filters
developed in the future that have
MWCOs that can achieve 4-log virus
removal.
  When monitoring on a continuous
basis, the system must notify the State
any time the residual disinfectant
concentration or irradiance falls below
the State-prescribed level and is not
restored within four hours. This
notification must be made as soon as
possible, but in no case later than the
end of the next business day.
  When the  system takes daily grab
sample measurements, the system must
notify the State any time the residual
disinfectant  concentration falls below
the State-prescribed level and is not
restored within four hours. This
notification must be made as soon as
possible, but in no case later than the
end of the next business day.
  Any time a system using membrane
filtration as a treatment technology fails
to operate the process in accordance
with State-specified compliance criteria,
or as provided by EPA, or a failure of
the membrane integrity occurs, and the
compliance operation or integrity is not
restored within four hours, the system
must notify the State. This notification
must be made as soon as possible, but
in no case later than the end of the next
business day.
  These requirements are consistent
with those for surface water systems.
Four hours is the cutoff time by which
a surface water system must restore the
free chlorine residual level at entry  to
the distribution system to 0.2 mg/L, if
the free chlorine residual at entry to the
distribution  system falls below 0.2 mg/
L. In addition, a surface water system
must notify the State anytime the
residual disinfectant entering the
distribution  system falls below 0.2 mg/
L and is not  restored within 4 hours.
This notification must be made by the
end of the next business day.
  EPA proposes that systems which
were required to provide treatment  for
uncorrected significant deficiencies or
fecally contaminated source water may
discontinue  treatment if the State
determines the need for treatment no
longer exists and documents such a
decision.

d. Eliminating the Source of
Contamination
  For systems eliminating the source of
contamination, EPA proposes that the
system and State develop a strategy
using appropriate BMPs considering the
characteristics of the system and the
nature of the significant deficiency  or
contamination.

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30240
Federal Register/Vol. 65, No.  91/Wednesday, May 10,  2000/Proposed Rules
e. Reporting Outbreaks
  As required in 141.32(a)(iii)(D) for
undisinfected surface water systems;
EPA proposes that if any ground water
system has reason to believe that a
disease outbreak is potentially
attributable to their drinking water, it
must report the outbreak to the State as
soon as possible, but in no case later
than the end of the next business day.

f. Treatment Technique Violations
  The GWR proposes the following
three treatment technique violations,
requiring the ground water system to
give public notification:
  (a) A ground water system with a
significant deficiency identified by a
State, which does not correct the
deficiency, provide an alternative
source, or provide 4-log inactivation or
removal of viruses within 90 days, or
does not obtain, within the same 90
days, State approval of a plan and
schedule for meeting the treatment
technique requirement, is in violation of
the treatment technique.
  (b) A ground water system that detects
fecal contamination in the source water
and does not eliminate the source of
contamination, correct the significant
deficiency, provide an alternate source
water, or provide a treatment which
reliably achieves at least 99.99 percent
(4-log) inactivation or removal of viruses
before or at the first customer within 90
days, or does not obtain within the same
90 days, State approval of a plan for
meeting this treatment technique
requirement, is in violation of the
treatment technique Unless the detected
sample is invalidated by the State or the
treatment technique is waived by the
State. Ground water systems which
provide 4-log inactivation or removal of
viruses will be required to conduct
compliance monitoring to demonstrate
treatment effectiveness.
  (c) A ground water system which fails
to address either a significant deficiency
as provided in (a) or fecal contamination
as provided in (b) according to the State-
approved plan, or by the State-approved
deadline, is in violation of the treatment
technique. In addition, a ground water
system which fails to maintain 4-log
inactivation or removal  of viruses, once
required, is in violation of the treatment
technique, if the failure is not corrected
within four hours.
  EPA requests comment on which (if
any) of these proposed treatment
technique violations should or should
not be treatment technique violations.
EPA also requests comment  as to
whether a ground water system which
has a source water sample that is
positive for E. coli, coliphage or
                      enterococci should be in violation of the
                      treatment technique.

                      3. Public Notification

                         Sections 1414(c)(l) and (c)(2) of the
                      1996 SDWA, as amended, require that
                      public water systems notify persons
                      served when violations of drinking
                      water standards occur. EPA has recently
                      (64 FR 25963, May 13, 1999) proposed
                      to revise the public notification
                      regulations to incorporate new statutory
                      provisions enacted under the 1996  ,
                      SDWA amendments. EPA recently
                      promulgated the final Public
                      Notification Rule (PNR), under part 141.
                      Subsequent EPA drinking water
                      regulations that affect public
                      notification requirements will amend
                      the PNR as a part of each individual
                      rulemaking. The GWR is proposing Tier
                      1 (discussed next) public notification
                      requirements for the treatment
                      technique violations (see § 141.405).
                      EPA requests comment on the GWR ;
                      public notification requirements.
                         The purpose of public notification is
                      to alert customers to 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 public water system 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 proposed 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 regulations
                      requiring a Tier 1 notice include:
                      Violation of the TCR, where fecal
                      contamination is present; nitrate
                      violations; chlorine dioxide violations;
                      and other waterborne emergencies. The
                      State is explicitly authorized to add
                      other violations and situations to the
                      Tier 1 list when necessary to protect
                      public health from short-term exposure.
                         Tier 2 is for other violations and
                      situations with potential to have serious
                      adverse effects on human health. Notice
                      is required within 30 days, with
                      extension up to three months at the
                      discretion of the State  or primacy
                      agency. Violations requiring a Tier 2 •
                      notice include all other MCL and
                      treatment technique violations 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
the monitoring violations.
  Today's regulatory action proposes to
make the presence of a fecal indicator in
a source water sample, failure to
monitor source water and treatment
technique violations as Tier 1 public
notification requirements. Any GWSs
with a violation or situation requiring
Tier 1 public notification must notify
the public within 24 hours of the
violation. GWS's that must make an
annual CCR report, as discussed in
III.A.7.d., must include any Tier 1
violations or situations in their next
CCR report and include the health
effects language described later in
Appendix B of subpart Q. The following
violations or situations require Tier 1
notice:
  (a) A ground water system which has
a source water sample that is positive
for E. coli, coliphage, or enterococci
under § 141.403, unless it is invalidated
under § 141.403(1);
  (b) Failure to conduct required
monitoring, including triggered
monitoring when a system has a
positive total coliform sample in the
distribution system and routine
monitoring when the system is
identified by the State as
hydrogeologically sensitive;
  (c) A ground water system with a
significant deficiency identified by a
State which does  not correct the
deficiency, provide an alternative
source, or provide 4-log inactivation or
removal of viruses within 90 days,  or
does not obtain, within the same 90
days, State approval of a plan and
schedule for meeting the treatment
technique requirement in § 141.404;
  (d) A ground water system that
detects fecal contamination in the
source water and  does not eliminate the
source of contamination, provide an
alternative water source, or provide 4-
log inactivation or removal of viruses
within 90 days, or does not obtain
within the same 90 days, State approval
of a plan for meeting this treatment
technique requirement (unless the
detected sample is invalidated under
§ 141.403(1) or the treatment technique
is waived under § 141.403(j)); and
  (e) A ground water system which fails
to address either a significant deficiency
as provided in (c) or fecal contamination
as provided in (d) according to the

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                                                                     30241
 State-approved plan, or by the State-
 approved deadline. (In addition, a
 ground water system which fails to
 maintain 4-log inactivation or removal
 of viruses, once required, is in violation
 of the treatment technique if the failure
 is not corrected within 4 hours.)
  EPA believes that these violations
 pose an immediate and serious public
 health threat Fecal contamination is an
 acute contaminant and therefore
 illnesses and even deaths can occur
 through small volumes or short
 exposure to fecally contaminated
 drinking water. Illnesses can be avoided
 by alerting the public immediately. The
 proposed tiering requirements under the
 GWR are designed to be consistent with
 those for the Total Coliform Rule.
 Failure to test for fecal coliform or E.
 coll when any repeat sample tests
 positive for coliform is considered a
 Tier 1 violation requiring a Tier 1 notice
 under current Public Notification
 Regulations. EPA believes that failure to
 collect source water samples as
 proposed under the GWR poses an
 equivalent public health threat to the
 failure to test for fecal coliform or E. coli
 under the TCR, EPA believes that an
 undisinfocted ground water system with
 either a TC positive in the distribution
 system or with a source found to be
 hydrogoologically sensitive has an
 increased likelihood of microbial
 contamination that if not monitored,
 presents a public health threat which
 requires immediate notice. EPA
 acknowledges that in some
 circumstances, die hydrogeologic
 sensitivity assessment may not be as
 indicative of the presence of microbial
 contamination in the ground water
 system as is the presence of total
 coliform in the distribution system.
 Given this potential situation, the
 Agency requests comment upon
 whether the failure to perform routine
 source Water monitoring should be
 considered a lower Tier violation to
 avoid alarming the public
 unnecessarily. EPA also requests
 comment on the other proposed public
 notification requirements presented in
 this section.
 4. Request for Comments
  EPA requests comments on all the
 information presented earlier and the
 potential impacts on public health and
regulatory provisions of the GWR. In
 addition, EPA specifically  requests
comments on the following alternative
approaches. In particular, EPA requests
comment on the following public health
issues associated with disinfection.
Stakeholders have raised concern about
the potential risk from improperly
managed or applied chemical
 disinfectants. Some stakeholders suggest
 that requiring small system operators
 who may lack training or expertise to
 apply chemical disinfection could lead
 to collateral health and safety risks. EPA
 requests comment on this issue. The
 Agency also requests input on
 alternative approaches for addressing
 demonstrated microbial contamination
 and the associated acute microbial
 health risks.

 Alternative Approaches
 a. Distribution System Residuals
  EPA requests comment on requiring a
 0.2 mg/L free chlorine residual at the
 entry points to the distribution system
 and a detectable free chlorine residual
 throughout the distribution system for
 all or some systems (e.g., all systems
 serving 3,300 or more people). EPA also
 seeks comment on whether or not
 systems should be able to use a 0.2 mg/
 L free chlorine residual at the entry to,
 and detectable throughout, the
 distribution system to meet the
 disinfection requirements proposed as
 part of the GWR.

 b. Other Log-Inactivation Levels
  EPA seeks comment on the  adequacy
 of 4-log virus inactivation or removal to
 protect public health from fecally
 contaminated ground water sources.
 Additionally, EPA requests comment on
 requiring additional levels of
 disinfection under certain
 circumstances. For example, increasing
 the log virus  inactivation may be
 appropriate for contaminated systems
 with known sources of fecal
 contamination in close proximity to a
 well.

 c. Supplemental Disinfection Strategies
  EPA requests comment on whether,
 for certain systems with  source water
 contamination, it may not be possible to
 achieve 4-log virus inactivation at the
 first customer either because of the
 distribution system size  or configuration
 (e.g., the first customer is relatively
 close to the point of disinfectant
 application).  EPA requests comment on
possible supplemental disinfection
 strategies.

 d. Mandatory Disinfection for Systems
 in Sensitive Hydrogeology

  EPA seeks comment on requiring
 disinfection for ground water systems
which obtain their water from a
sensitive aquifer regardless of microbial
monitoring results (see section III.B.).
This would provide proactive public
health protection by disinfecting a
sensitive source water before
contamination becomes apparent.
 e. Point-of-Entry Devices
   EPA seeks comment on EPA
 approving the use of point-of-entry
 devices to disinfect contaminated
 source water. This would allow systems
 to provide protection to individual
 households, and may be cost-effective
 for some very small systems. However,
 the system would be responsible  for
 maintaining the devices and this  could
 result in significant expenditure of
 resources.

 f. Across-the-Board Disinfection
   EPA seeks comment on requiring all
 systems to disinfect, or requiring
 disinfection based on system type (e.g.,
 CWS), or size of the system (e.g.,  greater
 than 3,300). The SWTR requires all
 systems obtaining their water from a
 surface water source to disinfect.  EPA
 notes that 1996 SDWA, as amended
 requires that EPA should develop
 regulations requiring disinfection for
 ground water systems  "as necessary".

 g. Health and Fiscal Impacts on Small
 Systems  (i.e., Competing Priorities)
   EPA requests comment on whether or
 not potential health effects and fiscal
 impacts specific for small systems
 should be included in the GWR.
 Specifically, EPA seeks comment on
 what other regulatory priorities will
 compete with the GWR and what
 implementation issues this will present
 (e.g., disinfection under the GWR versus
 compliance with the DBPR, difficulty in
 obtaining resources for simultaneous
 compliance with arsenic, radon, ground
 water and DBF regulations).
 h. Differing Disinfection Strategies for
 Significant Deficiencies and Source
 Water Contamination
  EPA seeks comment on whether a
 different disinfection strategy should be
 required depending on whether the
 system has an uncorrected significant
 deficiencies or fecally contaminated
 source water. Under this alternative,
 EPA could require systems with
 uncorrected significant deficiencies to
 provide only a disinfectant residual of
 0.2 mg/L free chlorine at entry to  the
 distribution system, while those systems
 with fecally contaminated source water
 would be required to provide
 disinfection to ensure that the system
 achieves 4-log virus inactivation or
 removal prior to entry to the
 distribution system.

 i. Shutting Down Systems With
 Uncorrected Significant Deficiencies
  EPA seeks comment on whether and
based on what criteria systems with
uncorrected significant deficiencies
should not be allowed to disinfect as a

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Federal Register/Vol.  65,  No. 91/Wednesday, May 10, 2000/Proposed Rules
treatment technique, but instead would
not be allowed to serve water to the
public. Under certain circumstances this
approach is used by some States. For
example, disinfection is not an effective
strategy for treating the significant
deficiency of poor distribution system
integrity.

j. Correction Time Frame
  EPA requests comment on the criteria
States must use to determine the
adequacy of schedules which go beyond
90 days (e.g., corrections which require
significant capital investments or
external technical expertise).
  EPA also requests comment on an
alternative approach for addressing
correction of significant deficiencies.
The alternate approach consists of: (1) A
requirement that the State notify the
system in writing within 30 days of
conducting the sanitary survey listing
the significant deficiency, (2) a
requirement for the system  to correct the
significant deficiencies as soon as
possible, but no  later than 180 days of
receipt of the letter from the State or in
compliance with a schedule of any
length agreed upon by the State, and (3)
the requirement that the system notify
the State in writing that the significant
deficiencies have been corrected within
10 days after the date of completion.
Under this alternative, a system that
does not correct significant deficiencies
within 180 days or within the time
frames of a schedule agreed upon by the
State is in violation of a treatment
technique and must provide public
notice. The Agency seeks comment on
whether this particular alternative
correction scheme would be appropriate
for the purposes of this rule.
  The Agency is also seeking comment
on a second alternative approach for
establishing deadlines to complete  .
corrective actions of significant
deficiencies. Under this approach,
States, as part of their primacy
requirement to identify and define the
significant deficiencies, may develop
and submit to EPA for approval,
deadlines for the completion of
corrective actions for specific types or
categories of significant deficiencies.
When a specific  corrective action is not
implemented within the State deadline,
a State must take appropriate action to
ensure that the system meets the
corrective action requirement. Any
corrective action that extends beyond
180 days to complete, must be
enforceable by the State through a
compliance agreement or an
administrative order or judicial order.
As part of primacy, the State must also
provide a plan for how the State will
meet the  time frames established in
                      their procedures for identifying,
                      reporting, correcting, and certifying
                      significant deficiencies within the 180
                      days. The Agency seeks comment on
                      whether this alternative correction
                      scheme might also be appropriate.

                      k. Required Disinfectant Residual
                      Concentration
                        EPA requests comment on requiring
                      systems that disinfect to maintain a
                      specified default disinfectant residual
                      level. This requirement would apply
                      when the State fails to provide the
                      system with a State-determined
                      disinfectant concentration to meet tjhe 4-
                      log inactivation/removal requirement
                      within the 90-day correction time frame.
                      Under this approach, systems  that must
                      treat would be required to maintain a
                      0.2 mg/L free chlorine residual at entry
                      to the distribution system and a
                      detectable free chlorine residual
                      throughout the distribution system. EPA
                      also requests comment on other
                      concentrations of residual free chlorine
                      to be maintained both at entry to the
                      distribution system and throughout the
                      distribution system (e.g., 0.5 mg/L free
                      chlorine at entry to the distribution
                      system and 0.2 mg/L free chlorine
                      throughout the distribution system),

                      1. Record Keeping for 4-log Inactivation
                      Requirements
                        EPA requests  comment upon whether
                      systems which disinfect to comply with
                      the GWR must maintain records of the
                      State notification of the proper residual
                      concentrations (when using chemical
                      disinfection), irradiance level (when
                      using UV), or State-specified
                      compliance criteria (when using
                      membrane filtrations) needed to achieve
                      4-log inactivation or removal of virus.
                      EPA also requests comment on systems
                      keeping records of the level of
                      disinfectant residuals maintained, as
                      well as how long the system should
                      keep the records (e.g., three years).
                      These records may be valuable in the
                      operation of the system because they
                      will serve as permanent records for
                      subsequent operators and/or owners of
                      the ground water system.

                      m. Differing Monitoring Requirements
                      for Consecutive Systems
                       EPA requests  comment on any GWR
                      requirements that should not apply to
                      consecutive systems. Consecutive
                      systems are those PWSs that receive
                      some or all of then: water from other
                      PWSs. Such systems would certainly
                      need to undergo the proposed  sanitary
                      survey to assure that they are delivering
                      safe water to their customers. EPA aiso
                      requests comment on whether the
                      hydrogeologic sensitivity assessment
 and any corresponding source water
 monitoring should be the responsibility
 of the water seller or the consecutive
 system. EPA requests comments on
 whether or not a consecutive system
 should be required to monitor treatment
 compliance in their distribution system
 if the seller has met 4-log inactivation or
 removal of viruses. In addition, EPA
 requests comment on the selling system
 being required to conduct triggered
 source water monitoring when the
 consecutive system has a total-coliform
 positive in the distribution system.

 n. State Primacy Requirements
  EPA requests comment on the scope
 and appropriateness of the GWR State
 primacy requirements. The primacy
 requirements include the following:
  •  Sanitary surveys: State will describe
 how it will implement the sanitary
 survey, including rationales and time
 frames for phasing in sanitary surveys,
 how it will decide that a CWS has
 outstanding performance, and how the
 State will utilize data from its SWAPP;
  •  Hydrogeologic Sensitivity
 Assessment: State will identify its
 approach to determining the adequacy
 of a hydrogeologic barrier, if present;
  •  Source Water Monitoring: State will
 describe its approach and rationale for
 determining which of the fecal
 indicators (E. Coli, coliphage or
 enterococci) ground water systems must
 use for routine and/or triggered
 monitoring;
  •  Treatment Techniques: State will
 describe treatment techniques,
 including how it will provide systems
 with the disinfectant concentration (or
 irradiance) and contact time required to
 achieve 4-log virus inactivation; the
 approach the State must use to
 determine which specific treatment
 option (correcting the deficiency,
 eliminating the source of contamination,
 providing an alternative source, or
 providing 4-log inactivation or removal
 of viruses) is appropriate for addressing
 significant  deficiencies or fecally
 contaminated source water and under
 what circumstances; and how the State
 will consult with ground water systems
 regarding the treatment technique
 requirements.

 o. State Reporting Requirements
  The proposed rule contains many.
reporting requirements for States to
 submit to EPA. EPA requests comment
 on the scope and appropriateness of
these reporting requirements. The GWR
reporting requirements include the
 following:
  • Sanitary Survey: State will report
an annual list of ground water systems
that have had a sanitary survey

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                                                                    30243
completed during the previous year and
an annual evaluation of the State's
program for conducting sanitary
surveys,
  • Hydrogeologic Sensitivity
Assessment: State will report lists of
ground water systems that have had a
sensitivity assessment completed during
the previous year, those ground water
systems which are sensitive, ground
water systems which are sensitive, but
for which the State has determined that
a hydrogeologic barrier exists, and an
anmial evaluation of the State's program
for conducting hydrogeologic sensitivity
assessments.
  • Source Wafer Monitoring: State will
report an annual list of ground water
systems that have had to test the source
water, a list of determinations of invalid
samples, and a list of waivers of source
water monitoring provided by the State.
  • Treatment Techniques: State will
report lists of ground water systems that
have had to meet treatment technique
requirements for significant deficiencies
or contaminated source water,
determinations to discontinue 4-log
inactivation or removal of viruses,
ground water systems that violated the
treatment technique requirements, and
an annual list of ground water systems
that have notified the State that they are
currently providing 4-log inactivation or
removal of viruses.
IV. Implementation
  This section describes the regulations
and other procedures and policies States
have to adopt, and the requirements that
public ground water systems would
have to meet to implement today's
proposal were it to be finalized as
proposed. Also discussed are the
compliance deadlines for these
requirements. States must continue to
meet all other conditions of primacy in
Part 142 and ground water systems must
continue to meet all other applicable
requirements of Part 141.
   Section 1413 of the SDWA establishes
requirements that a State or eligible
Indian Tribe must meet to maintain
  Erimary enforcement responsibility
  jrimacy) for its public water systems.
•fhese include (1J adopting drinking
water regulations that are no less
stringent than Federal NPDWRs in effect
under sections 1412(a) and 1412(b) of
the Act, (2) adopting and implementing
adequate procedures for enforcement,
(3) keeping records and making reports
available on activities that EPA requires
by regulation, (4) issuing variances and
exemptions (if allowed by the State)
under conditions no less stringent than
allowed by sections 1415 and 1416, and
(5) adopting and being capable of
implementing an adequate plan for the
provision of safe drinking water under
emergency situations.
  40 CFR part 142 sets out the specific
program implementation requirements
for States to obtain primacy for the
Public Water Supply Supervision
(PWSS) Program, as authorized under
section 1413 of the Act. In addition to
adopting the basic primacy
requirements, States may be required to
adopt special primacy provisions
pertaining to a specific regulation.
These regulation-specific provisions
may be necessary where
implementation of the NPDWR involves
activities beyond those in the generic
rule. States are required by 40 CFR
142.12 to include these regulation-
specific provisions in an application for
approval of their program revisions.
These State primacy requirements apply
to today's proposed rule, along with the
special primacy requirements discussed
next. The proposed regulatory language
under section 142 applies to the States.
The proposed regulatory language in
section 141 applies to the public water
systems.
   The 1996 SDWA amendments (see
section 1412 (b) (10)) provide 3 years
after promulgation for compliance with
new regulatory requirements.
Accordingly, the GWR requirements
that apply to the PWS directly,
specifically requirements found under
section 141 of this proposal (monitoring
and corrective action), are effective
three years after the promulgation date.
The State may, in the case of an
individual system, provide additional
time of up to two years if necessary, for
capital improvements in accordance
with the statute.
   Section 1413(a)(l) allows States two
years after promulgation of the final
GWR to adopt drinking water
regulations that are no less stringent
than the final GWR. EPA proposes to
require States to submit their primacy
application concerning the GWR (see
section 142 of the proposed regulatory
language) within two years of the
promulgation of the final GWR and EPA
will review and approve (if appropriate)
the application within 90 days of
submittal (1413(b)(2). This schedule
will provide all States with approved
primacy for the GWR by the three years
after [DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL
REGISTER].
   If the GWR is finalized as proposed
today, the States will have three years
from the effective date (six years from
the GWR promulgation date) to
complete all community water system
sanitary surveys and five years from the
effective date (eight years from the GWR
promulgation date) to complete all non-
 community water system sanitary
surveys. The monitoring and corrective
action requirements would be effective
on the effective date of the final rule
(three years after the GWR promulgation
date).
V. Economic Analysis (Health Risk
Reduction and Cost Analysis)
  This section summarizes the Health
Risk Reduction and Cost Analysis in
support of the GWR as required by
section 1412(b)(3)(C) of the 1996 SDWA.
In addition, under Executive Order
12866, Regulatory Planning and Review,
EPA must estimate the costs and
benefits of the GWR in a Regulatory
Impact Analysis (RIA) and submit the
analysis to the Office of Management
and Budget (OMB) in conjunction with
publishing the proposed rule. EPA has
prepared an RIA to comply with the
requirements of this Order and the
SDWA Health Risk Reduction and Cost
Analysis (USEPA, 1999a). The RIA has
been published on the Agency's web
site, and can be found at http://
www.epa.gov/safewater. The RIA can
also be found in the docket for this
rulemaking (US EPA, 1999a).
  The goal of the following section is to
provide an analysis of the costs,
benefits, and other impacts to support
decision making during the
development of the GWR.
A. Overview
  The analysis conducted for this rule
quantifies cost and benefits for four
scenarios; the proposed regulatory
option (multi-barrier option), the
sanitary survey option, the sanitary
survey and triggered monitoring option,
and the across-the-board  disinfection
option. All options include the sanitary
survey provision. The sanitary survey
option would require the primacy agent
to perform surveys every  three to five
years, depending on the type of system.
If any significant deficiency is
identified, a system is required to
correct it. The sanitary survey and
triggered monitoring option adds a
source water fecal indicator monitoring
requirement triggered by  a total coliform
positive sample in the distribution
system. The multi-barrier option adds a
hydrogeologic sensitivity assessment to
these elements which, if a system is
found to be sensitive, results in a
routine source water fecal indicator
monitoring requirement.  The multi-
barrier option and the sanitary survey
and triggered monitoring options are
both a targeted regulatory approach
designed to identify wells that are
fecally contaminated or are at a high
risk for contamination. The across-the-
board disinfection option would require
all systems to install treatment instead
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of trying to identify only the high risk
systems; therefore, it has no requirement
for sensitivity assessment or microbial
monitoring.
  Costs for each option varied and were
driven by the number of systems that
would need to fix a significant
deficiency or take corrective action,
such as installing treatment or
rehabilitating a well, in response to fecal
contamination. The majority of costs for
all options, with the exception of the
across-the-board option, are the result of
systems having to fix an actual or
potential fecal contamination problem.
The mean annual costs of the various
options range from $73 million to $777
million using a three percent discount
rate and $76 million to $866 million
using a seven percent discount rate.
(Note some costs have not been
quantified and are not included in these
totals, see section V.B.)
  These total annual quantified costs
can be compared to the annual
monetized benefits of the GWR. The
annual mean benefits of the various rule
options range from $33 million to $283
million. This result is based on the
quantification of the number of acute
viral illnesses and deaths avoided
attributable to this rule. This rule will
also decrease bacterial illness and death
associated with fecal contamination of
ground water. EPA did not directly
calculate the actual numbers of illness
associated with bacterially
contaminated ground water because the
Agency lacked the necessary bacterial
pathogen occurrence data (e.g., number
of wells contaminated with Salmonella)
to include it in the risk model. However,
in order to monetize the benefit from
reduced bacterial illnesses and deaths
from fecally contaminated ground
water, the Agency used the ratio of viral
                      and unknown etiology outbreak
                      illnesses to bacterial outbreak illnesses
                      reported to CDC for waterborne
                      outbreaks in ground water systems.
                        Several non-health benefits from this
                      rule were also considered by EPA but
                      were not monetized. The non-health
                      benefits of this rule include avoided
                      outbreak response costs (such as the
                      costs of providing public health
                      warnings and boiling drinking water),
                      and possibly the avoided costs of
                      averting behavior and reduced
                      uncertainty about drinking water
                      quality. There are also non-monetized
                      disbenefits, such as increased exposure
                      to DBFs.'
                        Additional analysis was conducted by
                      EPA to look at the incremental impacts
                      of the various rule options, impacts on
                      households, benefits from reduction in
                      co-occurring contaminants, and
                      increases in risk from other
                      contaminants. Finally, the Agency
                      evaluated the uncertainty regarding the
                      risk, benefits, and cost estimates.
                      B. Quantifiable and Non-Quantifiable
                      Costs
                        In estimating the cost of each rule
                      option, the Agency considered impacts
                      on public water systems and on States.
                      The GWR will result in increased costs
                      to some PWSs for monitoring, corrective
                      action of significant deficiencies, and
                      installing treatment, but these vary  ,
                      depending on the option. With all rule
                      options, a greater portion of the
                      regulatory burden will be placed on
                      those systems that do not currently  ;
                      disinfect to a 4-log inactivation of virus.
                      States will  incur costs for an
                      incremental increase in sanitary survey
                      requirements, for conducting
                      hydrogeologic sensitivity assessment?,
                      and for follow-up inspections. Both
systems and States would incur
implementation costs. Some costs of
today's rule options were not quantified
(such as land acquisition, public
notification costs and corrections to all
potential significant deficiencies (See
section V.B.4.)).

1. Total Annual Costs
  In order 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
allowed the Agency to capture the
variability in PWS configuration,
current treatment in place and source
water quality.
  Table V—1 shows the estimated mean
and range of annual costs for each rule
option. At both a three and seven
percent discount rate for the first three
options, the costs increase as more
components are added for identifying
fecally contaminated wells and wells
vulnerable to fecal contamination. The
fourth option of across-the-board
disinfection is the most costly because
it would require all systems to install
treatment regardless of actual fecal
contamination or the potential to
become fecally contaminated. Costs for
the States to implement these rule
options are also included in the four
cost estimates. Discount rates of three
and seven percent were used to
calculate the annualized value for the
national compliance cost estimate. The
seven percent rate represents the
standard discount rate required by OMB
for benefit-cost analyses of government
programs and regulations.
                             TABLE v-1—ANNUAL COSTS OF RULE OPTIONS ($MILLION)
Option
Sanitary Survey 	 	 	
Sanitary Survey and Triggered Monitoring 	 , 	
Multi-barrier (Proposed) Option 	 	 	
Across-the-Board Disinfection 	 	 	

3% Discount
rate
Smillion
mean
[range]
$73
[$71 -$74]
$158
[$1 53-4162]
$183
[$177-188]
$777
[$744-$810]
7% Discount
rate
Smillion
mean
[range]
$76
[$74-78]
$169
[$163-174]
$199
[$192-206]
$866
[$823-$909]
2. System Costs

   In order to calculate the cost impact
of each rule option on public water
systems, EPA had to estimate the
                      current baseline of systems and their
                      current treatment practices, and then
                      estimate how many systems would be
                      affected by the various option
                      requirements based on national
occurrence information. The industry
baseline discussion is located in section
I.C. of this preamble. Estimates of the
cost compliance requirements for each
rule option are captured in a decision

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                                                                      30245
troo analysis. The decision tree is
comprised of various percentage
estimates of the number of systems that
will fall into each regulatory component
category. Rule components include
corrective action costs or costs to
address significant deficiencies,
monitoring costs, start-up costs, and
reporting costs. Each of the rule options
contains varidus combinations of these
rule components with the sanitary
survey option containing the fewest
requirements.
  Overall, these rule options provide a
great amount of flexibility, with the
exception of across-the-board
disinfection, and this has complicated
Ilia cost analysis. Data were not always
available to estimate the number of
systems that would fall under the
various rule components. EPA used
data, where available but also consulted
with experts and stakeholders to get the
best possible estimates of the cost of this
rule. More information on the GWR
decision tree and how each element was
estimated can be found in the Appendix
to the GWR RIA (US EPA. 1999a).
  As previously mentioned, the main
cost component of the first three rule
options results from systems having to
take corrective action in response  to
fecal contamination or to fix significant
deficiencies that could result in well
contamination. In order to analyze the
different rule options, the Agency had to
distinguish between correction of
significant deficiencies and the
corrective actions that result from a
confirmed source water positive sample
for E. coli, enterocpcci or cpliphage. In
addition, it would be extremely
challenging to cost out all conceivable
corrective actions or significant
deficiencies that a system could
potentially encounter. As a result, the
Agency focused on a representative
estimate of potential types of corrective
actions and significant deficiencies as
shown in Table V-2 and Table V-3,
respectively.
  The choice of treatment technique (in
consultation with the State) is also
influenced by the size of the system.
This is captured in the decision tree
analysis by assigning probabilities (by
system size) that a certain corrective
action will be chosen. These
probabilities are based on the relative
cost of each action, data on existing
disinfection practices, and best
professional judgment. Additional
significant deficiencies related to
improper treatment were included in
the cost analysis for systems that
currently disinfect. These deficiencies
are also captured in the decision tree
and are listed in Table V-3.
TABLE V-2.—TREATMENT TECHNIQUES
  To  ADDRESS   POSITIVE   SOURCE
  WATER SAMPLES

           Corrective action:1

Rehabilitating an existing well
Drilling a new well
Purchasing water (consolidation)
Eliminating known sources of contamination
Installing  disinfection  (8 choices  of tech-
  nologies)

  1 Choice varies with systems size and cor-
rective action feasibility.
  Each treatment technique can be.
addressed by various low or high cost
alternatives. For example, a lower cost
fix for many systems would be to
rehabilitate a well while a higher cost
fix would be to drill a new well. It is
possible that not all States, in
coordination with systems, would
choose the relatively lower cost
alternative of well rehabilitation. It
would depend on the  well itself and
also the problem that was being
addressed. In addition, if the model
predicted that a system would install
treatment, the choice of treatment is
contingent on system  size. To capture
these alternative possibilities, the
Agency considered different
combinations of low and high cost
alternatives. For instance, when the low
cost corrective action  alternative was
run, the model estimated a greater
percentage of systems choosing the
lower cost well rehabilitation option
versus the higher cost option of drilling
a new well. To account for the
uncertainty in the types of significant
deficiencies identified and in the
treatment technique taken, the cost
model was run for each of the following
combinations of low and high costs
alternatives.
  • Low significant deficiency cost/low
treatment technique cost
  • Low significant deficiency cost/
high treatment technique cost
  • High significant deficiency cost/low
treatment technique cost
  • High significant deficiency cost/
high treatment technique cost
  These combinations of low and high
cost are reflected in the range of cost
estimates shown in Table V—1 for the
multi-barrier option (proposed option),
the sanitary survey and triggered
monitoring option, and the across-the-
board option. For the sanitary survey
option, only the high and low costs
associated with significant deficiencies
were included in the analysis. As stated
earlier, treatment technique costs are the
result of source water monitoring which
is not included with the sanitary survey
option.
      TABLE V-3.—SIGNIFICANT
            DEFICIENCIES

          Significant deficiencies

Unsealed well or inadequate well seal
Improper well construction
Inadequate roofing on a  finished water stor-
  age tank
Evidence of vandalism at finished water stor-
  age tank
Unprotected cross connection in the distribu-
  tion system
Booster pump station which lacks duplicate
  pumps
Additional  significant  deficiencies  for dis-
  infecting systems:
  Inadequate disinfection contact time
  Inadequate application  of treatment chemi-
    cals

  In addition to the treatment technique
costs, EPA estimated the cost to systems
for monitoring. All options would have
some monitoring costs. However, the
monitoring costs vary  depending on the
rule option as indicated in Table V-4.
Regardless of the option, the triggered
and routine monitoring applies only to
systems that do not disinfect to a 4-log
inactivation of virus.
  Both the triggered and routine
monitoring costs are calculated based on
the cost of the test and the operator's
time to take and transport the sample.
EPA assumed that if this source water
sample is positive, all  systems would
take five repeat samples to confirm the
positive (although this is an optional
rule component). For routine
monitoring, the Agency assumed that all
systems would monitor their source
water monthly for the  first year and
quarterly thereafter at  the States'
determination. However, in some cases
the State may allow the system to
discontinue monitoring after 12
monthly samples or it could also require
the system to continue with monthly
monitoring. The cost of disinfectant
compliance monitoring varies with
system size and would be required for
any system that currently disinfects or
installs treatment as a  result of the
GWR. For large systems, EPA assumed
that an automated monitoring system
would be installed; for smaller systems,
EPA assumed that a daily grab sample
would be taken. A more detailed
explanation of each of these monitoring
schemes is located in section III. D. and
section III E.2.c.

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      TABLE V-4.—MONITORING
   REQUIREMENTS BY RU'LE'OPTION
Option
Sanitary Survey
Sanitary Survey
and Triggered
Monitoring
Option 	
Multi-barrier
(Proposed)
Option
Across-the
Board Dis-
infection Op-
tion 	
Trig-
gered
moni-
toring



Rou-
tine
moni-
toring



Dis-
infect-
ant
compli-
ance
moni-
toring
'


  Finally, the Agency accounted for a
system's start-up costs to comply with
the GWR . These costs include time to
read and understand the rule,
mobilization and planning, and training.
EPA assumed start-up costs would
remain constant across the rule options.
The Agency also estimated system costs
for reporting and recordkeeping of any
positive source water samples.

3. State Costs
  Similar to the system cost, State costs
also vary by rule option. Depending on
the option, States would face increased
costs from the incremental difference in
the sanitary survey requirements and
frequency, from conducting a one-time
hydrogeologic sensitivity assessments,
and tracking monitoring information for
those options with a monitoring
requirement. States would also have
start-up and annual costs for data
management and training. If a system
needs longer than 90 days to  complete
a treatment technique or repair a
significant deficiency, the State would
have to approve the time schedule and
plan.
  By including start-up costs, annual
fixed costs, and incremental sanitary
survey costs in the decision tree
analysis for all rule options, EPA
accounted for these State costs. The
analysis also assumed costs for State
review and approval of plans for
treatment techniques. The cost for the
one-time sensitivity assessments is
included for the proposed rule option
analysis.

4. Non-Quantifiable Costs
  Although EPA has estimated the cost
of all the rule's components on drinking
                      water systems and States, there are some
                      costs that the Agency did not quantify.
                      These non-quantifiable costs result from
                      uncertainties surrounding rule
                      assumptions and from modeling
                      assumptions. For example, EPA did not
                      estimate a cost for systems to acquire
                      land if they needed to build a treatment
                      facility or drill a new well. This was not
                      considered because many systems will
                      be able to construct new wells or
                      treatment facilities on land already
                      owned by the utility. In addition, if the
                      cost of land was prohibitive, a system
                      may chose another lower cost
                      alternative such as connecting to
                      another source. A cost for systems
                      choosing this alternative is quantified in
                      the analysis. The cost estimates do not
                      include costs for public notification
                      which are proposed. These estimates
                      have not been included because EPA
                      has no data on which to base an
                      estimate of the number of treatment
                      techniques violations or the number of
                      times systems will fail to perform source
                      water monitoring.
                        In addition, the Agency did not
                      develop costs for all conceivable
                      significant deficiencies or corrective
                      actions that a system may encounter.
                      Instead, a representative sample was
                      chosen as shown in Tables V—2 and V—
                      3.
                      C. Quantifiable and Non-Quantifiable
                      Health and Non-Health Related Benefits
                        The primary benefits of today's
                      proposed rule come from reductions in
                      the risks of microbial illness from
                      drinking water. In particular, the GWR
                      focuses on reducing illness and death1
                      associated with viral infection.
                      Exposure to waterborne bacterial
                      pathogens are also reduced by this rule
                      and the benefits are monetized, but not
                      by the same method used to calculate
                      reductions in viral illness and death
                      because of data limitations. It is likely
                      that these monetized illness calculations
                      which are based on a cost of illness
                      (COI) rather than a willingness to pay
                      (WTP) approach, underestimate the true
                      benefit because they do not include pain
                      and suffering associated with viral and
                      bacterial illness.            - v   '   .
                        Additional health benefits such as :
                      reduced chronic illness were
                      investigated, but were not quantified or
                      monetized in this analysis. Other non-
                      health benefits •will likely result from
                      this rule but were also not quantified br
                      monetized. These non-health related ;
                      benefits are discussed in sections V.A.
                      and V.C. 2.
1. Quantifiable Health Benefits

   The benefits analysis focused on
estimating reductions in viral and
bacterial illness and death that would
result from each of the rule options. The
first part of the analysis estimates the
baseline (pre-GWR) level of illness as a
result of microbial contamination of
ground water. A discussion about how
the Agency estimated this baseline risk
is located in section II. E. of today's
proposal. An important component of
these risk estimates is the effect that
these pathogens have on children
(especially infants) because they are
more likely to have severe illness and
die from viral infection than the general
population. A detailed discussion of
risks to children is located in section VI.
G.
  The second part of the analysis
focused on the reduction in risk that
results from the various rule
components.  These components include
identifying high risk wells, fixing
significant deficiencies, increased
monitoring for some systems, and
possibly installing treatment in the
event that a problem can not be fixed or
a new source found. To calculate these
changes, the risk-assessment model was
re-run using new assumptions based on
reductions in viral exposure which
results from different levels of fecal
contamination identified by each rule
option.
  To model the reduction in source
contamination that would result from
implementation of the four regulatory
options, EPA  assumed reductions in the
number of ground water systems/points
of entry that are potentially
contaminated with viral pathogens
under baseline conditions. The
reduction varies with expectations
regarding the effectiveness of each
option in identifying and correcting
significant defects at the source.
Reductions in treatment failure rate and
in distribution system contamination
are also addressed for each option. The
estimated reductions  in contamination
which are expected for each rule option
are summarized in Table V—4a. These
estimates are  based upon information
from consultations by the Agency with
stakeholders and the Agency's best ,
professional judgement regarding the
effectiveness  of sanitary surveys and
upon co-occurrence rates of fecal
indicators with pathogenic viruses. See
section 5.3 of the GWR RIA for a
detailed discussion of the basis for the
estimated reductions.

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                 Federal Register/Vol. 65, No.  91/Wednesday, May 10, 2000/Proposed Rules
                                                                     30247
                      TABLE V-4A. ESTIMATED CONTAMINATION REDUCTIONS FOR GWR OPTIONS
                                                     [In Percent]
Regulatory option
Option 1. Sanitary Survey Only 	
Option 2, Sanitary Survey and Triggered Monitoring ....
Option 3 Multi-Barrier (Proposed) 	
Option 4, Across-tne-Board Disinfection 	

Estimated reduction in viral source con-
tamination of undisinfected ground water
sources
Properly
constructed
0
30-54
38-77
100
Improperly
constructed
40-60
58-82
63-91
100
Estimated reduction
in rate of disinfec-
tion failure for
GWSswith viral
contamination of
the source
0-26 (CWS)
0-43 (NCWS)1
77-100
J
77-100
^-4 !;
Estimated reduction
in distribution sys-
tem contamination
with virus of GWSs
0-25
(NAforTNC)2
0-25
(NAforTNC)2
0—25
(NAforTNC)2
0-25
(NAforTNC)2
  1 Non-community water systems (NCWS), both transient and nontransient, have an estimated reduced risk of contamination of 0-43%; com-
munity water systems (CWS) reduced risk is 0-26%.
  a Reduction of risk in transient non-community (TNC) systems was not considered.
  After the reductions in viral illnesses
and death were estimated, the Agency
estimated the monetized benefit from
the reduction in bacterial illnesses and
death associated with each rule option.
EPA could not directly calculate the
actual numbers of illnesses and death
associated with bacterially
contaminated ground water because the
Agency lacked the necessary pathogen
occurrence information to include it in
the risk model. In order to estimate the
benefit from reducing bacterial illnesses
and deaths from fecally contaminated
ground \vater, the Agency relied on
CDG's outbreak data ratio of viral
outbreaks and outbreaks of unknown
etiology believed to be viral to bacterial
outbreaks in ground water. These data
indicate that for every five viral
outbreaks, there is one bacterial
outbreak. It was further assumed that
the cost of these bacterial illnesses
would be comparable to viral illness
estimates.
  To assign a monetary value to the
illness, EPA estimated costs-of-illness
ranging from $158 to $19,711 depending
upon the age of the individual and
severity of illness (see Exhibits 5-9 and
5-10 in the RIA). These are considered
lower-bound estimates of actual benefits
because it does not include the pain and
discomfort associated with the illness.
This issue is discussed in greater detail
in the GWR RIA (USEPA, 1999a).
Mortalities were valued using a value of
statistical life estimate (VSL) of $6.3
million consistent with EPA policy. The
VSL estimate is based on a best-fit
distribution of 26 VSL studies and this
distribution has a mean of $4.8 million
per life in 1990 dollars. For this
analysis, EPA updated this number to
1999 dollars which results in a mean
VSL value of $6.3 million. Table V-5
shows the annual monetized benefits by
rule option.
                   TABLE V-5.—QUANTIFIED AND MONETIZED BENEFITS BY RULE OPTION ($MILLION)
Options
Sanitary Survey 	 	 	 	
Sanitary Survey and Triggered Monitoring 	
Multi-Barrier Proposed ( Option) 	
Acfoss-thQ-Board Disinfection . 	

Morbidity
Smillion
[range]
$22
[$7 to $38]
$120
. „ [$100 to $140]
$139
[$115 to $163]
$192
[$174 to $210]
iviortality
$million
[range]
$11
[$2 to $20]
$58
[$47 to $68]
$66
[$54 to $79]
$91
[$81 to $101]
Total
$million
[range]
, $33
[$9 to $58]
$178
[$147 to $209]
$205
[$169 to $242]
$283
[$255 to $311]
2. Non-Quantifiable Health and Non-
Health Related Benefits
  Although viral and some bacterial
illness have been linked to chronic
diseases, insufficient data was available
to forecast the number of avoided
chronic cases that would result from
each rule option. A review of medical
and epidemiological data identified
several chronic diseases linked to viral
infections. The strongest evidence links
Group B coxsackievlrus infections with
Type 1-insulin-dependent  diabetes and
also to heart disease. Bacterial illness
can also result in longer-term
complications including arthritis,
recurrent colitis, and hemolytic uremic
syndrome. Most of these chronic
illnesses and longer term complications
are extremely costly to treat.
  Using cost-of-illness (COI) estimates
instead of willingness-to-pay (WTP)
estimates to monetize the benefit from
illness reduction generally results in
underestimating the actual benefits of
these reductions. In general, the COI
approach is considered a lower bound
estimate of WTP because COI does not
include pain and suffering. EPA
requests comment on the use of an
appropriate WTP study to calculate the
reduction in illness benefits of this rule.

D. Incremental Costs and Benefits

  Today's proposed rule options
represent the incremental costs and
benefits of this rule. Both costs and
benefits increase as more fecal
contamination detection measures are
added to the sanitary surveys for the
first three options. The proposed option
has the highest cost of these three
incremental options, but it also
produces incrementally more benefits.

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Federal  Register/Vol. 65, No. 91/Wednesday, May 10, 2000/Proposed  Rules
  The fourth option, across-the-board
disinfection, is the most costly because
it would require all systems to install
treatment or to upgrade to 4-log
removal/inactivation. It would not
provide the flexibility of the other three
options and would not target
specifically high risk systems. Similar to
                      the first three options, this option also
                      includes the sanitary survey provision.
                      This is included to address problems in
                      the distribution systems and with
                      disinfection failure.
                        Table V-6 and Table V-6a show the
                      monetized costs, benefits and net
                      benefits for all four options using both
a three percent and seven percent
discount rate, respectively. It is
important to remember that non-
quantified costs and benefits are not
included in these net benefit numbers.
                            TABLE V-6.—NET BENEFITS—3% DISCOUNT RATE ($MILLION)
Options
Sanitary Survey . 	 	 	 	
Sanitary Survey and Triggered Monitoring 	 ...
Multi-Barrier (Proposed) 	 	
Across-the-board Disinfection 	 ...
Mean annual
costs (3%)
Smillion
$73
158
183
777
Mean annual
benefits 1 '
Smillion
$33
178
205
283
Net benefits of
the
means
Smillion
($40)
20
22
(494)
  1 Does not include non-quantified benefits which would increase the net benefits of these rule options.

                           TABLE V-6A.—NET BENEFITS—7% DISCOUNT RATE ($MILLION)
Options
Sanitary Survey .
Sanitary Survey and Triggered Monitoring 	 ,..
Multi-Barrier (Proposed) 	 ;..
Across-the-board Disinfection 	
Mean annual
costs
(7%)
Smillion
$76
169
199
866
Mean annual
benefits 1
$million
$33
178
205
283
Net benefits
$mi!lion
($43)
9
6
(583)
  1 Does not include non-quantified benefits which would increase the net benefits of these rule options.
E. Impacts on Households

  Overall, the average annual cost per
household for the first three rule options
are small across most system size
categories as shown in Table V—7.
However, costs are greater for the
smallest size category across all options.
This occurs because there are fewer
households per system to share the cost
of any corrective action or monitoring
                      incurred by the systems. For example,
                      under the Multi-Barrier option
                      household costs would increase by
                      approximately $5 per month for those
                      served by the smallest size systems
                      (<100 people) while those served by the
                      largest size systems (>100,000 people)
                      would face only a $0.02 increase in
                      monthly household costs. As previously
                      mentioned, the majority of the cost from
                      the first three rule options is the result
of systems having to correct significant
deficiencies in their systems or to take
corrective action in response to fecal
contamination. On average, household
costs resulting from the first three rule
options increase from $2.45 to $3.86
annually. The most expensive option,
across-the-board disinfection, also has
the highest average household costs at
$19.37 annually.
   TABLE V-7.—AVERAGE ANNUAL HOUSEHOLD COST FOR GWR OPTIONS FOR CWS TAKING CORRECTIVE ACTION OR
                                           FIXING SIGNIFICANT DEFECTS
Size categories
<100
101-500 	 	
501-1 ,000 	
1,001-3,300 	
3301-10000
10,001-50,000 	
50,001-100,000 	 	
100,001-1,000,000 	 	 	 .. . ..
Average

Sanitary sur-
vey option
$2986
11 23
572
2.99
1 39
062
030
032
245

Sanitary sur-
vey and trig-
gered moni-
toring option
$67 19
1502
6.29
2.91
1 46
059
070
020
334

Multi-barrier
option
(proposed)
$6248
18.95
6.25
3.39
2 74
062
1 01
027
3 86

Across-the-
board disinfec-
tion option
$191 87
81.38
38.79
23.45
1678
487
1037
1 66
1937


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                                                                     30249
 F, Cost Savings From Simultaneous
 Reduction of Co-Occurring
 Contaminants
  If a system chooses to install
 treatment, it may choose a technology
 that would also address other drinking
 water contaminants. For example, when
 using packed tower aeration to treat
 radon, it is the accepted engineering
 practice, and in some States an existing
 requirement, to also install disinfection
 treatment for removal of microbial
 contaminants introduced in the aeration
 treatment process. Depending on the
 dosage and contact time, the routine
 disinfection would also address possible
 or actual fecal contamination in the
 source water. If systems had an iron or
 manganese problem, the addition of an
 oxidant and filtration can 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 is currently in the process
 of proposing rules to address radon and
 arsenic. Because of the difficulties in
 establishing which systems would have
 all  three problems of fecal
 contamination, radon, and arsenic or
 any combination of the three, no
 estimate was made of the potential cost
 savings from addressing more than one
 contaminant simultaneously. EPA also
 recognizes that while there may be
 savings from treating several
 contaminants simultaneously relative to
 treating each of them separately, there
 may also be significant economic
 impacts to some systems (especially
 small systems), if they have to address
 several contaminants in a relatively
 short time frame. Because of the lack of
 good data on co-occurrence of
 contaminants, EPA has not considered
 these simultaneous impacts in the
 analysis of household and per system
 costs.
 G. Bisk Increases From  Other
 Contaminants
  The RIA for today's rule contains a
 detailed discussion of the increased risk
 from other contaminants that may result
 from GWR requirements. Most of the
 risk stems from currently untreated
 systems installing disinfection. When
 disinfection is first introduced into a
 previously undisinfected system, the
 disinfectant can react with pipe scale
 causing increased risk from some
contaminants and water quality
problems. Contaminants that may be
released include lead, copper, and
arsenic. It could also lead to a temporary
discoloration of the water as the scale is
loosened from the pipe. These risks can
 be reduced by gradually phasing in
 disinfection to the system, by routine
 flushing of distribution system mains
 and by maintaining a proper corrosion
 control program.
   Using  a chlorine-based disinfectant or
 ozone could also result in an increased
 risk from disinfection byproducts
 (DBFs). Risk from DBFs has already
 been addressed in the Stage \
 Disinfection Byproducts Rule and is
 currently being further considered by
 the Stage II M-DBP FACA. Systems
 could avoid this problem by choosing
 an alternative disinfection technology
 such as ultraviolet disinfection or
 membrane filtration, though this may
 increase  treatment costs. The GWR cost
 estimate includes such additional
 treatment costs for a portion of systems
 taking corrective action.

 H. Other Factors: Uncertainty in Risk,
 Benefits, and Cost Estimates

   Today's proposal models the current
 baseline  risk from fecal contamination
 in ground water as well as the reduction
 in risk and the cost for four rule options.
 There is  uncertainty in the baseline
 number of systems, the risk calculation,
 the cost estimates, and the interaction of
 other rules currently being developed.
 These uncertainties are discussed
 further in the following section.
   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. Therefore, EPA does
 not have a reliable estimate of how
 many of these mixed systems exist. To
 the extent that systems classified in
 SOWS as surface water or ground water
 under the influence of surface water
 may also have ground water wells not
 under the influence of surface water and
 thus be subject to this rule, the costs and
benefits estimated here would be
 understated. In addition, the SDWIS
 data on non-community water systems
 does not  have a consistent reporting
convention for population served. Some
States may report the population served
over the course of a year, while others
may report the population served on an
average day. Also, SDWIS does not
require States to provide information on
current disinfection practices and, in
some cases, it may overestimate  the
daily population served. For example, a
park may report the population served
yearly instead of daily. EPA is looking
at new approaches to address these
issues, and both are discussed in the
Requests  for Comment section V.I.
   The risk calculations concerning the
 baseline number of illnesses and the
 reduction of illnesses that results from
 the various rule options contains
 uncertainty. For example, a nationally
 representative study of baseline
 microbial occurrence in ground water
 does not exist. EPA chose the AWWARF
 study (described in section II.C.l) to
 represent properly constructed wells
 because, of the thirteen available
 studies, it is the most representative of
 national geology. EPA also relied on
 data from the EPA/AWWARF study to
 represent improperly constructed wells
 because this study targeted wells
 vulnerable to contamination and tested
 wells monthly for a year. However, EPA
 recognizes the variable nature of these
 studies, as discussed in detail in section
 II.C. Additionally, EPA had to rely on
 CDC outbreak data to characterize the
 'causes of eridemic ground water disease.
 As discussed in section II. B., the U.S.
 National Research Council suggests that
 CDC numbers only represent a small
 percentage of actual waterborne disease
 outbreaks. The Agency also 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 ground
 water systems or if other rules, such as
 the TMDL, CAFO, and Class V UIC Well
 Rules result in decreased fecal
 contamination.
  EPA did  not have dose-response data
 for all viruses and bacteria associated
 •with previous ground water disease
 outbreaks. For viral illness, the Agency
 used echo and rota viruses 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 low-to-medium
 infectivity viruses that cause severe
 illness and high infectivity viruses that
 cause more mild illness. Further, there
 is considerable uncertainty in the dose-
 response functions used, even for these
 two viruses. Dose-response 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. There is likely to be
variability in both of these parameters
across populations and based on case
specific circumstances, and only limited
data are ava lable. Another uncertainty

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concerns the number of baseline
bacterial illness caused by ground water
contamination. The bacterial risk could
not be modeled because of lack of
occurrence and dose-response data.
Estimates of bacterial illness were made
based on a ratio of bacterial  to viral
outbreak as documented by  CDC and
applied to the viral risk estimate
discussed previously. There is also
considerable uncertainty in  quantifying
the effectiveness of various regulatory
options in reducing risk. There is little
data currently on which to base
quantitative estimates of the
effectiveness  of sanitary surveys or
routine monitoring in reducing
microbial risk, though there is some
qualitative research suggesting that
these can be effective strategies. To
model risk reduction quantitatively,
EPA relied primarily on best
professional judgment. The  quantitative
estimates of risk reduction used in the
analysis are summarized in  Table V—4a.
  There is also uncertainty in the
valuation of risk reduction benefits. For
this analysis EPA used a 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. In general, however, COI
estimates understate benefits because
they do not account for the value people
place on reduced pain and suffering.
  Some costs of today's proposed rule
are also uncertain because of the  diverse
nature of possible significant
deficiencies systems would  need to
address. Also, the rule's flexibility leads
to some uncertainty in estimates of who
will be  affected by each rule component
and how States and systems will
respond to significant deficiencies.
These uncertainties could either under
or overestimate the costs of  the rule.
  EPA is in the process of proposing
regulations for radon and arsenic in
drinking water, which can impact some
ground water systems. EPA  also intends
to finalize the Stage II Disinfection
Byproducts Rule by the statutory
deadline of May 2002. It is extremely
difficult to estimate the combined
effects of these future regulations on
ground water systems because of
various combinations of contaminants
that some systems may need to address.
However, it is possible for a system to
choose  treatment technologies that
would deal with multiple problems.
Therefore, the total cost impact of these
drinking water rules is uncertain;
however, it may be less than the
estimated total cost of all  individual
rules  combined. Conversely, the impacts
on households and individual systems
                      of multiple rules is cumulative, and in
                      some cases maybe greater than the
                      impacts estimated in the RIA of each
                      rule separately.

                      /. Benefit Cost Determination

                        The Agency has determined that the
                      benefits of the proposed GWR justify the
                      costs. The mean quantified benefits
                      exceed the mean quantified costs by $22
                      million using a three percent discount
                      rate and $6 million using a seven
                      percent discount rate. EPA made this
                      determination based on provisions of
                      the multi-barrier option that include  •
                      improved sanitary surveys,
                      hydrogeologic sensitivity assessments
                      triggered and routine monitoring
                      provisions corrective actions, and     :
                      compliance monitoring. Overall, these
                      elements will reduce the risk of
                      microbial contamination reaching the
                      consumer. The quantified cost of these
                      provisions were compared to the
                      monetized benefits that result from the
                      reduction in viral and bacterial illness
                      and death. In addition, other non-     ;
                      monetized benefits further justify the
                      costs of this rule.

                      /. Request for Comment

                        The Agency requests comment on all
                      aspects of the GWR RIA. Specifically, '
                      EPA seeks input into the following two
                      issues.  .                   ...
                      1. NTNC and TNC Flow Estimates     ;

                        In the GWR RIA, EPA estimates the
                      cost of the GWR on NTNC and TNC
                      water systems by using flow models.
                      However, these flow models were
                      developed to estimate flows only for  :
                      CWS and they may not accurately
                      represent the much smaller flows
                      generally found in NTNC and TNC    ,
                      systems. The effect of the overestimate,
                      in flow would be to inflate the cost of :
                      the rule for these systems. The Agency
                      requests comment on an alternative flow
                      analysis for NTNC and TNC water
                      systems described next.
                        Instead of using the population served
                      data to determine the average flow for
                      use in the rule's cost calculations, this
                      alternative approach would re-
                      categorize NTNC and TNC water
                      systems based on service type (e.g.,
                      restaurants or parks). Service type
                      would be obtained from SDWIS  data.
                      However, service type data is not always
                      available because it is a voluntary
                      SDWIS data field. Where unavailable, •
                      the service type would be assigned
                      based on statistical analysis. Estimates:
                      of service type design flows would be '
                      obtained from engineering design
                      manuals and best professional judgment
                      if no design manual specifications exist.
  In addition, each service type category
would also have corresponding rates for
average population served and average
water consumption. These would be
used to determine contaminant
exposure which is used in the benefit
determination. Note that the current
approach of assuming that the entire
population served drinks an average of
1.2 liters per day for 250 days (from
NTNCWSs) and 15 days (from TNCWs)
may lead to an overestimation of
benefits. For example, schools and
churches would be two separate service
type categories. They each would have
their own corresponding average design
flow, average population served (rather
than the population as reported in
SDWIS), and average water
consumption rates. These elements
could be used to estimate a rule's
benefits and costs for the average church
and the average school.

2. Mixed Systems
  Current regulations require that all
systems that use any amount of surface
water as a source be categorized as
surface water systems. This
classification applies even if the
majority of water in a system is from a
ground water source. Therefore, SDWIS
does not provide the Agency with
information to identify how many
mixed systems exist. This information
would help the Agency to better
understand regulatory impacts.  Further,
to the extent that mixed systems are
classified as surface water, the costs and
benefits of this proposed rule are
underestimated.
  EPA is investigating ways to identify
how many mixed systems exist and how
many mix their ground and surface
water sources at the same entry point or
at separate entry points within the same
distribution systems. For example, a
system may have several plants/entry
points that feed the same distribution
system. One of these entry points may
mix and treat surface water with ground
water prior to its entry into the
distribution system. Another entry point
might use ground water exclusively for
its source while a different entry point
would exclusively use surface water.
However, all three entry points would
supply the same system classified in
SDWIS as surface water.
  One method EPA could use to address
this issue would be to analyze CWSS
data then extrapolate this information to
SDWIS to obtain a national estimate of
mixed systems. CWSS data, from
approximately 1,900 systems, details
sources of supply at the level of the
entry point to the distribution system
and further subdivides flow by source
type. The Agency is considering this

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                                                                    30251
national estimate of mixed systems to
regroup surface water systems for
certain impact analyses when
regulations only impact one type of
source. For example,  surface water
systems that get more than 50 percent of
their flow from ground water would be
counted as a ground water system in the
regulatory impact analysis for this rule.
The Agency requests  comment on this
methodology and its applicability for
use in regulatory impact analysis.
VI. Other Requirements
A, Regulatory Flexibility Act (RFA), as
Amended by the Small Business
Regulatory Enforcement Fairness Act of
1996(SBREFA), 5 U.S.C. 601 etseq.
I. Background
  The 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.
2. Use of Alternative Definition
  The RFA provides default definitions
for each type of small entity. It 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. sees. 601(3}—(5)). In addition,
agencies must consult with SBA's Chief
Counsel for Advocacy to establish an
alternative small business definition.
  EPA is proposing the GWR which
contains provisions which apply to
small PWSs serving fewer than 10,000
persons. This is the cut-off level
specified by Congress in the 1996
Amendments to the Safe Drinking Water
Act for small system flexibility
provisions. Because this definition does
not correspond to the definitions of
"small" for small businesses,
governments, and non-profit
organizations, EPA requested comment
on an alternative definition of "small
entity" in the preamble to the proposed
Consumer Confidence Report (CCR)
regulation (63 FR 7620, February 13,
1098). Comments showed that
stakeholders support  the proposed
alternative definition. EPA also
consulted with the  SBA Office of
Advocacy on the definition as it relates
to small business analysis. In the
preamble to the final CCR regulation (63
FR 4511, August 19,1998). EPA stated
its intent to establish this alternative
definition for regulatory flexibility
assessments under the RFA for all
drinking water regulations and has thus
used it in this proposed rulemaking.
The SBA Office of Advocacy agrees with
the use of this definition in this
rulemaking.

3. Initial Regulatory Flexibility Analysis
  In accordance with section 603 of the
RFA, EPA prepared an initial regulatory
flexibility analysis (IRFA) that examined
the impact of the proposed rule on small
entities along with regulatory
alternatives that could reduce that
impact. The IRFA addresses the
following  issues:
  • The reasons the Agency is
considering this action;
  • The objectives of, and legal basis for
the proposed rule;
  • The number and types of small
entities to which the rule will apply;
  • Projected reporting, recordkeeping,
and other  compliance requirements of
the proposed rule, including the  classes
of small entities which will be subject
to the requirements and the type of
professional skills necessary for
preparation of the reports and records;
  • The other relevant Federal rules
which may duplicate, overlap, or
conflict with the proposed rule; and,
  • Any significant alternatives to the
components under consideration which
accomplish the stated objectives  of
applicable statutes and which may
minimize  any significant economic
impact of the proposed rule on small
entities.
a. The Reasons the Agency Is
Considering This Action
  EPA believes that there is a
substantial likelihood that fecal
contamination of ground water supplies
is occurring at frequencies and levels
which 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 which consume them.
  Fecal contamination is introduced to
ground water from a number of sources
including, septic systems, leaking sewer
pipes, landfills, sewage lagoons,
cesspools, and storm water runoff.
Microorganisms can be transported with
the ground water as it moves through an
aquifer. In addition, the transport of
microorganisms to wells or other ground
water system sources can also be
affected by poor well construction (e.g.,
improper well seals) which can result in
large, open conduits for fecal
contamination to pass unimpeded into
the water supply.
  Waterborne pathogens contained in
fecally contaminated water can result in
a variety of illnesses which range in the
severity of their outcomes from mild
diarrhea to kidney failure or heart
disease. The populations which are
particularly sensitive to waterborne and
other pathogens include, infants, young
children, pregnant and lactating women,
the elderly and the chronically ill.
These individuals may be more likely to
become ill as a result of exposure to the
pathogens, and are likely to have a more
severe illness. A complete discussion of
the public health concerns addressed by
the GWR can be found in section II of
the preamble.

b. The Objectives of, and the Legal Basis
for, the Proposed Rule
  EPA is proposing the GWR pursuant
to section 1412(b)(8) of the SDWA, as
amended in 1996, 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 1996 amendments establish a
statutory deadline of May  2002. EPA,
however, intends to finalize the GWR in
the year 2000 to coincide with
implementation of other drinking water
regulations and programs, such as the
Disinfection Byproducts Rule,  the
Arsenic Rule, the Radon Rule and the
Source Water Assessment and
Protection Program (SWAPP). EPA
believes systems and States will better
plan for changes in operation and
capital improvements if they presented
them with future regulatory
requirements at  one time.

c. Number of Small Entities Affected
  According to the December 1997 data
from EPA's Safe Drinking Water
Information System (SDWIS), there are
156,846 community water systems and
non-community water supplies
providing potable ground water to the
public, of which 155,254 (99 percent)
are classified by EPA as small entities.
EPA estimates that these small ground
water systems serve a population of
more than 48 million. Roughly one-
quarter of these systems are estimated to
be community water systems serving
fixed populations on a year-round basis.
  Under the proposed option, all
community and non-community water
systems are affected by at least one
requirement; the sanitary survey
provision. The other GWR components
are estimated to affect different numbers

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of small systems. For example, over
4,300 small systems are expected to
have to fix significant deficiencies each
year.
d. Small Entity Impacts
Reporting and Recordkeeping for the
Proposed GWR
  Under the proposed Multi-Barrier
option, there are a number of
recordkeeping and reporting
requirements for all ground water
system (including small systems). To
minimize the burden with these
provisions, the EPA is proposing a
targeted risk-based regulatory strategy
•whereby the monitoring requirements
are based on system characteristics and
not directly related to system size. In
this manner, the multi-barrier option
takes a system-specific approach to
regulation, although a sanitary survey is
required of all community and non-
transient non-community water
systems. However, the implementation
schedule for this requirement is
staggered (e.g., every three to five years
for CWSs and every five years for
NCWSs), which should provide some
relief for small systems because there
are proportionately more NCWSs.
  To address concerns over the
potential cost of additional monitoring
for small systems, the proposed GWR
leverages the existing TCR monitoring
framework to the extent possible (e.g.,
                      by using the results of the routine TGR
                      monitoring to determine if source water
                      monitoring is required). In this
                      proposal, only systems that do not
                      reliably treat to 4-log inactivation or
                      removal of viruses are required to test
                      for the presence of E. coli, coliphage, or
                      enterococci in the source water within
                      24 hours of a total coliform positive ;
                      sample in the distribution system.
                        Only systems determined to be  ;
                      hydrogeologically sensitive and do not
                      already treat to 4-log inactivation or
                      removal of viruses are required to
                      conduct the additional routine
                      monitoring. If no fecal indicators are,
                      found after 12 months of monitoring,
                      the State may reduce the monitoring
                      frequency for that system. Similarly,: if
                      a non-sensitive system does not have a
                      distribution system, any sample taken
                      for TCR compliance is effectively a
                      source water sample, so an additional
                      triggered source water sample would
                      not be required. In both cases, however,
                      if the system has a positive sample for
                      E. coli, coliphage, or fecal coliform, the
                      system is required to conduct the
                      necessary follow-up actions.
                      Small Entity Compliance Costs for the
                      Proposed GWR
                        Estimates of the cost of complying
                      with each component of the multi-
                      barrier approach are presented next. The
                      estimated impacts for this proposed'
option are based on the national mean
compliance cost across the four
compliance scenarios. System-level '
impacts are investigated using various
corrective action and significant defects
scenarios. The high correction action/
low significant defect scenario is
considered a typical cost estimate. For
more information on these scenarios
and cost assumptions, consult the
Regulatory Impact Analysis for the
Proposed Ground Water Rule (USEPA,
1999a) which is available for review in
the water docket.
  In determining the costs and benefits
of this proposed rule, EPA considered
the full range of both potential costs and
benefits for the rule. The flexibility  of
the risk-based targeted approach of the
rule aims to reduce the cost of
compliance with the rule. Small systems
will benefit from the flexibility provided
in this design. For example, a small
system with fecal contamination will, in
consultation with the State, be able  to
select the least costly corrective action.
Also, small systems serving less than
3,300 people which disinfect will only
be required to monitor their treatment
effectiveness one time per day as
opposed to the continuous monitoring
required for larger systems which
disinfect. Estimates of annual CWS
compliance costs for the multi-barrier
approach are presented in Table VI—1.
        TABLE Vl-1 .—ANNUAL COMPLIANCE COSTS FOR THE PROPOSED GWR BY CWS SYSTEM SIZE AND TYPE
CWS system type
Publicly-Owned 	
Privately-Owned 	
All Systems 	

System size/population served
<100
$825
799
805
101-500
$934
933
933
501-1,000
$1,238$
1,449
1,328
1,001-3,300
$1,950
1,730
1,893
3,301-1 OK
$4,480
5,358
4,652
e. Coordination With Other Federal
Rules
   To avoid duplication of effort, the
proposed GWR encourages States to use
their source water assessments when the
'assessment provides data relevant to the
sensitivity assessment of a system.
Although not a regulatory program,
source water assessments are currently
being performed by States. The schedule
for the sensitivity assessment (within
six years for CWS and eight years for
NCWS) should allow States to complete
the assessment and the first round of
sanitary surveys concurrently if they
choose to do so.
   EPA has structured this GWR
proposal as  a targeted, risk-based
approach to reducing fecal
contamination. The only regulatory
requirement that applies to all ground
                      water systems is the sanitary survey.
                      The Agency has also considered other
                      drinking water contaminants that may
                      be of concern when a system install.
                      disinfection. Specifically, adding
                      disinfection may result in an increase in
                      other contaminants of concern,
                      depending on the characteristics of the
                      source water and the distribution
                      system. These contaminants include
                      disinfection byproducts, lead, copper,
                      and arsenic. EPA believes that these,
                      issues, when they occur will be very
                      localized and may be addressed through
                      selection of the appropriate corrective
                      action. EPA has provided States and
                      systems with the flexibility to select
                      among a variety of corrective actions.
                      These include options such as UV
                      disinfection, or purchasing water from
another source, which would avoid
these types of problems.
f. Minimization of Economic Burden
Description of Regulatory Options
  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. These options are
described in more detail in section III of
this preamble.
  On an annual basis, the cost of the
proposed alternative ranges from $182.7
million to $198.6  million, using a three
and seven percent discount rate. System
costs make up 89  percent of the total

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                                                                    30253
rule costs. In developing this proposal,
however, EPA considered the
recommendations to minimize the cost
impact to small systems. The proposed
multi-barrier, risk-based approach was
designed to achieve maximum public
health protection while avoiding
excessive compliance costs associated
with Across-the-Board Disinfection
regulatory compliance requirements.
  To mitigate the associated compliance
cost increases across water systems, the
proposed GWR also provides States
with considerable flexibility when
implementing the rule. This flexibility
will al|ow States to work wjthin their
existing program. Similarly, the rule
allows States to consider the
characteristics of individual systems
when determining an appropriate
corrective action. For example, States
have the flexibility to allow systems to
obtain a new source, or use any
disinfection treatment technology,
provided it achieves 4-log inactivation
or removal of pathogens.
4. Small Entity Outreach and Small
Business Advocacy Review Panel
  As required by section 609(b) of the
RFA, as amended by SBREFA, EPA also
conducted outreach to small entities
and convened a Small Business
Advocacy Review Panel to obtain advice
and recommendations of representatives
of the small entities that potentially
would be subject to die rule's
requirements. The SBAR Panel members
for the GWR were the Small Business
Advocacy Chair of the Environmental
Protection Agency, the Director of the
Standards and Risk Management
Division in the Office of Ground Water
and Drinking Water (OGWDW) within
EPA's Office of Water, the
Administrator for the Office of
Information and Regulatory Affairs of
the Office of Management and Budget
(OMB), and the Chief Counsel for
Advocacy of the Small Business
Administration (SBA). The Panel
convened on April 10,1998, and met
seven times before the end of the 60-day
Panel period on June 8,1998. The SBAR
Panel's report Final Report of the
SBREFA Small Business Advocacy
Review Panel on EPA's Planned
Proposed Rule for National Primary
Drinking Water Regulations: Ground
Water, the small entity representatives
(SERs) comments on components of the
GWR, and the background information
provided to the SBAR Panel and the
SERs are available for review in the
Office of Water docket. This information
and the Panel's recommendations are
summarized in section VI.A,4.a.
  Prior to convening the SBAR Panel,
EPA consulted with a group of 22 SERs
likely to be impacted by a GWR. The
SERs included small system operators,
local government officials (including
elected officials), small business owners
(e.g., a bed and breakfast with its own
water supply), and small nonprofit
organizations (e.g., a church with its
own water supply for the congregation).
The SERs were provided with
background information on the GWR, on
the need for the rule and the potential
requirements. The SERs were asked to
provide input on the potential impacts
of the rule from their perspective. All 22
SERs commented on the information
provided. These comments were
provided to the SBAR Panel when the
Panel convened. After a teleconference
between the SERs and the Panel, the
SERs were invited to provide additional
comments on the information provided.
Three SERs provided additional
comments on the rule components after
the teleconference. In general, the SERs
consulted on the GWR were concerned
about the impact of the rule on small
water systems (because of their small
staff and limited budgets), the
additional monitoring that might be
required, and the data and resources
necessary to conduct a hydrogeologic
sensitivity assessment or sanitary
survey. There was also considerable
discussion about how nationally
representative the source data was. SER
suggested providing flexibility to the
States implementing these provisions
and opposed mandatory disinfection
across-the-board. SERs expressed
support for existing monitoring
requirements as a means of determining
compliance, and some supported
increased requirements for total
coliform monitoring.
  Consistent with the RFA/SBREFA
requirements, the Panel evaluated the
assembled materials and small-entity
comments related to the elements of the
IRFA. A copy of the Panel report is in
the Office of Water docket for this
proposed rule.

a. Number of Small Entities to Which
the Rule Will Apply
  When the IRFA was prepared, EPA
estimated that there were over 157,000
small ground water systems that could
be affected by the GWR, serving a
population of more than 48 million.
Roughly one-third of these systems are
community water systems (CWS). The
remainder are non-community water
systems (NCWS) (i.e. non-transient non-
community such as schools and
transient non-community such as
restaurants). A more detailed and
current discussion of the impact of the
proposed rule on small entities can be
found in section V of this preamble.
  The SBAR Panel recommended that,
given the number of systems that could
be affected by the rule, EPA should
consider focusing compliance
requirements on those systems most at
risk of fecal contamination. The GWR
addresses this issue and is designed to
target the systems at highest risk. Risk
characterization is based on system
characteristics, i.e., significant
deficiencies in operation or
maintenance and hydrogeologic
sensitivity to contamination. A system
is not required to perform an action
such as source water microbial
monitoring until the State has cause to
believe the system is at risk.
  The Panel also recommended that the
rule requirements be based on system
size. Because the GWR is a targeted risk-
based rule, the regulatory strategy is
based on system-specific risk indicators
that are not directly related to system
size. However, the monitoring required
for treatment effectiveness  (compliance
monitoring) varies based on system size.
Ninety-seven percent of all ground
water systems serve less than 3,300
people.  Under the proposed GWR,
disinfecting ground water systems
serving less than 3,300 people must
monitor treatment by taking daily grab
samples. Disinfecting ground water
systems serving 3,300 or more people
must monitor treatment continuously.
  The SBAR Panel advocated that States
be provided with flexibility when
implementing the rule. The GWR also
addresses this issue. As discussed
earlier in sections III.A.I. and 2. of this
proposal, States have considerable
flexibility in addressing potential
problems in small systems. In
particular, States have the flexibility to
define and identify significant system
deficiencies and to describe their
approaches to identifying the presence
of hydrogeologic barriers to
contamination. States also have the
flexibility to require correction of fecal
contamination or use any disinfection
treatment technology, provided it
achieves 4-log (99.99%) inactivation or
removal of viruses. Similarly, the rule
allows States to consider the
characteristics of individual systems
when determining an appropriate
corrective action.

b. Record Keeping and Reporting and
Other Compliance Requirements
  Because small systems frequently
have minimal staff and resources,
including data on the underlying
hydrogeology of the system, the SBAR
Panel recommended that EPA focus the
record keeping, reporting, and
compliance requirements on those
systems at greatest risk of fecal

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contamination. The Panel also
recommended that EPA consider
tailoring the requirements based on
system size (e.g., the smaller systems
would not have to monitor as frequently
or perform sanitary surveys on the same
schedule.)
  The GWR proposed today is a targeted
risk-based regulatory strategy. The
regulatory strategy is based on system
characteristics (i.e., hydrogeologic
sensitivity; TCR positive in the
distribution system) and is not directly
related to system size. However, the
monitoring required for treatment
effectiveness (compliance monitoring)
varies based on system size. Ninety-
seven percent of all ground water
systems serve less than 3,300 people.
Under the proposed GWR, disinfecting
ground water systems serving less than
3,300 people must monitor treatment by
taking daily grab samples. Disinfecting
ground water systems serving 3,300 or
more people must monitor treatment
continuously. In addition, the only
across-the-board requirement is for
sanitary surveys, but the
implementation schedule is staggered
(e.g., every 3 years for CWS and every
5 years for NCWS) which should
provide some relief for small systems
because there are proportionately more
that are NCWS. EPA is also requesting
comment on several options that would
reduce the required frequency of
sanitary surveys. Because many small
systems may not have easy access to the
records that would ideally be available
for a hydrogeologic sensitivity
assessment or a sanitary survey, EPA,
after consulting with stakeholders and
the SBAR Panel, has determined that it
will not use the lack of adequate well
records, the lack of a cross connection
program, or intermittent pressure
fluctuations as automatic triggers to
indicate risk of potential contamination.
These factors may be considered along
with others that more definitively
demonstrate risk. This strategy will
enable States to focus their resources on
the systems which need the most
surveillance or follow-up action and
will avoid penalizing systems with
limited resources.
  With respect to the potential cost of
additional monitoring for small systems,
particularly if the rule required viral
monitoring, the SBAR Panel offered
several recommendations. First, the
Panel suggested that, to the extent
possible, the GWR should build "on the
existing monitoring framework in the
TCR. Given the low cost of the Total
Coliform test, the Panel noted that an
increase in the frequency and the
locations for TCR monitoring or
additional samples in the source water
                      if the system has a Total Coliform
                      positive sample would be preferable to
                      other fecal indicator tests, given the
                      current cost of a viral test. However, the
                      Panel also recommended that the EPA
                      continue to develop a lower cost, more
                      accurate test to identify viral and
                      bacterial contamination in drinking
                      water.
                        Today's proposal does build on the
                      existing TCR monitoring framework by
                      using the results of the TCR monitoring
                      to determine if source water monitoring
                      is required. In the proposal, a system; is
                      required to test for the presence of E.
                      coli, coliphage, or enterococci in the
                      source water within 24 hours of a total
                      coliform positive sample in the
                      distribution system. Only systems
                      determined to be hydrogeologically
                      sensitive that do not already treat their
                      water to 4-log inactivation or removal
                      are required to conduct the additional
                      routine monitoring. These systems  must
                      test their source water monthly. If no
                      fecal indicators are found after 12
                      consecutive months of monitoring, the
                      State may reduce the monitoring
                      frequency for that system. Similarly, if
                      a non-sensitive system does not have a
                      distribution system, any sample taken
                      for TCR compliance is effectively a
                      source water sample so an additional
                      triggered source water sample would
                      not be required. In both cases, however,
                      if the system has an E. coli, coliphage,
                      or fecal coliform positive sample, the
                      system is required to conduct the   ,
                      necessary follow-up actions.
                        The GWR also has incorporated low-
                      cost fecal contamination indicator tests.
                      EPA-approved methods for detecting
                      bacterial indicators of fecal
                      contamination, including E. coli and
                      enterococci, are already widely used
                      and are low cost (approximately $25.per
                      sample). In addition, EPA is currently
                      developing viral monitoring methods
                      which will cost approximately the  same
                      as existing bacterial methods.       ;
                        The SBAR Panel recommended that
                      States be provided with flexibility when
                      implementing the rule. For example,
                      while States must have the authority to
                      require the correction of significant
                      deficiencies, States should also have the
                      flexibility to determine which      :
                      deficiencies are "significant" from a
                      public health perspective. When a  State
                      determines that corrective action is ;
                      necessary, it should have the flexibility
                      to determine what actions a system '
                      should take, including but not limited to
                      disinfection. Similarly, States should
                      also have the flexibility to require
                      disinfection across-the-board for all or a
                      subset of the public water supply
                      systems in their State. States should also
                      be given the flexibility to choose from
the full range of disinfection
technologies that will meet the public
health goals of the rule.
  As discussed earlier in sections
III. A.I. and 2. of this proposal, States
have considerable flexibility in
addressing potential problems in small
systems particularly with respect to
sanitary survey, where States define and
identify significant deficiencies, and in
conducting hydrogeologic sensitivity
assessments. The GWR allows States
flexibility to work within their existing
programs and define and identify
significant deficiencies. States also have
the flexibility to require correction of
fecal contamination or use any
disinfection treatment technology,
provided it achieves 4-log (99.99%)
inactivation or removal of viruses.
Similarly, the rule allows States to
consider the characteristics of
individual systems when determining
an appropriate corrective action.
  The Panel was also concerned about
the potential cost of disinfection and
recommended that EPA include a full
range of variables when determining
both the potential cost burden and
benefits of the rule.
  In determining the costs and benefits
of today's proposed rule, EPA
considered the full range of both
potential costs and benefits for the rule.
The flexibility in the rule is designed to
reduce the cost of compliance with the
rule, particularly for small systems.
While determining the costs of the
various technologies, EPA has estimated
the percentage of systems in
consultation with the States that will
choose between the different
technologies, in part based on system
size. When determining the benefits of
today's proposal, EPA considered a
range of benefits from reduction in
illness and mortality to outbreak cost
avoided and possibly reduced
uncertainty and averting behaviors.
However, only reductions  in acute viral
and bacterial illness and decreases in
mortality from virus are monetized.
More detailed cost and benefit
information is included in the GWR RIA
(US EPA,  1999a) for today's proposal.
Because systems are highly variable, the
SBAR Panel recommended that States
be given the flexibility to'determine
appropriate maintenance or cross
connection control measures for each
system and to the extent practicable
maintenance measures should be
performance-based.
  EPA recognizes that systems'
characteristics are highly variable.
States have considerable flexibility
when working with systems to address
significant deficiencies, conduct
hydrogeological sensitivity assessments,

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                                                                    30255
and take corrective action. Cross
connection control will be considered
under a future rulemaking (i.e., the Long
Term 2 Enhanced Surface Water
Treatment Rule).
c. Other Federal Rules
  To avoid duplication of effort, the
SBAR Panel recommended using the
State Source Water Assessment and
Protection Program (SWAPP) plans and
susceptibility assessments as a
component of the hydrogeologic
sensitivity assessment process. To
further streamline the process,
especially for small systems, the Panel
also recommended combining the
hydrogeologic sensitivity assessment
with the sanitary surveys.
  In today's GWR proposal, States are
encouraged to use their SWAPP
assessments when the assessment
provides data relevant to the
hydrogeologic sensitivity assessment of
a system. The schedule for sensitivity
assessments (six years after the GWR is
promulgated in the Federal  Register for
CWS and eight years after the GWR is
promulgated in the Federal  Register for
NCWSJ should allow States  to complete
the assessment and the first  round of
sanitary surveys concurrently if they
choose to do so.
d. Significant Alternatives
  Because the SBREFA consultation
was conducted early in the regulatory
development process before there was a
draft proposal, few comments were
received on specific regulatory
alternatives. In general, the SERs
supported the approach described in the
outreach materials while at the same
lime commenting on particular aspects
of the approach that might be
burdensome or otherwise problematic.
Their concerns echo the comments
received on other parts of the IRFA.
  The SBAR Panel reiterated their
suggestion that compliance
requirements be tailored to the system
size. In particular, if the minimum
monitoring frequency and the frequency
for sanitary surveys for the smallest
systems (e.g,, those serving less than 500
people) could be reduced, it would
reduce both the resources necessary to
comply with the rule and record
keeping required by the system.
  EPAjias structured today's proposal
as a targeted risk-based approach to
reducing fecal contamination. The only
requirement that affects all GWSs is the
sanitary survey. The required frequency
for sanitary surveys for community
systems is once every three years which
may be changed by the State to once
every five years if the system either
treats to 4-log inactivation or removal of
virus or has an outstanding performance
record documented in previous
inspections and has no history of total
coliform MCL or monitoring violations
since the last sanitary survey under
current ownership. The required
frequency for sanitary surveys is once
every five years for noncommunity
systems. The majority of the small
systems are noncommunity systems so
the majority of systems will only have
a sanitary survey once every five years.
At this frequency, EPA believes that the
requirements will not be burdensome
for even the smallest  systems, however
EPA is also requesting comment on less
frequent sanitary survey requirements.
  Similarly, the only.additional
monitoring requirements in today's
proposal are for undisinfected systems
that are either located in sensitive
hydrogeologic settings or have a total
coliform positive sample in the
distribution system. The monitoring
required for a total coliform positive
sample under the TCR would be a one-
time event while the monitoring for
sensitive systems would be on a routine
monthly basis for at least 12 samples.
  Finally, the SBAR Panel noted that
disinfection of public water supplies
may result in an increase in other
contaminants of concern, depending  on
the characteristics of the source water
and the distribution system. Of
particular concern were disinfection
byproducts, lead, copper, and arsenic.
  EPA has discussed  these issues
previously in section V.G. of the GWR
preamble. EPA believes that these
issues, when they occur, will typically
be localized and transitory. These risk/
risk tradeoffs are considered
qualitatively in the RIA and EPA will
provide guidance on how to address
these issues when the rule  is finalized.

e. Other Comments
  The panel members could not reach
consensus regarding the use of
occurrence data to support the rule.
Some panel members expressed the
concern that the occurrence estimates
discussed by EPA with the SERs
overestimated the actual occurrence of
fecal contamination and the studies
used did not provide  a true picture of
national occurrence. EPA recognizes
and understands the concerns about the
available data expressed by these panel
members. However, the Agency
believes, after consulting with experts in
the field, that the available data may
underestimate the extent of ground
water contamination because of
limitations with sampling methods and
frequency. EPA believes that a central
issue for all participants and
stakeholders in this rulemaking is how
to interpret the available data. EPA
agrees that the GWR must be based on
the best available data, good science and
sound analysis. The studies described in
the materials presented to the SERs and
SBAR Panel during the SBREFA process
were conducted at  different times and
for different reasons; each requires
careful analysis to ensure its proper use
and to avoid misuse. A more detailed
discussion of the occurrence studies and
request for comment on their
interpretation is provided in section
II.C. of today's proposal.
  EPA invites comments on all aspects
of the proposal and its impacts on small
entities.

B. Paperwork Reduction Act
  The information  collection
requirements in this proposed rule have
been submitted for approval to the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act, 44 U.S.C. 3501 et seq. An
Information Collection Request (ICR)
document has been prepared by EPA
(ICR No. 1934.01) and a copy may be
obtained from Sandy Farmer by mail at
Collection Strategies Division; U.S.
Environmental Protection Agency
(2822); 1200 Pennsylvania Ave., NW,
Washington, DC 20460, by email at
farmer.sandy@epamail.epa.gov, or by
calling (202) 260-2740. A copy may also
be downloaded from the Internet at
http://www.epa.gov/icr. For technical
information about the collection contact
Jini Mohanty by calling (202) 260-6415.
  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
in Part 141, for systems, and Part 142,
for States are mandatory. The
information  collected is not
confidential.
  EPA estimates that the annual burden
on PWSs and States for reporting and
record keeping will be 326,215 hours.
This is based on an estimate that 56
States and territories will each need to
provide  3 responses each year with an
average of 524 hours per response, and
that 52,331 systems will each provide
2.3 responses each year with an average
of less than 2 hours per response.  The
labor burden is estimated for the
following activities: Reading and
understanding the rule, planning,
training, and meeting primacy
requirements. The recordkeeping and
reporting burden also includes capital
costs of $1,376,302  for capital

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Federal Register/Vol.  65, No. 91/Wednesday, May  10,  2000/Proposed Rules
improvements by PWSs (installation of
disinfection monitoring equipment}.
  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 are listed
in 40 CFR Part 9 and 48 CFR Chapter
15.
  Comments are requested on the
Agency's need for this information, the
accuracy of the provided burden
estimates, and any suggested methods
for minimizing respondent burden,
including the use of automated
collection techniques. Send comments
on the ICR to the Director, Collection
Strategies Division; U.S. Environmental
Protection Agency (2822); 1200
Pennsylvania Ave, N.W.; Washington,
DC 20460; and to the Office of
Information and Regulatory Affairs,
Office of Management and Budget, 725
17th St., N.W., Washington, DC 20503,
marked "Attention: Desk Officer for
EPA." Include the ICR number in any
correspondence. Since OMB is required
to make a decision concerning the ICR
between 30 and 60 days after May 10,
2000, a comment to OMB is best assured
of having its full effect if OMB receives
it by June 9, 2000. The final rule will
respond to any OMB or public
comments on the information collection
requirements contained in this proposal.

C, Unfunded Mandates Reform Act

1. Summary of UMRA Requirements
  Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), Public
Law 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 UMRA section 202, EPA
generally must prepare a written
statement, including a cost-benefit
                      analysis, for proposed and final rules
                      with "Federal mandates" that may
                      result in State, local and tribal
                      government expenditures, in the
                      aggregate, or private sector
                      expenditures, 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 the1
                      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
                      notification to  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.

                      2. Written Statement for Rules With
                      Federal Mandates of $100 Million or ;
                      More
                        EPA has determined that this rule
                      contains a Federal mandate that may
                      result in expenditures of $100 million or
                      more for the private sector in any one
                      year.
                        Table VI—2 presents a breakdown of
                      the estimated $182.7 to$198.6 million
                      annual cost for today's proposed rule!
                      (the proposed Multi-Barrier Option).
                      Public ground  water systems owned by
                      State, local  and tribal governments will
                      incur $51.2 to $56.5 million of these :
                      costs and States will incur an additional
                      $20.1 to $22.1  million for a total public
                      sector cost of $71.3 to $78.7 million
                      dollars per  year. Public ground water
                      systems which are owned by private
                      entities will incur a total cost of $111.5
                      to $ 119.9 million per year, $5.5 to $7
                      million of which is incurred by entities
                      that operate a public water system as :a
                      means of supporting their primary
                      business (e.g., a mobile home park
                      operator).
  TABLE V|-2.-
 COSTS FOR OF
•PUBLIC AND PRIVATE
THE PROPOSED GWR
System type
Public PWS Cost
State Cost

Total Public Cost
Private PWS Cost
Ancillary PWS
Cost.
Total Private
Cost.
Total Cost 	
Annual mean
cost range*
(millions $)
$51 .2 to $56.5
20 1 to 22 1

71. 3 to 78.7 ....
106.0 to 113.0
5.5 to 7.0 	
111.5 to 119.9
182.7 to 198.6
Per-
cent of
total
cost
28
11

40
57
4
60
100
  Note: Cost range based upon a 3% and 7%
discount rate.
  Thus, today's rule is subject to the
requirements of sections 202 and 205 of
the UMRA, and EPA has prepared a
written statement which is summarized
next. A more detailed description of this
analysis is presented in EPA's
Regulatory Impact Analysis of the GWR
(US EPA, 1999a) which is included in
the Office of Water docket for this rule.

a. Authorizing Legislation
  Today's proposed rule is promulgated
pursuant to section 1412(b)(8) of the
SDWA, as amended in 1996, 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."
  Section 1412 (b)(8) also establishes a
statutory deadline for promulgation of
the GWR of no later than the date on
which the Administrator promulgates a
Stage II rulemaking for disinfectants and
disinfection byproducts. EPA intends to
finalize the GWR in the year 2000 to
allow systems to consider the combined
impact of this rule, the radon rule, the
arsenic rule and the Stage 1 DBF rule on
their design and treatment modification
as well as their capital investment
decisions. EPA believes States and
systems will better plan for changes in
operation and capital improvements, if
they are presented with future
requirements at one time.

b. Cost Benefit Analysis
  Section V of this preamble discusses
the cost and benefits associated with the
GWR . Also, EPA's Regulatory Impact
Analysis of the GWR (US EPA, 1999a)
contains a detailed cost benefit analysis.
The analysis quantifies cost and benefits
for four scenarios: the proposed
regulatory option, the sanitary survey

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                 Federal  Register/Vol. 65, No. 91/Wednesday, May  10,  2000/Proposed Rules
                                                                     30257
option, the sanitary survey and triggered  summarizes the range of annual costs
monitoring option, and the across-the-    and benefits for each rule option.
board disinfection option. Table VI-3
                        ':"                 „                                               !l
                      TABLE VI-3.—ANNUAL BENEFITS AND COSTS OF RULE OPTIONS ($MILLION)
Option

Sunitafy Survey and Triggered Monitoring 	
MutU-bufTkjr (Proposed ) Option 	
Acfoss*th0-8oard Disinfection 	

Annual benefits 1
mean
[range]
Smilhon
$33
	 [$9to$58]
$178
- [$147 to $209]
$205
[$169 to $242]
$283
[$255 to $311]
Annual costs
(3%)
mean
[range]
$million
$73
[$71 to $74]
$158
[$152 to $19]
$183
[$177 to $188]
$777
[$744 to $810]
Annual costs2
(7%)
mean
[range]
Smillion
$76
[$74 to $78]
$169
[$163 to $174]
$199
[$192 to $206]
$866
[$823 to $909]
  1 does not include benefits from reduction in chronic illness, reduced pain and suffering, or non-health benefits.
  2 does not include non-quantified costs such as land acquisition or increases in other contaminants (e.g., DBPs).
  Costs varied with each option and
wore driven by the number of systems
that would need to fix a significant
deficiency, take corrective action in
response to fecal contamination, or
install treatment. The annual mean cost
of the four rule options ranges from $73
million to S866 million using a three
percent and seven percent discount rate.
For tho first three options, the costs
increase as more components are added
for identifying fecally contaminated
wells and wells sensitive to fecal
contamination. However, the cost of
these components (e.g., hydrogeologic
sensitivity assessment, routine and
triggered monitoring) are minor
compared to the costs of correcting fecal
contamination. The fourth option of
across-the-board disinfection is the most
costly because it would require all
systems to have treatment regardless of
actual or potential fecal contamination.
Costs for the States to implement this
rule are also included in the four cost
estimates. Some costs, such as land
acquisition where necessary to install
treatment, were not included because of
the difficulty of estimating them.
  These total annual monetized costs •
can be compared to the annual
monetized benefits of the GWR. The
annual monetized mean benefits of
today's rule range from $33 million to
§283 million as shown in Table VI-2.
This result is based on  the
quantification of the  number of acute
viral illnesses and deaths avoided
attributable to each option as well as the
reduction in acute bacterial illness
attributable to each option. For illness,
EPA used a cost-of-illness number to
estimate the benefits from the reduction
in viral illness that result from this rule.
This is considered a lower-bound
estimate of actual benefits because it
does not include the pain and
discomfort associated with the illness.
Mortalities were valued using a value of
statistical life estimate consistent with
EPA policy.
  This rule will also decrease bacterial
illness associated with fecal
contamination of ground water. EPA did
not directly calculate the actual
numbers of illness associated with
bacterially contaminated ground water
because the Agency lacked the
necessary pathogen occurrence data to
include it in the risk model. However,
in order to get an estimate of the number
of bacterial illness from fecally
contaminated ground water, the Agency
used the ratio of viral and unknown
etiology outbreak illness to bacterial
outbreak illnesses reported to CDC's for
waterborne outbreaks in ground water.
It was further assumed that the cost of
these bacterial illnesses would be
comparable to viral illness estimates.
This rule also considered but did not
monetize the health benefit from the
reduction in chronic illness associated
with some viral and bacterial infections
(see section II.D.).
  Various Federal programs exist to
provide financial assistance to State,
local, and tribal governments in
complying with this rule. The Federal
government provides funding to States
that have primary enforcement
responsibility for their drinking water
programs through the Public Water
Systems Supervision Grants Program.
Additional funding is available from
other programs administered either by
EPA or other Federal agencies. These
include EPA's Drinking Water State
Revolving Fund (DWSRF), U.S.
Department of Agriculture's Rural
Utilities' Loan and Grant Program, and
Housing and Urban Development's
Community Development Block Grant
Program.
  For example, SDWA authorizes the
Administrator of the EPA to award
capitalization grants to States, which in
turn can provide low cost loans and
other types of assistance to eligible
public water systems. The DWSRF
assists public water systems with
financing the costs of infrastructure
needed to achieve or maintain
compliance with SDWA requirements.
Each State has considerable flexibility
in determining the design of its DWSRF
Program and to direct funding toward
its most pressing compliance and public
health protection needs. States may
also, on a matching basis, use up to 10
percent of their DWSRF allotments for
each fiscal year to assist in running the
State drinking water program. In
addition, States have the flexibility to
transfer a portion of funds to the
Drinking Water State Revolving Fund
from the Clean Water State Revolving
Fund.   '  ]
  Furthermore, a State can use the
financial resources of the DWSRF to
assist small systems, the majority of
which are ground water systems. In fact,
a minimum of 15% of a State's DWSRF
grant must be used to provide
infrastructure loans to small systems.
Two percent of the State's grant may be
used to provide technical assistance to
small systems. For small systems that
are disadvantaged, up to 30% of a
State's DWSRF may be used for
increased loan subsidies. Under the
DWSRF, Tribes have a separate set-aside
which they can use.
  In addition to the DWSRF, money is
available from the Department of
Agriculture's Rural Utility Service
(RUS) and Housing and Urban
Development's Community

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Development Block Grant (CDBG)
program. RUS provides loans,
guaranteed loans, and grants .to improve,
repair, or construct water supply and
distribution systems in rural areas and
towns up to 10,000 people. In Fiscal
Year 1997, the RUS had over $1.3
billion in available funds. Also, three
sources of funding exist under the
CDBG program to finance building and
improvements of public facilities such
as water systems. The three sources of
funding include: (1) direct grants to
communities with populations over
200,000; (2) direct grants to States,
which they in turn award to smaller
communities, rural areas, and colonias
in Arizona, California, New Mexico, and
Texas; and (3)  direct grants to US.
Territories and Trusts. The CDBG
budget for Fiscal Year 1997 totaled over
$4 billion dollars.
c. Estimates of Future Compliance Costs
and Disproportionate Budgetary Effects
  To meet the UMRA requirement in
section 202, EPA analyzed future
                      compliance costs and possible
                      disproportionate budgetary effects. The
                      Agency believes that the cost estimates,
                      indicated earlier and discussed in more
                      detail in section V of this rule,
                      accurately characterize future
                      compliance costs of the proposed rule.
                        In analyzing disproportionate
                      impacts, the Agency considered three
                      measures: reviewing the impacts on
                      small systems versus large systems;
                      reviewing the costs to public versus  •
                      private water systems; and reviewing
                      the household costs for each proposed
                      rule option. It is also possible that some
                      States or EPA Regions may face greater
                      challenges from the GWR because they
                      have  comparatively more ground water
                      systems. However, States that have a ;
                      larger percentage of systems also receive
                      a greater share of the Public Water
                      Systems Supervision Grants Program'
                      and the DWSRF. A detailed analysis  of
                      these impacts is presented in the
                      Regulatory Impact Analysis of the GWR
                      [US EPA, 1999a).
   The first measure of disproportionate
 impact considers the cost incurred by
 small and large systems. As a group,
 small systems will experience a greater
 impact than large systems under the
 GWR. The higher cost to the small
 ground water systems is mostly
 attributable to the large number of these
 types of systems (i.e., 99% of ground
 water systems serve <10,000). Other
 reasons for the disparity include: (1)
 Large systems are more likely to already
 disinfect their ground water
 (disinfection exempts a system from
 triggered and routine monitoring), (2)
 large systems typically have greater
 technical and operational expertise, and
 (3) they are more likely to engage in
 source water protection programs. The
 potential economic impact among the
 small systems will be the greatest for
 systems serving less than 100 persons,
 as shown in Table VI—4.
  TABLE Vl-4.—-AVERAGE ANNUAL HOUSEHOLD COSTS FOR GWR OPTIONS FOR CWS TAKING CORRECTIVE ACTION OR
                                           FIXING SIGNIFICANT DEFECTS
Size categories
100 	 	
101-500 	 	
501-1,000 	
1 001-3 300
3,301-10,000 	
10,001-50,000 	
50,001-100,000 	
100,001-1,000,000
Average 	

Sanitary survey
option
2986
1 1 23
572
2 99
1 39
062
030
032
245

Sanitary survey
and triggered
monitoring option
67 19
1 5 02
6 29
2 91
1 46
059
070
' ' 0 20
3 34

Multi-barrier option
(proposed)
6248
18 95
6 25
3 39
2 74
0 62
1 01
0 27
3 86

Across-the-board
disinfection option
191 87
81 38
38 79
23 45
16 78
487
10 37
1 66
19 37

  The second measure of impact is the
relative total cost to privately owned
water systems compared to that
incurred by publicly owned water
systems. The majority of the small
systems are privately-owned (61% of
the total). As a result, privately-owned
systems as a group will have a slightly
larger share of the total costs of the rule.
However, EPA has no basis for
expecting cost per-system to differ
systematically with ownership.
  The third measure, household costs,
can also be used to gauge the impact of
a regulation and to determine whether
there are disproportionately high
impacts in particular segments of the
population. Table VI-4 shows
household costs by system size for each
rule component. On average, annual
household costs increases attributable to
the first three rule options range from
$2.45 to $3.86 (Table VI-4). For these
three options, 90 percent of households
                     will face less than a $5 increase in
                     annual household costs. The most
                     expensive option, Across-the-Board
                     Disinfection, results in the highest
                     average annual household costs of
                     $19.37.  However, household costs
                     increase across all options for those  ,
                     households served by the smallest sized
                     systems. This occurs because they serve
                     fewer households, and as a result, there
                     are fewer households to share the
                     system's compliance costs.
                     d. Macro-economic Effects
                       Under UMRA section 202, EPA is
                     required to estimate the potential
                     macro-economic effects of the
                     regulation; These types of effects
                     include those on productivity, economic
                     growth, full employment, creation of
                     productive jobs, and international    ;
                     competitiveness. Macro-economic
                     effects tend to be measurable in
                     nationwide econometric models only if
the economic impact of the regulation
reaches 0.25 percent to 0.5 percent of
Gross Domestic Product (GDP). In 1998,
real GDP was $7,552 billion, so a rule
would have to cost at least $18 billion
to have a measurable effect. A regulation
with a smaller aggregate effect is
unlikely to have any measurable impact
unless it is highly focused on a
particular geographic region or
economic sector. The macro-economic
effects on the national  economy from
the GWR should not have a measurable
effect because the total annual costs for
the proposed option range from $183
million to $199 million per year using
a three and seven percent discount rate.
Even the most expensive option, Across-
the-Board Disinfection falls below the
measurable threshold.  The costs are not
expected to be highly focused on a
particular geographic region or sector.

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                                                                    30259
o. Summary of EPA's Consultation With
State. Local, and Tribal Governments
and Their Concerns
  Consistent with tho intergovernmental
consultation provisions of section 204 of
UMRA, EPA has initiated consultations
with the governmental entities affected
by this rule. EPA held four public
meetings for all stakeholders and three
Association of State Drinking Water
Administrators early involvement
meetings. 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. A more
detailed description of the SBREFA
process can bo found in section VI.A. of
this preamble. 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. Twelve State
drinking water representatives also
participated in the Agency's GWR
workgroup.
  In addition to these consultations,
EPA circulated a draft of this proposed
rule and  requested comment from the
public through an informal process.
Specifically, on February 3,1999, EPA
posted on the EPA's Internet web page
and mailed out over 300 copies of the
draft to people who had attended the
1997 and 1998 public stakeholder
meetings as well as people on the EPA
workgroup. EPA received 80 letters or
electronic responses to this draft: 34
from State government (representing 30
different States), 26 from local
governments, ten from trade
associations, six from Federal
government agencies, and four from
other people/organizations. No
comments were received from tribal
governments. EPA reviewed the
comments carefully and considered
their merit. Today's proposal reflects
many of  the commenters' points and
suggestions. For example, numerous
commenters felt that proposing a
requirement to monitor source water
using coliphage at this time was
premature based on currently available
data, EPA has recently completed round
robin testing of coliphage methods and
is requesting comment on the use of
these methods.
  To inform and involve tribal
governments in the rulemaking process,
EPA presented the GWR at the 16th
Annual Consumer Conference of the
National Indian Health Board, at the
annual conference of the National Tribal
Environmental Council, and at an EPA
Office of Ground Water and Drinking
Water (OGWDW)/Inter Tribal Council of
Arizona, Inc. tribal consultation
meeting. Over 900 attendees
representing Tribes from across the
country attended the National Indian
Health Board's Consumer Conference
and over 100 Tribes were represented at
the annual conference of the National
Tribal Environmental Council. At both
conferences, an EPA representative
conducted two workshops  on EPA's
drinking water program and upcoming
regulations, including the GWR.
  Comments received from tribal
 tovernments regarding the GWR
 Dcused on concerns and some
opposition to mandatory disinfection for
ground water systems. They also
suggested that any waiver process be
adequately characterized by guidance
and simple to  implement. EPA agrees
with concerns of Tribes and has
designed the proposed GWR so that
disinfection is not mandatory. Systems
will have the opportunity to correct
significant deficiencies, eliminate the
source of contamination, obtain a new
source of water, or install disinfection to
achieve 4-log inactivation or removal of
virus. However, some systems in
coordination with the primacy agent or
State, might choose disinfection over
these other options because it may be
the least costly alternative.
  At die OGWDW/Inter Tribal Council
of Arizona meeting, representatives
from 15 Tribes participated. In addition,
over 500 Tribes and tribal organizations
were sent the presentation materials and
meeting summary. Because many Tribes
have ground water systems, participants
expressed concerns over some elements
of the rule. Specifically,  they had
concerns about how the  primacy agent
would determine  significant
deficiencies identified in a sanitary
survey and how the sensitivity
assessment would be conducted.
Because no Tribes currently have
primacy, EPA is the primacy agent and
will identify significant deficiencies as
part of sanitary surveys and conduct the
hydrogeologic sensitivity assessment as
outlined in section III. A. and ffl.B. of
this preamble.
  The Agency believes the proposed
option in the GWR will provide public
health benefits to individuals by
reducing their exposure to fecal
contamination through targeted
expenditures to address significant
deficiencies or fecal contamination. As
discussed earlier in paragraph IV.C.l.c,
over 90 percent of households will incur
additional costs of less than $3.00 per
month based on EPA's proposed
regulatory approach. EPA will consider
other options for the final rule as
outlined in this proposal and discussed
next.
f. Regulatory Alternatives Considered
  As required under section 205 of the
UMRA, EPA considered several
regulatory alternatives and numerous
methods to identify ground water
systems most at risk to microbial
contamination. A detailed discussion of
these alternatives can be found in
section V of the preamble and also in
the RIA for the GWR(US EPA, 1999a).
Today's proposal also seeks comment
on many regulatory options that EPA
will consider for the final rule.
g. Selection of the Least Costly, Most
Cost-Effective or Least Burdensome
Alternative That Achieves the
Objectives of the Rule
  As discussed earlier, EPA has
considered various regulatory options
that would reduce microbial
contamination in ground water systems.
EPA believes that the proposed option
as described in today's rule, is the most
cost effective option that achieves the
rule's objective to reduce the risk of
illness and death from microbial
contamination in PWS relying on
ground water. This option is  a targeted
approach where costs are driven by the
number of systems having to fix fecal
contamination problems and correct
significant deficiencies that could lead
to fecal contamination. EPA requests
comment on how possible modifications
to the proposed option, as outlined in
section III of the preamble, may affect
not only the cost but also the objectives
of this rule.

3. Impacts on Small Governments
  In developing this rule, EPA
consulted with small governments to
address impacts of regulatory
requirements in the rule that might
significantly or uniquely affect small
governments. In preparation  for the
proposed GWR, EPA conducted an
analysis on small government impacts
and included small government officials
or their designated representatives in
the rulemaking process. As discussed
previously, a variety of stakeholders,
including small governments, had the
opportunity for timely and meaningful
participation in the regulatory

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Federal Register/Vol.  65, No. 91/Wednesday,  May 10, 2000/Proposed Rules
development process through the
SBREFA process, public stakeholder
meetings, and tribal meetings.
Representatives of small governments
took part in the SBREFA process for this
rulemaking and they also attended
public stakeholder meetings. Through
such participation and exchange, EPA
notified some potentially affected small
governments of requirements under
consideration and provided officials of
affected small governments with an
opportunity to have meaningful and
timely input into the development of
regulatory proposals. A more detailed
discussion of the SBREFA process and
stakeholder meetings can be  found  in
section VI.A. and section VI,C.2.e,
respectively.
  In addition, EPA will educate, inform,
and advise small systems including
those operated by small government
about GWR requirements. One of the
most important components  of this
process will be the Small Entity
Compliance Guide which is required by
the SBREFA of 1996. This plain-English
guide will explain what actions  a small
entity must take  to comply with the
rule. Also, the Agency is developing fact
sheets that concisely describe various
aspects and requirements of the GWR.

D. National Technology Transfer and
Advancement Act
  Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 ("NTTAA"), Pub L.  No.
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 the Office of
Management and Budget (OMB),
explanations when the Agency decides
not to use available  and applicable
voluntary consensus standards.
  EPA also notes that the Agency plans
to implement in the future a
performance-based measurement system
(PBMS) that would  allow the option of
using either performance criteria or
reference methods in its drinking water
regulatory programs. The Agency is
determining the  specific steps necessary
to implement PBMS in its programs.
Final decisions have not yet been made
concerning the implementation  of
PBMS in water programs. However, EPA
is evaluating what relevant performance
characteristics should be specified for
                      monitoring methods used in the water
                      programs under a PBMS approach to
                      ensure adequate data quality. EPA
                      would then specify performance
                      requirements in its regulations to ensure
                      that any method used for determination
                      of a regulated analyte is at least
                      equivalent to the performance achieved
                      by other currently approved methods,
                        Once EPA has made its final
                      determinations regarding
                      implementation of PBMS in programs
                      under the Safe Drinking Water Act, EPA
                      would incorporate specific provisions of
                      PBMS into its regulations, which may
                      include specification of the performance
                      characteristics for measurement of
                      regulated contaminants in the drinking
                      water program regulations.

                      1. Microbial Monitoring Methods
                        The proposed rulemaking involves
                      technical standards. Ground water
                      systems that are identified by the State
                      as having hydrogeologically sensitive,
                      wells as described in §§ 142.16(k)(3) and
                      141.403(a), and ground water systems
                      that have a TCR positive sample as
                      described in § 141.403(b) of today's   ;
                      proposed rule must sample and test  ,
                      their source water. GWSs must test for
                      at least one of the following fecal
                      indicators: E. coli, enterococci and
                      coliphage using one of the methods in
                      § 141.403(d) and discussed in greater
                      detail in III.D.4. Table VI-5 lists the
                      microbial methods which must be used
                      for source water monitoring.
                        EPA proposes to use several approyed
                      methods. For testing E. coli and
                      enterococci, the methods in § 141.403(d)
                      are either consensus methods or new
                      methods that EPA has recently
                      approved for drinking •water monitoring
                      with the exception of Enterolert (a
                      method for enterococci) for which EPA
                      is proposing approval through this
                      rulemaking. EPA is also proposing   ;
                      testing source waters for the presence
                      for coliphage. EPA proposes to use EPA
                      Method 1601: Two-Step Enrichment  :
                      Presence-Absence Procedure and EPA
                      Method 1602: Single Agar layer
                      Procedure.
                        While the Agency identified
                      Standards Methods, Method 9211D
                      Coliphage Detection (20th edition of  ;
                      Standard Methods for the Examination
                      of Water and Wastewater) as being   :
                      potentially applicable, EPA does not
                      propose to use it in this rulemaking. The
                      use of this voluntary consensus
                      standard would not meet the Agency's
                      needs because the method does not
                      detect male specific coliphage, the
                      sample volume is inappropriately small
                      (20 ml versus the GWR's proposed 100
                      ml  sample requirement), and according
                      to the method, the sensitivity may not
be high enough to detect one coliphage
in a 100 ml sample. EPA welcomes
comments on this aspect of the
proposed rulemaking and, specifically,
invites the public to identify
potentially-applicable voluntary
consensus standards and to explain why
such standards should be used in this
regulation.

  TABLE Vl-5.—MICROBIAL METHODS
 Analytical methods for source water moni-
                toring
   Indicator
£ coli .
enterococci	
Coliphage
                      Method1
Colilert Test (Method
  92236)23
Colisure Test (Method
  9223B)23
Membrane Filter Method
  with Ml Agar45
m-ColiBIue24Test46
E*Colite Test47
May also use the EC-MUG
  (Method 9212F)2 and NA-
  MUG (Method 9222G)2 E
  coli confirmation step
  §141.21 (f)(6) after the
  EPA approved Total Coli-
  form methods in
  §141.21(f)(3)
Multiple-Tube Tech. (Method
  9230B) 1
Membrane Filter Tech.
  (Method 9230C)18
Enterolert3
EPA Method 1601: Two-
  Step Enrichment Pres-
  ence-Absence Procedure9
EPA Method 1602: Single
  Agar layer Procedure9
  1The time from sample collection to initi-
ation of analysis may not exceed 30 hours.
Systems are encouraged  but not required to
hold samples below 10 °C during transit.
  2 Methods  are  approved and described in
Standard  Methods  for the  Examination of
Water and Wastewater (20th edition).
  3 Medium available through IDEXX Labora-
tories, Inc.,  One  IDEXX Drive, Westbrook,
Maine 04092.
  4 EPA approved drinking water methods.
  5 Brenner,  K.P., C.C. Rankin, Y.R. Roybal,
G.N. Stelma, P.V. Scarpino, and A.P. Dufour.
1993. New medium for the simultaneous de-
tection of total  conforms and  Escherichia coli
in  water. Appl.  Environ. Microbiol. 59:3534-
3544.
  6Hach Company, 100 Dayton Ave., Ames,
IA 50010.
  7Charm Sciences,  Inc., 36  Franklin St.,
Maiden, MA 02148-4120.
  8 Proposed for EPA approval, EPA Method
1600: MF Test  Method  for enterococci in
Water (EPA-821-R-97-004 (May 1997)) is an
approved  variation  of  Standard  Method
9230C.
  9 Proposed for EPA approval are EPA Meth-
ods 1601 and 1602, which are available from
the EPA's Water Resources  Center,  Mail
code: RC-4100, 1200 Pennsylvania Ave. NW,
Washington, DC 20460.

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                 Federal  Register/Vol. 65, No. 91/Wednesday, May 10, 2000/Proposed Rules
                                                                     30261
E, Executive Order 12866: Regulatory
Planning and Review
  Under Executive Order 12866, (58 FR
51,735,October 4,1993) the Agency must
determine whether the regulatory action
is "significant" and therefore subject to
OMB review and the requirements of
the Executive Order. The Order defines
"significant regulatory action" as one
that is likely to result in a rule that may:
(l) Have an annual effect on the
ocoribmY of S100 million or more or
advejsefy affect in a material way the
economy, a sector of the economy,
productivity, competition, jobs, the
environment, public health or safety, or
State, local, or tribal governments or
communities; (2] create a serious
inconsistency or otherwise interfere
with an action taken or planned by
another agency; (3) materially alter the
budgetary impact of entitlement, grants,
usei; fees, or loan programs or the rights
and obligations of recipients thereof; or
(4) raise novel legal or policy issues
arising out of legal mandates, the
President's priorities,  or the principles
set forth in the Executive Order.
  Pursuant to the terms of Executive
Order 12866, EPA has determined that
this rule is a "significant regulatory
action". As such, this  action was
submitted to OMB for review. Changes
made in response to OMB suggestions or
recommendations are  documented in
the public record.
F. Executive Order 12898:
Environmental Justice
  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 Agency
has considered environmental justice
issues concerning the potential impacts
of this action and has  consulted with
minority and low-income stakeholders.
  The Environmental Justice Executive
Order requires the Agency to consider
environmental justice issues in the
rulomaking and to consult with
minority and low-income stakeholders.
There are two aspects of today's
proposed rule that relate specifically to
this policy: the overall nature of the
rule, and the convening of a stakeholder
meeting specifically to address
environmental justice issues. The GWR
applies to all public water systems:
community water systems, nontransient
noncommunity water systems, and
transient noncommunity water systems
that use ground water as their source
water. Consequently, the health
protection benefits provided by this
proposal are equal across all income and
minority groups served by these
systems. Existing regulations such as the
SWTR and IESWTR provide similar
health benefit protection to
communities that use surface water or
ground water under the direct influence
of surface water.
  As part of EPA's responsibilities to
comply with Executive Order 12898, 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. Topics discussed included
treatment techniques, costs  and benefits,
data quality, health effects, and the
regulatory process. Participants
included national, State, tribal,
municipal, and individual stakeholders.
EPA conducted the meetings by video
conference call with participants in
eleven cities. This meeting was a
continuation of stakeholder meetings
that started in 1995 to obtain input on
the Agency's drinking water programs.
The major objectives for the March 12,
1998 meeting were:  solicit ideas from
environmental justice (EJ) stakeholders
on known issues concerning current
drinking water regulatory efforts;
identify key issues of concern to EJ
stakeholders; and receive suggestions
from EJ stakeholders concerning ways to
increase representation of EJ
communities in EPA's Office of Water
regulatory efforts, hi addition, EPA
developed a plain-English guide
specifically for this meeting to assist
stakeholders in understanding the
multiple and sometimes complex
drinking water issues.

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 "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.
  This proposed rule is subject to this
Executive Order because it is an
economically significant regulatory
action as defined by Executive Order
12866, and EPA believes that the
environmental health or safety risk
addressed by this action may have a
disproportionate effect on children.
Accordingly, EPA has evaluated the
environmental health or safety effects of
viruses on children. The results of this
evaluation are contained in section II.E.
of the preamble and in the RIA for
today's rule (US EPA, 1999a). A copy of
RIA and its supporting documents have
been placed  in the Office of Water
docket for this proposal.

1. Risk of Viral Illness to Children and
Pregnant Women
  The risk of illness and death due to
viral contamination of drinking water
depends on several factors, including
the age and the immune status of the
exposed individual. Two groups that are
at increased  risk of illness and mortality
due to waterborne pathogens are
children and pregnant women (Gerba et
al., 1996). For example, rotavirus
infections can occur in people of all
ages, however they primarily affect
young children (US EPA, 1999b). Infants
and young children have higher rates of
infection and disease from enteroviruses
than other age groups (US EPA, 1999b).
Several viruses 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 paralytic
polio, heart disease, encephalitis,
hemorrhagic conjunctivitis, hand-foot-
and-mouth disease and diabetes mellitis
(CDC, 1997;  Modlin, 1997; Melnick,
1996; Cherry, 1995; Berlin and
Rorabaugh, 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 ch^ld late in pregnancy,
sometimes resulting in severe illness in
the newborn (US EPA, 1999c).
Coxsackievirus and echovirus may be
transmitted from the mother to the child
in utero (Gerba et al., 1996).
  To  comply with Executive Order
13045, EPA  calculated the baseline risk
(e.g., risk without this rule) and with-
rule reduction of risk from waterborne
illness and mortality for children. To
address the disproportionate risk of
waterborne illness and mortality to
children under this rulemaking, EPA
applied age-specific parameters
regarding morbidity to the risk
assessment.  The risk assessment first

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extracted the proportion of the
population that falls into several age
categories that may be more or less
susceptible to waterborne viral illness
than the general population. The
extraction was done separately for two
model viruses. Bacterial illnesses are
not addressed in this analysis, however,
EPA estimates that bacterial illnesses
account for an additional 20% of viral
illnesses.
  When assessing the risk of illness due
to viruses of low-to-medium infectivity
(using echovirus as a surrogate), the age
categories used were less than one
month of age, one month to five years
of age, five to sixteen years of age and
greater than sixteen years of age. It was
assumed that 50% of children less than
five years old would become ill once
infected with low-to-medium infectivity
viruses; while 57% of children five
years to sixteen years of age and 33% of
people over sixteen would become ill
once infected.  This estimate was based
on a community-wide echovirus type 30
epidemic (Hall, 1970). See Appendix A
oftheRIA.
  When assessing the risk of illness due
to viruses of high infectivity (using
                      rotavirus as a surrogate) the age     '•
                      categories used were less than two years
                      of age, two to five years of age, five to
                      sixteen years old and greater than
                      sixteen years old. It was assumed that
                      88% of children less than two years Old
                      would become ill once infected with
                      high infectivity viruses; while 40% was
                      assumed for everyone else. The
                      morbidity rates for high infectivity  '
                      viruses were based on data from
                      Kapikian and Chariock (1996) for
                      children less than two. For other age
                      categories, EPA has conservatively
                      estimated a morbidity of 10 based upon
                      studies of rotavirus illness in       :
                      households with newborn children
                      (Wenman etal., 1979) and of an
                      outbreak in an isolated community
                      (Foster et. al., 1980). See Appendix A of
                      theRIA.
                        In addition to illness, EPA also   :
                      considered child mortality attributable
                      to •waterborne microbial illness. For '
                      low-to-medium infectivity viruses,  ;
                      0.92% of children less than one month
                      of age who become ill were assumed to
                      die based on information from Jenista et
                      al., (1984) and Modlin (1986), while
                      .041% of people greater than one month
old who become ill were assumed to
die. For viruses of high infectivity,
0.00073% of infected children less than
four years old were assumed to die
(Tucker et al, 1998). The low-to-
medium infectivity viruses result in a
higher mortality rate than the high
infectivity viruses because the low-to-
medium infectivity viruses cause more
serious health effects.
  The proposed GWR specifically
targets systems with existing or
potential fecal contamination, including
viral contamination. To estimate the
benefits to children from today's
proposed rule, the Agency calculated
the number of illnesses and deaths
avoided by the rule  for the children less
than 5 years old and for children
between the ages of 5 and 16. Table VI-
6 presents a summary of these estimates.
Overall, the proposed rule would result
in 26,566 less illnesses  caused by
viruses per year occurring in children
16 years of age and less. The proposed
rule is also expected to  result in 2 less
deaths per year due to viral  illness
among children aged 16 or less.
    TABLE Vl-6.—REDUCTIONS OF VIRAL ILLNESS AND DEATH IN CHILDREN RESULTING FROM VARIOUS REGULATORY
                                                   APPROACHES
Options
Sanitary Survey Only 	
Sanitary Survey and Triggered Monitoring 	
Multi-barrier (Proposed) 	 	 	
Across-the-board Disinfection 	

Illness reduction
(ages 0-5)
2,292
13,044
15,058
21,125

Death reduction
(ages 0-5)
0
1
1
1

Illness reduction
(5-1 6 years old)
1,773
9,974
11,508
16,059

Death reduction '
(5-16 years old)
0
1
1
2

  The Agency believes the proposed
multi-barrier approach will provide the
most cost-effective method of reducing
viral and bacterial illness in children
that results from contaminated ground
water. The proposed option will reduce
3,500 more cases of viral illness in
children each year than the sanitary
survey and triggered monitoring option.
This additional reduction is obtained
with only a slightly larger increase in
total annual costs. Conversely, the
additional reductions in illness gained
with the across-the-board option comes
at a much higher cost. It is estimated
that the across-the-board option will
cost approximately $12,000 more per
case of illness  avoided than the multi-
barrier approach.

2. Full Analysis of the Microbial Risk
Assessment

  A full analysis of the microbial risk
assessment is provided in the Appendix
to the RIA for the proposed GWR, and
                      a summary is provided in this preamble
                      (see section II.E.).
                        The public is invited to submit or
                      identify peer-reviewed studies and data,
                      of which EPA may not be aware, that
                      assessed results of early life exposure to
                      viruses and bacteria.
                      H. Consultations with the Science
                      Advisory Board, National Drinking  ;
                      Water Advisory Council, and the    '
                      Secretary of Health and Human Services

                        In accordance with section 1412 (d)
                      and (e) of the SDWA, the Agency did
                      consult with the Science Advisory  '
                      Board and will request comment from
                      the National Drinking Water Advisory
                      Council (NDWAC) and the Secretary of
                      Health and Human Services on the
                      proposed rule.
                      /. Executive Order on 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". Under
section  6 of Executive Order 13132, EPA
may not issue a regulation that has
Federalism 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 State and
local governments, or EPA consults with
State and local officials early in the
process  of developing the proposed
regulation. EPA also may not issue a
regulation that has Federalism
implications and that preempts State

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                                                                    30263
law, unless the Agency consults with
State and local officials early in the
process of developing the proposed
regulation.
  If EPA complies by consulting,
Executive Order 13132 requires EPA to
provide to the Office of Management
and Budget (OMB), in a separately
identified section of the preamble to the
final rule, a Federalism summary impact
statement (FSIS). The FSIS must include
a description of the extent of EPA's
prior consultation with State and local
officials, a summary of the nature of
their concerns and the Agency's
position supporting the need to issue
the regulation, and a statement of the
extent to which the concerns of State
and local officials have been met. Also,
when EPA transmits a draft final rule
with Federalism implications to OMB
for review pursuant to Executive Order
12866, EPA must include a certification
from the Agency's Federalism Official
stating that EPA has met the
requirements of Executive Order 13132
in a meaningful and timely manner.
  EPA has concluded that this proposed
rule may have Federalism implications
since it may impose substantial direct
compliance costs on local governments,
and the Federal government will not
provide the funds necessary to pay
those cost. Accordingly, EPA provides
the following FSIS as required by
section 6(b) of Executive Order 13132.
  As discussed in section I.A., EPA met
with a variety of State and local
representatives including several local
elected officials, who provided
meaningful and timely input in the
development of the proposed rule.
Summaries of the meetings have been
included in the public record for this
proposed rulemaking. EPA consulted
extensively with State, local, and tribal
governments. For example, four public
stakeholder meetings were held in
Washington, DC, Portland, Oregon,
Madison Wisconsin and Dallas, Texas.
EPA also held three early involvement
meetings with the Association of State
Drinking Water Administrators. Several
key issues were raised by stakeholders
regarding the GWR provisions, many of
which were related to reducing burden
and maintaining flexibility. The Office
of Water was able to reduce burden and
increase flexibility by creating a targeted
risk based approach which builds upon
existing State programs. It should be
noted that this rule is important because
it will reduce the incidence  of fecally
contaminated drinking water supplies
by requiring corrective actions for
focally contaminated systems or systems
with a significant risk of fecal
contamination resulting in a reduced
waterborne illness. Because
consultation on this proposed rule
occurred before the November 2,1999,
effective date of Executive Order 13132,
EPA will initiate discussions with State
and local elected officials regarding the
implications of this rule during the
public comment period.

/. Executive Order 13084: Consultation
and Coordination With Indian Tribal
Governments
  Under Executive Order 13084, EPA
may not issue a regulation that is not
required by statute, that significantly or
uniquely affects the communities of
Indian tribal governments, and that
imposes substantial direct compliance
costs on those communities, unless the
Federal government provides the funds
necessary to pay the direct compliance
costs incurred by the tribal
governments, or EPA consults with
those governments. If EPA complies by
consulting, Executive Order 13084
requires EPA to provide to the OMB, in
a separately identified section of the
preamble to the rule, a description of
the extent of EPA's prior consultation
with representatives of affected tribal
governments, a summary of the nature
of their concerns, and a statement
supporting the need to issue the
regulation. In addition, Executive Order
13084 requires EPA to develop an
effective process permitting elected
officials and other representatives of
Indian tribal governments "to provide
meaningful and timely input in the
development of regulatory policies on
matters that significantly or uniquely
affect their communities."
  EPA has concluded that this rule will
significantly affect communities of
Indian tribal governments because 92
percent of PWSs in Indian Country are
ground water systems. It will also
impose substantial direct compliance
costs on such communities, and the
Federal government will not provide the
funds necessary to pay the direct costs
incurred by the tribal governments in
complying with the rule. In developing
this rule, EPA consulted with
representatives of tribal governments
pursuant to Executive Order 13084.
EPA's consultation, the nature of the
tribal governments' concerns, and EPA's
position supporting the need for this
rule are discussed in section VI.C.
which addresses compliance with
UMRA.
  As described in section VI.C.2.e. of
the UMRA discussion, EPA held
extensive public meetings that provided
the opportunity for meaningful and
timely input in the development of the
proposed rule. Summaries of the
meetings have been included in the
Office of Water public docket for this
rulemaking. In addition, the Agency
presented the rule and asked for
comment at three tribal conferences.
Two consultations took place at national
conferences; one for the National Indian
Health Board and the other for the
National Tribal Environmental Council.
The third consultation was conducted
in conjunction with the Inter-Tribal
Council of Arizona, Inc. A more detailed
discussion of these consultations can be
found in the UMRA consultation section
(section VI.C.2.C.).

K. Plain Language
  Executive Order 12866 and the
President's memorandum of June 1,
1998, require each agency to write its
rules  in plain language. EPA invites
comments on how to make this
proposed rule easier to understand. For
example: Has EPA organized the
material to suit commenters' needs? Are
the requirements in the rule clearly
stated? Does the rule contain technical
language or jargon that is not clear?
Would a different format (grouping and
order of sections, use of headings,
paragraphs)  make the rule easier to
understand? Would shorter sections
make this rule easier to understand?
Could EPA improve clarity by adding
tables, lists,  or diagrams? What else
could EPA do to make the rule easier to
understand?
VII. Public Comment Procedures
  EPA invites you to provide your
views on this proposal, approaches we
have not considered, the potential
impacts of the various options
(including possible unintended
consequences), and any data or
information that you would like the
Agency to consider. Many of the
sections within today's proposed rule
contain "Request for Comment"
portions  which the Agency is also
interested in receiving comment on.

A. Deadlines for Comment
  Send your comments on or before July
10, 2000. Comments received after this
date may not be considered in decision
making on the proposed rule.

B. Where To Send Comment
  Send an original and 3 copies of your
comments and enclosures (including
references) to W-98-23 Comment Clerk,
Water Docket (MC4101), USEPA, 1200
Pennsylvania Ave., NW, Washington DC
20460. Hand deliveries should be
delivered to  the Comment Clerk, Water
Docket (MC4101), USEPA 401 M ,
Washington, D.C. 20460. Comments
may also be submitted electronically to
ow-docket^epamail.epa.gov. Electronic
comments must be submitted as an

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Federal Register/Vol. 65,  No.  91/Wednesday, May 10, 2000/Proposed Rules
ASCII, WP5.1, WP6.1 or WPS file
avoiding the use of special characters
and form of encryption. Electronic
comments must be identified by the
docket number W—98—23. Comments
and data will also be accepted on disks
in WP 5.1, 6.1, 8 or ASCII file format.
Electronic comments on this notice may
be filed online at many Federal
Depository Libraries. Those who
comment and want EPA to acknowledge
receipt of their comments must enclose
a self-addressed stamped envelope. No
facsimiles (faxes) will be accepted.
Comments may also be submitted
electronically to ow-
docket@epamail.epa.gov.

C. Guidelines for Commenting
  To ensure that EPA can read,
understand and therefore properly
respond to comments, the Agency
would prefer that commenters cite,
where possible, the paragraph(s) or
sections in the notice or supporting
documents to which each comment
refers. Commenters should use a
separate paragraph for each issue
discussed. Note that the Agency is not
soliciting comment on, nor will it
respond to, comments on previously
published regulatory language that is
included in this notice to ease the
reader's understanding of proposed
language. You may find the following
suggestions helpful for preparing your
comments:
  1. Explain your views as clearly as
possible.
  2. Describe any assumptions that you
used.
  3. Provide technical information and/
or data to support your views.
  4. If you estimate potential burden or
costs, explain how you arrived at the
estimate.
  5. Indicate what you support, as well
as what you disagree with.
  6. Provide specific examples to
illustrate your concerns.
  7. Make sure to submit your
comments by the deadline in this
proposed rule.
  8. At the beginning of your comments
(e.g., as part of the "Subject" heading),
be sure to  properly identify the
document you are commenting on. You
can do this by providing the docket
control number assigned to the
proposed rule, along with the name,
date, and Federal Register citation.
VIII. References
Abbaszadegan, M, P.W. Stewart, M.W.
  LeChevallier, Rosen, Jeffery S. and C.P.
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  American Water Works Association
  Research Foundation. Denver, CO, 189 p.
                        Abbaszadegan, M., P.W. Stewart, and M.W.
                          LeChevallier. 1999. A Strategy for     \
                          Detection of Viruses in Groundwater by
                          PCR. Applied and Environmental
                          Microbiology Vol 65(2):444-449.
                        Adham S.S., R.S. Trussell, P.P. Gagliardo,
                          and R.R. Trussell. 1998. Rejection of MS-
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                        Angulo, F. ]., S. Tippen, D. Sharp, B.J. Payne,
                          C. Collier, J. Hill, T. J. Barrett, R.M. Clark,
                          E. Geldreich, H.D. Donnell, and D. L   '
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                        Association of State Drinking Water
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                        Battigelli, D.A.1999. Monitoring ground
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Federal  Register/Vol.  65, No. 91/Wednesday, May 10,  2000/Proposed Rules
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  (USEPA). 1991d. Phase II. 56 FR 30268.

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                  Federal Register/Vol. 65, No. 91/Wednesday, May 10, 2000/Proposed Rules
                                                                         30267
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List of Subjects in 40 CFR Parts 141 and
142

  Environmental protection, Indians-
lands, Intergovernmental relations,
Radiation protection, Reporting and
recordkeeping requirements, Water.
  Dated: April 17, 2000.
Carol M. Browner,
Administrator.

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

PART 141—NATIONAL PRIMARY
DRINKING  WATER REGULATIONS

  1. The  authority citation for part 141
continues to read as follows:
  Authority: 42  U.S.C. 300f, 300g-l, 300g-2,
300g-3, 300g-4, 300g-5, 300g-6, 300J-4,
SOOj-9, and 300J-11.
  2. Section 141.21 is amended by
adding paragraph (d)(3) to read as
follows:

§141.21   Coliform sampling.
*****
  (d)*  * ;
  (3) Sanitary surveys conducted by the
State under § 142.16(k)(2) of this
chapter,  at the frequencies specified,
may be used to meet the sanitary
surveys requirements of this section.
*    *     *    *    *
  3. Section 141.154 is amended by
adding paragraph (f) to read as follows:

§ 141.154  Required additional health
information.
*****
  (f) Ground water systems that detect
E. coli, enterococci or coliphage in the
source water as required by § 141.403
must include the health effects language
prescribed by Appendix B of  subpart Q
of this part.
*****
  4. Section 141.202 as added by the
final rule published on May 4, 2000 is
amended by adding entry (9)  in
numerical order to the table in
paragraph (a) to read as follows:

§ 141.202  Tier 1 Public Notice—Form,
manner, and frequency of notice.
  (a) *  * *

Table 1 to §141.202—violation categories and
 other situations requiring a tier 1  public notice
  (9) Violation of the treatment technique for
    the Ground Water Rule (as specified in
    §141.405(a) through (c) or when E. coli,
    enterococci, or coliphage are present as
    specified  in §141.403)  or when  the
    water system  fails to test  for E. coli,
    enterococci, coliphage  (as  specified in
    §141.403).
   5. Appendix A of subpart Q as added
by the final rule published on May 4,
2000 is amended by adding entry 8.
under LA. "Microbiological
Contaminants" and by adding entry G.
under IV. "Other Situations Requiring
Public Notification" to read as follows:

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30268
Federal Register/Vol. 65, No. 91/Wednesday, May 10, 2000/Proposed Rules
 APPENDIX A TO SUBPART Q OF PART 141.—NPDWR VIOLATIONS AND OTHER SITUATIONS REQUIRING PUBLIC NOTICE 1
                                     (INCLUDING D/DBP AND IESWTR VIOLATIONS)
                                                                          MCL/MRDL/TT violations2
                               Contaminant
                                                        Tier of pub-
                                                          lic notice
                                                          required
                                                                                        Citation
            Monitoring and testing
             procedure violations

           Tier of pub-
            lic notice      Citation
            required
A. Microbiological Contaminants
8. GWR TT violations
                                                                                          141.405
                                                                                                          N/A
                                                                                                                      N/A
                                       IV. Other Situations Requiring Public Notification
G. Fecal indicators for GWR: E. coli, enterococci, coliphage
                                                                                   1
                                                                                          141.403
                                                                                                            1
                                                                                                                   141.403
  Appendix A Endnotes                                                          ;
  1 Violations and other situations not listed in this table (e.g., reporting violations and failure to prepare Consumer Confidence Reports), do not
require notice, unless otherwise determined by the primacy agency. Primacy agencies may, at their option, also require a more stringent public
notice tier (e.g., Tier 1 instead of Tier 2 or Tier 2 instead of Tier 3) for specific violations and situations listed in this Appendix, as authorized
under §&141.202(a) and §141.203(a).
  2 MCL—Maximum contaminant level, MRDL-Maximum residual disinfectant level, TT—Treatment technique.
    6.  Appendix B to subpart  Q as added by the final  rule  published on May 4, 2000 is  amended  by adding a new
entry  Ic in numerical order  un A.  "Microbiological Contaminants" and by  redisinating entries C.  through H.  as D.
through I. and adding a new C. in alphabetical order to read as follows:

     APPENDIX B OF SUBPART Q OF PART 141.—STANDARD HEALTH EFFECTS LANGUAGE FOR PUBLIC NOTIFICATION
          Contaminant
                                    MCLG1
                                mg/L
MCL2
mg/L
A. Microbiological Contaminants
 1c. Fecal indicators (GWR):
    i. E. coll	  Zero .
        ii. enterococci 	  None
        iii. coliphage 	  None
                             None 	  Fecal indicators are bacteria or viruses whose  presence indicates that
                                            the water may be contaminated with human or animal wastes.  Mi-
                                            crobes in these wastes can cause short-term effects, such as diarrhea,
                                            cramps,  nausea, headaches, or other symptoms. They may pose a
                                            special health risk for infants, young children, some of the elderly, and
                                            people with severely compromised immune systems
C. Ground  Water Rule (GWR)  TT
  violations.
                                 None
                                          Inadequately treated  or inadequately protected water may contain dis-
                                            ease-causing organisms. These  organisms include  bacteria and vi-
                                            ruses which can cause symptoms such as diarrhea,  nausea, cramps,
                                            and associated headaches.
  Appendix B Endnotes
  1. MCLG—Maximum contaminant level goal.
  2. MCL—Maximum contaminant level.

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                 Federal Register /Vol.  65, No.  91/Wednesday, May 10,  2000/Proposed Rules
                                                                      30269
  7. Appendix C to subpart Q as added
in the final rule published on May 4,
2000 amended by adding the following
abbreviation in alphabetical order to
read as follow:
Appendix C to Subpart Q of Part 141—List
of Acronyms Used in Public Notification
Regulation
*    *     *,   *     *

GVVR Ground Water Rule
*    *     *    *     *
  9, A new subpart S is proposed to be
added to read as follows:
Subpart S—Ground Water Rule
See.
141.400  General requirements and
    applicability.
141.401  Sanitary survey information
    request.
141,402  Hydrogeologic sensitivity
    assessment information request.
141.403  Microbial monitoring of source
    wiiter and analytical methods.
141.404  Treatment technique requirements.
141,405  Treatment technique violations.
141.406  Reporting and record keeping.

Subpart S—Ground Water Rule

§ 141.400  General requirements and
applicability.
  (a) Scope of this subpart. The
requirements of this subpart S constitute
national primary drinking water
regulations.
  tb) Applicability. All public water
systems that are served solely by ground
water. The requirements in this subpart
also apply to subpart H systems that
distribute ground water that is not
treated to 4-log inactivation or removal
of viruses before entry into the
distribution system. Systems supplied
by ground water under the direct
influence of surface water are regulated
under subparts H and P  of this part, not
under this subpart. For the purposes of
this subpart, "ground  water system" is
defined as any public  water system
meeting this applicability statement.
  (c) General requirements. These
regulations in this subpart establish
requirements related to sanitary surveys,
hydrogeologic sensitivity assessments,
and source water microbial monitoring
performed at ground water systems as
defined by paragraph (b) of this section.
The regulations in this subpart also
establish treatment technique
requirements for these ground water
systems which have fecally
contaminated source waters, as
demonstrated under § 141.403, or
significant deficiencies as identified in
a sanitary survey conducted by a State
under either § 142.16(k)(2) of this
chapter or by EPA under SD WA section
1445. Ground water systems with
fecally contaminated source water or
significant deficiencies must meet one
or more of the following treatment
technique requirements: eliminate the
source of contamination, correct the
significant deficiency, provide an
alternate source water, or provide a
treatment which reliably achieves at
least 99.99 percent (4-log) inactivation
or removal of viruses before or at the
first customer. Ground water systems
which provide 4-log inactivation or
removal of viruses will be required to
conduct compliance monitoring to
demonstrate treatment effectiveness.
   (d) Compliance dates. Ground water
systems must comply with the
requirements of this subpart beginning
[DATE 3 YEARS AFTER PUBLICATION
OF THE FINAL RULE IN THE FEDERAL
REGISTER.

§ 141.401  Sanitary survey information
request.
   Ground water systems must provide
the State at its request, any pertinent
existing information that would allow
the State to perform a sanitary survey as
described in § 142.16(k)(2) of this
chapter. For the purposes of this
subpart, "sanitary survey,"  as
conducted by the State, includes but is
not limited to an onsite review of the
water source (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.

§141.402  Hydrogeologic sensitivity
assessment information request.
   Ground water systems must provide
the State at its request, any pertinent
existing information that would allow
the State to perform a hydrogeologic
sensitivity assessment as described in
§ 142.16(k)(3) of this chapter.

§ 141.403  Microbial monitoring of source
water and analytical methods.
   (a) Routine monitoring. Any ground
water system tiiat draws water from a
hydrogeologically sensitive drinking
water source, as determined under
§ 142.16(k)(3) of this chapter, and that
does not provide 4-log inactivation or
removal of viruses,  must collect a source
water sample each month that it
provides water to the public and test the
sample for the fecal indicator specified
by the State under paragraph (d) of this
section. Ground water systems must
.begin monitoring the month after being
notified of the hydrogeologic sensitivity
assessment.
  (b) Triggered monitoring. Any ground
water system that does not provide 4-log
inactivation or removal of viruses, and
is notified of a total coliform-positive
sample under § 141.21, must collect,
within 24 hours of notification, at least
one source water sample and have the
sample tested for the fecal indicator
specified by the State under paragraph
(d) of this section. This requirement is
in addition to all monitoring and testing
requirements under § 141.21.
  (c) Systems with disinfection. Ground
water systems currently providing 4-log
inactivation or removal of viruses must
notify the State of such and must
conduct compliance monitoring in
accordance with § 141.404(c). This
notification must be made by the
effective date of the rule. All new
systems must notify the State of the
level of virus inactivation they are
achieving prior to serving their first
customer.
  (d) Analytical methods. Source water
samples must be tested for one of the
following fecal indicators: E. coli,
coliphage, or enterococci, as  specified
by the State. For whichever fecal
indicator is specified by the State, the
ground water system must use one of
the analytical methods listed in the
following table:

 ANALYTICAL METHODS FOR SOURCE
         WATER  MONITORING
   Indicator
E. coli .
enterococci ,
Coliphage ...
                      Method1
Colilert Test (Method
  9223B)2.3
Colisure Test (Method
  9223B)2.3
Membrane Filter Method
  with Ml Agar4.5
m-CoIi6lue24Test4.6
E*ColiteTesf.7
May also use the EC-MUG
  (Method 9212F) 2 and NA-
  MUG (Method 9222G) 2 E.
  coli confirmation step
  § 141.21 (f)(6) after the
  EPA approved Total Coli-
  form methods in
  §141.21(f)(3)
Multiple-Tube Tech.  (Method
  92306)1
Membrane Filter Tech.
  (Method 9230C)1^8
Enterolert3
EPA Method 1601:Two-
  Step Enrichment Pres-
  ence-Absence Procedure9
EPA Method 1602: Single
  Agar layer Procedure9
  1The time from sample collection to initi-
ation of analysis may not exceed 30 hours.
Systems are encouraged  but not required to
hold samples below 10°C during transit.
  2 Methods are  approved and described in
Standard  Methods for the  Examination  of
Water and Wastewater (20th edition).

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30270
Federal Register/Vol. 65, No.  91/Wednesday, May  10,  2000/Proposed  Rules
  3 Medium available through IDEXX Labora-
tories, Inc.,  One  IDEXX Drive, Westbrook,
Maine 04092.
  4 EPA approved drinking water methods.
  5 Brenner,  K.P.,  C.C. Rankin, Y.R. Roybal,
G.N. Stelma, P.V.  Scarpino, and A.P. Dufour.
1993. New medium for the  simultaneous de-
tection of total conforms and Escherichia coli
in  water.  Appl. Environ. Microbiol. 59:3534-
3544.
  6Hach Company, 100 Dayton Ave., Ames,
IA 50010.
  7 Charm  Sciences,  Inc.,  36 Franklin  St.,
Maiden, MA 02148-4120.
  8 Proposed for EPA approval, EPA Method
1600: MF Test Method for  enterococci in
Water (EPA-821-R-97-004 (May 1997)) is an
approved   variation   of  Standard  Method
9230C.
  9 Proposed for EPA approval are EPA Meth-
ods 1601  and  1602, which are available from
the  EPA's Water Resources  Center,   Mail
code: RC-4100, 1200 Pennsylvania Ave. NW,
Washington, DC 20460.
   (e) Notification of State. If any source
water sample is positive for E. coli,
coliphage, or enterococci, the ground
water system shall notify the State as
soon as possible after the system is
notified of the test result, but in no case
later than the end of the next business
day, and take corrective action in
accordance with § 141.404(b).
   (f) Resampling after invalidation.
Where the State invalidates a positive
source water sample under paragraph (i)
of this section, the ground water system
must collect another source water
sample and have it analyzed for the
same fecal indicator within 24 hours of
being notified of the invalidation.
   (g) Triggered monitoring waiver. The
State may waive triggered source water
monitoring as described in § 141.403(b)
due to a total coliform-positive sample,
on a case-by-case basis, if the State
determines that the total coliform
positive sample  is associated solely with
a demonstrated distribution system
problem. In such a case, a State official
must document the decision, including
the rationale for the decision, in writing,
and sign the document.
   (h) Reduce frequency for routine
monitoring. The State may reduce
routine source water monitoring to
quarterly if a hydrogeologically
sensitive ground water system detects
no fecal indicator-positive samples in
the most recent twelve monthly
samples, during the months the ground
water system is in operation. Moreover,
the State may, after those twelve
monthly samples, waive source water
monitoring altogether for a ground water
system if the State determines, and
documents the determination in writing,
that fecal contamination of the well(s)
has not been identified and is highly
unlikely based on the sampling history,
land use pattern, disposal practices in
the recharge area, and proximity of
septic tanks and other fecal
                      contamination sources. If the State
                      determines that circumstances have
                      changed, the State has the discretion to
                      reinstate routine monthly monitoring.1 In
                      any case, a State official must document
                      the determination in writing, including
                      the rationale for the determination,   :
                      addressing each factor noted in this
                      paragraph and sign the document.   ;
                        (i) Invalidation of samples. A source
                      water sample may be determined by the
                      State to be invalid only if the laboratory
                      establishes that improper sample
                      analysis occurred or the State has    ;
                      substantial grounds to believe that a
                      sample result is due to circumstances;
                      that do not reflect source water quality.
                      In such a case, a State official must
                      document the decision, including the
                      rationale for the decision, in writing,
                      and sign the document. The written
                      documentation must state the specific
                      cause of the invalid sample and what'
                      action the ground water system or
                      laboratory has taken or will take to
                      correct this problem. A positive sample
                      may not be invalidated by the State
                      solely on the grounds that repeat
                      samples are negative.      ,        '
                        (j) Repeat sampling. A ground wafer'"
                      system may apply to the  State, and the
                      State may consider,-on a on6-tiine basis,
                      to waive compliance with the treatmeht
                      technique requirements in  § 141.404(b),
                      after a single fecal indicator-positive
                      from a routine source water sample as
                      required in § 141.403(a),  if all the    .
                      following conditions are met:
                        (1) The ground water system collects
                      five repeat source water samples within
                      24 hours after being notified of a source
                      water fecal indicator positive result;
                        (2) The ground water system has the
                      samples analyzed for the same fecal
                      indicator as the original sample;     '
                        (3) All the repeat samples are fecal '
                      indicator negative; and             '.
                        (4) All required source water samples
                      (routine and triggered) during the past
                      five years were fecal indicator-negative.

                      §141.404  Treatment technique
                      requirements.         '
                        (a) Ground water systems with
                      significant deficiencies. As soon as
                      possible, but no later than 90 days after
                      receiving written notification from the
                      State of a significant deficiency, a
                      ground water system must do one or
                      more of the following: eliminate the
                      source of contamination, correct the .
                      significant deficiency, provide ah  ',
                      alternate source water, or provide a
                      treatment which reliably achieves at
                      least 99.99 percent (4-log) inactivation
                      or removal of viruses before or at the ;
                      first customer. Ground water systems;
                      which provide 4-log inactivation or
                      removal of viruses will be required to;
conduct compliance monitoring to
demonstrate treatment effectiveness.
The ground water system must consult
with the State to determine which of the
approaches, or combination of
approaches, are appropriate for meeting
the treatment technique requirement.
Ground water systems unable to address
the significant deficiencies in 90 days,
must develop a specific plan and
schedule for meeting this treatment
technique requirement, submit them to
the State, and receive State approval
before the end of the same 90-day
period. For the purposes of this
paragraph, a "significant deficiency"
includes: 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
potential for causing the introduction of
contamination into the water delivered
to consumers.
  (b) Ground water systems with source
water contamination. As soon as
possible, but no later than 90 days after
the ground water system is notified that
a source water sample is positive for a
fecal indicator, the ground water system
must do one or more of the following:
eliminate the source of contamination,
correct the significant deficiency,
provide an alternate source water, or
provide a treatment which reliably
achieves at least 99.99 percent (4-log)
inactivation or removal of viruses before
or at the first customer. Ground water
systems which provide 4-log
inactivation or removal of viruses will
be required to conduct compliance
monitoring to demonstrate treatment
effectiveness. The ground water system
must consult with the State to
determine which of the approaches, or
combination of approaches, are
appropriate for meeting the treatment
technique requirement. Ground water
systems unable to address the
contamination problem in 90 days must
develop a specific plan and schedule for
meeting this treatment technique
requirement, submit them to the State,
and receive State approval before the
end of the same 90-day period specified
previously. This requirement also
applies to ground water systems for
which States have waived source water
monitoring under § 141.403 (h) and have
a fecal coliform-or E. coli-positive while
testing under § 141.21.
  (c) Compliance monitoring. Ground
water systems that provide 4-log
inactivation or removal of viruses, or
begin treatment pursuant to paragraph
(a) or (b) of this section, must monitor
the effectiveness and reliability of
treatment as follows:

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                 Federal  Register/Vol.  65,  No. 91/Wednesday, May  10,  2000 /Proposed Rules
                                                                     30271
  (l) Chemical disinfection, (i) Ground
water systems serving 3,300 or more
people must continuously monitor and
maintain the State-determined residual
disinfectant concentration every day the
ground water system serves water to the
public.
  (it) Ground water systems serving
fewer than 3,300 people must monitor
and maintain the State-determined
residual disinfectant concentration
every day the ground water system
serves water to the public. The ground
watet system will monitor by taking a
daily grab sample during the hour of
peak flow or another time specified by
the State. If any daily grab sample
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.
  (2) UV disinfection. Ground water
systems using UV disinfection must
continuously monitor for and maintain
the State-prescribed UV irradiance level
every day the ground water system
serves water to the public.
  (3) Membrane filtration. Ground water
systems that use membrane filtration as
a treatment technology are assumed to
be achieving at least 4-log removal of
viruses when the membrane process is
operated in accordance with State-
specified compliance criteria developed
under § 142.16(k)(5)(ii) of this chapter,
or as provided by EPA, and the integrity
of the membrane is intact. Applicable
membrane filtration technologies are
reverse osmosis (RO), nanofiltration
(NF), and any membrane filters
developed in the future that have
absolute MVVCOs (molecular weight cut-
offs) that can achieve 4-log virus
removal,
  (dj Discontinuing treatment. Ground
wate'r systems may discontinue 4-log
inactivation or removal of viruses if the
State determines based on an on-site
investigation, and documents that
determination in writing, that the need
for 4-log inactivation or removal of
viruses no longer exists. Ground water
systems are subject to triggered
monitoring in accordance with
§141.403(b).
§ 141.405  Treatment technique violations.
  The following are treatment technique
violations which require the ground
water system to give public notification
pursuant to Appendix A of subpart Q of
this part, using the language  specified in
Appendix B of subpart Q of this part.
  (a) A ground water system with a
significant deficiency identified by a
State (as defined in § 141.401) which
does not correct the deficiency, provide
an alternative source, or provide 4-log
inactivation or removal of viruses
within 90 days, or does not obtain,
within the same 90 days, State approval
of a plan and schedule for meeting the
treatment technique requirement in
§ 141.404, is in violation of the
treatment technique.
  (b) A ground water system that detects
fecal contamination in the source water
and does not eliminate the source of
contamination, correct the significant
deficiency, provide an alternate source
water, or provide a treatment which
reliably achieves at least 99.99 percent
(4-log) inactivation or removal of viruses
before or at the first customer within 90
days, or does not obtain within the same
90 days, State approval of a plan for
meeting this treatment technique
requirement, is in violation of the
treatment technique unless the detected
sample is invalidated under § 141.403 (i)
or the treatment technique is waived
under § 141.403(j). Ground water
systems which provide 4-log
inactivation or removal of viruses will
be required to  conduct compliance
monitoring to demonstrate treatment
effectiveness.
  (c) A ground water system which fails
to address either a significant deficiency
as provided in paragraph (a) of this
section or fecal contamination as
provided in paragraph (b) of this section
according to the State-approved plan, or
by the State-approved deadline, is in
violation of the treatment technique. In
addition, a ground water system which
fails to maintain 4-log inactivation or
removal of viruses, is in violation of the
treatment technique, if the failure is not
corrected within four hours.

§ 141.406  Reporting and record keeping.
  (a) Reporting. In addition to the
requirements of § 141.31, ground water
systems regulated under this subpart
must provide the following information
to the State:
  (1) Ground water systems conducting
continuous, monitoring must notify the
State any time the residual disinfectant
concentration  (irradiance in the case of
UV) falls below the State-determined
value and is not restored within 4 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) Ground water systems taking daily
grab samples must notify the State any
time the residual disinfectant
concentration  falls below the State-
determined value and is not restored
within 4 hours, as determined by
follow-up samples. 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.
  (3) Ground water systems using
membrane filtration must notify the
State any time the membrane is not
operated in accordance with standard
operation  and maintenance procedures
for more than 4 hours, or any failure of
the membrane integrity occurs and is
not restored within 4 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.
These operation and maintenance
procedures will be provided by EPA or
developed by the State under
§ 142.16(k)(5)(ii)  of this chapter.
  (4) If any source water sample is
positive for E. coli, coliphage, or
enterococci, the ground water system
shall notify the State as soon as
possible, but in no case later than the
end of the next business day, and take
corrective action in accordance with
§ 141.404(b).
  (5) If any ground water system has
reason to believe that a disease outbreak
is potentially attributable to their
drinking water, it must report the
outbreak to the State as soon as possible,
but in no case later than the end of the
next business day.
  (6) After implementation of any
required treatment techniques, a ground
water system must provide as soon as
possible, but in no case later than the
end of the next business day, written
confirmation to the State that the
corrective action required by
§ 141.404(a) and (b) were met.
  (7) Notification that the ground water
system is currently providing 4-log
inactivation or removal of viruses.
  (b) Record keeping. In addition to the
requirements of § 141.33, ground water
systems regulated under this subpart
must maintain the following
information in their records:
  (1) Documentation showing the fecal
indicator the State is requiring the
ground water system to use.
  (2) Documentation showing
consultation with the State on
approaches for addressing  significant
deficiencies including alternative plans
and schedules and State approval of
such plans and schedules.
  (3) Documentation showing
consultation with the State on
approaches for addressing  source water
fecal contamination including
alternative plans and schedules and
State approval of such plans and
schedules.

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30272
Federal Register/Vol. 65,  No. 91/Wednesday, May  10,  2000/Proposed Rules
PART 142—NATIONAL PRIMARY
DRINKING WATER REGULATIONS
IMPLEMENTATION

  1. The authority citation for part 142
continues to read as follows:
  Authority: 42 U.S.C. 300f, 300g-l, 300g-2,
300g-3, 300g-4, 300g-5, 300g-6, 300J-4, 300J-
9, and 300J-11.
  2. Section 142.14 is amended by
adding paragraph (d)(17) to read as
follows:

§ 142.14  Records kept by States.
*****
  (d) * * *
  (17) Records of the currently
applicable or most recent State
determinations, including all supporting
information and an explanation of the
technical basis for each decision, made
under the following provisions of 40
CFR part 141, subpart S for the Ground
Water Rule.
  (i) Section 142.16(k)(3)—State
determinations of source water
hydrogeologic sensitivity, and
determinations of the presence of
hydrogeologic barriers.
  (ii) Section 141.404(c) " notification
to individual ground water systems of
the proper residual disinfection
concentrations (when using chemical
disinfection), irradiance level (when
using UV), or EPA-specified or State
specified compliance criteria (when
using membrane filtration) needed to
achieve 4-log inactivation of viruses.
  (iii) Section 141.403(g)—waivers of
triggered monitoring.
  (iv) Section 141.403(h)—reductions of
monitoring.
  (v) Section 141.403(1)—invalidation of
positive source water samples.
  (vi) Section 141.403(j)—waiver of
compliance with treatment technique
requirements.
  (vii) Section 141.404(a)—notifications
of significant deficiencies, consultation
with the ground water systems,
including written confirmation of
corrections of significant deficiencies by
ground water systems and written
records of State site visits and approved
plans and schedules.
  (ix) Section 141.404(d)—
determinations of when a ground water
system can discontinue 4-log
inactivation or removal of viruses.
*****
  3. Section 142.15 is amended by
adding paragraphs (c)(6) through (10) to
read as follows:

§ 142.15   Reports by States.
*****
  (c) * * *
  (6) Sanitary surveys. An annual list of
ground water systems that have had a
                      sanitary survey completed during the
                      previous year and an annual evaluation
                      of the State's program for conducting
                      sanitary surveys under § 142.16(k)(2).!
                        (7) Hydrogeologic sensitivity
                      assessments. An annual list of ground
                      water systems that have had a
                      sensitivity assessment completed during
                      the previous year, a list of those ground
                      water systems which are sensitive, a list
                      of ground water systems which are
                      sensitive, but for which the  State has
                      determined that a hydrogeologic barrier
                      exists at the site sufficient for protecting
                      public health, and an annual evaluation
                      of the State's program for conducting
                      hydrogeologic sensitivity assessments
                      under § 142.16 (k)(3).               ]
                        (8) Source water microbial
                      monitoring. An annual list of ground
                      water systems that have had to test the
                      source water as described under
                      § 141.403 of this chapter, a list of    '
                      determinations of invalid samples, and
                      a list of waivers of source water
                      monitoring provided by the State.    .
                        (9) Treatment technique compliance.
                      An annual list of ground water systems
                      that have had to meet treatment
                      technique requirements for significant
                      deficiencies or contaminated source
                      water under § 141.404 of this chapter, a
                      list of determinations to discontinue 4-
                      log inactivation or removal of viruses,1
                      and a list of ground water systems that
                      violated the treatment technique
                      requirements.
                        (10) Ground water systems providing
                      4-log inactivation  or removal of viruses.
                      An annual list of ground water systems
                      that have notified the State that they are
                      currently providing 4-log inactivation: or
                      removal of viruses.                 i
                      *****
                        4. Section 142.16 is amended by
                      adding and reserving paragraphs (i) and
                      (j) and adding paragraph (k) to read as
                      follows:

                      §142.16  Special primacy requirements.
                      *****
                        (i) [Reserved]                    ;
                        (i) [Reserved]                    :
                        (k) 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 a description of how the
                      State will accomplish the following
                      program requirements:
                        (1) Enforceable requirements, (i)
                      .States must have the appropriate rules
                      or other authority  to ensure  that ground
                      water systems take the steps necessary
to address, in accordance with
§ 141.404(a) of this chapter, any
significant deficiencies identified in the
written notification provided by the
State as required under paragraph (k)(2)
of this section.
  (ii) States must have appropriate rules
or other authority to ensure that ground
water systems respond in writing in
regard to the resolution of significant
deficiencies identified in the written
notification provided by the State
following identification of the
significant deficiencies.
  (iii) States must have the appropriate
rules or other authority to ensure that
ground water systems take the steps
necessary to address, in accordance
with § 141.404(b) of this chapter, any
fecal contamination identified during
routine or triggered monitoring in
accordance with § 141.403(a) and (b) of
this chapter.
  (2) Sanitary survey. In its  primacy
application the State must describe how
it, or an authorized agent, will
implement a sanitary survey program
that meets the requirements of this
section.
  (i) For the purposes of this paragraph
(k)(2), "sanitary survey" includes, but is
not limited to, an onsite review of the
water source (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.
  (ii) The State, or an authorized agent,
must conduct sanitary surveys for all
ground water systems. The sanitary
survey must address the eight sanitary
survey components listed in paragraphs
(k)(2)(ii)(A) through (H) of this section
no less frequently than every three years
for community systems and no less
frequently than every five years for
noncornmunity systems. The first
sanitary survey for community water
systems must be completed  by [DATE 6
YEARS AFTER DATE OF
PUBLICATION OF THE FINAL RULE
IN THE FEDERAL REGISTER] and for
noncommunity water systems, must be
completed by [DATE 8 YEARS AFTER
DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL
REGISTER].
  (A) Source.
  (B) Treatment.
  (C) Distribution system.
  (D) Finished water storage.
  (E) Pumps, pump facilities, and
controls.

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                 Federal Register/Vol.  65,  No. 91/Wednesday, May 10,  2000/Proposed Rules
                                                                     30273
  (F) Monitoring and reporting and data
verification,
  (G) System management and
operation.
  (H) Operator compliance with State
requirements,
  (Hi) After the initial sanitary survey
for ground water systems in accordance
with § 142.16(kK2)(ii), the State may
reduce the frequency of sanitary surveys
for community water systems to no less
frequently than every five years, if the
ground water system either treats to 4-
log inactivation or removal of viruses or
has an outstanding performance record
documented in previous inspections
and has no history of total coliform MCL
or monitoring violations under § 141.21
of this chapter as determined by the
State, since the last sanitary survey
under the current ownership. In its
primacy application, the State must
describe how it will decide whether a
community water system has
outstanding performance and is thus
eligible for sanitary surveys at a reduced
frequency.
  (iv) States may complete components
of a sanitary survey as part of a staged
or phased State review process within
the established frequency specified in
paragraph (k)(2)(ii) or (iii) of this
section, In its primacy application, a
State which plan to complete the
sanitary survey in a staged or phased
State review process must indicate
which approach it will take and provide
the rationale for the specified time
frames for sanitary surveys conducted
on a staged or phased approach basis.
  (v) Sanitary surveys that meet the
requirements of this subpart, including
the requisite eight components
identified in paragraph (k)(2)(ii) of this
section and conducted at the specified
frequency, are considered to meet the
requirements for sanitary surveys under
the Total Coliform Rule (TCR) as
described in § 141.21 of this chapter.
Note however, compliance only with
the TCR sanitary survey requirements
may not be adequate to meet the revised
scope and frequency sanitary survey
requirement of this subpart.
  fvi) States must provide ground water
systems with written notification
identifying and describing any
significant deficiencies identified at the
ground water system no later than 30
days after identifying the significant
deficiencies. States will provide ground
water systems with written notification
by certified mail or on-site from the
sanitary survey inspector. In its primacy
application, the State must indicate how
it will define what constitutes a
significant deficiency for purposes of
this subpart. For the purposes of this
paragraph, a "significant deficiency"
includes: a defect in design, operation,
or maintenance, or a failure qr
malfunction of the  sources, treatment,
storage, or distribution system that the
State determines to be causing, or has
potential for causing the introduction of
contamination into the water delivered
to consumers.
  (vii) In its primacy application, the
State must describe how it will consult
with the ground water system regarding
the treatment technique requirements
specified in § 141.404 and criteria for
determining when  a ground water
system has met the 4-log inactivation or
removal of viruses  of this chapter.
  (viii) States must confirm that the
deficiency has been addressed, either
through written confirmation from
ground water systems or a site visit by
the State, within 30 days after the
ground water system has met the
treatment technique requirements under
§ 141.404(a) of this chapter.
  (ix) In its primacy application, the
State must specify if and how it will
integrate Source Water Assessment and
Protection Program (SWAPP)
susceptibility determinations into the
sanitary survey and the definition of
significant deficiency.
  (3) Hydrogeologic sensitivity
assessments, (i) For the purposes of this
paragraph (k)(3), "hydrogeologic
sensitivity assessment" means the
methodology used by the State to
identify whether ground water systems
are obtaining water from karst, gravel, or
fractured bedrock aquifers. A State may
add additional hydrogeologic sensitive
settings, e.g., volcanic aquifers. A well
obtaining water from a karst, gravel or
fractured bedrock aquifer is sensitive to
fecal contamination unless the well is
protected by a hydrogeologic barrier. A
"hydrogeologic barrier" consists of
physical, chemical and biological
factors that, singularly or in
combination, prevent the movement of
viable patiiogens from a contaminant
source to a ground  water system well.
  (ii) The State, or an authorized agent,
must conduct a one-time hydrogeologic
sensitivity assessment for all existing
ground water systems not providing 4-
log inactivation or removal of viruses by
[DATE SIX YEARS AFTER DATE OF
PUBLICATION OF THE FINAL RULE
IN THE FEDERAL REGISTER] for
community water systems and by
[DATE EIGHT YEARS AFTER DATE OF
PUBLICATION OF THE FINAL RULE
IN THE FEDERAL REGISTER] for non-
community water systems. The State, or
an authorized agent, must conduct a
hydrogeologic sensitivity assessment for
new systems prior to their serving water
to the public.
  (iii) In its primacy application, a State
must identify its approach to determine
the adequacy of a hydrogeologic barrier,
if present, as part of its effort to
determine the sensitivity of a ground
water system in a hydrogeologic
sensitivity assessment.
  (4) Source water microbial
monitoring, (i) In its primacy
application, the State must identify its
approach and rationale for determining
which of the fecal indicators (E. coli,
coliphage, or enterococci) ground water
systems must use in accordance with
§ 141.403(d) of this chapter.
  (ii) The State may waive triggered
source water monitoring as described  in
§ 141.403(b) of this chapter due to a
total coliform-positive sample, on a
case-by-case basis, if the State
determines that the total coliform
positive sample is associated solely with
a demonstrated distribution system
problem. In such a case,  a State official
must document the decision, including
the rationale for the decision, in writing,
and sign the document.
  (iii) The State may reduce routine
source water monitoring to quarterly if
a hydrogeologically sensitive ground
water system detects no fecal indicator-
positive samples in the most recent
twelve consecutive monthly samples
during the months the ground water
system is in operation. Moreover, the
State may, after those twelve
consecutive monthly samples, waive
source water monitoring altogether for a
ground water system if the State,
determines, in writing, that fecal
contamination of the well(s) has not
been identified and is highly unlikely,
based on the sampling history, land use
pattern, disposal practices in the
recharge area, and proximity of septic
tanks and other fecal contamination
sources. If the State determines tiiat
circumstances have changed, the State
has the discretion to reinstate routine
monthly monitoring. In any case, a State
official must document die
determination in writing, including the
rationale for the determination, and sign
the document.
  (iv) The State may determine a source
water sample to be invalid only if the
laboratory establishes that improper
sample analysis occurred or the State
has substantial grounds to believe that
a sample result is due to  circumstances
that do not reflect source water quality.
In such a case, a State official must
document the decision, including the
rationale for the decision, in writing,
and sign the document. The written
documentation must state the specific
cause of the invalid sample and what
action the ground water system or
laboratory has taken or must take to

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30274
Federal Register/Vol.  65,  No. 91/Wednesday, May 10, 2000/Proposed  Rules
correct this problem. A positive sample
may not be invalidated by the State
solely on the grounds that repeat
samples are negative, though this could
be considered along with other evidence
that the original sample result does not
reflect source water quality.
  (v) A ground water system may apply
to the State, and the State may consider,
on a one-time basis, to waive
compliance with the treatment
technique requirements in § 141.404(a)
of this chapter, after a single fecal
indicator-positive from a routine source
water sample as required in § 141.403(a)
of this chapter, if all the following
conditions are met:
  (A) The ground water system collects
five repeat source water samples within
24 hours after being notified of a source
water fecal positive result;
  (B) The ground water system has the
samples analyzed for the same fecal
indicator as the original sample;
  (C) All the repeat samples are fecal
indicator negative; and
  (D) All previous source water samples
(routine and triggered) during the past 5
years were fecal indicator-negative.
                        (5) Treatment technique requirements.
                      (i) In its primacy application, the State1
                      must describe how it must provide
                      every ground water system treating to 4-
                      log inactivation or removal the
                      disinfectant concentration (or
                      irradiance) and contact time to achieve1
                      4-log virus inactivation or removal. EPA
                      recommends that the State use
                      applicable EPA-developed CT tables (IT
                      (the product of irradiance, in mW/cm2,
                      multiplied by exposure time, in
                      seconds) in the case of UV disinfection)
                      to determine the concentration (or
                      irradiance) and contact time that it will
                      require ground water systems to achieve
                      4-log virus inactivation.
                        (ii) If the State intends to approve
                      membrane filtration for treatment it
                      must, in its primacy application,
                      describe the monitoring and compliance
                      requirements, including membrane
                      integrity testing, that it will require of
                      ground water systems to demonstrate
                      proper operation of membrane filtration
                      technologies.                        '
                        (iii) In its primacy application, a State
                      must describe the approach it must use
to determine which specific treatment
technique option (correcting the
deficiency, eliminating the source of
contamination, providing an alternative
source, or providing 4-log inactivation
or removal of viruses) is appropriate for
addressing significant deficiencies or
fecally contaminated source water and
under what circumstances. In addition,
the State must describe the approach it
intends to use when consulting with
ground water systems on determining
the treatment technique options.
  (iv) States must confirm that the
ground water system has addressed the
source water fecal contamination
identified under routine or triggered
monitoring in accordance with
§ 141.403(a) and (b) of this chapter,
either through written confirmation
from ground water systems or a site visit
by the State, within 30 days after the
ground water system has met the
treatment technique requirements under
§ 141.404(b) of this chapter.
[FR Doc. 00-10763 Filed 5-9-00; 8:45 am]
BILLING CODE 6560-50-P

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