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69478 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9, 141, and 142
[WH–FRL–6199–9]
RIN 2040–AC91
National Primary Drinking Water
Regulations: Interim Enhanced Surface
Water Treatment
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: In this document, EPA is
finalizing the Interim Enhanced Surface
Water Treatment Rule (IESWTR). The
purposes of the IESWTR are to: Improve
control of microbial pathogens,
including specifically the protozoan
Cryptosporidium, in drinking water; and
address risk trade-offs with disinfection
byproducts. Key provisions established
in today's final IESWTR include: A
Maximum Contaminant Level Goal
(MCLG) of zero for Cryptosporidium; 2-
log Cryptosporidium removal
requirements for systems that filter;
strengthened combined filter effluent
turbidity performance standards and
individual filter turbidity provisions;
disinfection benchmark provisions to
assure continued levels of microbial
protection while facilities take the
necessary steps to comply with new
disinfection byproduct standards;
inclusion of Cryptosporidium in the
definition of ground water under the
direct influence of surface water
(GWUDI) and in the watershed control
requirements for unfiltered public water
systems; requirements for covers on new
finished water reservoirs; and sanitary
surveys for all surface water systems
regardless of size. The IESWTR builds
upon the treatment technique
requirements of the Surface Water
Treatment Rule.
EPA believes that implementation of
the IESWTR will significantly reduce
the level of Cryptosporidium in finished
drinking water supplies through
improvements in filtration. The Agency
estimates that the likelihood of endemic
illness from Cryptosporidium will
decrease by 110,000 to 463,000 cases
annually. The Agency believes that the
rule will also reduce the likelihood of
the occurrence of outbreaks of
cryptosporidiosis by providing a larger
margin of safety against such outbreaks
for some systems. In addition, the
filtration provisions of the rule are
expected to increase the level of
protection from exposure to other
pathogens (i.e., Giardia or other
waterborne bacterial or viral pathogens).
The IESWTR applies to public water
systems that use surface water or
GWUDI and serve 10,000 or more
people. The rule also requires primacy
States to conduct sanitary surveys for all
surface water and GWUDI systems
regardless of size.
EFFECTIVE DATE: This regulation is
effective February 16, 1999. Compliance
dates for specific components of the rule
are discussed in the Supplementary
Information section.
ADDRESSES: Public comments, the
comment/response document,
applicable Federal Register notices,
other major supporting documents, and
a copy of the index to the public docket
for this rulemaking are available for
review at EPA's Drinking Water Docket:
401 M Street, SW., Rm. EB57,
Washington, DC 20460 from 9 a.m. to 4
p.m., Monday through Friday, excluding
legal holidays. For access to docket
materials, please call (202) 260±3027 to
schedule an appointment.
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
Elizabeth Corr or Paul S. Berger, Ph.D.
(Microbiology), Office of Ground Water
and Drinking Water (MC 4607), U.S.
Environmental Protection Agency, 401
M Street SW, Washington DC 20460;
telephone (202) 260±8907 (Corr) or (202)
260±3039 (Berger). For Regional
contacts see Supplementary
Information.
SUPPLEMENTARY INFORMATION: This
regulation is effective 60 days after
publication of FR document for
purposes of the Administrative
Procedures Act and the Congressional
Review Act. Compliance dates for
specific components of the rule are
discussed below. Solely for judicial
review purposes, this final rule is
promulgated as of 1 p.m. Eastern Time
December 30, 1998 as provided in 40
CFR 23.7.
Regulated entities. Entities potentially
regulated by the IESWTR are public
water systems that use surface water or
ground water under the direct influence
of surface water and serve at least
10,000 people. (States are required to
carry out sanitary surveys for all surface
water and GWUDI systems including
those that serve less than 10,000
people.) Regulated categories and
entities include:
Category Examples of regulated entities
Industry ...............................................................Public Water Systems (PWSs) that use surface water or ground water under the direct influ-
ence of surface water and serve at least 10,000 people
State, Local, Tribal or Federal Governments .....PWSs that use surface water or ground water under the direct influence of surface water and
serve at least 10,000 people.
This table is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
regulated by the IESWTR. This table
lists the types of entities that EPA is
now aware could potentially be
regulated by the rule. 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 subpart H
(§141.70(a)Ðsystems subject to the
Surface Water Treatment Rule) and
subpart P (§141.170(a)Ðsubpart H
systems that serve 10,000 or more
people) of the final rule. If you have
questions regarding the applicability of
the IESWTR to a particular entity,
consult one of the persons listed in the
preceding FOR FURTHER INFORMATION
CONTACT section.
Regional Contacts
I. Kevin Reilly, Water Supply Section,
JFK Federal Bldg., Room 203, Boston,
MA 02203, (617) 565±3616
II. Michael Lowy, Water Supply Section,
290 Broadway, 24th Floor, New York,
NY 10007±1866, (212) 637±3830
III. Jason Gambatese, Drinking Water
Section (3WM41), 1650 Arch Street,
Philadelphia, PA 19103±2029, (215)
814±5759
IV. David Parker, Water Supply Section,
345 Courtland Street, Atlanta, GA
30365, (404) 562±9460
V. Kimberly Harris, Water Supply
Section, 77 W. Jackson Blvd., Chicago,
IL 60604, (312) 886±4239
69479Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
VI. Blake L. Atkins, Drinking Water
Section, 1445 Ross Avenue, Dallas,
TX 75202, (214) 665±2297
VII. Ralph Flournoy, Drinking Water/
Ground Water Management Branch,
726 Minnesota Ave., Kansas City, KS
66101, (913) 551±7374
VIII. Bob Clement, Public Water Supply
Section (8P2±W±MS), 999 18th Street,
Suite 500, Denver, CO 80202±2466,
(303) 312±6653
IX. Bruce Macler, Water Supply Section,
75 Hawthorne Street, San Francisco,
CA 94105, (415) 744±1884
X. Wendy Marshall, Drinking Water
Unit, 1200 Sixth Avenue (OW±136),
Seattle, WA 98101, (206) 553±1890
List of Abbreviations Used in This
Document
ASCE: American Society of Civil
Engineers
ASDWA: Association of State Drinking
Water Administrators
ASTM: American Society for Testing
and Materials
AWWA: American Water Works
Association
AWWARF: American Water Works
Association Research Foundation
°C: Degrees Centigrade
CCP: Composite Correction Program
CDC: Centers for Disease Control
CFE: Combined Filter Effluent
CFR: Code of Federal Regulations
CPE: Comprehensive Performance
Evaluation
CT: The Residual Concentration of
Disinfectant (mg/L) Multiplied by the
Contact Time (in minutes)
CTA: Comprehensive Technical
Assistance
DBPs: Disinfection Byproducts
DBPR: Disinfectants/Disinfection
Byproducts Rule
ESWTR: Enhanced Surface Water
Treatment Rule
FACA: Federal Advisory Committee Act
GAC: Granular Activated Carbon
GAO: Government Accounting Office
GWUDI: Ground Water Under the Direct
Influence of Surface Water
HAA5: Haloacetic acids
(Monochloroacetic, Dichloroacetic,
Trichloroacetic, Monobromoacetic
and Dibromoacetic Acids)
HPC: Heterotropic Plate Count
hrs: Hours
ICR: Information Collection Rule
IESWTR: Interim Enhanced Surface
Water Treatment Rule
IFA: Individual Filter Assessment
Log Inactivation: Logarithm of (N0/NT)
Log: Logarithm (common, base 10)
LTESWTR: Long Term Enhanced
Surface Water Treatment Rule
LT1: Long Term 1 Enhanced Surface
Water Treatment Rule
MCL: Maximum Contaminant Level
MCLG: Maximum Contaminant Level
Goal
M±DBP: Microbial and Disinfectants/
Disinfection Byproducts
MPA: Microscopic Particulate Analysis
NODA: Notice of Data Availability
NPDWR: National Primary Drinking
Water Regulation
NT: The Concentration of Surviving
Microorganisms at Time T
NTTAA: National Technology Transfer
and Advancement Act
NTU: Nephelometric Turbidity Unit
PE: Performance Evaluation
PWS: Public Water System
Reg. Neg.: Regulatory Negotiation
RIA: Regulatory Impact Analysis
RFA: Regulatory Flexibility Act
RSD: Relative Standard Deviation
SAB: Science Advisory Board
SDWA: Safe Drinking Water Act
SWTR: Surface Water Treatment Rule
TC: Total Coliforms
TCR: Total Coliform Rule
TTHM: Total Trihalomethanes
TWG: Technical Work Group
UMRA: Unfunded Mandates Reform Act
x log removal: Reduction to 1¤10x of
original concentration
Table of Contents
I. Background
A. Statutory Requirements and Legal
Authority
B. Regulatory History
1. Existing Regulations
ÐSurface Water Treatment Rule (SWTR)
ÐTotal Coliform Rule (TCR)
ÐTotal Trihalomethane (TTHM) Rule
ÐInformation Collection Rule (ICR)
2. Public Health Concerns to be Addressed
3. Regulatory Negotiation Process
4. Federal Advisory Committee Process
5. Overview of 1994 Proposal and 1997
Notice of Data Availability
II. Summary of the Final Rule
III. Explanation of Today's Action
A. MCLG for Cryptosporidium
1. Today's Rule
2. Background and Analysis
3. Summary of Major Comments
B. Removal of Cryptosporidium by Filtration
1. Today's Rule
2. Background and Analysis
3. Summary of Major Comments
C. Turbidity Control
1. Today's Rule
2. Background and Analysis
3. Summary of Major Comments
D. Disinfection Benchmark for Stage 1 DBPR
MCLs
1. Today's Rule
2. Background and Analysis
3. Summary of Major Comments
E. Definition of Ground Water Under the
Direct Influence of Surface Water
1. Today's Rule
2. Background and Analysis
3. Summary of Major Comments
F. Inclusion of Cryptosporidium in
Watershed Control Requirements
1. Today's Rule
2. Background and Analysis
3. Summary of Major Comments
G. Covered Finished Water Reservoirs
1. Today's Rule
2. Background and Analysis
3. Summary of Major Comments
H. Sanitary Survey Requirements
1. Today's Rule
2. Background and Analysis
3. Summary of Major Comments
I. Compliance Schedules
1. Today's Rule
2. Background and Analysis
3. Summary of Major Comments
IV. State Implementation
A. Special State Primacy Requirements
B. State Recordkeeping Requirements
C. State Reporting Requirements
D. Interim Primacy
V. Economic Analysis
A. Today's Rule
B. Overview of RIA for Proposed Rule
C. What's Changed Since the Proposed Rule
D. Summary of Cost Analysis
E. Household Costs
F. Summary of Benefits Analysis
G. Comparison of Costs and Benefits
VI. Additional Issues Discussed in 1994
Proposal and 1997 NODA
A. Inactivation of Cryptosporidium
B. Giardia Inactivation CT values for
Profiling/Benchmarking
C. Cross Connection Control
D. Filter Backwash Recycling
E. Certification Criteria for Water Plant
Operators
VII. Other Requirements
A. Regulatory Flexibility Act
B. Paperwork Reduction Act
C. Unfunded Mandates Reform Act
D. National Technology Transfer and
Advancement Act
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
H. Executive Order 12875: Enhancing the
Intergovernmental Partnership
I. Executive Order 13084: Consultation and
Coordination With Indian Tribal
Governments
J. Consultation with the Science Advisory
Board, National Drinking Water Council,
and Secretary of Health and Human
Services
K. Likely Effect of Compliance with the
IESWTR on the Technical, Financial,
and Managerial Capacity of Public Water
Systems
L. Submission to Congress and the General
Accounting Office
VIII. References
I. Background
A. Statutory Requirements and Legal
Authority
The Safe Drinking Water Act (SDWA
or the Act), as amended in 1986,
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requires USEPA to publish a ``maximum
contaminant level goal'' (MCLG) for
each contaminant which, in the
judgement of the USEPA Administrator,
``may have any adverse effect on the
health of persons and which is known
or anticipated to occur in public water
systems'' (Section 1412(b)(3)(A)).
MCLGs are to be set at a level at which
``no known or anticipated adverse effect
on the health of persons occur and
which allows an adequate margin of
safety'' (Section 1412(b)(4)).
The Act was amended in August
1996. As a result of these Amendments,
several of these provisions were
renumbered and augmented with
additional language. Other sections
were added establishing new drinking
water requirements. These
modifications are outlined below.
The Act also requires that at the same
time USEPA publishes an MCLG, which
is a non-enforceable health goal, it also
must publish a National Primary
Drinking Water Regulation (NPDWR)
that specifies either a maximum
contaminant level (MCL) or treatment
technique (Sections 1401(l) and
1412(a)(3)). USEPA is authorized to
promulgate a NPDWR ``that requires the
use of a treatment technique in lieu of
establishing a MCL,'' if the Agency finds
that ``it is not economically or
technologically feasible to ascertain the
level of the contaminant'' EPA's general
authority to set a maximum
contaminant level goal (MCLG) and
National Primary Drinking Water
Regulation (NPDWR) applies to
contaminants that may ``have an adverse
effect on the health of persons,'' that are
``known to occur or there is a substantial
likelihood that the contaminant will
occur in public water systems with a
frequency and at levels of public health
concern,'' and for which ``in the sole
judgement of the Administrator,
regulation of such contaminant presents
a meaningful opportunity for health risk
reduction for persons served by public
water systems'' (SDWA Section
1412(b)(1)(A)).
The amendments, also require EPA,
when proposing a NPDWR that includes
an MCL or treatment technique, to
publish and seek public comment on an
analysis of health risk reduction and
cost impacts. In addition, EPA is
required to take into consideration the
effects of contaminants upon sensitive
subpopulations (i.e. infants, children,
pregnant women, the elderly, and
individuals with a history of serious
illness), and other relevant factors.
(Section 1412 (b)(3)(C)).
The amendments established a
number of regulatory deadlines,
including schedules for a Stage 1
Disinfection Byproduct Rule (DBPR), an
Interim Enhanced Surface Water
Treatment Rule (IESWTR), a Long Term
Final Enhanced Surface Water
Treatment Rule (LTESWTR) affecting
Public Water Systems (PWSs) that serve
under 10,000 people, and a Stage 2
DBPR (Section 1412(b)(2)(C)). The Act
as amended also requires EPA to
promulgate regulations to address filter
backwash (Section 1412(b)(14)) and to
promulgate regulations specifying
criteria for requiring disinfection ``as
necessary'' for ground water systems.
Finally, as part of the 1996 SDWA
Amendments, recordkeeping
requirements were modified to apply to
every person who is subject to a
requirement of this title or who is a
grantee (Section 1445(a)(1)(A)). Such
persons are required to establish and
maintain such records, make such
reports, conduct such monitoring, and
provide such information as the
Administrator may reasonably require
by regulation.
B. Regulatory History
1. Existing Regulations
Surface Water Treatment Rule (SWTR)
Under the Surface Water Treatment
Rule (SWTR) (54 FR 27486, June 29,
1989) (EPA, 1989b), EPA set maximum
contaminant level goals of zero for
Giardia lamblia, viruses, and Legionella;
and promulgated National Primary
Drinking Water Regulations for all PWSs
using surface water sources or ground
water sources under the direct influence
of surface water. The SWTR includes
treatment technique requirements for
filtered and unfiltered systems that are
intended to protect against the adverse
health effects of exposure to Giardia
lamblia, viruses, and Legionella, as well
as many other pathogenic organisms.
Briefly, those requirements include (1)
requirements for maintenance of a
disinfectant residual in the distribution
system; (2) removal and/or inactivation
of 3 log (99.9%) for Giardia and 4 log
(99.99%) for viruses; (3) combined filter
effluent turbidity performance standard
of 5 NTU as a maximum and 0.5 NTU
at the 95th percentile monthly, based on
4-hour monitoring for treatment plants
using conventional treatment or direct
filtration (with separate standards for
other filtration technologies); and (4)
watershed protection and other
requirements for unfiltered systems.
Total Coliform Rule (TCR)
The Total Coliform Rule (TCR) (54 FR
27544, June 29, 1989) applies to all
public water systems (EPA, 1989c). This
regulation sets compliance with the
Maximum Contaminant Level (MCL) for
total coliforms (TC) as follows. For
systems that collect 40 or more samples
per month, no more than 5.0% of the
samples may be TC-positive; for those
that collect fewer than 40 samples, no
more than one sample may be TC-
positive. In addition, if two consecutive
samples in the system are TC-positive,
and one is also fecal coliform or E. coli-
positive, then this is defined as an acute
violation of the MCL. If a system
exceeds the MCL, it must notify the
public using mandatory language
developed by the EPA. The required
monitoring frequency for a system
depends on the number of people
served and ranges from 480 samples per
month for the largest systems to once
annually for certain of the smallest
systems. All systems must have a
written plan identifying where samples
are to be collected.
If a system has a TC-positive sample,
it must test that sample for the presence
of fecal coliforms or E. coli. The system
must also collect a set of repeat samples,
and analyze for TC (and fecal coliform
or E. coli if necessary) within 24 hours
of being notified of a TC-positive
sample.
The TCR also requires an on-site
inspection (referred to as a sanitary
survey) every 5 years for each system
that collects fewer than five samples per
month. (This requirement is extended to
every10 years for non-community
systems using only protected and
disinfected ground water.)
Total Trihalomethane (TTHM) Rule
In November 1979 (44 FR 68624)
(EPA, 1979) EPA set an interim MCL for
total trihalomethanes (TTHM) of 0.10
mg/L as an annual average. Compliance
is defined on the basis of a running
annual average of quarterly averages of
all samples. The value for each sample
is the sum of the measured
concentrations of chloroform,
bromodichloromethane,
dibromochloromethane and bromoform.
The interim TTHM standard only
applies to community water systems
using surface water and/or ground water
serving at least 10,000 people that add
a disinfectant to the drinking water
during any part of the treatment process.
At their discretion, States may extend
coverage to smaller PWSs; however,
most States have not exercised this
option.
Information Collection Rule (ICR)
The Information Collection Rule (ICR)
is a monitoring and data reporting rule
that was promulgated on May 14, 1996
(61 FR 24354) (EPA, 1996b). The
purpose of the ICR is to collect
occurrence and treatment information to
69481Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
help evaluate the need for possible
changes to the current SWTR and
existing microbial treatment practices,
and to help evaluate the need for future
regulation for disinfectants and
disinfection byproducts (DBPs). The ICR
will provide EPA with additional
information on the national occurrence
in drinking water of (1) chemical
byproducts that form when disinfectants
used for microbial control react with
naturally occurring compounds already
present in source water and (2) disease-
causing microorganisms, including
Cryptosporidium, Giardia, and viruses.
The ICR will also provide engineering
data on how PWSs currently control for
such contaminants. This information is
being collected because the 1992
Regulatory Negotiating (Reg. Neg.)
Committee on microbial pathogens and
disinfectants and DBPs concluded that
additional information was needed to
assess the potential health problem
created by the presence of DBPs and
pathogens in drinking water and to
assess the extent and severity of risk in
order to make sound regulatory and
public health decisions. The ICR will
also provide information to support
regulatory impact analyses for various
regulatory options, and to help develop
monitoring strategies for cost-effectively
implementing regulations.
The ICR pertains to large public water
systems serving populations of at least
100,000; a more limited set of ICR
requirements pertain to ground water
systems serving between 50,000 and
100,000 people. About 300 PWSs
operating 500 treatment plants are
involved with the extensive ICR data
collection. Under the ICR, these PWSs
monitor for water quality factors
affecting DBP formation and DBPs
within the treatment plant and in the
distribution system monthly for 18
months. In addition, PWSs must
provide operating data and a description
of their treatment plant design and
surface water systems must monitor for
bacteria, viruses, and protozoa. Finally,
a subset of PWSs must perform
treatment studies, using either granular
activated carbon (GAC) or membrane
processes, to evaluate DBP precursor
removal and control of DBPs.
Monitoring for treatment study
applicability began in September 1996.
The remaining occurrence monitoring
began in July 1997.
One initial intent of the ICR was to
collect pathogen occurrence data and
other information for use in developing
the Interim Enhanced Surface Water
Treatment Rule (IESWTR) and to
estimate national costs for various
treatment options. However, because of
delays in promulgating the ICR and
technical difficulties associated with
laboratory approval and review of
facility sampling plans, ICR monitoring
did not begin until July 1, 1997, which
was later than originally anticipated. As
a result of this delay and the new
statutory deadlines for promulgating the
Stage 1 DBPR and IESWTR in November
of 1998 (resulting from the 1996 SDWA
amendments), ICR data were not
available in time to support these rules.
In place of the ICR data, the Agency
worked with stakeholders to identify
other sources of data developed since
1994 that could be used to support the
development of the Stage 1 DBPR and
IESWTR. EPA will continue to work
with stakeholders in analyzing and
using the comprehensive ICR data and
research for developing future Enhanced
Surface Water Treatment requirements
and the Stage 2 DBPR.
2. Public Health Concerns To Be
Addressed
In 1990, EPA's Science Advisory
Board (SAB), an independent panel of
experts established by Congress, cited
drinking water contamination as one of
the most important environmental risks
and indicated that disease-causing
microbial contaminants (i.e., bacteria,
protozoa and viruses) are probably the
greatest remaining health risk
management challenge for drinking
water suppliers (EPA/SAB, 1990).
Information on the number of
waterborne disease outbreaks from the
U.S. Centers for Disease Control and
Prevention (CDC) underscores this
concern. CDC indicates that, between
1980 and 1996, 401 waterborne disease
outbreaks were reported, with over
750,000 associated cases of disease
(Craun 1998, 1997a; Kramer et al 1996).
During this period, a number of agents
were implicated as the cause, including
protozoa, viruses and bacteria, as well
as several chemicals. Most of the cases
(but not outbreaks) were associated with
surface water, and specifically with a
single outbreak of cryptosporidiosis in
Milwaukee (over 400,000 cases)
(MacKenzie et al, 1994).
It is important to note that for a
number of reasons, the CDC reports may
substantially understate the actual
number of waterborne disease outbreaks
and cases in the U.S. First, few States
have an active outbreak surveillance
program. Second, disease outbreaks are
often not recognized in a community or,
if recognized, are not traced to the
drinking water source. Third, a large
number of people experiencing
gastrointestinal illness (predominantly
diarrhea) do not seek medical attention.
Fourth, physicians may often not have
a broad enough community-wide basis
of information to attribute
gastrointestinal illness to any specific
origin such as a drinking water source.
Finally, an unknown but probably
significant portion of waterborne
disease is endemic (i.e., not associated
with an outbreak), and thus is even
more difficult to recognize.
Waterborne disease is usually acute
(i.e., sudden onset and typically lasting
a short time in healthy people). Some
pathogens (e.g., Giardia,
Cryptosporidium) may cause extended
illness, sometimes lasting months or
longer, in otherwise healthy
individuals. Most waterborne pathogens
cause gastrointestinal illness, with
diarrhea, abdominal discomfort, nausea,
vomiting, and/or other symptoms. Other
waterborne pathogens cause, or at least
are associated with, more serious
disorders such as hepatitis, gastric
cancer, peptic ulcers, myocarditis,
swollen lymph glands, meningitis,
encephalitis, and a myriad of other
diseases.
Gastrointestinal illness may be
chronic in vulnerable populations (e.g.,
immunocompromised individuals). The
severity and duration of illness is often
greater in immunocompromised persons
than in healthy individuals and may be
fatal among this population. For
instance, a follow-up study of the 1993
Milwaukee waterborne disease outbreak
reported that at least 50
Cryptosporidium-associated deaths
occurred among the severely
immunocompromised (Hoxie et al.,
1997). Immunocompromised persons
include infants, pregnant women, the
elderly, and especially those with
severely weakened immune systems
(e.g., AIDS patients, those receiving
treatment for certain types of cancer,
organ-transplant recipients and people
on immunosuppressant drugs) (Gerba et
al., 1996).
With specific reference to
cryptosporidiosis, the disease is caused
by ingestion of environmentally-
resistant Cryptosporidium oocysts,
which are readily carried by the
waterborne route. Humans and other
animals may excrete these oocysts.
Transmission of this disease often
occurs through ingestion of the infective
oocysts from contaminated water or
food, but may also result from direct or
indirect contact with infected persons or
animals (Casemore, 1990; Cordell and
Addiss, 1994). Symptoms of
cryptosporidiosis include typical
gastrointestinal symptoms (Current et
al., 1983). As noted above, these may
persist for several days to several
months.
While cryptosporidiosis is generally a
self-limiting disease with a complete
69482 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
recovery in otherwise healthy persons,
it can be very serious in
immunosuppressed persons. EPA has a
particular concern regarding drinking
water exposure to Cryptosporidium,
especially in severely
immunocompromised persons, because
there is no effective therapeutic drug to
cure the disease. There have been a
number of waterborne disease outbreaks
caused by Cryptosporidium in the
United States, United Kingdom and
many other countries (Rose, 1997).
There appears to be an immune
response to Cryptosporidium, but it is
not known if this results in protection
(Fayer and Ungar, 1986).
One of the key regulations EPA has
developed and implemented to counter
pathogens in drinking water is the
SWTR. Among its provisions, the rule
requires that a surface water system
have sufficient treatment to reduce the
source water concentration of Giardia
and viruses by at least 99.9% (3 log) and
99.99% (4 log), respectively. A
shortcoming of the SWTR is that the
rule does not specifically control for the
protozoan Cryptosporidium. The first
report of a recognized outbreak caused
by Cryptosporidium was published
during the development of the SWTR
(D'Antonio et al., 1985).
In terms of occurrence,
Cryptosporidium is common in the
environment. Runoff from unprotected
watersheds allows transport of these
microorganisms to water bodies used as
intake sites for drinking water treatment
plants. A particular public health
challenge is that simply increasing
existing disinfection levels above those
most commonly practiced in the United
States today does not appear to be an
effective strategy for controlling
Cryptosporidium, because the
Cryptosporidium oocyst is especially
resistant to disinfection practices
commonly used at water treatment
plants. Today's rule addresses the
concern of passage of Cryptosporidium
through physical removal processes
during water treatment. It also
strengthens the effectiveness and
reliability of physical removal for
particulate matter and microorganisms
in general, thereby reducing the
likelihood of the disinfection barrier
being over challenged. Waterborne
disease outbreaks have been associated
with a high level of particles passing
through a water treatment plant (Fox
and Lytle, 1996). This presents a
significant public health concern.
Hence, there is a need to optimize
treatment reliability and to enhance
physical removal efficiencies to
minimize the Cryptosporidium levels in
finished water. This rule, with tightened
turbidity performance criteria and
required individual filter monitoring, is
formulated to address these public
health concerns.
3. Regulatory Negotiation Process
In 1992 EPA initiated a negotiated
rulemaking to address public health
concerns associated with disinfectants,
DBPs and microbial pathogens. The
negotiators included representatives of
State and local health and regulatory
agencies, public water systems, elected
officials, consumer groups and
environmental groups. The Reg. Neg.
Committee met from November 1992
through June 1993.
Early in the process, the negotiators
agreed that large amounts of information
necessary to understand how to
optimize the use of disinfectants to
concurrently minimize microbial and
DBP risk on a plant-specific basis were
unavailable. Nevertheless, the Reg. Neg.
Committee agreed that EPA propose a
Stage 1 DBPR to extend coverage to all
community and nontransient
noncommunity water systems that use
disinfectants, reduce the current TTHM
MCL, regulate additional DBPs, set
limits for the use of disinfectants, and
reduce the level of organic precursor
compounds in the source water that
may react with disinfectants to form
DBPs.
EPA's most significant concern in
developing regulations for disinfectants
and DBPs was the need to ensure that
adequate treatment be maintained for
controlling risks from microbial
pathogens. One of the major goals
addressed by the Reg. Neg. Committee
was to develop an approach that would
reduce the level of exposure from
disinfectants and DBPs without
undermining the control of microbial
pathogens. The intention was to ensure
that drinking water is microbiologically
safe at the limits set for disinfectants
and DBPs and that these chemicals do
not pose an unacceptable health risk at
these limits. Thus, the Reg. Neg.
Committee also considered a range of
microbial issues and agreed that EPA
should also propose a companion
microbial rule (IESWTR).
Following months of intensive
discussions and technical analysis, the
Reg. Neg. Committee recommended the
development of three sets of rules: a
two-staged approach for the DBPs
(proposal: 59 FR 38668, July 29, 1994)
(EPA, 1994a), an ``interim'' ESWTR
(proposal: 59 FR 38832, July 29, 1994)
(EPA, 1994b) and ``long-term'' ESWTR,
and an Information Collection Rule
(proposal: 59 FR 6332, February 10,
1994) (EPA, 1994c) (promulgation:
61FR24354, May 14, 1996) (EPA,
1996b). The approach used in
developing these proposals considered
the constraints of simultaneously
treating water to control for both
microbial contaminants and
disinfectants/DBPs.
The Reg. Neg. Committee agreed that
the schedules for IESWTR and
LTESWTR should be ``linked'' to the
schedule for the Stage 1 DBPR to assure
simultaneous compliance and a
balanced risk-risk based
implementation. The Reg. Neg.
Committee agreed that additional
information on health risk, occurrence,
treatment technologies, and analytical
methods needed to be developed in
order to better understand the risk-risk
tradeoff, and how to accomplish an
overall reduction in health risks from
both pathogens and disinfectants/DBPs.
Finally, the Reg. Neg. Committee
agreed that to develop a reasonable set
of rules and to understand more fully
the limitations of the current SWTR
additional field data were critical. Thus,
a key component of the regulation
negotiation agreement was the
promulgation of the ICR previously
described.
4. Federal Advisory Committee Process
In May 1996, the Agency initiated a
series of public informational meetings
to provide an update on the status of the
1994 proposal and to review new data
related to microbial and DBP regulations
that had been developed since July
1994. In August 1996, Congress enacted
the 1996 SDWA Amendments which
contained a number of new
requirements, as discussed above, as
well as specifying deadlines for final
promulgation of the IESWTR and Stage
1 DBPR. To meet these deadlines and to
maximize stakeholder participation, the
Agency established the Microbial-
Disinfectants/Disinfection Byproducts
(M±DBP) Advisory Committee under the
Federal Advisory Committee Act
(FACA) in March 1997, to collect, share,
and analyze new information and data,
as well as to build consensus on the
regulatory implications of this new
information. The Committee consisted
of 17 members representing EPA, State
and local public health and regulatory
agencies, local elected officials, drinking
water suppliers, chemical and
equipment manufacturers, and public
interest groups.
The M±DBP Advisory Committee met
five times in March through July 1997
to discuss issues related to the IESWTR
and Stage 1 DBPR. Technical support
for these discussions was provided by a
Technical Work Group (TWG)
established by the Committee at its first
meeting in March 1997. The
69483Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
Committee's activities resulted in the
collection, development, evaluation,
and presentation of substantial new data
and information related to key elements
of both proposed rules. The Committee
reached agreement on a number of
major issues that were discussed in
Notices of Data Availability (NODA) for
the IESWTR (62 FR 59486, November 3,
1997) (EPA, 1997a) and the Stage 1
DBPR (62 FR 59388, November 3, 1997)
(EPA, 1997b). The major issues
addressed by the Committee and in the
NODAs include: (1) Maintain the
proposed MCLs for TTHMs, HAA5 and
bromate; (2) modify the enhanced
coagulation requirements as part of DBP
control; (3) include a microbial
benchmarking/profiling to provide a
methodology and process by which a
PWS and the State, working together,
assure that there will be no significant
reduction in microbial protection as the
result of modifying disinfection
practices in order to meet MCLs for
TTHM and HAA5; (4) continue credit
for compliance with applicable
disinfection requirements for
disinfection applied at any point prior
to the first customer, consistent with the
existing SWTR; (5) modify the turbidity
performance requirements and add
requirements for individual filters; (6)
establish an MCLG for Cryptosporidium;
(7) add requirements for removal of
Cryptosporidium; (8) provide for
mandatory sanitary surveys; and (9) a
commitment to additional analysis of
the role of Cryptosporidium inactivation
as part of a multiple barrier concept in
the context of a subsequent Federal
Register microbial proposal. The new
data and analysis supporting the
technical areas of agreement were
summarized and explained at length in
EPA's 1997 NODAs. The Committee's
recommendations are embodied in an
Agreement In Principle document dated
July 15, 1997.
5. Overview of 1994 Proposal and 1997
Notice of Data Availability
EPA proposed to amend the Surface
Water Treatment Rule in 1994 to
provide additional protection against
disease-causing organisms (pathogens)
in drinking water (59 FR 38832: July 29,
1994). In November 1997 EPA
published a Notice of Data Availability
(62 FR 59486) (EPA, 1997a, b) that
summarized the 1994 proposal;
described new data and information that
the Agency had obtained and analyses
that had been developed since the
proposal; provided information
concerning the July 1997
recommendations of the M±DBP
Advisory Committee described above on
key issues related to the proposal; and
requested comment on these
recommendations as well as on other
regulatory implications that flowed from
the new data and information. The
Agency also solicited additional data
and information that were relevant to
the issues discussed in the Notice. In
addition, EPA provided notice that the
Agency was re-opening the comment
period for the 1994 proposal for 90 days.
EPA also requested that any information
that members of the public would like
the Agency to consider as part of the
final rule development process
regarding data or views submitted to the
Agency since the close of the comment
period on the 1994 proposal be formally
resubmitted during the reopened 90-day
comment period unless already in the
underlying record in the Docket for the
Notice of Data Availability.
II. Summary of the Final Rule
The primary purposes of the IESWTR
are (1) to improve control of microbial
pathogens in drinking water,
particularly for the protozoan
Cryptosporidium, and (2) to guard
against significant increases in
microbial risk that might otherwise
occur when systems implement the
Stage 1 Disinfectants/Disinfection
Byproducts Rule. Major components of
the IESWTR include the following
provisions:
(a) A Maximum Contaminant Level
Goal (MCLG) of zero is established for
the protozoan genus Cryptosporidium.
(b) Surface water systems serving
10,000 or more people, that are required
to filter under the SWTR, must achieve
at least 2 log removal of
Cryptosporidium. Systems that use
conventional or direct filtration meet
this requirement if they comply with
strengthened turbidity performance
standards for combined filter effluent
(described below) and the current
requirements under the SWTR (e.g.,
meet design and operating conditions as
specified by the State). Systems that use
slow sand filtration or diatomaceous
earth meet the 2 log removal
requirement if they are in compliance
with existing turbidity performance
standards under the SWTR (less than or
equal to 1 NTU in at least 95% of
measurements taken each month or, for
slow sand, alternative criteria as
approved by the State; and a maximum
of 5 NTU).
(c) The rule includes a series of
requirements related to turbidity. These
address the following:
Strengthened turbidity performance
requirements for the combined filter
effluent. For all surface water or GWUDI
systems that use conventional treatment
or direct filtration, serve 10,000 or more
people, and are required to filter: (a) The
turbidity level of a system's combined
filtered water at each plant must be less
than or equal to 0.3 NTU in at least 95
percent of the measurements taken each
month, and (b) the turbidity level of a
system's combined filtered water at each
plant must at no time exceed 1 NTU.
For both the maximum and the 95th
percentile requirements, compliance is
determined based on measurements of
the combined filter effluent at four-hour
intervals.
Individual Filter Requirements. All
surface water or GWUDI systems that
use conventional or direct filtration,
serve 10,000 or more people, and are
required to filter must conduct
continuous monitoring of turbidity for
each individual filter and must provide
an exceptions report to the State on a
monthly basis. Exceptions reporting
must include the following: (1) Any
individual filter with a turbidity level
greater than 1.0 NTU based on two
consecutive measurements fifteen
minutes apart; and (2) any individual
filter with a turbidity level greater than
0.5 NTU at the end of the first 4 hours
of filter operation based on two
consecutive measurements fifteen
minutes apart. A filter profile (which is
a graphical representation of an
individual filter performance) must be
produced within seven days of the
exceedance if no obvious reason for the
abnormal filter performance can be
identified.
If an individual filter has turbidity
levels greater than 1.0 NTU based on
two consecutive measurements fifteen
minutes apart at any time in each of
three consecutive months, the system
must make an exceptions report and
conduct a self-assessment of the filter. If
an individual filter has turbidity levels
greater than 2.0 NTU based on two
consecutive measurements fifteen
minutes apart at any time in each of two
consecutive months, the system must
make an exception report and arrange
for the conduct of a Comprehensive
Performance Evaluation (CPE) by the
State or a third party approved by the
State.
State Authority. States must have
rules or other authority to require
systems to conduct a Composite
Correction Program (CCP) and to assure
that systems implement any follow-up
recommendations that result as part of
the CCP. The CCP consists of two
elementsÐa CPE and Comprehensive
Technical Assistance (CTA). The CPE is
a thorough review and analysis of a
plant's performance-based capabilities
and associated administrative, operation
and maintenance practices. It is
conducted to identify factors that may
69484 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
be adversely impacting a plant's
capability to achieve compliance and
emphasizes approaches that can be
implemented without significant capital
improvements. The CPE must include
the following components: (1)
Assessment of plant performance; (2)
evaluation of major unit processes; (3)
identification and prioritization of
performance limiting factors; (4)
assessment of the applicability of
comprehensive technical assistance; and
(5) preparation of a CPE report. A CTA
is the performance improvement phase
that is implemented if the CPE results
indicate improved performance
potential. During the CTA phase, the
system must identify and systematically
address plant-specific factors. The CTA
is a combination of utilizing CPE results
as a basis for follow up, implementing
process control priority-setting
techniques, and maintaining long-term
involvement to systematically train staff
and administrators.
(d) Microbial benchmarking/profiling
requirements are included to provide a
methodology and process by which a
public water system and the State,
working together, assure that there will
be no significant reduction in microbial
protection as the result of significant
disinfection practice modifications in
order to meet MCLs for TTHM and
HAA5. The disinfection profiling
requirement included in today's rule
applies to surface water systems serving
10,000 or more people and which have,
based on a one year running annual
average of representative samples taken
in the distribution system, (1) measured
TTHM levels of at least 80% of the MCL
(0.064 mg/L) or (2) measured HAA5
levels of at least 80% of the MCL (0.048
mg/L). Those PWSs required to develop
a disinfection profile that subsequently
decide to make a significant change in
disinfection practice must consult with
the State prior to implementing such a
change.
(e) States are required to conduct
sanitary surveys for all public water
systems using surface water or ground
water under the direct influence of
surface water, regardless of system size.
Sanitary surveys are required no less
frequently than every three years for
community systems and no less
frequently than every five years for
noncommunity systems. For community
systems determined by the State to have
outstanding performance based on prior
sanitary surveys, subsequent sanitary
surveys may be conducted no less
frequently than every five years. States
must 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, indicating how
and on what schedule the system will
address significant deficiencies noted in
the survey. States must also have the
appropriate rules or other authority to
assure that facilities take the steps
necessary to address significant
deficiencies identified in the survey
report that are within the control of the
PWS and its governing body.
(f) Cryptosporidium is added to the
definition of ground water under the
direct influence of surface water (for
systems serving 10,000 or more people).
(g) Cryptosporidium is added to the
watershed protection requirements for
systems that are avoiding filtration (for
systems serving 10,000 or more people).
(h) Surface Water and GWUDI
systems serving 10,000 or more people
are required to cover all new treated
water reservoirs, holding tanks or other
storage facilities for which construction
begins after the effective date of the rule.
The Surface Water Treatment Rule
remains the base rule regulating public
water systems that use surface water
and ground water under the influence of
surface water. All systems, filtered and
unfiltered, must continue to comply
with all the requirements of the SWTR
and, where applicable, meet the new
requirements of the IESWTR. The
IESWTR's requirements for filtered
systems are intended to ensure that
where a filtration plant is required to
protect public health, as specified in the
SWTR, that plant will be operating well
for the removal of Cryptosporidium and
other microorganisms. EPA wishes to
emphasize that compliance with today's
requirements in no way relieves a
public water system of its obligation to
comply fully with pre-existing SWTR
requirements. With regard to unfiltered
systems in particular, development of
today's rule was based on the
assumption of full compliance with all
filtration avoidance criteria in the
SWTR.
Finally, EPA notes that today's
Federal Register also contains the final
Stage 1 Disinfectants/Disinfection
Byproducts Rule (DBPR). EPA proposed
this rule at the same time as the
IESWTR and has finalized it along with
the IESWTR.
III. Explanation of Today's Action
A. MCLG for Cryptosporidium
1. Today's Rule
The Agency is establishing an MCLG
of zero for Cryptosporidium, as
proposed. During the 1997 M±DBP
Advisory Committee discussions, the
Committee supported the proposed
establishment of an MCLG of zero for
Cryptosporidium. A key issue identified
by the Advisory Committee and public
commenters was whether the MCLG
should be set at the genus level (i.e.,
Cryptosporidium) or at the more specific
species level (i.e., C. parvum). Because
of the uncertainties regarding taxonomy,
cross reactions and cross transmission
among mammals, EPA believes it is
premature to establish the
Cryptosporidium MCLG at the species
level. In addition, the Agency believes
that establishing an MCLG for
Cryptosporidium at the genus level is
consistent with the Safe Drinking Water
Act, which requires EPA to set the
MCLG with an adequate margin of
safety (Section 1412(b)(4)(A)).
2. Background and Analysis
In the 1994 proposal of the IESWTR
(59 FR 145, p. 38855; July 29, 1994),
EPA proposed to establish an MCLG of
zero for Cryptosporidium. The Agency
based its proposal upon concerns about
significant health effects on persons
consuming inadequately treated surface
waters and ground water under the
influence of surface waters. Technical
justifications for the proposed MCLG
relied upon animal studies and human
epidemiology studies of waterborne
outbreaks of cryptosporidiosis.
Since the proposed rule, results of a
human feeding study have become
available which further warrant the
establishment of an MCLG of zero (1997
NODA 59492). DuPont et al. (1995) fed
29 healthy volunteers single doses
ranging from 30 to 1 million C. parvum
oocysts obtained from a calf. Of the 16
volunteers who received 300 or more
oocysts, 88% became infected. Of the
five volunteers who received the lowest
dose (30 oocysts), one became infected.
According to a mathematical model
based upon the DuPont et al. data, if an
individual ingests a single viable oocyst
there is about a 0.5% chance of
infection (Haas et al., 1996). The
probability of infection from C. parvum
may be different for different strains.
In the process of further reviewing
new information since 1994, EPA has
re-examined the issues related to setting
an MCLG at the genus level versus the
species level. This issue was discussed
in some detail during the M±DBP
Advisory Committee meetings.
Currently, the classification of a number
of Cryptosporidium species is based, in
part, on the animal host from which
they were isolated. The Agency is aware
that investigators have not found a
Cryptosporidium species other than C.
parvum that infects humans (with one
highly questionable exception). To the
Agency's knowledge, however, no
human infectivity studies have been
conducted to date with any species
69485Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
other than C. parvum. Moreover, the
taxonomy of the genus Cryptosporidium
is uncertain and changing (Tzipori and
Griffiths, 1998; Fayer et al., 1997). As a
result, EPA cannot preclude the
possibility that a new classification of
the species comprising the genus
Cryptosporidium may include more
than one species capable of infecting
humans. Recently, for example, Peng et
al. (1997) analyzed 39 isolates of C.
parvum from humans and cattle and
found they could be separated into
either of two genotypes, one of which
could infect humans but not cattle or
mice. In the future, these two genotypes
may be separated into two different
species.
In addition to the taxonomic issue,
the current tests for C. parvum in stool
specimens and water, which involve the
microscopic examination of a stained
specimen, may give positive results for
Cryptosporidium species other than C.
parvum. Often this results because other
Cryptosporidium species (as well as
other microorganisms) may react with
the stains used to detect C. parvum.
This is especially true for the commonly
used acid-fast stain. In addition, C.
parvum oocysts do not differ in size and
shape from those of C. baileyi and C.
meleagridis (Arrowood, 1997). As a
result, it is not necessarily certain that
oocysts in a human fecal specimen
identified by a clinical laboratory as C.
parvum are always C. parvum. (In
general, clinical labs do not use a stain
or other procedure that can distinguish
between C. parvum and other
Cryptosporidium species).
The Agency is aware that a few
attempts have been made to infect one
type of animal (e.g., mammals) with
Cryptosporidium species isolated from
other types of animals (e.g., birds),
generally without success (Fayer, 1997).
In addition, Graczyk et al. (1996b) found
that C. parvum was not transmissible to
fish, amphibia, or reptiles. Nevertheless,
until more cross-species transmission
data are available, the Agency cannot
foreclose on the possibility that species
other than C. parvum may be infective
to humans. In their review of the
literature, Fayer et al. (1990) concluded
that the success of transmission studies
is contingent upon not only species
specificity, but also the condition and
age of the oocysts, the route of
inoculation of oocysts, and the age and
immune status of the recipient.
Therefore, negative results to date on
transmission are not necessarily
conclusive regarding host specificity.
EPA believes that it is prudent to set
an MCLG at zero not only for taxonomic
reasons but also because of concern that
certain populations are at greater risk of
waterborne cryptosporidiosis than
others. This concern is heightened by
the fact that currently there is no cure
for cryptosporidiosis (for healthy
individuals the disease tends to be self
limiting). Thus, the importance of
prevention and avoidance of infection
becomes even more central to EPA's
consideration of this issue. Until the
taxonomy of Cryptosporidium has been
clarified, EPA believes that an MCLG of
zero for Cryptosporidium at the genus
level is appropriate especially in light of
the statutory requirement to establish
MCLGs with ``an adequate margin of
safety''.
3. Summary of Major Comments
Regarding the value of the MCLG
most commenters supported the
establishment of a MCLG of zero for
Cryptosporidium. Reasons that were
given for their support included: (1)
Uncertainty exists in the infective dose
for both healthy and vulnerable
(immunocompromised) individuals; (2)
an MCLG of zero is consistent with the
regulatory approach for pathogens
under the existing Surface Water
Treatment Rule (SWTR); (3) one viable
oocyst can cause an infection at least in
some people; and (4) Cryptosporidium
has particularly adverse effects on
persons with immune disorders. No
commenter proposed an MCLG value
other than zero. Some commenters
opposed any MCLG for
Cryptosporidium, arguing that: (1)
Current levels of treatment have some
level of effectiveness against
Cryptosporidium transmission to
drinking water; (2) uncertainty exists
associated with the analytical
procedures used to detect
Cryptosporidium; (3) current technology
limits the ability to determine viability,
infectivity, and species; and (4) the
infectivity threshold has not been
determined.
EPA agrees with the commenters who
supported an MCLG of zero for
Cryptosporidium for reasons stated in
the previous section. EPA does not agree
with comments opposing any MCLG for
Cryptosporidium. While it is true that
current levels of treatment control
Cryptosporidium to some extent, studies
have found Cryptosporidium oocysts in
filtered water supplies of some
treatment plants (LeChevallier, 1991b;
LeChevallier, 1995). Therefore, the
Agency believes that regulation of
Cryptosporidium and enhanced
treatment practices are warranted.
Furthermore, the effectiveness of
treatment is irrelevant to the question of
setting an MCLG, which asks what is the
level of (uncontrolled) Cryptosporidium
in drinking water that will pose no risk
to the health of persons. For the reasons
discussed, that level is at zero. The
availability of effective treatment merely
ensures that EPA can regulate to control
the health risk from Cryptosporidium
reflected by the MCLG.
Comments which address the
uncertainty related to the analytical
method for Cryptosporidium and the
fact that current technology does not
allow viability, infectivity, and species
to be determined may relate to the issue
of whether EPA establishes an MCL
versus treatment technique
requirements for Cryptosporidium.
However, they are not compelling with
regard to the public health goal that
should be set for this contaminant.
With regard to the infectivity
threshold for Cryptosporidium,
according to a mathematical model
based upon the DuPont et al., 1995 data,
if an individual ingests a single viable
oocyst there is a 0.5% chance of
infection (Haas et al., 1996). It is known
that Cryptosporidium oocysts are
capable of causing an infection in both
healthy and seriously ill individuals.
Death has been associated with some
cryptosporidiosis cases, particularly
among sensitive subpopulations (i.e.,
immunocompromised individuals)
(Hoxie et al., 1997). For such reasons,
EPA considers an MCLG of zero for
Cryptosporidium to be appropriate.
EPA also received comments on
whether the MCLG for Cryptosporidium
should be set at the genus or the species
level. Commenters offered several
reasons for supporting an MCLG for C.
parvum, as opposed to
Cryptosporidium. Several professed that
only C. parvum could infect humans,
and therefore EPA should establish an
MCLG based on that particular species.
Commenters also contended that if, in
future regulations, EPA were to
establish a treatment technique
requirement based on the
Cryptosporidium density in the source
water, publishing an MCLG for
Cryptosporidium at the genus level
might require systems to provide an
additional level of treatment for
Cryptosporidium species that are not
known to be infectious to humans. In
contrast, other commenters who
supported the establishment of an
MCLG for Cryptosporidium at the genus
level stated that, unless further research
justifies an MCLG at the species level,
the MCLG should be set at the genus
level. They reasoned that
Cryptosporidium method limitations
argued for setting the MCLG at the
genus level.
In response to comments that did not
support establishing an MCLG of zero
for Cryptosporidium at the genus level,
69486 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
EPA has carefully considered the issue
of genus versus species level for
Cryptosporidium. As mentioned earlier,
EPA concludes that there exists much
uncertainty regarding Cryptosporidium
taxonomy, cross reactions and cross
transmissions. Thus, EPA cannot
conclude that these other species pose
no health risk. For reasons mentioned
above, the Agency believes that it is
more appropriate to establish an MCLG
for Cryptosporidium at the genus level
at this time. This decision does not
affect the level of treatment required
under the IESWTR. EPA will revisit the
impact of the MCLG in the context of
future rules that include consideration
of risk-based options.
B. Removal of Cryptosporidium by
Filtration
1. Today's Rule
Today's final rule establishes a
requirement for 2-log removal of
Cryptosporidium for surface water and
GWUDI systems serving 10,000 or more
people that must filter under the SWTR.
The requirement for at least 99 percent
(2-log) removal of Cryptosporidium
applies between a point where the raw
water is not subject to recontamination
by surface water runoff and a point
downstream before or at the first
customer. As discussed below, the data
available to EPA indicate that rapid
granular filtration systems (i.e., systems
using conventional or direct filtration)
when operated under appropriate
coagulation conditions and optimized to
meet the turbidity performance
standards of the IESWTR (less than or
equal to 0.3 NTU in 95% of the
measurements each month and a
maximum of 1 NTU) are achieving at
least 2-log removal.
2. Background and Analysis
The 1994 proposal to amend the
Surface Water Treatment Rule included
several proposed treatment alternatives.
Two of these alternativesÐAlternatives
B and CÐspecifically addressed
Cryptosporidium. Alternative B
envisioned treatment options for
Cryptosporidium based on levels of
source water occurrence. Alternative C
called for 99% (2-log) removal of
Cryptosporidium. EPA was unable to
consider Alternative B for the IESWTR
because occurrence data and related
analysis from the ICR sampling and
analysis survey discussed above were
not available in time to meet the
statutory promulgation deadline of
November 1998. For the reasons
outlined below and as recommended by
the M±DBP Advisory Committee, EPA is
proceeding with a 2-log removal
requirement for Cryptosporidium for
surface water and GWUDI systems
serving 10,000 or more people that are
required to filter under the SWTR.
As part of the 1997 M±DBP Advisory
Committee process, substantial new
data and information related to removal
of Cryptosporidium by filtration were
collected, evaluated and analyzed. The
Committee recommended adoption of a
2-log Cryptosporidium removal
requirement for all surface water
systems that serve more than 10,000
people and are required to filter. The
Committee also recommended that
systems which use rapid granular
filtration (direct filtration or
conventional filtration treatment) and
meet today's strengthened combined
filter effluent turbidity requirements
would be in compliance with the
requirement for at least a 2-log removal
of Cryptosporidium. Systems which use
slow sand filtration and diatomaceous
earth filtration and meet existing SWTR
turbidity performance requirements
(less than or equal to 1 NTU for the 95th
percentile or alternative criteria as
approved by the State) also would be in
compliance with the requirement for at
least a 2-log removal of
Cryptosporidium.
In November of 1997, EPA issued a
Notice of Data Availability (NODA)
which discussed new data and
information that the Agency had
obtained and analyses that had been
developed since the 1994 proposal. It
also summarized recommendations of
the M±DBP Advisory Committee on
Cryptosporidium removal. The 1997
NODA requested comment on the new
information, the Advisory Committee's
recommendations, and on other
regulatory implications and impacts.
The November 3, 1997 NODA
provided new information regarding
eight studies (Patania et al., 1995;
Nieminski and Ongerth, 1995; Ongerth
and Pecoraro, 1995; LeChevallier and
Norton, 1992; LeChevallier et al., 1991b;
Foundation for Water Research, 1994;
Kelley et al., 1995; and West et al., 1994)
that indicated that rapid granular
filtration when operated under
appropriate coagulation conditions and
optimized to achieve a filtered water
turbidity of less than 0.3 NTU should
achieve at least 2-log of
Cryptosporidium removal. These studies
were analyzed as part of the 1997
IESWTR NODA.
3. Summary of Major Comments
In response to the 1994 Proposal,
most commenters addressing the issue
of treatment alternatives supported
Alternative C which would require 2-log
physical removal of Cryptosporidium.
Some opposed any treatment
requirement greater than a 2-log removal
due to a lack of better understanding of
dose-response, effectiveness of
treatment and analyses to justify the
higher treatment costs involved. Today's
rule requires at least 2-log removal for
Cryptosporidium. EPA will revisit
issues related to further control of
Cryptosporidium in future rulemakings.
The majority of commenters to the
November 1997 NODA agreed with the
appropriateness of establishing a 2-log
removal requirement for
Cryptosporidium in the IESWTR,
although some commenters had
additional concerns. One major concern
was that a quantitative relationship
between removal of Cryptosporidium
and lowered turbidity was premature
and had not been established. EPA
believes that the studies identified in
the NODA illustrate the removal
efficiencies for Cryptosporidium by
several filtration technologies. While
these studies demonstrated a range of
Cryptosporidium log-removals, it is
important to realize that 2-log removal
was consistently obtainable at turbidity
levels of less than 0.3 NTU when
systems were operated under
appropriate coagulation conditions and
optimized to achieve a filtered water
turbidity level of less than 0.3 NTU.
EPA will continue to assess data for
control of Cryptosporidium by physical
removal and disinfection as it becomes
available, and will consider such data in
subsequent regulations.
Another significant issue noted by
several commenters was that systems
should be provided the opportunity to
demonstrate greater log removal of
Cryptosporidium. Consistent with a key
point made during M±DBP Advisory
Committee discussions on this issue,
EPA takes this opportunity to note the
Agency's position that the requirement
for at least 2-log removal is not intended
to prevent a facility from demonstrating
that it can achieve higher than 2-log
removal of Cryptosporidium on a site-
specific basis or States from
demonstrating based on site-specific
information that a specific facility may
actually be achieving less than 2-log
removal of Cryptosporidium even
though it is meeting strengthened
turbidity standards of 0.3 NTU for the
95th percentile and a maximum of 1
NTU.
C. Turbidity Control
1. Today's Rule
Today's rule establishes a number of
requirements for filtration performance
and filter monitoring and reporting,
outlined below, which apply to surface
69487Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
water systems or ground water under
the direct influence of surface water
(GWUDI) that serve 10,000 or more
people and are required to filter under
the SWTR. The basis for these
provisions is explained at greater length
in background sections of the 1997
IESWTR NODA.
Combined Filter Effluent Requirements
For conventional and direct filtration
systems, the turbidity level of
representative samples of a system's
combined filter effluent water must be
less than or equal to 0.3 NTU in at least
95 percent of the measurements taken
each month. The turbidity level of
representative samples of a system's
filtered water must at no time exceed 1
NTU. For slow sand and diatomaceous
earth filtration, the turbidity level of
representative samples of a system's
filtered water must be less than or equal
to 1 NTU in at least 95 percent of the
measurements taken each month and
the turbidity level of representative
samples of a system's filtered water
must at no time exceed 5 NTU (no
change from the combined filter effluent
turbidity requirements in the 1989
SWTR). For both the maximum and
95th percentile requirements,
compliance is determined based on
measurements of the combined filter
effluent at four-hour intervals.
In carrying out these combined
effluent requirements, and the
individual filter requirements described
below, systems must use methods for
turbidity measurement previously
approved by EPA. These are Method
2130B, published in Standard Methods
for the Examination of Water and
Wastewater (19th ed.); Great Lakes
Instrument Method 2; and the revised
EPA Method 180.1, approved in August
1993 in Methods for the Determination
of Inorganic Substances in
Environmental Samples (EPA±600/R±
93±100). EPA notes that today's rule
requires the measurement of turbidity.
Turbidity is a method-defined
parameter. Turbidity therefore is not a
candidate for, and will not be subject to,
the performance-based measurements
system.
Individual Filter Requirements
Conventional and direct filtration
systems must conduct continuous
monitoring of turbidity for each
individual filter and must provide an
exceptions report to the State on a
monthly basis as part of the existing
combined filter effluent reporting
process. Exceptions reporting must
include the following: (1) Any
individual filter with a turbidity level
greater than l.0 NTU based on two
consecutive measurements fifteen
minutes apart; and (2) any individual
filter with a turbidity level greater than
0.5 NTU at the end of the first 4 hours
of filter operation based on two
consecutive measurements fifteen
minutes apart. The system must
produce a filter profile for either
situation if no obvious reason for the
abnormal filter performance can be
identified. EPA is including a
discussion on filter profiles in its
guidance document on turbidity which
is currently being developed with input
from stakeholders.
Individual Filter Follow-Up Activities
If an individual filter has turbidity
levels greater than l.0 NTU based on two
consecutive measurements fifteen
minutes apart at any time in each of
three consecutive months, the system
must, in addition to filing an exceptions
report, conduct a self-assessment of the
filter. The self-assessment must consist
of at least the following components: (1)
Assessment of filter performance; (2)
development of a filter profile; (3)
identification and prioritization of
factors limiting filter performance; (4)
assessment of the applicability of
corrections; and (5) preparation of a
filter self-assessment report. The system
must conduct the self-assessment within
14 days of the exceedance and report to
the State that the self-assessment was
conducted. If an individual filter has
turbidity levels greater than 2.0 NTU
based on two consecutive measurements
fifteen minutes apart at any time in each
of two consecutive months, the system
must file an exceptions report and must
no later than 30 days following the
exceedance arrange for the conduct of a
CPE by the State or a third party
approved by the State. The CPE must be
completed and submitted to the State no
later than 90 days following the
exceedance.
2. Background and Analysis
A primary focus of the 1994 proposal
was the establishment of treatment
requirements that would address public
health risks from high densities of
pathogens in poor quality source waters
and from the waterborne pathogen
Cryptosporidium. Approaches outlined
in the 1994 proposal included treatment
requirements based on site-specific
concentrations of pathogens in source
water and a proposed 2-log removal
requirement for Cryptosporidium by
filtration.
EPA specifically requested comment
on what criteria, if any, should be
included to ensure that systems
optimize treatment plant performance
and on whether any of the existing
turbidity performance criteria should be
modified (e.g., should systems be
required to base compliance with the
turbidity standards on individual filter
effluent monitoring in lieu of or in
addition to monitoring the confluence of
all filters; and should any performance
standard value be changed). In addition,
the Agency also requested comment in
the 1994 proposal on possible
supplemental requirements for State
notification of persistent high turbidity
levels (e.g., broadening the requirements
for State notification of turbidity
exceedances).
The 1997 M-DBP Advisory Committee
meetings resulted in the collection,
development, evaluation, and
presentation of substantial data and
information related to turbidity control.
The Committee's recommendations are
reflected in today's rule.
The November 3, 1997 IESWTR
NODA discussed new data and
information regarding turbidity control
with respect to three areas: (1) Current
turbidity levels at systems throughout
the country; (2) individual filter
performance; and (3) turbidity
measurement.
Current Turbidity Levels
The November 3, 1997 NODA
discussed three data sets that
summarized the historical turbidity
performance of various filtration plants
(AWWSC, 1997; Bissonette, 1997; SAIC,
1997b). These were evaluated to assess
the national impact of modifying
existing turbidity requirements. Each of
the data sets was analyzed to assess the
current performance of plants with
respect to the number of months in
which selected 95th percentile and
maximum turbidity levels were
exceeded. The data show that upwards
of 90% of the systems are currently
meeting the new requirements of a
maximum turbidity limit of 1 NTU.
With respect to the 95th percentile
turbidity limit, roughly 78% of the
systems are currently meeting the new
requirement of 0.3 NTU. Estimates for
systems needing to make changes to
meet a turbidity performance limit of
0.3 NTU were based on the ability of
systems currently to meet a 0.2 NTU.
This assumption was intended to take
into account a utility's concern with
possible turbidity measurement error
and to reflect the expectation that a
number of utilities will ``aim'' lower
than the regulatory performance level to
assure compliance. The percentage of
systems estimated to modify treatment
practices to meet the revised turbidity
requirements (i.e., 0.3 NTU 95th
percentile and 1 NTU maximum
combined filter effluent levels) is
69488 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
approximately 50%. Based on the
turbidity performance data, EPA
assumed that for systems serving less
than 100,000 people, 51.2 percent of the
systems can be expected to make
treatment changes to consistently
comply with a monthly 95th percentile
limit of 0.3 NTU. Similarly, for systems
serving over 500,000 people, EPA
assumed that 41.7 percent can be
expected to make treatment changes to
comply with a 0.3 NTU regulatory limit.
For systems serving 100,000 to 500,000
people, EPA assumed that 46.5 percent
of systems can be expected to make
changes. As discussed in greater detail
in the November 3, 1997 NODA, the
tighter turbidity performance criteria for
combined filter effluent in today's rule
reflect actual current performance for a
substantial percentage of systems
nationally. Revising the turbidity
criteria effectively ensures that these
systems continue to perform at these
levels (in addition to improving
performance of systems that currently
meet existing SWTR criteria but operate
at turbidity levels higher than those in
today's final rule).
Individual Filter Performance
Several of the studies published since
1994, considered by both EPA and the
M-DBP Advisory Committee and
outlined in the 1997 NODA, note that
the greatest potential for a peak in
turbidity (and thus, pathogen break-
through) is near the beginning of the
filter run after filter backwash or start
up of operation (Amirtharajah 1988;
Bucklin et al. 1988; Cleasby 1990; and
Hall and Croll 1996). During a turbidity
spike, significant amounts of particulate
matter (including oocysts, if present)
may pass through the filter. Various
factors affect the duration and
amplitude of filter spikes, including
sudden changes to the flow rate through
the filter, treatment of the filter
backwash water, filter-to-waste
capability, and site-specific water
quality conditions. As discussed in the
1997 IESWTR NODA, these issues
highlighted the need to ensure that
systems have a greater understanding of
individual filter performance and thus
for establishment of individual filter
monitoring and reporting requirements.
Turbidity Measurement
The November 3, 1997 NODA
discussed several issues relating to
measurement of turbidity. It was noted
that issues exist concerning the
accuracy and precision of turbidity
measurement due to design criteria,
calibration methods, calibration
standards, and sampling technique.
Performance evaluation (PE) studies
conducted by EPA provide an
indication of the current level of
accuracy and precision for turbidity
measurements among different
laboratories for a common synthetically
prepared water. In PE studies, PE
samples with known turbidity levels are
sent to participating laboratories (which
are not informed of the turbidity level).
Laboratories participating in these
studies used turbidimeters from various
manufacturers and conducted their
analysis in accordance with calibration
and analytical procedures they are
familiar with. Thus, the variability of
the results reflects differences resulting
from using different turbidimeter
models and methods and the effects of
different laboratory procedures. Four PE
studies were discussed in the NODA
with turbidities in the range of 0.35 to
0.72 NTU. The Relative Standard
Deviations (RSD) at turbidity levels
considered in these PE studies are
slightly below 20%.
3. Summary of Major Comments
In response to the 1994 proposal, EPA
received a range of comments both in
support of and in opposition to
optimizing existing water treatment
processes to address Cryptosporidium
removal. Several commenters supported
tighter turbidity standards as well as
monitoring of individual filters. Other
commenters suggested no modifications
be made to turbidity standards until
further implementation of the SWTR
and/or further supporting data was
gathered.
Commenters on the 1997 NODA
provided additional views on the
general subject of filtration performance
and turbidity. Commenters generally
supported tightening combined filter
effluent performance standards as well
as the establishment of individual filter
monitoring requirements. EPA agrees
with these comments, as reflected in
today's rule. EPA also notes that
turbidity performance data that reflects
implementation of the SWTR was
analyzed as part of the M±DBP Advisory
Committee discussions and was
considered by the Committee in
developing the recommendations for
turbidity which are reflected in today's
rule.
Several commenters discussed the
ability of systems to measure turbidity
at low levels (<0.3 NTU) with accuracy
and consistency. EPA believes that the
performance evaluation (PE) studies
cited in the NODA provide an
indication of the precision and accuracy
of turbidity measurements at low levels.
While turbidities in these studies only
ranged from 0.35 to 0.72 NTU, they
provided an understanding of the ability
to measure at such levels. EPA
recognizes that accurate and consistent
measurements are not only a function of
available technology but also a function
of a range of operator/technician factors
including calibration, maintenance,
training, and adherence to manufacturer
instructions. In conjunction with the
IESWTR, EPA is currently developing
guidance, with stakeholder input,
targeted at assisting owners/operators
with understanding turbidity as well as
focusing on the importance of accuracy
and consistency in turbidity
measurement, including the low level
measurement concerns noted by the
commenters.
Many commenters discussed the issue
of lime-softening plants and how the
new requirements would affect such
plants which, because of the softening
processes, have artificially elevated
levels of turbidity. The IESWTR allows
acidification of samples for the
combined filter effluent at lime
softening plants. In addition, EPA is
allowing systems that use lime softening
to apply to States for alternative
exceedance reporting levels for
individual filters if they can
demonstrate that higher turbidity levels
in individual filters are due to lime
carryover and not due to degraded filter
performance.
Several commenters noted that
special filters would present difficulties
in complying with the individual filter
monitoring requirements. While EPA
realizes that variations exist in filter
configurations and filters in use at
systems throughout the country, the
IESWTR will not seek to address the
specific requirements of each and every
one. EPA intends to provide States the
flexibility and the tools necessary to
effectively deal with special filters
discussed by the commenters on a more
appropriate case-by-case basis.
Another issue raised in public
comments was the need to clarify how
public notice requirements in the
IESWTR would be integrated with
future public notice requirements under
the SDWA. EPA notes that today's
action addresses public notification by
using the existing public notification
language for microbiological
contaminants in 40 CFR 141.32 (e)(10)
for violations of treatment technique
requirements under the IESWTR. EPA
takes this opportunity to note that the
1996 amendments to the SDWA require
the Agency to make certain technical
changes to the public notice regulations.
EPA intends to propose changes to the
public notice requirements in the
Federal Register shortly after
promulgation of the IESWTR.
Applicable changes in the public notice
69489Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
requirements, when they become
effective, will supersede today's
provisions. EPA also takes this
opportunity to note that today's rule
amends the Consumer Confidence
Report Regulation (CCR) to extend the
CCR requirements to apply to Subpart P
violations.
Several respondents indicated that it
would be necessary to provide guidance
materials to systems to aid in
compliance with these rules. EPA is
currently developing a number of
guidance manuals, with stakeholder
input, to aid systems in understanding
and complying with requirements. One
such manual will address issues of
turbidity control and filter performance.
D. Disinfection Benchmark for Stage 1
DBPR MCLs
1. Today's Rule
Today's rule establishes the
disinfection benchmark as a procedure
requiring certain PWSs to evaluate the
impact on microbial risk of proposed
changes in disinfection practice. It
reflects the recommendation of the M±
DBP Advisory Committee to develop a
mechanism that allows utilities and
States working together to assure that
pathogen control is maintained while
the Stage 1 DBPR provisions are
implemented. In essence, this procedure
involves a PWS charting daily levels of
Giardia lamblia inactivation for a period
of at least one year to create a profile of
inactivation performance. The PWS
must then use this profile to determine
a baseline or benchmark of inactivation
against which proposed changes in
disinfection practices can be measured.
However, only certain systems are
required to develop a profile and keep
it on file for State review during sanitary
surveys. When those systems required
to develop a profile plan a significant
change in disinfection practice, they
must submit the profile, along with an
analysis of how the proposed change
will affect the current disinfection
benchmark, to the State for review. The
disinfection benchmark provisions,
then, contain three major components:
applicability requirements,
characterization of disinfection practice,
and State review of proposed changes in
disinfection practice. Each of these
components is discussed in turn below.
Applicability
Systems are required to prepare a
disinfection profile if at least one of the
following criteria is met:
(1) TTHM levels are at least 80% of
the MCL (0.064 mg/L) as an annual
average
(2) Haloacetic acid (HAA5) levels are
at least 80% of the MCL (0.048 mg/L) as
an annual average
In connection with TTHM and HAA5
monitoring to create a disinfection
profile, the following provisions apply:
First, the TTHM annual average must
be the annual average during the same
period as is used for the HAA5 annual
average. Second, systems that have
collected TTHM and HAA5 data under
the ICR must use the results of samples
collected during the last 12 months of
monitoring unless the State determines
that there is a more representative
annual data set. Third, systems not
required to collect data under the ICR
but which have collected four
consecutive quarters of TTHM and
HAA5 data that substantially meet the
sample location, handling, and
analytical methods requirements of the
ICR may use those data if approved by
the State. (Systems must coordinate
with the State to confirm acceptability
of the existing data). Fourth, if the
system does not have four quarters of
acceptable HAA5 and TTHM data by the
end of 90 days following the IESWTR
promulgation date, the PWS must
conduct HAA5 and TTHM monitoring
to determine an annual average.
Alternatively, the system may elect to
conduct profiling, as described below,
and forego TTHM/HAA5 monitoring to
determine applicability. This
monitoring must be completed no later
than 15 months after promulgation of
this rule and conform to the monitoring
location requirements of the 1979
TTHM Rule and the analytical methods
in the May 1996 Information Collection
Rule.
Today's rule applies profiling
requirements to systems with TTHM or
HAA5 concentrations of at least 80% of
the MCL, based upon the M±DBP
Advisory Committee technical
recommendation that this level will
cover most systems that might be
expected to modify their disinfection
practices to comply with the Stage 1
DBPR. Also, EPA previously considered
this 80% target level at the
recommendation of the 1992 Reg Neg
Committee to evaluate Stage 1 DBPR
compliance forecasts and costs, based
upon the judgment that most facilities
will take additional steps to ensure
continuing MCL compliance if they are
at or above this level.
Developing the Profile and Benchmark
Profiling is the characterization of a
system's disinfection practice over a one
year period. The system can create the
profile by conducting new daily
monitoring and also by using
``grandfathered'' data (as explained
below). A disinfection profile consists of
a compilation of daily Giardia lamblia
log inactivations (plus virus
inactivations for systems using either
chloramines or ozone for primary
disinfection), computed over the period
of a year, based on daily measurements
of operational data (disinfectant residual
concentration(s), contact time(s),
temperature(s), and, where necessary,
pH).
Grandfathered data are those
operational data that a system has
previously collected at a treatment plant
during the course of normal operation.
These data may or may not have been
used previously for compliance
determinations with the SWTR. Those
systems that have all necessary data to
determine profiles using existing
operational data collected prior to
promulgation of the IESWTR may use
these data in developing profiles.
However, grandfathered data must be
substantially equivalent to operational
data that would be collected under this
rule. These data must be representative
of inactivation through the entire
treatment plant and not just of certain
treatment segments. The State
determines whether grandfathered data
are acceptable. (EPA believes that
grandfathered data used in constructing
profiles should be the most recent data
available, unless the State determines
that there is a more representative data.)
Systems required to develop
disinfection profiles under this rule
must exercise one of the following three
options:
Option 1ÐSystems must conduct
daily monitoring as described below.
This monitoring must begin no later
than 15 months after IESWTR
promulgation and must continue for a
period of one year. The data collected
from this monitoring must be used to
develop a one year disinfection profile;
Option 2ÐSystems that conduct
monitoring under this rule, as described
under Option 1, may also use one or two
years of acceptable grandfathered data,
in addition to the one year of new
operational data, in developing the
disinfection profile;
Option 3ÐSystems that have three
years of acceptable existing operational
data are not required to conduct
monitoring to develop the disinfection
profile under this rule. Instead, they
may use grandfathered data to develop
a three year disinfection profile.
Systems must coordinate with the State
to confirm acceptability of
grandfathered data no later than 15
months after promulgation of this rule,
but must conduct the required
monitoring until the State approves the
system's request to use grandfathered
69490 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
data. In order to develop the profile, a
system must:
ÐMeasure disinfectant residual
concentration (C, in mg/L) before or at
the first customer and just prior to
each additional point of disinfectant
addition, whether with the same or a
different disinfectant.
ÐDetermine contact time (T, in
minutes) for each residual
disinfectant monitoring point during
peak flow conditions. T can be based
on either a tracer study or
assumptions based on contactor basin
geometry and baffling. However,
systems must use the same method for
both grandfathered data and new data.
ÐMeasure water temperature (°C).
ÐMeasure pH (for chlorine only).
The system must then convert daily
operational data to daily log inactivation
values for Giardia (and viruses when
chloramines or ozone is used for
primary disinfection) as follows:
ÐDetermine CTcalc for each
disinfection segment.
ÐDetermine CT99.9 (i.e., 3-log
inactivation) from tables in the SWTR
using temperature (and pH for
chlorine) for each disinfection
segment. Alternatively, States may
allow an alternate calculation
procedure (e.g. use of spreadsheet).
ÐFor each segment, log inactivation =
(CTcalc/CT99.9)´3.0.
ÐSum the log inactivations for each
segment to get the daily log
inactivation.
A log inactivation benchmark is then
calculated as follows:
1. Calculate the average log
inactivation of all the days for each
calendar month.
2. Determine the calendar month with
the lowest average log inactivation.
3. The lowest average month becomes
the critical period for that year.
4. If acceptable data from multiple
years are available, the average of
critical periods for each year becomes
the benchmark.
5. If only one year of data is available,
the critical period (lowest monthly
average inactivation level) for that year
is the benchmark.
State Review
If a system that is required to produce
a disinfection profile decides to make a
significant change in disinfection
practice after the profile is developed, it
must consult with the State before
implementing such a change.
Significant changes in disinfection
practice are defined as: (1) Moving the
point of disinfection (this is not
intended to) include routine seasonal
changes already approved by the State),
(2) changing the type of disinfectant or
(3) changing the disinfection process, (4)
making other modifications designated
as significant by the State. Supporting
materials for such consultation with the
State must include a description of the
proposed change, the disinfection
profile developed under this rule for
Giardia lamblia (and, if necessary,
viruses), and an analysis of how the
proposed change will affect the current
disinfection benchmark. In addition, the
State is required to review disinfection
profiles as part of its periodic sanitary
survey.
EPA is currently developing, with
stakeholder input, the Disinfection
Benchmarking Guidance Manual for
States and systems. This manual will
provide instruction on the development
of disinfection profiles, identification
and evaluation of significant changes in
disinfection practices, and
considerations for setting an alternative
benchmark. This manual will also
provide guidance for systems that are
required to develop a profile based on
virus inactivation instead of Giardia
lamblia inactivation.
2. Background and Analysis
A fundamental principle of the 1992±
93 regulatory negotiation reflected in
the 1994 proposal for the IESWTR was
that new standards for control of
disinfection byproducts must not result
in significant increases in microbial
risk. This principle was also one of the
underlying premises of the 1997 M-DBP
Advisory Committee's deliberations,
i.e., that existing microbial protection
must not be significantly reduced or
undercut as a result of systems taking
the necessary steps to comply with the
Stage 1 DBPR. The Advisory Committee
reached agreement on the use of
microbial profiling and benchmarking
as a process by which a PWS and the
State, working together, assure that
there will be no significant reduction in
microbial protection as the result of
modifying disinfection practices in
order to meet MCLs for TTHM and
HAA5.
The strategy of disinfection profiling
and benchmarking stemmed from data
provided to the EPA and M-DBP
Advisory Committee by PWSs and
reviewed by stakeholders, in which the
baseline of microbial inactivation
(expressed as logs of Giardia lamblia
inactivation) demonstrated high
variability. Inactivation varied by
several log on a day-to-day basis at any
particular treatment plant and by as
much as tens of logs over a year due to
changes in water temperature, flow rate
(and, consequently, contact time),
seasonal changes in residual
disinfectant, pH, and disinfectant
demand (and, consequently,
disinfectant residual). There were also
differences between years at individual
plants. To address these variations, M-
DBP stakeholders developed the
procedure of profiling a plant's
inactivation levels over a period of at
least one year, and then establishing a
benchmark of minimum inactivation as
a way to characterize disinfection
practice. This approach makes it
possible for a plant that may need to
change its disinfection practice in order
to meet DBP MCLs to determine the
impact the change would have on its
current level of disinfection and,
thereby, to assure that there is no
significant increase in microbial risk.
3. Summary of Major Comments
In the 1997 IESWTR NODA, EPA
requested public comment on all
aspects of the benchmarking procedure,
along with any alternative suggestions,
from stakeholders and other interested
parties. EPA specifically requested
comment on the following issues:
Applicability requirements;
characterization of disinfection
practices and components; use of TTHM
and HAA5 data from the same time
period instead of TTHM data from one
year and HAA5 data from another;
definition of significant changes to
disinfection practice; different
approaches to evaluating possible
changes in disinfection practice against
a disinfection profile; and whether the
use of grandfathered data, if available,
should be mandatory for profiling and
benchmarking.
The majority of comments on the
overall benchmarking procedure
outlined in the 1997 IESWTR NODA
were positive. Commenters
acknowledged the procedure as a way to
maintain microbial control in systems
changing their disinfection practices to
comply with DBP MCLs. However, a
significant area of concern expressed in
comments was that if PWSs believe they
will be held to a relatively higher
regulatory standard as a result of
maintaining a greater level of
disinfection than is currently required,
then some PWSs may reduce log
inactivation during profiling in order to
lower their benchmarks. EPA
emphasizes that benchmarking is not
intended to function as a regulatory
standard. Rather, the objective of the
disinfection benchmark is to facilitate
interactions between the States and
PWSs for the purpose of assessing the
impact on microbial risk of proposed
significant changes to existing
disinfection practices. Final decisions
regarding levels of disinfection beyond
69491Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
those required by the SWTR that are
necessary to protect public health will
continue to be left to the States. For this
reason EPA has not mandated specific
evaluation protocols or decision
matrices for analyzing changes in
disinfection practice. EPA is, however,
providing support to the States in
making these analyses through the
issuance of guidance. This approach is
consistent with a majority of comments
on this issue which requested that EPA
not require specific procedures for the
setting of alternative benchmarks but,
rather, provide guidance to States.
Several commenters suggested that
instead of requiring profiling and
benchmarking in regulations, EPA
should place these procedures in
guidance and allow the States to
implement them at their discretion. EPA
considers benchmarking to be an
important measure in preventing
significant increases in microbial risk
during implementation of the M-DBP
rule cluster. Moreover, States have
different statutory authorities governing
what they can mandate and some State
agencies are prohibited by State law
from adopting procedures not required
by federal regulations. Consequently,
EPA believes the inclusion of
benchmarking as a regulation is
warranted.
Commenters were concerned that the
benchmarking procedure would not take
into account source water
characteristics and that benchmarking
would not be accurate for systems
switching from one disinfectant to
another (e.g. chlorine to ozone). EPA
will cover both of these topics in the
Disinfection Benchmarking Guidance
Manual in sections that address setting
an alternative benchmark. Commenters
also asked EPA to provide instruction
on awarding disinfection credits taking
into account possible synergistic effects
for different sequential disinfectants.
However, as discussed in other parts of
this preamble, research in this area is
not adequate for a disinfection credit
scheme to be developed based on
synergistic inactivation.
Most comments submitted to EPA on
the issue of applicability favored using
80% of the MCLs for TTHM and HAA5
as threshold levels for profiling.
Commenters agreed with the EPA and
M-DBP Advisory Committee that these
values would capture most of the PWSs
likely to change their disinfection
processes to meet DBP MCLs. One
commenter proposed that using TTHM
and HAA5 data from two different years
would not present a problem because
either one of these parameters can
trigger the profiling requirement.
However, the majority of comments on
this subject supported requiring TTHM
and HAA5 data to be collected during
the same period since changes in water
quality and treatment conditions
influence not only the total quantity of
DBPs but also the relative formation of
different DBP species. In today's rule
EPA requires that TTHM and HAA5
data used in determining applicability
be collected during the same period. A
few commenters recommended that the
applicability requirements for profiling
should also include ozonation systems
with bromate concentrations at least
80% of the MCL (i.e. 8mg/L). EPA has
elected not to include bromate levels in
the profiling requirements because
operational changes, such as dropping
the pH during ozonation, can decrease
bromate formation without reducing
disinfection efficacy.
Certain commenters felt that
disinfection profiling should only be
required in the event that a system
planned to change disinfection practice
and that requiring plants which meet
water quality standards to perform
additional studies is unwarranted. EPA
believes, however, that a profile should
span all seasons of at least one year to
show how seasonal variations impact
the log inactivation provided.
Consequently, waiting to profile until a
disinfection change is needed is not
practical because at least one year of
monitoring is required and this could
significantly delay the desired
modifications. Accordingly, EPA
maintains that profiling in advance of a
decision to change disinfection
practices will allow systems to comply
with TTHM and HAA5 MCLs in a
timely manner without increasing
microbial risk. For this reason, EPA
requires profiling of those PWSs most
like to modify their disinfection
procedures (i.e. those with TTHM and
HAA5 concentrations at or above 80%
of the MCLs).
Many comments advocated allowing
the use of grandfathered data in
developing disinfection profiles.
However, commenters were
predominantly against making the use
of existing operational data mandatory.
They expressed concern that such a
requirement would be inherently
inequitable, could entail significant
retrieval costs, and that the data might
not be representative of a system's
current operations. EPA believes that
grandfathered data will often provide
the most accurate picture of historic
levels of microbial disinfection and
encourages its use in constructing the
disinfection profile. However, EPA
recognizes that certain problems, such
as those identified by commenters, may
justify the exclusion of grandfathered
data and, therefore, has made the use of
such data optional. EPA notes that
States may consider issues related to
profiling data when determining
whether a proposed change in
disinfection practice is acceptable.
The benchmarking procedure in
today's rule, therefore, reflects the
concerns of commenters in many
respects. On issues such as the use of
grandfathered data, applicability
requirements, and evaluating proposed
changes in disinfection practice, the
disinfection benchmark requirements
conform to the majority view of
comments. In cases where the rule is at
variance with certain commenters'
suggestions, such as making the
disinfection benchmarking procedure
discretionary and requiring profiling
only in advance of a proposed change in
disinfection practice, EPA has acted in
accordance with the need to achieve
risk-risk balancing, which is a central
objective of the M±DBP rule cluster.
E. Definition of Ground Water Under
the Direct Influence of Surface Water
1. Today's Rule
In today's rule, EPA includes
Cryptosporidium in the definition of
ground water under the direct influence
of surface water (GWUDI). This change
in definition applies only to public
water systems that serve 10,000 or more
people.
2. Background and Analysis
EPA issued guidance in October 1992
as the Consensus Method for
Determining Groundwater Under the
Direct Influence of Surface Water Using
Microscopic Particulate Analysis (MPA).
As part of this method, a microscopic
examination is made of the ground
water to determine whether insect parts,
plant debris, rotifers, nematodes,
protozoa, and other material associated
with the surface or near surface
environment are present. Additional
guidance for making GWUDI
determinations is also available (EPA,
1994d, e). Since 1990, States have
acquired substantial experience in
making GWUDI determinations and
have documented their approaches
(Massachusetts Department of
Environmental Protection, 1993;
Maryland, 1993; Sonoma County Water
Agency, 1991). Guidance on existing
practices undertaken by States in
response to the SWTR may also be
found in the State Sanitary Survey
Resource Directory, jointly published in
December 1995 by EPA and the
Association of State Drinking Water
Administrators. AWWARF has also
69492 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
published guidance (Wilson et al.,
1996).
In the existing MPA guidance (EPA,
1992), Cryptosporidia oocysts are
included under the general category of
coccidian protozoans, a more
encompassing grouping, some of which
are pathogenic to humans. The score
assigned to an occurrence of a coccidian
is equivalent to the score assigned to an
occurrence of a Giardia cyst. Thus, it
not anticipated that any change is
needed in the MPA scoring
methodology to accommodate the
regulation of Cryptosporidium by this
rule.
The 1997 NODA summarized the
available guidance and additional
information provided by the States and
regulated community. Most recently,
Hancock et al. (1998) summarized some
of the available data on parasitic
protozoan occurrence in ground water
and EPA compiled additional data on
such occurrence in wells (SAIC, 1997a).
3. Summary of Major Comments
The July 29, 1994, Federal Register
notice proposed to amend the SWTR by
including Cryptosporidium in the
definition of a GWUDI system. Under
the 1994 IESWTR proposal, a system
using ground water considered
vulnerable to Cryptosporidium
contamination would be subject to the
provisions of the SWTR. EPA proposed
that this determination be made by the
State for individual sources using State-
established criteria. The 1994 proposed
IESWTR also requested comment on
revisions to EPA's guidance on this
issue.
Commenters generally agreed that
Cryptosporidium should be added to the
definition.
F. Inclusion of Cryptosporidium in
Watershed Control Requirements
1. Today's Rule
In today's final rule, EPA is extending
the existing watershed control
regulatory requirements for unfiltered
systems serving 10,000 or more people
to include the control of
Cryptosporidium. Cryptosporidium will
be included in the watershed control
provisions for these systems wherever
Giardia lamblia is mentioned.
2. Background and Analysis
Watershed control requirements were
initially established in 1989 (EPA,
1989b, 54 FR 27496, June 29, 1989) as
one of a number of preconditions that a
public water system using surface water
must meet to avoid filtration. As part of
its 1994 IESWTR proposal (EPA, 1994b,
59 FR 38839, July 29, 1994), EPA
requested comment on extending these
existing watershed control requirements
for unfiltered systems at 40 CFR
141.71(b)(2) to include the control of
Cryptosporidium. This was intended to
be analogous to and build upon the
existing requirements for Giardia
lamblia and viruses; Cryptosporidium
would be included in the watershed
control provisions wherever Giardia
lamblia is mentioned. In the November
3, 1997 NODA (EPA, 1997a, 62 FR
59506), the Agency also requested
comment on issues pertaining to
monitoring for Giardia and
Cryptosporidium for unfiltered systems
serving 10,000 or more people.
As noted above, the SWTR specifies
the conditions under which a system
can avoid filtration (40 CFR 141.71).
These conditions include good source
water quality, as measured by
concentrations of coliforms and
turbidity; disinfection requirements;
watershed control; periodic on-site
inspections; the absence of waterborne
disease outbreaks; and compliance with
the Total Coliform Rule and the MCL for
TTHMs. This watershed control
program under the SWTR must include
a characterization of the watershed
hydrology characteristics, land
ownership, and activities which may
have an adverse effect on source water
quality, and must minimize the
potential for source water
contamination by Giardia lamblia and
viruses. The SWTR Guidance Manual
(EPA, 1991a) identifies both natural and
human-caused sources of contamination
to be controlled. These sources include
wild animal populations, wastewater
treatment plants, grazing animals,
feedlots, and recreational activities. The
Guidance Manual recommends that
grazing and sewage discharges not be
permitted within the watershed of
unfiltered systems, but indicates that
these activities may be permissible on a
case-by-case basis where there is a long
detention time and a high degree of
dilution between the point of activity
and the water intake. Although there are
no specific monitoring requirements in
the watershed protection program, the
non-filtering utility is required to
develop State-approved techniques to
eliminate or minimize the impact of
identified point and non-point sources
of pathogenic contamination. The
guidance already suggests identifying
sources of microbial contamination,
other than Giardia, transmitted by
animals, and points out specifically that
Cryptosporidium may be present if there
is grazing in the watershed.
As discussed in the 1997 IESWTR
NODA, the Seattle Water Department
summarized the Giardia and
Cryptosporidium monitoring results
from several unfiltered water systems
(Montgomery Watson, 1995). The
central tendency of this data is
approximately 1 oocyst/100L. In light of
data previously discussed that indicates
that at least 2-log removal of
Cryptosporidium is achievable with
filtration, and considering the Seattle
data analysis, it appears that unfiltered
water systems that comply with the
source water requirements of the SWTR
have a risk of cryptosporidiosis
equivalent to that of a water system with
a well-operated filter plant using a water
source of average quality. EPA plans to
continue to evaluate this issue when
additional data becomes available.
3. Summary of Major Comments
Commenters generally supported
specific inclusion of Cryptosporidium in
the watershed control requirements for
unfiltered systems. Some commenters
supported watershed control programs
in general without specifically offering
an opinion on Cryptosporidium. A few
commenters specifically opposed the
inclusion of Cryptosporidium in the
watershed control program, maintaining
that other avenues of watershed control
could be promoted without including
this organism in the control plan and
that environmental sources of Giardia
and Cryptosporidium were not
sufficiently understood.
In response, EPA believes that the
environmental sources of
Cryptosporidium are sufficiently
understood, as described above, to
support rule requirements.
Cryptosporidium cannot be easily
controlled with conventional
disinfection practices, and therefore its
presence in source water serving
unfiltered surface water systems must
be addressed. EPA also believes that
Cryptosporidium poses a potential
hazard to public health and, as noted
above, is establishing in today's rule an
MCLG of zero for this pathogenic
protozoan. EPA is therefore amending
the existing watershed control
requirements for unfiltered systems to
include Cryptosporidium in order to
protect public health. EPA believes that
an effective watershed protection
program will help to improve source
water quality. Existing guidance already
references the need to guard against
pathogenic protozoa including
specifically Cryptosporidium. EPA is
proceeding on the presumption that
existing watershed programs already
consider and State reviews have
evaluated the adequacy of watershed
provisions to assure that raw drinking
water supplies are adequately protected
against Cryptosporidium contamination.
69493Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
To the extent this is not the case,
however, EPA expects that unfiltered
systems, and States in their annual
review, will reassess their program with
regard to this concern and take whatever
steps are necessary to ensure that
potential vulnerability to
Cryptosporidium contamination is
considered and adequately addressed.
With regard to monitoring, many
NODA commenters supported some
form of routine monitoring for Giardia
and Cryptosporidium in unfiltered
watershed systems serving 10,000 or
more people. A few NODA commenters
supported event monitoring (i.e., an
occasion where the raw water turbidity
and/or fecal/total coliform
concentration exceeds a specific value
or possibly a site-specific 90th
percentile value) for large unfiltered
systems while others were silent on the
issue or against event monitoring. In
response, today's final rule does not
include monitoring requirements for
unfiltered systems for several reasons.
The IFA method is the only method
currently and widely available to
evaluate the presence or absence of
Cryptosporidium in a water supply.
However, EPA does not believe this
method is appropriate for regulatory
compliance purposes because of its low
recovery and variability. EPA therefore
believes that monitoring is most
appropriately handled through guidance
at this time. EPA is working with
stakeholders to develop a guidance
document for unfiltered systems which
will describe possible monitoring
programs. Moreover, the Agency is
supporting and participating in the
development of improved
Cryptosporidium analytical methods,
including a draft interim method 1622.
At the moment, it is unclear when
prototype Cryptosporidium methods
(both method 1622, as well as methods
under development to determine
viability and infectivity) will be
adequate for regulatory use and
compliance determinations at low
concentration levels, but ongoing
research appears promising in this area.
As a result, establishment of
Cryptosporidium monitoring
requirements for unfiltered systems will
be considered during the development
of future microbial rules when EPA has
more information on which to base a
regulation (e.g. availability of better
methods, ICR monitoring data, and
research characterizing the relationship
between watershed control and
pathogen occurrence).
G. Covered Finished Water Reservoirs
1. Today's Rule
In today's final rule EPA is requiring
surface water and GWUDI systems that
serve 10,000 or more people to cover all
new reservoirs, holding tanks or other
storage facilities for finished water for
which construction begins after the
effective date of this rule, February 16,
1999. Today's final rule does not apply
these requirements to existing
uncovered finished water reservoirs.
2. Background and Analysis
The proposed IESWTR (EPA, 1994b,
59 FR 38841) indicated that EPA was
considering whether to issue regulations
requiring systems to cover finished
water reservoirs and storage tanks, and
requested public comment. The
IESWTR Notice of Data Availability
(EPA, 1997a, 62 FR 59509) indicated
that EPA was considering a requirement
that systems cover all new reservoirs,
holding tanks or other storage facilities
for finished water for which
construction begins after the effective
date of the rule and invited comment on
this issue. The IESWTR NODA also
invited further comment on whether
there should be a requirement that all
finished water reservoirs, holding tanks
and other storage facilities be covered as
part of the development of future
regulations.
As discussed in the 1997 IESWTR
Notice of Data Availability, when a
finished water reservoir is open to the
atmosphere it may be subject to some of
the environmental factors that surface
water is subject to, depending upon site-
specific characteristics and the extent of
protection provided. Potential sources
of contamination to uncovered
reservoirs and tanks include airborne
chemicals, surface water runoff, animal
carcasses, animal or bird droppings and
growth of algae and other aquatic
organisms due to sunlight that results in
biomass (Bailey and Lippy, 1978). In
addition, uncovered reservoirs may be
subject to contamination by persons
tossing items into the reservoir or illegal
swimming (Pluntze 1974; Erb, 1989).
Increases in algal cells, heterotrophic
plate count (HPC) bacteria, turbidity,
color, particle counts, biomass and
decreases in chlorine residuals have
been reported (Pluntze, 1974, AWWA
Committee Report, 1983, Silverman et
al., 1983, LeChevallier et al. 1997a).
Small mammals, birds, fish, and the
growth of algae may contribute to the
microbial degradation of an open
finished water reservoir (Graczyk et al.,
1996a; Geldreich, 1990; Fayer and
Ungar, 1986; Current, 1986). In one
study, sea gulls contaminated a 10
million gallon reservoir and increased
bacteriological growth, and in another
study waterfowl were found to elevate
coliform levels in small recreational
lakes by twenty times their normal
levels (Morra, 1979). Algal growth
increases the biomass in the reservoir,
which reduces dissolved oxygen and
thereby increases the release of iron,
manganese, and nutrients from the
sediments. This, in turn, supports more
growth (Cooke and Carlson, 1989). In
addition, algae can cause drinking water
taste and odor problems as well as
impact water treatment processes.
EPA suggested in the proposal that
covering reservoirs and storage tanks
would reduce the potential for
contamination of the finished water by
pathogens and hazardous chemicals, as
well as limit the potential for taste and
odor problems and increased operation
and maintenance costs resulting from
algal blooms associated with
environmental factors such as sunlight.
Because of these concerns, EPA
guidelines recommend that all finished
water reservoirs and storage tanks be
covered (EPA, 1991a,b). The American
Water Works Association (AWWA) also
has issued a policy statement strongly
supporting the covering of reservoirs
that store potable water (AWWA, 1993).
In addition, a survey of nine States was
conducted in the summer of 1996
(Montgomery Watson, 1996). The States
which were surveyed included several
in the West (Oregon, Washington,
California, Idaho, Arizona, and Utah),
two States in the East known to have
water systems with open reservoirs
(New York and New Jersey), and one
midwestern State (Wisconsin). Seven of
the nine States which were surveyed
require by direct rule that all new
finished water reservoirs and tanks be
covered.
EPA is currently developing, with
stakeholder input, an Uncovered
Finished Water Reservoir Guidance
Document. The manual will discuss
methods to maintain water quality,
control aquatic and microbial growths,
describe methods to cover and line
reservoirs, and discuss the use of
sampling and sampling points to
monitor reservoir water quality.
3. Summary of Major Comments
Most commenters on the proposed
rule supported either federal or State
requirements for covered finished water
reservoirs. Some commenters on the
proposed rule suggested that regulations
apply only to new reservoirs while other
commenters opposed any requirement,
citing high cost, the notion that ``one
size does not fit all,'' and aesthetic
benefits of an open reservoir. Nearly all
69494 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
the commenters on the NODA
supported regulatory requirements for
covered finished water reservoirs in
order to protect human health. Many
commenters on the NODA supported
requirements for covered finished water
reservoirs for both new and existing
reservoirs. Some commenters on the
NODA supported requirements for new
reservoirs only to be covered and
believed that requirements for existing
uncovered reservoirs should be
included in a future regulation rather
than in today's rule. Several
commenters on the NODA were against
a federal requirement for covered
finished reservoirs. One commenter
thought that EPA should provide States
with sufficient flexibility to make the
final decision on this issue while
another commenter suggested that any
future regulatory action for existing
reservoirs should take the form of
guidance to States. One commenter
believes that EPA does not have enough
information to require covered finished
reservoirs.
In response, EPA believes, in light of
the substantial information summarized
above, that microbial contamination
risks are posed by uncovered finished
water reservoirs and therefore is
requiring that all new reservoirs be
covered. The final rule requires that
finished water reservoirs for which
construction begins after the effective
date of today's rule be built with covers.
With respect to existing reservoirs, EPA
needs more time to collect and analyze
additional information to evaluate
regulatory impacts on systems with
existing uncovered reservoirs on a
national basis. EPA needs this
information in order to carry out the
cost benefit analysis for a requirement
that existing reservoirs be covered. The
IESWTR therefore does not require that
existing reservoirs have covers installed.
EPA will further consider whether to
require the covering of existing
reservoirs during the development of
subsequent microbial regulations when
additional data and analysis to develop
the national costs of coverage are
available.
H. Sanitary Survey Requirements
1. Today's Rule
The State must complete sanitary
surveys for all surface water and
GWUDI systems no less frequently than
every three years for community
systems and no less frequently than
every five years for noncommunity
systems. The State may ``grandfather''
sanitary surveys conducted after
December 1995 for the first set of
required sanitary surveys if the surveys
address the eight survey components of
the 1995 EPA/State guidance. The rule
also provides that for community
systems determined by the State to have
outstanding performance based on prior
sanitary surveys, successive sanitary
surveys may be conducted no less
frequently than every five years. In its
primacy application, the State must
include: (1) How it will decide whether
a system has outstanding performance
and is thus eligible for sanitary surveys
at a reduced frequency, and (2) how it
will decide whether a deficiency
identified during a survey is significant.
In the IESWTR, a sanitary survey is
defined as an onsite review of the water
source (identifying sources of
contamination using results of source
water assessments 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.
Components of a sanitary survey may
be completed as part of a staged or
phased State review process within the
established frequency interval set forth
below. A sanitary survey must address
each of the following eight elements:
Source; treatment; distribution system;
finished water storage; pumps, pump
facilities, and controls; monitoring and
reporting and data verification; system
management and operation; and
operator compliance with State
requirements. In addition, sanitary
surveys include review of disinfection
profiles for systems required to comply
with the disinfection benchmarking
requirements discussed elsewhere in
today's notice.
States must have the appropriate rules
or other authority to assure that
facilities take the steps necessary to
address any significant deficiencies
identified in the survey report that are
within the control of the public water
system and its governing body. As noted
above, a State must also, as part of its
primary application, include how it will
decide; (1) Whether a system has
outstanding performance and is thus
eligible for sanitary surveys at a reduced
frequency, and (2) whether a deficiency
identified during a survey is significant
for the purposes of this rule. In addition,
a State must have appropriate rules or
other authority to ensure that a public
water system responds to significant
deficiencies outlined in a sanitary
survey report within 45 days of receipt
of the report, indicating how and on
what schedule the system will address
significant deficiencies noted in the
survey.
EPA notes that it will consider
sanitary surveys that meet IESWTR
requirements to also meet the
requirements for sanitary surveys under
the Total Coliform Rule (TCR), since the
definition of a sanitary survey under the
IESWTR is broader than that for the TCR
(i.e., a survey as defined under the
IESWTR includes all the elements, and
more, of a sanitary survey as required
under the TCR). Moreover, with regard
to TCR sanitary survey frequency, the
IESWTR requires that surveys be
conducted at least as frequently, or, in
some cases, possibly more often than
required under the TCR.
2. Background and Analysis
The July 29, 1994, Federal Register
proposed to amend the SWTR to require
periodic sanitary surveys for all public
water systems that use surface water, or
ground water under the direct influence
of surface water, regardless of whether
they filter or not. States would be
required to review the results of each
sanitary survey to determine whether
the existing monitoring and treatment
practices for that system are adequate,
and if not, what corrective measures are
needed to provide adequate drinking
water quality.
The July 1994 notice proposed that
only the State or an agent approved by
the State would be able to conduct the
required sanitary survey, except in the
unusual case where a State has not yet
implemented this requirement, i.e., the
State had neither performed the
required sanitary survey nor generated a
list of approved agents. The proposal
suggested that under exceptional
circumstances the sanitary survey could
be conducted by the public water
system with a report submitted to the
State within 90 days. EPA also
requested comment on whether sanitary
surveys should be required every three
or every five years.
In 1993, the Government Accounting
Office (GAO) issued a report
summarizing the findings of a survey
conducted to examine sanitary survey
programs as well as GAO's key
observations (GAO, 1993). ``On the basis
of a nationwide questionnaire and a
review of 200 sanitary surveys
conducted in four States (Illinois,
Montana, New Hampshire and
Tennessee), GAO found that sanitary
surveys are often deficient in how they
are conducted, documented and/or
interpreted.''
The GAO survey found that 45 States
omit one or more of the key elements of
surveys that EPA recommends be
evaluated. The report also indicated
that, ``regardless of a system's size,
69495Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
deficiencies previously disclosed
frequently went uncorrected.''
In summary, GAO observed that
problems with sanitary survey programs
are compounded by the lack of any
minimum requirements on how surveys
are to be conducted and documented.
The GAO report notes that the result
``has been that a key benefit of surveysÐ
identifying and correcting problems
before they become larger problems
affecting water qualityÐ has often not
been realized.''
Sanitary surveys have historically
been conducted by State drinking water
programs as a preventive tool to identify
water system deficiencies that could
pose a threat to public health. The
general requirements for State primacy
in §142.10(b)(2) of subpart B include a
provision that the State have a
systematic program for conducting
sanitary surveys for public water
systems, with priority given to those
systems not in compliance with the
State's primary drinking water
regulations. In addition, the TCR
includes regulatory requirements for
systems to have a periodic on-site
sanitary survey (54 FR 27544±27568, 29
June 1989). This rule requires all
systems that collect fewer than 5 total
coliform samples each month to
undergo such surveys. These sanitary
surveys must be conducted by the State
or an agent approved by the State.
Community water systems were to have
had the first sanitary survey conducted
by June 29, 1994, and every five years
thereafter while non-community water
systems are to have the first sanitary
survey conducted by June 29, 1999, and
every five years thereafter unless the
system is served by a protected and
disinfected ground water supply, in
which case, a survey must be conducted
every 10 years. The TCR does not
specify in detail what must be
addressed in a sanitary survey or how
such a survey should be conducted.
The SWTR does not specifically
require water systems to undergo a
sanitary survey. Instead, it requires that
unfiltered water systems, as one
criterion to remain unfiltered, have an
annual on-site inspection to assess the
system's watershed control program and
disinfection treatment process. The on-
site survey must be conducted by the
State or a party approved by the State.
This on-site survey is not a substitute
for a more comprehensive sanitary
survey, but the information can be used
to supplement a full sanitary survey.
EPA's SWTR Guidance Manual (EPA,
1991a), Appendix K, suggests that, in
addition to the annual on-site
inspection, a sanitary survey be
conducted every three to five years by
both filtered and unfiltered systems.
This time period is suggested ``since the
time and effort needed to conduct the
comprehensive survey makes it
impractical for it to be conducted
annually.''
Since the publication of the proposed
ESWTR and GAO report, EPA and the
States (through the Association of State
Drinking Water Authorities) have issued
a joint guidance on sanitary surveys
entitled EPA/State Joint Guidance on
Sanitary Surveys (1995). The Guidance
outlines the following elements as
integral components of a comprehensive
sanitary survey:
·Source
ÐProtection
ÐPhysical Components and
Condition
·Treatment
·Distribution System
·Finished Water Storage
·Pumps/Pump Facilities and
Controls
·Monitoring/Reporting/Data
Verification
·Water System Management/
Operations
·Operator Compliance with State
Requirements
The guidance also addresses the
qualifications for sanitary survey
inspectors, the development of
assessment criteria, documentation,
follow-up after the survey, tracking and
enforcement.
As discussed earlier, EPA published a
NODA (62 FR 59485) in November 1997
discussing new information the Agency
has received since the 1994 IESWTR
proposal as well as recommendations of
the M-DBP Advisory Committee. The
Advisory Committee made
recommendations on the definition and
frequency of surveys, as well as on
survey components based on the 1995
EPA/State Guidance, and follow-up
activities. In the 1997 Notice, EPA
requested comment on the Advisory
Committee recommendations. In
addition, the Agency requested
comment on whether systems should be
required to respond in writing to a
State's sanitary survey report. EPA also
requested comment on (1) what would
constitute ``outstanding performance''
for purposes of allowing sanitary
surveys for a community water system
to be conducted every five years and (2)
how to define ``significant deficiencies.''
3. Summary of Major Comments
Commenters on the 1994 proposal
generally voiced support for requiring a
periodic sanitary survey for all systems.
One commenter suggested that EPA
develop sanitary survey guidance for
administration by the States, while
another commenter suggested that
sanitary surveys by the private sector be
certified by States or national
associations using EPA-defined criteria.
Commenters recommended that surveys
be conducted either by the State or a
private independent party/contractor.
One respondent contended that sanitary
surveys, as presently conducted, were
insufficient to assess operational
effectiveness in surface water systems.
With regard to sanitary survey
frequency, commenters on the 1994
proposal were nearly evenly divided
between every three years and every five
years. Some commenters argued that the
frequency should depend on: (1)
Whether a system's control is effective
or marginal, (2) system size (less
frequent for small systems), (3) source
water quality, (4) whether the State
believes a system's water quality is
likely to change over time, (5) results of
the previous survey, and (6) population
density on the watershed. One
commenter suggested an annual sanitary
survey.
In terms of the frequency of
conducting a sanitary survey,
commenters on the 1997 notice
generally voiced support for the
frequencies recommended by the M±
DBP Advisory Committee. One
commenter suggested that all public
water systems should have a sanitary
survey no less often than once every
three years and that systems with
unsatisfactory or provisional ratings
should be surveyed annually or more
often. Another commenter suggested
that even outstanding systems should be
surveyed on a three year cycle because
personnel or management changes can
impact plant performance. One
respondent recommended that sanitary
surveys be required at a maximum
frequency of every five years for all
public water systems using surface
water or ground water under the direct
influence of surface water as a source.
One commenter suggested that three
and five year schedules be given as
targets rather than requirements to allow
States flexibility in deploying resources.
EPA believes that the frequencies in
today's rule allow States the flexibility
to prioritize and carry out the sanitary
survey process, while also ensuring that
these surveys will be conducted as an
effective preventive tool to identify and
correct water system deficiencies that
could pose a threat to public health.
Given these considerations and
recognizing that there are many more
non-community than community water
systems, EPA believes that the required
frequencies for sanitary surveys are
reasonable.
69496 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
With respect to the definition of
outstanding performance, most
commenters on the 1997 notice
suggested some combination of both a
history of no rule or public health
violations and past surveys without
significant deficiencies. One commenter
suggested that a system with no rule
violations in a year meeting 0.1 NTU
ninety-five percent of the time and
practicing filter to waste should get
some type of formal recognition from
EPA and be considered to have
outstanding performance. Another
respondent pointed out that in addition
to performance, other factors such as
management, emergency preparedness
and backup structures are critical to
maintain outstanding performance.
EPA believes that today's rule
provides State flexibility to work within
their existing programs in addressing
how to define outstanding performance
and significant deficiencies as part of
their primacy application. The Agency
will discuss these issues in further
detail in Sanitary Survey Guidance
which is currently under development
with stakeholder input.
I. Compliance Schedules
1. Today's rule
Today's action establishes revised
compliance deadlines for States to adopt
and for public water systems to
implement the requirements in this
rulemaking. Central to the
determination of these deadlines are the
principles of simultaneous compliance
between the Stage 1 DBPR and the
corresponding rules (Interim Enhanced
Surface Water Treatment Rule, Long
Term Enhanced Surface Water
Treatment Rule, and Ground Water
Rule) to ensure continued microbial
protection, and minimization of risk-
risk tradeoffs. These deadlines also
reflect new legislative provisions
enacted as part of 1996 SDWA
amendments. Section 1412 (b)(10) of the
SDWA as amended provides PWSs must
comply with new regulatory
requirements 36 months after
promulgation (unless EPA or a State
determines that an earlier time is
practicable or that additional time up to
two years is necessary for capital
improvements). In addition, section
1413(a)(1) provides that States have 24
instead of the previous 18 months from
promulgation to adopt new drinking
water standards.
Applying the 1996 SDWA
Amendments to today's action, this
rulemaking provides that States have
two years from promulgation to adopt
and implement the requirements of this
regulation. Simultaneous compliance
will be achieved as follows.
Subpart H water systems that serve a
population of 10,000 or more generally
have three years from promulgation to
comply with all requirements of this
rule, except for profiling and
benchmarking, which require systems to
begin sampling after three months. In
cases where capital improvements are
needed to comply with the rule, States
may grant such systems up to an
additional two years to comply. These
deadlines were consistent with those for
the Stage 1 DBPR.
While only subpart H systems serving
at least 10,000 people are affected by
today's rule, EPA has included
information on the compliance
requirements for other system categories
for the reader. Subpart H systems that
serve a population of less than 10,000
and all ground water systems will be
required to comply with applicable
Stage 1 DBPR requirements within five
years from promulgation. Since the
Long Term 1 Enhanced Surface Water
Treatment Rule (LT1) requirements that
apply to systems under 10,000 and the
Ground Water Rule (GWR) are
scheduled to be promulgated two years
after today's rule or in November 2000,
the net result of this staggered deadline
is that these systems will be required to
comply with both Stage 1 DBPR and
LT1/GWR requirements three years after
promulgation of LT1/GWR at the same
end date of November 2003. For reasons
discussed in more detail below, EPA
believes this is both consistent with the
requirements of section 1412(b)(10) as
well as with legislative history affirming
the Reg. Neg. objectives of simultaneous
compliance and minimization of risk-
risk tradeoff.
2. Background and Analysis
The background, factors, and
competing concerns that EPA
considered in developing the
compliance deadlines in today's rule are
explained in detail in both the Agency's
IESWTR and Stage 1 DBPR November
1997 NODAs. As explained in those
NODAs, EPA identified four options to
implement the requirements of the 1996
SDWA Amendments. The requirements
outlined above reflect the fourth option
that EPA requested comment upon in
November 1997.
By way of background, the SDWA
1996 Amendments affirmed several key
principles underlying the M±DBP
compliance strategy developed by EPA
and stakeholders as part of the 1992
regulatory negotiation process. First,
under section 1412(b)(5)(A), Congress
recognized the critical importance of
addressing risk/risk tradeoffs in
establishing drinking water standards
and gave EPA the authority to take such
risks into consideration in setting MCL
or treatment technique requirements.
The technical concerns and policy
objectives underlying M±DBP risk-risk
tradeoffs are referred to in the initial
sections of today's rule and have
remained a key consideration in EPA's
development of appropriate compliance
requirements. Second, Congress
explicitly adopted the phased M±DBP
regulatory development schedule
developed by the Negotiating
Committee. Section 1412(b)(2)(C)
requires that the M±DBP standard
setting intervals laid out in EPA's
proposed ICR rule be maintained even
if promulgation of one of the M±DBP
rules is delayed. As explained in the
1997 NODA, this phased or staggered
regulatory schedule was specifically
designed as a tool to minimize risk/risk
tradeoff. A central component of this
approach was the concept of
``simultaneous compliance'', which
provides that a PWS must comply with
new microbial and DBP requirements at
the same time to assure that in meeting
a set of new requirements in one area,
a facility does not inadvertently increase
the risk (i.e., the risk ``tradeoff'') in the
other area.
A complicating factor that EPA took
into account in developing today's
deadlines is that the SDWA 1996
Amendments changed two statutory
provisions that elements of the 1992
Negotiated Rulemaking Agreement were
based upon. The 1994 Stage 1 DBPR and
ICR proposals provided that 18 months
after promulgation large PWS would
comply with the rules and States would
adopt and implement the new
requirements. As noted above, Section
1412(b)(10) of the SDWA as amended
now provides that drinking water rules
shall become effective 36 months after
promulgation (unless the Administrator
determines that an earlier time is
practicable or that additional time for
capital improvements is necessaryÐup
to two years). In addition, section
1413(a)(1) now provides that States have
24 instead of the previous 18 months to
adopt new drinking water standards that
have been promulgated by EPA.
Today's compliance deadline
requirements reflect the principle of
simultaneous compliance and the
concern with risk-risk tradeoffs. Subpart
H systems serving a population of at
least 10,000 will be required to comply
with the key provisions of this rule on
the same schedule as they will be
required to comply with the parallel
requirements of the accompanying Stage
1 DBPR that is also included in today's
Federal Register.
69497Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
With regard to subpart H systems
serving fewer than 10,000, EPA believes
that providing a five year compliance
period under Stage 1 DBPR is
appropriate and warranted under
section 1412(b)(10), which expressly
allows five years where necessary for
capital improvements. As discussed in
more detail in the 1997 IESWTR NODA,
capital improvements require, of
necessity, preliminary planning and
evaluation. An essential prerequisite of
such planning is a clear understanding
of final compliance requirements that
must be met. In the case of the staggered
M±DBP regulatory schedule established
as part of the 1996 SDWA Amendments,
LT1 microbial requirements for systems
under 10,000 are required to be
promulgated two years after the final
Stage 1 DBPR. As a result, small systems
will not even know what their final
combined compliance obligations are
until promulgation of the LT 1 rule.
Thus, an additional two year period
reflecting the two year Stage 1 DBPR/LT
1 regulatory development interval
established by Congress is required to
allow for the preliminary planning and
design steps which are inherent in any
capital improvement process.
In the case of ground water systems,
the statutory deadline for promulgation
of the GWR is May 2002. However, EPA
intends to promulgate this rule by
November 2000, in order to allow three
years for compliance and still ensure
simultaneous compliance by ground
water systems with the Stage 1 DBPR
and the GWR. As in the case of subpart
H systems serving fewer than 10,000,
system operators will not know until
November 2000 what the final
compliance requirements for both rules
are. EPA thus believes it appropriate to
grant the additional two years for
compliance with the Stage 1 DBPR
allowed by the statute.
EPA has been very successful in
meeting all of the new statutory
deadlines and is on track for the LT1
Rule and GWR. While EPA fully intends
to meet the schedule discussed earlier,
if those rules are delayed the Agency
will evaluate all available options to
protect against unacceptable risk-risk
trade-offs. Part of this effort is the
extensive outreach to systems already
underway to fully inform water supplies
of the likely elements in the upcoming
rules. In addition, EPA would consider
including provisions for streamlined
variance and/or exemption processing
in these rules if they were delayed, in
order to enhance State flexibility in
ensuring that compliance with the Stage
1 DBPR is not required before the
corresponding microbial protection rule.
Under today's Stage 1 DBPR, EPA has
already provided small subpart H
systems and ground water systems the
two-year extension for capital
improvements since these systems will
not know with certainty until November
2000 if capital improvements will be
needed for simultaneous compliance
with the Stage 1 DBPR and LT1/GWR.
States considering whether to grant a
two-year capital improvement extension
for compliance with the GWR or LT1
will also need to consider the impact of
such extensions on compliance with
today's rule, since the two-year
extension for the Stage 1 DBPR has
already been used. EPA believes,
however, that these systems will
generally not require extensive capital
improvements that take longer than
three years to install to meet Stage 1
DBPR, GWR, and LT1 requirements, or
will require no capital improvements at
all. However if needed, EPA will work
with States and utilities to address
systems that require time beyond
November 2003 to comply. This strategy
may include exemptions. In addition,
EPA will provide guidance and
technical assistance to States and
systems to facilitate timely compliance
with both DBP and microbial
requirements. EPA will request
comment on how best to do this when
the Agency proposes the LTESWTR and
GWR.
3. Summary of Major Comments
Commenters were in general
agreement that the compliance deadline
strategy contained in the fourth option
of the 1997 NODA did the best job of
complying with the requirements to
1996 SDWA Amendments and meeting
the objectives of the 1993 Reg. Neg.
Agreement that Congress affirmed as
part of the 1996 Amendments.
Nonetheless, a number of commenters
expressed concern about the ability of
large surface water systems that had to
make capital improvements to comply
with all requirements of the Stage 1
DBPR and IESWTR. They pointed out
that capital improvements include more
than just the construction, but also
financing, design, and approval.
EPA believes that the provisions of
section 1412(b)(10) of the SDWA as
amended allow systems the flexibility
needed to comply. As noted earlier in
this section, States may grant up to an
additional two years compliance time
for an individual system if capital
improvements are necessary. Moreover,
as both of these rules have been under
negotiation since 1992, proposed in
1994 and further clarified in 1997, EPA
believes that most systems have had
substantial time to consider how to
proceed with implementation and to
initiate preliminary planning. Several
commenters also supported delaying the
promulgation of the Stage 1 DBPR for
ground water systems until the GWR is
promulgated, in order to ensure
simultaneous compliance with both
rules. EPA believes that this option
would not be consistent with the reg-
neg agreement, as endorsed by Congress,
because the agreement specifies that the
Stage 1 DBPR will apply to all
community and nontransient
noncommunity water systems.
Moreover, EPA has committed to the
LT1 and GWR promulgation schedule
outlined above precisely to address this
issue.
In conclusion EPA believes that the
compliance deadlines outlined above
for systems covered by this rule are
appropriate and consistent with the
requirements of the 1996 SDWA
amendments. The Agency notes,
however, that some elements of Option
4 outlined in the 1997 NODA apply to
systems that may be covered by future
Long Term Enhanced and Ground Water
rules. EPA intends to follow the
deadline strategy outlined in Option 4
for these future rules. However, as
today's action only relates to the
IESWTR, the Agency will defer final
action on deadlines associated with
future rules until those rules,
themselves, are finalized.
IV. State Implementation
This section describes the regulations
and other procedures and policies States
have to adopt, or have in place, to
implement today's final rule. States
must continue to meet all other
conditions of primacy in section 142.
Section 1413 of the SDWA establishes
requirements that a State or eligible
Indian tribe must meet to maintain
primary enforcement responsibility
(primacy) for its public water systems.
These include (1) 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
69498 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
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 final rule, along with the
special primacy requirements discussed
below.
To implement today's final rule,
States are required to adopt revisions to
§141.2Ðdefinitions; §141.32Ðpublic
notification; §142.14Ðrecords kept by
States; §142.15Ðreports by States;
§142.16Ðspecial primacy requirements;
§141.52Ðmaximum contaminant level
goals for microbiological contaminants;
§141.70Ðgeneral requirements;
§141.71Ðcriteria for avoiding filtration;
§141.73Ðfiltration; §141.153Ðcontent
of the reports; and a new subpart P,
consisting of §141.170 to §141.175.
A. Special State Primacy Requirements
In addition to adopting drinking water
regulations at least as stringent as the
Federal regulations listed above, EPA
requires that States adopt certain
additional provisions related to this
regulation to have their program
revision application approved by EPA.
This information advises the regulated
community of State requirements and
helps EPA in its oversight of State
programs. States which require without
exception all public water systems using
a surface water source or a ground water
source under the direct influence of
surface water to provide filtration need
not demonstrate that the State program
has provisions that apply to systems
which do not provide filtration
treatment. However, such States must
provide the text of the State statutes or
regulations which specifies that public
water systems using a source water must
provide filtration.
EPA is currently developing, with
stakeholder input, several guidance
documents to aid the States and water
systems in implementing today's final
rule. This includes guidance for the
following topics: Enhanced coagulation,
disinfection benchmark and profiling,
turbidity, alternative disinfectants, M±
DBP simultaneous compliance, sanitary
survey, unfiltered systems and
uncovered finished water reservoirs. In
addition, upon promulgation of the
IESWTR, EPA will work with States to
develop a State implementation
guidance manual.
To ensure that the State program
includes all the elements necessary for
a complete enforcement program, the
State's application must include the
following in order to obtain EPA's
approval for implementing this rule:
(1) Adoption of the promulgated
IESWTR.
(2) Description of how the State will
implement its sanitary survey program
and how the State will assure that a
system responds in writing to a sanitary
survey report within 45 days indicating
how and on what schedule the system
will address significant deficiencies
noted in the survey. The description
must also identify the appropriate rules
or other authority of the State to assure
that PWSs respond to significant
deficiencies. The State must conduct
sanitary surveys that include eight
specified components (described below)
for all surface water and GWUDI
systems no less frequently than every 3
years for community systems and no
less frequently than every five years for
noncommunity systems. The State may
``grandfather'' sanitary surveys
conducted after December 1995 for the
first set of required sanitary surveys if
the surveys address the eight sanitary
survey components (source; treatment;
distribution system; finished water
storage; pumps, pump facilities and
controls; monitoring and reporting and
data verification; system management
and operation; and operator compliance
with State requirements). For
community systems determined by the
State to have outstanding performance
based on prior sanitary surveys,
subsequent sanitary surveys may be
conducted no less than every five years.
The State must include how it will
decide whether a system has
outstanding performance in its primacy
application. Components of a sanitary
survey may be completed as part of a
staged or phased State review process
within the established frequency. The
State must also describe how it will
decide whether a deficiency identified
during a sanitary survey is significant.
(3) Description of the procedures the
State will use to determine the adequacy
of changes in disinfection process by
systems required to profile and
benchmark under §141.172 and how
the State will consult with PWSs to
evaluate modifications to disinfection
practice.
(4) Description of existing or adoption
of appropriate rules or other authority to
assure PWSs to conduct a Composite
Correction Program (CCP) and to require
that PWSs implement any follow up
recommendations that results as part of
the CCP.
(5) Description of how the State will
approve a more representative annual
data set than the data set determined
under §141.172(a)(1) or (2) for the
purpose of determining applicability of
the requirements of §141.172
(disinfection benchmarking/profiling).
(6) Description of how the State will
approve a method to calculate the logs
of inactivation for viruses for a system
that uses either chloramines or ozone
for primary disinfection.
(7) For filtration technologies other
than conventional filtration treatment,
direct filtration, slow sand filtration or
diatomaceous earth filtration, a
description of how the State will
determine that a public water system
may use a filtration technology if the
PWS demonstrates to the State, using
pilot plant studies or other means, that
the alternative filtration technology, in
combination with the disinfection
treatment that meets the requirements of
§141.172(b) of this title, consistently
achieves 99.9 percent removal and/or
inactivation of Giardia lamblia cysts
and 99.99 percent removal and/or
inactivation of viruses, and 99 percent
removal of Cryptosporidium oocysts;
and a description of how, for the system
that makes this demonstration, the State
will set turbidity performance
requirements that the system must meet
95 percent of the time and that the
system may not exceed at any time at a
level that consistently achieves 99.9
percent removal and/or inactivation of
Giardia lamblia cysts, 99.99 percent
removal and/or inactivation of viruses,
and 99 percent removal of
Cryptosporidium oocysts.
B. State Recordkeeping Requirements
Today's rule includes changes to the
existing record-keeping provisions to
implement the requirements in today's
final rule. States must maintain records
of the following: (1) Turbidity
measurements must be kept for not less
than one year, (2) disinfectant residual
measurements and other parameters
necessary to document disinfection
effectiveness must be kept for not less
than one year, (3) decisions made on a
system-by-system basis and case-by-case
basis under provisions of part 141,
subpart H or subpart P, (4) a list of
systems consulting with the State
concerning a modification of
disinfection practice (including the
status of the consultation), (5) a list of
decisions that a system using alternative
filtration technologies can consistently
achieve a 99 percent removal of
Cryptosporidium oocysts as well as the
required levels of removal and/or
69499Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
inactivation of Giardia and viruses for
systems using alternative filtration
technologies, including State-set
enforceable turbidity limits for each
system. A copy of the decision must be
kept until the decision is reversed or
revised and the State must provide a
copy of the decision to the system, (6)
a list of systems required to do filter
self-assessments, CPE or CCP. These
decision records must be kept for 40
years (as currently required by §142.14
for other State decision records) or until
a subsequent determination is made,
whichever is shorter.
C. State Reporting Requirements
Currently States must report to EPA
information under 40 CFR 142.15
regarding violations, variances and
exemptions, enforcement actions and
general operations of State public water
supply programs. Today's rule requires
States to provide additional information
to EPA within the context of the existing
special report requirements for the
SWTR (§142.15(c)(1)). States must
report a list of Subpart H systems that
have had a sanitary survey completed
during the previous year and an
evaluation of the State's program for
conducting sanitary surveys.
D. Interim Primacy
On April 28, 1998, EPA amended its
State primacy regulations at 40 CFR
142.12 (EPA 1998d, 63 FR 23362) to
incorporate the new process identified
in the 1996 SDWA amendments for
granting primary enforcement authority
to States while their applications to
modify their primacy programs are
under review. The new process grants
interim primary enforcement authority
for a new or revised regulation during
the period in which EPA is making a
determination with regard to primacy
for that new or revised regulation. This
interim enforcement authority begins on
the date of the primacy application
submission or the effective date of the
new or revised State regulation,
whichever is later, and ends when EPA
makes a final determination. However,
this interim primacy authority is only
available to a State that has primacy for
every existing national primary drinking
water regulation in effect when the new
regulation is promulgated.
As a result, States that have primacy
for every existing NPDWR already in
effect may obtain interim primacy for
this rule, beginning on the date that the
State submits its complete and final
application for primacy for this rule to
EPA, or the effective date of its revised
regulations, whichever is later. In
addition, a State which wishes to obtain
interim primacy for future NPDWRs
must obtain primacy for this rule. After
the effective date of today's rule, any
State that does not have primacy for this
rule cannot obtain interim primacy for
future rules.
V. Economic Analysis
A. Today's Rule
EPA has estimated that the total
annualized cost for implementing the
IESWTR is $307 million, in 1998
dollars, at 7 percent rate cost of capital.
This estimate includes annualized
treatment costs to utilities ($192
million), start-up and annualized
monitoring costs to utilities ($99
million), and start-up and annualized
monitoring costs to States ($16 million).
Annualized treatment costs to utilities
includes annual operation and
maintenance costs ($106 million) and
annualized capital costs assuming 7
percent cost of capital ($86 million).
The two cost elements which have the
greatest impact on total annualized costs
are treatment ($192 million), which for
the most part reflects turbidity treatment
costs, and turbidity monitoring ($96
million). More detail including the basis
for these estimates and alternate cost
estimates using different cost of capital
assumptions are described later in this
section. The benefits resulting from this
rule range from $0.263 billion to $1.240
billion per year using a valuation of
$2,000 in health damages avoided per
cryptosporidiosis illness prevented
(based on the mean of a distribution of
values ascribed to health damages
avoided, as discussed below). Based on
this analysis, EPA has determined that
the benefits of today's rule justify the
costs.
B. Overview of RIA for Proposed Rule
The Regulatory Impact Analysis (RIA)
(EPA, 1994f) for the proposed IESWTR
(59 FR 38832, July 29, 1994) only
considered one of the rule options that
were proposed: that which would
require systems to provide enough
treatment to achieve less than a 10´4
risk level from giardiasis while meeting
the Stage 1 DBPR. Other rule options
were not considered for the RIA because
of insufficient data at the time of
proposal. The RIA for the proposed
1994 IESWTR estimated national capital
and annualized costs (amortized capital
and annual operating costs) for surface
water systems serving at least 10,000
people at $4.4 billion and $468 million
(in 1998 dollars at a 10% cost of capital)
respectively. In estimating these costs, it
was assumed that additional Giardia
reduction beyond the requirements of
the SWTR to achieve the 10´4 risk level
would be achieved solely by using
chlorine as the disinfectant and
providing additional contact time by
increasing the disinfectant contact basin
size. Under the 1994 RIA, EPA also
estimated that 400,000 to 500,000
Giardia infections per year that could be
avoided would have an economic value
of $1.4 to $1.7 billion per year (in 1998
dollars at a 10% cost of capital),
suggesting under this rule option, the
benefit nationwide of avoiding Giardia
infections would be as much as three or
four times greater than the estimated
$468 million national annual cost of
providing additional contact time.
Development of the proposed rule
option was based on the availability of
an analytical method to quantify Giardia
source water concentrations and
prescribe appropriate levels of treatment
to achieve the 10´4 risk level. This rule
option was dropped from consideration
of a final IESWTR since adequate
methods for measuring Giardia were not
available during the final development
phase of this rule. Also, ICR data was
not available to evaluate the validity of
assumed national Giardia source water
concentration levels under the RIA for
the proposed rule.
C. What's Changed Since the Proposed
Rule
National source water occurrence data
for Giardia and Cryptosporidium are
being collected as part of the ICR but
this data will not become available until
after promulgation of the IESWTR.
Since February 1997, the Agency
worked with stakeholders to identify
additional data available since 1994 to
support the RIA for the IESWTR
published today. USEPA established the
Microbial and Disinfectants/
Disinfection Byproducts Advisory
Committee to collect, share and analyze
new information and data, as well as to
build consensus on the regulatory
implications of this new information.
D. Summary of Cost Analysis
The IESWTR will result in increased
costs to public water systems for
improved turbidity treatment,
monitoring, disinfection benchmarking
and covering new finished water
reservoirs, as well as State
implementation costs. As discussed
earlier in this Notice, the rule will only
apply to systems using surface water or
ground water under the direct influence
of surface water that serve 10,000 or
more persons. (EPA notes that the rule
does include provisions for primacy
States to conduct sanitary surveys for all
surface water and GWUDI systems
regardless of size.) EPA intends to
address systems serving less than 10,000
people, under the Long Term 1
69500 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
Enhanced Surface Water Treatment
Rule.
Table V.1 indicates estimated annual
costs associated with implementing the
IESWTR in 1998 dollars for different
cost of capital assumptions. A cost of
capital rate of 7 percent was used to
calculate the unit costs for the national
compliance cost model. This rate
represents the standard discount rate
preferred by the Office of Management
and Budget (OMB) for benefit-cost
analyses of government programs and
regulations. The 3 percent rate and 10
percent rate are provided as a sensitivity
analysis. The 10 percent rate also
provides a link to the 1994 Stage 1
DBPR cost analysis which was based on
a 10 percent rate.
Estimated costs are presented as
either public water system (utility) or
State costs. Utility costs include all
costs associated with improved
turbidity treatment, start-up and annual
costs for turbidity monitoring, the one-
time cost of performing disinfection
benchmarking, and costs for covering
new finished water reservoirs. State
costs include program start-up and
ongoing implementation costs,
including sanitary surveys.
The 1994 proposal, in 1998 dollars, is
equivalent to $4.370 billion for total
capital costs, a difference of $3.611
billion (in 1998 dollars) from the capital
costs estimated for today's final rule.
The difference is accounted for
primarily by rule criteria evaluated in
the benefit-cost analysis, i.e., changes in
the level of disinfection required. Under
the final IESWTR virtually no systems
would need to install additional
disinfection contact basins. Also, the
capital costs associated with physical
removal under the final IESWTR are
substantially lower than those estimated
in the 1994 RIA.
To comply with the IESWTR, systems
would be expected to employ treatment
enhancement and/or modifications.
These activities were grouped into 10
decision tree categories based on general
process descriptions as follows:
chemical addition, coagulant
improvements, rapid mixing,
flocculation improvements, settling
improvements, filtration improvements,
hydraulic improvements, administration
culture improvements, laboratory
modifications and process control
testing modifications. Descriptions of
how systems were expected to evaluate
these activities are included in the
document Technologies and Costs for
the Interim Enhanced Surface Water
Treatment Rule (USEPA, 1998b).
The decision tree stratifies public
water systems into groups or categories
based on the number of people served
and the range of treatment choices
available to them to achieve
compliance. The decision tree
incorporates estimates of the percent of
public water systems in each category
selecting a particular approach to
achieve compliance. These percentages
were factors in the national cost model
and represent the percentage of systems
needing to modify treatment to meet the
limits. Further description of the
compliance decision tree and
methodology are included in the
Regulatory Impact Analysis for the
Interim Enhanced Surface Water
Treatment Rule (USEPA, 1998a). Based
on this decision tree analysis and the
total costs indicated in Table V.1, the
two cost elements which have the
greatest impact on national costs are
Total Treatment, which for the most
part reflects turbidity treatment costs,
and Turbidity Monitoring. The percent
of systems estimated to modify
treatment practices to meet the revised
turbidity requirements (i.e., 0.3 NTU 95
percentile and 1 NTU maximum
combined filter effluent levels) is 50
percent (or 691 out of a possible 1,381
systems), as shown in Table V.2.
Turbidity monitoring is required of all
systems covered by the rule and using
rapid granular filtration (i.e.,
conventional or direct filtration). As
shown in table V.3, total annual cost to
utilities for turbidity monitoring are $96
million.
E. Household Costs
Household costs are a way to
represent water system treatment costs
as costs to the system customer. Under
the IESWTR, households will face the
increases in annual costs displayed in
Figure V.1. All households served by
large surface water systems will incur
additional costs under the IESWTR
since all systems are required to perform
turbidity monitoring activities.
However, as shown in the cumulative
distribution of households affected by
the rule, 92 percent of households (60
million) will incur less than a cost of $1
per month. 7 percent of households (5
million) will face an increase in cost of
between $1 and $5 per month. The
highest cost faced by 23,000 households
is approximately $100 per year ($8 per
month).
The assumptions and structure of this
analysis, in describing the curve, tend to
overestimate the highest costs. To be on
the upper bound of the curve, a system
would have to implement all, or almost
all, of the treatment activities. These
systems, however, might seek less costly
alternatives, such as connecting into a
larger regional water system.
F. Summary of Benefits Analysis
The economic benefits of the IESWTR
derive from the increased level of
protection to public health. The primary
goal of these provisions is to improve
public health by increasing the level of
protection from exposure to
Cryptosporidium and other pathogens
(i.e., Giardia, or other waterborne
bacterial or viral pathogens) in drinking
water supplies through improvements
in filtration at water systems. The
IESWTR is expected to reduce the level
of Cryptosporidium and other pathogen
contamination in finished drinking
water supplies through improvements
in filtration at water systems (i.e.,
revised turbidity requirements). In this
case, benefits will accrue due to the
decreased likelihood of endemic
incidences of cryptosporidiosis,
giardiasis and other waterborne disease,
and the avoidance of resulting health
costs. In addition to reducing the
endemic disease, the provisions are
expected to reduce the likelihood of the
occurrence of Cryptosporidium
outbreaks and their associated economic
costs, by providing a larger margin of
safety against such outbreaks for some
systems.
The benefit analysis attempts to take
into account some of the uncertainties
in the analysis by estimating benefits
under two different current treatment
assumptions and three improved
removal assumptions. The benefit
analysis also used Monte Carlo
simulations to derive a distribution of
estimates, rather than a single point
estimate.
The benefits analysis focused on
estimating changes in incidence of
cryptosporidiosis that would result from
the rule. The analysis included
estimating the baseline (pre-IESWTR)
levels of exposure from
Cryptosporidium in drinking water,
reductions in such exposure resulting
from treatment changes to comply with
the IESWTR, and resultant reductions of
risk.
Baseline levels of Cryptosporidium in
finished water were estimated by
assuming national source water
occurrence distribution (based on data
by LeChevallier and Norton 1995) and a
national distribution of
Cryptosporidium removal by treatment.
In the IESWTR RIA, the following two
assumptions were made about the
performance of current treatment in
removing oocysts to estimate finished
water Cryptosporidium concentrations.
Based on treatment removal efficiency
data presented in the 1997 IESWTR
NODA, EPA assumed a national
distribution of physical removal
69501Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
efficiencies with a mean of 2.5 logs and
a standard deviation of ±0.63 logs.
Under this assumption, average log
removal for different plants would
generally range from 1.25 logs to 3.75
logs. Because the finished water
concentrations of oocysts represent the
baseline against which improved
removal from the IESWTR is compared,
variations in the log removal
assumption could have considerable
impact on the risk assessment. To
evaluate the impact of the removal
assumptions on the baseline and
resulting improvements, an alternative
mean log removal/inactivation
assumption of 3.0 logs and a standard
deviation of ±0.63 logs was also used to
calculate finished water concentrations
of Cryptosporidium. Under this
assumption average log removal for
different plants would generally range
from 1.75 to 4.25 logs.
For each of the two baseline
assumptions, USEPA assumed that a
certain number of plants would show
low, mid or high improved removal,
depending upon factors such as water
matrix conditions, filtered water
turbidity effluent levels, and coagulant
treatment conditions. As a result, the
RIA considers six scenarios that
encompass the range of endemic health
damages avoided based on the rule.
The finished water Cryptosporidium
distributions that would result from
additional log removal with the
turbidity provisions were derived
assuming that additional log removal
was dependent on current removal, i.e.,
that sites currently operating at the
highest filtered water turbidity levels
would show the largest improvements
or high improved removal assumption
(e.g., plants now failing to meet a 0.4
NTU limit would show greater removal
improvements than plants now meeting
a 0.3 NTU limit).
Table V.4 indicates estimated annual
benefits associated with implementing
the IESWTR. The benefits analysis
quantitatively examines endemic health
damages avoided based on the IESWTR
for each of the six scenarios mentioned
above. For each of these scenarios, EPA
calculated the mean of the distribution
of the number of illnesses avoided. The
assessment also discusses, but does not
quantify, other economic benefits that
may result from the provisions,
including the avoided health damage
costs associated with reduced risk of
outbreaks and avoided costs of averting
behavior such as boiling water or use of
an alternative water source during
outbreaks or periods of high turbidity.
According to the RIA performed for
the IESWTR published today, the rule is
estimated to reduce the mean annual
number of illnesses caused by
Cryptosporidium in water systems
improving filtration by 110,000 to
463,000 cases depending upon which of
the six baseline and improved
Cryptosporidium removal assumptions
was used. Based on these values, the
mean estimated annual benefits of
reducing the illnesses ranges from
$0.263 billion to $1.240 billion per year.
This calculation is based on a valuation
of $2,000 per incidence of
cryptosporidiosis prevented which is
the mean of a distribution of values
ascribed to health damages avoided. The
RIA also indicated that the rule could
result in a mean reduction of 14 to 64
fatalities each year, depending upon the
varied baseline and improved removal
assumptions. Using a mean value of
$5.6 million per statistical life saved,
reducing these fatalities could produce
benefits in the range of $0.085 billion to
$0.363 billion.
G. Comparison of Costs and Benefits
Given the costs summarized in Table
V.1 and the benefits summarized in
Table V.4, the IESWTR results in
positive net benefits under all three
improved removal scenarios (low, mid,
and high) assuming that current
treatment as a national average achieves
2.5 log of Cryptosporidium removal,
taking into account only the value of
cost of illness avoided. Using a current
national average treatment removal
assumption of 3.0 logs, net benefits are
positive under the high and mid
improved removal scenarios. Net
benefits using the 3.0 log current
removal assumption are negative under
the low improved removal scenario
using only the value of cost of illness
avoided, however, when the value of
mortalities prevented is added into the
benefits, all scenarios have positive net
benefits at the mean.
Thus, the monetized net benefits are
positive across most of the range of
current treatment assumptions,
improved log removal scenarios, and
discount rates. The benefits due to the
illnesses avoided may be slightly
overstated when aggregated with
benefits due to mortalities avoided,
because the mortalities were not netted
out of the number of illnesses. This
value is minimal and would not be
captured at the level of significance of
the analysis. Several categories of
benefits, including reducing the risk of
outbreaks, reducing exposure to other
pathogens such as Giardia, and avoiding
the cost of averting behavior have not
been quantified for this analysis, but
could represent substantial additional
economic value. In addition, the
estimates for avoided costs of illness do
not include the value for pain and
suffering or the risk premium.
TABLE V.1.—ANNUAL COSTS OF THE INTERIM ENHANCED SURFACE WATER TREATMENT RULE ($000S)
Final Rule (1998 dollars)1994 Proposal
3% Cost of
Capital
7% Cost of
Capital
10% Cost of
Capital
10% Cost of
Capital
1992 dollars
10% Cost of
Capital
1998 dollars
Utility Costs
Utility Treatment Capital ....................................................................$758,965 $758,965 $758,965 $3,665,568 $4,370,389
Annual Costs
Annualized Capital †..........................................................................65,999 85,611 103,437
Annual O&M ......................................................................................105,943 105,943 105,943
Total Treatment .................................................................................171,942 191,554 209,380 391,702 466,891
Turbidity Monitoring ...........................................................................95,924 95,924 95,924
Turbidity Exceptions*.........................................................................195 195 195
Disinfection Benchmarking ................................................................2,841 2,841 2,841
Subtotal ......................................................................................270,902 290,514 308,340 391,702 466,891
Annualized One-Time Costs**
Turbidity Monitoring Start-Up ............................................................289 405 504 .................... ....................
69502 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
TABLE V.1.—ANNUAL COSTS OF THE INTERIM ENHANCED SURFACE WATER TREATMENT RULE ($000S)—Continued
Final Rule (1998 dollars)1994 Proposal
3% Cost of
Capital
7% Cost of
Capital
10% Cost of
Capital
10% Cost of
Capital
1992 dollars
10% Cost of
Capital
1998 dollars
HAA Benchmarking ...........................................................................175 246 306 .................... ....................
Subtotal ......................................................................................464 651 810 .................... ....................
Total Annual Utility Costs ....................................................271,366 291,165 309,150 .................... ....................
State Costs
Annual Costs
Turbidity Monitoring ...........................................................................5,256 5,256 5,256 .................... ....................
Turbidity Exceptions***......................................................................409 409 409 .................... ....................
Sanitary Survey .................................................................................6,979 6,979 6,979 867 1,034
Disinfection Benchmarking ................................................................2,789 2,789 2,789 .................... ....................
Subtotal ......................................................................................15,433 15,433 15,433 867 1,034
Annualized One-Time Costs**
Turbidity Monitoring Start-Up ............................................................27 38 48 .................... ....................
Disinfection Benchmarking Start-Up .................................................22 30 38 .................... ....................
Sanitary Survey Start-Up ...................................................................39 55 69 .................... ....................
Subtotal ......................................................................................88 123 155 .................... ....................
Total Annual State Costs ....................................................15,521 15,556 15,588 .................... ....................
Total Annual Costs ..............................................................286,887 306,721 324,738 392,569 467,925
*Costs associated with Individual Filter Effluent Turbidity Requirements for exceptions reporting, Individual Filter Assessments.
**All one-time costs are annualized over 20 years.
***Costs associated with Reporting Exceptions and Comprehensive Performance Evaluations.
†Most costs are annualized over 20 years. Some costs, including turbidimeters and process control monitoring, are annualized over 7 years.
TABLE V.2.—FINAL ANNUAL COST ESTIMATES FOR TURBIDITY TREATMENT REQUIREMENTS
[0.3 NTU CFE 95th percentile, 1 NTU CFE Maximum 1998 $000s]
System Size (population served)Number of
Systems
Systems
Modifying
Treatment
3 Percent
Cost of
Capital
7 Percent
Cost of
Capital
10 Percent
Cost of
Capital
10,000–25,000 ..........................................................................................594 303 $ 33,946 $ 37,624 $40,932
25,000–50,000 316 161 29,316 31,862 35,304
50,000–75,000 ..........................................................................................124 63 15,450 17,143 18,564
75,000–100,000 ........................................................................................52 27 7,958 8,861 9,508
100,000–500,000 ......................................................................................259 122 56,895 63,544 69,080
500,000–1 Million ......................................................................................26 11 16,310 18,381 20,092
>1 Million ..................................................................................................10 4 10,130 11,641 12,927
Total ...................................................................................................1,381 691 170,005 189,056 206,407
TABLE V.3.—UTILITY TURBIDITY START-UP AND MONITORING ANNUAL COSTS
Compliance Activities Respondents Affected Unit Costs CF *Annual Costs
Utility Start-Up Costs **..............................................1,381 Systems .....................................$3,108 0.09439 $405,136
Utility Plant Monitoring Costs ....................................1,728 Plants .........................................52,644 90,968,832
Utility System Monitoring Costs .................................1,381 Systems .....................................3,588 4,955,028
Total Annual Utility Costs for Turbidity Monitor-
ing and Start-Up.
.........................................................96,328,996
*The Capitalization Factor (CF) is calculated using the cost of capital (7%), the number of years of capitalization (20 years), and the current
value of money ($1).
**Start-up costs are annualized over 20 years with a CF of 0.09439.
69503Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
TABLE V.4.—SUMMARY OF POTENTIAL ANNUAL BENEFITS
Baseline Assumes
2.5 Log Cryptosporidium Removal 3.0 Log Cryptosporidium Removal
Mean Range Mean Range
Cryptosporidiosis Illness
Avoided Annually
Low Estimate of Number of
Illnesses Avoided.
338,000 ..........................0–1,029,000 ...................110,000 ..........................0–322,500
Cost of Illness Avoided ..$0.950 billion ..................0–1.883 billion ................0.263 billion ....................0–0.585 billion
Mid Number of Illnesses
Avoided.
432,000 ..........................0–1,074,000 ...................141,000 ..........................0–333,000
Cost of Illness Avoided ..1.172 billion ....................0–1.960 billion ................0.327 billion ....................0–0.608 billion
High Number of Illnesses
Avoided.
463,000 ..........................0–1,080,000 ...................152,000 ..........................0–338,000
Cost of Illness Avoided ..1.240 billion ....................0–1.999 billion ................0.359 billion ....................0–0.620 billion
Value of Cryptosporidiosis
Mortalities Avoided Annually
Low Number of Mortalities
Avoided.
48 ...................................0–129 .............................14 ...................................0–40
Value of Mortalities
Avoided.
0.272 billion ....................0–0.674 billion ................0.085 billion ....................0–0.209 billion
Mid Number of Mortalities
Avoided.
60 ...................................0–135 .............................18 ...................................0–42
Value of Mortalities
Avoided.
0.341 billion ....................0–0.706 billion ................0.107 billion ....................0–0.219 billion
High Number of Mortalities
Avoided.
64 ...................................0–136 .............................20 ...................................0–42
Value of Mortalities
Avoided.
0.363 billion ....................0–0.708 billion ................0.115 billion ....................0–0.221 billion
Reduced Risk of
Cryptosporidiosis Outbreaks
Cost of Illness Avoided
Emergency Expenditures
Liability Costs Benefits not quantified, but could be substantial for large outbreak ($0.800 billion cost of illness avoided for a
Milwaukee-level outbreak).
Reduced Risk from Other
Pathogens.
Benefits not quantified.
Enhanced Aesthetic Water
Quality.
Difference may not be noticeable to consumer.
Averting Behavior ......................Benefits not quantified, but could be substantial for large outbreak ($0.020 billion to $0.062 billion for a Mil-
waukee-level outbreak).
BILLING CODE 6560–50–P
69504 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
BILLING CODE 6560–50–C
VI. Additional Issues Discussed in 1994
Proposal and 1997 NODA
A. Inactivation of Cryptosporidium
When the IESWTR was proposed in
1994, EPA recognized that chlorine
disinfectants were relatively ineffective
in inactivating Cryptosporidium, but
was not certain if alternative
disinfectants might be more effective
than chlorine. In the NODA for the
IESWTR, EPA discussed the present
data on Cryptosporidium disinfection
for a variety of disinfectants. Many
commenters thought that sufficient data
was not available to develop guidelines
for estimating inactivation of
Cryptosporidium in water. Several
commenters pointed out the
inconsistency of inactivation data from
different studies. Some commenters also
supported the use of Giardia as the
target organism for defining the
disinfection benchmark required by
today's rule. EPA believes that
variability in inactivation results is not
surprising, given the absence of
standard testing protocol and
methodology, and agrees that the
existing data is not sufficient to enable
the development of guidelines for
estimating inactivation efficiencies for
Cryptosporidium in water. The Agency
also notes that research is underway to
better clarify inactivation efficiencies for
Cryptosporidium and anticipates that
new research results will be available
for consideration during the
development of the Long Term 2
Enhanced Surface Water Treatment Rule
which EPA plans to promulgate
simultaneously with the Stage 2 DBPR.
B. Giardia Inactivation CT Values for
Profiling/Benchmarking
In the 1997 NODA for the IESWTR,
EPA requested comment on developing
CT tables for free chlorine at pH levels
above 9, which are not currently
available in EPA's guidance to the
SWTR. This effort was intended to
support implementation of the
microbial profiling/benchmarking
required in the today's rule. Under the
profiling/benchmarking requirement,
certain utilities must determine CT
values and compute daily average log
inactivation of Giardia.
While some commenters supported
the CT tables for high pHs presented in
the NODA, other commenters opposed
them because they thought that the
literature data were not sufficient for
development of these CT tables.
Commenters also noted that for the
systems with pH levels higher than 9,
States currently provide guidelines by
which utilities can estimate inactivation
levels for the purpose of compliance
with the SWTR. State guidelines are to
use inactivation levels at pH 9 for above
pH 9 conditions. EPA believes these
guidelines, along with existing CT
tables, are sufficient for implementing
the benchmark/profiling requirements
and therefore no additional CT tables
have been developed at this time.
As explained previously, in
conjunction with today's rule, EPA is
also concurrently promulgating the
Stage 1 DBPR under which the
maximum disinfectant residual level for
free chlorine is 4 mg/L. However, the CT
tables for free chlorine that appear in
the SWTR Guidance Manual only cover
the chlorine residual up to 3 mg/L.
Some commenters expressed a need for
CT values for higher chlorine residuals.
Since it has been observed that the free
chlorine residual concentration (C) is
not as significant as the contact time (T)
in terms of inactivation kinetics for
Giardia cysts and no data are currently
available to support the development of
additional CT tables for the range of
chlorine residuals between 3 and 4 mg/
L, EPA recommends that for the purpose
of microbial profiling/benchmarking the
value of 3 mg/L as Cl2 be used for
estimating log inactivation when the
chlorine residual level is higher than 3
mg/L.
C. Cross Connection Control
Today's Rule
EPA is not establishing requirements
for cross connection control in today's
final rule. The Agency does plan to
consider cross connection control issues
during the development of subsequent
microbial regulations, in the context of
a broad range of issues related to
distribution systems. At that time the
results of research currently in progress
should be available to the Agency and
enable EPA to make regulatory
decisions.
Background and Analysis
The proposed IESWTR (EPA, 1994b,
59 FR 38841, July 29, 1994) requested
69505Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
public comment on whether the Agency
should require States and/or systems to
have a cross-connection control
program. In addition, the Agency
solicited comment on a number of
associated issues, including (1) what
specific criteria, if any, should be
included in such a requirement, (2) how
often such a program should be
evaluated, (3) whether EPA should limit
any requirement to only those
connections identified as a cross
connection by the public water system
or the State, and (4) conditions under
which a waiver from this requirement
would be appropriate. The Agency also
requested commenters to identify other
regulatory measures EPA should
consider to prevent contamination of
drinking water in the distribution
system (e.g., minimum pressure
requirements in the distribution
system).
Historically, a significant portion of
waterborne disease outbreaks reported
by CDC are caused by distribution
system deficiencies. Distribution system
deficiencies are defined in CDC's
publication Morbidity and Mortality
Weekly Report as cross connections,
contamination of water mains during
construction or repair, and
contamination of a storage facility.
Between 1971±1994, approximately 53
waterborne disease outbreaks reported
were associated with cross connections
or backsiphonage. Fifty-six outbreaks
were associated with other distribution
system deficiencies (Craun, Pers. Comm.
1997b). Some outbreaks have resulted
from water main breaks or repairs.
There is no centralized repository
where backflow incidents are reported
or recorded. The vast majority of
backflow incidents are probably not
reported. Examples of specific backflow
incidents are described in detail in
EPA's Cross-Connection Control Manual
(EPA, 1989a).
Where cross connections exist, some
protection is still afforded to the
distribution system by the maintenance
of a positive water pressure in the
system. Adequate maintenance of
pressure provides a net movement of
water out through breaks in the
distribution pipes and prevents
contaminated water outside of the pipes
from entering the drinking water
supply. The loss of pressure in the
distribution system, less than 20 psi,
can cause a net movement of water from
outside the pipe to the inside, possibly
allowing the introduction of fecal
contamination into the system. This
problem is of special concern where
wastewater piping is laid in the same
street as the water pipes, creating a
potential threat to public health
whenever there is low or no pressure.
A number of States have cross
connection control programs, although
the extent to which they vary is unclear.
A Florida Department of Environmental
Protection survey evaluated cross-
connection control regulations in the 50
States (Florida DEP 1996). The survey
results showed that 29 of the 40 States
that responded to the survey request
have programs. The rigor of the
programs and the extent to which they
are enforced was not addressed by the
survey. An EPA report suggests that the
responsibility for administration and
enforcement of the State programs is
generally at the local level (EPA, 1995a).
Summary of Major Comments
Most commenters supported either a
federal or State cross connection control
program in order to prevent disease
outbreaks and injury to the public.
Some commenters suggested EPA
update its guidance document on cross
connection control. Commenters
opposed to a cross connection control
program indicated that (1) a federally-
mandated program would be
impractical, burdensome, and would
fail, (2) a State or local program would
be more appropriate than an EPA-
mandated program, (3) most States
already have a comprehensive program,
thus negating need for federal
regulations, (4) EPA should publish
general guidelines only, and (5) there
should be a separate regulation because
a cross connection control program
would affect both surface water and
ground water.
As noted above, EPA plans to
consider cross connection control in the
context of future microbial rules rather
than in the IESWTR. The Agency will
consider cross connection control issues
in connection with a broad range of
issues related to distribution systems as
it develops these microbial rules. Issues
to be considered include biofilm growth
and the potential for biofilm associated
with pathogens, water treatment and
distribution system operations to
minimize microbial growth, and causes
of pathogen intrusion into the
distribution system. These are all areas
that are the focus of a significant
research effort, most of which is still in
progress. The American Water Works
Association Research Foundation
(AWWARF) presently has 17 projects
pertaining to maintenance of water
quality in the distribution system that
are not yet complete. EPA's laboratories
are also working on important research
questions in these areas. EPA intends to
evaluate this large body of distribution
system research as well as data on State
and local government requirements and
their impact in order to develop
comprehensive regulations and
guidance on distribution system
maintenance and operations, including
the prevention of cross-connections.
EPA has previously published
guidance on cross connection control
entitled the Cross Connection Control
Manual (EPA, 1989a, EPA 570/9±89±
007, June 1989). This guidance
describes methods, devices, etc. for
prevention of backflow and back-
siphonage, testing procedures for
backflow preventers, administration of
cross-connection programs and cross-
connection control ordinance
provisions. The Agency plans to update
this Cross Connection Control Manual
during the development of future
microbial rules that address cross
connection. The Agency will request
public comment on issues related to
cross connection control at that time.
EPA would also like to point out that a
number of States and local governments
have existing cross connection control
programs and strongly encourages States
and local governments to implement
effective cross connection control
programs.
D. Filter Backwash Recycling
The SDWA Amendments of 1996
require that the EPA promulgate a
regulation governing the recycle of filter
backwash water within the treatment
process by August 2000. The Agency is
currently developing data and collecting
information to consider these issues in
a separate rule rather than in the
IESWTR. The Agency held a public
meeting in Denver, Colorado, in July
1998 and plans to hold another meeting
in early 1999 to discuss available data
and possible regulatory options, and
intends to propose a rule in August of
1999.
E. Certification Criteria for Water Plant
Operators
The July 29, 1994 notice requested
comment on whether the ESWTR
should define minimum certification
criteria for surface water treatment plant
operators. Currently, the SWTR (141.70)
requires such systems to be operated by
``qualified personnel who meet the
requirements specified by the State''.
EPA is not further defining ``qualified''
in the IESWTR as the operator
certification requirements discussed
below will address this issue. The 1996
Amendments to the SDWA direct the
Administrator, EPA, in cooperation with
the States, to publish guidelines in the
Federal Register specifying minimum
standards for certification and
recertification of operators of
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community and nontransient
noncommunity public water systems.
Draft guidelines were published in the
Federal Register Friday, March 27, 1998
(EPA 1998f) with a 90-day public
comment period. Final guidelines are
required to be published by February
1999. States then have two years to
adopt and implement an operator
certification program that meets these
guidelines. After that date, if a State has
not adopted and implemented an
approved program, the Administrator
must withhold 20 percent of the funds
a State is otherwise entitled to receive
in its Drinking Water State Revolving
Fund (DWSRF) capitalization grants
under section 1452 of SDWA. Questions
regarding the draft guidelines may be
directed to Jenny Jacobs (202±260±2939)
or Richard Naylor (202±260±5135) of
EPA's Office of Ground Water and
Drinking Water. Their e-mail addresses
are: [e-mail] and
[e-mail]. In light
of the 1996 Amendments and the draft
guidelines, certification criteria need
not be included in today's rule.
VII. Other Requirements
A. Regulatory Flexibility Act
Under the Regulatory Flexibility Act
(RFA), 5 U.S.C. 601 et seq., as amended
by the Small Business Regulatory
Enforcement Fairness Act of 1996, EPA
is generally required to prepare a
regulatory flexibility analysis describing
the impact of the regulatory action on
small entities as part of the rulemaking.
However, under section 605(b) of the
RFA, if EPA certifies that the rule will
not have a significant economic impact
on a substantial number of small
entities, EPA is not required to prepare
a regulatory flexibility analysis.
Pursuant to section 605(b) of the RFA,
the Administrator certifies that this rule
will not have a significant economic
impact on a substantial number of small
entities.
The RFA authorizes use of an
alternative definition to that of the
Small Business Administration for a
small water utility. Throughout the
1992±93 negotiated rulemaking process
for the Stage 1 DBPR and IESWTR and
in the July 1994 proposals for these
rules, a small public water system
(PWS) was defined as a system serving
fewer than 10,000 persons. This
definition reflects the fact that the
original 1979 standard for total
trihalomethanes applied only to systems
serving at least 10,000 people. The
definition thus recognizes that baseline
conditions from which systems serving
fewer than 10,000 people will approach
disinfection byproduct control and
simultaneous control of microbial
pathogens is different than that for
systems serving 10,000 or more persons.
EPA again discussed this approach to
the definition of a small system for these
rules in the March 1998 Disinfectants/
Disinfection Byproducts Notice of Data
Availability (63 FR 15676, March 31,
1998). EPA is continuing to define
``small system'' for purposes of this rule
and the Stage 1 DBPR as a system which
serves fewer than 10,000 people. The
IESWTR applies only to systems serving
at least 10,000 people and accordingly
does not have a significant economic
impact on a substantial number of small
entities. Accordingly EPA has not
completed a regulatory flexibility
analysis for the IESWTR or a small
entity compliance guide.
The Agency has since proposed and
taken comment on its intent to define
``small entity'' as a public water system
that serves 10,000 or fewer persons for
purposes of its regulatory flexibility
assessments under the RFA for all future
drinking water regulations. (See
Consumer Confidence Reports Rule, 63
FR 7620, Feb. 13, 1998.) In that
proposal, the Agency discussed the
basis for its decision to use this
definition and to use a single definition
of small public water system whether
the system was a ``small business'',
``small nonprofit organization'', or
``small governmental jurisdiction.'' EPA
also consulted with the Small Business
Administration on the use of this
definition as it relates to small
businesses. Subsequently, the Agency
has used this definition in developing
its regulations under the Safe Drinking
Water Act. This approach is virtually
identical to the approach used in the
IESWTR and Stage 1 DBPR.
B. Paperwork Reduction Act
The Office of Management and Budget
(OMB) has approved the information
collection requirements contained in
this rule under the provisions of the
Paperwork Reduction Act, 44 U.S.C.
3501 et seq. and has assigned OMB
control number 2040±0205.
The information collected as a result
of this rule will allow the States and
EPA to evaluate PWS compliance with
the rule. For the first three years after
promulgation of this rule, the major
information requirements pertain to
monitoring, compliance reporting and
sanitary surveys. Responses to the
request for information are mandatory
(Part 141). The information collected is
not confidential.
EPA is required to estimate the
burden on PWS for complying with the
final rule. 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.
EPA estimates that the annual burden
on PWS and States for reporting and
recordkeeping will be 150,557 hours.
This is based on an estimate that there
will be 998 respondents per year who
will each, on average, need to provide
3,803 responses and that the average
response will take 40 hours. The total
annual cost burden is $27,448,013. This
includes total annual labor costs of
$4,615,791 for the following activities:
reading and understanding the rule,
planning, training, data collection, data
review, data reporting, recordkeeping,
compliance tracking and making
determinations. The cost burden also
includes capital costs of $17,137,222 for
turbidimeter installation by PWS, and
an operations and maintenance cost of
$5,695,000 for turbidimeters.
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.
EPA is amending the table in 40 CFR
part 9 of currently approved ICR control
numbers issued by OMB for various
regulations to list the information
requirements contained in this final
rule. This ICR was previously subject to
public notice and comment prior to
OMB approval. As a result, EPA finds
that there is ``good cause'' under section
553 (b) (B) of the Administrative
Procedures Act (5 U.S.C. 553 (b) (B) to
amend this table without prior notice
and comment. Due to the technical
nature of the table, further notice and
comment would be unnecessary.
C. Unfunded Mandates Reform Act
1. Summary of UMRA requirements
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), Pub. L.
104±4, establishes requirements for
Federal agencies to assess the effects of
their regulatory actions on State, local,
69507Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
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 expenditures to State, local,
and tribal governments, in the aggregate,
or to the private sector, of $100 million
or more in any one year. Before
promulgating an EPA rule for which a
written statement is needed, section 205
of the UMRA generally requires EPA to
identify and consider a reasonable
number of regulatory alternatives and
adopt the least costly, most cost-
effective or least burdensome alternative
that achieves the objectives of the rule.
The provisions of section 205 do not
apply when they are inconsistent with
applicable law. Moreover, section 205
allows EPA to adopt an alternative other
than the least costly, most cost effective
or least burdensome alternative if the
Administrator publishes an explanation
why that alternative was not adopted
with the final rule.
Before EPA establishes any regulatory
requirements that may significantly or
uniquely affect small governments,
including tribal governments, it must
have developed under section 203 of the
UMRA a small government agency plan.
The plan must provide for notifying
potentially affected small governments,
enabling officials of affected small
governments to have meaningful and
timely input in the development of EPA
regulatory proposals with significant
Federal intergovernmental mandates,
and informing, educating and advising
small governments on compliance with
the regulatory requirements.
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 State, local, and tribal
governments, in the aggregate and the
private sector in any one year.
Accordingly, EPA has prepared under
section 202 of the UMRA a written
statement which is summarized below.
The written statement addresses the
following areas: (a) Authorizing
legislation; (b) cost-benefit analysis
including an analysis of the extent to
which the costs of State, local and
Tribal governments will be paid for by
the Federal government; (c) estimates of
future compliance costs and
disproportionate budgetary effects; (d)
macro-economic effects; and (e) a
summary of EPA's consultation with
State, local, and Tribal governments and
their concerns, including a summary of
the Agency's evaluation of those
comments and concerns; (f)
identification and consideration of
regulatory alternatives; and (g) selection
of the least costly, most cost-effective or
least burdensome alternative that
achieves the objectives of the rule. The
major points of this written statement
are summarized below. A more detailed
description of this analysis is presented
in EPA's Unfunded Mandates Reform
Act Analysis for the IESWTR
(EPA,1998c) which is included in the
docket for this rule.
a. Authorizing Legislation
Today's rule is promulgated pursuant
to (section 1412(b)(2)(C)) of the 1996
amendments to the SDWA; paragraph C
of this section establishes a statutory
deadline of November 1998 to
promulgate this rule. In addition, the
Interim Enhanced Surface Water
Treatment Rule (IESWTR) is closely
integrated with the Stage 1 DBPR, which
also has a statutory deadline of
November 1998.
b. Cost Benefit Analysis
Section V of this preamble discusses
in detail the cost and benefits associated
with the IESWTR. Also, the EPA's
Regulatory Impact Analysis of the
Interim Enhanced Surface Water
Treatment Rule (EPA, 1998a) contains a
detailed cost benefit analysis. The
analysis includes both qualitative and
monetized benefits for improvements to
health and safety. Because of scientific
uncertainty regarding the exposure
assessment and the risk assessment for
Cryptosporidium, the Agency calculated
partial monetary benefit estimates for
three different scenarios (low, medium,
high) of improved removal of
Cryptosporidium concentrations
assuming two different levels of current
inactivation (2.5 log baseline or 3.0 log
baseline). Potential monetized annual
benefits for illness avoided associated
with Cryptosporidium ranged from a
mean of $0.263 billion (3.0 log) to a
mean of $1.24 billion (2.5 log) for this
rule depending upon varied baseline
and improved Cryptosporidium removal
assumptions. The benefits from
reduction in exposure to
Cryptosporidium have been compared
with the aggregate annualized costs to
State, local, and tribal governments and
the private sector that totaled
approximately $307 million (annualized
at 7%).
Using a current national average
treatment removal assumption of 3.0
logs, net benefits are positive under the
high and mid improved removal
scenarios. Net benefits using the 3.0 log
current removal assumption are
negative near and below the mean
associated with the low improved
removal assumption using only the
value of cost of illness avoided;
however, when the value of mortalities
prevented is added with the benefits, all
scenarios have positive net benefits at
the mean.
Thus, the monetized net benefits are
positive across most of the range of
current treatment assumptions,
improved log removal scenarios, and
discount rates. The benefits due to the
illnesses avoided may be slightly
overstated because mortalities were not
netted out of the number of illnesses
avoided. This value is minimal and
would not be captured at the level of
significance of the analysis. Other
possible benefits considered in the
analysis but not monetized are reducing
the risk of outbreaks, reducing the
exposure to other pathogens, enhancing
aesthetic water quality, avoiding the
cost of averting behavior, and reducing
the cost of pain and suffering. These
benefits could add substantial economic
value to this rule.
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 primacy 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 the Drinking Water State
Revolving Fund (DWSRF) 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 will have considerable
flexibility to determine the design of its
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 ten
percent of their DWSRF allotments for
each fiscal year to assist in running the
State drinking water program.
c. Estimates of Future Compliance Costs
and Disproportionate Budgetary Effects
EPA believes that the cost estimates
indicated above in Section V to be a
fairly accurate assessment of future
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compliance costs and generally does not
anticipate any disproportionate
budgetary effects. In general, the costs
that a public water system, whether
publicly or privately owned, will incur
to comply with this rule will depend on
many factors that are not generally
based on location. However, the data
needed to confirm this assessment and
to analyze other impacts of this problem
are not available; therefore, EPA looked
at three other factors: The impacts of the
regulation on small versus large
systems, the costs to public versus
private water systems, and the costs to
households. First, EPA notes that the
IESWTR does not have a significant
impact on a substantial number of small
entities, as discussed previously in
Section VII.A. These small systems are
the subject of a subsequent rulemaking
planned for 2000.
Second, the review of costs to public
versus private systems is based on
estimates of the allocation of the
systems across size categories and can
only be viewed as an indication of
possible impacts. More important,
implementation of the rule affects both
public and private water systems
equally, with the variance in total cost
by system size merely a function of the
number of affected systems. This
analysis is presented in further detail in
the IESWTR UMRA Analysis Document
(EPA, 1998c).
Finally, the highest estimated
household costs would be for those
households served by systems that
would have to implement all proposed
combined filter effluent alternative
treatment activities to meet the 0.3 NTU
requirement for 95 percent of samples in
a given month and a maximum of 1
NTU. However, this analysis may
overstate costs because these systems
may choose a less costly alternative
such as point-of-use devices, selecting
alternative water sources, or connecting
to a larger regional water system.
d. Macro-economic Effects
As required under UMRA Section
202, EPA is required to estimate the
potential macro-economic effects of the
regulation. 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 1997,
real GDP was $7,188 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 IESWTR should be negligible based
on the fact that the total annual costs are
about $307 million per year (at a 7
percent cost of capital) and the costs are
not expected to be highly focused on a
particular geographic region or sector.
e. Summary of EPA's Consultation With
State, Local, and Tribal Government and
Their Concerns
Under UMRA section 202, EPA is to
provide a summary of its consultation
with elected representatives (or their
designated authorized employees) of
affected State, local and Tribal
governments in this rulemaking.
Although this rule was proposed before
UMRA became a statutory requirement,
EPA initiated consultations with
governmental entities and the private
sector affected by this rule through
various means. This included
participation on a Regulatory
Negotiation Committee, chartered under
the Federal Advisory Committee Act
(FACA), in 1992±93 that included
stakeholders representing State and
local governments, public health
organizations, public water systems,
elected officials, consumer groups, and
environmental groups.
After the amendments to SDWA in
1996, the Agency initiated a second
FACA process, similarly involving a
broad range of stakeholders, and held
meetings during 1997 to address the
expedited deadline for promulgation of
the IESWTR in November 1998. EPA
established the M±DBP Advisory
Committee to collect, share, and analyze
new data reviewed since the earlier Reg.
Neg. process and also to build a
consensus on the regulatory
implications of this new information.
The M±DBP Advisory Committee
established a technical working group to
assist them with the many scientific
issues surrounding this rule. The
Committee included representatives
from organizations such as the National
League of Cities, the National
Association of City and County Health
Officials, the Association of
Metropolitan Water Agencies, the
Association of State Drinking Water
Administrators, and the National
Association of Water Companies. In
addition, the Agency invited the Native
American Water Association to
participate in the FACA process to
develop this rule. Although they
eventually decided not to take part, the
Association continued to be informed of
meetings and developments through a
stakeholders mailing list. Stakeholders
who participated in the FACA
processes, as well as all other interested
members of the public, were invited to
comment on the proposed rule and
NODA. Also, as part of the Agency's
Communication Strategy, EPA sent
copies of the proposed rule and NODA
to many stakeholders, including six
tribal associations.
In addition, the Agency notified
governmental entities and the private
sector of opportunities to provide input
on this rule in the Federal Register on
July 29, 1994 (59 FR 38832) and on
November 3, 1997 (62 FR 59485). EPA
received written comments from
approximately 37 commenters on the
July 29, 1994 notice and from
approximately 157 commenters on the
November 3, 1997 notice. Of the 37
commenters on the 1994 proposed rule,
approximately 22% were States and
35% were local governments. Of the 157
commenters on the 1997 Notice of Data
Availability, approximately 8% were
States and 27% were local governments.
The public docket for this rulemaking
contains all comments received by the
Agency and provides details about the
nature of State and local governments'
concerns. Issues addressed by State and
local government commenters included
concerns about the cost and feasibility
of proposed regulatory alternatives to
require treatment levels based on
Giardia and/or Cryptosporidium
occurrence in a public water system's
source water; preferences for requiring 2
log removal of Cryptosporidium for
filtered systems; and concerns about the
feasibility of requiring source water
monitoring for unfiltered systems. A
number of commenters on the issue of
sanitary survey frequencies supported
the three and five years frequencies for
community and non-community water
systems, respectively, as recommended
by the M±DBP Advisory Committee.
Some State commenters, however,
expressed concern about resources for
carrying out the surveys on such a
schedule. On the issue of flexibility in
implementing the Stage 1 DBPR and
IESWTR to ensure that the rules are
implemented simultaneously, most
commenters preferred option four
(discussed in the November 1997
IESWTR NODA) that calls for
simultaneous implementation of both
the IESWTR and the Stage 1 DBPR.
EPA understands the State and local
government concerns noted above. EPA
agrees that of the regulatory alternatives
proposed, the appropriate alternative is
the 2 log removal requirement for
Cryptosporidium included in the final
rule; the rule does not include treatment
requirements based on microbial
occurrence in source water. Nor does it
require source water monitoring for
unfiltered systems, based in part on
concerns about current availability of
69509Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
analytical methods. With respect to
sanitary survey frequencies, the final
IESWTR reflects the M±DBP Advisory
Committee's recommendations,
including provisions that allow States to
(1) grandfather surveys done after
December 1995 if they address eight
elements that are currently part of
existing State/EPA guidance; (2) do
sanitary surveys on a five-year instead
of a three-year schedule for community
water systems that the State determines
to be outstanding performers; and (3)
carry out survey components in a staged
or phased manner within the
established frequency. EPA believes that
these frequencies and associated
provisions in the final rule allow States
the flexibility to prioritize and carry out
the sanitary survey process as an
effective tool to identify and correct
water system deficiencies that could
pose a threat to public health. EPA
agrees that concurrent implementation
of the Stage 1 DBPR and IESWTR, as
described in option 4 and reflected in
the final Stage 1 DBPR compliance
schedules, is the most effective means of
implementing both rules. Finally, the
Agency believes that the final IESWTR
will provide public health benefits that
justify the costs of the rule by reducing
the public's exposure to microbial
pathogens, including Cryptosporidium.
EPA notes that, as discussed in Section
V. above, over 90% of affected
households will incur costs of less than
$1 per month.
f. Regulatory Alternatives Considered
As required under section 205 of the
UMRA, EPA considered several
regulatory alternatives that developed
from the Regulatory Negotiation
process, M±DBP Advisory Committee,
and stakeholder comments. These
approaches sought to improve microbial
protection and balance the risk/risk
tradeoff of controlling microbial
pathogens while simultaneously
limiting the formation of disinfection
byproducts. EPA proposed core
requirements related to ground water
under the direct influence of surface
water, watershed control for unfiltered
systems and sanitary surveys for all
surface water systems, as well as five
treatment alternatives for controlling
pathogens, including a number of sub-
options. In addition, the Agency
requested comment on possible
supplemental treatment requirements
for requiring covers on finished water
reservoirs, cross connection control
programs and State notification of high
turbidity levels and other issues related
to turbidity control. Among these
various approaches, the Agency was
unable to pursue certain ones in the
final IESWTR because additional data
was needed.
Additional analysis of the regulatory
alternatives was provided by the M±
DBP Advisory Committee. The M±DBP
Advisory Committee assessed tightening
turbidity performance criteria and
monitoring individual filtration
performance. The Committee discussed
at least one alternative that would have
required the use of membrane
technology to improve turbidity
performance but concluded that utilities
could more affordably achieve sufficient
performance levels through changes in
operation and administrative practices.
The Committee considered three
different turbidity standards as well as
some existing State requirements for
individual filter monitoring. A more
detailed description of these alternatives
is discussed in Chapter V of the IESWTR
Regulatory Impact Analysis (EPA,
1998a).
g. Selection of the Least Costly, Most
Cost-Effective or Least Burdensome
Alternative That Achieves the
Objectives of the Rule
As discussed above, EPA considered
various regulatory options that would
reduce exposures to pathogens and
disinfectant byproducts that are the
objectives of the SDWA. For instance,
the M±DBP Committee analyzed the
cost for three different levels of turbidity
performance for the combined filter
effluent turbidity requirements
(measured in NTUs). The three NTU
limits considered at the 95th percentile
were 0.1, 0.2, and 0.3 and their cost
estimates show a clear distinction
among the three different levels. At the
0.1 NTU, the total annual costs of
treatment were estimated to be $3,213
million. At 0.2 NTU and 0.3 NTU, the
total annual costs of treatment were
estimated to be $317 million and $174
million, respectively. The costs of the
0.1 NTU requirement were roughly 20
times the 0.3 NTU scenario and 10 times
the 0.2 NTU scenario.
The large increase in costs for the 1.0
NTU scenario occurs because it was
assumed that 95 percent of systems
would need to install costly membrane
technology to comply with this level.
Most of the difference between the 0.2
and 0.3 levels is attributable to twice as
many systems having to install
coagulant aid polymer feed and filter
aid polymer feed capabilities in
complying with the 0.2 NTU limit as
compared with the 0.3 NTU limit. The
Committee recommended the 0.3 option
because they felt that this level would
provide adequate health protection at
the least cost. The 0.3 NTU limit was
the option that was eventually adopted
as part of this rule and is the least costly
option that accomplishes the objectives
of the IESWTR.
3. Impacts on Small Governments
EPA has determined that this rule
contains no regulatory requirements that
might significantly or uniquely effect
small governments. Thus this rule is not
subject to the requirements of section
203 of UMRA. For purposes of the
IESWTR, EPA has defined small public
water systems as those that serve a
population of fewer than 10,000, as
discussed above in Section VIIA.
Consequently, section 203 of UMRA
does not apply because, as discussed
above, the IESWTR applies to systems
serving 10,000 or more people. As noted
above, EPA plans to address surface
water systems serving fewer than 10,000
people in the Long Term 1 Enhanced
Surface Water Treatment Rule.
Even though section 203 does not
apply, the FACA processes gave a
variety of stakeholders, including small
governments, the opportunity for timely
and meaningful participation in the
regulatory development process. Groups
such as the National Association of City
and County Health Officials and the
National League of Cities participated in
the rule making process. Through such
participation and exchange, EPA
notified small governments of
requirements under consideration and
provided officials of these small
governments with an opportunity to
have meaningful and timely input into
the development of regulatory
proposals.
D. National Technology Transfer and
Advancement Act
Under section 12(d) of the National
Technology Transfer and Advancement
Act (``ANTTAA''), the Agency is
required 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, business
practices, etc.) that are developed or
adopted by voluntary consensus
standards bodies. Where available and
potentially applicable voluntary
consensus standards are not used by
EPA, the Act requires the Agency to
provide Congress, through the Office of
Management and Budget, an
explanation of the reasons for not using
such standards.
Today's rule requires the use of
previously approved technical
standards for the measurement of
turbidity. In previous rulemakings, EPA
69510 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
approved three methods for measuring
turbidity in drinking water. Turbidity is
a method-defined parameter and
therefore modifications to any of the
three approved methods requires prior
EPA approval. One of the approved
methods was published by the Standard
Methods Committee of American Public
Health Association, the American Water
Works Association, and the Water
Environment Federation, a voluntary
consensus standard body. That method,
Method 2130B is published in Standard
Methods for the Examination of Water
and Wastewater (19th ed.). Standard
Methods is a widely used reference
which has been peer-reviewed
throughout the scientific community. In
addition to this voluntary consensus
standard, EPA approved Great Lakes
Instrument Method 2 as an alternate test
procedure for the measurement of
turbidity. Finally, the Agency approved
a revised EPA Method 180.1 for
turbidity measurement in August 1993
in Methods for the Determination of
Inorganic Substances in Environmental
Samples (EPA±600/R±93±100).
In 1994, EPA reviewed and rejected
an additional technical standard for the
measurement of turbidity, the ISO 7027
standard, which measures turbidity at a
higher wavelength than the approved
test measurement standards. The ISO
7027 is an analytical method for the
measurement of turbidity. ISO 7027
measures turbidity using either 90°
scattered or transmitted light depending
on the turbidity concentration
evaluated. Although instruments
conforming to ISO 7027 specifications
are similar to the GLI instrument, only
the GLI instrument uses pulsed,
multiple detectors to simultaneously
read both 90° scattered and transmitted
light. EPA has no data upon which to
evaluate whether the separate 90°
scattered or transmitted light
measurement evaluations according to
the ISO 7027 method would produce
results that are equivalent to results
produced using GLI Method 2, Standard
Method 2130B, or EPA Method 180.1.
Today's final rule also requires
continuous individual filter monitoring
for turbidity and requires PWSs to
calibrate the individual turbidimeter
according to the turbidimeter
manufacturer's instructions. These
calibration instructions may constitute
technical standards as that term is
defined in the NTTAA. EPA has looked
for voluntary consensus standards with
regard to calibration of turbidimeter.
The American Society for Testing and
Materials (ASTM) is developing such
voluntary consensus standards;
however, there do not appear to be any
voluntary consensus standards available
at this time.
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:
(1) Have an annual effect on the
economy of $100 million or more or
adversely 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 entitlements, grants, user 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, it has been determined
that this rule is a ``significant regulatory
action'' because it will have an annual
effect on the economy of $100 million
or more. 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 (59 FR 7629)
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
related issues concerning the potential
impacts of this action and has consulted
with minority and low-income
stakeholders.
Three aspects of today's rule comply
with the Environmental Justice
Executive Order and they can be
classified as follows: (1) The overall
nature of the rule; (2) the inclusion of
sensitive sub-populations in the
regulatory development process; and (3)
the convening of a stakeholder meeting
specifically to address environmental
justice issues. The IESWTR applies
uniformly to all surface water and
GWUDI systems that serve a population
of at least 10,000 and consequently, the
health protection benefits this rule
provides are equal across all income and
minority groups within these
communities. A complementary
regulation is under development that
will address similar issues for systems
serving fewer than 10,000 people.
In addition, concerns of the sensitive
sub-populations were included in the
IESWTR through the Reg. Neg. and M-
DBP Advisory Committee process
undertaken to craft the regulation. Both
Committees were chartered under the
FACA authorization, and included a
broad cross-section of regulators,
regulated communities, industry, public
interest groups, and State and local
public health officials. Representatives
of sensitive sub-populations, in
particular people with AIDS,
participated in the regulatory
development process. Extensive
discussion on setting treatment
requirements that provide the maximum
feasible protection took place, and the
final consensus that resulted in the rule
considered issues of affordability,
equity, and safety.
Finally, as part of EPA's
responsibilities to comply with E.O.
12898, the Agency held a stakeholder
meeting on March 12, 1998 (EPA 1998e)
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 between 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 (EPA
1998e) 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 OGWDW regulatory
efforts.
In addition, EPA developed a plain-
English guide specifically for this
69511Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
meeting to assist stakeholders in
understanding the multiple and
sometimes complex issues surrounding
drinking water regulation.
Overall, EPA believes this rule will
equally protect the health of all minority
and low income populations within
communities served by public water
systems regulated under this rule.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
Executive Order 13045 (62 FR 19885,
April 23, 1997) applies to any rule
initiated after April 21, 1997, or
proposed after April 21, 1998, that (1) is
determined to be ``economically
significant'' as defined under E.O. 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.
The final rule is not subject to the
Executive Order because EPA published
a notice of proposed rulemaking before
April 21, 1998. However, EPA's policy
since November 1, 1995, is to
consistently and explicitly consider
risks to infants and children in all risk
assessments generated during its
decision making process including the
setting of standards to protect public
health and the environment.
In promulgating the IESWTR the
Agency recognizes that the health risks
associated with exposure to the
protozoan Cryptosporidium are of
particular concern for certain sensitive
subpopulations, including children and
immunocompromised individuals.
These concerns were considered as part
of the regulatory development process,
particularly in the establishment of the
MCLG for Cryptosporidium in drinking
water, and are reflected in the final rule.
The IESWTR establishes a Maximum
Contaminant Level Goal (MCLG) of zero
for Cryptosporidium at the genus level,
taking into account the need to protect
sensitive populations (e.g., children)
and providing for an adequate margin of
safety. For public water systems that use
surface water, filter and serve at least
10,000 people, the Agency is
establishing physical removal treatment
requirements for Cryptosporidium. For
systems that use conventional or direct
filtration, the Agency is strengthening
the existing turbidity standards for
finished water and is also requiring
individual filter monitoring to assist in
controlling pathogen breakthrough
during the treatment process.
H. Executive Order 12875: Enhancing
the Intergovernmental Partnership
Under Executive Order 12875, EPA
may not issue a regulation that is not
required by statute and that creates a
mandate upon a State, local or tribal
government, unless the Federal
government provides the funds
necessary to pay the direct compliance
costs incurred by those governments, or
EPA consults with those governments. If
EPA complies by consulting, Executive
Order 12875 requires EPA to provide to
the Office of Management and Budget a
description of the extent of EPA's prior
consultation with representatives of
affected State, local and tribal
governments, the nature of their
concerns, copies of any written
communications from the governments,
and a statement supporting the need to
issue the regulation. In addition,
Executive Order 12875 requires EPA to
develop an effective process permitting
elected officials and other
representatives of State, local and tribal
governments ``to provide meaningful
and timely input in the development of
regulatory proposals containing
significant unfunded mandates.''
EPA has concluded that this rule will
create a mandate on State, local, and
tribal governments and that the Federal
government will not provide all of the
funds necessary to pay the direct costs
incurred by the State, local, and tribal
governments in complying with the
mandate. In developing this rule, EPA
consulted with State and local
governments to enable them to provide
meaningful and timely input in the
development of this rule. EPA also
invited the Native American Water
Association to participate in the FACA
process to develop this rule. Although
they decided not to take part in the
deliberations, the Association continued
to be informed of meetings and
developments through a stakeholders
mailing list.
As described above in Section VII.
C.2(e), EPA held extensive meetings
with a variety of State and local
representatives who provided
meaningful and timely input in the
development of the proposed rule. State
and local representatives were part of
the FACA committees involved in the
development of this rule. Summaries of
the meetings have been included in the
public docket for this rulemaking. See
section VII.C.2(e) for summaries of the
extent of EPA's consultation with State,
local, and tribal governments; the nature
of the government concerns; and EPA's
position supporting the need to issue
the rule.
I. 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 Office of
Management and Budget, 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.''
Today's rule does not significantly or
uniquely affect the communities of
Indian tribal governments. There are
very few Tribal surface water systems
that serve 10,000 or more people.
Moreover, the rule does not impose
requirements on the Tribal systems that
differ from those required for other
water systems covered under the rule.
Accordingly, the requirements of
section 3(b) of Executive Order 13084
do not apply to this rule.
J. Consultation With the Science
Advisory Board, National Drinking
Water Council, and Secretary of Health
and Human Services
In accordance with section 1412(d)
and (e) of SDWA, EPA consulted with
the Science Advisory Board, National
Drinking Water Council, and Secretary
of Health and Human Services, and
requested and considered their
comments in developing this rule.
K. Likely Effect of Compliance With the
IESWTR on the Technical, Financial,
and Managerial Capacity of Public
Water Systems
Section 1420(d)(3) of the SDWA as
amended requires that, in promulgating
a NPDWR, the Administrator shall
69512 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
include an analysis of the likely effect
of compliance with the regulation on
the technical, financial, and managerial
capacity of public water systems. The
following analysis has been performed
to fulfill this statutory obligation.
Overall water system capacity is
defined in EPA guidance (EPA 816±R±
98±006) (EPA 1998g) as the ability to
plan for, achieve, and maintain
compliance with applicable drinking
water standards. Capacity has three
components: technical, managerial, and
financial.
Technical capacity is the physical and
operational ability of a water system to
meet SDWA requirements. Technical
capacity refers to the physical
infrastructure of the water system,
including the adequacy of source water
and the adequacy of treatment, storage,
and distribution infrastructure. It also
refers to the ability of system personnel
to adequately operate and maintain the
system and to otherwise implement
requisite technical knowledge. A water
system's technical capacity can be
determined by examining key issues
and questions, including:
·Source water adequacy. Does the
system have a reliable source of
drinking water? Is the source of
generally good quality and adequately
protected?
·Infrastructure adequacy. Can the
system provide water that meets SDWA
standards? What is the condition of its
infrastructure, including well(s) or
source water intakes, treatment, storage,
and distribution? What is the
infrastructure's life expectancy? Does
the system have a capital improvement
plan?
·Technical knowledge and
implementation. Is the system's operator
certified? Does the operator have
sufficient technical knowledge of
applicable standards? Can the operator
effectively implement this technical
knowledge? Does the operator
understand the system's technical and
operational characteristics? Does the
system have an effective operation and
maintenance program?
Managerial capacity is the ability of a
water system to conduct its affairs in a
manner enabling the system to achieve
and maintain compliance with SDWA
requirements. Managerial capacity refers
to the system's institutional and
administrative capabilities.
Managerial capacity can be assessed
through key issues and questions,
including:
·Ownership accountability. Are the
system owner(s) clearly identified? Can
they be held accountable for the system?
·Staffing and organization. Are the
system operator(s) and manager(s)
clearly identified? Is the system
properly organized and staffed? Do
personnel understand the management
aspects of regulatory requirements and
system operations? Do they have
adequate expertise to manage water
system operations? Do personnel have
the necessary licenses and
certifications?
·Effective external linkages. Does the
system interact well with customers,
regulators, and other entities? Is the
system aware of available external
resources, such as technical and
financial assistance?
Financial capacity is a water system's
ability to acquire and manage sufficient
financial resources to allow the system
to achieve and maintain compliance
with SDWA requirements.
Financial capacity can be assessed
through key issues and questions,
including:
·Revenue sufficiency. Do revenues
cover costs? Are water rates and charges
adequate to cover the cost of water?
·Credit worthiness. Is the system
financially healthy? Does it have access
to capital through public or private
sources?
·Fiscal management and controls.
Are adequate books and records
maintained? Are appropriate budgeting,
accounting, and financial planning
methods used? Does the system manage
its revenues effectively?
1,381 systems are affected by the
IESWTR. Of these, 691 may need to
modify their treatment process and
undertake turbidity monitoring, and
will need to meet the disinfection
benchmarking and turbidity exceptions
reporting requirements. The other 690
systems will need to do turbidity
monitoring and will need to meet the
disinfection benchmarking and turbidity
exceptions reporting requirements as
applicable, but will not need to modify
their treatment process.
Systems not modifying treatment will
need to do turbidity monitoring,
disinfection benchmarking, and
turbidity exceptions reporting, These
systems are not generally expected to
require significantly increased
technical, financial, or managerial
capacity to comply with these new
requirements. Some individual facilities
may have weaknesses in one or more of
these areas, but overall surface water
systems should have or be able to easily
obtain the capacity needed for these
activities.
Systems needing to modify treatment
will employ one or more of a variety of
steps. The steps expected to be
employed by 25% or more of systems in
virtually all size categories covered by
the rule are: install backwash water
polymer feed capability; install
individual filter turbidimeters; account
for recycle flow in process control
decisions; implement a policy and
commitment to lower water quality
goals; utilize alternative process control
testing equipment; modify/implement
process control monitoring and control;
and designate a process control strategy
facilitator.
Furthermore, there are a number of
actions that are expected to be taken
disproportionately by the smaller sized
systems covered under the IESWTR
(that is to say, a greater percentage of
smaller sized systems will undertake
these activities than will larger sized
systems). These steps include:
Structural and mechanical rapid mix
improvements; filter underdrain
retrofits and gravel media; filter rate-of-
flow controller replacement; hydraulic
improvements in flow distribution/
control/measurement; increase plant
staffing; replace obsolete bench top
turbidimeters; purchase jar test
apparatus; and train staff to understand
process control strategy.
For many systems serving between
10,000 and 100,000 persons which need
to make treatment modifications an
enhancement of technical, financial,
and managerial capacity may likely be
needed. As the preceding paragraph
makes clear, these systems will be
making structural improvements and
enhancing laboratory and staff capacity.
Larger sized systems have typically
already made these improvements as
part of normal operations. Meeting the
requirements of the IESWTR will
require operating at a higher level of
sophistication and in a better state of
repair than some plants in the 10,000±
100,000 person size category have
considered acceptable in the past.
Certainly there will be exceptions
both between 10,000 and 100,000
persons and above. Some larger plants
are expected to find that their technical,
managerial, and financial capacity
needs to be upgraded to support the
system in meeting the new
requirements. Likewise, some plants
serving 10,000±100,000 persons will
already have more than adequate
technical, financial, and managerial
capacity to meet these requirements.
However, in general, the systems
serving 10,000±100,000 persons needing
to make treatment modifications will be
the ones most needing to enhance their
capacity.
L. Submission to Congress and the
General Accounting Office
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
69513Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This rule is a ``major rule'' as defined by
5 U.S.C. 804(2). This rule will be
effective February 16, 1999.
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and Drinking Water to John H. Sullivan,
Deputy Executive Director, AWWA.
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Determining Groundwater Under the Direct
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910/9±92±029.
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compliance with the filtration and
disinfection requirements for public water
systems using surface water sources.
Environmental Protection Agency,
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in 1991)
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List of Subjects
40 CFR Parts 9
Reporting and recordkeeping
requirements.
40 CFR Parts 141 and 142
Drinking water, Environmental
protection, Public utilities, Reporting
and recordkeeping requirements,
Reservoirs, Utilities, Water supply,
Watersheds.
Dated: November 30, 1998.
Carol M. Browner,
Administrator.
For the reasons set out in the
preamble, title 40 chapter I of the Code
of Federal Regulations is amended as
follows:
PART 9—[AMENDED]
1. The authority citation for part 9
continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136±136y;
15 U.S.C. 2001, 2003, 2005, 2006, 2601±2671;
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
1321, 1326, 1330, 1342, 1344, 1345 (d) and
(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971±1975 Comp. p. 973; 42 U.S.C. 241,
242b, 243, 246, 300f, 300g, 300g-1, 300g-2,
300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-
2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901±
6992k, 7401±7671q, 7542, 9601±9657, 11023,
11048.
2. In §9.1 the table is amended by
adding under the indicated heading the
new entries in numerical order to read
as follows:
§9.1 OMB approvals under the Paperwork
Reduction Act.
* * * * *
40 CFR citation OMB control
no.
* * * * *
National Primary Drinking Water
Regulations
* * * * *
141.170 .................................2040–0205
141.172 .................................2040–0205
141.174–141.175 ..................2040–0205
* * * * *
PART 141—National Primary Drinking
Water Regulations
3. The authority citation for part 141
continues to read as follows:
Authority: 42 U.S.C. 300f, 300g±1, 300g±2,
300g±3, 300g±4, 300g±5, 300g±6, 300j±4,
300j±9, and 300j±11.
4. Section 141.2 is amended by
revising the definition of ``ground water
under the direct influence of surface
water'' and adding the following
definitions in alphabetical order to read
as follows:
§141.2 Definitions.
* * * * *
Comprehensive performance
evaluation (CPE) is a thorough review
and analysis of a treatment plant's
performance-based capabilities and
associated administrative, operation and
maintenance practices. It is conducted
to identify factors that may be adversely
impacting a plant's capability to achieve
compliance and emphasizes approaches
that can be implemented without
significant capital improvements. For
purposes of compliance with subpart P
of this part, the comprehensive
performance evaluation must consist of
at least the following components:
Assessment of plant performance;
evaluation of major unit processes;
identification and prioritization of
performance limiting factors;
assessment of the applicability of
comprehensive technical assistance; and
preparation of a CPE report.
* * * * *
Disinfection profile is a summary of
daily Giardia lamblia inactivation
through the treatment plant. The
procedure for developing a disinfection
profile is contained in §141.172.
* * * * *
Filter profile is a graphical
representation of individual filter
performance, based on continuous
turbidity measurements or total particle
counts versus time for an entire filter
run, from startup to backwash
inclusively, that includes an assessment
of filter performance while another filter
is being backwashed.
* * * * *
Ground water under the direct
influence of surface water means any
water beneath the surface of the ground
with significant occurrence of insects or
other macroorganisms, algae, or large-
diameter pathogens such as Giardia
lamblia or (for subpart H systems
serving at least 10,000 people only)
Cryptosporidium, or significant and
relatively rapid shifts in water
characteristics such as turbidity,
temperature, conductivity, or pH which
closely correlate to climatological or
surface water conditions. Direct
influence must be determined for
individual sources in accordance with
criteria established by the State. The
State determination of direct influence
may be based on site-specific
measurements of water quality and/or
documentation of well construction
characteristics and geology with field
evaluation.
* * * * *
Uncovered finished water storage
facility is a tank, reservoir, or other
facility used to store water that will
undergo no further treatment except
residual disinfection and is open to the
atmosphere.
* * * * *
5. Section 141.32 is amended by
revising paragraph (e)(10) to read as
follows:
§141.32 Public notification.
* * * * *
(e) * * *
(10) Microbiological contaminants (for
use when there is a violation of the
treatment technique requirements for
filtration and disinfection in subpart H
or subpart P of this part). The United
States Environmental Protection Agency
(EPA) sets drinking water standards and
has determined that the presence of
microbiological contaminants are a
health concern at certain levels of
exposure. If water is inadequately
treated, microbiological contaminants in
that water may cause disease. Disease
symptoms may include diarrhea,
cramps, nausea, and possibly jaundice,
and any associated headaches and
fatigue. These symptoms, however, are
not just associated with disease-causing
organisms in drinking water, but also
may be caused by a number of factors
other than your drinking water. EPA has
set enforceable requirements for treating
drinking water to reduce the risk of
these adverse health effects. Treatment
such as filtering and disinfecting the
water removes or destroys
microbiological contaminants. Drinking
water which is treated to meet EPA
requirements is associated with little to
none of this risk and should be
considered safe.
* * * * *
6. In §141.52, the table is amended by
adding a new entry, in numerical order,
to read as follows:
§141.52 Maximum contaminant level goals
for microbiological contaminants.
* * * * *
69516 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
Contaminant MCLG
* * * * *
(5) Cryptosporidium .........................zero.
7. Section 141.70 is amended by
adding paragraph (d) to read as follows:
§141.70 General requirements.
* * * * *
(d) Additional requirements for
systems serving at least 10,000 people.
In addition to complying with
requirements in this subpart, systems
serving at least 10,000 people must also
comply with the requirements in
subpart P of this part.
8. Section 141.71 is amended by
revising paragraph (b)(6) to read as
follows:
§141.71 Criteria for avoiding filtration.
* * * * *
(b) * * *
(6) The public water system must
comply with the requirements for
trihalomethanes in §§141.12 and 141.30
until December 17, 2001. After
December 17, 2001, the system must
comply with the requirements for total
trihalomethanes, haloacetic acids (five),
bromate, chlorite, chlorine,
chloramines, and chlorine dioxide in
subpart L of this part.
* * * * *
9. Section 141.73 is amended by
adding paragraph (a)(3) and revising
paragraph (d) to read as follows:
§141.73 Filtration.
* * * * *
(a) * * *
(3) Beginning December 17, 2001,
systems serving at least 10,000 people
must meet the turbidity requirements in
§141.173(a).
* * * * *
(d) Other filtration technologies. A
public water system may use a filtration
technology not listed in paragraphs (a)
through (c) of this section if it
demonstrates to the State, using pilot
plant studies or other means, that the
alternative filtration technology, in
combination with disinfection treatment
that meets the requirements of
§141.72(b), consistently achieves 99.9
percent removal and/or inactivation of
Giardia lamblia cysts and 99.99 percent
removal and/or inactivation of viruses.
For a system that makes this
demonstration, the requirements of
paragraph (b) of this section apply.
Beginning December 17, 2001, systems
serving at least 10,000 people must meet
the requirements for other filtration
technologies in §141.173(b).
10. Section 141.153 is amended by
revising the first sentence of paragraph
(d)(4)(v)(C) to read as follows:
§141.153 Content of the reports.
* * * * *
(d) * * *
(4) * * *
(v) * * *
(C) When it is reported pursuant to
§§141.73 or 141.173: The highest single
measurement and the lowest monthly
percentage of samples meeting the
turbidity limits specified in §§141.73 or
141.173 for the filtration technology
being used. ** *
* * * * *
11. Part 141 is amended by adding a
new subpart P to read as follows:
Subpart P—Enhanced Filtration and
Disinfection
Sec.
141.170 General requirements.
141.171 Criteria for avoiding filtration.
141.172 Disinfection profiling and
benchmarking.
141.173 Filtration.
141.174 Filtration sampling requirements.
141.175 Reporting and recordkeeping
requirements.
§141.170 General requirements.
(a) The requirements of this subpart P
constitute national primary drinking
water regulations. These regulations
establish requirements for filtration and
disinfection that are in addition to
criteria under which filtration and
disinfection are required under subpart
H of this part. The requirements of this
subpart are applicable to subpart H
systems serving at least 10,000 people,
beginning December 17, 2001 unless
otherwise specified in this subpart. The
regulations in this subpart establish or
extend treatment technique
requirements in lieu of maximum
contaminant levels for the following
contaminants: Giardia lamblia, viruses,
heterotrophic plate count bacteria,
Legionella, Cryptosporidium, and
turbidity. Each subpart H system serving
at least 10,000 people must provide
treatment of its source water that
complies with these treatment
technique requirements and are in
addition to those identified in §141.70.
The treatment technique requirements
consist of installing and properly
operating water treatment processes
which reliably achieve:
(1) At least 99 percent (2-log) removal
of Cryptosporidium between a point
where the raw water is not subject to
recontamination by surface water runoff
and a point downstream before or at the
first customer for filtered systems, or
Cryptosporidium control under the
watershed control plan for unfiltered
systems.
(2) Compliance with the profiling and
benchmark requirements under the
provisions of §141.172.
(b) A public water system subject to
the requirements of this subpart is
considered to be in compliance with the
requirements of paragraph (a) of this
section if:
(1) It meets the requirements for
avoiding filtration in §§141.71 and
141.171 and the disinfection
requirements in §§141.72 and 141.172;
or
(2) It meets the applicable filtration
requirements in either §141.73 or
§141.173 and the disinfection
requirements in §§141.72 and 141.172.
(c) Systems are not permitted to begin
construction of uncovered finished
water storage facilities beginning
February 16, 1999.
§141.171 Criteria for avoiding filtration.
In addition to the requirements of
§141.71, a public water system subject
to the requirements of this subpart that
does not provide filtration must meet all
of the conditions of paragraphs (a) and
(b) of this section.
(a) Site-specific conditions. In
addition to site-specific conditions in
§141.71(b), systems must maintain the
watershed control program under
§141.71(b)(2) to minimize the potential
for contamination by Cryptosporidium
oocysts in the source water. The
watershed control program must, for
Cryptosporidium:
(1) Identify watershed characteristics
and activities which may have an
adverse effect on source water quality;
and
(2) Monitor the occurrence of
activities which may have an adverse
effect on source water quality.
(b) During the onsite inspection
conducted under the provisions of
§141.71(b)(3), the State must determine
whether the watershed control program
established under §141.71(b)(2) is
adequate to limit potential
contamination by Cryptosporidium
oocysts. The adequacy of the program
must be based on the
comprehensiveness of the watershed
review; the effectiveness of the system's
program to monitor and control
detrimental activities occurring in the
watershed; and the extent to which the
water system has maximized land
ownership and/or controlled land use
within the watershed.
§141.172 Disinfection profiling and
benchmarking.
(a) Determination of systems required
to profile. A public water system subject
to the requirements of this subpart must
determine its TTHM annual average
using the procedure in paragraph (a)(1)
of this section and its HAA5 annual
average using the procedure in
69517Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
paragraph (a)(2) of this section. The
annual average is the arithmetic average
of the quarterly averages of four
consecutive quarters of monitoring.
(1) The TTHM annual average must be
the annual average during the same
period as is used for the HAA5 annual
average.
(i) Those systems that collected data
under the provisions of subpart M
(Information Collection Rule) must use
the results of the samples collected
during the last four quarters of required
monitoring under §141.142.
(ii) Those systems that use
``grandfathered'' HAA5 occurrence data
that meet the provisions of paragraph
(a)(2)(ii) of this section must use TTHM
data collected at the same time under
the provisions of §§141.12 and 141.30.
(iii) Those systems that use HAA5
occurrence data that meet the provisions
of paragraph (a)(2)(iii)(A) of this section
must use TTHM data collected at the
same time under the provisions of
§§141.12 and 141.30.
(2) The HAA5 annual average must be
the annual average during the same
period as is used for the TTHM annual
average.
(i) Those systems that collected data
under the provisions of subpart M
(Information Collection Rule) must use
the results of the samples collected
during the last four quarters of required
monitoring under §141.142.
(ii) Those systems that have collected
four quarters of HAA5 occurrence data
that meets the routine monitoring
sample number and location
requirements for TTHM in §§141.12
and 141.30 and handling and analytical
method requirements of §141.142(b)(1)
may use those data to determine
whether the requirements of this section
apply.
(iii) Those systems that have not
collected four quarters of HAA5
occurrence data that meets the
provisions of either paragraph (a)(2)(i)
or (ii) of this section by March 16, 1999
must either:
(A) Conduct monitoring for HAA5
that meets the routine monitoring
sample number and location
requirements for TTHM in §§141.12
and 141.30 and handling and analytical
method requirements of §141.142(b)(1)
to determine the HAA5 annual average
and whether the requirements of
paragraph (b) of this section apply. This
monitoring must be completed so that
the applicability determination can be
made no later than March 16, 2000, or
(B) Comply with all other provisions
of this section as if the HAA5
monitoring had been conducted and the
results required compliance with
paragraph (b) of this section.
(3) The system may request that the
State approve a more representative
annual data set than the data set
determined under paragraph (a)(1) or (2)
of this section for the purpose of
determining applicability of the
requirements of this section.
(4) The State may require that a
system use a more representative annual
data set than the data set determined
under paragraph (a)(1) or (2) of this
section for the purpose of determining
applicability of the requirements of this
section.
(5) The system must submit data to
the State on the schedule in paragraphs
(a)(5)(i) through (v) of this section.
(i) Those systems that collected
TTHM and HAA5 data under the
provisions of subpart M (Information
Collection Rule), as required by
paragraphs (a)(1)(i) and (a)(2)(i) of this
section, must submit the results of the
samples collected during the last 12
months of required monitoring under
§141.142 not later than December 16,
1999.
(ii) Those systems that have collected
four consecutive quarters of HAA5
occurrence data that meets the routine
monitoring sample number and location
for TTHM in §§141.12 and 141.30 and
handling and analytical method
requirements of §141.142(b)(1), as
allowed by paragraphs (a)(1)(ii) and
(a)(2)(ii) of this section, must submit
those data to the State not later than
April 16, 1999. Until the State has
approved the data, the system must
conduct monitoring for HAA5 using the
monitoring requirements specified
under paragraph (a)(2)(iii) of this
section.
(iii) Those systems that conduct
monitoring for HAA5 using the
monitoring requirements specified by
paragraphs (a)(1)(iii) and (a)(2)(iii)(A) of
this section, must submit TTHM and
HAA5 data not later than March 16,
2000.
(iv) Those systems that elect to
comply with all other provisions of this
section as if the HAA5 monitoring had
been conducted and the results required
compliance with this section, as
allowed under paragraphs (a)(2)(iii)(B)
of this section, must notify the State in
writing of their election not later than
December 16, 1999.
(v) If the system elects to request that
the State approve a more representative
annual data set than the data set
determined under paragraph (a)(2)(i) of
this section, the system must submit
this request in writing not later than
December 16, 1999.
(6) Any system having either a TTHM
annual average ³0.064 mg/L or an HAA5
annual average ³0.048 mg/L during the
period identified in paragraphs (a)(1)
and (2) of this section must comply with
paragraph (b) of this section.
(b) Disinfection profiling. (1) Any
system that meets the criteria in
paragraph (a)(6) of this section must
develop a disinfection profile of its
disinfection practice for a period of up
to three years.
(2) The system must monitor daily for
a period of 12 consecutive calendar
months to determine the total logs of
inactivation for each day of operation,
based on the CT99.9 values in Tables
1.1±1.6, 2.1, and 3.1 of §141.74(b), as
appropriate, through the entire
treatment plant. This system must begin
this monitoring not later than March 16,
2000. As a minimum, the system with
a single point of disinfectant application
prior to entrance to the distribution
system must conduct the monitoring in
paragraphs (b)(2)(i) through (iv) of this
section. A system with more than one
point of disinfectant application must
conduct the monitoring in paragraphs
(b)(2)(i) through (iv) of this section for
each disinfection segment. The system
must monitor the parameters necessary
to determine the total inactivation ratio,
using analytical methods in §141.74(a),
as follows:
(i) The temperature of the disinfected
water must be measured once per day at
each residual disinfectant concentration
sampling point during peak hourly flow.
(ii) If the system uses chlorine, the pH
of the disinfected water must be
measured once per day at each chlorine
residual disinfectant concentration
sampling point during peak hourly flow.
(iii) The disinfectant contact time(s)
(``T'') must be determined for each day
during peak hourly flow.
(iv) The residual disinfectant
concentration(s) (``C'') of the water
before or at the first customer and prior
to each additional point of disinfection
must be measured each day during peak
hourly flow.
(3) In lieu of the monitoring
conducted under the provisions of
paragraph (b)(2) of this section to
develop the disinfection profile, the
system may elect to meet the
requirements of paragraph (b)(3)(i) of
this section. In addition to the
monitoring conducted under the
provisions of paragraph (b)(2) of this
section to develop the disinfection
profile, the system may elect to meet the
requirements of paragraph (b)(3)(ii) of
this section.
(i) A PWS that has three years of
existing operational data may submit
those data, a profile generated using
those data, and a request that the State
approve use of those data in lieu of
monitoring under the provisions of
69518 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
paragraph (b)(2) of this section not later
than March 16, 2000. The State must
determine whether these operational
data are substantially equivalent to data
collected under the provisions of
paragraph (b)(2) of this section. These
data must also be representative of
Giardia lamblia inactivation through the
entire treatment plant and not just of
certain treatment segments. Until the
State approves this request, the system
is required to conduct monitoring under
the provisions of paragraph (b)(2) of this
section.
(ii) In addition to the disinfection
profile generated under paragraph (b)(2)
of this section, a PWS that has existing
operational data may use those data to
develop a disinfection profile for
additional years. Such systems may use
these additional yearly disinfection
profiles to develop a benchmark under
the provisions of paragraph (c) of this
section. The State must determine
whether these operational data are
substantially equivalent to data
collected under the provisions of
paragraph (b)(2) of this section. These
data must also be representative of
inactivation through the entire
treatment plant and not just of certain
treatment segments.
(4) The system must calculate the
total inactivation ratio as follows:
(i) If the system uses only one point
of disinfectant application, the system
may determine the total inactivation
ratio for the disinfection segment based
on either of the methods in paragraph
(b)(4)(i)(A) or (b)(4)(i)(B) of this section.
(A) Determine one inactivation ratio
(CTcalc/CT99.9) before or at the first
customer during peak hourly flow.
(B) Determine successive CTcalc/
CT99.9 values, representing sequential
inactivation ratios, between the point of
disinfectant application and a point
before or at the first customer during
peak hourly flow. Under this
alternative, the system must calculate
the total inactivation ratio by
determining (CTcalc/CT99.9) for each
sequence and then adding the (CTcalc/
CT99.9) values together to determine (S
(CTcalc/CT99.9)).
(ii) If the system uses more than one
point of disinfectant application before
the first customer, the system must
determine the CT value of each
disinfection segment immediately prior
to the next point of disinfectant
application, or for the final segment,
before or at the first customer, during
peak hourly flow. The (CTcalc/CT99.9)
value of each segment and ((CTcalc/
CT99.9)) must be calculated using the
method in paragraph (b)(4)(i) of this
section.
(iii) The system must determine the
total logs of inactivation by multiplying
the value calculated in paragraph
(b)(4)(i) or (ii) of this section by 3.0.
(5) A system that uses either
chloramines or ozone for primary
disinfection must also calculate the logs
of inactivation for viruses using a
method approved by the State.
(6) The system must retain
disinfection profile data in graphic
form, as a spreadsheet, or in some other
format acceptable to the State for review
as part of sanitary surveys conducted by
the State.
(c) Disinfection benchmarking. (1)
Any system required to develop a
disinfection profile under the provisions
of paragraphs (a) and (b) of this section
and that decides to make a significant
change to its disinfection practice must
consult with the State prior to making
such change. Significant changes to
disinfection practice are:
(i) Changes to the point of
disinfection;
(ii) Changes to the disinfectant(s) used
in the treatment plant;
(iii) Changes to the disinfection
process; and
(iv) Any other modification identified
by the State.
(2) Any system that is modifying its
disinfection practice must calculate its
disinfection benchmark using the
procedure specified in paragraphs
(c)(2)(i) through (ii) of this section.
(i) For each year of profiling data
collected and calculated under
paragraph (b) of this section, the system
must determine the lowest average
monthly Giardia lamblia inactivation in
each year of profiling data. The system
must determine the average Giardia
lamblia inactivation for each calendar
month for each year of profiling data by
dividing the sum of daily Giardia
lamblia of inactivation by the number of
values calculated for that month.
(ii) The disinfection benchmark is the
lowest monthly average value (for
systems with one year of profiling data)
or average of lowest monthly average
values (for systems with more than one
year of profiling data) of the monthly
logs of Giardia lamblia inactivation in
each year of profiling data.
(3) A system that uses either
chloramines or ozone for primary
disinfection must also calculate the
disinfection benchmark for viruses
using a method approved by the State.
(4) The system must submit
information in paragraphs (c)(4)(i)
through (iii) of this section to the State
as part of its consultation process.
(i) A description of the proposed
change;
(ii) The disinfection profile for
Giardia lamblia (and, if necessary,
viruses) under paragraph (b) of this
section and benchmark as required by
paragraph (c)(2) of this section; and
(iii) An analysis of how the proposed
change will affect the current levels of
disinfection.
§141.173 Filtration.
A public water system subject to the
requirements of this subpart that does
not meet all of the criteria in this
subpart and subpart H of this part for
avoiding filtration must provide
treatment consisting of both
disinfection, as specified in §141.72(b),
and filtration treatment which complies
with the requirements of paragraph (a)
or (b) of this section or §141.73 (b) or
(c) by December 17, 2001.
(a) Conventional filtration treatment
or direct filtration. (1) For systems using
conventional filtration or direct
filtration, the turbidity level of
representative samples of a system's
filtered water must be less than or equal
to 0.3 NTU in at least 95 percent of the
measurements taken each month,
measured as specified in §141.74(a) and
(c).
(2) The turbidity level of
representative samples of a system's
filtered water must at no time exceed 1
NTU, measured as specified in
§141.74(a) and (c).
(3) A system that uses lime softening
may acidify representative samples
prior to analysis using a protocol
approved by the State.
(b) Filtration technologies other than
conventional filtration treatment, direct
filtration, slow sand filtration, or
diatomaceous earth filtration. A public
water system may use a filtration
technology not listed in paragraph (a) of
this section or in §141.73(b) or (c) if it
demonstrates to the State, using pilot
plant studies or other means, that the
alternative filtration technology, in
combination with disinfection treatment
that meets the requirements of
§141.72(b), consistently achieves 99.9
percent removal and/or inactivation of
Giardia lamblia cysts and 99.99 percent
removal and/or inactivation of viruses,
and 99 percent removal of
Cryptosporidium oocysts, and the State
approves the use of the filtration
technology. For each approval, the State
will set turbidity performance
requirements that the system must meet
at least 95 percent of the time and that
the system may not exceed at any time
at a level that consistently achieves 99.9
percent removal and/or inactivation of
Giardia lamblia cysts, 99.99 percent
removal and/or inactivation of viruses,
69519Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
and 99 percent removal of
Cryptosporidium oocysts.
§141.174 Filtration sampling
requirements.
(a) Monitoring requirements for
systems using filtration treatment. In
addition to monitoring required by
§141.74, a public water system subject
to the requirements of this subpart that
provides conventional filtration
treatment or direct filtration must
conduct continuous monitoring of
turbidity for each individual filter using
an approved method in §141.74(a) and
must calibrate turbidimeters using the
procedure specified by the
manufacturer. Systems must record the
results of individual filter monitoring
every 15 minutes.
(b) If there is a failure in the
continuous turbidity monitoring
equipment, the system must conduct
grab sampling every four hours in lieu
of continuous monitoring, but for no
more than five working days following
the failure of the equipment.
§141.175 Reporting and recordkeeping
requirements.
In addition to the reporting and
recordkeeping requirements in §141.75,
a public water system subject to the
requirements of this subpart that
provides conventional filtration
treatment or direct filtration must report
monthly to the State the information
specified in paragraphs (a) and (b) of
this section beginning December 17,
2001. In addition to the reporting and
recordkeeping requirements in §141.75,
a public water system subject to the
requirements of this subpart that
provides filtration approved under
§141.173(b) must report monthly to the
State the information specified in
paragraph (a) of this section beginning
December 17, 2001. The reporting in
paragraph (a) of this section is in lieu of
the reporting specified in §141.75(b)(1).
(a) Turbidity measurements as
required by §141.173 must be reported
within 10 days after the end of each
month the system serves water to the
public. Information that must be
reported includes:
(1) The total number of filtered water
turbidity measurements taken during
the month.
(2) The number and percentage of
filtered water turbidity measurements
taken during the month which are less
than or equal to the turbidity limits
specified in §141.173(a) or (b).
(3) The date and value of any
turbidity measurements taken during
the month which exceed 1 NTU for
systems using conventional filtration
treatment or direct filtration, or which
exceed the maximum level set by the
State under §141.173(b).
(b) Systems must maintain the results
of individual filter monitoring taken
under §141.174 for at least three years.
Systems must report that they have
conducted individual filter turbidity
monitoring under §141.174 within 10
days after the end of each month the
system serves water to the public.
Systems must report individual filter
turbidity measurement results taken
under §141.174 within 10 days after the
end of each month the system serves
water to the public only if
measurements demonstrate one or more
of the conditions in paragraphs (b)(1)
through (4) of this section. Systems that
use lime softening may apply to the
State for alternative exceedance levels
for the levels specified in paragraphs
(b)(1) through (4) of this section if they
can demonstrate that higher turbidity
levels in individual filters are due to
lime carryover only and not due to
degraded filter performance.
(1) For any individual filter that has
a measured turbidity level of greater
than 1.0 NTU in two consecutive
measurements taken 15 minutes apart,
the system must report the filter
number, the turbidity measurement, and
the date(s) on which the exceedance
occurred. In addition, the system must
either produce a filter profile for the
filter within 7 days of the exceedance (if
the system is not able to identify an
obvious reason for the abnormal filter
performance) and report that the profile
has been produced or report the obvious
reason for the exceedance.
(2) For any individual filter that has
a measured turbidity level of greater
than 0.5 NTU in two consecutive
measurements taken 15 minutes apart at
the end of the first four hours of
continuous filter operation after the
filter has been backwashed or otherwise
taken offline, the system must report the
filter number, the turbidity, and the
date(s) on which the exceedance
occurred. In addition, the system must
either produce a filter profile for the
filter within 7 days of the exceedance (if
the system is not able to identify an
obvious reason for the abnormal filter
performance) and report that the profile
has been produced or report the obvious
reason for the exceedance.
(3) For any individual filter that has
a measured turbidity level of greater
than 1.0 NTU in two consecutive
measurements taken 15 minutes apart at
any time in each of three consecutive
months, the system must report the
filter number, the turbidity
measurement, and the date(s) on which
the exceedance occurred. In addition,
the system must conduct a self-
assessment of the filter within 14 days
of the exceedance and report that the
self-assessment was conducted. The self
assessment must consist of at least the
following components: assessment of
filter performance; development of a
filter profile; identification and
prioritization of factors limiting filter
performance; assessment of the
applicability of corrections; and
preparation of a filter self-assessment
report.
(4) For any individual filter that has
a measured turbidity level of greater
than 2.0 NTU in two consecutive
measurements taken 15 minutes apart at
any time in each of two consecutive
months, the system must report the
filter number, the turbidity
measurement, and the date(s) on which
the exceedance occurred. In addition,
the system must arrange for the conduct
of a comprehensive performance
evaluation by the State or a third party
approved by the State no later than 30
days following the exceedance and have
the evaluation completed and submitted
to the State no later than 90 days
following the exceedance.
PART 142—NATIONAL PRIMARY
DRINKING WATER REGULATIONS
IMPLEMENTATION
12. The authority citation for Part 142
continues to read as follows:
Authority: 42 U.S.C. 300f, 300g±1, 300g±2,
300g±3, 300g±4, 300g±5, 300g±6, 300j±4,
300j±9, and 300j±11.
13. Section 142.14 is amended by
revising paragraphs (a)(3), (a)(4)(i), and
(a)(4)(ii) introductory text, and adding
paragraph (a)(7) to read as follows:
§142.14 Records kept by States.
(a) * * *
(3) Records of turbidity measurements
must be kept for not less than one year.
The information retained must be set
forth in a form which makes possible
comparison with the limits specified in
§§141.71, 141.73, 141.173 and 141.175
of this chapter. Until June 29, 1993, for
any public water system which is
providing filtration treatment and until
December 30, 1991, for any public water
system not providing filtration
treatment and not required by the State
to provide filtration treatment, records
kept must be set forth in a form which
makes possible comparison with the
limits contained in §141.13 of this
chapter.
* * * * *
(4)(i) Records of disinfectant residual
measurements and other parameters
necessary to document disinfection
effectiveness in accordance with
§§141.72 and 141.74 of this chapter and
69520 Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
the reporting requirements of §§141.75
and 141.175 of this chapter must be kept
for not less than one year.
(ii) Records of decisions made on a
system-by-system and case-by-case basis
under provisions of part 141, subpart H
or subpart P of this chapter, must be
made in writing and kept at the State.
* * * * *
(7) Any decisions made pursuant to
the provisions of part 141, subpart P of
this chapter.
(i) Records of systems consulting with
the State concerning a modification to
disinfection practice under §141.172(c)
of this chapter, including the status of
the consultation.
(ii) Records of decisions that a system
using alternative filtration technologies,
as allowed under §141.173(b) of this
chapter, can consistently achieve a 99.9
percent removal and/or inactivation of
Giardia lamblia cysts, 99.99 percent
removal and/or inactivation of viruses,
and 99 percent removal of
Cryptosporidium oocysts. The decisions
must include State-set enforceable
turbidity limits for each system. A copy
of the decision must be kept until the
decision is reversed or revised. The
State must provide a copy of the
decision to the system.
(iii) Records of systems required to do
filter self-assessment, CPE, or CCP
under the requirements of §141.175 of
this chapter.
* * * * *
14. Section 142.15 is amended by
adding paragraph (c)(5) to read as
follows:
§142.15 Reports by States.
* * * * *
(c) * * *
(5) Sanitary surveys. A list of subpart
H 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 §141.16(b)(3) of this
chapter.
* * * * *
15. Section 142.16 is amended by
redesignating paragraph (b)(1) as
(b)(1)(i), and adding paragraphs
(b)(1)(ii), (b)(3), and (g) to read as
follows:
§142.16 Special primacy requirements.
* * * * *
(b) * * *
(1) Enforceable requirements. (i)
* * *
(ii) States must have the appropriate
rules or other authority to assure that
PWSs respond in writing to significant
deficiencies outlined in sanitary survey
reports required under paragraph (b)(3)
of this section no later than 45 days after
receipt of the report, indicating how and
on what schedule the system will
address significant deficiencies noted in
the survey.
(iii) States must have the appropriate
rules or other authority to assure that
PWSs take necessary steps to address
significant deficiencies identified in
sanitary survey reports required under
paragraph (b)(3) of this section, if such
deficiencies are within the control of the
PWS and its governing body.
* * * * *
(3) Sanitary survey. In addition to the
general requirements for sanitary
surveys contained in §142.10(b)(2), an
application must describe how the State
will implement a sanitary survey
program that meets the requirements in
paragraphs (b)(3)(i) through (v) of this
section. For the purposes of this
paragraph, ``sanitary survey'' means an
onsite review of the water source
(identifying sources of contamination
using results of source water
assessments where available), facilities,
equipment, operation, maintenance, and
monitoring compliance of a public
water system to evaluate the adequacy
of the system, its sources and operations
and the distribution of safe drinking
water.
(i) The State must conduct sanitary
surveys for all surface water systems
(including groundwater under the
influence) that address the eight
sanitary survey components listed in
paragraphs (b)(3)(i)(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 noncommunity
systems. The State may allow sanitary
surveys conducted after December 1995
to serve as the first set of required
sanitary surveys if the surveys address
the eight sanitary survey components
listed in paragraphs (b)(3)(i)(A) through
(H) of this section.
(A) Source.
(B) Treatment.
(C) Distribution system.
(D) Finished water storage.
(E) Pumps, pump facilities, and
controls.
(F) Monitoring and reporting and data
verification.
(G) System management and
operation.
(H) Operator compliance with State
requirements.
(ii) For community systems
determined by the State to have
outstanding performance based on prior
sanitary surveys, subsequent sanitary
surveys may be conducted no less than
every five years. In its primacy
application, the State must describe
how it will decide whether a system has
outstanding performance and is thus
eligible for sanitary surveys at a reduced
frequency.
(iii) Components of a sanitary survey
may be completed as part of a staged or
phased state review process within the
established frequency.
(iv) When conducting sanitary
surveys for systems required to comply
with the disinfection profiling
requirements in §141.172 of this
chapter, the State must also review the
disinfection profile as part of the
sanitary survey.
(v) In its primacy application, the
State must describe how it will decide
whether a deficiency identified during a
sanitary survey is significant for the
purposes of paragraph (b)(1)(ii) of this
section.
* * * * *
(g) Requirements for States to adopt
40 CFR part 141, subpart P Enhanced
Filtration and Disinfection. In addition
to the general primacy requirements
enumerated elsewhere in this part,
including the requirement that State
provisions are no less stringent than the
federal requirements, an application for
approval of a State program revision
that adopts 40 CFR part 141, subpart P
Enhanced Filtration and Disinfection,
must contain the information specified
in this paragraph:
(1) Enforceable requirements. States
must have the appropriate rules or other
authority to require PWSs to conduct a
Composite Correction Program (CCP)
and to assure that PWSs implement any
followup recommendations that result
as part of the CCP. The CCP consists of
two elementsÐa Comprehensive
Performance Evaluation (CPE) and
Comprehensive Technical Assistance
(CTA). A CPE is a thorough review and
analysis of a plant's performance-based
capabilities and associated
administrative, operation and
maintenance practices. It is conducted
to identify factors that may be adversely
impacting a plant's capability to achieve
compliance and emphasizes approaches
that can be implemented without
significant capital improvements. A
CTA is the performance improvement
phase that is implemented if the CPE
results indicate improved performance
potential. During the CTA phase, the
system must identify and systematically
address plant-specific factors. The CTA
is a combination of utilizing CPE results
as a basis for followup, implementing
process control priority-setting
techniques and maintaining long-term
involvement to systematically train staff
and administrators.
69521Federal Register /Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations
(2) State practices or procedures. (i)
Section 141.172(a)(3) of this chapterÐ
How the State will approve a more
representative annual data set than the
data set determined under §141.172
(a)(1) or (2) of this chapter for the
purpose of determining applicability of
the requirements of §141.172 of this
chapter.
(ii) Section 141.172(b)(5) of this
chapterÐHow the State will approve a
method to calculate the logs of
inactivation for viruses for a system that
uses either chloramines or ozone for
primary disinfection.
(iii) Section 141.172(c) of this
chapterÐHow the State will consult
with PWSs to evaluate modifications to
disinfection practice.
(iv) Section 141.173(b) of this
chapterÐFor filtration technologies
other than conventional filtration
treatment, direct filtration, slow sand
filtration, or diatomaceous earth
filtration, how the State will determine
that a public water system may use a
filtration technology if the PWS
demonstrates to the State, using pilot
plant studies or other means, that the
alternative filtration technology, in
combination with disinfection treatment
that meets the requirements of
§141.172(b) of this chapter, consistently
achieves 99.9 percent removal and/or
inactivation of Giardia lamblia cysts
and 99.99 percent removal and/or
inactivation of viruses, and 99 percent
removal of Cryptosporidium oocysts.
For a system that makes this
demonstration, how the State will set
turbidity performance requirements that
the system must meet 95 percent of the
time and that the system may not
exceed at any time at a level that
consistently achieves 99.9 percent
removal and/or inactivation of Giardia
lamblia cysts, 99.99 percent removal
and/or inactivation of viruses, and 99
percent removal of Cryptosporidium
oocysts.
[FR Doc. 98±32888 Filed 12±15±98; 8:45 am]
BILLING CODE 6560–50–P