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National Primary Drinking Water Regulations:
Interim Enhanced Surface Water Treatment
Federal Register Document
Related Material
[Federal Register: December 16, 1998 (Volume 63, Number 241)]
[Rules and Regulations]
[Page 69477-69521]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de98-18]
[[Page 69477]]
_______________________________________________________________________
Part V
Environmental Protection Agency
_______________________________________________________________________
40 CFR Parts 9, 141, and 142
National Primary Drinking Water Regulations: Interim Enhanced Surface
Water Treatment; Final Rule
[[Page 69478]]
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 influence of surface water and
serve at least 10,000 people
State, Local, Tribal or PWSs that use surface water or ground
Federal Governments. 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 (Sec. 141.70(a)--systems subject to
the Surface Water Treatment Rule) and subpart P (Sec. 141.170(a)--
subpart 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
[[Page 69479]]
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
deg.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 (N<INF>0</INF>/N<INF>T</INF>)
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
N<INF>T</INF>: 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 \1/10\<SUP>x </SUP>of original
concentration
Table of Contents
I. Background
A. Statutory Requirements and Legal Authority
B. Regulatory History
1. Existing Regulations
--Surface Water Treatment Rule (SWTR)
--Total Coliform Rule (TCR)
--Total Trihalomethane (TTHM) Rule
--Information 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,
[[Page 69480]]
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
[[Page 69481]]
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
[[Page 69482]]
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
[[Page 69483]]
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 elements--a 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
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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
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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,
[[Page 69486]]
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
alternatives--Alternatives B and C--specifically 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
[[Page 69487]]
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
[[Page 69488]]
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
[[Page 69489]]
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 1--Systems 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 2--Systems 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 3--Systems 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
[[Page 69490]]
data. In order to develop the profile, a system must:
--Measure 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.
--Determine 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.
--Measure water temperature ( deg.C).
--Measure 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:
--Determine CTcalc for each disinfection segment.
--Determine CT<INF>99.9</INF> (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).
--For each segment, log inactivation = (CTcalc/
CT<INF>99.9</INF>) x 3.0.
--Sum 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
[[Page 69491]]
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.
8<greek-m>g/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
[[Page 69492]]
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.
[[Page 69493]]
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
[[Page 69494]]
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,
[[Page 69495]]
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 surveys-- identifying and
correcting problems before they become larger problems affecting water
quality-- 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 Sec. 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:
<bullet> Source
--Protection
--Physical Components and Condition
<bullet> Treatment
<bullet> Distribution System
<bullet> Finished Water Storage
<bullet> Pumps/Pump Facilities and Controls
<bullet> Monitoring/Reporting/Data Verification
<bullet> Water System Management/Operations
<bullet> 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.
[[Page 69496]]
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
necessary--up 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.
[[Page 69497]]
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
[[Page 69498]]
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 Sec. 141.2--definitions; Sec. 141.32--public notification;
Sec. 142.14--records kept by States; Sec. 142.15--reports by States;
Sec. 142.16--special primacy requirements; Sec. 141.52--maximum
contaminant level goals for microbiological contaminants; Sec. 141.70--
general requirements; Sec. 141.71--criteria for avoiding filtration;
Sec. 141.73--filtration; Sec. 141.153--content of the reports; and a
new subpart P, consisting of Sec. 141.170 to Sec. 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 Sec. 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 Sec. 141.172(a)(1)
or (2) for the purpose of determining applicability of the requirements
of Sec. 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 Sec. 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
[[Page 69499]]
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 Sec. 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
(Sec. 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<SUP>-4</SUP> 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<SUP>-4</SUP> 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<SUP>-4</SUP> 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
[[Page 69500]]
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
[[Page 69501]]
efficiencies with a mean of 2.5 logs and a standard deviation of
<plus-minus>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 <plus-minus>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
----------------------------------------------------------------
10% Cost of 10% Cost of
3% Cost of 7% Cost of 10% Cost of Capital Capital
Capital Capital Capital 1992 1998
dollars dollars
----------------------------------------------------------------------------------------------------------------
Utility Costs
Utility Treatment Capital.................. $758,965 $758,965 $758,965 $3,665,568 $4,370,389
Annual Costs
Annualized Capital <dagger>................ 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 ........... ...........
[[Page 69502]]
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.
<dagger> 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]
----------------------------------------------------------------------------------------------------------------
Systems 3 Percent 7 Percent 10 Percent
System Size (population served) Number of Modifying Cost of Cost of Cost of
Systems Treatment Capital Capital 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 ...................... 96,328,996
Turbidity Monitoring and Start-Up.
----------------------------------------------------------------------------------------------------------------
* 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.
[[Page 69503]]
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 338,000........... 0-1,029,000....... 110,000........... 0-322,500
Illnesses Avoided.
Cost of Illness Avoided. $0.950 billion.... 0-1.883 billion... 0.263 billion..... 0-0.585 billion
Mid Number of Illnesses 432,000........... 0-1,074,000....... 141,000........... 0-333,000
Avoided.
Cost of Illness Avoided. 1.172 billion..... 0-1.960 billion... 0.327 billion..... 0-0.608 billion
High Number of Illnesses 463,000........... 0-1,080,000....... 152,000........... 0-338,000
Avoided.
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 48................ 0-129............. 14................ 0-40
Avoided.
Value of Mortalities 0.272 billion..... 0-0.674 billion... 0.085 billion..... 0-0.209 billion
Avoided.
Mid Number of Mortalities 60................ 0-135............. 18................ 0-42
Avoided.
Value of Mortalities 0.341 billion..... 0-0.706 billion... 0.107 billion..... 0-0.219 billion
Avoided.
High Number of Mortalities 64................ 0-136............. 20................ 0-42
Avoided.
Value of Mortalities 0.363 billion..... 0-0.708 billion... 0.115 billion..... 0-0.221 billion
Avoided.
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 Benefits not quantified.
Pathogens.
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 Milwaukee-level outbreak).
----------------------------------------------------------------------------------------------------------------
BILLING CODE 6560-50-P
[[Page 69504]]
[GRAPHIC] [TIFF OMITTED] TR16DE98.009
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
Cl<INF>2</INF> 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
[[Page 69505]]
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
[[Page 69506]]
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: jacobs.jenny@epamail.epa.gov and
naylor.richard@epamail.epa.gov. 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,
[[Page 69507]]
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
[[Page 69508]]
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
[[Page 69509]]
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
[[Page 69510]]
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 deg. 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 deg. scattered and
transmitted light. EPA has no data upon which to evaluate whether the
separate 90 deg. 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:
<bullet> Solicit ideas from Environmental Justice (EJ) stakeholders
on known issues concerning current drinking water regulatory efforts;
<bullet> Identify key issues of concern to EJ stakeholders; and
<bullet> 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
[[Page 69511]]
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
[[Page 69512]]
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:
<bullet> Source water adequacy. Does the system have a reliable
source of drinking water? Is the source of generally good quality and
adequately protected?
<bullet> 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?
<bullet> 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:
<bullet> Ownership accountability. Are the system owner(s) clearly
identified? Can they be held accountable for the system?
<bullet> 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?
<bullet> 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:
<bullet> Revenue sufficiency. Do revenues cover costs? Are water
rates and charges adequate to cover the cost of water?
<bullet> Credit worthiness. Is the system financially healthy? Does
it have access to capital through public or private sources?
<bullet> 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
[[Page 69513]]
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.
VIII. References
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Dupont H L, C L Chappell, C R Sterling, P C Okhuysen, J B Rose,
W Jakubowski (1995). The infectivity of Cryptosporidium parvum in
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E&S Environmental Chemistry (1997) Portland Water Bureau Water
Utility Survey--Draft. City of Portland, Oregon Open Reservoir
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EPA (1998a). Environmental Protection Agency. Regulatory Impact
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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 Sec. 9.1 the table is amended by adding under the indicated
heading the new entries in numerical order to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB control
40 CFR citation 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:
Sec. 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 Sec. 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:
Sec. 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 Sec. 141.52, the table is amended by adding a new entry, in
numerical order, to read as follows:
Sec. 141.52 Maximum contaminant level goals for microbiological
contaminants.
* * * * *
[[Page 69516]]
------------------------------------------------------------------------
Contaminant MCLG
------------------------------------------------------------------------
* * * * *
(5) Cryptosporidium......................... zero.
------------------------------------------------------------------------
7. Section 141.70 is amended by adding paragraph (d) to read as
follows:
Sec. 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:
Sec. 141.71 Criteria for avoiding filtration.
* * * * *
(b) * * *
(6) The public water system must comply with the requirements for
trihalomethanes in Secs. 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:
Sec. 141.73 Filtration.
* * * * *
(a) * * *
(3) Beginning December 17, 2001, systems serving at least 10,000
people must meet the turbidity requirements in Sec. 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
Sec. 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 Sec. 141.173(b).
10. Section 141.153 is amended by revising the first sentence of
paragraph (d)(4)(v)(C) to read as follows:
Sec. 141.153 Content of the reports.
* * * * *
(d) * * *
(4) * * *
(v) * * *
(C) When it is reported pursuant to Secs. 141.73 or 141.173: The
highest single measurement and the lowest monthly percentage of samples
meeting the turbidity limits specified in Secs. 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.
Sec. 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 Sec. 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 Sec. 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
Secs. 141.71 and 141.171 and the disinfection requirements in
Secs. 141.72 and 141.172; or
(2) It meets the applicable filtration requirements in either
Sec. 141.73 or Sec. 141.173 and the disinfection requirements in
Secs. 141.72 and 141.172.
(c) Systems are not permitted to begin construction of uncovered
finished water storage facilities beginning February 16, 1999.
Sec. 141.171 Criteria for avoiding filtration.
In addition to the requirements of Sec. 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 Sec. 141.71(b), systems must maintain the watershed
control program under Sec. 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
Sec. 141.71(b)(3), the State must determine whether the watershed
control program established under Sec. 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.
Sec. 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
[[Page 69517]]
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 Sec. 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
Secs. 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 Secs. 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 Sec. 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 Secs. 141.12 and 141.30 and handling
and analytical method requirements of Sec. 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 Secs. 141.12 and
141.30 and handling and analytical method requirements of
Sec. 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 Sec. 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 Secs. 141.12 and 141.30 and handling and
analytical method requirements of Sec. 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 <gr-thn-eq>0.064
mg/L or an HAA5 annual average <gr-thn-eq>0.048 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 Sec. 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 Sec. 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
[[Page 69518]]
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/CT<INF>99.9</INF>)
before or at the first customer during peak hourly flow.
(B) Determine successive CTcalc/CT<INF>99.9</INF> 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/
CT<INF>99.9</INF>) for each sequence and then adding the (CTcalc/
CT<INF>99.9</INF>) values together to determine (<greek-S> (CTcalc/
CT<INF>99.9</INF>)).
(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/CT<INF>99.9</INF>)
value of each segment and ((CTcalc/CT<INF>99.9</INF>)) 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.
Sec. 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 Sec. 141.72(b), and filtration
treatment which complies with the requirements of paragraph (a) or (b)
of this section or Sec. 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 Sec. 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
Sec. 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 Sec. 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 Sec. 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,
[[Page 69519]]
and 99 percent removal of Cryptosporidium oocysts.
Sec. 141.174 Filtration sampling requirements.
(a) Monitoring requirements for systems using filtration treatment.
In addition to monitoring required by Sec. 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 Sec. 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.
Sec. 141.175 Reporting and recordkeeping requirements.
In addition to the reporting and recordkeeping requirements in
Sec. 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
Sec. 141.75, a public water system subject to the requirements of this
subpart that provides filtration approved under Sec. 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
Sec. 141.75(b)(1).
(a) Turbidity measurements as required by Sec. 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 Sec. 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 Sec. 141.173(b).
(b) Systems must maintain the results of individual filter
monitoring taken under Sec. 141.174 for at least three years. Systems
must report that they have conducted individual filter turbidity
monitoring under Sec. 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
Sec. 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:
Sec. 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
Secs. 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 Sec. 141.13 of
this chapter.
* * * * *
(4)(i) Records of disinfectant residual measurements and other
parameters necessary to document disinfection effectiveness in
accordance with Secs. 141.72 and 141.74 of this chapter and
[[Page 69520]]
the reporting requirements of Secs. 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 Sec. 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 Sec. 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 Sec. 141.175 of this chapter.
* * * * *
14. Section 142.15 is amended by adding paragraph (c)(5) to read as
follows:
Sec. 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
Sec. 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:
Sec. 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 Sec. 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 Sec. 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
elements--a 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.
[[Page 69521]]
(2) State practices or procedures. (i) Section 141.172(a)(3) of
this chapter--How the State will approve a more representative annual
data set than the data set determined under Sec. 141.172 (a)(1) or (2)
of this chapter for the purpose of determining applicability of the
requirements of Sec. 141.172 of this chapter.
(ii) Section 141.172(b)(5) of this chapter--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.
(iii) Section 141.172(c) of this chapter--How the State will
consult with PWSs to evaluate modifications to disinfection practice.
(iv) Section 141.173(b) of this chapter--For 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 Sec. 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
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