[Federal Register Volume 63, Number 241 (Wednesday, December 16, 1998)]
[Rules and Regulations]
[Pages 69478-69521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32888]



[[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

Federal Register / Vol. 63, No. 241 / Wednesday, December 16, 1998 / 
Rules and Regulations

[[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 (N0/NT)
Log: Logarithm (common, base 10)
LTESWTR: Long Term Enhanced Surface Water Treatment Rule
LT1: Long Term 1 Enhanced Surface Water Treatment Rule
MCL: Maximum Contaminant Level
MCLG: Maximum Contaminant Level Goal
M-DBP: Microbial and Disinfectants/Disinfection Byproducts
MPA: Microscopic Particulate Analysis
NODA: Notice of Data Availability
NPDWR: National Primary Drinking Water Regulation
NT: The Concentration of Surviving Microorganisms at Time T
NTTAA: National Technology Transfer and Advancement Act
NTU: Nephelometric Turbidity Unit
PE: Performance Evaluation
PWS: Public Water System
Reg. Neg.: Regulatory Negotiation
RIA: Regulatory Impact Analysis
RFA: Regulatory Flexibility Act
RSD: Relative Standard Deviation
SAB: Science Advisory Board
SDWA: Safe Drinking Water Act
SWTR: Surface Water Treatment Rule
TC: Total Coliforms
TCR: Total Coliform Rule
TTHM: Total Trihalomethanes
TWG: Technical Work Group
UMRA: Unfunded Mandates Reform Act
x log removal: Reduction to \1/10\x 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

[[Page 69484]]

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

[[Page 69485]]

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 CT99.9 (i.e., 3-log inactivation) from tables in 
the SWTR using temperature (and pH for chlorine) for each disinfection 
segment. Alternatively, States may allow an alternate calculation 
procedure (e.g. use of spreadsheet).
--For each segment, log inactivation = (CTcalc/
CT99.9) 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. 
8g/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:
     Source
    --Protection
    --Physical Components and Condition
     Treatment
     Distribution System
     Finished Water Storage
     Pumps/Pump Facilities and Controls
     Monitoring/Reporting/Data Verification
     Water System Management/Operations
     Operator Compliance with State Requirements
    The guidance also addresses the qualifications for sanitary survey 
inspectors, the development of assessment criteria, documentation, 
follow-up after the survey, tracking and enforcement.
    As discussed earlier, EPA published a NODA (62 FR 59485) in 
November 1997 discussing new information the Agency has received since 
the 1994 IESWTR proposal as well as recommendations of the M-DBP 
Advisory Committee. The Advisory Committee made recommendations on the 
definition and frequency of surveys, as well as on survey components 
based on the 1995 EPA/State Guidance, and follow-up activities. In the 
1997 Notice, EPA requested comment on the Advisory Committee 
recommendations. In addition, the Agency requested comment on whether 
systems should be required to respond in writing to a State's sanitary 
survey report. EPA also requested comment on (1) what would constitute 
``outstanding performance'' for purposes of allowing sanitary surveys 
for a community water system to be conducted every five years and (2) 
how to define ``significant deficiencies.''

3. Summary of Major Comments

    Commenters on the 1994 proposal generally voiced support for 
requiring a periodic sanitary survey for all systems. One commenter 
suggested that EPA develop sanitary survey guidance for administration 
by the States, while another commenter suggested that sanitary surveys 
by the private sector be certified by States or national associations 
using EPA-defined criteria. Commenters recommended that surveys be 
conducted either by the State or a private independent party/
contractor. One respondent contended that sanitary surveys, as 
presently conducted, were insufficient to assess operational 
effectiveness in surface water systems.
    With regard to sanitary survey frequency, commenters on the 1994 
proposal were nearly evenly divided between every three years and every 
five years. Some commenters argued that the frequency should depend on: 
(1) Whether a system's control is effective or marginal, (2) system 
size (less frequent for small systems), (3) source water quality, (4) 
whether the State believes a system's water quality is likely to change 
over time, (5) results of the previous survey, and (6) population 
density on the watershed. One commenter suggested an annual sanitary 
survey.
    In terms of the frequency of conducting a sanitary survey, 
commenters on the 1997 notice generally voiced support for the 
frequencies recommended by the M-DBP Advisory Committee. One commenter 
suggested that all public water systems should have a sanitary survey 
no less often than once every three years and that systems with 
unsatisfactory or provisional ratings should be surveyed annually or 
more often. Another commenter suggested that even outstanding systems 
should be surveyed on a three year cycle because personnel or 
management changes can impact plant performance. One respondent 
recommended that sanitary surveys be required at a maximum frequency of 
every five years for all public water systems using surface water or 
ground water under the direct influence of surface water as a source. 
One commenter suggested that three and five year schedules be given as 
targets rather than requirements to allow States flexibility in 
deploying resources.
    EPA believes that the frequencies in today's rule allow States the 
flexibility to prioritize and carry out the sanitary survey process, 
while also ensuring that these surveys will be conducted as an 
effective preventive tool to identify and correct water system 
deficiencies that could pose a threat to public health. Given these 
considerations and recognizing that there are many more non-community 
than community water systems, EPA believes that the required 
frequencies for sanitary surveys are reasonable.

[[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 10-4 risk level from 
giardiasis while meeting the Stage 1 DBPR. Other rule options were not 
considered for the RIA because of insufficient data at the time of 
proposal. The RIA for the proposed 1994 IESWTR estimated national 
capital and annualized costs (amortized capital and annual operating 
costs) for surface water systems serving at least 10,000 people at $4.4 
billion and $468 million (in 1998 dollars at a 10% cost of capital) 
respectively. In estimating these costs, it was assumed that additional 
Giardia reduction beyond the requirements of the SWTR to achieve the 
10-4 risk level would be achieved solely by using chlorine 
as the disinfectant and providing additional contact time by increasing 
the disinfectant contact basin size. Under the 1994 RIA, EPA also 
estimated that 400,000 to 500,000 Giardia infections per year that 
could be avoided would have an economic value of $1.4 to $1.7 billion 
per year (in 1998 dollars at a 10% cost of capital), suggesting under 
this rule option, the benefit nationwide of avoiding Giardia infections 
would be as much as three or four times greater than the estimated $468 
million national annual cost of providing additional contact time. 
Development of the proposed rule option was based on the availability 
of an analytical method to quantify Giardia source water concentrations 
and prescribe appropriate levels of treatment to achieve the 
10-4 risk level. This rule option was dropped from 
consideration of a final IESWTR since adequate methods for measuring 
Giardia were not available during the final development phase of this 
rule. Also, ICR data was not available to evaluate the validity of 
assumed national Giardia source water concentration levels under the 
RIA for the proposed rule.

C. What's Changed Since the Proposed Rule

    National source water occurrence data for Giardia and 
Cryptosporidium are being collected as part of the ICR but this data 
will not become available until after promulgation of the IESWTR. Since 
February 1997, the Agency worked with stakeholders to identify 
additional data available since 1994 to support the RIA for the IESWTR 
published today. USEPA established the Microbial and Disinfectants/
Disinfection Byproducts Advisory Committee to collect, share and 
analyze new information and data, as well as to build consensus on the 
regulatory implications of this new information.

D. Summary of Cost Analysis

    The IESWTR will result in increased costs to public water systems 
for improved turbidity treatment, monitoring, disinfection benchmarking 
and covering new finished water reservoirs, as well as State 
implementation costs. As discussed earlier in this Notice, the rule 
will only apply to systems using surface water or ground water under 
the direct influence of surface water that serve 10,000 or more 
persons. (EPA notes that the rule does include provisions for primacy 
States to conduct sanitary surveys for all surface water and GWUDI 
systems regardless of size.) EPA intends to address systems serving 
less than 10,000 people, under the Long Term 1

[[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 
0.63 logs. Under this assumption, average log removal for 
different plants would generally range from 1.25 logs to 3.75 logs. 
Because the finished water concentrations of oocysts represent the 
baseline against which improved removal from the IESWTR is compared, 
variations in the log removal assumption could have considerable impact 
on the risk assessment. To evaluate the impact of the removal 
assumptions on the baseline and resulting improvements, an alternative 
mean log removal/inactivation assumption of 3.0 logs and a standard 
deviation of 0.63 logs was also used to calculate finished 
water concentrations of Cryptosporidium. Under this assumption average 
log removal for different plants would generally range from 1.75 to 
4.25 logs.
    For each of the two baseline assumptions, USEPA assumed that a 
certain number of plants would show low, mid or high improved removal, 
depending upon factors such as water matrix conditions, filtered water 
turbidity effluent levels, and coagulant treatment conditions. As a 
result, the RIA considers six scenarios that encompass the range of 
endemic health damages avoided based on the rule.
    The finished water Cryptosporidium distributions that would result 
from additional log removal with the turbidity provisions were derived 
assuming that additional log removal was dependent on current removal, 
i.e., that sites currently operating at the highest filtered water 
turbidity levels would show the largest improvements or high improved 
removal assumption (e.g., plants now failing to meet a 0.4 NTU limit 
would show greater removal improvements than plants now meeting a 0.3 
NTU limit).
    Table V.4 indicates estimated annual benefits associated with 
implementing the IESWTR. The benefits analysis quantitatively examines 
endemic health damages avoided based on the IESWTR for each of the six 
scenarios mentioned above. For each of these scenarios, EPA calculated 
the mean of the distribution of the number of illnesses avoided. The 
assessment also discusses, but does not quantify, other economic 
benefits that may result from the provisions, including the avoided 
health damage costs associated with reduced risk of outbreaks and 
avoided costs of averting behavior such as boiling water or use of an 
alternative water source during outbreaks or periods of high turbidity.
    According to the RIA performed for the IESWTR published today, the 
rule is estimated to reduce the mean annual number of illnesses caused 
by Cryptosporidium in water systems improving filtration by 110,000 to 
463,000 cases depending upon which of the six baseline and improved 
Cryptosporidium removal assumptions was used. Based on these values, 
the mean estimated annual benefits of reducing the illnesses ranges 
from $0.263 billion to $1.240 billion per year. This calculation is 
based on a valuation of $2,000 per incidence of cryptosporidiosis 
prevented which is the mean of a distribution of values ascribed to 
health damages avoided. The RIA also indicated that the rule could 
result in a mean reduction of 14 to 64 fatalities each year, depending 
upon the varied baseline and improved removal assumptions. Using a mean 
value of $5.6 million per statistical life saved, reducing these 
fatalities could produce benefits in the range of $0.085 billion to 
$0.363 billion.

G. Comparison of Costs and Benefits

    Given the costs summarized in Table V.1 and the benefits summarized 
in Table V.4, the IESWTR results in positive net benefits under all 
three improved removal scenarios (low, mid, and high) assuming that 
current treatment as a national average achieves 2.5 log of 
Cryptosporidium removal, taking into account only the value of cost of 
illness avoided. Using a current national average treatment removal 
assumption of 3.0 logs, net benefits are positive under the high and 
mid improved removal scenarios. Net benefits using the 3.0 log current 
removal assumption are negative under the low improved removal scenario 
using only the value of cost of illness avoided, however, when the 
value of mortalities prevented is added into the benefits, all 
scenarios have positive net benefits at the mean.
    Thus, the monetized net benefits are positive across most of the 
range of current treatment assumptions, improved log removal scenarios, 
and discount rates. The benefits due to the illnesses avoided may be 
slightly overstated when aggregated with benefits due to mortalities 
avoided, because the mortalities were not netted out of the number of 
illnesses. This value is minimal and would not be captured at the level 
of significance of the analysis. Several categories of benefits, 
including reducing the risk of outbreaks, reducing exposure to other 
pathogens such as Giardia, and avoiding the cost of averting behavior 
have not been quantified for this analysis, but could represent 
substantial additional economic value. In addition, the estimates for 
avoided costs of illness do not include the value for pain and 
suffering or the risk premium.

              Table V.1.--Annual Costs of the Interim Enhanced Surface Water Treatment Rule ($000s)
----------------------------------------------------------------------------------------------------------------
                                                       Final Rule (1998 dollars)              1994 Proposal
                                                ----------------------------------------------------------------
                                                                                        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 ................       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.
 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 
Cl2 be used for estimating log inactivation when the 
chlorine residual level is higher than 3 mg/L.

C. Cross Connection Control

Today's Rule

    EPA is not establishing requirements for cross connection control 
in today's final rule. The Agency does plan to consider cross 
connection control issues during the development of subsequent 
microbial regulations, in the context of a broad range of issues 
related to distribution systems. At that time the results of research 
currently in progress should be available to the Agency and enable EPA 
to make regulatory decisions.

Background and Analysis

    The proposed IESWTR (EPA, 1994b, 59 FR 38841, July 29, 1994) 
requested

[[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: [email protected] and 
[email protected]. 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:
     Solicit ideas from Environmental Justice (EJ) stakeholders 
on known issues concerning current drinking water regulatory efforts;
     Identify key issues of concern to EJ stakeholders; and
     Receive suggestions from EJ stakeholders concerning ways 
to increase representation of EJ communities in OGWDW regulatory 
efforts.
In addition, EPA developed a plain-English guide specifically for this

[[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:
     Source water adequacy. Does the system have a reliable 
source of drinking water? Is the source of generally good quality and 
adequately protected?
     Infrastructure adequacy. Can the system provide water that 
meets SDWA standards? What is the condition of its infrastructure, 
including well(s) or source water intakes, treatment, storage, and 
distribution? What is the infrastructure's life expectancy? Does the 
system have a capital improvement plan?
     Technical knowledge and implementation. Is the system's 
operator certified? Does the operator have sufficient technical 
knowledge of applicable standards? Can the operator effectively 
implement this technical knowledge? Does the operator understand the 
system's technical and operational characteristics? Does the system 
have an effective operation and maintenance program?
    Managerial capacity is the ability of a water system to conduct its 
affairs in a manner enabling the system to achieve and maintain 
compliance with SDWA requirements. Managerial capacity refers to the 
system's institutional and administrative capabilities.
    Managerial capacity can be assessed through key issues and 
questions, including:
     Ownership accountability. Are the system owner(s) clearly 
identified? Can they be held accountable for the system?
     Staffing and organization. Are the system operator(s) and 
manager(s) clearly identified? Is the system properly organized and 
staffed? Do personnel understand the management aspects of regulatory 
requirements and system operations? Do they have adequate expertise to 
manage water system operations? Do personnel have the necessary 
licenses and certifications?
     Effective external linkages. Does the system interact well 
with customers, regulators, and other entities? Is the system aware of 
available external resources, such as technical and financial 
assistance?
    Financial capacity is a water system's ability to acquire and 
manage sufficient financial resources to allow the system to achieve 
and maintain compliance with SDWA requirements.
    Financial capacity can be assessed through key issues and 
questions, including:
     Revenue sufficiency. Do revenues cover costs? Are water 
rates and charges adequate to cover the cost of water?
     Credit worthiness. Is the system financially healthy? Does 
it have access to capital through public or private sources?
     Fiscal management and controls. Are adequate books and 
records maintained? Are appropriate budgeting, accounting, and 
financial planning methods used? Does the system manage its revenues 
effectively?
    1,381 systems are affected by the IESWTR. Of these, 691 may need to 
modify their treatment process and undertake turbidity monitoring, and 
will need to meet the disinfection benchmarking and turbidity 
exceptions reporting requirements. The other 690 systems will need to 
do turbidity monitoring and will need to meet the disinfection 
benchmarking and turbidity exceptions reporting requirements as 
applicable, but will not need to modify their treatment process.
    Systems not modifying treatment will need to do turbidity 
monitoring, disinfection benchmarking, and turbidity exceptions 
reporting, These systems are not generally expected to require 
significantly increased technical, financial, or managerial capacity to 
comply with these new requirements. Some individual facilities may have 
weaknesses in one or more of these areas, but overall surface water 
systems should have or be able to easily obtain the capacity needed for 
these activities.
    Systems needing to modify treatment will employ one or more of a 
variety of steps. The steps expected to be employed by 25% or more of 
systems in virtually all size categories covered by the rule are: 
install backwash water polymer feed capability; install individual 
filter turbidimeters; account for recycle flow in process control 
decisions; implement a policy and commitment to lower water quality 
goals; utilize alternative process control testing equipment; modify/
implement process control monitoring and control; and designate a 
process control strategy facilitator.
    Furthermore, there are a number of actions that are expected to be 
taken disproportionately by the smaller sized systems covered under the 
IESWTR (that is to say, a greater percentage of smaller sized systems 
will undertake these activities than will larger sized systems). These 
steps include: Structural and mechanical rapid mix improvements; filter 
underdrain retrofits and gravel media; filter rate-of-flow controller 
replacement; hydraulic improvements in flow distribution/control/
measurement; increase plant staffing; replace obsolete bench top 
turbidimeters; purchase jar test apparatus; and train staff to 
understand process control strategy.
    For many systems serving between 10,000 and 100,000 persons which 
need to make treatment modifications an enhancement of technical, 
financial, and managerial capacity may likely be needed. As the 
preceding paragraph makes clear, these systems will be making 
structural improvements and enhancing laboratory and staff capacity. 
Larger sized systems have typically already made these improvements as 
part of normal operations. Meeting the requirements of the IESWTR will 
require operating at a higher level of sophistication and in a better 
state of repair than some plants in the 10,000-100,000 person size 
category have considered acceptable in the past.
    Certainly there will be exceptions both between 10,000 and 100,000 
persons and above. Some larger plants are expected to find that their 
technical, managerial, and financial capacity needs to be upgraded to 
support the system in meeting the new requirements. Likewise, some 
plants serving 10,000-100,000 persons will already have more than 
adequate technical, financial, and managerial capacity to meet these 
requirements. However, in general, the systems serving 10,000-100,000 
persons needing to make treatment modifications will be the ones most 
needing to enhance their capacity.

L. Submission to Congress and the General Accounting Office

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement

[[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

    Amirtharajah A (1988). Some theoretical and conceptual views of 
filtration. Journal AWWA (Dec 1988), pgs 36-46.
    Arrowood, M J (1997). Diagnosis. pp. 43-64, In: R. Fayer (ed.), 
Cryptosporidium and Cryptosporidiosis. CRC Press, New York.
    AWWA Water Industry Data Base (WIDB) (1996) AWWA, Denver, CO.
    AWWA (1993). American Water Works Association. Officers and 
Committee Directory. AWWA Denver, CO.
    AWWA Committee Report (1983). Deterioration of water quality in 
large distribution reservoirs (open reservoirs). AWWA Committee on 
Control of Water Quality in Transmission and Distribution Systems. 
Journal AWWA (June 1983), pgs 313-318.
    AWWSC (1997). Treatment Plant Turbidity Data. Provided to the 
Technical Work Group, American Water Works Service Company, 1997.
    Bailey S W and E C Lippy (1978). Should all finished water 
reservoirs be covered. Public Works for April 1978. p66-70.
    Bissonette E (1997). Summary of the Partnership for Safe Water 
Initial Annual Technical Report.
    Bucklin K, A Amirtharajah, and KO Cranston (1988). The 
characteristics of initial effluent quality and its implications for 
the filter-to-waste procedure. AWWARF, Nov 1988.
    Casemore D P (1990). Epidemiological aspects of human 
cryptosporidiosis. Epidemiol. Infect. 104:1-28.
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(1995). A study of two US Army installations drinking water sources 
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88(3): 66-80.
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Protozoa in open reservoirs. Journal AWWA (Sept 1997), 89(9): 84-96.
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between particle counts and Giardia, Cryptosporidium and turbidity. 
Journal AWWA (Dec 1992), pgs 52-60.
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Giardia and Cryptosporidium spp in surface water supplies. Appl 
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Cryptosporidium spp. in filtered drinking water supplies. Appl 
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Rose, M Sobsey (1994). The removal and disinfection efficiency of 
lime softening process for Giardia and Viruses. AWWARF, Denver, CO.
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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 0.064 
mg/L or an HAA5 annual average 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/CT99.9) 
before or at the first customer during peak hourly flow.
    (B) Determine successive CTcalc/CT99.9 values, 
representing sequential inactivation ratios, between the point of 
disinfectant application and a point before or at the first customer 
during peak hourly flow. Under this alternative, the system must 
calculate the total inactivation ratio by determining (CTcalc/
CT99.9) for each sequence and then adding the (CTcalc/
CT99.9) values together to determine ( (CTcalc/
CT99.9)).
    (ii) If the system uses more than one point of disinfectant 
application before the first customer, the system must determine the CT 
value of each disinfection segment immediately prior to the next point 
of disinfectant application, or for the final segment, before or at the 
first customer, during peak hourly flow. The (CTcalc/CT99.9) 
value of each segment and ((CTcalc/CT99.9)) must be 
calculated using the method in paragraph (b)(4)(i) of this section.
    (iii) The system must determine the total logs of inactivation by 
multiplying the value calculated in paragraph (b)(4)(i) or (ii) of this 
section by 3.0.
    (5) A system that uses either chloramines or ozone for primary 
disinfection must also calculate the logs of inactivation for viruses 
using a method approved by the State.
    (6) The system must retain disinfection profile data in graphic 
form, as a spreadsheet, or in some other format acceptable to the State 
for review as part of sanitary surveys conducted by the State.
    (c) Disinfection benchmarking. (1) Any system required to develop a 
disinfection profile under the provisions of paragraphs (a) and (b) of 
this section and that decides to make a significant change to its 
disinfection practice must consult with the State prior to making such 
change. Significant changes to disinfection practice are:
    (i) Changes to the point of disinfection;
    (ii) Changes to the disinfectant(s) used in the treatment plant;
    (iii) Changes to the disinfection process; and
    (iv) Any other modification identified by the State.
    (2) Any system that is modifying its disinfection practice must 
calculate its disinfection benchmark using the procedure specified in 
paragraphs (c)(2)(i) through (ii) of this section.
    (i) For each year of profiling data collected and calculated under 
paragraph (b) of this section, the system must determine the lowest 
average monthly Giardia lamblia inactivation in each year of profiling 
data. The system must determine the average Giardia lamblia 
inactivation for each calendar month for each year of profiling data by 
dividing the sum of daily Giardia lamblia of inactivation by the number 
of values calculated for that month.
    (ii) The disinfection benchmark is the lowest monthly average value 
(for systems with one year of profiling data) or average of lowest 
monthly average values (for systems with more than one year of 
profiling data) of the monthly logs of Giardia lamblia inactivation in 
each year of profiling data.
    (3) A system that uses either chloramines or ozone for primary 
disinfection must also calculate the disinfection benchmark for viruses 
using a method approved by the State.
    (4) The system must submit information in paragraphs (c)(4)(i) 
through (iii) of this section to the State as part of its consultation 
process.
    (i) A description of the proposed change;
    (ii) The disinfection profile for Giardia lamblia (and, if 
necessary, viruses) under paragraph (b) of this section and benchmark 
as required by paragraph (c)(2) of this section; and
    (iii) An analysis of how the proposed change will affect the 
current levels of disinfection.


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