EPA 815-Z-02-001
Monday,
January 14, 2002
Part H
Environmental
Protection Agency
40 CFR Parts 9, 141, and 142
National Primary Drinking Water
Regulations: Long Term 1 Enhanced
Surface Water Treatment Rule; Final Rule
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Federal Register/Vol. 67, No. 9/Monday, January 14, 2002/Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9,141, and 142
[WH-FRL-7124-2]
BIN 2040-AD18
National Primary Drinking Water
Regulations: Long Term 1 Enhanced
Surface Water Treatment Rule
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: In this document, EPA is
finalizing the Long Term 1 Enhanced
Surface Water Treatment Rule
(LTlESWTR). The purposes of the
LTlESWTR are to improve control of
microbial pathogens, specifically the
protozoan Cryptosporidium, in drinking
water and address risk trade-offs with
disinfection byproducts. The rule will
require systems to meet strengthened
filtration requirements as well as to
calculate levels of microbial inactivation
to ensure that microbial protection is
not jeopardized if systems make changes
to comply with disinfection
requirements of the Stage 1 Disinfection
and Disinfection Byproducts Rule
(DBPR). The LTlESWTR applies to
public water systems that use surface
water or ground water under the direct
influence of surface water and serve
fewer than 10,000 persons. The
LTlESWTR builds upon the framework
established for systems serving a
population of 10,000 or more in the
Interim Enhanced Surface Water
Treatment Rule (IESWTR). This rule
was proposed in combination with the
Filter Backwash Recycling Rule (FBRR)
in April 2000.
DATES: This regulation is effective
February 13, 2002. As discussed in the
supplementary information section and
consistent with sections 1412(b)(10) and
1445 of SDWA, regulated entities must
comply with this rule starting March 15,
2002. For judicial review purposes, this
final rule is promulgated as of 1 p.m.
eastern time on January 14,2002.
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 (W-99-10, Final
Long Term 1 Enhanced Surface Water
Treatment Rule) 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., Eastern
Time, Monday through Friday,
excluding legal holidays. For access to
docket materials or to schedule an
appointment please call (202) 260-3027.
FOR FURTHER INFORMATION CONTACT: For
technical inquiries contact Tom Grubbs
at 1200 Pennsylvania Avenue, NW.,
MC4607, Washington, DC 20460, (202)
564-5262. 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.
SUPPLEMENTARY INFORMATION:
Regulated Entities
Entities potentially regulated by the
LTlESWTR are public water systems
(PWSs) that use surface water or ground
water under the direct influence of
'surface water (GWUDI) and serve fewer
than 10,000 persons. Regulated
categories and entities include:
Category
industry
State, Local, Tribal or
Federal Govern-
ments.
Examples of regu-
lated entities
PWSs that use sur-
face water or
GWUDI.
PWSs that use sur-
face water or
GWUDI.
This table is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
regulated by the LTlESWTR. This table
lists the types of entities that EPA is
now aware could potentially be
regulated by this 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
definition of PWS in § 141.2 of title 40
of the Code of Federal Regulations and
applicability criteria in § 141.501 of
today's final rule. If you have questions
regarding the applicability of the
LTlESWTR to a particular entity,
consult the person listed in the
preceding FOR FURTHER INFORMATION
CONTACT section.
List of Abbreviations Used in This
Document:
AWWA American Water Works
Association
AWWSCo American Water Works
Service Company
°C Degrees Celsius
CCP Composite Correction Program
CCR Consumer Confidence Report
CDC Centers for Disease Control
CFR Code of Federal Regulations
CFSII Continuing Survey of Food
Intakes by Individuals
COI Cost of Illness
CPE Comprehensive Performance
Evaluation
CTA Comprehensive Technical
Assistance
DAF Dissolved Air Flotation
DBF Disinfection Byproducts
DBPR Disinfectants and Disinfection
Byproduct Rule
EPA Environmental Protection Agency
ESWTR Enhanced Surface Water
Treatment Rule
FACA Federal Advisory Committee
Act
FBRR Filter Backwash Recycle Rule
FR Federal Register
gpm Gallons per Minute
GWUDI Ground Water Under Direct
Influence of Surface Water
HAAS Haloacetic Acids
(Monochloroacetic, Dichloroacetic,
Trichloroacetic, Monobromoacetic
and Dibromoacetic Acids)
HRRCA Health Risk Reduction and
Cost Analysis
ICR Information Collection Request
IESWTR Interim Enhanced Surface
Water Treatment Rule
LTlESWTR Long Term 1 Enhanced
Surface Water Treatment Rule
MCLG Maximum Contaminant Level
Goal
M-DBP Microbial and Disinfectants/
Disinfection Byproducts
NDWAC National Drinking Water
Advisory Council
NPDWR National Primary Drinking
Water Regulation
NODA Notice of Data Availability
NTTAA National Technology Transfer
and Advancement Act
NTU Nephelometric Turbidity Units
O&M Operation and Maintenance
OMB Office of Management and
Budget
PBMS Performance-based
Measurement System
PRA Paperwork Reduction Act
PWS Public Water System
PWSS Public Water Supply
Supervision
RFA Regulatory Flexibility Act
RIA Regulatory Impact Analysis
SAB Science Advisory Board
SBA Small Business Administration
SBAR Small Business Advocacy
Review
SBREFA Small Business Regulatory
Enforcement Fairness Act of 1996
SDWA Safe Drinking Water Act
SDWIS Safe Drinking Water
Information System
SWTR Surface Water Treatment Rule
TTHM Total Trihalomethanes
UMRA Unfunded Mandates Reform
Act
WTP Willingness to Pay
Table of Contents
I. Summary
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1813
A. Why is EPA Promulgating the
LT1ESWTR? . '
B. What is Cryptosporidiuin? ,
C. What are the Health Concerns
Associated with Cryptosporidium?
D. Does this Regulation Apply to My Water
System?
E. How is the EPA Regulating
Cryptosporidium in the LT1ESWTR?
F. What Other Requirements are Included
in this Rule?
G. How Will this Regulation Protect Public
•Health?
II. Background
A. What is the Statutory Authority for the
LT1ESWTR?
B. What is the Regulatory History for the
LT1ESWTR?
C. How were Stakeholders Involved in
Developing the LT1ESWTR?
D. What did the April 10, 2000 Proposal
Contain?
III. Discussion of the Final Rule
A. What Level of Cryptosporidium
Removal does the LT1ESWTR Require?
B. What Combined Filter Effluent
Requirements does the LTlESWTR
Contain?
, C. What Individual Filter Monitoring
Requirements does the LTlESWTR
Contain?
D. What Disinfection Profiling and
Benchmarking Requirements does the
LTlESWTR Contain?
E. How does the Definition of Ground
Water Under the Direct Influence of
: Surface Water Change?
F. What Additional Requirements does the
LTlESWTR Contain for Unfiltered
Systems?
G. What does the LTlESWTR Require for
Finished Water Reservoirs?
H. What is the Compliance Schedule for
the LTlESWTR?
I. What Public Notification and Consumer
Confidence Report Requirements are
Contained in the LTlESWTR?
IV. State Implementation
A. What Special State Primacy
Requirements does the LTlESWTR
Contain?
B. What State Recordkeeping Requirements
does the LTlESWTR Contain?
C. What State Reporting Requirements does
the LTlESWTR Contain?
D. How Must a State Obtain Interim
Primacy for the LTlESWTR?
V. Economic Analysis (Health Risk
Reduction and Cost Analysis)
A. What are the Costs of the LTlESWTR?
B. What are the Household Costs of the
LTlESWTR?
C. What are the Benefits of the
LTlESWTR?
D. What are the Incremental Costs and
Benefits?
E. Are there Benefits From the Reduction
of Co-Occurring Contaminants?
F. Is there Increased Risk From Other
Contaminants?
• G. What are the Uncertainties in the Risk,
Benefit, and Cost Estimates for the
LTlESWTR?
H. What is the Benefit/Cost Determination
for the LTlESWTR?
VI. Other Requirements
A. Regulatory Flexibility Act (RFA), as
amended by the Small Business
Regulatory Enforcement Fairness Act of
1996 (SBREFA), 5 U.S.C. 601 et seq.
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. Consultations with the Science
Advisory Board, National Drinking
Water Advisory Council, and the
Secretary of Health and Human Services
I. Executive Order 13132: Executive Orders
on Federalism
J. Executive Order 13175: Consultation and
Coordination With Indian Tribal
Governments
K. Likely Effect of Compliance with the
LTlESWTR on the Technical, Financial,
and Managerial Capacity of Public Water
Systems
L. Plain Language
M. Congressional Review Act
N. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
VII. References
I. Summary
A. Why Is EPA Promulgating the
LTlESWTR?
The Safe Drinking Water Act (SDWA)
requires EPA to set enforceable
standards to protect public health, from
contaminants that may occur in
drinking water. As explained in more
detail in the April 10, 2000 proposal for
today's rale (65 FR 19046), EPA has
determined that the presence of
microbiological contaminants is a
substantial health concern. If finished
water supplies contain microbiological
contaminants, disease outbreaks may
result. Disease symptoms may include
diarrhea, cramps, nausea, jaundice,
headaches, and fatigue. EPA has set
enforceable drinking water treatment
techniques to reduce the risk of
waterborne disease outbreaks.
Treatment technologies such as
filtration and disinfection can remove or
inactivate microbiological
contaminants.
Physical removal is critical to the
control of Cryptosporidium because it is
highly resistant to standard disinfection
practices. Cryptosporidiosis, the
infection caused by Cryptosporidium,
may manifest itself as a severe infection
that can last several weeks and may
cause the death of individuals with
compromised immune systems. In 1993,
Cryptosporidium caused over 400,000
people in Milwaukee, WI to experience
intestinal illness. More than 4,000 were
hospitalized and at least 50 deaths were
attributed to the Cryptosporidiosis
outbreak. There have also been
Cryptosporidiosis outbreaks in Nevada,
Oregon, and Georgia over the past
several years.
In 1990, the EPA Science Advisory
Board (SAB) 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
(USEPA/SAB, 1990). The LTlESWTR
addresses this challenge by improving
the control of a wide range of microbial.
pathogens hi public drinking .water
systems and, specifically addressing
Cryptosporidium for the first time in
systems serving fewer than 10,000
people.
B. What Is Cryptosporidium?
Cryptosporidium is a protozoan
parasite found in humans, other
mammals, birds, fish, and reptiles. It is
common in the environment and widely
found in surface water supplies (Rose,
1998; LeChevallier and Norton, 1995;
Atherholt et al., 1998; EPA, 2000a). In
the infected animal, the parasite
multiplies in the gastrointestinal tract.
The animal then excretes Oocysts of the
parasite in its feces. These oocysts are
tiny spore-like organisms 4 to 6 microns
in diameter (too small to be seen.
without a microscope), which carry
within them the infective sporozoites.
The oocysts of Cryptosporidium are very
resistant to adverse factors in the
environment and can survive dormant
for months in cool, dark conditions such
as moist soil, or for up to a year in clean
water. When ingested by another animal
they can transmit the Cryptosporidiosis
disease and start a new cycle of
infection. Cryptosporidiosis is primarily
a waterborne disease, but has also been
transmitted by consumption of
contaminated food, unhygienic diaper
changing practices (and other person-to-
person contact), and contact with young
farm animals.
Cryptosporidium oocysts are not
easily killed by commonly-used
disinfectants. They are relatively
unaffected by chlorine and chloramines
in the concentrations that are used for
drinking water treatment. Oocyst
infectivity appears to persist under
normal temperatures, although oocysts
may lose infectivity if sufficiently
cooled or heated (USEPA, 2000a).
Research indicates that oocysts may
remain viable even after freezing (Payer
and Nerad, 1996).
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C. What Are the Health Concerns
Associated With Cryptosporidium?
When someone is infected with
Cryptosporidium, they may contract
cryptosporidiosis, a disease which can
cause diarrhea, stomach cramps, nausea,
loss of appetite, and a mild fever.
Cryptosporidium has become
recognized as one of the most common
causes of waterborne disease (drinking
and recreational) in humans in the
United States. The parasite is found in
every region of the United States and
throughout the world (www.cdc.gov/
ncidod/dpd/parasites/cryptosporidiosis/
factsht_cryptosporidiosis.htm).The
symptoms of cryptosporidiosis begin an
average of seven days after infection.
Persons with a normal, healthy immune
system can expect then1 illness to last for
two weeks or less, with constant or
intermittent diarrhea. However, even
after symptoms cease, an individual can
still pass Cryptosporidium in the stool
for up to two months, and may be a
source of infection for others.
Cryptosporidiosis is not treatable with
antibiotics, so prevention of infection is
critical. People with weakened immune
systems (those with HIV/AIDS, on
cancer chemotherapy, or who have
received organ transplants) •will have
cryptosporidiosis for a longer period of
time, and it could become life-
threatening. Young children, pregnant
women, or the elderly infected with
cryptosporidiosis can quickly become
severely dehydrated.
Twelve waterborne cryptosporidiosis
outbreaks have occurred at drinking
water systems since 1984 (Craun, 1998;
USEPA, ZOOOa). The largest of the
known outbreaks occurred in
Milwaukee and was responsible for over
400,000 illnesses and at least 50 deaths
(Hoxie, et al., 1997; MacKenzie et al.,
1994); other known outbreaks have
occurred in smaller communities and
have involved many fewer people. An
incident such as a rainstorm that flushes
many oocysts into the source water or
causes a sanitary sewer overflow
combined with a water treatment plant
upset could allow a large pulse of
oocysts to move past the multiple
barriers of a water treatment plant.
D. Does This Regulation Apply to My
Water System?
Today's final regulation applies to all
small (serving less than 10,000 people)
public water systems (PWSs) that use
surface water or ground water under the
direct influence of surface water
(GVVUDI).
E. How Is the EPA Regulating
Cryptosporidium in the LTlESWTR?
In the IESWTR (63 FR 69478), EPA
established a maximum contaminant
level goal (MCLG) of zero for
Cryptosporidium. When establishing an
MCLG, EPA must also establish either a
corresponding Maximum Contaminant
Level (MCL) or a treatment technique. In
the IESWTR and in today's LTlESWTR,
the Agency chose to establish a
treatment technique that relies on
strengthening water treatment processes
already in place. For filtered systems
this means achieving at least 2-log (99
percent) removal of Cryptosporidium by
meeting strengthened combined filter
effluent turbidity limits as established
by today's rule. For unfiltered systems
it means maintaining and improving
Cryptosporidium control under existing
watershed control plans.
F. What Other Requirements Are
Included in This Rule?
Today's final regulation includes
several requirements.
—All surface water and GWUDI systems
serving fewer than 10,000 people
must meet the requirements for
achieving a 2-log removal or control
of Cryptosporidium;
—Conventional and direct filtration
systems must comply with specific
combined filter effluent turbidity
requirements while alternative
filtration systems (systems using
filtration other than conventional
filtration, direct filtration, slow sand
filtration, or diatomaceous earth
filtration), must demonstrate the
ability to achieve 2-log removal of
Cryptosporidium and comply with
specific State-established combined
filter effluent turbidity requirements;
—Conventional and direct filtration
systems must continuously monitor
the turbidity of individual filters and
perform follow-up activities if this
monitoring indicates a potential
problem;
—Systems must develop a disinfection
profile unless they can demonstrate
that their TTHM and HAAS
disinfection byproduct (DBF) levels
are less than 0.064 mg/L, and 0.048
mg/L respectively;
—Systems considering a significant
change to their disinfection practice
must develop a disinfection
inactivation benchmark of their
existing level of microbial protection
and consult with the State for
approval prior to implementing the
disinfection change;
—Finished water reservoirs for which
construction begins after the effective
date of today's rule must be covered;
and
—Unfiltered systems must comply with
updated watershed control
requirements that add
Cryptosporidium as a pathogen of
concern.
G. How Will This Regulation Protect
Public Health?
Today's rule for the first time
establishes Cryptosporidium control
requirements for small systems by
requiring a minimum 2-log removal for
Cryptosporidium. The rule also
strengthens filter performance
requirements to ensure 2-log
Cryptosporidium removal, establishes
individual filter monitoring to minimize
contaminant pass-through and support
improved performance, includes
Cryptosporidium in the definition of
GWUDI, and explicitly considers
unfiltered system watershed control
provisions. Today's rule also reflects a
commitment to the importance of
maintaining existing levels of microbial
protection in public water systems as
plants take steps to comply with newly
applicable DBF standards. Systems
considering significant changes to ,their
disinfection practices must first evaluate
current levels of Giardia inactivation
(and virus inactivation if applicable)
and consult with their State Primacy
Agency for approval before
implementing those changes to assure
that current microbial protection is not
significantly reduced. Thus, compliance
with the provisions of today's rule will
improve public health protection by
reducing the risk of exposure to
Cryptosporidium in small systems
serving fewer than 10,000 people even
as those systems begin to take steps to
comply with related DBF standards.
II. Background
A. What Is the Statutory Authority for
the LTlESWTR?
The Safe Drinking Water Act (SDWA
or the Act), as amended in 1986,
requires EPA to publish a maximum
contaminant level goal (MCLG) for each
contaminant which in the judgement of
the EPA Administrator, may have an
adverse effect on the health of persons,
occurs in public water systems with a
frequency and at a level of public health
concern, and whose regulation would
represent a meaningful public health
risk reduction (Section 1412(b)(l)(A)).
MCLGs are non-enforceable health goals
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 again
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1815
amended in August 1996 (Public Law
104-83), resulting in the renumbering
and augmentation of certain sections
with additional statutory language. New
sections were added establishing new
drinking water requirements.
The 1986 Amendments to SDWA
requires EPA to publish an enforceable
National Primary Drinking Water
Regulation (NPDWR) that specifies
either a maximum contaminant level
(MCL) or treatment technique (Sections
1401(1) and 1412(7)(a)) at the same time
it publishes an MCLG. EPA is
authorized to promulgate a NPDWR that
requires the use of a treatment
technique in lieu of establishing an
MCL, if the Agency finds that it is not
economically or technologically feasible
to ascertain the level of the
contaminant. Today's rule relies upon
the treatment technique of improved
filter performance based on
strengthened turbidity limits to control
for Cryptosporidium because an
analytical method suitable for finished
water compliance purposes is currently
not economically or technologically
feasible. In accordance with a schedule
established by Section 1412(b)(2)(C) of
SDWA as added by the 1996
Amendments to SDWA, EPA is required
to promulgate today's rule by November
2000.
B. What Is the Regulatory History for the
LTtESWTR?
In 1989, EPA promulgated the Surface
Water Treatment Rule (SWTR) (54 FR
27486, June 29, 1989 (USEPA, 1989))
that set MCLGs of zero for Giardia
lamblia, viruses, and Legionella and
promulgated regulatory requirements for
all PWSs using surface water or GWUDI.
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 percent) for Giardia and 4-log
(99.99 percent) for viruses; (3) combined
filter effluent turbidity performance
standard of 5 nephelometric turbidity
units (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.
Systems seeking to avoid filtration were
required to meet avoidance criteria and
obtain avoidance determinations from
States by December 30,1991, otherwise
filtration must have been provided by
June 29,1993. For systems properly
avoiding filtration, later failures to meet
avoidance criteria triggered a
requirement that filtration be provided
within 18 months.
The intention of the SWTR was to
provide appropriate multiple barriers of
treatment to control pathogen
occurrence in finished drinking water.
Cryptosporidium, however, was not
addressed under the SWTR, because
EPA lacked sufficient health,
occurrence, and water treatment control
data regarding this organism at the time
of the rale's development. The ffiSWTR
and today's final rule address these gaps
in microbial protection.
In 1992, EPA initiated a negotiated
rulemaking (Reg-Neg) to develop a
disinfectants and disinfection
byproducts rule. The Reg-Neg
Committee consisting of a variety of
stakeholder groups met from November
1992 through June 1993. As part of this
effort, the Committee concluded that the
SWTR needed to be revised to address
the health risk of high densities of
pathogens in poorer quality source
waters, than the SWTR addressed as well
as the health risks of Cryptosporidium.
The Committee recommended the
development of three sets of rules: a
two-staged Disinfectants/Disinfection
Byproducts Rule (DBPR), an "interim"
Enhanced Surface Water Treatment Rule
(IESWTR), a "long term" Enhanced
Surface Water Treatment Rule
(LT1ESWTR), and an Information
Collection Rule. The IESWTR was only
to apply to those systems serving 10,000
or more persons. The Committee agreed
that the "long term" Enhanced Surface
Water Treatment Rule would be needed
for systems serving fewer than 10,000
persons.
Congress legislatively affirmed this
Microbial/Disinfection Byproduct (M-
DBP) strategy as part of the 1996 SDWA
Amendments. As part of those new
Amendments, Congress also established
a new schedule lor EPA promulgation of
these rules (which is the basis for the
November 2000 schedule for today's
rale). EPA established the M-DBP
Advisory Committee under the Federal
Advisory Committee Act (FACA) in
1997 to seek advice on how to proceed
towards these deadlines in light of new
information available since the 1993
negotiated rulemaking discussions. The
Committee met five times in March
through July 1997 to discuss issues
related to the IESWTR and the Stage 1
DBPR. The Committee reached
agreement in July of 1997 and its
recommendations are embodied in an
Agreement in Principle document dated
July 15,1997, which is also found in
two Notices of Data Availability (NODA)
(USEPAl997a,b). The major issues
addressed in the Agreement in Principle
were discussed in the NODA for the
IESWTR (62 FR 59486, November 3,
1997) and Stage 1 DBPR (62 FR 59388,
November 3,1997).
On December 16,1998, EPA
promulgated the IESWTR (63 FR 69478),
which applies to surface water and
GWUDI systems serving 10,000 or more
persons. The purposes of the IESWTR
are to improve control of microbial
pathogens (specifically
Cryptosporidium) and to address risk
trade-offs with DBFs. Key provisions
established in the IESWTR include: (1)
An MCLG of zero for Cryptosporidium;
(2) a 2-log Cryptosporidium removal
requirements for systems that filter; (3)
strengthened combined filter effluent
turbidity performance standards and
individual filter turbidity provisions; (4)
disinfection benchmarking provisions to
assure continued levels of microbial
protection while facilities take the
necessary steps to comply with new
DBP standards; (5) inclusion of
Cryptosporidium in the definition of
GWUDI, as another pathogen that would
indicate the presence of GWUDI, and in
the watershed control requirements for
unfiltered public water systems; (6)
requirements for covers on new finished
water reservoirs; and (7) sanitary
surveys for all surface water and
GWUDI systems regardless of size.
Today's rale is based in large part
upon the data, research, and technical
analysis that supported the major
components included in the 1998
IESWTR. To that degree, it reflects the
national interim microbial protection
control strategy ratified by a wide range
of experts and stakeholders as part of
the 1997 M/DBP Agreement in
Principle. However, as was discussed in
the April 10, 2000 proposal, today's rule
also is based on new small system
information that became available since
1998 and, equally important, it also
reflects a major commitment to
significantly reduce small system
compliance burdens wherever possible,
while maintaining public health
. protection.
C. How Were Stakeholders Involved in
the Development of the LTlESWTR?
EPA began outreach efforts to develop
the LTlESWTR in the summer of 1998
with two public meetings: one in
Denver, Colorado and the other in
Dallas, Texas (USEPA, 1999a,b).
Building on these two public meetings,
EPA has also held a number of
additional meetings with stakeholders,
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trade associations, environmental
groups, and representatives of State and
local elected officials. Of particular
importance for this rule, given its focus
on small systems, EPA received
valuable input from small entity
representatives as part of the Small
Business Regulatory Enforcement
Fairness Act (SBREFA) panel. The panel
was initiated in April of 1998 and
officially convened in August of 1998.
Many of the panel's recommendations
are reflected in today's rule.
EPA provided numerous
opportunities for stakeholder and public
involvement. In early June 1999, EPA
mailed an informal draft of the
LTlESWTR preamble to the
approximately 100 stakeholders who
attended either of the public stakeholder
meetings. Members of trade associations
and the SBREFA panel also received the
draft preamble. EPA received valuable
suggestions and stakeholder input from
15 State representatives, trade
associations, environmental interest
groups, and individual stakeholders.
EPA proposed the LTlESWTR on April
10, 2000. During the comment period,
the Agency held a public meeting in
Washington B.C. on April 14, 2000.
Additionally, the proposed rule was
presented to industry, State
representatives, and the public in nearly
50 meetings across the US, including a
May 30,2000 meeting in Washington,
D.C. with ten representatives of elected
State and local officials (USEPA
2000g,h). Finally, EPA mailed
approximately 200 copies of the
proposed rule to stakeholders.
D. What Did the April 10, 2000 Proposal
Contain?
The proposed rulemaking package,
which is the basis for today's final rule,
was entitled The Long Term 1 Enhanced
Surface Water Treatment and Filter
Backwash Proposed Rule (USEPA,
2000b).
The proposed rule included two
distinct sets of provisions: LTlESWTR
provisions and Filter Backwash
Recycling Rule (FBRR) provisions. The
Agency promulgated the final FBRR in
a Federal Register announcement on
June 8, 2001 (66 FR 31086), separate
from today's final rule. The LTlESWTR
proposed rule provisions applied to
surface and GWUDI systems serving
fewer than 10,000 persons and included
the following provisions:
—2-log removal of Cryptosporidium;
—Compliance with specific combined
filter effluent turbidity requirements;
—Continuous turbidity monitoring for
individual filters with follow-up
activities if monitoring results
indicated a potential problem;
—Development of a disinfection profile
unless optional monitoring at a
particular plant demonstrated TTHM
and HAAS levels less than 0.064 mg/
L and 0.048 mg/L respectively;
—Development of a Giardia inactivation
disinfection benchmark and
consultation with the State for
approval before making a significant
change in disinfection practices;
—Mandatory covers for all newly
constructed finished water reservoirs;
and
—Unfiltered system compliance with
updated watershed control
requirements that add
Cryptosporidium as a pathogen of
concern-
Hi. Discussion of the Final Rule
A. What Level of Cryptosporidium
Removal Does the LTlESWTR Require?
1. What Does Today's Rule Require?
Today's final rule establishes a
treatment technique requirement for 2-
log removal of Cryptosporidium for
surface water and GWUDI systems
serving fewer than 10,000 persons. This
requirement applies between a point
where the raw water is not subject to
contamination by surface water runoff
and a point downstream before or at the
first customer.
2. How Was This Requirement
Developed?
As discussed previously in today's
rule, Cryptosporidium is a
microbiological contaminant that has
caused several outbreaks of
cryptosporidiosis and poses serious
health risks. For these reasons, the
Agency set forth to develop
requirements to minimize risks
associated with Cryptosporidium in
drinking water. In the IESWTR, EPA
established a MCLG of zero for
Cryptosporidium. EPA decided to
establish 2-log removal of
Cryptosporidium as the accompanying
treatment technique for this MCLG. This
requirement is based on a number of
treatment effectiveness studies that
demonstrate the ability of well-operated
conventional and direct filtration plants
to achieve at least a 2-log removal of
Cryptosporidium (Patania et al., 1995;
Nieminski and Ongerth, 1995; Ongerth
and Pecoraro, 1995; LeChevallier and
Norton, 1992; LeChevallier et al., 1991;
Foundation for Water Research, 1994;
Kelly et al., 1995; and West et al., 1994).
The information and data in these eight
studies provide convincing evidence
that conventional and direct nitration
plants that employ coagulation,
flocculation, sedimentation (in
conventional filtration only), and
filtration steps, have the ability to
achieve a minimum of 2-log removal of
Cryptosporidium when meeting specific
turbidity limits. EPA has also provided ,
data in the proposal for today's final
rule that indicate the ability of slow
sand filtration, diatomaceous earth
filtration, and alternative filtration
(membrane filtration, cartridge
filtration, etc.) to achieve at least 2-log
removal of Cryptosporidium (Jacangelo
et al., 1995; Drozd & Schartzbrod, 1997;
Hirata & Hashimoto, 1998; Goodrich et
al., 1995; Collins et al., 1996; Lykins et
al., 1994; Adliam et al., 1998; Shuler &
Ghosh, 1991; Timms et al., 1995; Shuler
et al., 1990; and Ongerth & Hutton,
1997). The Agency believes that the
technological feasibility for 2-log
removal is demonstrated for both large
and small systems and therefore today's
rule extends the 2-log Cryptosporidium
removal requirement established for
large and medium systems in the 1998
IESTWR to small systems serving fewer
than 10,000 persons.
3. What Major Comments Were
Received?
The majority of the commenters on
the proposed rule agreed with the
appropriateness of establishing a 2-log
removal requirement for
Cryptosporidium. A few commenters
noted that small systems should not be
required to meet the same
Cryptosporidium log removal
requirements as large systems. EPA
disagrees. The technological feasibility
of 2-log removal is well demonstrated
(as shown in the studies discussed in
the proposal for today's final rule) and
the Agency believes that persons served
by all sized systems should be afforded
comparable levels of public health
protection (i.e., the small systems
subject to the LTlESWTR should have
the same MCLG, and the 2-log
Cryptosporidium removal treatment
technique as large systems subject to the
IESWTR).
B. What Combined Filter Effluent
Requirements Does the LTlESWTR
Contain?
1. What Does Today's Rule Require?
Today's final rule requires
strengthened combined filter effluent
performance for conventional filtration,
direct filtration, and alternative
filtration systems (systems using
filtration technologies other than
conventional filtration, direct filtration,
diatomaceous earth filtration, or slow
sand filtration) as the treatment
technique for achieving a 2-log removal
of Cryptosporidium. For conventional
and direct filtration systems, the
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1817
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. Under today's rule,
conventional and direct filtration plants
meeting these filter performance
requirements are presumed to achieve at
least a 2-log removal of
Cryptosporidium. Slow sand and
diatomaceous earth filtration plants are
presumed to achieve at least 2-log
removal of Cryptosporidium if they
continue to meet the existing filter
performance requirements established
in the SWTR. Systems using alternative
filtration (i.e., membrane filtration,
cartridge filtration, etc.) must
demonstrate to the State that their
system achieves 2-log removal of
Cryptosporidium. The State will then
establish appropriate turbidity limits to
reflect this performance. At the end of
each month, systems must report the
total number of combined filter effluent
turbidity measurements taken each
month, as well as the number and
percentage of turbidity measurements
that exceeded their 95th percentile
turbidity limit and the number of
measurements that exceeded their
maximum turbidity limit. Combined
filter effluent turbidity measurements
must be kept for at least three years.
2. How Was This Requirement
Developed?.
In establishing the 2-log removal as a
treatment technique for
Cryptosporidium, the Agency relied on
the aforementioned studies to
demonstrate the technological feasibility
of establishing the 2-log removal. These
studies demonstrated that specific
treatment would achieve 2-log removal
of Cryptosporidium when operated to
achieve specific turbidity performance
limits. For conventional and direct
filtration systems, studies demonstrated
that achieving a turbidity of 0.3 NTU 95
percent of the time and never exceeding
1 NTU would ensure at least 2-log
removal of Cryptosporidium. For slow
sand and diatomaceous earth filtration
systems, the studies demonstrated that
meeting existing SWTR turbidity limits
would ensure at least 2-log removal of
Cryptosporidium. Alternative filtration
systems were shown to achieve at least
2-log removal of Cryptosporidium at a
variety of turbidities based on the type
of filtration and other site-specific
characteristics. The requirements of
today's final rule reflect the
recommendations of the 1997 M-DBP
Committee.
As part of the LT1ESWTR
development process, EPA analyzed
performance data from 211 small
systems in 15 different States. That data
indicated that a substantial number of
small systems are presently meeting the
tighter performance standards of today's
rule. For example, 50 percent of the 211
systems are currently meeting 0.3 NTU
12 months out of the year. In addition,
93 percent of the 211 systems never
exceeded the 1 NTU maximum 12
months out of the year. Therefore, EPA
believes that the strengthened filter
performance standards established for
small systems in today's final rule are
feasible and achievable.
3. What Major Comments Were
Received?
The majority of the commenters on
the proposal agreed with the
appropriateness of the combined filter
effluent requirements. Many
commenters raised concerns with the
proposal's reliance on turbidity as an
indicator for demonstrating that
membrane filtration meets the same
Cryptosporidium removal requirements
as conventional and direct filtration
systems. Commenters indicated that
although turbidity is the most prevalent
form of water quality monitoring,
establishing a 0.3 NTU 95th percentile
limit and 1 NTU maximum limit would
not be as appropriate an indicator of the
performance of membranes than other
parameters such as flux or membrane
integrity. They noted that using
turbidity was appropriate if site specific
turbidity limits were utilized. At most
facilities these limits would typically be
much lower than 0.3 NTU.
Additionally, commenters asserted that
since the typical operational turbidities
of membranes (< 0.05 NTU) were so
much lower than those of conventional
filtration, it would be inappropriate to
require membranes to meet turbidity
limits that were significantly higher
than standard operating practices. In
response, EPA notes that in the
proposed rule, EPA allowed membrane
systems to meet either conventional
filtration or alternative filtration
combined filter effluent requirements.
After further evaluating existing studies
and information provided by
commenters, EPA agrees that other
appropriate indicators may be used to
determine the treatment efficiency of
membrane filtration, and that given the
-different operational turbidities of
conventional filtration and membrane
filtration, different turbidity limits are
appropriate. Therefore, today's final rule
treats membrane filtration as an
available alternative filtration
technology, instead of requiring
membranes to meet the same turbidity
limits as conventional and direct
filtration.
C. What Individual Filter Monitoring
Requirements Does the LT1ESWTR
Contain?
1. What Does Today's Rule Require?
Today's final rule establishes a
requirement that all systems using
surface water or GWUDI, serving fewer
than 10,000 persons, and utilizing
conventional or direct filtration must
continuously monitor the individual
filter turbidity for each filter used at the
system. For purposes of this rule,
continuous monitoring means at least
every 15 minutes. Systems must keep
the results of this monitoring for at least
three years. Each month systems must
report to the State that they have
conducted individual filter turbidity
monitoring, and are required to indicate
the dates, filter number, and turbidities
of any measurements that exceeded 1.0
NTU. Today's rule provides that
systems with two or fewer filters may
monitor combined filter effluent
turbidity continuously, in lieu of
individual filter turbidity monitoring.
Based on this monitoring, if a system
exceeds 1.0 NTU in two consecutive
measurements the system must include
the filter number, date, time and reason
for the exceedance at the end of the
month in its monthly filter performance
report to the State. If this occurs three
months in a row for the same filter, a
system is required to conduct a self-
assessment of the filter. If a self-
assessment is required, it must take
place within 14 days of the day the filter
exceeded 1.0 NTU in two consecutive
measurements for the third straight
month. The system must report to the
State that the self-assessment was
completed. A self-assessment must
include 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 self-assessment
report.
If a system exceeds 2.0 NTU (in two
consecutive measurements 15 minutes
apart) for two months in a row, the
system must contact the State to arrange
for the State or an approved third party
to conduct a Comprehensive
Performance Evaluation (CPE) not later
than 60 days following the day the filter
exceeded 2.0 NTU in two consecutive
measurements for the second straight
month. The CPE must be completed and
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submitted to the State no later than 120
days following the day the filter
exceeded 2.0 MTU in two consecutive
measurements for the second straight
month.
2. How Was This Requirement
Developed?
Performance of individual filters
within a plant is of paramount
importance in preventing pathogen
breakthrough. Two important concepts
regarding individual filters underlie
today's individual filter monitoring
requirement. First, as discussed in more
detail in the April 10, 2000 proposal,
poor performance (and potential
pathogen breakthrough) of one filter can
combined filter effluent turbidity
performance standards. Second, recent
filter performance research
demonstrates that individual filters are
susceptible to turbidity spikes of short
duration that may not be captured by
four-hour combined filter effluent
measurements. Several studies
(Amirthatajah, 1988; Bucklin et al.,
1988; Cleasby 1990; Hall and Croll 1996;
and McTigue et al., 1998) have
confirmed the frequency and magnitude
of individual filter turbidity spikes. To
address these spikes and the potential
for masking, and provide system
operators with information and
advanced warning with regards to
individual filter performance problems
' before they lead to treatment technique
violations, the Agency proposed
individual filter turbidity monitoring.
EPA proposed one option and requested
comment on two alternative approaches.
The alternatives consisted of an
approach identical to the IESWTR that
entailed significantly more burden, and
an approach that included 95th
percentile and maximum triggers
instead of a trigger based on two
consecutive measurements. The
proposed option has been revised in
three minor ways. In today's rule:
—Systems with two or fewer filters may
monitor combined filter effluent
turbidity continuously, in lieu of
individual filter turbidity (the
proposal required all filters be
monitored);
—Systems must schedule CPEs within
60 days and complete them within
120 days (the proposal required 30
and 90 days);
—A system has 14 days following a
turbidimeter malfunction to resume
continuous individual filter
monitoring before a violation occurs
(the proposal required 5 days).
3. What Major Comments Were
Received?
The majority of the commenters on
the proposal agreed with the
appropriateness of the individual filter
monitoring requirements. The Agency
requested comment on a variety of
issues to which commenters responded.
Most commenters supported the
modification that States be provided the
opportunity to allow systems with two
or fewer filters to monitor combined
filter effluent turbidity continuously, in
lieu of individual filter turbidity
indicating that poor performance of one
filter could not simply be masked by
optimal performance of an additional
filter. The Agency has included this
modification in today's final rule
because it reduces the burden on small
systems while still providing
continuous monitoring that can be used
to indicate whether filters are
performing poorly.
Several commenters supported a
modification to lengthen CPE schedules
by 30 days. The Agency has included
this modification in today's final rule in
order to provide States added flexibility
in performing these activities. The extra
30 days will provide States the
opportunity to marshal unique
resources (specifically, employees
trained in conducting CPEs) and
prioritize the conduct of CPEs, when
several systems trigger them during the
same time period.
Several commenters indicated that
allowing only five working days for an
on-line turbidimeter to be off-line before
a violation resulted would be
inappropriate for small systems.
Commenters indicated that smaller
systems often do not have back-up units
onsite and would be required to contact
manufacturers and await shipping and
installation which could easily exceed
the five days. EPA agrees and has
modified the requirement to allow
systems serving fewer than 10,000
persons, 14 days to resume online
monitoring prior to incurring a
violation.
Several commenters noted that
systems serving fewer than 10,000
persons should be subject to less
frequent monitoring of individual filter
effluent. EPA believes that continuous
individual filter monitoring is feasible
and assures improved performance of
filtration systems. As explained in the
proposal, continuous filter monitoring is
necessary to identify short duration
turbidity spikes which are likely to be
missed with less frequent monitoring.
This is true for systems of all sizes. Less
frequent monitoring would not identify
many turbidity spikes and accordingly
would not provide a comparable level of
public health protection as that of
continuous monitoring required for
large systems under the IESWTR. In
fact, the actual frequency of individual
filter monitoring has little effect on
burden as much of the costs associated
with monitoring are derived from the
purchase of the necessary equipment
and would be incurred regardless of the
frequency. Reduced monitoring would
represent reduced public health
protection and the Agency firmly
believes that the consumers of these
small systems should be afforded a
comparable level of public health
protection as larger systems.
D. What Disinfection Profiling and
Benchmarking Requirements Does the
LTlESWTR Contain?
I. What Does Today's Rule Require?
Today's final rule requires community
and non-transient non-community
systems that use surface water or
GWUDI and serve fewer than 10,000
persons to develop a disinfection profile
based on a 52 week period. Systems
serving between 500 and 9,999 must
begin profiling and notify the State to
this effect by July 1, 2003. Systems
serving fewer than 500 must begin
profiling and notify the State to this
effect by January 1, 2004. To conduct
the profile, systems must:
—Monitor disinfectant residual
concentration, water temperature in
degrees Celsius, pH, and contact time
during peak hourly flow once a week
(on the same calendar day) during all
months that the system is operational;
—Calculate Giardia lamblia inactivation
for each of the 52 weeks; and
—Plot graphically, the 52 weekly
inactivations.
Results of the profile must be kept
indefinitely. EPA is developing
guidance materials that provide detailed
information on this procedure. A State
may determine that a system's profile is
unnecessary where a system submits
TTHM and HAAS data that:
—Is taken during the month of warmest
water temperature (beginning no
earlier than 1998);
—Is taken at the point of maximum
residence time; and
—Reports levels of TTHM and HAAS of
less than 0.064 mg/L and 0.048 mg/L
respectively.
Today's final rule also requires any
system which developed a profile and
which decides to make a significant
change to their disinfection practice to
determine their disinfection benchmark
(the average microbial inactivation
during the month with the lowest
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1819
inactivation), consult with the State for
approval, and provide the following
•information during consultation:
—Description of the proposed change;
—Disinfection profile (and data used to
develop profile); and
—Analysis of how the proposed change
will affect the current levels of
disinfection.
Results of the disinfection benchmark
(including the raw data and analysis)
must be kept indefinitely.
2. How Was This Requirement
Developed?
The disinfection benchmarking
requirements provide the necessary link
between simultaneous compliance with
microbial protection requirements of the
IESWTR and LT1ESWTR and
disinfection byproduct requirements of
the DBPR. The requirements were
established pursuant to the authority of
Section 1445 of SDWA to ensure that
systems would not jeopardize microbial
protection when making changes in
disinfection practices to comply with
the DBPR.
During the 1997 M/DBP FACA
deliberations, all participants agreed to
the fundamental premise that new
standards for control of DBFs must not
lead to significant reductions in existing
levels of microbial protection. This
premise is reflected in the 1997 M-DBP
Advisory Committee Agreement in
Principle document. The Advisory
Committee reached agreement on the
use of a microbial profiling and
benchmarking process, whereby a
system and State, working together,
could assure that there would not be a
significant increase in microbial risk as
a result of modifying disinfection
practices to meet MCLs for TTHM and
HAAS. The final IESWTR established
the disinfection benchmark procedure
to require large systems (serving 10,000
or more persons) that might be
considering a significant change to their
disinfection practice (defined as systems
with TTHM or HAAS concentrations at
or above 80 percent of the respective
MCLs (e.g., 0.064 mg/L TTHM or 0.048
mg/L HAAS)) to evaluate the impact on
microbial risk. Under the IESWTR, large
systems whose TTHM and/or HAAS
average levels exceeded the
aforementioned values were required to
develop a disinfection profile of
microbial inactivation over the course of
a year by calculating the daily level of
Giardia inactivation. Those large
systems required to develop a
disinfection profile that also plan to
make a significant change to
disinfection practices were required to
develop a "benchmark" of existing
levels of Giardia microbial protection
and to consult with the State prior to
implementing the change.
In developing the disinfection
benchmarking requirements of the
LT1ESWTR, EPA used the IESWTR
requirements as a starting point and,
using significant input from
stakeholders, modified the requirements
to significantly reduce burden yet
maintain a comparable level of public
health protection. The April 10, 2000
proposal included several alternatives
for establishing the microbial profiling
and benchmarking process.
Of the four TTHM and HAAS
monitoring alternatives, the first was
identical to the IESWTR, and included
four quarters of monitoring at four
points in the distribution system. The
second alternative matched DBF
compliance monitoring, requiring
systems serving fewer than 500 to
monitor once per year, and systems
serving 500 or greater to monitor
quarterly. A third alternative required
only one sample taken at the point of
maximum residence time for all
systems. The fourth alternative (which
was proposed) made TTHM and HAAS
monitoring optional. This alternative
was chosen over the others, because it
significantly reduces burden and the
concern about "early implementation,"
that is, the need for systems to comply
with requirements of a rule before
primacy states have adopted new
conforming regulations, while still
retaining the ability for systems and
States to utilize monitoring data to
demonstrate low TTHM and HAAS
levels, and therefore avoid profiling.
Since this monitoring is no longer
required to determine the applicability
of systems to conduct profiles, the final
LT1ESWTR refers to this monitoring as
"optional monitoring." The associated
TTHM and HAAS samples that must be
conducted under this optional
monitoring, are described in section
141.531. Of the four profiling
alternatives, the first was identical to
the IESWTR, requiring daily profiling
for a year. The second alternative did
not require profiling. The third
alternative, which was proposed,
required weekly profiling for a year. The
fourth alternative required daily
profiling during a single month. The
Agency proposed weekly profiling over
the course of a full year because it
significantly reduces burden associated
with conducting profiling (as compared
to the first alternative), but still provides
information on the seasonal variation
associated with microbial inactivation,
and develops an accurate microbial
benchmark as systems moved to comply
with the Stage 1 DBPR. The second and
fourth profiling alternatives would not
Erovide such information. The Agency
. as revised the proposed option in one
minor way. In today's rule:
—Systems serving between 500 and
9,999 persons must begin weekly
profiling no later than July 1, 2003,
and systems serving fewer than 500
persons must begin weekly profiling
no later than January 1, 2004 (the
proposal required all systems to begin
profiling no later than January 7,
2003).
3. What Major Comments Were
Received?
The Agency received significant
comment on the disinfection
benchmarking provisions of the
proposed rule. Commenters both
supported and opposed the proposed
"optional" TTHM and HAAS
monitoring. Several commenters argued
that EPA should not require systems or
states to undertake activities, even
optional monitoring, before three years
from the date a rule is promulgated
because it would result in early
implementation.of the rule. While the
Agency agrees that to the extent
possible, implementation should be
minimized in the first three years after
the promulgation of a national primary
drinking water regulation, as required
by Section 1412(b)(10) of SDWA, the
Agency continues to believe that
allowing systems to conduct optional
monitoring prior to three years after
promulgation is appropriate and
authorized under section 1445 of
SDWA.
Several commenters raised "early
implementation" concerns with
profiling as well, and suggested
profiling should take place only after
using the first round of DBF monitoring
in 2004 as optional monitoring for
profiling activities. The Agency does
agree, that to the extent possible, early
implementation should be minimized in
the first two years after the
promulgation of the rule. However, the
Agency believes that developing a
microbial profile and benchmark prior
to compliance monitoring under the
Stage 1 DBPR is key to ensuring that
systems do not jeopardize existing
microbial protection when making
changes to their disinfection practices to
comply with the Stage 1 DBPR.
Consequently, today's final rule requires
systems serving fewer than 500 persons
to begin profiling in January 2004, while
systems serving greater than 500 to
9,999 persons are required to begin
profiling in July 2003.
Other commenters believed that the
proposed requirement represented
burden reduction for small systems and
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States while still achieving the goals of
optional monitoring and profiling as
developed by the 1997 FACA and EPA.
Additionally, conunenters noted that
EPA should provide States and systems
the ability to use more representative
data if available (i.e., allowing systems
to average over several quarters of data
similar to the IESWTR requirements).
EPA agrees that systems and States
should be allowed the opportunity to
use more representative samples, and
today's final rule affords States the
opportunity to allow more
representative data for optional
monitoring and profiling.
E. How Does the Definition of Ground
Water Under the Direct Influence of
Surface Wafer Change?
1. What Does Today's Rule Require?
Today's final rule modifies the
definition of ground water under the
direct influence of surface water
(GWUDI) to include Cryptosporidium,
as another pathogen that would indicate
the presence of GWUDI, for all PWSs.
2. How Was This Requirement
Developed?
Although ground water is typically
protected from microbial contaminants
that are characteristic of surface water
supplies, some ground water systems
are susceptible to microbial
contamination from surface water.
Ground water that exhibits physical
water quality indicators that closely
correlate with nearby surface water and
which contain surface water indicator
organisms is "under the influence," of
that surface water. In order to protect
customers of such systems from
illnesses resulting from exposure to
Giardia and other microbial pathogens,
the Agency addressed this issue during
development of the 1989 SWTR. The
final SWTR requires that systems with
source water found to be GWUDI are
subject to the filtration and disinfection
requirements of Section 141 subpart H.
During development of today's final
rule, the Agency proposed to modify the
definition of GWUDI to include
Cryptosporidium, as another pathogen
that would indicate the presence of
GWUDI. This is consistent with the
approach taken by the Agency in the
IESWTR and is further supported by
recently available data indicating
Cryptosporidium occurrence in 21
public water system wells (Hancock et
al., 1998), As a result, EPA believes it
appropriate and necessary to include
Cryptosporidium in the definition of
GWUDI for systems serving fewer than
10,000 persons in today's rule.
3. What Major Comments Were
Received?
Commenters agreed with the
appropriateness of modifying the
definition of GWUDI to include
Cryptosporidium for all PWSs. Today's
final rule reflects the GWUDI definition
as proposed.
F. What Additional Requirements Does
the LT1ESWTR Contain for Unfiltered
Systems?
I. What Does Today's Rule Require?
Today's rule modifies the
requirements for surface water or
GWUDI systems serving fewer than
10,000 persons that do not provide
filtration by including Cryptosporidium
in the watershed control provisions
everywhere Giardia lamblia is
mentioned.
2. How Was This Requirement
Developed?
Watershed control requirements were
initially established in 1989 as part of
the SWTR. The SWTR contains specific
conditions that a system must meet in
order to avoid filtration. These
conditions include good source water
quality disinfection requirements,
periodic on-site inspections, the absence
of waterborne disease outbreaks,
compliance with the Total Coliform
Rule, and a watershed control program.
. The SWTR requires that the watershed
control program must be maintained
specifically to minimize the potential
for contamination by Giardia lamblia
cysts and viruses in the source water.
During development of today's rule,
the Agency proposed that
Cryptosporidium should also be
included as a focus in watershed
program for unfiltered systems. For the
same public health reasons explained in
detail as part of the April 10, 2000
proposal and outlined earlier regarding
the risks associated with exposure to
Cryptosporidium, the Agency believes it
is important that watershed control
requirements for unfiltered systems be
revised to include Cryptosporidium.
This is particularly important since
such systems do not have the additional
treatment barrier provided by filtration
to protect against possible pass-through
of Cryptosporidium into the distribution
system.
3. What Major Comments Were
Received?
Commenters agreed with the
appropriateness of including
Cryptosporidium in the watershed
control program requirements for
unfiltered systems. No substantive
changes were made to this provision
between proposal and today's final rule.
G. What Does the LT1ESWTR Require
for Finished Water Reservoirs
1. What Does Today's Rule Require?
Today's final rule requires that all
finished water reservoirs, holding tanks,
or storage water facilities for finished
water at systems serving fewer than
10,000 persons, for which construction
begins after March 15, 2002 must be
covered.
2. How Was This Requirement
Developed?
Open finished water reservoirs,
holding tanks, and storage tanks are
utilized by PWSs throughout the
country. Because these reservoirs are
open to the environment and outside
influences, they can be subject to the
reintroduction of contaminants that the
treatment plant was designed to remove.
Existing EPA guidelines recommend
that all finished water reservoirs and
storage tanks be covered (USEPA, 1991).
Additionally, many States currently
require that finished water storage be
covered, and the American Water Works
Association (AWWA) has issued a
policy statement strongly supporting the
covering of reservoirs that store potable
water (AWWA, 1983). In the July 29,
1994 IESWTR proposal (59 FR 38832),
the Agency requested comment on
whether to issue regulations requiring
systems to cover finished water storage.
Most commenters supported either
Federal or State requirements, with
some suggesting requirements should
only apply to newly constructed
reservoirs. In the final IESWTR, the
Agency required systems using surface
water and GWUDI and serving 10,000
persons or more to cover any newly
constructed finished water reservoirs,
holding tanks, or storage tanks. Through
discussions with stakeholders and
evaluations of available information, the
Agency is unaware of any newly
constructed uncovered finished water
reservoirs at small systems since
discussions with stakeholders regarding
the LT1ESWTR began in 1998. The
Agency is furthermore unaware of any
future plans of small systems to
construct uncovered finished water
reservoirs. In fact the drinking water
industry (regulators, consultants, and
industry groups) have discouraged the
construction of new uncovered
reservoirs for many years. Furthermore,
creating a prohibition on newly
constructed uncovered finished water
reservoirs would not affect current
unfinished water reservoirs or even any
system, which, despite the industry
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1821
standard of constructing only covered
finished water reservoirs, may have
already commenced construction on an
uncovered finished water reservoir
unbeknownst to the Agency or
stakeholders which provided input on
the rule. Therefore, in accordance with
Section 1412(b)(10) of SDWA, the '
Agency has determined it is practicable
to require as part of today's rule that
systems serving fewer than 10,000
people provide covers for all finished
water reservoirs, holding tanks, or
storage reservoirs constructed after
March 15, 2002.
3. What Major Comments Were
Received?
Commenters agreed with the
appropriateness of requiring that newly
constructed finished water storage be
covered. Several States noted that they
currently require that all finished water
reservoirs be covered. No substantive
changes were made to this provision
between proposal and today's final rule.
H. What Is the Compliance Schedule for
the LT1ESWTR?
1. When Must My System Comply With
Each of the Requirements of the Rule?
Each of the components of the final
LTlESWTR has a specific compliance
date. The following table lists each
requirement, along with the appropriate
Federal Register citation and the .
compliance date:
Rule requirements
FR citation
Compliance date
Cover new finished water reservoirs
Comply with updated watershed control
requirements (unfiltered PWSs).
Begin Developing Disinfection Profile
Complete the Disinfection Profile
§141.511
§§141.520, 141.521 & 141.522
§§ 141.530-141.536 ,'.
Combined Filter Effluent Turbidity Limits
Individual Filter Turbidity Monitoring
§§141.530-141.536
§§141.550, 141.551, 141.552, &
141.553.
§§141.560, 141.561, 141.562, 141.563,
141.564.
March 15, 2002.
January 14, 2005.
July 1, 2003 for systems serving between 500 and 9,999 .
persons and January 1, 2004 for systems serving fewer
than 500 persons.
July 1, 2004 for systems serving between 500 and 9,999
persons and January 1, 2005 for systems serving fewer
than 500 persons.
January 11, 2005.
January 11, 2005.
2. What Major Comments Were
Received?
Many commenters noted that they
would not support requirements that
would take place prior to two years after
the promulgation of today's final rule.
Several others recommended requiring
that no portions of the rule should take
effect until three years after the date of
promulgation. The Agency does agree
that to the extent possible,
implementation should be minimized in
the first two years after the
.promulgation of the rule. However,
today's final rule requires systems
serving fewer than 500 persons to begin
profiling in January 2004, while systems
serving greater than 500 to 9,999
persons are required to begin profiling
in July 2003. This would allow time for
States to work with systems, yet still
provide profiling data prior to
compliance sampling under the Stage 1
DBPR. .
I. What Public Notification and
Consumer Confidence Report
Requirements Are Contained in the
LTlESWTR?
Today's final rule modifies the Public
Notification (PN) requirements found in
Appendix A and B of subpart Q. of Part
141 to include public notification
requirements for systems subject to the
LTlESWTR that are consistent with
those for systems subject to the
IESWTR.
Today's rule does not specifically
modify the Consumer Confidence
Report (CCR) Requirements found in
subpart O of Part 141. However,
consumer confidence reports must
contain any violations of treatment
techniques or requirements of NPDWRs
as specified in § 141.153(d)(6] and
§ 141.153(f). This includes any such
violations of the LTlESWTR.
Updated CCR and PN appendices can
be found on the Agency's Web site at
http://www/epa.gov/safewater/
tables.html.
TV. State Implementation
A. What Special State Primacy
Requirements does the LTlESWTR
Contain?
In addition to adopting drinking water
regulations at least as stringent as the
Federal regulations of the LTlESWTR,
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
assists EPA in its oversight of State
programs.
Under the final LTlESWTR, there are
several special primacy requirements
that a State's application must include:
—Description of how the State will
consult with the system and approve
modifications to disinfection
practices;
—Description of how the State will
approve a more representative data set
for optional monitoring and profiling
under §§ 141.530-141.536.
—Description of how existing rules,
adoption of appropriate rules or other
authority under § 142.16(i)(l) require
systems to participate in a
Comprehensive Technical Assistance
(CTA) activity, and the performance
• improvement phase of the Composite
Correction Program (CCP);
—Description of now the State will
approve a method to calculate the logs
of inactivation for viruses for a system
that uses either chloramines, chlorine
dioxide, or ozone for primary
disinfection; and
—For alternative filtration technologies
(filtration other than conventional
filtration treatment, direct filtration,
slow sand filtration or diatomaceous
.earth filtration), a description of how
the State will determine under
§ 142.16(i)(2)(iv), that a PWS may use
a filtration technology if the PWS
demonstrates to the State, using pilot
plant studies or other means, that the
alternative filtrationtechnology, in
combination with the disinfection
treatment that meets the requirements
of subpart T of this title, consistently
achieves 3-log (99.9 percent) removal
and/or inactivation of Giardia lamblia
cysts and 4-log (99.99 percent)
removal and/or inactivation of
viruses, and 2-log (99 percent)
removal of Cryptosporidium oocysts;
and a description of how, for the
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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.
B. What State Recordkeeping
Requirements Does theLTlESWTR
Contain?
Today's rule includes changes to the
existing recordkeeping provisions to
implement the requirements in today's
final rule. States must maintain records
of the following:
(1) Records of turbidity
measurements;
(2) Records of disinfectant residual
measurements and other parameters
necessary to document disinfection
effectiveness;
(3) Decisions made on a system-by-
system basis and case-by-case basis
under provisions of section 141, subpart
H or subpart P or subpart T;
(4) Records of systems consulting
with the State concerning a significant
modification to their disinfection
practice (including the status of the
consultation);
(5) Records of decisions that a system
using alternative filtration technologies
can consistently achieve a 2-log (99
percent) removal of Cryptosporidium
oocysts, as well as the required levels of
removal and/or 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, and;
(6) Records of those systems required
to perform filter self-assessments, CPE
orCCP.
C. What State Reporting Requirements
Does the LTlESWTR Contain?
Currently States must report
information to EPA under section
142.15 regarding violations, variances
and exemptions, enforcement actions
and general operations of State public
water supply programs. There are no
additional requirements under this rule,
but States are required to report
violations, variances and exemptions,
and enforcement actions related to this
rule.
D, How Must a State Obtain Interim
Primacy for the LTlESWTR?
To maintain primacy for the Public
Water Supply Supervision (PWSS)
program and to be eligible for interim
primacy enforcement authority for
future regulations, States must adopt
today's final rule. A State must submit
a request for approval of program
revisions that adopt the revised MCL or
treatment technique and implement
regulations within two years of
promulgation, unless EPA approves an
extension per § 142.12(b). Interim
primacy enforcement authority allows
States to implement and enforce
drinking water regulations once State
regulations are effective and the State
has submitted a complete and final
primacy revision application. To obtain
interim primacy, a State must have
primacy with respect to each existing
NPDWR. Under interim primacy
enforcement authority, States are
effectively considered to have primacy
during the period that EPA is reviewing
their primacy revision application.
V. Economic Analysis (Health Risk
Reduction and Cost Analysis)
This section summarizes the Health
Risk Reduction and Cost Analysis
(HRRCA) in support of the LTlESWTR
as required by section!412(b)(3)(C) of
the 1996 SDWA. In addition, under
Executive Order 12866, Regulatory
Planning and Review, EPA must
estimate the costs and benefits of the
LTlESWTR. EPA has prepared an
economic analysis to comply with the
requirements of this order and the
SDWA Health Risk Reduction and Cost
Analysis (USEPA, 2001a). The final
economic analysis has been published
on the Agency's Web site, and can be
found at http://www.epa.gQv/safewater/
Itleswtr. The analysis can also be found
in the docket for this rulemaking.
EPA has estimated the total
annualized cost for implementing the
LTlESWTR and analyzed the total
benefits that result from the rule. Total
annual costs for the rule are $39.5
million, in 1999 dollars, using three
percent discount rate [$44.8 million
using a seven percent discount rate].
The cost estimate includes capital costs
for treatment changes and start-up and
annual labor costs for monitoring and
reporting activities. More detailed
information, including the basis for
these estimates and alternate cost
estimates using different cost of capital
assumptions are described in the
LTlESWTR economic analysis (USEPA,
2001a). Combining the value of illness
and mortalities avoided, the estimate of
the total quantified annual benefits of
the LTlESWTR range from $18.9
million to $90.9 million. However, this
range does not incorporate many of the
sources of uncertainty related to
quantifying benefits, including many
benefits the Agency was unable to
evaluate. Accordingly, incorporating
additional uncertainties would
necessarily increase the size of the
range. For example, the number of
avoided cases of cryptosporidiosis
might be higher or lower than the
number reflected in this range. More
detailed information, including the
basis for these estimates, are described
in the LTlESWTR economic analysis
(USEPA, 2001a).
A. What Are the Costs of the
LTlESWTR?
In estimating the costs of today's final
rule, the Agency considered impacts on
PWSs and on States (including
territories and EPA implementation in
non-primacy States). The LTlESWTR
will result in increased costs to public
water systems for implementing the
components of today's final rule. States
will also incur implementation costs.
EPA estimates that the annualized cost
of today's final rule will be $39.5
million using a three percent discount
rate ($44.8 million using a seven percent
discount rate).
Approximately 84 percent ($33.1
million using a 3 percent discount rate
and $38.2 million using a 7 percent
discount rate) of the rule's.total annual
costs are imposed on drinking water
utilities. States incur the remaining 16
percent ($6.4 million using 3 percent
and $6.6 million using 7 percent) of the
LTlESWTR's total annual cost. The
turbidity provisions, which include
treatment changes, monitoring, and
reporting, account for the largest portion
of the total rule costs ($37.7 million
using 3 percent and $42.7 million using
7 percent). Systems will incur most of
the turbidity provision costs and this is
discussed in more detail in the next
section. The national estimate of annual
system costs is based on estimates of
system-level costs for the rule and
estimates of the number of systems
expected to incur each type of cost.
Total capital costs for the LTlESWTR
(non-annualized) is $173.6 million.
Turbidity Provision Costs—The
turbidity provisions are estimated to
cost both public drinking water systems
and States approximately $37.7 million
annually using a three percent discount
rate ($42.7 million using 7 percent).
.However, the majority of these costs
will be borne by the systems and are the
result of treatment changes to meet the
0.3 MTU turbidity standard as well as
the cost for some systems to purchase
turbidimeters in order to meet the
monitoring requirements of this rule.
The Agency estimates that 2,207
systems will modify their water
treatment in response to this rule
provision while 2,327 conventional and
direct filtration systems will need to
install turbidimeters. In addition to the
capital costs associated with this rule
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1823
provision there will also be increases in
operation and maintenance (O&M)
costs. These combined capital and O&M
costs have an estimated cost to systems
of $27.1 million annually using a 3
percent discount rate ($31.8 million
using a 7 percent discount rate). The
O&M expenditures account for 59
percent of the $27.1 million using a 3
percent discount rate ($31.8 million
using a 7 percent discount rate) while
the remaining 41 percent represents
annualized capital costs. In addition to
the turbidity treatment costs, turbidity
monitoring costs apply to all small
surface water or GWUDI systems using
conventional or direct filtration
methods. There are an estimated 5,817
systems that fall under this criterion.
The annualized individual filter
turbidity monitoring cost to PWSs is
approximately $4.5 million using a 3
percent discount rate ($4.7 million
using 7 percent). In addition to the
turbidity treatment and monitoring
costs, individual filter turbidity
exceedance reporting is estimated to
cost systems $0.6 million annually
(using either a 3 percent or 7 percent
discount rate).
The Agency estimated that the total
State cost for the turbidity provision
(monitoring and exceptions) is $6.1
million annually (using either a 3
percent or 7 percent discount rate), with
start-up and monitoring comprising of
81 percent of these annual costs ($4.9
million annually using either a 3
percent or 7 percent discount rate): The
remaining $1,2 million (using either a 3
percent or 7 percent discount rate) in
annual costs includes the costs for
States to review the individual filter
turbidity exceedance reports and
individual filter self-assessment costs.
Disinfection Benchmarking Costs—
The disinfection benchmarking
provision involves three components:
benchmarking, profiling, and optional
monitoring. The start-up costs for this
provision are estimated to cost systems
$2.9 million ($0.2 million annualized
using a three percent discount rate and
$0.3 million using a seven percent
discount rate). Disinfection
benchmarking and profiling are
estimated to cost systems approximately
$0.4 million annually using a 3 percent
discount rate ($0.5 million using 7
percent). TTHM and HAA5 monitoring
is optional and estimated to cost $0.3
million annually using a 3 percent
discount rate ($0.4 million using a 7
percent discount rate). State disinfection
benchmarking annualized costs are
estimated to be $0.4 million using a 3
percent discount rate ($0.5 million
using a 7 percent discount rate). This
estimate includes start-up, compliance
tracking/recordkeeping, and
consultatioii costs.
Covered Finished Water Reservoir
Provision Costs—The LT1ESWTR
requires that small systems cover all
newly constructed finished water
reservoirs, holding tanks, or other
storage facilities for finished water.
Total annual costs, including
annualized capital costs and one year of
O&M costs are expected to be $0.8
million (using either a 3 percent or 7
percent discount rate) for this provision.
This estimate is calculated from a
projected construction rate of new
reservoirs and unit cost assumptions for
covering new finished water reservoirs.
Also, the Agency believes that this is an
overestimate since there may be
additional States that currently require
finished water requirement.
Although EPA has estimated the cost
of all the rule's components on drinking
water systems and States, there are some
costs that the Agency did not quantify.
These non-quantifiable costs result from
uncertainties surrounding rule
assumptions and from modeling
assumptions. For example, EPA did not
estimate a cost for systems to acquire
land if they needed to build a treatment
facility or significantly expand their
current facility because the need for and
cost of land is highly system specific.
Additionally, if the cost for land was
prohibitive, an alternative compliance
option may be available (such as
connecting to another source). Once
again, the Agency has not quantified
costs for this scenario due to the high
degree of site specificity. However,
based on evaluations of Comprehensive
Performance Evaluations (CPEs), EPA
believes that most systems possess more
than adequate property to construct new
facilities.
In addition, other LTlESWTR
provisions may affect some systems but
the Agency was not able to quantify
these costs. These non-quantified costs
include those for systems that incur
incremental costs increases as a result of
including Cryptosporidium in the
definition of GWUDI and also by
including Cryptosporidium in the
watershed control requirements for •
unfiltered systems. The Agency lacked
data on the number of systems
potentially affected by these two
provisions and was therefore, unable to
estimate their costs. By including
Cryptosporidium in the definition, more
ground water systems may be
determined to be under the direct
influence of surface water resulting in
additional cost because these systems
must comply with the 1989 Surface
Water Treatment Rule and today's rule.
EPA also did not estimate the costs for
unfiltered systems to control
Cryptosporidium in their watersheds.
These systems already control for other
pathogens from similar sources as
Cryptosporidium so it is likely that this
provision will have a relatively minor
impact.
B. What Are the Household Costs of the
LTlESWTR?
The mean annual cost per household
is $6.24 and the cost per household is
less than $15 for 90 percent of 6.3
million households potentially affected
by today's final rule. Of the remaining
• households, nine percent will
experience a range of annual costs from
$15 to $120 ($10/month), while only
one percent of households are estimated
to experience annual costs exceeding
$120.
As indicated in the economic analysis
supporting today's final rule, per-
household costs exceed $240/year for
approximately 5,600 households out of
the 6.3 million households potentially
impacted by the LTlESWTR. However,
this analysis likely overestimates costs
for most of these households, allowing
that systems might choose to incur costs
with up to 28 separate treatment
changes when in fact it is likely to be
more cost-effective to install a new
treatment system. (This can be thought
of as building an automobile piece by
piece from an auto parts store compared
to buying one at a dealership.) The
aforementioned 5,600 households are
associated with the end of the cost
distribution where systems undertake
an unrealistically large number of
treatment changes.
C. What Are the Benefits of the
LTlESWTR?
The primary benefits of today's final
rule come from reductions in the risks
of microbial illness from drinking water.
In particular, LTlESWTR focuses on
reducing the risk associated with
disinfection resistant pathogens, such as
Cryptosporidium. Exposure to other
pathogenic protozoa, such as Giardia, or
other waterborne bacteria, viral
pathogens, and other emerging
pathogens are likely to be reduced by
the provisions of this rule as well, but .
are not quantified. In addition,
LTlESWTR produces non-quantifiable
benefits associated with the risk
reductions that result from the
uncovered reservoir provision,
including Cryptosporidium in GWUDI
definition, and including
Cryptosporidium in watershed
requirements for unfiltered systems.
Non-quantifiable benefits also include
reducing the risks to sensitive
subpopulations and the likelihood of
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incurring costs associated with
outbreaks.
1. Quantifiable Health Benefits
The quantified benefits from this rule
are based solely on the reductions in the
risk of cryptosporidiosis that result from
the turbidity provision. As a result of
data limitation, this analysis only
addresses endemic illness and not
illness that results from epidemic
disease outbreaks. Cryptosporidiosis is
an infection caused by Cryptosporidium
which is an acute, self-limiting illness
lasting 7 to 14 days, with symptoms that
include diarrhea, abdominal cramping,
nausea, vomiting and fever (Juranek,
1995). The monetized value of an
avoided case of cryptosporidiosis is
estimated to range from $796 to $1,411
per case based on a cost-of-illness
methodology (Harrington et al., 1985;
USEPA 2001a). The high end of the
range includes losses for medical costs,
work time, productivity, and leisure
time. However, the low end of the range
only values medical costs and work
time. The medical costs may be
overestimated as they are assumed to be
the same as medical costs for a case of
Giardiasis which has a significantly
longer duration. However, the Agency •
believes it is appropriate not to prorate
medical costs for the shorter duration of
Cryptosporidiosis because (1) available
data suggests that the median length of
hospitalstays is essentially the same for
Cryptosporidiosis compared to
Giardiasis; (2) the Harrington et al.
study was conducted in the mid-1980's,
and consequently, the higher direct
medical costs associated with treating
individuals with HIV/AIDS, who are
more severely impacted by
Cryptosporidiosis, was not included;
and (3) Cryptosporidiosis has no known
medical treatment and available data
indicates that the range of the length of
hospital stays for immunocompromised
individuals is larger for cases of
Cryptosporidiosis compared to
Giardiasis. The Agency also recognizes
however, that many individuals with
Cryptosporidiosis do not seek medical
treatment and thus have little or no
associated medical cost, and that the
percentage of such cases may be higher
for Cryptosporidiosis than Giardiasis
given its shorter duration.
The benefits of the turbidity
provisions of LTlESWTR come from
improvements in filtration performance
at water systems. The benefits analysis
accounts for some of the variability and
uncertainty in the analysis by estimating
benefits under two different current
treatment and three improved removal
assumptions. In addition, EPA used
Monte Carlo simulations to derive a
distribution of estimates to address
uncertainty.
In order to quantify the benefits of
this rule, the Agency estimated changes
in the incidence of cryptosporidiosis
.that would result from the rule. The
analysis included estimating the
baseline (pre-LTlESWTR) level of
exposure and risk from
Cryptosporidium in drinking water and
the reductions in such exposure and
risk resulting from the turbidity
provisions of the LTlESWTR. 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 LTlESWTR economic analysis,
the following two assumptions were
made regarding the current
Cryptosporidium oocyst removal
performance to estimate finished water
Cryptosporidium concentrations. First,
based on treatment removal efficiency
data presented in the proposal, EPA
assumed a national distribution of
physical removal efficiencies with a
mean of 2.0 logs and a standard
deviation of 0.63 logs. Because the
finished water concentrations of oocysts
represent the baseline against which
improved removal from the LTlESWTR
is compared, variations in the log
removal assumption could have
considerable impact on the risk
assessment. Second, to evaluate the
impact of the removal assumptions on
the baseline and resulting
improvements, an alternative mean log
removal/inactivation assumption of 2.5
logs and a standard deviation of 0.63
logs were also used to calculate finished
water concentrations of
or each of the two baseline
assumptions, EPA assumed that a
certain number of plants would show
low, mid, or high improved removal as
a result of the turbidity provisions. The
amount of improved removal depends
upon factors such as water matrix
conditions, filtered water turbidity
effluent levels, and coagulant treatment
conditions. The low, mid, and high
improved removals were derived from
Patania et al., (1995). This study
demonstrated that an incremental
decrease in turbidity from 0.3 NTU to .
0.1 NTU (or a 0.2 NTU reduction
overall) resulted in increased oocyst
removals of up to one-log. The Agency
used this data to construct low, mid,
and high removal assumptions that
would capture uncertainty associated
with improved removal. The Agency
also utilized different low, mid, and
high removal assumptions for distinct
categories of current turbidity
performance (<.2NTU, 0.2-0.3 NTU,
0.3-0.4 NTU, and > 0.4 NTU). For
instance, systems currently operating at
greater than 0.4 NTU would need to
target 0.2 NTU to ensure compliance
with the 0.3 NTU limit and EPA
accordingly assumed a low improved
removal of 0.5-log, a mid improved
removal of 0.75-log and a high improved
removal of 0.9-log. However, systems
currently operating between 0.2 NTU
and 0.3 NTU were only expected to
minimally improve turbidity
performance and would therefore only
expect improved log removals of 0.15,
0.25, and 0.3 (low, mid, and high). As
a result, the economic analysis
considers various baseline and with-rule
scenarios to develop a range of endemic
health damages avoided. Additional
information is found in the Benefits
chapter of the Economic Analysis
supporting today's final 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 systems currently operating at the
highest filtered water turbidity levels
would show the largest improvements
or high improved removal assumption.
For example, plants now failing to meet
a 0.4 NTU limit would show greater
removal improvements than plants now
meeting a 0.3 NTU limit.
In addition to assuming the more
conservative baseline and removal
assumptions, the lower-end of the
. LTlESWTR's benefit estimate does not
include valuations for leisure time,
productivity losses (returning to work
but still experiencing symptoms), and
other loss categories that the authors
discuss but do not quantify (e.g., "high
valued" leisure). The authors
(Harrington et al.) were highly confident
in the estimates for direct medical
expenditures and work losses which
comprise the lower benefit estimate; and
less confident in the values for leisure
time losses and productivity losses
which are included in the upper benefit
estimate only. The decreased level of
confidence was based on the data and
methods used to estimate only these
losses. The authors also conclude that:
"* * * nonetheless, the loss categories
in this group-[productivity, leisure
time, etc.] are unquestionably present
and therefore, raise losses above those
reported in [the lower-end benefit
estimate]". The Agency believes that
these categories have positive value as
stated in Harrington et al. consequently
the lower-end estimate for the
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1825
LT1ESWTR understates the true value
of these loss categories.
The Agency further notes that the
medical expense component of the
valuation may be overstated because it
is not prorated for the shorter duration
of Cryptosporidiosis relative to
Giardiasis (mean duration of 11.5 v. 41.6
days). The Agency believes this is
appropriate however, because (1)
available data suggests that the median
length of hospital stays is essentially the
same for Cryptosporidiosis compared to
Giardiasis; (2) the Harrington et al.
study was conducted in the rnid-1980's,
and consequently, the higher direct
medical costs associated with treating
individuals with HIV/AIDS, who are
more severely impacted by
Cryptosporidiosis, was not included;
and (3) Cryptosporidiosis has no known
medical treatment and available data
indicates that the range of the length of
hospital stays for immunocompromis'ed
individuals is larger for cases of
Cryptosporidiosis compared to
Giardiasis. The Agency also recognizes
however, that many individuals with
Cryptosporidiosis do not seek medical
treatment and thus have little or no
associated medical cost, and that the
percentage of such cases may be higher
for Cryptosporidiosis than Giardiasis
given its shorter duration.
Table V.I indicates estimated annual
quantified benefits associated with
implementing the LTlESWTR. The
benefits analysis examines only the
endemic health damages avoided based
on the LTlESWTR for each of the
turbidity provision scenarios discussed
previously. For each of these scenarios,
EPA calculated the mean of the
distribution of the number of illnesses
avoided. The 10th and 90th percentiles
imply that there is a 10 percent chance
that the estimated value could be lower
than the 10th percentile and there is a
10 percent chance that the estimated
value could be higher than the 90th
percentile. The modeling assumptions
used to obtain the distribution of illness
and mortality avoided for each baseline
and the removal scenarios considers
both variability and uncertainty.
Specifically, the Agency used a 2-
dimensional Monte Carlo simulation to
include both uncertainty and variability
inputs. The components that EPA
considered uncertain include the
probability of illness given an infection,
the variability of Cryptosporidium to
cause either an infection or illness, and
the infectivity dose-response factor. The
variability components include:
Cryptosporidium occurrence in the
finished water, individual daily
drinking water consumption, and the
number of days per year of exposure.
In the 2-dimensional simulation
structure, a set of values for the
uncertainty parameters is chosen from
their respective distributions. This set of
values is then "frozen" and a specified
number of iterations are run where
different values are chosen for the
variability factors. This process is
repeated for some specified number of
sets of uncertainty parameters. For this
analysis, 250 sets of uncertainty
parameters were used, with 1,000
variability iterations performed on each
of the 250 uncertainty sets.
This modeling exercise provides the
Agency with 250 sets of statistics for
individual annual risk of illness (e.g.,
mean, standard deviation) that each
reflect different possible combinations
of uncertainty factors. The 250 estimates
for each set of statistics (i.e., mean,
confidence intervals) were then used to
compute an overall population average
annual risk of illness.
Next, the Agency estimates cases of
illness and mortality from the average
annual risk of illness estimates. In order
to do this, the average annual
probability of illness is multiplied by
the number of exposed individuals. In a
separate Monte Carlo simulation for this
calculation, the average annual
probability of illness is treated as an
uncertainty variable. As a result, the
Agency has mean estimates with
confidence intervals for various baseline
and post LTlESWTR assumptions
regarding Cryptosporidium removal
from-source water. The 90th percentile
confidence bounds on the expected
values largely reflect the following
uncertainty variables: the probability of
illness given infection, the variability of
Cryptosporidium to cause either an
infection or illness, and the infectivity
dose-response factor.
The Agency has done its best to
represent a reasonable range of
quantifiable uncertainty using standard
modeling techniques. However, the
Agency recognizes that additional
sources of uncertainty exist which could
not be quantified. To the extent that
these are significant, the true range of
uncertainty may be greater than that
reflected in the quantified analysis.
EPA has evaluated drinking water
consumption data from USDA's 1994-
1996 Continuing Survey of Food Intakes
by Individuals (CSFII) Study. EPA's
analysis of the CSFII Study using the
"all sources, consumer only"
information resulted in a daily water
ingestion lognormally distributed with a
mean of 1.2 liters per person per day
(USEPA, 2000J). Results of alternative
model calculations based on USDA
consumption data for "community
water supplies, all respondents" (mean
of 0.93 liters per person per day) are
presented in the appendix to the
economic analysis as a lower bound
estimate.
TABLE V.1.—QUANTIFIED BENEFITS FROM ILLNESSES AND MORTALITIES AVOIDED ANNUALLY FROM TURBIDITY
PROVISIONS
[SMillions]*
Quantified benefits
Mean Benefit from Avoided Ill-
nesses
10th Percentile
90th Percentile
Mean Benefits from Avoided Mor-
talities . . ..
10th Percentile
90th Percentile
Total Mean Quantified Bene-
fits ....
Daily drinking water ingestion and baseline Cryptosporidium log-removal assumptions, SMillions, 1999
2.0 log
Low
$23.9-$42.4
11.4-20.3
50.1-88.8
23.7
11.3
49.6
47.6-66.1
Mild
$31.6-$56.0
15.2-27.0
58.8-104.2
31.3
15.0
58.2
62.9-87.3
• High
$32.9-$58.3
14.1-24.9
56.5-100.2
32.5
13.9
55.9
65.4-90.9
2.5 log
Low
S9.5-S16.8
2.2-3.9
26.6-^7.2
9.4
2.2
26.3
18.9-26.2
Mid
$11.2-$19.8
2.8-5.0
27.6-48.9
11.1
2.8
27.3
22.2-30.9
High
$12.7-$22.6
4.2-7.5
33.6-59.5
12.6
4.2
33.2
25.4-35.2
'Totals may not equal due to rounding.
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According to the economic analysis
performed for the LT1ESWTR published
today, the rule is estimated to reduce
the mean annual number of illnesses
caused by Cryptosporidium in water
systems with improved filtration
performance by 12,000 to 41,000 cases
per year depending upon which of the
six baseline and improved
Cryptosporidium removal assumptions
was used, and assuming the 1.2 liter
drinking water consumption
distribution. Based on these values, the
mean estimated annual benefits of
reducing the illnesses ranges from $9.5
million to $58.3 million per year. The
economic analysis also indicated that
the rule could result in a mean
reduction of 1 to 5 fatalities each year,
depending upon the varied baseline and
improved removal assumptions. Using a
mean value of $6.3 million per
statistical life saved, reducing these
fatalities could produce benefits in the
range of $9.4 million to $32.5 million.
Combining the value of illness and
mortalities avoided, the estimate of the
total quantified annual benefits of the
LTlESWTR range from $18.9 million to
$90.9 million. However, this range does
not incorporate many of the sources of
uncertainty related to quantifying
benefits, including many benefits the
Agency was unable to evaluate.
Accordingly, incorporating additional
uncertainties would necessarily increase
the size of the range.
New occurrence data and infectivity
data is currently being evaluated by the
Agency in the context of the Long Term
2 Enhanced Surface Water Treatment
Rule (LT2ESWTR). The analysis is
currently ongoing and peer review has
not been completed. EPA conducted a
sensitivity analysis in the economic
analysis supporting today's-final rule to
predict the effect that new data may
have on the benefits presented earlier.
Table V.2 provides a summary of this
sensitivity analysis and depicts the
cumulative change to the benefits range
that each of the four new changes (new
occurrence data, new infectivity data,
new morbidity data, and new viability
data) could have on benefits. The
economic analysis includes a more
detailed analysis using this data.
TABLE V.2.—SUMMARY OF RESULTS OF SENSITIVITY ANALYSIS To PREDICT EFFECTS OF NEW DATA AND INFORMATION
ON RANGE OF BENEFITS
Benefits Range
Current EA
No Changes
$18.9-590.9
New occurence data
Occurrence changes
from 4.7 oocyst/L
to 1.06 oocyst/L.
$5.4-325.2
New infectivity data
Rate of infection from
.00424 to .0231 7.
$17.3-$74.4
New morbidity data
Morbidity changes
from 0.39 to 0.5.
$22.5-$88.0
New viability data
Viability changes from
16.4 percent to
55.2 percent.
$51.2-$195.8
2. Non-Quantified Health and Non-
Health Related Benefits
The quantified benefits from filter
performance improvements do not fully
capture all the benefits of the turbidity
provision. Even the upper bound
estimates, which are based on a cost-of-
illness (COI) methodology (expanded to
incorporate lost leisure time and lost
productivity while working], may not
fully capture the willingness-to-pay to
avoid a case of Cryptosporidiosis. In
addition, the Harrington, et al. study
was conducted in the mid-1980's in a
rural community and may not be fully
representative of the current national
population including individuals with
HIV/AIDS and chemotherapy patients
that are more severely impacted by
Cryptosporidiosis. If this population
was more accurately represented, it may
he that the average per-case valuation
would be higher than the range
presented in this analysis. Further, the
turbidity provisions are also expected to
decrease the risk of waterborne disease
outbreaks. However, the quantified
benefits reflect only the reduction in
endemic Cryptosporidiosis and not any
outbreak-related illness or mortalities.
Other disinfection resistant pathogens
may also be removed more efficiently
due to implementation of the
LTlESWTR. Exposure to other
pathogenic protozoa, such as Giardia, or
other waterborne bacterial or viral
pathogens are likely to be reduced by
the provisions of this rule as well.
In addition to preventing illnesses,
this rule is expected to have other non-
health related benefits. During an
outbreak, local governments and water
systems must issue warnings and alerts
and may need to provide an alternative
source of water. Systems also face
negative publicity and possibly legal
costs. Businesses have to supply their
customers and employees with
alternative sources of water and some,
especially restaurants, may even have to
temporarily close. Households also have
to boil their water, purchase water, or
obtain water from another source. A
study of a Giardia outbreak in Luzerne
County, Pennsylvania showed that these
non-health related outbreak costs can be
quite significant (Harrington et al.,
1985). This outbreak resulted in an
estimated loss to individuals of $31
million to $92 million. Additional
losses were also calculated for
restaurants and bars ($2 million to $7
million), government agencies ($0.4
million) and the water supply utility ($3
million).
The remaining rule provisions
(disinfection benchmarking, covered
finished water reservoirs, inclusion of
Cryptosporidium in the GWUDI
definition, and inclusion of
Cryptosporidium in watershed control
requirements for unfiltered systems)
provide additional benefits. However,
EPA is only able to discuss the benefits
of these rule provisions qualitatively
because of data limitations. The
disinfection benchmark provision will
ensure that adequate microbial
protection is in place if a system must
make changes to its disinfection
practices as a result of the Stage 1 DBF
rule. Covering finished water reservoirs
will protect the finished water from
becoming re-contaminated from such
things as animal or bird droppings,
surface water runoff, and algae. If
Cryptosporidium is found in ground
water supplies, they will be required to
change treatment practice to prevent
illness. Finally, by requiring
Cryptosporidium control in watersheds
of unfiltered systems, this will minimize
the potential for illness and may also
lower the overall costs of drinking water
treatment.
D. What Are the Incremental Costs and
Benefits?
EPA evaluated the incremental or
marginal costs of today's final rule
turbidity provision by analyzing various
turbidity limits, 0.3 NTU, 0.2 NTU, and
0.1 NTU. For each turbidity limit, EPA
developed assumptions about which
process changes systems might
implement to meet the turbidity level
and how many systems would adopt
each change. The comparison of total
compliance cost estimates shows that
costs are expected to increase
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1827
significantly across other turbidity
limits considered by the Agency. The
total cost of a 0.2 NTU limit is 346
percent higher than the final rule limit
of 0.3 NTU, and a 0.1 NTU limit would
be 1,192 percent higher.
E. Are There Benefits From the
Reduction of Co-Occurring
Contaminants?
If a system chooses to install
treatment, it may choose a technology
that would also address other drinking
water contaminants. For example, some
membrane technologies installed to
remove bacteria or viruses can reduce or
eliminate many other drinking water
contaminants including arsenic.
The technologies used to reduce
individual filter turbidities have the
potential to reduce concentrations of
other pollutants as well. Reductions in
turbidity that result from today's
proposed rule are aimed at reducing
Cryptosporidium by physical removal.
However, health risks from Giardia
lamblia and emerging disinfection
resistant pathogens, such as
microsporidia, Toxoplasma, and
Cyclospora, are also likely to be reduced
as a result of improvements in turbidity •
removal. The frequency and extent that
LTlESWTR would reduce risk from
other contaminants has not been
quantitatively evaluated because of the
Agency's lack of data on the removal
efficiencies of various technologies for
emerging pathogens and the lack of co-
occurrence data for microbial pathogens
and other contaminants from drinking
water systems.
F. Is There Increased Risk From Other
Contaminants?
It is unlikely that LTlESWTR will
result in any increased risk from other
contaminants. Improvements in plant
turbidity performance will not result in
any increases in risk. In fact the
disinfection benchmarking component
of today's final LTlESWTR will provide
information to systems so they can
minimize the increased risk from
microbial contaminants as they take
steps to address risks associated with
DBFs under the Stage 1 DBPR.
G. What Are the Uncertainties in the
Risk, Benefit and Cost Estimates for the
LTlESWTR?
EPA has included in the economic
analysis, a detailed discussion of the
possible sources of uncertainty in risk,
benefit and cost estimates. Some sources
of possible uncertainty associated with
calculation of risk and benefits include
occurrence of Cryptosporidium oocysts
in source waters and finished waters,
reduction of Cryptosporidium oocysts
due to improved treatment, viability and
infectivity of Cryptosporidium oocysts,
characterization of risk, and willingness
to reduce risk and avoid costs.
Uncertainty associated with costs
includes assumptions with respect to
treatment a system might choose to
employ to comply with the rule,
assumptions about costs of labor,
maintenance, and capital, and the
number of systems expected to
undertake certain activities. The Agency
believes that the risks, benefits, and
costs have been accurately portrayed.
Discussions and analyses of risks,
benefits, and costs in the economic
analysis indicate where uncertainty may
be introduced and to the extent
possible, the effect uncertainty may
have on analysis (USEPA, 2001aJ.
H. What Is the Benefit/Cost
Determination for the LTlESWTR?
The Agency has determined that the
benefits of the LTlESWTR justify the
costs. As shown in Table V.3, the
quantified net benefits of this rule based
on the Agency's estimate range from
$20.6 million to $51.4 million using the
3 percent discount rate ($25.9 million to
$46.1 million at the 7 percent discount
rate). Additionally, EPA believes that
quantified net benefits would be larger
if both unquantified benefits and costs
•were able to be monetized.
TABLE V.3.—ANNUALIZED NET BENEFITS OF THE LT1ESWTR, MILLIONS, 1999 DOLLARS
Estimate of Benefits :
Benefit range
$18.9-$90.9
Costs using a 3
percent dis-
count rate
$39.5
Costs using a 7
percent dis-
count rate
$44.8
Net benefits (3
percent)
$-20.6-$51.4
Net benefits (7
percent)
$-25.9-$46.1
VI. Other Requirements
A. Regulatory Flexibility Act (RFA), as
Amended by the Small Business
Regulatory Enforcement Fairness Act of
1996 (SBREFA), 5 U.S.C. 601 et seq.
The RFA generally requires an agency
to prepare a regulatory flexibility
analysis of any rule subject to notice
and comment rulemaking requirements
under the Administrative Procedure Act
or any other statute unless the agency
certifies that the rule will not have a
significant economic impact on a
substantial number of small entities.
Small entities include small businesses,
small organizations, and small
governmental jurisdictions.
The RFA provides default definitions
for each type of small entity. It also
authorizes an agency to use alternative
definitions for each category of small
entity, "which are appropriate to the
activities of the agency" after proposing
the alternative definition(s) in the
Federal Register and taking comment. 5
"U.S.C. 601(3)-(5). In addition to the
above, to establish an alternative small
business definition, agencies must
consult with SBA's Chief Counsel for
Advocacy.
For purposes of assessing the impacts
of today's rule on small entities, EPA
considered small entities to be PWSs
serving fewer than 10,000 persons. This
is the cut-off level specified by Congress
in the 1996 Amendments to the SDWA
for small system flexibility provisions.
In accordance with the RFA
requirements, EPA proposed using this
alternative definition in the Federal
Register (63 FR 7620, February 13,
1998), requested comment, consulted
with the Small Business Administration
(SBA), and expressed its intention to
use the alternative definition for all
future drinking water regulations in the
Consumer Confidence Reports
regulation (63 FR 44511, August 19,
1998). As stated in that final rule, the
alternative definition would be applied
to this regulation as well.
. After considering the economic
impacts of today's final rule on small
entities, I certify that this action will not
have a significant economic impact on
a substantial number of small entities.
In accordance with section 603 of the
RFA, EPA convened a Small Business
Advocacy Review (SBAR) Panel to
obtain advice and recommendations
from representatives of small entities
that would potentially be regulated by
the rule in accordance with section
609(b) of the RFA. A detailed discussion
of the Panel's advice and
recommendations is found in the Panel
Report found in the docket for today's
final rule (USEPA, 1998k). The Panel
recommendations emphasized the need
to provide small systems flexibility. The
Agency has structured today's final
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LTlESWTR with an emphasis on
providing flexibility and reducing
burden for small systems. For example,
the Agency originally contemplated
requiring four quarters of TTHM and
HAAS monitoring and disinfection
profiling based on daily measurements.
Today's final rule requires profiling
based on weekly measurements and
allows systems the option of using one
quarter of TTHM and HAAS monitoring
to opt-out of profiling. Today's rule also
provides systems with two or fewer
filters the flexibility to monitor
combined filter effluent in lieu of
individual filter turbidity monitoring,
effectively allowing these systems to
reduce their recordkeeping burden. A
complete summary of the Panels
recommendations is presented in the
proposal (65 FR19046,19127-19130).
While EPA could have certified the
proposed rule based on the proposed
rule requirements, the Agency originally
developed an IRFA (see 65 FR 19046,
19126-19127) and convened an SBAR
Panel because several of the additional
alternatives EPA was requesting
comment on would have resulted in
substantial costs for small systems
thereby preventing the Agency from
certifying. While EPA included these
additional alternatives in the proposal
and estimated costs in the economic
analysis for the proposal, the Agency re-
evaluated the economic effects on small
entities after publication of the April 10,
2000 LTlESWTR proposal using the
rule requirements of today's final rule
and was able to certify that today's final
rule will not have a significant
economic impact on a substantial
number of small entities.
EPA's analysis showed that of the
approximately 11,000 small entities
potentially affected by the LTlESWTR,
over 5,000 are expected to incur average
annualized costs of less than $70 dollars
(0.003 percent of average annual
revenue) while slightly more than 3,000
are expected to incur average
annualized costs of less than $850
dollars (0.03 percent of average annual
revenue). Of the remaining systems,
approximately 500 systems are expected
to incur average annualized costs of
approximately 52,500 dollars (0.1
percent of average annual revenue),
approximately 2,000 systems are
expected to incur average annualized
costs of approximately $13,000 dollars
(0.6 percent of average annual revenue).
Loss than 100 systems are expected to
incur average annualized costs of
approximately 315,700 dollars (0.7
percent of average annual revenue). The
Agency has included a detailed
description of this analysis in the
Regulatory Flexibility Screening
Analysis prepared for the rule (USEPA,
2000e).
B. Paperwork Reduction Apt
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 2040-0229. The
information collected as a result of this
rule will allow the States and EPA to
determine appropriate requirements for
specific systems, in some cases, and to
evaluate compliance with the rule. For
the first three years after February 13,
2002, the major information
requirements are related to disinfection
profiling activities. The information
collection requirements in §§ 141.530-
141;536, 141.540-141.544, 141.550-
141.553,141.560-141.564, and 141.570-
141.571, for systems, and §§ 142.14 and
142.16, for States, are mandatory. The
information collected is not
confidential. The final estimate of
aggregate annual average burden hours
for LTlESWTR is 330,329_. Annual
average aggregate cost estimate is
$1,583,538 for capital (expenditures for
monitoring equipment), and $1,919,563
for operation and maintenance
including lab costs (which is a purchase
of service). The burden hours per
response is 21.8. The frequency of
response (average responses per
respondent) is 2.8 annually. The
estimated number of likely respondents
is 5,404 (the product of burden hours
per response, frequency, and
respondents does not total the annual
average burden hours due to rounding).
Burden means the total time, effort, or
financial resources expended by persons
to generate, maintain, retain, or disclose
or provide information to or for a
Federal agency. This includes the time
needed to review instructions; develop,
acquire, install, and utilize technology
and systems for the purposes of
collecting, validating, and verifying
information; processing and
maintaining information, and disclosing
and providing information; adjust the
existing ways to comply with any
previously applicable instructions and
requirements; train personnel to be able
to respond to a collection of
information; search data sources;
complete and review the collection of
information; and transmit or otherwise
disclose the information.
An Agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
unless it displays a currently valid OMB
control number. The OMB control
numbers for EPA's regulations are listed
in 40 CFR part 9 and 48 CFR Chapter
15. 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.
C. Unfunded Mandates Reform Act
1. Summary of UMRA Requirements
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for
Federal agencies to assess the effects of
their regulatory actions on State, local,
and Tribal governments and the private
sector. Under UMRA section 202, EPA
generally must prepare a written
statement, including a cost-benefit
analysis, for proposed and final rules
with "Federal mandates" that may
result in expenditures by State, local,
and Tribal governments, in the
aggregate, or by the private sector, of
$100 million or more in any one year.
Before promulgating an EPA rule for
which a written statement is needed,
section 205 of the UMRA generally
requires EPA to identify and consider a
reasonable number of regulatory
alternatives and adopt the least costly,
most cost-effective or least burdensome
alternative 'that achieves the objectives
of the rule. The provisions of section
205 do not apply when they are
inconsistent with applicable law.
Moreover, section 205 allows EPA to
adopt an alternative other than the least
costly, most cost effective or least
burdensome alternative if the
Administrator publishes with the final
rule an explanation why that alternative
•was not adopted.
Before EPA establishes any regulatory
requirements that may significantly or
uniquely affect small governments,
including Tribal governments, it must
have developed, under section 203 of
trie UMRA, a small government agency
plan. The plan must provide for
notifying potentially affected small
governments, enabling officials of
affected small governments to have
meaningful and timely input in the
development of EPA regulatory
proposals with significant Federal
intergovernmental mandates and
informing, educating, and advising
small governments on compliance with
the regulatory requirements.
EPA has determined that this rule
does not contain a Federal mandate that
may result in expenditures of $100
million or more for State, local and
Tribal governments, in the aggregate, or
the private sector in any one year. The
estimated annual cost of this rule is
$39.5 million. Thus today's rule is not
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1829
subject to the requirements of sections
202 and 205 of the UMRA.
EPA has determined that this rule
contains no regulatory requirements that
might significantly or uniquely affect
small governments. Of die
approximately 6,500 small government
entities potentially affected by the
LTlESWTR, approximately 3,000 are
expected to incur average annualized
costs of less dian $70 dollars (0.003
percent of average annual revenue)
while approximately 2,000 are expected
to incur average annualized costs of less
than $850 dollars (0.03 percent of
average annual revenue). Of the
remaining systems, less than 300 are
expected to incur average annualized
costs of approximately $2,500 dollars
(0.1 percent of average annual revenue),
approximately 1,200 systems are
expected-to incur average annualized •
costs of approximately $13,000 dollars
(0.6 percent of average annual revenue).
Less than 100 systems are expected to
incur average annualized costs of
approximately $15,700 dollars (0.7
percent of average annual revenue).
While today's final rule only applies to
systems serving fewer than 10,000, it is
not unique as it provides a comparable
level of health protection to individuals
served by small systems as the IESWTR
provided to individuals served by large
systems. While there are small
differences between the LTlESWTR and
IESWTR, these differences reflect an
effort to reduce burden for small
systems while still maintaining a
comparable level of health protection.
Thus, today's rule is not subject to the
requirements of section 203 of UMRA.
Nevertheless, EPA has tried to ensure
that State, local, and Tribal governments
had opportunities to provide comment.
EPA consulted with small governments
to address impacts of regulatory
requirements in the rule that might
significantly or uniquely affect small
governments. As discussed next, a
variety of stakeholders, including small
governments, were provided the
opportunity for timely and meaningful
participation in the regulatory
development process. EPA used these
opportunities to notify potentially
affected small governments of regulatory
requirements being considered.
EPA began outreach efforts to develop
the LTlESWTR in the summer of 1998.
Two public stakeholder meetings,
which, were announced in the Federal
Register, were held on July 22-23,1998,
in Lakewood, Colorado, and on March
3-4,1999, in Dallas, Texas.
Stakeholders include representatives of
State, local and Tribal governments,
environmental groups and publicly
owned and privately owned public
water systems. In addition to these
meetings, EPA has held several formal
and informal meetings with
stakeholders including the Association
of State Drinking Water Administrators
and representatives of State and local
elected officials. A summary of each
meeting and attendees is available in the
public docket for this rule. EPA also
convened a Small Business Advocacy
Review (SBAR) Panel in accordance
with the RFA, as amended by the Small
Business Regulatory Enforcement
Fairness Act (SBREFA) to address small
entity concerns including those of small
local governments. The SBAR Panel
allows small regulated entities to
provide input to EPA early in the
regulatory development process. In
early June 1999, EPA mailed an
informal draft of the LTlESWTR
preamble to the approximately 100
stakeholders who attended one of the
public stakeholder meetings. Members
of trade associations and the SBREFA
Panel also received the draft preamble.
EPA received valuable suggestions and
stakeholder input from 15 State
representatives, trade associations,
environmental interest groups, and
individual stakeholders. The majority of
concerns dealt with reducing burden on
small systems and maintaining
flexibility.
To inform and involve Tribal
governments in the rulemaking process,
EPA presented the LTlESWTR at three
venues: the 16th Annual Consumer
Conference of the National Indian
Health Board, the annual conference of
the National Tribal Environmental
Council, and the EPA/Inter Tribal
Council of Arizona, Inc. Tribal
consultation meeting. Over 900
attendees representing Tribes from
across the country attended the National
Indian Health Board's Consumer
Conference and over 100 Tribes were
represented at the annual conference of
the National Tribal Environmental
Council. At the first two conferences, an
EPA representative conducted two
workshops on EPA's drinking water
program and upcoming regulations,
including the LTlESWTR.
At the EPA/Inter Tribal Council of
Arizona meeting, representatives from
15 Tribes participated. The presentation
materials and meeting summary were
sent to over 500 Tribes and Tribal
organizations. Additionally, EPA
contacted each of the 12 Native
American Drinking Water State
Revolving Fund Advisors to invite
them, and representatives of their
organizations to the stakeholder
meetings described previously.
During the comment period for
today's final rule, the Agency held a
public meeting in Washington D.C. on
April 14, 2000. Additionally, the
proposed rule was either presented or
discussed in nearly 50 meetings across
the U.S. Finally, EPA mailed
approximately 200 copies of the
proposed rule to stakeholders requesting
comment. EPA received 67 comments
from a variety of stakeholders including
24 States, 21 municipalities, one Tribe,
one elected official, two consultants,
eight trade groups, and four private
industries.
In addition, EPA will educate, inform,
and advise small systems, including
those run by small governments, about
the LTlESWTR requirements. The
Agency is developing plain-English
guidance that will explain what actions
a small entity must take to comply with
the rule. Also, the Agency has
developed a fact sheet that concisely
describes various aspects and
requirements of the LTlESWTR. This
fact sheet is available by calling the Safe
Drinking Water Hotline at 800-426-
4791.
D. National Technology Transfer and
Advancement Act
As noted in the proposed rule, section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law No. 104-113,
section 12(d) (15 U.S.C. 272 note),
directs EPA to use voluntary consensus
standards in its regulatory activities
unless to do so would be inconsistent
with applicable law or otherwise
impractical. Voluntary consensus
standards are technical standards (e.g.,
materials specifications, test methods,
sampling procedures, and business
practices) that are developed or adopted
by voluntary consensus standards
bodies. The NTTAA directs EPA to
provide Congress, through the Office of
Management and Budget, explanations
when the Agency decides not to use
available and applicable voluntary
consensus standards.
Today's rule does not establish any
technical standards, dius, NTTAA does
not apply to this rule. It should be
noted, however, that systems complying
with, this rule need to use one of three
previously approved technical
standards already included in § 141.74
(a). Method 2130B (APHA, 1995), is
published in Standard Methods for the
Examination of Water and Wastewater
(19th ed.) and is a voluntary consensus
standard. The Great Lakes Instrument
Method 2, has been approved by USEPA
as an alternate test procedure (Great
Lakes Instruments, 1992). EPA Method
180.1 for turbidity measurement was
published in August 1993 in Methods
for the Determination of Inorganic
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Substances in Environmental Samples
(EPA-600/R-93-100) (USEPA, 1993).
Today's final rule also requires
calibration of the individual
turbidimeter to be conducted using
procedures specified by the
manufacturer. EPA encouraged
comments on this aspect of the.
rulemaking and specifically invited the
public to identify potentially applicable
voluntary consensus standards and to
explain why such standards should be
used in this regulation. EPA received no
comments on this issue.
E. Executive Order 12866: Regulatory
Planning and Review
Under Executive Order 12866 (58 FR
51735, 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, 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 the Executive
Order 12866, it has been determined
that this rule is a "significant regulatory
action." As such, this action was
submitted to OMB for review. Changes
made in response to OMB suggestions or
recommendations are documented in
the public record.
F. Executive Order 12898:
Environmental Justice
Executive Order 12898 establishes a
Federal policy for incorporating
environmental justice into Federal
agency missions by directing agencies to
identify and address disproportionately
high and adverse human health or
environmental effects of its programs,
policies, and activities on minority and
low-income populations. The Agency
has considered environmental justice
related issues concerning the potential
impacts of this action and consulted
with minority and low-income
stakeholders.
This preamble has discussed how the
IESWTR served as a template for the
development of the LTlESWTR. As
such, the Agency also built on the
efforts conducted during the ffiSWTRs
development to comply with Executive
Order 12898. On March 12,1998, the
Agency held a stakeholder meeting 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 11 cities. This
meeting was a continuation of
stakeholder meetings that started in
1995 to obtain input on the Agency's
Drinking Water Programs. The major
objectives for the March 12,1998
meeting were to:
—Solicit ideas from stakeholders on
known issues concerning current
drinking water regulatory efforts;
—Identify key issues of concern to
stakeholders, and;
—Receive suggestions from stakeholders
concerning ways to increase
representation of communities in
EPA's Office of Water drinking water
regulatory efforts.
In addition, EPA developed a plain-
English guide specifically for this
meeting to assist stakeholders in
understanding the multiple and
sometimes complex issues surrounding
drinking water regulation.
The LTlESWTR applies to
community water systems, non-
transient non-community water
systems, and transient non-community
water systems that use surface water or
GWUDI as their source water for PWSs
serving less than 10,000 people. These
requirements will also be consistent
with the protection already afforded to
people being served by systems serving
10,000 or more persons.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
Executive Order 13045: "Protection of
Children from Environmental Health
Risks and Safety Risks" (62 FR 19885,
April 23, 1997) applies to any rule that:
(1) Is determined to be economically
significant as denned under Executive
Order 12866, and; (2) concerns an
environmental health or safety risk that
EPA has reason to believe may have a
disproportionate effect on children. If
the regulatory action meets both criteria,
the Agency must evaluate the
environmental health or safety effects of
the planned rule on children and
explain why the planned regulation is
preferable to other potentially effective
and reasonably feasible alternatives
considered by the Agency.
While this final rule is not subject to
the Executive Order because it is not
economically significant as defined in
Executive Order 12866, we nonetheless
have reason to believe that the
environmental health or safety risk
addressed by this action may have a
disproportionate effect on children. As
a matter of EPA policy, we therefore
have assessed the environmental health
effects of Cryptosporidium on children.
The results of this assessment are
contained in the LTlESWTR economic
analysis (USEPA, 2001a). A copy of the
analysis and supporting documents are
found in the public docket for today's
final rule (W-99-10, Final Long Term I
Enhanced Surface Water Treatment
Rule. The docket is available for public
review at EPA's Drinking Water Docket:
401 M Street, SW., Rm. EB57,
Washington, DC 20460.
The risk of illness and death due to
cryptosporidiosis depends on several
factors, including age, nutrition,
exposure, genetic variability, disease
and immune status of the individual.
Mortality resulting from diarrhea shows
the greatest risk of mortality occurring
among the very young and elderly
(Gerba et al., 1996). For
Cryptosporidium, young children are a
vulnerable population subject to
infectious diarrhea (CDC 1994).
Cryptosporidiosis is prevalent
worldwide, and its occurrence is higher
in children than in adults (Payer and
Ungar, 1986).
Cryptosporidiosis appears to be more
prevalent in populations, such as
infants, that may not have established
immunity against the disease and may
be in greater contact with
environmentally contaminated surfaces
(DuPont, et al, 1995). An infected child
may spread the disease to other children
or family members. Evidence of such
secondary transmission of
cryptosporidiosis from children to
household and other close contacts has
been found in a number of outbreak
investigations (Casemore, 1990; Cordell
et al, 1997; Frost et al, 1997). Chapelle
et al., (1999) found that prior exposure
to Cryptosporidium through the
ingestion of a low oocyst dose provides
protection from infection and illness.
However, it is not known whether this
immunity is life-long or temporary. Data
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1831
also indicate that either mothers confer
short term immunity to their children or
that babies have reduced exposure to
Cryptosporidium, resulting in a
decreased incidence of infection during
the first year of life. For example, in a
survey of over 30,000 stool sample
analyses from different patients in the
United Kingdom, the one to five year
age group suffered a much higher
infection rate than individuals less than
one year of age. For children under one
year of age, those older than six months
of age showed a higher rate of infection
than individuals aged fewer than six
months (Casemore, 1990).
EPA has not been able to quantify the
health effects for children as a result of
Cryptosporidium-contaminated
drinking water. However, the result of
the LTlESWTR will be a reduction in
the risk of illness for the entire
population, including children. Because
available evidence indicates that
children may be more vulnerable to
Cryptosporidiosis than the rest of the
population, the LTlESWTR would,
therefore, result in greater risk reduction
for children than for the general
population.
H. Consultations With the Science
Advisory Board, National Drinking
Water Advisory Council, and the
Secretary of Health and Human Services
In accordance with section 1412 (d)
and (e) of the SDWA, the Agency
consulted with the National Drinking
•Water Advisory Council (NDWAC), the
Secretary of Health and Human
Services, and the EPA Science Advisory
Board (SAB) on the proposed
LTlESWTR. None of the three
consultations resulted in substantive
comments on the LTlESWTR.
On March 13 and 14, 2000 in
Washington, DC, the Agency met with
SAB during meetings open to the public
where several of the Agency's drinking
water rules were discussed. A copy of
the SAB's comments are found in the
docket (USEPA, 20001). Comments on
the LTlESWTR were generally
supportive.
On May 10, 2000 in San Francisco,
California, the Agency met with
'NDWAC. A copy of the materials
presented to the NDWAC, as well as the
charge presented to the council are
found in the docket (USEPA, 2000f,
NDWAC, 2000).
EPA invited the Secretary of Health
and Human Services to the April 14th,
2000 informational meeting regarding
the proposed Long Term 1 Enhanced
Surface Water Treatment Rule and
consulted with the Centers for Disease
Control (CDC) during a June 20, 2000
conference call with the Centers'
Working Group on Waterborne
Cryptosporioiiosis. The meeting notes
for that call are found in the docket
(CDC, 2000). CDC's role as an Agency of
the Department of Health and Human
Services is to provide a system of health
surveillance to monitor and prevent the
outbreak of diseases. With the assistance
of States and other partners, CDC guards
against international disease
transmission, maintains national health
statistics, and provides for
immunization services and supports
research into disease and injury
prevention.
I. Executive Order 13132: Executive
Orders on Federalism
Executive Order 13132, entitled
"Federalism" (64 FR 43255, August 10,
1999), requires EPA to develop an
accountable process to ensure
"meaningful and timely input by State
and local officials in the development of
regulatory policies that have federalism
implications." "Policies that have
federalism implications" is defined in
the Executive Order to include
regulations that have "substantial direct
effects on the States, on the relationship
between ,the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government."
This final rule does not have
federalism implications. It will not have
substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132. Today's final
rule does not have a substantial direct
effect on local and State governments
because it is not expected to impose
substantial direct compliance costs. The
rule imposes annualized compliance
costs on State and local governments of
approximately $30.6 million. $6.4
million of these costs are attributable to
States, while $24.2 million is
attributable to local governments
serving fewer than 10,000 persons. As
described in Section Vl.A of the
preamble for today's final rule, this rule
will not have a significant economic
impact on a substantial number of small
entities, including small governments.
Furthermore, the rule does not have a
substantial direct effect on the
relationship between the national
government and the States, or the
distribution of power and
responsibilities among the various
levels of government as specified in
Executive Order 13132 because the rule
does not change the current roles and
relationships of the Federal government,
State governments and local
governments in implementing drinking
water-programs. Thus Executive Order
13132 does not apply to this rule.
Although the Executive Order does not
apply to this rule, EPA did consult with
State and local officials in developing
this rule. In addition to our outreach
efforts described earlier, on May 30,
2000, the Agency held a meeting in
Washington, DC with ten
representatives of elected State and
local officials to discuss how new
Federal drinking water regulations
(LTlESWTR, FBRR, Ground Water Rule,
Radon Rule, Radionuclides Rule, and
Arsenic Rule) may affect State, county,
and local governments. Throughout the
consultation, stakeholders asked EPA
for clarification of basic concepts and
rule elements. EPA addressed these
issues throughout the consultation and
provided background and clarification
to promote better understanding of the
issues. For example, stakeholders asked
EPA to describe what Cryptosporidium
is and how individuals are diagnosed
with Cryptosporidiosis. A detailed
summary of this consultation meeting
and the concerns raised is found in the
docket (USEPA, 2000g). No significant
concerns were raised regarding the
LTlESWTR.
/. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
On November 6, 2000, the President
issued Executive Order 13175 (65 FR
67249) entitled, "Consultation and
Coordination with Indian Tribal
Governments." Executive Order 13175
took effect on January 6, 2001, and
revoked Executive Order 13084 (also
entitled Consultation and Coordination
with Indian Tribal Governments.") as of
that date. However, EPA developed and
proposed this final rule when Executive
Order 13084 was in effect, and before
the effective date of the consultation
requirements of Executive Order 13175.
Therefore, the consultation
requirements of Executive Order 13084
apply to this rule.
Under Executive Order 13084, EPA
could not issue a regulation that was not
required by statute, that significantly or
uniquely affected the communities of
Indian Tribal governments, and that
imposed substantial direct compliance.
costs on those communities, unless the
Federal government provided the funds
necessary to pay the direct compliance
costs incurred by the Tribal
governments, or EPA consulted with
those governments.
Executive Order 13084 required EPA
to provide to the Office of Management
and Budget, in a separately identified
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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 required EPA to develop an
effective process permitting elected
officials and other representatives of
Indian Tribal governments "to provide
meaningful and timely input in the
development of regulatory policies on
matters that significantly or uniquely
affect their communities."
EPA has concluded that this rule will
not significantly or uniquely affect
communities of Indian Tribal
governments, and will not impose
substantial direct compliance costs on
such communities. This rule will affect
approximately 70 of the 700 total Tribal
drinking water systems. Of these 70
systems, half are estimated to incur
annualized compliance costs of less
than $70 per year (0.003 percent of
average annual revenue) and
approximately 20 systems are estimated
to incur annualized compliance costs of
less than $850 per year (0.03 percent of
average annual revenue). The remaining
systems would incur an estimated
annualized compliance costs of less
than $13,000, or 0.6 percent of average
annual revenue.
Nonetheless, EPA provided
representatives of Tribal governments
with several opportunities to become
knowledgeable of the proposed rule and
to provide meaningful and timely input
in its development. EPA began outreach
efforts to develop the LT1ESWTR in the
summer of 1998 as discussed in detail
above in the UMRA and Federalism
sections. To inform and involve the
representatives of Tribal governments
specifically, EPA presented the
LT1ESWTR at three venues: The 16th
Annual Consumer Conference of the
National Indian Health Board, the
annual conference of the National Tribal
Environmental Council, and the EPA/
Inter Tribal Council of Arizona, Inc.
Tribal consultation meeting. Summaries
of the meetings have been included in
the public docket for this rulemaking.
EPA's consultation, the nature of the
Tribal concerns, and the position
supporting the need for this rule are
discussed in Section VI.C., which
addresses compliance with UMRA.
Over 900 Tribal representatives from
across the country attended the National
Indian Health Board's Consumer
Conference and over 100 Tribes were
represented at the annual conference of
the National Tribal Environmental
Council. At the first two conferences, an
EPA representative conducted two
workshops on EPA's drinking water
program and upcoming regulations,
including the LTIESWTR. At the EPA/
Inter Tribal Council of Arizona meeting,
representatives from 15 Tribes
participated. The presentation materials
and meeting summary were sent to over
500 Tribes and Tribal organizations.
Additionally, EPA contacted and
invited each of the 12 Native American
Drinking Water State Revolving Fund
Advisors to attend the meetings
described above.
During the comment period for
today's final rule, the Agency held a
public meeting in Washington, DC on
April 14, 2000 which was announced in
the Federal Register. Additionally, the
proposed rule was either presented or
discussed in nearly 50 meetings across
the country. Finally, EPA mailed
approximately 200 copies of the
proposed rule to stakeholders, including
Tribal representatives, requesting
comment. EPA received 67 comments,
one of which was from a Tribe. The
Tribe indicated that they operated one
surface water treatment plant and asked
several clarifying questions with respect
to optional monitoring and turbidity
monitoring.
K. Likely Effect of Compliance With the
LTIESWTR 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
include an analysis of the likely effect
of compliance with the regulation on
the technical, financial, and managerial
capacity of public water systems. This
analysis can be found in the LTIESWTR
economic analysis (USEPA, 2001a).
Overall water system capacity is defined
in EPA guidance (USEPA, 1998J) 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. Managerial capacity is the
ability of a water system to conduct its
affairs to achieve and maintain
compliance with SDWA requirements.
Managerial capacity refers to the
system's institutional and
administrative capabilities. 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. Technical, managerial,
and financial capacity can be assessed
through key issues and questions,
including:
Technical Capacity
Source water adequacy
Infrastructure adequacy
Technical knowledge and
mentation.
imple-
Does the system have a reliable source of drinking water? Is the source of generally good quality and ade-
quately protected?
Can the system provide water that meets SDWA standards? What is the condition of its infrastructure, in-
cluding 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?
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 under-
stand the system's technical and operational characteristics? Does the system have an effective oper-
ation and maintenance program?
Managerial Capacity
Ownership accountability
Staffing and organization
Are the system owner(s) clearly identified? Can they be held accountable for the system?
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 op-
erations? Do they have adequate expertise to manage water system operations? Do personnel have the
necessary licenses and certifications?
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Federal Register/Vol. 67, No. 9/Monday, January 14, 2002/Rules and Regulations
1833
Effective external linkages
Does the system interact well with customers regulators and other entities'** 1
able external resources, such as technical and financial assistance?
Financial Capacity
Revenue sufficiency
Credit worthiness
Fiscal management and controls
Do revenues cover costs? Are water rates and charges adequate to cover the cost of water?
Is the system financially healthy? Does it have access to capital through public or private sources?
Are adequate books and records maintained? Are appropriate budgeting, accounting, and financial plan-
ning methods used? Does the system manage its revenues effectively?
Systems not making significant
modifications to the treatment process
to meet LT1ESWTR requirements are
not expected to require significantly
increased technical, financial, or
managerial capacity. As noted
previously, less than 1 percent of
affected systems are expected to incur
annual costs exceeding 1 percent of
their annual revenue as described in
Section VI.A. Accordingly, most
systems are not expected to require
significantly increased technical,
financial, or managerial capacity. EPA
does recognize that a very small number
of facilities may realize some technical,
managerial, or financial capacity
concerns as a result of the rule. EPA
works closely with organizations such
as the National Rural Water Association
and the American Water Works
Association to develop technical and
managerial tools, materials, and
assistance to aid small systems.
Additionally, the Safe Drinking Water
Act, as amended in 1996, established
the Drinking Water State Revolving
Fund (DWSRF) to make funds available
to drinking water systems to finance
infrastructure improvements. The
program emphasizes providing funds to
small and disadvantaged communities
and to programs that encourage
pollution prevention as a tool for
ensuring safe drinking water.
-~-L. Plain Language
Executive Order 12866 requires each
agency to write its rules in plain
language. Readable regulations help the
public find requirements quickly and
understand them easily. They increase
compliance, strengthen enforcement,
and decrease mistakes, frustration,
phone calls, appeals, and distrust of
government. Of the several techniques
typically utilized for writing readably,
using a question and answer format, and
using the word 'you' for whoever must
comply, do the most to improve the look
and sound of a regulation. Today's
preamble and final rule use both of
these principles and was developed
using a plain language format, except in
the case of modifications or additions to
existing subparts of parts 141 and 142,
where such a format would not fit into
existing rule language. The Agency
requested comment on this approach
and several commenter's indicated that
the proposal was clear and easy to
understand.
M. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a "major rule" as
defined by 5 U.S.C. 804(2). This rule
will be effective February 13, 2002.
N. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This rule is not a "significant energy
action" as defined in Executive Order
13211, Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use" 66 FR 28355, (May
22, 2001), because it is not likely to have
a significant adverse effect on the
supply, distribution, or use of energy.
The requirements in this rule would
have a negligible impact upon the
energy demands of some public water
supply systems. Therefore, there-is not
a significant adverse effect on energy
supply, distribution, or use.
VII'. References
Adham, S., Gagliado, P., Smith, D., Ross, D.,
Gramith, K., and Trussell, R. 1998.
Monitoring of Reverse Osmosis for Virus
Rejection, Proceedings Water Quality
and Technology Conference. 9pp.
American Water Works Association
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. J. AWWA. June 1983, 313-318.
Amirtliarajah, A. 1988. Some theoretical and
conceptual views of nitration. J. AWWA.
(80:12: 36-46).
APHA. 1995.19th Edition of Standard
Methods for the Examination of Water
and Wastewater, 1995. American Public
Health Association. 1015 15th Street
NW, Washington D.C. 20005. (Includes
method 2130A, B).
Atherholt, T., LeChevallier, M., Norton, W.,
and Rosen, J. 1998. Effect of rainfall on
Giardia and crypto. J.AWWA (90:9:66-
80).
Bucklin, K., Amirtharajah, A., and Cranston,
K. 1988. The characteristics of initial
effluent quality and its implications for
the filter-to-waste procedure. AWWARF.
Denver, 158pp.
Casemore, D. 1990. Epidemiological aspects
of human cryptosporidiosis. Epidemiol.
Infect. (104:1-28).
CDC 1994. Addressing Emerging Infectious
Disease Threats: A Prevention Strategy
for the United States. Executive
Summary. P. 1-3.
CDC 2000. Notes from June 20, and October
10,2000, CDC Working Group on
Waterborne Cryptosporidiosis
Teleconference. October 10, 2000.
Chappell, C., Okhuysen, P., Sterling, C.,
Wang, C., Jakubowski, W., and Dupont,
H. 1999. Infectivity of Cryptosporidium
Parvum in Healthy Adults with Pre-
existing Anti-C. Parvum Serum
Immunoglobulin G. Am. J. Trop. Med.
Hyg. (60:1:157-164).
Cleasby, J. 1990. Filtration, Chapter 8, IN: (F.
Pontius, ed) Water Quality and
Treatment. AWWA, Denver, 57pp.
Collins, M., Dwyer, P., Margolin, A., and
Hogan, S. 1996. Assessment of MS2
Bacteriphage Virus Giardia Cyst and
: Cryptosporidium Oocyst Removal by
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Cordell, R., Thor, P., Addiss, D., Theurer, J.,
Lichterman, R., Ziliak, S., Juranek, D.,
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Craun, Gunther. 1998. Memorandum from G.
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Drozd, C., and Schartzbrod, J. 1997.
"Removal of Cryptosporidium from River
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1834
Federal Register/Vol. 67, No. 9/Monday, January 14, 2002/Rules and Regulations
Dupont, H., Chappell, C., Sterling, C.,
Okhuysen, P., Rose, J., and Jakubowski,
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Payer, R., and T. Nerad. 1996. Effects of low
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Frost, F., Craun, G., Calderon, R., and Hubbs,
S. 1997. So many oocysts, so few
outbreaks. J. AWWA (89:12:8-10).
Gorba, C.P., J.B. Rose and C.N. Haas (1996).
Sensitive populations: who is at the
greatest risk? International Journal of
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Goodrich, J., Sylvana, Y., and Lykins, B.
1995. Cost and Performance Evaluations
of Alternative Filtration Technologies for
Small Communities. Proceedings
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Great Lakes Instruments. 1992. Analytical
Method for Turbidity Measurement: GLI
Method 2. GLI, Milwaukee, WI. 8 pp.
Hall, T., and Croll, B. 1996. The UK
Approach to Cryptosporidium Control in
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Hancock, C., Rose, J., and Callahan, M. 1998.
Crypto and Giardia in U.S. groundwater.
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Harrington W., Krupnick, A.J., and W.O.
Spofford. 1985. "The Benefits of
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to Drinking Water Contamination." EPA/
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Hirata, T., and Hashimoto, A. 1998.
"Experimental Assessment of the
Efficacy of Microfiltration and
Ultrafiltration for Cryptosporidium
Removal," Water Science and
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Hoxie, N., Davis, J., Vergeront, J., Nashold, R.,
and Blair, K. 1997. Cryptosporidiosis-
associated mortality following a massive
waterborne outbreak in Milwaukee,
Wisconsin. Amer. J. Publ. Health
(87:12:2032-2035).
Jacangelo, J., Adham, S., and Laine, J. 1995.
Mechanism of Cryptosporidium, Giardia,
and MS2 virus removal by MF and UF.
J. AWWA (87:9:107-121).
Juranek, D. 1995. Cryptosporidiosis: Sources
of Infection and Guidelines for
Prevention. Clinical Infectious Diseases:
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dpd/sourcesJhtml
Kelley, M., Warner, P., Brokaw, J., Barrett, K.
and Komisar, S. 1995. A Study of Two
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Removal of Giardia and
Cryptosporidium. Proceedings AWWA
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LeChevallier, M., Norton, W., and Lee, R.
1991. Giardia and Cryptosporidium spp.
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Environ. Microbial. (57:9:2617-2621).
LeChevallier, M., and Norton, W. 1992.
Examining relationships between
particle counts and Giardia,
Cryptosporidium and turbidity. J.
AWWA (84:120:54-60).
LeChevallier, M., and Norton, W. 1995.
Giardia and Cryptosporidium in raw and
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Lykins, B., Adams, J., Goodrich, J., and Clark,
R., Meeting Federal Regulations with
MF/UF—EPA Ongoing Projects.
Microfiltration II Conference, November
12-13,1994, San Diego, CA.
MacKenzie, W.R., N.J. Hoxie, M.E. Proctor,
M.S. Gradus, K.A. Blair, D.E. Peterson,
J.J. Kazmierczak, D.G. Addiss, K.R. Fox,
J.B. Rose, and J.P. Davis. 1994. A massive
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England Jour. Med. 331(3):161-167.
McTigue, N., LeChevallier, M., Arora, H., and
Clancy, J. 1998. National Assessment of
Particle Removal by Filtration.
AWWARF. Denver, 256pp.
NDWAC, 2000. National Drinking Water
Advisory Council Meeting Minutes and
Recommendations, June 14, 2000.
Nieminski, E., and Ongerth, J. 1995.
Removing Giardia and Cryptosporidium
by Conventional Treatment and Direct
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Ongerth, J., and Pecoraro, J. 1995. Removing
Cryptosporidium Using Multimedia
Filters. J. AWWA. (87:12:83-89).
Ongerth, J., and Hutton, P. 1997. DE
Filtration to Remove Cryptosporidium.
JAWWA. December, pp. 39-46.
Patania, N., Jacangelo, J., Cummings, L.,
Wilczak, A., Riley, K., and Oppenheimer,
J. 1995. Optimization of Filtration for
Cyst Removal. AWWARF. Denver,
178pp.
Rose, J.B., 1988, "Occurrence and
Significance of Cryptosporidium in
water, J. AWWA 80(2):53-58.
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Diatomaceous Earth Filtration of Cysts
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82(12):67-75.
Schuler, P., and Gosh, M. 1991. Slow Sand
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Timms, S., Slade, J. arid Fricker, C. 1995.
Removal of Cryptosporidium by Slow
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USEPA.1989. National Primary Drinking
Water Regulations: Filtration,
Disinfection; Turbidity, Giardia lamblia,
Viruses, Legionella, and Heterotrophic
Bacteria; Final Rule (SWTR). 54 FR
27486, June 29,1989.
USEPA.1991. Guidance Manual for
compliance with the filtration and
disinfection requirements for public
water systems using surface water
sources. Washington, D.C., 574pp. [Also
published by AWWA].
USEPA.1993. Methods for the Determination
of Inorganic Substances in
Environmental Samples. Environmental
Monitoring Systems Laboratory.
Cincinnati, OH 45268. August. 169pp.
600/R-93-100. .
USEPA.1997a. National Primary Drinking
Water Regulations: Interim Enhanced
Surface Water Treatment Notice of Data
Availability. 62 FR 59486. EPA-815-Z-
97-001.
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Disinfection Byproducts; Notice of Data
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97-002/USEPA.1998a. National Primary
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Enhanced Surface Water Treatment;
Final Rule. 63 FR 69477, December 16,
1998. EPA 815-Z-98-009.
USEPA.1998b. Cryptosporidium and Giardia
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FR 69389, December 16,1998.
USEPA.1998d. Addendum to the Drinking
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Prepared for Office of Water, Office of
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1999. Gunther F. Craun & Associates.
271pp.
USEPA 1998e. Demographic Distribution of
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24).
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19,1998.
USEPA 1998g. Revision of Existing Variance
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Water Act. 63 FR 43833, August 14,
1998.
USEPA 1998h. Announcement of the
Drinking Water Contaminant Candidate
' List; Notice. 63 FR 10273, March 2,1998.
USEPA.1998i. Revisions to State Primacy
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Capacity Development Provisions of the
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98-006.
USEPA.1998k. Final Report of the SBREFA
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on EPA's Planned Proposed Rule: Long
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USEPA.19981. Response to Comment
Document for the Interim Enhanced
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1 Enhanced Surface Water Treatment
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llpp.
USEPA.1999b. Stakeholder Meeting
Summary: Long Term 1 Enhanced
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Federal Register/Vol. 67, No. 9/Monday, January 14, 2002/Rules and Regulations
1835
Surface Water Treatment Rule and Filter
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the Long Term 1 Enhanced Surface
Water Treatment and Filter Backwash
Recycle Rule, (EPA/815/R/00/019),
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Enhanced Surface Water Treatment and
Filter Backwash Rule; Proposed Rule. 65
FR19046. April 10, 2000. (EPA/815/Z/
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USEPA.2000C. Summary of the Proposed
Long Term 1 Enhanced Surface Water
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April, 14, 2000.
USEPA.2000d. Application of the Microbial
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Options, M/DBP FACA Meeting, June 1,
2000.
USEPA.2000e. Regulatory Flexibility
Screening Analysis for the Long Term 1
Enhanced Surface Water Treatment Rule,
September 26, 2000.
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Filter Backwash Rule (LT1FBR) Issues
for the National Drinking Water
Advisory Council. April 20, 2000.
USEPA.2000g. Meeting Summary,
Government Dialogue on EPA's
Upcoming Drinking Water Regulations,
May 30, 2000.
USEPA.2000h. Representative List of
Meetings Attended where Presentations
were Made or where Materials were
Handed out (LT1ESWTR and FBRR).
USEPA.2000i. Response to Comment
Document for the Filter Backwash
Recycle Rule.
USEPA.2000J. Estimated Per Capita Water
Ingestion in the United States. Office of
Science and Technology. February, 2000.
USEPA.2000k. M/DBP FACA Meeting
Materials. June 1-2, 2000.
USEPA.20001. SAB Commentary on EPA's
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2000.
USEPA.2001a. Economic Analysis for the
Long Term 1 Enhanced Surface Water
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815-R-00-021. October 12, 2001.
USEPA.2001b. Response to Comment
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Surface Water Treatment Rule. EPA
Document Number EPA 815-R-01-026.
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Environmental Protection. U.S.
Environmental Protection Agency
Science Advisory Board (A-101),
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493-504.
List of Subjects
40 CFR Parts 9
Reporting and recordkeeping
requirements.
40 CFR Part 141
Environmental protection, Chemicals,
Indians-lands, Intergovernmental
relations, Radiation protection,
Reporting and recordkeeping
requirements, Water supply.
40 CFR Part 142 .
Environmental protection,
Administrative practice and procedure,
Chemicals, Indians-lands, Radiation
protection, Reporting and recordkeeping
requirements, Water supply.
Dated: December 20, 2001.
Christine Todd Whitman,
Administrator.
For the reasons set forth 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 etseq., 136-136y;
15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671;
21 U.S.C. 331), 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 etseq., 1311,1313d, 1314,1318,
1321,1326,1330, 1342, 1344,1345 (d) and
(e), 1361; Executive Order 11735, 38 FR
21243, 3 CFR, 1971-1975 Comp. p. 973; 42
U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-
1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6,
300J-1, 300J-2, 300J-3, 300J-1, 300J-9, 1857
et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657,11023,11048.
2. In § 9.1 the table is amended by
adding under the indicated heading:
a. By adding entries 141.530-141.536,
141.540-141.544, 141.550-141.553,
141.560-141.564 and 141.570-141.571
in munerical order.
b. By removing the entry 142.14(a)-
(d)(7) and adding in its place a new
entry § 142.14(bHdK7).
c.JBy adding a new entry for 142.14(a)
in numerical order.
d. By adding new entries for 142.16(g)
and 142.16(j) in numerical order.
The additions read as follows:
§ 9.1 OMB approvals under the Paperwork
Reduction Act.
40 CFR citation
OMB control
No.
National Primary Drinking Water
Regulations
141.530-141.536
141.5407-141.544
141.550-141.553
141.560-141.564
141.570-141.571
2040-0229
2040-0229
2040-0229
2040-0229
2040-0229
40 CFR citation
OMB control
No.
National Primary Drinking Water
Regulations Implementation
142.14(a)
142.14(bHd)(7)
142.16(g)
142.160) -
2040-0229
2040-0090
2040-0090
2040-0229
2040-0229
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-l, 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 definitions of
"Comprehensive performance
evaluation" (CPE), "Ground "water under
the direct influence of surface water"
and "Disinfection profile" to read as
follows:
§141.2 Definitions.
* * *, * *
Comprehensive performance
evaluation (CPE) is a thorough review
and analysis of a treatment plant's
performance-based capabilities and
associated administrative, operation and
maintenance practices. It is conducted
to identify factors that may be adversely
impacting a plant's capability to achieve
compliance and emphasizes approaches
that can be implemented without
significant capital improvements. For
purpose of compliance with subparts P
and T 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
Giardia lamblia inactivation through the
treatment plant. The procedure for
developing a disinfection profile is
contained in § 141.172 (Disinfection
profiling and benchmarking) in subpart
P and §§ 141.530-141.536 (Disinfection
profile) in subpart T of this part.
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1836
Federal Register/Vol. 67, No. 9/Monday, January 14, 2002/Rules and Regulations
Ground water under the direct
influence of surface water (GWUDI)
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 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.
*****
5. Section 141.70 is amended by
adding paragraph (e) to read as follows:
§141.70 General requirements.
*****
(e) Additional requirements for
systems serving fewer than 10,000
people. In addition to complying with
requirements in this subpart, systems
serving fewer than 10,000 people must
also comply with the requirements in
subpart T of this part.
6. Section 141.73 is amended by
adding paragraph (a)(4) and revising
paragraph (d) to read as follows:
§141.73 Filtration.
*****
(a) * * *
(4) Beginning January 14, 2005,
systems serving fewer than 10,000
people must meet the turbidity
requirements in §§ 141.550 through
141.553.
*****
(d) Other filtration technologies. A
public water system may use a filtration
technology not listed in paragraphs (a]
through (c) of this section if it
demonstrates to the State, using pilot
plant studies or other means, that the
alternative filtration technology, in
combination with disinfection treatment
that meets the requirements of
§ 141.72(b), consistently achieves 99.9
percent removal and/or inactivation of
Giardia lamblia cysts and 99.99 percent
removal and/or inactivation of viruses.
For a system that makes this
demonstration, the requirements of
paragraph (b) of this section apply.
Beginning January 1, 2002, systems
serving at least 10,000 people must meet
the requirements for other filtration
technologies in § 141.173(b). Beginning
January 14, 2005, systems serving fewer
than 10,000 people must meet the
requirements for other filtration
technologies in § 141.550 through
141.553.
7. Section 141.153 is amended by
revising the first sentence of paragraph
(d)(4)(v)(C) to read as follows:
§ 141.153 Content of the reports.
*****
(d)* * *
(4) * * *
(V)* * *
(C) When it is reported pursuant to
§ 141.73 or § 141.173 or § 141.551: the
highest single measurement and the
lowest monthly percentage of samples
meeting the turbidity limits specified in
§ 141.73 or § 141.173, or § 141.551 for
the filtration technology being used.
8. The heading to Subpart P is revised
to read as follows:
Subpart P—Enhanced Filtration and
Disinfection—Systems Serving 10,000
or More People
9. Section 141.170 is amended by
adding paragraph (d) to read as follows:
§141.170 General requirements.
*****
(d) Subpart H systems that did not
conduct optional monitoring under
§ 141.172 because they served fewer
than 10,000 persons when such
monitoring was required, but serve.more
than 10,000 persons prior to January 14,
2005 must comply with §§ 141.170,
141.171, 141.173,141.174, and 141.175.
These systems must also consult with
the State to establish a disinfection
benchmark. A system that decides to
make a significant change to its
disinfection practice, as described in
§ 141.172(c)(lXi) through (iv) must
consult with the State prior to making
such change.
10. Section 141.202 is amended in
Table 1 by revising entry 6 to read as
follows:
§ 141.202 Tier 1 Public Notice—Form,
manner, and frequency of notice.
(a)* *
TABLE 1 TO SEC. 141.202.—VIOLATION CATEGORIES AND OTHER SITUATIONS REQUIRING A TIER 1 PUBLIC NOTICE
«.****«
(6) Violation of the Surface Water Treatment Rule (SWTR), Interim Enhanced Surface Water Treatment Rule (IESWTR) or Long Term 1 En-
hanced Surface Water Treatment Rule (LT1ESWTR) treatment technique requirement resulting from a single exceedance of the maximum al-
lowable turbidity limit (as identified in Appendix A), where the primacy agency determines after consultation that a Tier 1 notice is required or
where consultation does not take place within 24 hours after the system leams of the violation;
11. Section 141.203 is amended by
revising paragraph (b)(3)(ii) to read as
follows:
§141.203 Tier 2 Public Notice—Form,
manner, and frequency of notice.
*****
(b)* * *
(3)* * *
(ii) Violation of the SWTR, IESWTR or
LT1ESWTR treatment technique
requirement resulting from a single
exceedance of the maximum allowable
turbidity limit.
12. Appendix A to subpart Q is
amended:
a. Under LA. by revising entry 5.
b. Under LA. by revising entry 7.
c. Adding a new entry 9.
d. Under I.G. by revising entry 10.
e. Revising endnote 6.
The additions and revisions read as
follows:
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Federal Register/Vol. 67, No. 9/Monday, January 14, 2002/Rules and Regulations
1837
APPENDIX A TO SUBPART Q OF PART 141.—NPDWR VIOLATIONS AND OTHER SITUATIONS REQUIRING PUBLIC NOTICE 1
MCL/MRDl/TT violations2
Monitoring & testing procedure violations
Contaminant
Tier of pub-
lic notice re-
quired
Citation
Tier of pub-
lic notice re-
quired
Citation
I. Violations of National Primary Drinking
Water Regulations (NPDWR):3
A. Microbiological Contaminants
5. Turbidity (for TT violations resulting
from a single exceedance of max-
imum allowable turbidity level).
62,1
141.73(a)(2), 141.73 (b)(2),
141.73 (c)(2), 141.73(d),
141.173(a)(2), 141.173(b),
141.551(b).
3 141.74(a)(1), 141.74(b)(2),
141.74(c)(1), 141.174,
141.560(aHc), 141.561.
7. Interim Enhanced Surface Water
Treatment Rule violations, other than
violations resulting from single ex-
ceedance of max. turbidity level (TT).
72
141.170-141.173,
141.553.
141.500-
3 141.172, 141.174, 141.530-
141.544, 141.560-141.564.
9. Long Term 1 Enhanced Surface
Water Treatment Rule violations.
2 141.500-141.553
3 141.530-141.544,
141.564.
141.560-
G. Disinfection Byproducts (DBPs), Byprod-
uct Precursors, Disinfectant Residuals.
Where disinfection is used in the treatment
of drinking water, disinfectants combine
with organic and inorganic matter present
in water to form chemicals called disinfec-
tion byproducts (DBPs). EPA sets stand-
ards for controlling the levels of disinfect-
ants and DBPs in drinking water, including
trihalomethanes (THMs) and haloacetic
acids (HAAs).9
10. Bench marking and disinfection
profiling.
N/A N/A ,
3 141.172 141.530-141.544.
Appendix A-Endnotes:
1 Violations and other situations not listed in this table (e.g., reporting violations and failure to prepare Consumer Confidence Reports), do not
require notice, unless otherwise determined by the primacy agency. Primacy agencies may, at their option, also require a more stringent public
notice tier (e.g., Tier 1 instead of Tier 2 or Tier 2 instead of Tier 3) for specific violations and situations listed in this Appendix, as authorized
under § 141.202(a) and § 141.203(a).
2 MCL—Maximum contaminant level, MRDL—Maximum residual disinfectant level, TT—Treatment technique
3 The term Violations of National Primary Drinking Water Regulations (NPDWR) is used here to include violations of MCL, MRDL, treatment
technique, monitoring, and testing procedure requirements.
ic * * * * * *
6 Systems with treatment technique violations involving a single exceedance of a maximum turbidity limit under the Surface Water Treatment
Rule (SWTR), the Interim Enhanced Surface Water Treatment Rule (IESWTR), or the Long Term 1 Enhanced Surface Water Treatment Rule
(LT1ESWTR) are required to consult with the primacy agency within 24 hours after learning of the violation. Based on this consultation, the pri-
macy agency may subsequently decide to elevate the violation to Tier 1. If a system is unable to make contact with the primacy agency in the
24-hour period, the violation is automatically elevated to Tier 1.
7Most of the requirements of the Interim Enhanced Surface Water Treatment Rule (63 FR 69477) (§§ 141.170—141.171, 141.173—141.174)
become effective January 1, 2002 for the Subpart H systems (surface water systems and ground water systems under the direct influence of sur-
face water) serving at least 10,000 persons. However, § 141.172 has some requirements that become effective as early as April 16, 1999. The
Surface Water Treatment Rule remains in effect for systems serving at least 10,000 persons even after 2002; the Interim Enhanced Surface
Water Treatment Rule adds additional requirements and does not in many cases supercede the SWTR.
* * * * * * . . *
9 Subpart H community and non-transient non-community systems serving >10,000 must comply with new DBP MCLs, disinfectant MRDLs,
and related monitoring requirements beginning January 1, 2002. All other community and non-transient non-community systems must meet the
MCLs and MRDLs beginning January 1, 2004. Subpart H transient non-community systems serving 10,000 or more persons and using chlorine
dioxide as a disinfectant or oxidant must comply with the chlorine dioxide MRDL begining January 1, 2002. Subpart H transient non-community
systems serving fewer than 10,000 persons and using only ground water not under the direct influence of surface water and using chlorine diox-
ide as a disinfectant or oxidant must comply with the chlorine dioxide MRDL beginning January 1, 2004.
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Federal Register/Vol. 67, No. 9/Monday, January 14, 2002/Rules and Regulations
Appendix B—[Amended]
13. Appendix B to subpart Q is
amended by:
a. Revising entry A.2c.
b. Revising heading B.
• c. Revising entries B.3., B.4, B.5, B.6.,
andB.7.
d. Revising endnotes 4, 6 and 10.
e. Revising endnote 8.
The revisions read as follows:
APPENDIX B TO SUBPART Q OF PART 141.—STANDARD HEALTH EFFECTS LANGUAGE FOR PUBLIC NOTIFICATION
Contaminant MCLG'.mg/LMCL* mg/L Standard health effed*'?n9ua9e for Public notifi-
National Primary Drinking Water Regulations
(NPDWR):
A. Microbiological Contaminants
2c. Turbidity (IESWTR TT and LT1ESWTR
TT)e.
None
Turbidity has no health effects. However, turbidity
can interfere with disinfection and provide a
medium for microbial growth. Turbidity may in-
dicate the presence of disease-causing orga-
nisms. These organisms include bacteria, vi-
ruses, and parasites that can cause symptoms
such as nausea, cramps, diarrhea and associ-
ated headaches.
B. Surface Water Treatment Rule (SWTR), Interim
Enhanced Surface Water Treatment Rule
(IESWTR). Long Term 1 Enhanced Surface
Water Treatment Rule (LT1ESWTR) and the
Filter Backwash Recycling Rule (FBRR) viola-
tions:
3. Giardia lamblia
(SWTR/IESWTR/LT1ESWTR)
4. Viruses
(SWTR/IESWTR/LT1 ESWTR)
5. Heterotrophic plate count (HPC) bacteria9
(SWTR/IESWTR/LT1 ESWTR)
6. Legionella
(SWTR/IESWTR/LT1ESWTR)
7. Cryptosporidium
(IESWTR/FBRR/LT1 ESWTR}
Zero , TT10
Inadequately treated water may contain disease-
causing organisms. These organisms include
bacteria, viruses, and parasites which can
cause symptoms such as nausea, cramps, diar-
rhea, and associated headaches.
1MCLG—Maximum contaminant level goal.
2 MCL—Maximum contaminant level.
4There are various regulations that set turbidity standards for different types of systems, including 40 CFR 141.13, and the 1989 Surface
Water Treatment Rule, the 1998 Interim Enhanced Surface Water Treatment Rule and the 2001 Long Term 1 Enhanced Surface Water Treat-
ment Rule. The MCL for the montly turbidity average is 1 NTU; the MCL for the 2-day average is 5 NTU for systems that are required to filter but
have not yet installed filtration (40 CFR 141.13).
"There are various regulations that set turbidity standards for different types of systems, including 40 CFR 141.13, and the 1989 Surface
Water Treatment Rule, the 1998 Interim Enhanced Surface Water Treatment Rule and the 2001 Long Term 1 Enhanced Surface Water Treat-
ment Rule. Systems subject to the Surface Water Treatment Rule (both filtered and unfiltered) may not exceed 5 NTU. In addition, in filtered sys-
tems, 95 percent of samples each month must not exceed 0.5 NTU in systems using conventional or direct filtration and must not exceed 1 NTU
in systems using slow sand or diatomaceous earth filtration or other filtration technologies approved by the primacy agency.
BThere are various regulations that set turbidity standards for different types of systems, including 40 CFR 141.13, the 1989 Surface Water
Treatment Rule (SWTR), the 1998 Interim Enhanced Surface Water Treatment Rule (IESWTR) and the 2001 Long Term 1 Enhanced Surface
Water Treatment Rule (LT1 ESWTR). For systems subject to the IESWTR (systems serving at least 10,000 people, using surface water or
ground water under the direct influence of surface water), that use conventional filtration or direct filtration, after January 1, 2002, the turbidity
level of a system's combined filter effluent may not exceed 0.3 NTU in at least 95 percent of monthly measurements, and the turbidity level of a
system's combined filter effluent must not exceed 1 NTU at any time. Systems subject to the IESWTR using technologies other than conven-
tional, direct, slow sand, or diatomaceous earth filtration must meet turbidity limits set by the primacy agency. For systems subject to the
LT1 ESWTR (systems serving fewer than 10,000 people, using surface water or ground water under the direct influence of surface water) that
use conventional filtration or direct filtration, after January 14, 2005 the turbidity level of a system's combined filter effluent may not exceed 0.3
NTU in at least 95 percent of monthly measurements, and the turbidity level of a system's combined filter effluent must not exceed 1 NTU at any
time. Systems subject to the LT1 ESWTR using technologies other than conventional, direct, slow sand, or diatomaceous earth filtration must
meet turbidity limits set by the primacy agency.
9The bacteria detected by heterotrophic plate count (HPC) are not necessarily harmful. .HPC is simply an alternative method of determining
disinfectant residual levels. The number of such bacteria is an indicator of whether there is enough disinfectant in the distribution system.
10SWTR, IESWTR, and LT1 ESWTR treatment technique violations that involve turbidity exceedances may use the health effects language for
turbidity instead.
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1839
14. Part 141 is amended by adding a
new subpart T to read as follows:
Subpart T—Enhanced Filtration and
Disinfection—Systems Serving Fewer Than
10,000 People
General Requirements
141.500 General requirements-
141.501 Who is subject to the requirements
of subpart T?
141.502 When must my system comply
with these requirements?
141.503 What does subpart T require?
Finished Water Reservoirs
141.510 Is my system subject to the new
finished water reservoir requirements?
141.511 What is required of new finished
water reservoirs?
Additional Watershed Control Requirements
for Unfiltered Systems
141.520 Is my system subject to the updated
watershed control requirements?
141.521 What'updated watershed control
requirements must my unaltered system
•implement to continue to avoid
filtration?
141.522 How does the State determine
whether my system's watershed control
requirements are adequate?
Disinfection Profile
141.530 What is a Disinfection Profile and
who must develop one?
141.531 What criteria must a State use to
determine that a profile is unnecessary?
141.532 How does my system develop a
Disinfection Profile and when must it
begin?
141.533 What data must my system collect
to calculate a Disinfection Profile?
141.534 How does my system use this data
to calculate an inactivation ratio?
141.535 What if my system uses
chloramines, ozone, or chlorine dioxide
for primary disinfection?
141.536 My system has developed an
inactivation ratio; what must we do
now?
Disinfection Benchmark
141.540 Who has to develop a Disinfection
Benchmark?
141.541 What are significant changes to
disinfection practice?
141.542 What must my system do if we are
considering a significant change to
disinfection practices?
141.543 How is the Disinfection Benchmark
calculated?
141.544 What if my system uses
chloramines, ozone, or chlorine dioxide
for primary disinfection?
Combined Filter Effluent Requirements
141.550 Is my system required to meet
subpart T combined filter effluent
turbidity limits?
141.551 What strengthened combined filter
effluent turbidity limits must my system
meet?
141.552 My system consists of "alternative
filtration" and is required to conduct a
demonstration. What is required of my
system and how does the State establish
my turbidity limits? ;
141.553 My system practices lime
softening—is there any special provision
regarding my combined filter effluent?
Individual Filter Turbidity Requirements
141.560 Is my system subject to individual
filter turbidity requirements?
141.561 What happens if my system's
turbidity monitoring equipment fails?
141.562 My system only has two or fewer
filters—is there any special provision
regarding individual filter turbidity
monitoring?
141.563 What follow-up action is my
system required to take based on
continuous turbidity monitoring?
141.564 My system practices lime
softening—is there any special provision
regarding my individual filter turbidity
monitoring?
Reporting and Recordkeeping Requirements
141.570 What does subpart T require that
my system report to the State?
141.571 What records does subpart T
require my system to keep?
Subpart T—Enhanced Filtration and
Disinfection—Systems Serving Fewer
Than 10,000 People
General Requirements
§141.500 General requirements.
The requirements of this subpart
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 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. The
treatment technique requirements
consist of installing and properly .
operating water treatment processes
which reliably achieve:
(a) 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; and
(b) Compliance with the profiling and
benchmark requirements in §§ 141.530
through 141.544.
§ 141.501 Who is subject to the
requirements of subpart T?
You are subject to these requirements
if your system:
(a) Is a public water system;
• (b) Uses surface water or GWUDI as a
source; and
(c) Serves fewer than 10,000 persons.
§141.502 When must my system comply
with these requirements?
You must comply with these
requirements in this subpart beginning •
January 14, 2005 except where
otherwise noted.
§ 141.503 What does subpart T require?
There are seven requirements of this
subpart, and you must comply with all
requirements that are applicable to your
system. These requirements are:
(a) You must cover any finished water
reservoir that you began to construct on
or after March 15, 2002 as described in
§§ 141.510 and 141.511;
(b) If your system is an unfiltered
system, you must comply with the
updated watershed control requirements
described in §§ 141.520-141.522;
(c) If your system is a community or
non-transient non-community water
systems you must develop a disinfection
profile as described in §§ 141.530-
141.536;
(d) If your system is considering
making a significant change to its
disinfection practices, you must develop
a disinfection benchmark and consult
with the State for approval of the change
as described in §§ 141.540-141.544;
(e) If your system is a filtered system,
you must comply with the combined
filter effluent requirements as described
in §§141.550-141,553;
(f) If your system is a filtered system •
that uses conventional or direct
filtration, you must comply with the
individual filter turbidity requirements
as described in §§ 141.560-141.564; and
(g) You must comply with the
applicable reporting and fecordkeeping
requirements as described in §§ 141.570
and 141.571.
Finished Water Reservoirs
§ 141.510 Is my system subject to the new
finished water reservoir requirements?
All subpart H systems which serve
fewer than 10,000 are subject to this
requirement.
§ 141.511 What is required of new finished
water reservoirs?
If your system begins construction of '
a finished water reservoir on or after
March 15, 2002 the reservoir must be
covered. Finished water reservoirs for
which your system began construction
prior to March 15, 2002 are not subject
to this requirement.
Additional Watershed Control ,
Requirements for Unfiltered Systems
§141.520 Is my system subject to the
updated watershed control requirements?
If you are a subpart H system serving
fewer than 10,000 persons which does
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Federal Register/Vol. 67, No. 9/Monday, January 14, 2002/Rules and Regulations
not provide filtration, you must
continue to comply with all of the
filtration avoidance criteria in § 141.71,
as well as the additional watershed
control requirements in § 141.521.
§ 141.521 What updated watershed control
requirements must my unfiltered system
Implement to continue to avoid filtration?
Your system must take any additional
steps necessary to minimize the
potential for contamination by
Cryptosporidium oocysts in the source
water. Your system's watershed control
program must, for Cryptosporidium:
(a) Identify watershed characteristics
and activities which may have an
adverse effect on source water quality;
and
(b) Monitor the occurrence of
activities which may have an adverse
effect on source water quality.
§141.522 How does the State determine
whether my system's watershed control
requirements are adequate?
During an onsite inspection
conducted under the provisions of
§141.71(bX3), the State must determine
whether your watershed control
program 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 your
program to monitor and control
detrimental activities occurring in the
watershed; and the extent to which your
system has maximized land ownership
and/or controlled land use within'the
watershed.
Disinfection Profile
§ 141.530 What is a Disinfection Profile
and who must develop one?
A disinfection profile is a graphical
representation of your system's level of
Giardia lamblia or virus inactivation
measured during the course of a year. If
you are a subpart H community or non-
transient non-community water systems
which serves fewer than 10,000 persons,
your system must develop a disinfection
profile unless your State determines that
your system's profile is unnecessary.
Your State may approve the use of a
more representative data set for
disinfection profiling than the data set
required under §§ 141.532-141.536.
§ 141.531 What criteria must a State use to
determine that a profile is unnecessary?
States may only determine that a
system's profile is unnecessary if a
system's TTHM and HAAS levels are
below 0.064 mg/L and 0.048 mg/L,
respectively. To determine these levels,
TTHM and HAAS samples must be
collected after January 1,1998, during
the month with the warmest water
temperature, and at the point of
maximum residence time in your
distribution system.
§ 141.532 How does my system develop a
Disinfection Profile and when must it
begin?
A disinfection profile consists of three
steps:
(a) First, your system must collect
data for several parameters from the
plant as discussed in § 141.533 over the
course of 12 months. If your system
serves between 500 and 9,999 persons
you must begin to collect data no later
than July 1, 2003. If your system serves
fewer than 500 persons you must begin
to collect data no later than January 1,
2004.
(b) Second, your system must use this
data to calculate weekly log inactivation
as discussed in §§ 141.534 and 141.535;
and
(c) Third, your system must use these
• weekly log inactivations to develop a
disinfection profile as specified in
§141.536.
§ 141.533 What data must my system
collect to calculate a Disinfection Profile?
Your system must monitor the
following parameters to determine the
total log inactivation using the
analytical methods in § 141.74 (a), once
per week on the same calendar day, over
12 consecutive months:
(a) The temperature of the disinfected
water at each residual disinfectant
concentration sampling point during
peak hourly flow;
(b) If your system uses chlorine, the
pH of the disinfected water at each
residual disinfectant concentration
sampling point during peak hourly flow;
(c) The disinfectant contact time(s)
("T") during peak hourly flow; and
(d) The residual disinfectant
concentration(s) ("C") of the water
before or at the first customer and prior
to each additional point of disinfection
during peak hourly flow.
§ 141.534 How does my system use this
data to calculate an inactivation ratio?
Calculate the total inactivation ratio
as follows, and multiply the value by
3.0 to determine log inactivation of
Giardia lamblia:
If your system *,*
Your system must determine *
(a) Uses only one point of disinfect-
ant application.
(b) Uses more than one point of
disinfectant application before the
first customer.
(1) One inactivation ratio (CTcalc/CT99.9) before or at the first customer during peak hourly flow
or
(2) Successive CTcalc/CT99.9 values, representing sequential inactivation ratios, between the point of dis-
infectant application and a point before or at the first customer during peak hourly flow. Under this alter-
native, your system must calculate the total inactivation ratio by determining (CTcalc/CT99.9) for each se-
quence and then adding the (CTcalc/CT99.9) values together to determine (3CTcalc/CT99.9).
The (CTcalc/CT99 9) 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 using the
procedure specified in paragraph (a)(2) of this section.
§141.535 What If my system uses
chloramlnes, ozone, or chlorine dioxide for
primary disinfection?
If your system uses chloramines,
ozone, or chlorine dioxide for primary
disinfection, you must also calculate the
logs of inactivation for viruses and
develop an additional disinfection
profile for viruses using methods
approved by the State.
§ 141.536 My system has developed an
inactivation ratio; what must we do now?
Each log inactivation serves as a data
point in your disinfection profile. Your
system will have obtained 52
measurements (one for every week of
the year). This will allow your system
and the State the opportunity to
evaluate how microbial inactivation
varied over the course of the year by
looking at all 52 measurements (your
Disinfection Profile). Your system must
retain the Disinfection Profile data in
graphic form, such as a spreadsheet,
which must be available for review by
the State as part of a sanitary survey.
Your system must use this data to
calculate a benchmark if you are
considering changes to disinfection
practices.
Disinfection Benchmark
§ 141.540 Who has to develop a
Disinfection Benchmark?
If you are a subpart H system required
to develop a disinfection profile under
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1841
§§ 141.530 through 141.536, your
system must develop a Disinfection
Benchmark if you decide to make a
significant change to your disinfection
'practice.-Your system must consult with
the State for approval before you can
implement a significant disinfection
practice change.
§141.541 What are significant changes to
disinfection practice?
Significant changes to disinfection
practice include:
(a) Changes to the point of
disinfection;
(b) Changes to the disinfectant(s) used
in the treatment plant;
(c) Changes to the disinfection
process; or
(d) Any other modification identified
by the State.
§ 141.542 What must my system do if we
are considering a significant change to
disinfection practices?
If your system is considering a
significant change to its disinfection
practice, your system must calculate a
disinfection benchmark(s) as described
in §§ 141.543 and 141.544 and provide
the benchmark(s) to your State. Your
system may only make a significant
disinfection practice change after
consulting with the State for approval.
Your system must submit the following
information to the State as part of the
consultation and approval process:
(a) A description of the proposed
change;
(b) The disinfection profile for Giardia
lamblia (and, if necessary, viruses) and
disinfection benchmark;
(c) An analysis of how the proposed
change will affect the current levels of
disinfection; and
(d) Any additional information
requested by the State.
§ 141.543 How is the Disinfection
Benchmark calculated?
If your system is making a significant
change to its disinfection practice, it
must calculate a disinfection benchmark
using the procedure specified in the
following table.
To calculate a disinfection benchmark your system must perform the following steps
Step 1: Using the data your system collected to develop the Disinfection Profile, determine the average Giardia lamblia inactivation for each cal-
endar month by dividing the sum of all Giardia lamblia inactivations for that month by the number of values calculated forthat month.
Step 2: Determine the lowest monthly average value out of the twelve values. This value becomes the disinfection benchmark.
§ 141.544 What if my system uses
chloramines, ozone, or chlorine dioxide for
primary disinfection?
If your system uses chloramines,
ozone or chlorine dioxide for primary
disinfection your system must calculate
the disinfection benchmark from the
data your system collected for viruses to
develop the disinfection profile in
addition to the Giardia lamblia
disinfection benchmark calculated
under § 141.543. This viral benchmark
must be calculated in the same manner
used to calculate the Giardia lamblia
disinfection benchmark in § 141.543.
Combined Filter Effluent Requirements
§ 141.550 Is my system required to meet
subpart T combined filter effluent turbidity
limits?
All subpart H systems which serve
populations fewer than 10,000, are
required to.filter, and utilize filtration
other than slow sand filtration or
diatomaceous earth filtration must meet
the combined filter effluent turbidity
requirements of §§ 141.551-141.553 . If
your system uses slow sand or
diatomaceous earth filtration you are
not required to meet the combined filter
effluent turbidity limits of subpart T,
but you must continue to meet the
combined filter effluent turbidity limits
in §141.73.
§ 141.551 What strengthened combined
filter effluent turbidity limits must my
system meet?
Your system must meet two
strengthened combined filter effluent
turbidity limits.
(a) The first combined filter effluent
turbidity limit is a "95th percentile"
turbidity limit that your system must
meet in at least 95 percent of the
turbidity measurements taken each
month. Measurements must continue to
be taken as described in § 141.74(a) and
(c). Monthly reporting must be
completed according to § 141.570. The
following table describes the required
limits for specific filtration
technologies.
If your system consists of * * *
(1) Conventional Filtration or Direct Filtration
(2) All other "Alternative" Filtration '
Your 95th percentile turbidity value is * * *
0.3 NTU.
A value determined by the State (no to exceed
1 NTU) based on the demonstration de-
scribed in §141.552.
(b) The second combined filter
effluent turbidity limit is a "maximum"
turbidity limit which your system may
at no time exceed during the month.
Measurements must continue to be
taken as described in § 141.74(a) and (c).
Monthly reporting must be completed
according to § 141.570. The following
table describes the required limits for
specific filtration technologies.
If your system consists of * * *
(1) Conventional Filtration or Direct Filtration
(2) All other "Alternative" . .
Your maximum turbidity value is * * *
1 NTU.
A value determined by the State (not to ex-
ceed 5 NTU) based on the demonstration as
described in §141.552.
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§ 141.552 My system consists of
"alternative filtration" and is required to
conduct a demonstration—what is required
of my system and how does the State
establish my turbidity limits?
(a) If ybur system consists of
alternative filtration(filtration other than
slow sand filtration, diatomaceous earth
filtration, conventional nitration, or
direct filtration) you are required to
conduct a demonstration (see tables in
§ 141.551). Your system must
demonstrate to the State, using pilot
plant studies or other means, that your
system's filtration, in combination with
disinfection treatment, consistently
achieves:
(1) 99 percent removal of
Cryptosporidium oocysts;
(2) 99.9 percent removal and/or
inactivation of Giordia lamblia cysts;
and
(3) 99.99 percent removal and/or
inactivation of viruses.
(b) [Reserved]
§ 141.553 My system practices lime
softening—is there any special provision
regarding my combined filter effluent?
If your system practices lime
softening, you may acidify
representative combined filter effluent
turbidity samples prior to analysis using
a protocol approved by the State.
Individual Filter Turbidity
Requirements
§ 141.560 Is my system subject to
individual filter turbidity requirements?
If your system is a subpart H system "
serving fewer than 10,000 people and
utilizing conventional filtration or direct
filtration, you must conduct continuous
monitoring of turbidity for each
individual filter at your system. The
following requirements apply to
continuous turbidity monitoring:
(a) Monitoring must be conducted
using an approved'method in
§ 14l.74(a);
(b) Calibration of turbidimeters must
be conducted using procedures
specified by the manufacturer;
(c) Results of turbidity monitoring
must be recorded at least every 15
minutes;
(d) Monthly reporting must be
completed according to § 141.570; and
(e) Records must be maintained
according to § 141.571.
§ 141.561 What happens if my system's
turbidity monitoring equipment fails?
If there is a failure in the continuous
turbidity monitoring equipment, your
system must conduct grab sampling
every four hours in lieu of continuous
monitoring until the turbidimeter is
back on-line. Your system has 14 days
to resume continuous monitoring before
a violation is incurred.
§ 141.562 My system only has two or fewer
filters—is there any special provision
regarding individual filter turbidity
monitoring?
Yes, if your system only consists of
two or fewer filters, you may conduct
continuous monitoring of combined
filter effluent turbidity in lieu of
individual filter effluent turbidity
monitoring. Continuous monitoring
must meet the same requirements set
forth in § 141.560(a) through (d) and
§141.561.
§ 141.563 What follow-up action is my
system required to take based on
continuous turbidity monitoring?
Follow-up action is required
according to the following tables:.
If* * *
Your system must * * *
(a) The turbidity of an individual filter (or the tur-
bidity of combined filter effluent (CFE) for sys-
tems with 2 filters that monitor CFE in lieu of
individual filters) exceeds 1.0 NTU in two con-
secutive recordings 15 minutes apart.
Report to the State by the 10th of the following month and include the filter number(s), cor-
responding date(s), turbidity value(s) which exceeded 1.0 NTU, and the cause (if known) for
the exceedance(s).
If a system was required to report to the State
Your system must
(b) For three months In a row and turbidity ex-
ceeded 1.0 NTU in two consecutive record-
ings 15 minutes apart at the same filter (or
CFE for systems with 2 filters that monitor
CFE In lieu of individual filters).
(c) For two months in a row and turbidity ex-
ceeded 2.0 BTU in 2 consecutive recordings
15 minutes apart at the same filter (or CFE
for systems with 2 filters that monitor CFE in
lieu of individual filters).
Conduct a self-assessment of the filter(s) within 14 days of the day the filter exceeded 1.0
NTU in two consecutive measurements for the third straight month unless a CPE as speci-
fied in paragraph (c) of this section was required. Systems with 2 filters that monitor CFE in
lieu of individual filters must conduct a self assessment on both filters. The self-assessment
must consist of at least the following components: assessment of filter performance; devel-
opment 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 re-
port. If a self-assessment is required, the date that it was triggered and the date that it was
completed.
Arrange to have a comprehensive performance evaluation (CPE) conducted by the State or a
third party approved by the State not later than 60 days following the day the filter exceeded
2.0 NTU in two consecutive measurements for the second straight month. If a CPE has
been completed by the State or a third party approved by the State within the 12 prior
months or the system and State are jointly participating in an ongoing Comprehensive Tech-
nical Assistance (CTA) project at the system, a new CPE is not required. If conducted, a
CPE must be completed and submitted to the State no later than 120 days following the
day the filter exceeded 2.0 NTU in two consecutive measurements for the second straight
month.
§ 141.564 My system practices lime
softening—Is there any special provision
regarding my individual filter turbidity
monitoring?
If your system utilizes lime softening,
you may apply to the State for
alternative turbidity exceedance levels
for the levels specified in the table in
§ 141.563. You must be able to
demonstrate to the State that higher
turbidity levels are due to lime
carryover only, and not due to degraded
filter performance.
Reporting and Recordkeeping
Requirements
§ 141.570 What does subpart T require that
my system report to the State?
This subpart T requires your system
to report several items to the State. The
following table describes the items
which must be reported and the
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1843
frequency of reporting. Your system is
required to report the information
described in the following table, if it is
subject to the specific requirement
shown in the first column.
Corresponding
requirement
Description of information to report
Frequency
(a) Combined Filter Effluent Re-
quirements.
(§§141.550-141.553)
(b) Individual Turbidity Require-
ments.
(§§141.560-141.564)
(c) Disinfection Profiling
(§§141.530-141.536)
(d) Disinfection Benchmarking
(§§141.540-141.544)
(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 your system's required 95th percentile limit.
(3) The date and value of any turbidity measurements taken
during the month which exceed the maximum turbidity
value for your filtration system.
(1) That your system conducted individual filter turbidity moni-
toring during the month.
(2) The filter numbers), corresponding date(s), and the tur-
bidity value(s) which exceeded 1.0 NTU during the month,
but only if .2 consecutive measurements exceeded 1.0 NTU.
(3) If a self-assessment is required, the date that it was trig-
gered and the date that it was completed.
(4) If a CPE is required, that the CPE is required and the
date that it was triggered.
(5) Copy of completed CPE report
(1) Results of optional monitoring which show TTHM levels
<0.064 mg/l and HAAS levels <0.048 mg/l (Only if your sys-
tem wishes to forgo profiling) or that your system has
begun disinfection profiling.
(1) A description of the proposed change in disinfection, your
system's disinfection profile for Giardia lamblia (and, if nec-
essary, viruses) and disinfection benchmark, and an anal-
ysis of how the proposed change will affect the current lev-
els of disinfection.
By the 10th of the following month.
By the 10th of the following month.
By the 10th of the following month.
By the 10th of the following month.
By the 10th of the following month.
By the 10th of the following month (or 14 days
after the self-assessment was triggered only
if the self-assessment was triggered during
the last four days of the month)
By the 10th of the following month.
Within 120 days after the CPE was triggered.
(i) For systems serving 500-9,999 by July 1,
2003;
(ii) For systems serving fewer than 500 by
January 1, 2004.
Anytime your system is considering a signifi-
cant change to its disinfection practice.
§ 141.571 What records does subpart T
require my system to keep?
Your system must keep several types
of records based on the requirements of
subpart T, in addition to recordkeeping
requirements under § 141.75. The
following table describes the necessary
records, the length of time these records
must be kept, and for which
requirement the records pertain. Your
system is required to maintain records
described in this table, if it is subject to
the specific requirement shown in the
first column.
Corresponding requirement
(§§141.560-141.564)
(b) Disinfection Profiling
(§§141.530-141.536)
(§§141.540-141.544)
Description of necessary records
Results of individual filter monitoring ,
Results of Profile (including raw data and. analysis)
Benchmark (including raw data and analysis)
Duration of time
records must be kept
At least 3 years.
Indefinitely.
Indefinitely.
PART 142—NATIONAL PRIMARY
DRINKING WATER REGULATIONS
IMPLEMENTATION
15. The authority citation for Part 142
continues to read as follows:
Authority: 42 U.S.C. 300f, 300g-l, 300g-2,
300g-3, 300g-4, 300g-5, 300g-6, 300J-4,
300J-9, and 300J-11.
16. Section 142.14 is amended by
revising paragraphs (a)(3), (a)(4)(i),
(a)(4Xii) introductory text, and (a)(7) to
read as foliows:
§142.14 Records kept by States.
(a) * * *
(3) Records of turbidity measurements
must be kept for not less than one year.
The information retained must be set
forth in a form which makes possible
comparison with the limits specified in
§§ 141.71,141.73,141.173 and 141.175,
141.550-141.553 and 141.560-141.564
of this chapter. Until June 29,1993, for
any public water system which is
providing filtration treatment and until
December 30,1991, for any public water
system not providing filtration
treatment and not required by the State
to provide filtration treatment, records
kept must be set forth in a form which
makes possible comparison with the
limits contained in § 141.13 of this
chapter.
(4)(i) Records of disinfectant residual
measurements and other parameters
necessary to document disinfection
effectiveness in accordance with
§§ 141.72 and 141.74 of this chapter and
the reporting requirements of §§ 141.75,
141.175, and 141.570, 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
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1844
Federal Register/Vol. 67, No. 9/Monday, January 14, 2002/Rules and Regulations
under provisions of part 141, subpart H,
subpart P, or subpart T of this chapter,
must be made in writing and kept by the
State.
*****
(7) Any decisions made pursuant to
the provisions of part 141, subpart P or
subpart T of this chapter.
(i) Records of systems consulting with
the State concerning a modification to
disinfection practice under
§§ 141.170(d), 141.172(c), and 141.542
of this chapter, including the status of
the consultation.
(ii) Records of decisions that a system
using alternative filtration technologies,
as allowed under §§ 141.173(b) and
§141.552 of this chapter, can
consistently achieve a 99.9 percent
removal and/or inactivation of Giardia
lamblia cysts, 99.99 percent removal
and/or inactivation of viruses, and 99
percent removal of Cryptosporidium
oocysts. The decisions must include
State-set enforceable turbidity limits for
each system. A copy of the decision
must be kept until the decision is
reversed or revised. The State must
provide a copy of the decision to the
system.
(iii) Records of systems required to do
filter self-assessment, CPE, or CCP
under the requirements of §§ 141.175
and 141.563 of this chapter.
*****
17. Section 142.16 is amended by
revising paragraph (g) introductory text
and adding paragraph (j) to read as
follows:
§142.16 Special primacy requirements.
*****
(g) Requirements for States to adopt
40 CFR part 141, Subpart P Enhanced
Filtration and Disinfection—Systems
Serving 10,000 or More People. 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—Systems Serving
10,000 or More People, must contain the
information specified in this paragraph:
*****
(j) Requirements for States to adopt 40
CFR part 141, Subpart T Enhanced
Filtration and Disinfection—Systems
Serving Fewer than 10,000 People. 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 T Enhanced Filtration
and Disinfection—Systems Serving
Fewer than 10,000 People, must contain
the information specified in this
paragraph:
(1) Enforceable requirements. States
must have rules or other authority to
require systems to participate in a
Comprehensive Technical Assistance
(CTA) activity, the performance
improvement phase of the Composite
Correction Program (CCPJ. The State
must determine whether a CTA must be
conducted based on results of a CPE
which indicate the potential for
improved performance, and a finding by
the State that the system is able to
receive and implement technical
assistance provided through the CTA. A
CPE is a thorough review and analysis
of a system'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. During the CTA phase, the
system must identify and systematically
address factors limiting performance.
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.
(2) State practices or procedures.
(i) Section 141.530-141.536—How the
State will approve a more representative
data set for optional TTHM and HAAS
monitoring and profiling.
(ii) Section 141.536 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, ozone, or chlorine dioxide
for primary disinfection.
(iii) Section 141.542 of this chapter—
How the State will consult with the
system and approve significant changes
to disinfection practices.
(iv) Section 141.552 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
§ 141.72(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. 02-409 Filed 1-11-02; 8:45 am]
BILLING CODE 6560-50-P
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