National Primary Drinking Water Regulations: Long Term 1 Enhanced
Surface Water Treatment Rule
[Federal Register: January 14, 2002 (Volume 67, Number 9)]
[Rules and Regulations]
[Page 1811-1844]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ja02-16]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9, 141, and 142
[WH-FRL-7124-2]
RIN 2040-AD18
National Primary Drinking Water Regulations: Long Term 1 Enhanced
Surface Water Treatment Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: In this document, EPA is finalizing the Long Term 1 Enhanced
Surface Water Treatment Rule (LT1ESWTR). The purposes of the LT1ESWTR
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 LT1ESWTR 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 LT1ESWTR 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 LT1ESWTR 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:
------------------------------------------------------------------------
Examples of regulated
Category entities
------------------------------------------------------------------------
Industry.................................. PWSs that use surface water
or GWUDI.
State, Local, Tribal or Federal PWSs that use surface water
Governments. 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
LT1ESWTR. 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 Sec. 141.2 of title 40 of the Code of Federal
Regulations and applicability criteria in Sec. 141.501 of today's final
rule. If you have questions regarding the applicability of the LT1ESWTR
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
deg.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
DBP 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
HAA5 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
LT1ESWTR 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
[[Page 1813]]
A. Why is EPA Promulgating the LT1ESWTR?
B. What is Cryptosporidium?
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 LT1ESWTR
Contain?
C. What Individual Filter Monitoring Requirements does the
LT1ESWTR Contain?
D. What Disinfection Profiling and Benchmarking Requirements
does the LT1ESWTR Contain?
E. How does the Definition of Ground Water Under the Direct
Influence of Surface Water Change?
F. What Additional Requirements does the LT1ESWTR Contain for
Unfiltered Systems?
G. What does the LT1ESWTR Require for Finished Water Reservoirs?
H. What is the Compliance Schedule for the LT1ESWTR?
I. What Public Notification and Consumer Confidence Report
Requirements are Contained in the LT1ESWTR?
IV. State Implementation
A. What Special State Primacy Requirements does the LT1ESWTR
Contain?
B. What State Recordkeeping Requirements does the LT1ESWTR
Contain?
C. What State Reporting Requirements does the LT1ESWTR Contain?
D. How Must a State Obtain Interim Primacy for the LT1ESWTR?
V. Economic Analysis (Health Risk Reduction and Cost Analysis)
A. What are the Costs of the LT1ESWTR?
B. What are the Household Costs of the LT1ESWTR?
C. What are the Benefits of the LT1ESWTR?
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 LT1ESWTR?
H. What is the Benefit/Cost Determination for the LT1ESWTR?
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 LT1ESWTR 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 LT1ESWTR?
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 rule (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 LT1ESWTR addresses this challenge by improving the control of a
wide range of microbial pathogens in 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 (Fayer and Nerad, 1996).
[[Page 1814]]
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 their 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, 2000a). 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 (GWUDI).
E. How Is the EPA Regulating Cryptosporidium in the LT1ESWTR?
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 LT1ESWTR, 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 HAA5 disinfection byproduct (DBP)
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 DBP 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
DBP standards.
II. Background
A. What Is the Statutory Authority for the LT1ESWTR?
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)(1)(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
[[Page 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 LT1ESWTR?
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
rule's development. The IESWTR 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 for
EPA promulgation of these rules (which is the basis for the November
2000 schedule for today's rule). 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) (USEPA1997a,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 DBPs. 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 rule 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 LT1ESWTR?
EPA began outreach efforts to develop the LT1ESWTR 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,
[[Page 1816]]
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
LT1ESWTR 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 LT1ESWTR on April 10, 2000.
During the comment period, the Agency held a public meeting in
Washington D.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:
LT1ESWTR 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 LT1ESWTR 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 HAA5 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.
III. Discussion of the Final Rule
A. What Level of Cryptosporidium Removal Does the LT1ESWTR 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 filtration 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;
Adham 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
LT1ESWTR 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 LT1ESWTR
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
[[Page 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
[[Page 1818]]
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.
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 be masked by optimal performance of the
remaining filters, without exceeding 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
LT1ESWTR Contain?
1. 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 HAA5 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 HAA5 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
[[Page 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 DBPs 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
HAA5. 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 HAA5 concentrations at or above 80
percent of the respective MCLs (e.g., 0.064 mg/L TTHM or 0.048 mg/L
HAA5)) to evaluate the impact on microbial risk. Under the IESWTR,
large systems whose TTHM and/or HAA5 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 HAA5 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
DBP 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 HAA5 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 HAA5 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
HAA5 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 provide such information. The Agency has 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 HAA5 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 DBP 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
[[Page 1820]]
States while still achieving the goals of optional monitoring and
profiling as developed by the 1997 FACA and EPA. Additionally,
commenters 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 Water 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?
1. 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
[[Page 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 LT1ESWTR 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 Sec. 141.511..... March 15, 2002.
reservoirs.
Comply with updated watershed Secs. 141.520, January 14, 2005.
control requirements 141.521 & 141.522.
(unfiltered PWSs).
Begin Developing Disinfection Secs. 141.530-141 July 1, 2003 for
Profile. .536. systems serving
between 500 and
9,999 persons and
January 1, 2004
for systems
serving fewer
than 500 persons.
Complete the Disinfection Secs. 141.530-141 July 1, 2004 for
Profile. .536. systems serving
between 500 and
9,999 persons and
January 1, 2005
for systems
serving fewer
than 500 persons.
Combined Filter Effluent Secs. 141.550, January 11, 2005.
Turbidity Limits. 141.551, 141.552,
& 141.553.
Individual Filter Turbidity Secs. 141.560, January 11, 2005.
Monitoring. 141.561, 141.562,
141.563, 141.564.
------------------------------------------------------------------------
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 LT1ESWTR?
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
LT1ESWTR 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 Sec. 141.153(d)(6)
and Sec. 141.153(f). This includes any such violations of the LT1ESWTR.
Updated CCR and PN appendices can be found on the Agency's Web site
at http://www/epa.gov/safewater/tables.html.
IV. State Implementation
A. What Special State Primacy Requirements does the LT1ESWTR Contain?
In addition to adopting drinking water regulations at least as
stringent as the Federal regulations of the LT1ESWTR, 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 LT1ESWTR, 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 Secs. 141.530-141.536.
--Description of how existing rules, adoption of appropriate rules or
other authority under Sec. 142.16(i)(1) require systems to participate
in a Comprehensive Technical Assistance (CTA) activity, and the
performance improvement phase of the Composite Correction Program
(CCP);
--Description of how 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 Sec. 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 filtration
technology, 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
[[Page 1822]]
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 the LT1ESWTR 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 or CCP.
C. What State Reporting Requirements Does the LT1ESWTR 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 LT1ESWTR?
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
Sec. 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 LT1ESWTR as required by section1412(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
LT1ESWTR. 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.gov/
safewater/lt1eswtr. The analysis can also be found in the docket for
this rulemaking.
EPA has estimated the total annualized cost for implementing the
LT1ESWTR 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 LT1ESWTR economic analysis
(USEPA, 2001a). Combining the value of illness and mortalities avoided,
the estimate of the total quantified annual benefits of the LT1ESWTR
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 LT1ESWTR economic analysis
(USEPA, 2001a).
A. What Are the Costs of the LT1ESWTR?
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 LT1ESWTR 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 LT1ESWTR'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 LT1ESWTR (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 NTU 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
[[Page 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 consultation 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 LT1ESWTR 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 LT1ESWTR?
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 LT1ESWTR. 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 LT1ESWTR?
The primary benefits of today's final rule come from reductions in
the risks of microbial illness from drinking water. In particular,
LT1ESWTR 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, LT1ESWTR 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
[[Page 1824]]
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 hospital
stays 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 LT1ESWTR 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-LT1ESWTR) 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 LT1ESWTR. 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 LT1ESWTR 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 LT1ESWTR 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 Cryptosporidium.
For 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 LT1ESWTR'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
[[Page 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 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.
Table V.1 indicates estimated annual quantified benefits associated
with implementing the LT1ESWTR. The benefits analysis examines only the
endemic health damages avoided based on the LT1ESWTR 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 LT1ESWTR 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
[$Millions]*
--------------------------------------------------------------------------------------------------------------------------------------------------------
Daily drinking water ingestion and baseline Cryptosporidium log-removal assumptions, $Millions, 1999
-----------------------------------------------------------------------------------------------------
Quantified benefits 2.0 log 2.5 log
-----------------------------------------------------------------------------------------------------
Low Mild High Low Mid High
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mean Benefit from Avoided Illnesses............... $23.9-$42.4 $31.6-$56.0 $32.9-$58.3 $9.5-$16.8 $11.2-$19.8 $12.7-$22.6
10th Percentile............................... 11.4-20.3 15.2-27.0 14.1-24.9 2.2-3.9 2.8-5.0 4.2-7.5
90th Percentile............................... 50.1-88.8 58.8-104.2 56.5-100.2 26.6-47.2 27.6-48.9 33.6-59.5
Mean Benefits from Avoided Mortalities............ 23.7 31.3 32.5 9.4 11.1 12.6
10th Percentile............................... 11.3 15.0 13.9 2.2 2.8 4.2
90th Percentile............................... 49.6 58.2 55.9 26.3 27.3 33.2
-----------------------------------------------------------------------------------------------------
Total Mean Quantified Benefits................ 47.6-66.1 62.9-87.3 65.4-90.9 18.9-26.2 22.2-30.9 25.4-35.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Totals may not equal due to rounding.
[[Page 1826]]
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 LT1ESWTR
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Current EA New occurence data New infectivity data New morbidity data New viability data
--------------------------------------------------------------------------------------------------------------------------------------------------------
Change............................. No Changes............ Occurrence changes Rate of infection Morbidity changes Viability changes
from 4.7 oocyst/L to from .00424 to from 0.39 to 0.5. from 16.4 percent to
1.06 oocyst/L. .02317. 55.2 percent.
Benefits Range..................... $18.9-$90.9........... $5.4-$25.2............ $17.3-$74.4.......... $22.5-$88.0.......... $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 be 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 LT1ESWTR. 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 DBP 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
[[Page 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 LT1ESWTR 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 LT1ESWTR 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 LT1ESWTR will provide
information to systems so they can minimize the increased risk from
microbial contaminants as they take steps to address risks associated
with DBPs under the Stage 1 DBPR.
G. What Are the Uncertainties in the Risk, Benefit and Cost Estimates
for the LT1ESWTR?
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, 2001a).
H. What Is the Benefit/Cost Determination for the LT1ESWTR?
The Agency has determined that the benefits of the LT1ESWTR 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs using a 3 Costs using a 7
Benefit range percent percent Net benefits (3 Net benefits (7
discount rate discount rate percent) percent)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimate of Benefits............................................... $18.9-$90.9 $39.5 $44.8 $-20.6-$51.4 $-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
[[Page 1828]]
LT1ESWTR with an emphasis on providing flexibility and reducing burden
for small systems. For example, the Agency originally contemplated
requiring four quarters of TTHM and HAA5 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 HAA5 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 Panel's
recommendations is presented in the proposal (65 FR 19046, 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 LT1ESWTR 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 LT1ESWTR, 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 $2,500 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). Less than 100 systems are expected to incur
average annualized costs of approximately $15,700 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 Act
The Office of Management and Budget (OMB) has approved the
information collection requirements contained in this rule under the
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq, and
has assigned OMB control number 2040-0229. 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 Secs. 141.530-141.536, 141.540-141.544, 141.550-
141.553, 141.560-141.564, and 141.570-141.571, for systems, and
Secs. 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 LT1ESWTR 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 the UMRA, a
small government agency plan. The plan must provide for notifying
potentially affected small governments, enabling officials of affected
small governments to have meaningful and timely input in the
development of EPA regulatory proposals with significant Federal
intergovernmental mandates and informing, educating, and advising small
governments on compliance with the regulatory requirements.
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
[[Page 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 the approximately 6,500 small government entities
potentially affected by the LT1ESWTR, approximately 3,000 are expected
to incur average annualized costs of less than $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 LT1ESWTR 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 LT1ESWTR 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 LT1ESWTR 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 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. 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 LT1ESWTR.
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 LT1ESWTR
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 LT1ESWTR. 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, thus,
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 Sec. 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
[[Page 1830]]
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 LT1ESWTR. As such, the Agency also built on the
efforts conducted during the IESWTRs 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 LT1ESWTR 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
defined under Executive Order 12866, and; (2) concerns an environmental
health or safety risk that EPA has reason to believe may have a
disproportionate effect on children. If the regulatory action meets
both criteria, the Agency must evaluate the environmental health or
safety effects of the planned rule on children and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
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 LT1ESWTR 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 1 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
(Fayer 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
[[Page 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 LT1ESWTR 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 LT1ESWTR 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 LT1ESWTR. None of the three
consultations resulted in substantive comments on the LT1ESWTR.
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, 2000l). Comments on the LT1ESWTR 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 Cryptosporidiosis. 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
V1.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
(LT1ESWTR, 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 LT1ESWTR.
J. 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
[[Page 1832]]
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 LT1ESWTR. 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 LT1ESWTR 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 LT1ESWTR 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............. Does the system have a reliable
source of drinking water? Is the
source of generally good quality
and adequately protected?
Infrastructure adequacy........... Can the system provide water that
meets SDWA standards? What is the
condition of its infrastructure,
including well(s) or source water
intakes, treatment, storage, and
distribution? What is the
infrastructure's life expectancy?
Does the system have a capital
improvement plan?
Technical knowledge and Is the system's operator certified?
implementation. Does the operator have sufficient
technical knowledge of applicable
standards? Can the operator
effectively implement this
technical knowledge? Does the
operator understand the system's
technical and operational
characteristics? Does the system
have an effective operation and
maintenance program?
------------------------------------------------------------------------
Managerial Capacity
------------------------------------------------------------------------
Ownership accountability.......... Are the system owner(s) clearly
identified? Can they be held
accountable for the system?
Staffing and organization......... Are the system operator(s) and
manager(s) clearly identified? Is
the system properly organized and
staffed? Do personnel understand
the management aspects of
regulatory requirements and system
operations? Do they have adequate
expertise to manage water system
operations? Do personnel have the
necessary licenses and
certifications?
[[Page 1833]]
Effective external linkages....... Does the system interact well with
customers, regulators, and other
entities? Is the system aware of
available external resources, such
as technical and financial
assistance?
------------------------------------------------------------------------
Financial Capacity
------------------------------------------------------------------------
Revenue sufficiency............... Do revenues cover costs? Are water
rates and charges adequate to cover
the cost of water?
Credit worthiness................. Is the system financially healthy?
Does it have access to capital
through public or private sources?
Fiscal management and controls.... Are adequate books and records
maintained? Are appropriate
budgeting, accounting, and
financial planning methods used?
Does the system manage its revenues
effectively?
------------------------------------------------------------------------
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
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Trussell, R. 1998. Monitoring of Reverse Osmosis for Virus
Rejection, Proceedings Water Quality and Technology Conference. 9pp.
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Deterioration of water quality in large distribution reservoirs
(open reservoirs). AWWA Committee on Control of Water Quality in
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Amirtharajah, A. 1988. Some theoretical and conceptual views of
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APHA. 1995. 19th Edition of Standard Methods for the Examination of
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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
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3.
CDC 2000. Notes from June 20, and October 10, 2000, CDC Working
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Chappell, C., Okhuysen, P., Sterling, C., Wang, C., Jakubowski, W.,
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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 Hollow Fiber Ultrafiltration (Polysulfone) Membranes.
Proceedings AWWA Membrane Conference, Reno, NV 1996.
Cordell, R., Thor, P., Addiss, D., Theurer, J., Lichterman, R.,
Ziliak, S., Juranek, D., and Davis, J. 1997. Impact of a massive
waterborne cryptosporidiosis outbreak on child care facilities in
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44).
Craun, Gunther. 1998. Memorandum from G. Craun to U. S.
Environmental Protection Agency (M. Negro), dated 10/26/98.
Waterborne outbreak data 1971-1996, community and noncommunity water
systems.
Drozd, C., and Schartzbrod, J. 1997. ``Removal of Cryptosporidium
from River Water by Crossflow Microfiltration: A Pilot Scale
Study,'' Water Science and Technology. (35:11-12:391-395).
[[Page 1834]]
Dupont, H., Chappell, C., Sterling, C., Okhuysen, P., Rose, J., and
Jakubowski, W. 1995. The Infectivity of Cryptosporidium parvum in
Healthy Volunteers. N. Engl. J. Med. (332:13:855-859).
Fayer, R. and Ungar, B. 1986. Cryptosporidium spp. and
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Fayer, R., and T. Nerad. 1996. Effects of low temperatures on
viability of Cryptosporidium parvum oocysts. Appl. Environ.
Microbiol. 62:1431-1433.
Foundation for Water Research. 1994. Removal of Cryptosporidium
oocysts by water treatment processes. Foundation for Water Research,
Britain. April.
Frost, F., Craun, G., Calderon, R., and Hubbs, S. 1997. So many
oocysts, so few outbreaks. J. AWWA (89:12:8-10).
Gerba, C.P., J.B. Rose and C.N. Haas (1996). Sensitive populations:
who is at the greatest risk? International Journal of Food
Microbiology: 30(1-2), 10pp.
Goodrich, J., Sylvana, Y., and Lykins, B. 1995. Cost and Performance
Evaluations of Alternative Filtration Technologies for Small
Communities. Proceedings AWWA Annual Conference.
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 Water Treatment. Proceedings AWWA Water Quality and
Technology Conference, 14pp.
Hancock, C., Rose, J., and Callahan, M. 1998. Crypto and Giardia in
U.S. groundwater. J. AWWA (90:3:58-61).
Harrington W., Krupnick, A.J., and W.O. Spofford. 1985. ``The
Benefits of Preventing an Outbreak of Giardiasis Due to Drinking
Water Contamination.'' EPA/Resources for the Future Report.
Hirata, T., and Hashimoto, A. 1998. ``Experimental Assessment of the
Efficacy of Microfiltration and Ultrafiltration for Cryptosporidium
Removal,'' Water Science and Technology. (38:12:103-107).
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: 21 (1). See
also www.cdc.gov/ncidod/dpd/sources.html
Kelley, M., Warrier, P., Brokaw, J., Barrett, K. and Komisar, S.
1995. A Study of Two U.S. Army Installation Drinking Water Sources
and Treatment Systems for the Removal of Giardia and
Cryptosporidium. Proceedings AWWA Annual Conference.
LeChevallier, M., Norton, W., and Lee, R. 1991. Giardia and
Cryptosporidium spp. in filtered drinking water supplies. Appl.
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 finished water. J. AWWA (87:9:54-68).
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 outbreak in Milwaukee of
Cryptosporidium infection transmitted through the public water
supply. New 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 Filtration. J.
AWWA (87:9:96-106).
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.
Schuler, P., and Gosh, M. 1990. Diatomaceous Earth Filtration of
Cysts and Other Particulates Using Chemical Additives. Journal AWWA
(Dec 1990). 82(12):67-75.
Schuler, P., and Gosh, M. 1991. Slow Sand Filtration of Cysts and
Other Particulates. AWWA Annual Conference Proceedings. June. Pp
235-252.
Timms, S., Slade, J. and Fricker, C. 1995. Removal of
Cryptosporidium by Slow Sand Filtration. Wat. Sci. Tech. Vol. 31.
No. 5-6, pp. 81-84.
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.
USEPA.1997b. National Primary Drinking Water Regulations:
Disinfectants and Disinfection Byproducts; Notice of Data
Availability. 62 FR 59388. EPA-815-Z-97-002/USEPA.1998a. National
Primary Drinking Water Regulations: Interim Enhanced Surface Water
Treatment; Final Rule. 63 FR 69477, December 16, 1998. EPA 815-Z-98-
009.
USEPA.1998b. Cryptosporidium and Giardia Occurrence Assessment for
the Interim Enhanced Surface Water Treatment Rule. Prepared for the
Office of Ground Water and Drinking Water, Washington, DC by Science
Applications International Corporation, McLean, VA, 185pp.
USEPA.1998c. National Primary Drinking Water Regulations:
Disinfectants and Disinfection Byproducts; Final Rule. 63 FR 69389,
December 16, 1998.
USEPA.1998d. Addendum to the Drinking Water Criteria Document for
Giardia. Prepared for Office of Water, Office of Science and
Technology, U.S. EPA, Washington, D.C., by ARCTECH, Inc., 1999.
Gunther F. Craun & Associates. 271pp.
USEPA 1998e. Demographic Distribution of Sensitive Population
Groups. Final Report. Prepared by SRA Technologies, Inc., Falls
Church, VA. Work Assignment No. B-11/22 (SRA 557-05/14: February
24).
USEPA 1998f. National Primary Drinking Water Regulation: Consumer
Confidence Reports; Final Rule. 63 FR 44511, August 19, 1998.
USEPA 1998g. Revision of Existing Variance and Exemption Regulations
To Comply With Requirements of the Safe Drinking 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 Requirements to Implement
Safe Drinking Water Act Amendments; Final Rule. 63 FR 23362.
USEPA.1998j. Guidance on Implementing the Capacity Development
Provisions of the Safe Drinking Water Act Amendments of 1996. EPA
Document Number: 816-R-98-006.
USEPA.1998k. Final Report of the SBREFA Small Business Advocacy
Review Panel on EPA's Planned Proposed Rule: Long Term 1 Enhanced
Surface Water Treatment Rule, 76pp.
USEPA.1998l. Response to Comment Document for the Interim Enhanced
Surface Water Treatment Rule.
USEPA.1999a. Meeting Summary: Long Term 1 Enhanced Surface Water
Treatment Rule (LT1ESWTR) and Filter Backwash Recycle Rule (FBR).
Dallas, TX. March. 11pp.
USEPA.1999b. Stakeholder Meeting Summary: Long Term 1 Enhanced
[[Page 1835]]
Surface Water Treatment Rule and Filter Backwash Recycle Rule.
Denver, CO. July. 67pp.
USEPA.2000a. Occurrence Assessment for the Long Term 1 Enhanced
Surface Water Treatment and Filter Backwash Recycle Rule, (EPA/815/
R/00/019).
USEPA.2000b. National Primary Drinking Water Regulations: Long Term
1 Enhanced Surface Water Treatment and Filter Backwash Rule;
Proposed Rule. 65 FR 19046. April 10, 2000. (EPA/815/Z/00/01).
USEPA.2000c. Summary of the Proposed Long Term 1 Enhanced Surface
Water Treatment and Filter Backwash Rule. April, 14, 2000.
USEPA.2000d. Application of the Microbial Framework to LT2ESWTR FACA
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.
USEPA.2000f. Proposed Long Term 1 Enhanced Surface Water Treatment
and 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.2000l. SAB Commentary on EPA's Draft Proposal for LT1ESWTR and
FBRR. EPA-SAB-DWC-COM-00-004. May 23, 2000.
USEPA.2001a. Economic Analysis for the Long Term 1 Enhanced Surface
Water Treatment Rule. EPA Document Number 815-R-00-021. October 12,
2001.
USEPA.2001b. Response to Comment Document for the Long Term 1
Enhanced Surface Water Treatment Rule. EPA Document Number EPA 815-
R-01-026.
USEPA/SAB 1990. Reducing Risk: Setting Priorities and Strategies for
Environmental Protection. U.S. Environmental Protection Agency
Science Advisory Board (A-101), Washington, D.C. Report No. SAB-EC-
90-021 (September).
West, T., Danile, P., Meyerhofer, P., DeGraca, A., Leonard, S., and
Gerba, C. 1994. Evaluation of Cryptosporidium Removal through High-
rate Filtration. Proceedings AWWA Annual Conference, June. Pp 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 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; 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-4, 300j-9, 1857 et seq., 6901-6992k, 7401-
7671q, 7542, 9601-9657, 11023, 11048.
2. In Sec. 9.1 the table is amended by adding under the indicated
heading:
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 numerical order.
b. By removing the entry 142.14(a)-(d)(7) and adding in its place a
new entry Sec. 142.14(b)-(d)(7).
c. By 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:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB control
40 CFR citation No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
National Primary Drinking Water Regulations
------------------------------------------------------------------------
* * * * *
141.530-141.536......................................... 2040-0229
141.540-141.544......................................... 2040-0229
141.550-141.553......................................... 2040-0229
141.560-141.564......................................... 2040-0229
141.570-141.571......................................... 2040-0229
------------------------------------------------------------------------
National Primary Drinking Water Regulations Implementation
------------------------------------------------------------------------
* * * * *
142.14(a)............................................... 2040-0229
2040-0090
142.14(b)-(d)(7)........................................ 2040-0090
* * * * *
142.16(g)............................................... 2040-0229
142.16(j)............................................... 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-1, 300g-2, 300g-3, 300g-4, 300g-
5, 300g-6, 300j-4, 300j-9, and 300j-11.
4. Section 141.2 is amended by revising the definitions of
``Comprehensive performance evaluation'' (CPE), ``Ground water under
the direct influence of surface water'' and ``Disinfection profile'' to
read as follows:
Sec. 141.2 Definitions.
* * * * *
Comprehensive performance evaluation (CPE) is a thorough review and
analysis of a treatment plant's performance-based capabilities and
associated administrative, operation and maintenance practices. It is
conducted to identify factors that may be adversely impacting a plant's
capability to achieve compliance and emphasizes approaches that can be
implemented without significant capital improvements. For 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 Sec. 141.172 (Disinfection
profiling and benchmarking) in subpart P and Secs. 141.530-141.536
(Disinfection profile) in subpart T of this part.
* * * * *
[[Page 1836]]
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:
Sec. 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:
Sec. 141.73 Filtration.
* * * * *
(a) * * *
(4) Beginning January 14, 2005, systems serving fewer than 10,000
people must meet the turbidity requirements in Secs. 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
Sec. 141.72(b), consistently achieves 99.9 percent removal and/or
inactivation of Giardia lamblia cysts and 99.99 percent removal and/or
inactivation of viruses. For a system that makes this demonstration,
the requirements of paragraph (b) of this section apply. Beginning
January 1, 2002, systems serving at least 10,000 people must meet the
requirements for other filtration technologies in Sec. 141.173(b).
Beginning January 14, 2005, systems serving fewer than 10,000 people
must meet the requirements for other filtration technologies in
Sec. 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:
Sec. 141.153 Content of the reports.
* * * * *
(d) * * *
(4) * * *
(v) * * *
(C) When it is reported pursuant to Sec. 141.73 or Sec. 141.173 or
Sec. 141.551: the highest single measurement and the lowest monthly
percentage of samples meeting the turbidity limits specified in
Sec. 141.73 or Sec. 141.173, or Sec. 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:
Sec. 141.170 General requirements.
* * * * *
(d) Subpart H systems that did not conduct optional monitoring
under Sec. 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 Secs. 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
Sec. 141.172(c)(1)(i) 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:
Sec. 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 Enhanced
Surface Water Treatment Rule (LT1ESWTR) treatment technique requirement
resulting from a single exceedance of the maximum allowable 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
learns of the violation;
* * * *
* * *
------------------------------------------------------------------------
* * * * *
11. Section 141.203 is amended by revising paragraph (b)(3)(ii) to
read as follows:
Sec. 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 I.A. by revising entry 5.
b. Under I.A. 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:
[[Page 1837]]
Appendix A to Subpart Q of Part 141.--NPDWR Violations and Other Situations Requiring Public Notice \1\
----------------------------------------------------------------------------------------------------------------
MCL/MRDL/TT violations \2\ Monitoring & testing procedure
-------------------------------------- violations
-------------------------------------
Contaminant Tier of Tier of
public Citation public
notice notice Citation
required required
----------------------------------------------------------------------------------------------------------------
I. Violations of National Primary
Drinking Water Regulations (NPDWR):
\3\
* * * * * *
*
A. Microbiological Contaminants
* * * * * *
*
5. Turbidity (for TT violations \6\ 2,1 141.71(a)(2),141.71(c)( 3 141.74(a)(1),
resulting from a single 2)(i), 141.73(a)(2), 141.74(b)(2),
exceedance of maximum allowable 141.73 (b)(2), 141.73 141.74(c)(1), 141.174,
turbidity level). (c)(2), 141.73(d), 141.560(a)-(c),
141.173(a)(2), 141.561.
141.173(b), 141.551(b).
* * * * * *
*
7. Interim Enhanced Surface \7\ 2 141.170-141.173, 3 141.172, 141.174,
Water Treatment Rule 141.500-141.553. 141.530-141.544,
violations, other than 141.560-141.564.
violations resulting from
single exceedance of max.
turbidity level (TT).
* * * * * *
*
9. Long Term 1 Enhanced Surface 2 141.500-141.553........ 3 141.530-141.544,
Water Treatment Rule violations. 141.560-141.564.
* * * * * *
*
G. Disinfection Byproducts (DBPs),
Byproduct 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 disinfection byproducts
(DBPs). EPA sets standards for
controlling the levels of
disinfectants and DBPs in drinking
water, including trihalomethanes
(THMs) and haloacetic acids
(HAAs).\9\
* * * * * *
*
10. Bench marking and N/A N/A.................... 3 141.172 141.530-
disinfection profiling. 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 Sec. 141.202(a) and Sec. 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.
* * * * * *
*
\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 primacy 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.
\7\ Most of the requirements of the Interim Enhanced Surface Water Treatment Rule (63 FR 69477) (Secs. 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 surface water) serving at least 10,000 persons.
However, Sec. 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 dioxide as a disinfectant or oxidant must comply with the
chlorine dioxide MRDL beginning January 1, 2004.
[[Page 1838]]
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., and B.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
----------------------------------------------------------------------------------------------------------------
Standard health effects
Contaminant MCLG \1\, mg/L MCL \2\ mg/L language for public
notification
----------------------------------------------------------------------------------------------------------------
National Primary Drinking Water
Regulations (NPDWR):
A. Microbiological Contaminants
* * * * * *
*
2c. Turbidity (IESWTR TT and None.................. TT Turbidity has no health
LT1ESWTR TT) \8\. effects. However,
turbidity can interfere
with disinfection and
provide a medium for
microbial growth.
Turbidity may indicate the
presence of disease-
causing organisms. These
organisms include
bacteria, viruses, and
parasites that can cause
symptoms such as nausea,
cramps, diarrhea and
associated 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) violations:
* * * * * *
*
3. Giardia lamblia............. Zero.................. TT \10\ Inadequately treated water
(SWTR/IESWTR/LT1ESWTR)......... may contain disease-
causing organisms. These
organisms include
bacteria, viruses, and
parasites which can cause
symptoms such as nausea,
cramps, diarrhea, and
associated headaches.
4. Viruses
(SWTR/IESWTR/LT1ESWTR).........
5. Heterotrophic plate count
(HPC) bacteria \9\
(SWTR/IESWTR/LT1ESWTR).........
6. Legionella
(SWTR/IESWTR/LT1ESWTR).........
7. Cryptosporidium
(IESWTR/FBRR/LT1ESWTR) ........
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
\1\ MCLG--Maximum contaminant level goal.
\2\ MCL--Maximum contaminant level.
\4\ 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 Treatment 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).
\6\ 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 Treatment Rule. Systems subject to the Surface Water Treatment
Rule (both filtered and unfiltered) may not exceed 5 NTU. In addition, in filtered systems, 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.
\8\ There 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 (LT1ESWTR). 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 conventional, direct, slow sand, or
diatomaceous earth filtration must meet turbidity limits set by the primacy agency. For systems subject to the
LT1ESWTR (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 LT1ESWTR using technologies other than conventional, direct, slow sand, or
diatomaceous earth filtration must meet turbidity limits set by the primacy agency.
\9\ The 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.
\10\ SWTR, IESWTR, and LT1ESWTR treatment technique violations that involve turbidity exceedances may use the
health effects language for turbidity instead.
[[Page 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
unfiltered 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
Sec. 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
Secs. 141.530 through 141.544.
Sec. 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.
Sec. 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.
Sec. 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 Secs. 141.510 and
141.511;
(b) If your system is an unfiltered system, you must comply with
the updated watershed control requirements described in Secs. 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
Secs. 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
Secs. 141.540-141.544;
(e) If your system is a filtered system, you must comply with the
combined filter effluent requirements as described in Secs. 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 Secs. 141.560-141.564; and
(g) You must comply with the applicable reporting and recordkeeping
requirements as described in Secs. 141.570 and 141.571.
Finished Water Reservoirs
Sec. 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.
Sec. 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
Sec. 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
[[Page 1840]]
not provide filtration, you must continue to comply with all of the
filtration avoidance criteria in Sec. 141.71, as well as the additional
watershed control requirements in Sec. 141.521.
Sec. 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.
Sec. 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
Sec. 141.71(b)(3), 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
Sec. 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 Secs. 141.532-141.536.
Sec. 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 HAA5 levels are below 0.064 mg/L and 0.048 mg/L,
respectively. To determine these levels, TTHM and HAA5 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.
Sec. 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 Sec. 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 Secs. 141.534 and 141.535; and
(c) Third, your system must use these weekly log inactivations to
develop a disinfection profile as specified in Sec. 141.536.
Sec. 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 Sec. 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.
Sec. 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 (1) One inactivation ratio (CTcalc/
disinfectant application. 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 disinfectant application
and a point before or at the first
customer during peak hourly flow.
Under this alternative, your system
must calculate the total
inactivation ratio by determining
(CTcalc/CT99.9) for each sequence
and then adding the (CTcalc/CT99.9)
values together to determine
(3CTcalc/CT99.9).
(b) Uses more than one point of The (CTcalc/CT99.9) value of each
disinfectant application before disinfection segment immediately
the first customer. 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.
------------------------------------------------------------------------
Sec. 141.535 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, you must also calculate the logs of inactivation
for viruses and develop an additional disinfection profile for viruses
using methods approved by the State.
Sec. 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
Sec. 141.540 Who has to develop a Disinfection Benchmark?
If you are a subpart H system required to develop a disinfection
profile under
[[Page 1841]]
Sec. Sec. 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.
Sec. 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.
Sec. 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 Secs. 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.
Sec. 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
calendar month by dividing the sum of all Giardia lamblia inactivations
for that month by the number of values calculated for that month.
Step 2: Determine the lowest monthly average value out of the twelve
values. This value becomes the disinfection benchmark.
------------------------------------------------------------------------
Sec. 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 Sec. 141.543. This viral
benchmark must be calculated in the same manner used to calculate the
Giardia lamblia disinfection benchmark in Sec. 141.543.
Combined Filter Effluent Requirements
Sec. 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 Secs. 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 Sec. 141.73.
Sec. 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 Sec. 141.74(a) and (c).
Monthly reporting must be completed according to Sec. 141.570. The
following table describes the required limits for specific filtration
technologies.
------------------------------------------------------------------------
Your 95th percentile
If your system consists of * * * turbidity value is * * *
------------------------------------------------------------------------
(1) Conventional Filtration or Direct 0.3 NTU.
Filtration.
(2) All other ``Alternative'' Filtration... A value determined by the
State (no to exceed 1 NTU)
based on the demonstration
described in Sec.
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 Sec. 141.74(a) and (c). Monthly reporting must be completed
according to Sec. 141.570. The following table describes the required
limits for specific filtration technologies.
------------------------------------------------------------------------
Your maximum turbidity
If your system consists of * * * value is * * *
------------------------------------------------------------------------
(1) Conventional Filtration or Direct 1 NTU.
Filtration.
(2) All other ``Alternative''.............. A value determined by the
State (not to exceed 5
NTU) based on the
demonstration as described
in Sec. 141.552.
------------------------------------------------------------------------
[[Page 1842]]
Sec. 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 your system consists of alternative filtration(filtration
other than slow sand filtration, diatomaceous earth filtration,
conventional filtration, or direct filtration) you are required to
conduct a demonstration (see tables in Sec. 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 Giardia lamblia
cysts; and
(3) 99.99 percent removal and/or inactivation of viruses.
(b) [Reserved]
Sec. 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
Sec. 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
Sec. 141.74(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 Sec. 141.570;
and
(e) Records must be maintained according to Sec. 141.571.
Sec. 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.
Sec. 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 Sec. 141.560(a)
through (d) and Sec. 141.561.
Sec. 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 Report to the State by the 10th of
filter (or the turbidity of the following month and include the
combined filter effluent (CFE) filter number(s), corresponding
for systems with 2 filters that date(s), turbidity value(s) which
monitor CFE in lieu of individual exceeded 1.0 NTU, and the cause (if
filters) exceeds 1.0 NTU in two known) for the exceedance(s).
consecutive recordings 15 minutes
apart.
------------------------------------------------------------------------
------------------------------------------------------------------------
If a system was required to report
to the State * * * Your system must * * *
------------------------------------------------------------------------
(b) For three months in a row and Conduct a self-assessment of the
turbidity exceeded 1.0 NTU in two filter(s) within 14 days of the day
consecutive recordings 15 minutes the filter exceeded 1.0 NTU in two
apart at the same filter (or CFE consecutive measurements for the
for systems with 2 filters that third straight month unless a CPE
monitor CFE in lieu of individual as specified in paragraph (c) of
filters). 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; development of a
filter profile; identification and
prioritization of factors limiting
filter performance; assessment of
the applicability of corrections;
and preparation of a filter self-
assessment report. If a self-
assessment is required, the date
that it was triggered and the date
that it was completed.
(c) For two months in a row and Arrange to have a comprehensive
turbidity exceeded 2.0 BTU in 2 performance evaluation (CPE)
consecutive recordings 15 minutes conducted by the State or a third
apart at the same filter (or CFE party approved by the State not
for systems with 2 filters that later than 60 days following the
monitor CFE in lieu of individual day the filter exceeded 2.0 NTU in
filters). 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 Technical 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.
------------------------------------------------------------------------
Sec. 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 Sec. 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
Sec. 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
[[Page 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.
------------------------------------------------------------------------
Description of
Corresponding requirement information to report Frequency
------------------------------------------------------------------------
(a) Combined Filter Effluent (1) The total number By the 10th of
Requirements. of filtered water the following
(Secs. 141.550-141.553)...... turbidity month.
measurements taken
during the month.
(2) The number and By the 10th of
percentage of the following
filtered water month.
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 By the 10th of
of any turbidity the following
measurements taken month.
during the month
which exceed the
maximum turbidity
value for your
filtration system.
(b) Individual Turbidity (1) That your system By the 10th of
Requirements. conducted individual the following
(Secs. 141.560-141.564)..... filter turbidity month.
monitoring during the
month.
(2) The filter By the 10th of
number(s), the following
corresponding month.
date(s), and the
turbidity value(s)
which exceeded 1.0
NTU during the month,
but only if 2
consecutive
measurements exceeded
1.0 NTU.
(3) If a self- By the 10th of
assessment is the following
required, the date month (or 14
that it was triggered days after the
and the date that it self-assessment
was completed. was triggered
only if the
self-assessment
was triggered
during the last
four days of
the month)
(4) If a CPE is By the 10th of
required, that the the following
CPE is required and month.
the date that it was
triggered.
(5) Copy of completed Within 120 days
CPE report. after the CPE
was triggered.
(c) Disinfection Profiling.... (1) Results of (i) For systems
(Secs. 141.530-141.536)...... optional monitoring serving 500-
which show TTHM 9,999 by July
levels 0.064 mg/l and 1, 2003;
HAA5 levels 0.048 mg/ (ii) For systems
l (Only if your serving fewer
system wishes to than 500 by
forgo profiling) or January 1,
that your system has 2004.
begun disinfection
profiling.
(d) Disinfection Benchmarking. (1) A description of Anytime your
(Secs. 141.540-141.544)...... the proposed change system is
in disinfection, your considering a
system's disinfection significant
profile for Giardia change to its
lamblia (and, if disinfection
necessary, viruses) practice.
and disinfection
benchmark, and an
analysis of how the
proposed change will
affect the current
levels of
disinfection.
------------------------------------------------------------------------
Sec. 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 Sec. 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.
----------------------------------------------------------------------------------------------------------------
Description of necessary
Corresponding requirement records Duration of time records must be kept
----------------------------------------------------------------------------------------------------------------
(a) Individual Filter Turbidity Results of individual filter At least 3 years.
Requirements. monitoring.
(Secs. 141.560-141.564).................
(b) Disinfection Profiling............... Results of Profile Indefinitely.
(Secs. 141.530-141.536)................. (including raw data and
analysis).
(c) Disinfection Benchmarking............ Benchmark (including raw Indefinitely.
(Secs. 141.540-141.544)................. data and analysis).
----------------------------------------------------------------------------------------------------------------
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-1, 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)(4)(ii) introductory text, and (a)(7) to read as follows:
Sec. 142.14 Records kept by States.
(a) * * *
(3) Records of turbidity measurements must be kept for not less
than one year. The information retained must be set forth in a form
which makes possible comparison with the limits specified in
Secs. 141.71, 141.73, 141.173 and 141.175, 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 Sec. 141.13 of this chapter.
(4)(i) Records of disinfectant residual measurements and other
parameters necessary to document disinfection effectiveness in
accordance with Secs. 141.72 and 141.74 of this chapter and the
reporting requirements of Secs. 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
[[Page 1844]]
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 Secs. 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 Secs. 141.173(b) and
Sec. 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 Secs. 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:
Sec. 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 (CCP). 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 HAA5 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 Sec. 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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