National Primary Drinking Water Regulations: Long Term 2 Enhanced Surface Water Treatment Rule

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: August 11, 2003 (Volume 68, Number 154)]
[Proposed Rules]
[Page 47739-47788]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11au03-41]

[[pp. 47739-47788]]
National Primary Drinking Water Regulations: Long Term 2 Enhanced
Surface Water Treatment Rule

[[Continued from page 47738]]

[[Page 47739]]

Table VI-1.--Summary of Regulatory Alternatives for Filtered Systems
------------------------------------------------------------------------
Average source water Cryptosporidium Additional treatment
monitoring result (oocysts/L) requirements \1\
------------------------------------------------------------------------
Alternative A1
2.0 log inactivation required for all systems
Alternative A2
------------------------------------------------------------------------
< 0.03........................................ No action.
£= 0.03 and < 0.1................... 0.5 log.
£= 0.1 and < 1.0.................... 1.5 log.
£= 1.0.............................. 2.5 log.
-----------------------------------------------
Alternative A3--Preferred Alternative
------------------------------------------------------------------------
< 0.075....................................... No action.
£= 0.075 and < 1.0.................. 1 log.
£= 1.0 and < 3.0.................... 2 log.
£= 3.0.............................. 2.5 log.
-----------------------------------------------
Alternative A4
------------------------------------------------------------------------
< 0.1......................................... No action.
£= 0.1 and < 1.0.................... 0.5-log.
£=1.0............................... 1.0 log.
------------------------------------------------------------------------
\1\ Note: ``Additional treatment requirements'' are in addition to
levels already required under existing rules (e.g., the IESWTR and
LT1ESWTR).

B. What Analyses Support Selecting the Proposed Rule Option?

EPA has quantified benefits and costs of each of the regulatory
alternatives in Table VI-1, as well as for the proposed requirements
for unfiltered systems. Quantified benefits stem from estimated
reductions in the incidence of cryptosporidiosis resulting from the
regulation. To make these estimates, the Agency developed a two-
dimensional Monte Carlo model that accounts for uncertainty and
variability in key parameters like Cryptosporidium occurrence,
infectivity, and treatment efficiency. Analyses involved estimating the
baseline (pre-LT2ESWTR) risk from Cryptosporidium in drinking water,
and then projecting the reductions in exposure and risk resulting from
the additional treatment requirements of the LT2ESWTR. Costs result
largely from the installation of additional treatment, with lesser
costs due to monitoring and other implementation activities. Results of
these analyses are summarized in the following subsections, and details
are shown in the LT2ESWTR EA (USEPA 2003a).
Cryptosporidium occurrence significantly influences the estimated
benefits and costs of regulatory alternatives. As discussed in section
III.C, EPA analyzed data collected under the Information Collection
Rule, the Information Collection Rule Supplemental Surveys of medium
systems (ICRSSM), and the Information Collection Rule Supplemental
Surveys of large systems (ICRSSL) to estimate the national occurrence
distribution of Cryptosporidium in surface water. EPA evaluated these
distributions independently when assessing benefits and costs for
different regulatory alternatives. In most cases, results from the
ICRSSM data set are within the range of results of the Information
Collection Rule and ICRSSL data sets.
EPA selected a Preferred Regulatory Alternative for the LT2ESWTR,
consistent with the recommendations of the Advisory Committee. As
described next, this selection was based on the estimated impacts and
feasibility of the alternatives shown in Table VI-1.
Alternative A1 (across-the-board 2-log inactivation) was not
selected because it was the highest cost option and imposed costs but
provided few benefits to systems with high quality source water (i.e.,
relatively low Cryptosporidium risk). In addition, there were concerns
about the feasibility of requiring almost every surface water treatment
plant to install additional treatment processes (e.g., UV or ozone) for
Cryptosporidium.
Alternatives A2-A4 were evaluated based on several factors,
including predictions of costs and benefits, performance of analytical
methods for classifying systems in the risk bins, and other specific
impacts (e.g., impacts on small systems or sensitive subpopulations).
Alternative A3 was recommended by the Advisory Committee because it
provides significant health benefits in terms of avoided illnesses and
deaths for an acceptable cost. In addition, the Agency believes this
alternative is feasible with available analytical methods and treatment
technologies.
Incremental costs and benefits of regulatory alternatives for the
LT2ESWTR are shown in section VI.F, and the LT2ESWTR EA contains more
detailed information about the benefits and costs of each regulatory
option (USEPA 2003a).

C. What Are the Benefits of the Proposed LT2ESWTR?

As discussed previously, the LT2ESWTR is expected to substantially
reduce drinking water related exposure to Cryptosporidium, thereby
reducing both illness and death associated with cryptosporidiosis. As
described in section II, cryptosporidiosis is an infection caused by
Cryptosporidium and is an acute, typically self-limiting, illness with
symptoms that include diarrhea, abdominal cramping, nausea, vomiting,
and fever (Juranek, 1995). Cryptosporidiosis patients in sensitive
subpopulations, such as infants, the elderly, and AIDS patients, are at
risk for severe illness, including risk of death. While EPA has
quantified and monetized the health benefits for reductions in endemic
cryptosporidiosis that would result from the LT2ESWTR, the Agency was
unable to quantify or monetize other health and non-health related
benefits associated with this rule. These unquantified benefits are
characterized next, followed by a summary of the quantified benefits.

[[Page 47740]]

1. Non-Quantifiable Health and Non-health Related Benefits
Although there are substantial monetized benefits that result from
this rule due to reduced rates of endemic cryptosporidiosis, other
potentially significant benefits of this rule remain unquantified and
non-monetized. The unquantified benefits that result from this rule are
summarized in Table VI-2 and are described in greater detail in the
LT2ESWTR EA (USEPA 2003a).

Table VI-2.--Summary of Nonquantified Benefits
------------------------------------------------------------------------
Potential effect
Benefit type on benefits Comments
------------------------------------------------------------------------
Reducing outbreak risks and Increase......... Some outbreaks are
response costs. caused by human or
equipment failures
that may occur even
with the proposed
new requirements;
however, by adding
barriers of
protection for some
systems, the rule
will reduce the
possibility of such
failures leading to
outbreaks.
Reducing averting behavior Increase / No Averting behavior is
(e.g., boiling tap water or Change. associated with both
purchasing bottled water). out-of-pocket costs
(e.g., purchase of
bottled water) and
opportunity costs
(e.g., time
requiring to boil
water) to the
consumer. Reductions
in averting behavior
are expected to have
a positive impact on
benefits from the
rule.
Improving aesthetic water Increase......... Some technologies
quality. installed for this
rule (e.g., ozone)
are likely to reduce
taste quality and
odor problems.
Reducing risk from co- Increase......... Although focused on
occurring and emerging removal of
pathogens. Cryptosporidium from
drinking water,
systems that change
treatment processes
will also increase
removal of pathogens
that the rule does
not specifically
regulate. Additional
benefits will
accrue.
Increased source water Increase......... The greater
monitoring. understanding of
source water quality
that results from
monitoring may
enhance the ability
of plants to
optimize treatment
operations in ways
other than those
addressed in this
rule.
Reduced contamination due to Increase......... Although insufficient
covering on treating finished data were available
water storage facilities. to quantify
benefits, the
reduction of
contaminants
introduced through
uncovered finished
water storage
facilities would
produce positive
public health
benefits.
------------------------------------------------------------------------
Source: Chapter 5 of the LT2ESWTR Economic Analysis (USEPA 2003a).

2. Quantifiable Health Benefits
EPA quantified benefits for the LT2ESWTR based on reductions in the
risk of endemic cryptosporidiosis. Several categories of monetized
benefits were considered in this analysis.
First, EPA estimated the number of cases expected to result in
premature mortality (primarily for members of sensitive subpopulations
such as AIDS patients). In order to estimate the benefits from deaths
avoided as a result of the rule, EPA multiplied the estimates for
number of illnesses avoided by a projected mortality rate. This
mortality rate was developed using mortality data from the Milwaukee
cryptosporidiosis outbreak of 1993 (described in section II), with
adjustments to account for the subsequent decrease in the mortality
rate among people with AIDS and for the difference between the 1993
Milwaukee AIDS rate and the current national rate. EPA estimated a
mortality rate of 16.6 deaths per 100,000 illnesses for those served by
unfiltered systems and a mortality rate of 10.6 deaths per 100,000
illnesses for those served by filtered systems. These different rates
are associated with the incidence of AIDS in populations served by
unfiltered and filtered systems. A complete discussion on how EPA
derived these rates can be found in subchapter 5.2 of the LT2ESWTR EA
(USEPA 2003a).
Reductions in mortalities were monetized using EPA's standard
methodology for monetizing mortality risk reduction. This methodology
is based on a distribution of value of statistical life (VSL) estimates
from 26 labor market and stated preference studies, with a mean VSL of
$6.3M in 2000, and a 5th to 95th percentile range of $1.0 to $14.5. A
more detailed discussion of these studies and the VSL estimate can be
found in EPA's Guidelines for Preparing Economic Analyses (USEPA
2000c). A real income growth factor was applied to these estimates of
approximately 2.3% per year for the 20 year time span following
implementation. Income elasticity for VSL was estimated as a triangular
distribution that ranged from 0.08 to 1.00, with a mode of 0.40. VSL
values for the 20 year span are shown in the LT2 EA in Exhibit C.13
(USEPA 2003a).
The substantial majority of cases are not expected to be fatal and
the Agency separately estimated the value of non-fatal illnesses
avoided that would result from the LT2ESWTR. For these, EPA first
divided projected cases into three categories, mild, moderate, and
severe, and then calculated a monetized value per case avoided for each
severity level. These were then combined into a weighted average value
per case based on the relative frequency of each severity level.
According to a study conducted by Corso et al. (2003), the majority of
illness falls into the mild category (88 percent). Approximately 11
percent of illness falls into the moderate category, which is defined
as those who seek medical treatment but are not hospitalized. The final
one percent have severe symptoms that result in hospitalization. EPA
estimated different medical expenses and time losses for each category.
Benefits for non-fatal cases were calculated using a cost-of-
illness (COI) approach. Traditional COI valuations focus on medical
costs and lost work time, and leave out significant categories of
benefits, specifically the reduced utility from being sick (i.e., lost
personal or non-work time, including activities such as child care,
homemaking, community service, time spent with family, and recreation),
although some COI studies also include an estimate for unpaid labor
(household production) valued at an estimated wage

[[Page 47741]]

rate designed to reflect the market value of such labor (e.g., median
wage for household domestic labor). This reduced utility is variously
referred to as lost leisure or a component of pain and suffering.
Ideally, a comprehensive willingness to pay (WTP) estimate would be
used that includes all categories of loss in a single number. However,
a review of the literature indicated that the available studies were
not suitable for valuing cryptosporidiosis; hence, estimates from this
literature are inappropriate for use in this analysis. Instead, EPA
presents two COI estimates: a traditional approach that only includes
valuation for medical costs and lost work time (including some portion
of unpaid household production); and an enhanced approach that also
factors in valuations for lost unpaid work time for employed people,
reduced utility (or sense of well-being) associated with decreased
enjoyment of time spent in non-work activities, and lost productivity
at work on days when workers are ill but go to work anyway.
Table VI-3 shows the various categories of loss and how they were
valued for each estimate for a ``typical'' case (weighted average of
severity level--see LT2ESWTR EA--Chapter 5 for more details (USEPA
2003a).

Table VI-3.--Traditional and Enhanced COI for Cryptosporidiosis
------------------------------------------------------------------------
Traditional
Loss category COI Enhanced COI
------------------------------------------------------------------------
Direct Medical Costs.................... $93.82 $93.82
Lost Paid Work Days..................... 109.88 109.88
Lost Unpaid Work Days \1\............... 20.22 40.44
Lost Caregiver Days \2\................. 20.70 54.31
Lost Leisure Time \3\................... \5\ 333.96
Lost Productivity at Work............... \5\ 112.49
Total \4\........................... 244.62 744.89
------------------------------------------------------------------------
\1\ Assigned to 38.2% of the population not engaged in market work;
assumes 40 hr, unpaid work week, valued at $5.46/hr in traditional COI
and $10.92/hr in enhanced COI. Does not include lost unpaid work for
employed people and may not include all unpaid work for people outside
the paid labor force.
\2\ Values lost work or leisure time for people caring for the ill.
Traditional approach does not include lost leisure time.
\3\ Includes child care and homemaking (to the extent not covered in
lost unpaid work days above), time with family, and recreation for
people within and outside the paid labor force.
\4\ Detail may not calculate to totals due to independent rounding;
Source: Appendix L in LT2ESWTR EA (USEPA 2003a).
\5\ Not included.

The various loss categories were calculated as follows: Medical
costs are a weighted average across the three illness severity levels
of actual costs for doctor and emergency room visits, medication, and
hospital stays. Lost paid work represents missed work time of paid
employees, valued at the median pre-tax wage, plus benefits of $18.47
hour. The average number of lost work hours per case is 5.95 (this
assumes that 62 percent of the population is in the paid labor force
and the loss is averaged over seven days). Medical costs and lost work
days reflect market transactions. Medical costs are always included in
COI estimates and lost work days are usually included in COI estimates.
In the traditional COI estimate, an equivalent amount of lost
unpaid work time was assigned to the 38% of the population that are not
in the paid labor force. This includes homemakers, students, children,
retires, and unemployed persons. EPA did not attempt to calculate what
percent of cases falls in each of these five groups, or how many hours
per week each group works, but rather assumed an across-the-board 40
hour unpaid work week. This time is valued at $5.46 per hour, which is
one half the median post-tax wage, (since work performed by these
groups is not taxed). This is approximately the median wage for paid
household domestic labor.
In the enhanced COI estimate, all time other than paid work and
sleep (8 hours per day) is valued at the median after tax wage, or
$10.92 per hour. This includes lost unpaid work (e.g., household
production) and leisure time for people within and outside the paid
labor force. Implicit in this approach, is that people would pay the
same amount not to be sick during their leisure time as they require to
give up their leisure time to work (i.e., the after tax wage). In
reality, people might be willing to pay either more than this amount
(if they were very sick and suffering a lot) or less than this amount
(if they were not very sick and still got some enjoyment out of
activities such as resting, reading and watching TV), not to be sick.
Multiplying 16 hours by $10.92 gives a value of about $175.00 for a day
of ``lost'' unpaid work and leisure (i.e., lost utility of being sick).
An estimate of lost unpaid work days for the enhanced approach was
made by assigning the value of $10.92 per hour to the same number of
unpaid work hours valued in the traditional COI approach (i.e., 40
unpaid work hours per week for people outside the paid labor force).
Lost unpaid work for employed people and any unpaid labor beyond 40
hours per week for those not in the labor market is shown as lost
leisure time in Table VI-3 for the enhanced approach and is not
included in the traditional approach. In addition, for days when an
individual is well enough to work but still experiencing symptoms, such
as diarrhea, the enhanced estimate also includes a 30% loss of work and
leisure productivity, based on a study of giardiasis illness
(Harrington et al. 1985) which is similar to cryptosporidiosis.
Appendix P in the EA describes similar productivity losses for other
illnesses such as influenza (35%-73% productivity losses). In the
traditional COI analysis, productivity losses are not included for
either work or non-work time.
The Agency believes that losses in productivity and lost leisure
time are unquestionably present and that these categories have positive
value; consequently, the traditional COI estimate understates the true
value of these loss categories. EPA notes that these estimates should
not be regarded as upper and lower bounds. In particular, the enhanced
COI estimate may not fully incorporate the value of pain and suffering,
as people may be willing to pay more than $201 to avoid a day of
illness. The traditional COI estimate includes a valuation for a lost
40 hour work week for all persons not in the labor force, including
children and retirees. This may be an overstatement of lost
productivity for these groups, which would depend on the impact of such
things as missed

[[Page 47742]]

school work or volunteer activities that may be affected by illness.
As with the avoided mortality valuation, the real wages used in the
COI estimates were increased by a real income growth factor that varies
by year, but is the equivalent of about 2.3% over the 20 year period.
This approach of adjusting for real income growth was recommended by
the SAB (USEPA 2000e) because the median real wage is expected to grow
each year (by approximately 2.3%)--the median real wage is projected to
be $38,902 in 2008 and $59,749 in 2027. Correspondingly, the real
income growth factor of the COI estimates increases by the equivalent
of 2.3% per year (except for medical costs, which are not directly tied
to wages). This approach gives a total COI valuation in 2008 of $268.92
for the traditional COI estimate and $931.06 for the enhanced COI
estimate; the valuation in 2027 is $362.75 for the traditional COI
estimate and $1,429.99 for the enhanced COI estimate. There is no
difference in the methodology for calculating the COI over this 20 year
period of implementation; the change in valuation is due to the
underlying change in projected real wages.
Table VI-4 summarizes the annual cases of cryptosporidiosis illness
and associated deaths avoided due to the LT2ESWTR proposal. The
proposed rule, on average, is expected to reduce 256,000 to 1,019,000
illnesses and 37 to 141 deaths annually after full implementation
(range based on the ICRSSL, ICRSSM, and Information Collection Rule
data sets).

Table VI-4.--Summary of Annual Avoided Illness and Deaths
----------------------------------------------------------------------------------------------------------------
Annual illinesses avoided Annual deaths avoided
-----------------------------------------------------------------------------
90 percent confidence 90 percent confidence
Data set bound bound
Mean -------------------------- Mean -------------------------
Lower (5th Upper Lower (5th Upper
%ile) (95th %ile) %ile) (95th %ile)
----------------------------------------------------------------------------------------------------------------
Annual Total After Full Implementation
----------------------------------------------------------------------------------------------------------------
ICR............................... 1,018,915 169,358 2,331,467 141 25 308
ICRSSL............................ 256,173 45,292 560,648 37 7 78
ICRSSM............................ 498,363 84,724 1,177,415 70 13 157
-----------------------------------
Annual Average Over 25 years
----------------------------------------------------------------------------------------------------------------
ICR............................... 720,668 119,694 1,647,796 100 18 218
ICRSSL............................ 181,387 32,179 396,845 26 5 55
ICRSSM............................ 352,611 59,942 833,290 50 9 111
----------------------------------------------------------------------------------------------------------------
Source: The LT2ESWTR Economic Analysis (USEPA 2003a).

Tables VI-5a and VI-5b show the monetized present value of the
benefit for reductions in endemic cryptosporidiosis estimated to result
from the LT2ESWTR for the enhanced and traditional COI values,
respectively. Estimates are given for the Information Collection Rule,
ICRSSL, and ICRSSM occurrence data sets.
With the enhanced COI and a three percent discount rate, the annual
present value of the mean benefit estimate ranges from $374 million to
$1.4 billion, with a 90 percent confidence bound of $52 million to $198
million at the lower 5th percentile and $959 million to $3.7 billion at
the upper 95th percentile; at a seven percent discount rate, this
estimate ranges from $318 million to $1.2 billion, with a 90 percent
confidence bound of $44 million to $168 million at the lower 5th
percentile and $816 million to $3.1 billion at the upper 95th
percentile. With the traditional COI, the corresponding benefit
estimate at a three percent discount rate ranges from $253 million to
$967 million, with a 90 percent confidence bound of $27 million to $105
million at the lower 5th percentile and $713 million to $2.7 billion at
the upper 95th percentile; for a seven percent discount rate, this
estimate ranges from $216 million to $826 million, with a 90 percent
confidence bound of $23 million to $89 million at the lower 5th
percentile and $610 million to $2.3 billion at the upper 95th
percentile. None of these values include the unquantified and non-
monetized benefits discussed previously.

Table VI-5A.--Summary of Quantified Benefits--Enhanced COI
[$millions, 2000$]
----------------------------------------------------------------------------------------------------------------
Value of benefits--Enhanced COI \1\
-----------------------------------------------
90 percent confidence bound
Data set -------------------------------
Mean Lower (5th Upper (95th
%ile) %ile)
----------------------------------------------------------------------------------------------------------------
Annualized Value (at 3%, 25 Years)
----------------------------------------------------------------------------------------------------------------
ICR............................................................. $1,445 $198 3,666
ICRSSL.......................................................... 374 52 959
ICRSSM.......................................................... 715 96 1,849
-----------------------------------------------------------------
Annualized Value (at 7%, 25 Years)
----------------------------------------------------------------------------------------------------------------
ICR............................................................. 1,230 168 3,120

[[Page 47743]]

ICRSSL.......................................................... 318 44 816
ICRSSM.......................................................... 609 81 1,577
----------------------------------------------------------------------------------------------------------------
\1\ The traditional COI only includes valuation for medical costs and lost work time (including some portion of
unpaid household production). The enhanced COI also factors in valuations for lost personal time (non-
worktime) such as child care and homemaking (to the extent not covered by the traditional COI), time with
family, and recreation, and lost productivity at work on days when workers are ill but go to work anyway.
Source: The LT2ESWR Economic Analysis (USEPA 2003a).

Table VI-5b.--Summary of Quantified Benefits--Traditional COI
[($Millions, 2000$]
------------------------------------------------------------------------
Value of Benefits--Traditional
COI \1\
--------------------------------
90 percent
Data Set confidence bound
---------------------
Mean Lower Upper
(5th 95th
%ile) %ile)
------------------------------------------------------------------------
Annualized Value (at 3%, 25 Years)
------------------------------------------------------------------------
ICR.................................... $967 $105 $2,713
ICRSSL................................. 253 27 713
ICRSSM................................. 481 50 1,372
----------------------------------------
Annualized Value (at 7%, 25 Years)
------------------------------------------------------------------------
ICR.................................... 826 89 2,315
ICRSSL................................. 216 23 610
ICRSSM................................. 411 43 1,172
------------------------------------------------------------------------
\1\ The traditional COI only includes valuation for medical costs and
lost work time (including some portion of unpaid household
production). The enhanced COI also factors in valuations for lost
personal time (non-worktime) such as child care and homemaking (to the
extent not covered by the traditional COI), time with family, and
recreation, and lost productivity at work on days when workers are ill
but go to work anyway. Source: The LT2ESWTR Economic Analysis (USEPA
2003a).

a. Filtered systems. Benefits to the approximately 161 million
people served by filtered surface water and GWUDI systems range from
88,000 to 472,000 reduction in mean annual cases of endemic illness
based on ICRSSL, ICRSSM, and ICR data sets. In addition, premature
mortality is expected to be reduced by an average of 9 to 50 deaths
annually.
b. Unfiltered systems. The 12 million people served by unfiltered
surface water or GWUDI systems will see a significant reduction in
cryptosporidiosis as a result of the LT2ESWTR. In this population, the
rule is expected to reduce approximately 168,000 to 547,000 cases of
illness and 28 to 91 premature deaths annually.
For unfiltered systems, only the Information Collection Rule data
set is used to directly calculate illness reduction because it is the
only data set that includes sufficient information on unfiltered
systems. Illness reduction in unfiltered systems was estimated for the
ICRSSL and ICRSSM data sets by multiplying the Information Collection
Rule unfiltered system result by the ratio, for the quantity estimated,
between filtered system results from the supplemental survey data set
(SSM or SSL) and filtered system results from the Information
Collection Rule.
3. Timing of Benefits Accrual (Latency)
In previous rulemakings, some commenters have argued that the
Agency should consider an assumed time lag or latency period in its
benefits calculations. The Agency has not conducted a latency analysis
for this rule because cryptosporidiosis is an acute illness; therefore,
very little time elapses between exposure, illness, and mortality.
However, EPA does account for benefits and costs that occur in future
years by converting these to present value estimates.

D. What Are the Costs of the Proposed LT2ESWTR?

In order to estimate the costs of today's proposed rule, the Agency
considered impacts on public water systems and on States (including
territories and EPA implementation in non-primacy States). EPA assumed
that systems would be in compliance with the IESWTR, which has a
compliance date of January 2002 for large systems and the LT1ESWTR,
which has a compliance date of January 2005 for small systems.
Therefore, this cost estimate only considers the additional
requirements that are a direct result of the LT2ESWTR. More detailed
information on cost estimates are described next and a complete
discussion can be found in chapter 6 of the LT2ESWTR EA (USEPA 2003a).
An detailed discussion of the proposed rule provisions is located in
section IV of this preamble.

[[Page 47744]]

1. Total Annualized Present Value Costs
Tables VI-6a and VI-6b summarize the annualized present value cost
estimates for the proposed LT2ESWTR at three percent and seven percent
discount rates, respectively. The mean annualized present value costs
of the proposed LT2ESWTR are estimated to range from approximately $73
to $111 million using a three percent discount rate and $81 to $121
million using a seven percent discount rate. This range in mean cost
estimates is associated with the ICRSSL and Information Collection Rule
Cryptosporidium occurrence data sets. Using different occurrence data
sets results in different bin classifications and, thus, impacts the
cost of the rule. Results for the ICRSSM fall within the range of
results for the Information Collection Rule and ICRSSL. In addition to
mean estimates of costs, the Agency calculated 90 percent confidence
bounds by considering the uncertainty in Cryptosporidium occurrence
estimates and around the mean unit technology costs (USEPA 2003a).
Public water systems will incur approximately 99 percent of the
rule's total annualized present value costs. States incur the remaining
rule costs. Table VI-7 shows the undiscounted initial capital and one-
time costs broken out by rule component. A comparison of annualized
present value costs among the rule alternatives considered by the
Agency is located in subsection VI.F. and in the LT2ESWTR EA (USEPA
2003a). Using a present value allows costs and benefits that occur
during different time periods to be compared. For any future cost, the
higher the discount rate, the lower the present value. Specifically, a
future cost evaluated at a seven percent discount rate will always
result in a lower total present value cost than the same future cost
evaluated at a three percent discount rate.
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2. Water System Costs
The proposed LT2ESWTR applies to all community, non-transient non-
community, and transient non-community water systems that use surface
water or GWUDI as a source (including both filtered and unfiltered
systems). EPA has estimated the cost impacts for these three types of
public drinking water systems. As shown in Table VI-6a and VI-6b, the
mean annualized present value costs for all drinking water systems
range from approximately $73 to $111 million using a three percent
discount rate ($81 to $121 million using a seven percent discount
rates).
The majority of costs of the rule result from treatment changes
incurred by filtered and unfiltered systems. Table VI-8 shows the
number of filtered and unfiltered systems that will incur costs by rule
provision. Subsection VI.D.2.b discusses treatment costs for filtered
system and subsection VI.D.2.c discusses treatment options for
unfiltered systems. All non-purchased surface water and GWUDI systems
subject to the LT2ESWTR (including filtered and unfiltered systems)
will incur one-time costs that include time for staff training on rule
requirements. Systems will incur monitoring costs to assess source
water Cryptosporidium levels, though monitoring requirements vary by
system size (large vs. small) and system type (filtered vs.
unfiltered). A discussion of future monitoring that will occur six
years after initial bin assignments can be found in subsection
VI.D.2.e.
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a. Source water monitoring costs. Source water monitoring costs are
structured on a per-plant basis. Also, as with implementation
activities, purchased plants are assumed not to treat source water and
will not have any monitoring costs. There are three types of monitoring
that plants may be required to conduct--turbidity, E. coli and
Cryptosporidium. Source water turbidity is a common water quality
parameter used for plant operational control. Also, to meet SWTR,
LT1ESWTR and IESWTR requirements, most water systems have turbidity
analytical equipment in-house and operators are experienced with
turbidity measurement. Thus, EPA assumes that the incremental turbidity
monitoring burden associated with the LT2ESWTR is negligible.
Filtered plants in small systems initially will be required to
conduct one year of biweekly E. coli source water monitoring. These
plants will be required to monitor for Cryptosporidium if, as a result
of initial bin classification, E. coli levels exceed the following
concentrations: (1) Annual mean £ 10 E. coli/100 mL for lakes
and reservoir sources, and (2) annual mean £ 50 E. coli/100
mL for flowing stream sources. EPA estimated the percent of small
plants that would be triggered into Cryptosporidium monitoring as being
equal to the percent of large plants that would fall into any bin
requiring additional treatment.
Estimates of laboratory fees, shipping costs, labor hours for
sample collection, and hours for reporting results were used to predict
system costs for initial source water monitoring under the LT2ESWTR.
Table VI-9 summarizes the present value of monitoring costs for initial
bin classification. Total present value monitoring costs for initial
bin classification range from $46 million to $60 million depending on
the occurrence data set and discount rate. Appendix D of the LT2ESWTR
EA provides a full explanation of how these costs were developed (USEPA
2003a).

[[Page 47749]]

Table VI-9.--Summary of Present Value Monitoring Costs for Initial Bin Classification
($millions, 2000$)
--------------------------------------------------------------------------------------------------------------------------------------------------------
System Size ICR (3%) A ICR (7%) B ICRSSL (3%) C ICRSSL (7%) D ICRSSM (3%) E ICRSSM (7%) F
--------------------------------------------------------------------------------------------------------------------------------------------------------
<=10K......................................................... $34.6 $29.7 $25.7 $22.2 $29.2 $25.1
10K........................................................... 25.7 24.3 25.7 24.3 25.7 24.3
--------------
Total..................................................... 60.3 54.0 51.4 46.5 54.9 49.4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Chapter 6 of the LT2ESWTR Economic Analysis (USEPA 2003a).

b. Filtered systems treatment costs. The Agency calculated
treatment costs by estimating the number of plants that will be adding
treatment technologies and coupling these estimates with unit costs ($/
plant) of the selected technologies. Table VI-10 shows the number of
plants estimated to select different treatment technologies; Table VI-
11 summarizes the present value treatment costs and annualized present
value costs for both filtered and unfiltered systems.
To estimate the number of filtered plants that would select a
particular treatment technology, the Agency followed a two step
process. First, the number of plants that must make treatment changes
to meet the proposed LT2ESWTR requirement was determined by the binning
process. Second, EPA predicted the treatment technologies that plants
would choose to meet the proposed requirements. The Agency used a
``least-cost decision tree'' as the basic framework for determining the
treatment technology selection. In other words, EPA assumed that
drinking water plants would select the least expensive technology or
combination of technologies to meet the log removal requirements of a
given action bin. However, these technology selections were constrained
by maximum use percentages, which recognize that some plants will not
be able to implement certain technologies because of site-specific
conditions. In addition, certain potentially lower cost components of
the microbial toolbox, such as changes to the plant intake, were not
included because the Agency lacked data to estimate the number of
plants that could select it. These limitations on technology use may
result in an overestimate of costs. An in-depth discussion of the
technology selection methodology and unit cost estimates can be found
in appendices E and F of the proposed LT2ESWTR EA (USEPA 2003a).

Table VI-10.--Technology Selection Forecasts for Filtered Plants
----------------------------------------------------------------------------------------------------------------
Data set
--------------------------------
ICR ICRSSL ICRSSM
----------------------------------------------------------------------------------------------------------------
Technology Selections

Bag Filter 1.0 Log............................................................. 1,545 1,236 1,441
Cartridge Filter 2.0 Log....................................................... 190 17 52
CL02 0.5 Log................................................................... 77 60 70
Combined Filter Performance 0.5 Log............................................ 16 12 14
In-bank Filtration 1.0 Log..................................................... 5 3 4
MF/UF 2.5 Log.................................................................. 10 3 5

Technology Selections \1\

03 0.5 Log..................................................................... 26 17 21
03 1.0 Log..................................................................... 24 18 21
03 2.0 Log..................................................................... 9 1 2
Secondary Filter 1.0 Log....................................................... 0 0 0
UV 2.5 Log..................................................................... 998 490 632
WS Control 0.5 Log............................................................. 0 0 0
Total Plants Selecting Technologies........................................ 2,893 1,852 2,255
----------------------------------------------------------------------------------------------------------------
\1\ Some plants are projected to select more than one technology to meet LT2ESWTR bin requirements;
consequently, the value for total plants does not equal the sum of all technologies selected. Source: Chapter
6 of the LT2ESWTR Economic Analysis (USEPA 2003a).

c. Unfiltered systems treatment costs. The proposed LT2ESWTR
requires all unfiltered plants to achieve 2 logs of inactivation if
their mean source water Cryptosporidium concentration is less than or
equal to 0.01 oocysts/L and 3 logs of inactivation if it is greater
than 0.01 oocysts/L. For most systems, UV appears to be the least
expensive technology that can achieve the required log inactivation of
Cryptosporidium, and it is expected to be widely used by unfiltered
systems to meet the rule requirement. However, as with filtered
systems, EPA estimated that a small percentage of plants would elect to
install a technology more expensive than UV due to the configuration of
existing equipment or other factors. Ozone is the next least expensive
technology that will meet the inactivation requirements for some
systems, and is estimated to be used by plants that do not use UV.
All unfiltered plants must meet requirements of the LT2ESWTR;
therefore, the percent of plants adding technology is 100 percent. This
also assumes that no unfiltered systems currently use these additional
treatment technologies. For this cost analysis, the Agency assumed 100
percent of very small unfiltered systems will use UV; for all other
unfiltered system sizes, the Agency estimated that 90 percent would
install UV and 10 percent would add ozone. This analysis is discussed
in more detail in the LT2ESWTR EA (USEPA 2003a). Treatment costs for
unfiltered systems are included in Table VI-11.

[[Page 47750]]

Table VI-11.--Total Present Value and Annualized Present Value Treatment Costs for Filtered and Unfiltered Plants
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Present
System Size Value Value Annualized Annualized Total Total
Data Set (population Capital Capital O&M Costs O&M Costs Annuallized Annualized
served) Costs at 3% Costs at 7% at 3% C at 7% D Costs at 3% Costs at 7%
A B E F
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICR....................................................... <=10,000 $76.1 $56.0 $5.2 $4.3 $9.6 $9.1
£10, 1,092.4 868.0 26.1 22.7 88.8 97.1
000
TOTAL................................................. .............. 1,168.5 924.0 31.3 26.9 98.4 106.2
--------------
ICRSSL.................................................... <=10,000 42.8 31.5 2.9 2.4 5.3 5.1
£10, 707.1 561.8 16.2 14.0 56.8 62.3
000
TOTAL................................................. .............. 749.8 593.3 19.0 16.4 62.1 67.3
--------------
ICRSSM.................................................... <=10,000 52.6 38.7 3.5 2.9 6.6 6.2
£10, 842.4 669.3 19.4 16.9 67.8 74.3
000
TOTAL................................................. .............. 894.9 708.0 23.0 19.8 74.4 80.6
--------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Chapter 6 of the LT2ESWTR Economic Analysis (USEPA 2003a)

d. Uncovered finished water storage facilities. As part of the
LT2ESWTR, systems with uncovered finished water storage facilities have
the option to cover the storage facility or provide disinfection after
the storage facility, unless the State has determined that existing
risk mitigation is adequate. Disinfection alternatives must achieve at
least four logs of virus inactivation. To develop national cost
estimates for systems to comply with this provision of the LT2ESWTR,
unit costs for each treatment alternative and the percentage of systems
selecting each alternative were estimated for the inventory of systems
with uncovered finished water storage facilities. A full description of
the unit costs and other assumptions used in this analysis is presented
in Chapter 6 and Appendix I of the LT2ESWTR EA (USEPA 2003a).
The Agency assumed that all systems with uncovered finished water
storage facilities will have to either install a cover or treat their
discharge. This overestimates the cost of this provision because States
can determine that systems with uncovered finished storage facilities
do not need to take these additional measures. The technology selection
for the uncovered finished water storage facilities was developed
through a least-cost approach.
For systems with uncovered storage facility capacities of five
million gallons (MG) or less, covering the storage facilities is the
least expensive alternative. Although chlorination is the least
expensive alternative for the remaining systems, the ability of a
system to use booster chlorination depends on their current residual
disinfectant type. Less than half of all surface water systems are
predicted to use chloramination following implementation of the Stage 2
DBPR. Adding chlorine to water that has been treated with chloramines
is not a feasible alternative; therefore, the fraction of systems
projected to add booster chlorination to the effluent from the storage
facility was estimated at 50 percent, with the remaining 50 percent
estimated to add covers. The technology selection for uncovered
finished water storage facilities is presented in Table VI-12.

Table VI-12.--Estimated Technology Selection for Uncovered Storage Facilities
----------------------------------------------------------------------------------------------------------------
Number of uncovered Floating Booster
Size category (MG) storage facilities cover (%) chlorination (%)
----------------------------------------------------------------------------------------------------------------
0-0.1................................................ 25 100 ..................
0.1-1................................................ 7 100 ..................
£1-5....................................... 44 100 ..................
£5-10...................................... 12 100 ..................
£10-20..................................... 10 100 ..................
£20-40..................................... 9 50 50
£40-60..................................... 4 50 50
£60-80..................................... 4 50 50
£80-100.................................... 6 50 50
£100-150................................... 6 50 50
£150-200................................... 2 50 50
£200-250................................... 4 50 50
£250-1,000................................. 4 50 50
£1,000..................................... 1 50 50
----------------------------------------------------------------------------------------------------------------
Source: Appendix I of the LT2ESWTR Economic Analysis (USEPA 2003a)

Table VI-13 summarizes total annualized present value costs for the
uncovered storage facility provision using both three and seven percent
discount rates. The Agency estimates the total annualized present value
cost for covering or treating uncovered finished water storage
facilities to be approximately $5.4 million at a three percent discount
rate and $6.4 million at a seven percent discount rate.

[[Page 47751]]

Table VI-13.--Estimated Annualized Present Value Cost for Uncovered Finished Water Storage Facility Provision
(2000$)
----------------------------------------------------------------------------------------------------------------
Annualized cost at 3% Annualized cost at 7%
System size (population served) ------------------------------------------------------------------------------
Capital O&M Total Capital O&M Total
----------------------------------------------------------------------------------------------------------------
<=10,000......................... $3,520 $1,649 $5,169 $4,713 $1,552 $6,264
£10,000................ 3,349,320 2,046,425 5,395,745 4,483,927 1,925,203 6,409,129
----------------------------------
Total...................... 3,352,840 2,048,074 5,400,915 4,488,639 1,926,754 6,415,393
----------------------------------------------------------------------------------------------------------------
Source: Appendix I of the LT2ESWTR Economic Analysis (USEPA 2003a)

e. Future monitoring costs. Six years after initial bin
classification, filtered and unfiltered plants will be required to
conduct a second round of monitoring to assess whether source water
Cryptosporidium levels have changed significantly. EPA will evaluate
new analytical methods and surrogate indicators of microbial water
quality in the interim. While the costs of monitoring are likely to
change in the six years following rule promulgation, it is difficult to
predict how they will change. In the absence of any other information,
it was assumed that the laboratory costs would be the same as for the
initial monitoring.
All plants that conducted initial monitoring were assumed to
conduct the second round of monitoring as well, except for those
systems that installed treatment that reduces 2.5 logs of
Cryptosporidium or greater as a result of the rule. These systems are
exempt from monitoring under the LT2ESWTR. Table VI-8 shows the number
of systems that are estimated to conduct the second round of monitoring
(listed as ``future'' monitoring in the table). EPA estimates the cost
of re-binning will range from $23 million to $38 million depending on
the occurrence data set and discount rate used in the estimate (see
Table VI-14). Costs differ among Cryptosporidium occurrence data sets
due to differences in estimates of the number of plants that will add
technologies to achieve at least 2.5 log Cryptosporidium reduction and
the number of small plants that will be triggered into monitoring for
Cryptosporidium. Appendix D of the EA provides further details (USEPA
2003a).

Table VI-14.--Present Value of Monitoring Costs of Future Re-binning
[$millions, 2000$]
----------------------------------------------------------------------------------------------------------------
ICR (3%) ICR (7%) ICRSSL ICRSSL ICRSSM ICRSSM
-------------------- (3%) (7%) (3%) (7%)
System size ---------------------------------------
A B C D E F
----------------------------------------------------------------------------------------------------------------
<=10K............................................... $23.5 $14.3 $18.4 $11.3 $20.7 $12.6
£10k...................................... 14.4 9.8 16.4 11.2 15.6 10.7
Total......................................... 37.8 24.1 34.8 22.5 36.3 23.3
----------------------------------------------------------------------------------------------------------------
Source: Chapter 6 of the LT2ESWTR Economic Analysis (USEPA 2003a)

f. Sensitivity analysis--influent bromide levels on technology
selection for filtered plants. One concern about the ICR data set was
that it may not actually reflect influent bromide levels in some plants
during droughts. High influent bromide levels (the precursor for
bromate formation) limits ozone use because the plant would not be able
to meet the MCL for bromate. The Agency conducted a sensitivity
analysis to estimate an impact of higher influent bromide levels would
have on technology decisions. The sensitivity analysis assumes influent
bromide concentrations of 50 parts per billion (ppb) above the ICR
concentrations. Overall, the impact of these assumptions have a minimal
impact on costs. A complete discussion of this sensitivity analysis is
located in LT2ESWTR EA (USEPA 2003a).
3. State/Primacy Agency Costs
The Agency estimates that States and primacy agencies will incur an
annualized present value cost of $0.9 to $1.0 million using a three
percent discount rate and $1.2 million at seven percent. State
implementation activities include regulation adoption and program
implementation, training State staff, training PWS staff, providing
technical assistance to PWSs, and updating the management system. To
estimate implementation costs to States/Primacy Agencies, the number of
full-time employees (FTEs) per activity is multiplied by the number of
labor hours per FTE, the cost per labor hour, and the number of States
and Territories.
In addition to implementation costs, States and primacy agencies
will also incur costs associated with monitoring data management.
Because EPA will directly manage the first round of monitoring by large
systems (serving at least 10,000 people), States are not predicted to
incur costs for these activities. States will, however, incur costs
associated with small system monitoring. This is a result of the
delayed start of small system monitoring, which will mean that some
States will assume primacy for small system monitoring. In addition,
States will review of the second round of monitoring results. States
will also incur costs in reviewing technology compliance data and
consulting with systems regarding benchmarking for systems that change
their disinfection procedures to comply with the rule. Appendix D of
the LT2ESWTR EA provides more information about the State and primacy
agency cost analysis (USEPA 2003a).
4. Non-Quantified Costs
EPA has quantified all the major costs for this rule and has
provided uncertainty analyses to bound the over or underestimates in
the costs. There are some costs that EPA has not quantified, however,
because of lack of data. For example, some systems may merge with
neighboring systems to comply with this rule. Such changes have both
costs (legal fees and connecting infrastructure) and benefits
(economies of scale). Likewise, systems would incur

[[Page 47752]]

costs for procuring a new source of water that may result in lower
overall treatment costs.
In addition, the Agency was unable to predict the usage or estimate
the costs of several toolbox options. These options include intake
management and demonstrations of performance. They have not been
included in the quantified analysis because data are not available to
estimate the number of systems that may use these toolbox options to
comply with the LT2ESWTR. Not including these generally low-cost
options may result in overestimation of costs.

E. What Are the Household Costs of the Proposed Rule?

Another way to assess a rule's impact is to consider how it might
impact residential water bills. This analysis considers the potential
increase in a household's water bill if a CWS passed the entire cost
increase resulting from this rule on to its customers. It is a tool to
gauge potential impacts and should not be construed as precise
estimates of potential changes to individual water bills.
Included in this analysis are all CWS costs, including rule
implementation, initial and future monitoring for bin classification,
additional Cryptosporidium treatment, and treating or covering
uncovered finished water storage facilities. Costs for small systems
Cryptosporidium monitoring, additional Cryptosporidium treatment, and
uncovered finished water storage facilities are assigned only to the
subset of systems expected to incur them. Although implementation and
monitoring represent relatively small, one-time costs, they have been
included in the analysis to provide a complete distribution of the
potential household cost. A detailed description of the derivation of
household costs is in section 6.10 and Appendix J of the LT2ESTWR EA
(USEPA 2003a).
For purchased systems that are linked to larger nonpurchased
systems, the households costs are calculated based on the unit costs of
the larger system but included in the distribution from the size
category of the purchased system. Households costs for these purchased
systems are based on the household usage rates appropriate for the
retail system and not the system selling the water. This approach for
the purchased systems reflects the fact that although they will not
face increased costs from adding their own treatment, whatever costs
the wholesale utility incurs would likely be passed on as higher water
costs.
Table VI-15 shows the results of the household cost analysis. In
addition to mean and median estimates, the Agency calculated the 90th
and 95th percentile. EPA estimates that all households served by
surface and GWUDI sources will face some increase in household costs
due to implementation of the LT2ESWTR (except for those few served by
systems that have already installed 5.5 logs of treatment for
Cryptosporidium). Of all the households subject to the rule, from 24 to
35 percent are projected to incur costs for adding treatment, depending
on the Cryptosporidium occurrence data set used.
Approximately 95 percent of the households potentially subject to
the rule are served by systems serving at least 10,000 people; these
systems experience the lowest increases in costs due to significant
economies of scale. Over 90 percent of all households will face an
annual cost increase of less than $5. Households served by small
systems that install advanced technologies will face the greatest
increases in annual costs. EPA expects that the model's projections for
these systems are, in some cases, overstated. Some systems are likely
to find alternative treatment techniques such as other toolbox options
not included in this analysis, or sources of water (ground water,
purchased water, or consolidating with another system) that would be
less costly than installing more expensive treatment techniques.

Table VI-15.--Potential Annual Household Costs Impacts for the Preferred Regulatory Option (2000$)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percent of Percent of
systems with systems with
System: type/size Households Mean Median 90th 95th household household
Percentile Percentile cost increase cost increase
< $12 < $120
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Systems--ICR
--------------------------------------------------------------------------------------------------------------------------------------------------------
All CWS................................. 65,816,979 $1.68 $0.13 $4.06 $7.57 98.37 99.99
CWS <= 10,000........................... 3,318,012 4.61 1.34 13.04 14.92 87.88 99.88
-----------------------------------------
All Systems--ICRSSL
--------------------------------------------------------------------------------------------------------------------------------------------------------
All CWS................................. 65,816,979 $1.07 $0.03 $3.24 $5.43 98.31 100.00
CWS <= 10,000........................... 3,318,012 2.68 0.80 6.10 9.39 95.71 99.95
-----------------------------------------
All Systems--ICRSSM
--------------------------------------------------------------------------------------------------------------------------------------------------------
All CWS................................. 65,816,979 $1.28 $0.03 $3.48 $6.47 99.07 100.00
CWS <= 10,000........................... 3,318,012 3.27 0.80 6.62 13.04 93.90 99.93
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Chapter 6 of the LT2ESWTR Economic Analysis (USEPA 2003a).

F. What Are the Incremental Costs and Benefits of the Proposed
LT2ESWTR?

Incremental costs and benefits are those that are incurred or
realized in reducing Cryptosporidium exposures from one alternative to
the next. Estimates of incremental costs and benefits are useful in
considering the economic efficiency of different regulatory options
considered by the Agency. Generally, the goal of an incremental
analysis is to identify the regulatory option where incremental
benefits most closely equal incremental costs. However, the usefulness
of this analysis is limited because many benefits from this rule are
unquantified and not monetized. Incremental analyses should consider
both quantified and non-quantified (where possible) benefits and costs.
Usually an incremental analysis implies increasing levels of
stringency along a single parameter, with each alternative providing
all the protection of the previous alternative, plus additional
protection. However, the

[[Page 47753]]

regulatory alternatives in this rule vary by multiple parameters (e.g,
risk bin boundaries, treatment requirements). The comparison between
any two alternatives is, therefore, between two separate sets of
benefits, in the sense that they may be distributed to somewhat
different population groups.
The regulatory alternatives, however, do achieve increasing levels
of benefits at increasing levels of costs. As a result, it is possible
to display incremental net benefits from the baseline and alternative
to alternative. Tables VI-16a and VI-16b show incremental costs,
benefits, and net benefits for the four regulatory alternatives shown
in Table VI-1, using the enhanced and traditional COI, respectively.
All values are annualized present values expressed in Year 2000
dollars. The displayed values are the mean estimates for the different
occurrence distributions.
With the enhanced COI, incremental costs are generally closest to
incremental benefits for A2, a more stringent alternative than the
Preferred Alternative, A3. For the traditional COI, incremental costs
most closely equal incremental benefits for A3, the Preferred
Alternative, under the majority of conditions evaluated.
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G. Are There Benefits From the Reduction of Co-Occurring Contaminants?

This section presents information on the unquantified benefits that
will accrue from removal of other contaminants, primarily pathogens,
due to improved control of Cryptosporidium. While the benefits analysis
for the LT2ESWTR only includes reductions in illness and mortality
attributable to Cryptosporidium, the LT2ESWTR is expected to reduce
exposure to other parasitic protozoans that EPA regulates, or is
considering for future regulation. For example, it is expected that the
LT2ESWTR will improve control of Giardia lamblia, Cyclospora sp. and
members of the Microsporididea class, seven genera (10 species) of
which have been recovered in humans (Mota et al., 2000). In addition,
greater Cryptosporidium control may improve control of the pathogenic
bacteria and viruses. Chemical contaminants such as arsenic, DBPs and
atrazine may also be controlled, in part, by control of
Cryptosporidium, depending on the technologies selected.
Giardia lamblia and Cyclospora sp. are larger than Cryptosporidium,
while Microsporididea, bacteria, and the viruses are smaller than
Cryptosporidium. The expected removal of co-occurring microorganisms
can often be predicted for those treatment unit processes whose removal
efficiency

[[Page 47755]]

depends in part, or entirely, on the size of the organism. For example,
a study by Goodrich and Lykins (1995) evaluating bag filters showed
that any microbe or object greater than 4.5 microns in size (the
average size of Cryptosporidium) would be subject to removal ranging
from 0.5 to 2.0 logs.
Although not directly dependent on organism size, other treatment
technologies identified in the LT2ESWTR should also provide additional
control of co-occurring microbial pathogens. Membrane processes that
remove Cryptosporidium are shown to achieve equivalent log removal of
Giardia under worst-case and normal operating conditions (USEPA 2003c).
Reduction in individual filter turbidities will reduce concentrations
of other pathogens as well as Cryptosporidium. For example, in Dutch
surface water, Giardia and Cryptosporidium occurrence appeared to
correlate well with each other and for the Rhine River, with turbidity
(Medema et al. 2001). Thus, improved control of Cryptosporidium should
also result in improved control of Giardia lamblia.
Some membrane technologies that might be installed to comply with
the LT2ESWTR can also reduce or eliminate chemical contaminants
including arsenic, DBPs and atrazine. EPA has recently finalized a rule
to further control arsenic levels in drinking water and is concurrently
proposing the Stage 2 DBPR to address DBP control.
The extent to which the LT2ESWTR can reduce the overall risk from
other contaminants has not been quantitatively evaluated because of the
Agency's lack of data regarding the co-occurrence among Cryptosporidium
and other microbial pathogens and contaminants. Because of the
difficulties in establishing which systems would have multiple
problems, such as microbial contamination, arsenic, and DBPs or any
combination of the three, no estimate was made of the potential cost
savings from addressing more than one contaminant simultaneously.

H. Are There Increased Risks From Other Contaminants?

It is unlikely that the LT2ESWTR will result in a significant
increase in risk from other contaminants. Many of the options that
systems will select to comply with the LT2ESWTR, such as UV, improved
filtration performance, and watershed control, do not form DBPs. Other
technologies that are effective against Cryptosporidium, such as ozone
and chlorine dioxide, do form DBPs. However, these DBPs are currently
regulated under the Stage 1 DBPR, and systems will have to comply with
these regulations when implementing technologies to meet the LT2ESWTR.

I. What Are The Effects of the Contaminant on the General Population
and Groups Within the General Populations That Are Identified as Likely
To Be at Greater Risk of Adverse Health Effects?

Section II of this preamble discusses the health effects associated
with Cryptosporidium on the general population as well as the effects
on other sensitive sub-populations. In addition, health effects
associated with children and pregnant women are discussed in greater
detail in section VII.G of this preamble.

J. What Are the Uncertainties in the Baseline, Risk, Benefit, and Cost
Estimates for the Proposed LT2ESWTR as Well as the Quality and Extent
of the Information?

Today's proposal models the current baseline risk from
Cryptosporidium exposure, as well as the reduction in risk and the cost
for various rule options. There is uncertainty in the risk calculation,
the benefit estimate, the cost estimates, and the interaction of other
upcoming rules. Section IV of the proposed rule considers the
uncertainty with the risk estimates; however, a brief summary of the
major risk uncertainties as they relate to benefit estimation is
provided next. In addition, the LT2ESWTR EA has a more extensive
discussion of all of the uncertainties (USEPA 2003a).
In addition, the Agency conducted sensitivity analyses to address
uncertainty. The sensitivity analyses focus on various occurrence,
benefit and cost factors that may have a significant effect on the
estimated impacts of the rule. All of these sensitivity analyses are
explained in more detail in the EA for the LT2ESWTR (USEPA 2003a).
One area of uncertainty is associated with the estimate of
Cryptosporidium occurrence on a national basis. The Information
Collection Rule plant-mean data were higher than the ICRSS medium or
large system plant-mean data at the 90th percentile. The reasons for
these differing results are not well understood but may stem from
differences in the populations sampled, year-to-year variation in
occurrence, and systematic differences in the sampling and measurement
methods employed. These data suggest that Cryptosporidium levels are
relatively low in most water sources, but there is a subset of sources
with significantly higher concentrations. Additional uncertainty is
associated with estimating finished water occurrence because the
analysis is based on assumptions about treatment plant performance. To
account for these uncertainties, the Agency used Monte Carlo simulation
models that allow substantial variation in each estimate and computed
finished water occurrence values based on statistical sampling of the
variable estimates.
The risk associated with finished water occurrence is of lesser
uncertainty than is typical for many contaminants because the health
effects are measured based on Cryptosporidium challenge studies to
human volunteer populations. Nevertheless, there is significant
uncertainty about the dose-response associated with Cryptosporidium
because there exists considerable differences in infectivity among the
various tested Cryptosporidium parvum isolates. As described in section
III.B, the Agency accounted for these differences using Monte Carlo
simulations that randomly sampled from infectivity distributions for
the three tested isolates. The different simulations were designed to
account for the limited number of challenge studies and the variability
in the infectivity of the isolates themselves. In addition, because the
Cryptosporidium dosing levels in the human feeding studies were above
typical drinking water exposure levels (e.g., one oocyst), there
remains significant uncertainty that could not be quantified into the
analysis.
While all of the significant costs of today's proposed rule have
been identified by EPA, there are uncertainties about some of the
estimates. However, the Agency explored the impact of the uncertainties
that might have the greatest impact by conducting sensitivity analyses
and using Monte Carlo techniques. For example, section VI.D.2.f of
today's rule explores the impact of influent bromide levels on
technology selection. As shown in the EA for this rule, the impact of
higher influent bromide levels will not have a significant impact on
the rule's costs. In addition, subsection 6.12 of the EA summarizes
other cost uncertainties including the Agency's inability to include
some lower cost toolbox options in the cost analysis (USEPA 2003a).
Last, EPA has recently finalized new regulations for arsenic,
radon, Cryptosporidium in small surface water systems, and filter
backwash in all system sizes (LT1ESWTR and Filter Backwash Rule);
proposed a rule for microbials in ground water systems (Ground Water
Rule); and is

[[Page 47756]]

concurrently proposing additional control of disinfection byproducts
(Stage 2 Disinfection Byproducts Rule). These rules may have
overlapping impacts on some drinking water systems but the extent is
not possible to estimate because of lack of information on co-
occurrence. However, it is possible for a system to choose treatment
technologies that would address multiple contaminants. Therefore, while
the total cost impact of these drinking water rules is uncertain, it is
most likely less than the estimated total cost of all individual rules
combined.

K. What is the Benefit/Cost Determination for the Proposed LT2ESWTR?

The Agency has determined that the benefits of the proposed
LT2ESWTR justify the costs. As discussed in section VI.C, the proposed
rule provides a large reduction in endemic cryptosporidiosis illness
and mortalities. More stringent alternatives provide greater reductions
but at higher costs. Alternative A1 provides the greatest overall
reduction in illnesses and mortalities but the incremental benefits
between this option and the preferred option are relatively small while
the incremental costs are significant. In addition, the preferred
regulatory option, unlike option A1, specifically targets those systems
whose source water requires higher levels of treatment.
Tables VI-17a and VI-17b present net benefits for the four
regulatory alternatives that were evaluated. Generally, analysis of net
benefits is used to identify alternatives where benefits exceed costs,
as well as the alternative that maximizes net benefits. However, as
with the analysis of incremental net benefits discussed previously, the
usefulness of this analysis in evaluating regulatory alternatives for
the LT2ESWTR is limited because many benefits from this rule are un-
quantified and non-monetized. Analyses of net benefits should consider
both quantified and non-quantified (where possible) benefits and costs.
Also, as noted earlier, the regulatory alternatives considered for
the LT2ESWTR vary both in the population that experiences benefits and
costs (i.e., risk bin boundaries) and the magnitude of the benefits and
costs (i.e., treatment requirements). Consequently, the more stringent
regulatory alternatives provide benefits to population groups that do
not experience any benefit under less stringent alternatives.
As shown by Tables VI-17a and VI-17b, net benefits are positive for
all four regulatory alternatives evaluated. With the enhanced COI
(Table VI-17a), net benefits are highest for the Preferred Alternative,
A3, under the majority of occurrence distributions and discount rates
evaluated. When the traditional COI (Table VI-17b) is used, the
Preferred Alternative has the highest net benefits at a three percent
discount rate for the two of the occurrence distributions, the
Information Collection Rule and ICRSSM, while the least stringent
alternative, A4, is highest for the ICRSSL. At a seven percent discount
rate, A4 maximizes net benefits under all occurrence distributions.

Table VI-17a.-- Mean Net Benefits by Rule Option--Enhanced COI
($millions, 2000$)

[[Page 47757]]
[GRAPHIC]
[TIFF OMITTED]
TP11AU03.018

BILLING CODE 6560-50-C
In addition to the net benefits of the proposed LT2ESWTR, the
Agency used several other techniques to compare costs and benefits. For
example, EPA calculated the cost of the rule per case avoided. Table
VI-18 shows both the cost of the rule per illness avoided and cost of
the rule per death avoided. This cost effectiveness measure is another
way of examining the benefits and costs of the rule but should not be
used to

[[Page 47758]]

compare alternatives because an alternative with the lowest cost per
illness/death avoided may not result in the highest net benefits. With
the exception of alternative A1, the rule options look favorable from a
cost effectiveness analysis when you compare them to both the average
cost of cryptosporidiosis illness ($745 and $245 for the two COI
approaches) and the mean value of a death avoided--approximately $7
million dollars. Additional information about this analysis and other
methods of comparing benefits and costs can be found in chapter 8 to
the LT2ESWTR EA (USEPA 2003a).

Table VI-18.--Cost Per Illness or Death Avoided
----------------------------------------------------------------------------------------------------------------
Cost per illness Cost per death
avoided ($) avoided ($
Data set Rule alternative ------------------ millions, 2000$)
-----------------
3% 7% 3% 7%
----------------------------------------------------------------------------------------------------------------
A1............................ 339 244 2.5 1.8
A2............................ 128 93 0.9 0.7
ICR......................................... A3--Preferred................. 107 78 0.8 0.6
A4............................ 62 45 0.4 0.3
---------------------------------------------
A1............................ 1,098 789 8.0 5.7
A2............................ 356 259 2.5 1.8
ICRSSL...................................... A3--Preferred................. 282 208 1.9 1.4
A4............................ 165 122 1.1 0.8
---------------------------------------------
A1............................ 631 453 4.6 3.3
A2............................ 213 155 1.6 1.1
ICRSSM...................................... A3--Preferred................. 170 125 1.2 0.9
A4............................ 99 73 0.7 0.5
----------------------------------------------------------------------------------------------------------------
Source: Chapter 8 of the LT2ESWTR Economic Analysis (USEPA 2003a)

L. Request for Comment

The Agency requests comment on all aspects of the proposed rule's
economic impact analysis. Specifically, EPA seeks input into the
following issues:
? Both of the methodologies for valuing non-fatal
cryptosporidiosis and the use of a real income growth factor to adjust
these estimates for the years 2008 through 2027;
? How can the Agency fully incorporate all toolbox options
into the economic analysis?
? How can the Agency estimate the potential benefits from
reduced epidemic outbreaks of cryptosporidiosis?

VII. Statutory and Executive Order Reviews

A. 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, or Tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
Pursuant to the terms of Executive Order 12866, it has been
determined that this rule is a ``significant regulatory action.'' As
such, this action was submitted to OMB for review. Changes made in
response to OMB suggestions or recommendations will be documented in
the public record.

B. Paperwork Reduction Act

The information collection requirements in this proposed rule have
been submitted for approval to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document prepared by EPA has been
assigned EPA ICR number 2097.01.
The information collected as a result of this rule will allow the
States and EPA to determine appropriate requirements for specific
systems, and to evaluate compliance with the rule. For the first 3
years after LT2ESWTR promulgation, the major information requirements
concern monitoring activities and compliance tracking. The information
collection requirements are mandatory (part 141), and the information
collected is not confidential.
The estimate of annual average burden hours for the LT2ESWTR during
the first three years following promulgation is 145,854 hours. The
annual average cost estimate is $3.9 million for labor and $9.8 million
per year for operation and maintenance including lab costs (which is a
purchase of service). The burden hours per response is 1.47 hours and
the cost per response is $138.12. The frequency of response (average
responses per respondent) is 39, annually. The estimated number of
likely respondents is 2,560 (the product of burden hours per response,
frequency, and respondents does not total the annual average burden
hours due to rounding). Note that the burden hour estimates for the
first 3-year cycle include large system but not small system
monitoring. Conversely, burden estimate for the second 3-year cycle
will include small system monitoring but not large system, which will
have been completed by then.
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

[[Page 47759]]

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 in 40 CFR are listed in 40 CFR part 9.
To comment on the Agency's need for this information, the accuracy
of the provided burden estimates, and any suggested methods for
minimizing respondent burden, including the use of automated collection
techniques, EPA has established a public docket for this rule, which
includes this ICR, under Docket ID No. OW-2002-0039. Submit any
comments related to the ICR for this proposed rule to EPA and OMB. See
Addresses section at the beginning of this notice for where to submit
comments to EPA. Send comments to OMB at the Office of Information and
Regulatory Affairs, Office of Management and Budget, 725 17th Street,
NW., Washington, DC 20503, Attention: Desk Office for EPA. Since OMB is
required to make a decision concerning the ICR between 30 and 60 days
after August 11, 2003, a comment to OMB is best assured of having its
full effect if OMB receives it by September 10, 2003. The final rule
will respond to any OMB or public comments on the information
collection requirements contained in this proposal.

C. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis for any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or 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. secs. 601(3)-(5). In
addition to the above, to establish an alternative small business
definition, agencies must consult with SBA's Chief Council for
Advocacy.
For purposes of assessing the impacts of today's proposed rule on
small entities, EPA considered small entities to be public water
systems serving 10,000 or fewer persons. This is the cut-off level
specified by Congress in the 1996 Amendments to the Safe Drinking Water
Act 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 public
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 is applied to this proposed
regulation.
After considering the economic impacts of today's proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. We have
determined that 274 small systems, which are 2.32% of the 11,820 small
systems regulated by the LT2ESWTR, will experience an impact of one
percent or greater of average annual revenues; further, 31 systems,
which are 0.26% of the systems regulated by this rule, will experience
an impact of three percent or greater of average annual revenues (see
Table VII-1).

Table VII-1.--Annualized Compliance Cost as a Percentage of Revenues for Small Entities ($2000)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Systems experiencing Systems experiencing
Average annual costs of £% costs of £% of
Number of small estimated their revenues their revenues
Entity by system size systems revenuses per ---------------------------------------------------
(Percent) system ($) Percent of Number of Percent of Number of
sustem systems systems systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
A B E F=A*E G H=A*G
---------------------------------------------------------------
Small Governments............................................. 5,910 50 2,434,200 2.4 140 0.3 15
Small Businesses.............................................. 4,846 41 2,391,978 2.4 115 0.3 13
Small Organizations........................................... 1,064 9 4,446,165 1.2 13 0.1 1
All Small Entities............................................ 11,820 100 2,597,966 2.3 274 0.3 31
Note: Detail may not add due to independent rounding. Data are based on the means of the highest modeled distributions using Information Collection Rule
occurrence data set. Costs are discounted at 3 percent, summed to present value, and annualized over 25 years. Source: Chapter 7 of the LT2ESWTR EA
(USEPA 2003a).

The LT2ESWTR contains provisions that will affect systems serving
fewer than 10,000 people that use surface water or GWUDI as a source.
In order to meet the LT2ESWTR requirements, approximately 1,382 to
2,127 small systems would need to make capital improvements. Impacts on
small entities are described in more detail in Chapters 6 and 7 of the
Economic Analysis for the LT2ESWTR (USEPA 2003a). Table VII-2 shows the
annual compliance costs of the LT2ESWTR on the small entities by system
size and type based on a three percent discount rate (other estimates
based on different data sets and discount rates produce lower costs).
EPA has determined that in each size category, fewer than 20% of
systems and fewer than 1000 systems will experience an impact of one
percent or greater of average annual revenues (USEPA 2003a).

[[Page 47760]]

Table VII-2.--Annual Compliance Costs for the Proposed LT2ESWTR by System Size and Type
[$Millions, 2000$]
----------------------------------------------------------------------------------------------------------------
System size (population served)
System type --------------------------------------------------------------- Total
<100 101-500 501-1,000 1,001-3,300 3,301-10,000
----------------------------------------------------------------------------------------------------------------
Public owned......................... $0.46 $0.88 $0.94 $2.62 $5.57 $10.37
Privately owned...................... 1.00 0.71 0.22 0.31 0.36 2.60
All systems.......................... 1.45 1.59 1.07 2.92 5.93 12.97
----------------------------------------------------------------------------------------------------------------
Note: Results are based on the mean of the Information Collection Rule Cryptosporidium occurrence distribution.
Costs are annualized at a three percent discount rate.
Source: Appendix D and Q of the LT2ESWTR EA (USEPA 2003a).

Although this proposed rule will not have a significant economic
impact on a substantial number of small entities, EPA nonetheless has
tried to reduce the impact of this rule on small entities. The LT2ESWTR
contains a number of provisions to minimize the impact of the rule on
systems generally, and on small systems in particular. The risk-
targeted approach of the LT2ESWTR will impose additional treatment
requirements only on the subset of systems with the highest
vulnerability to Cryptosporidium, as indicated by source water pathogen
levels. This approach will spare the majority of systems from the cost
of installing additional treatment. Also, development of the microbial
toolbox under the LT2ESWTR will provide both large and small systems
with broad flexibility in selecting cost-effective compliance options
to meet additional treatment requirements.
Small systems will monitor for E. coli as a screening analysis for
source waters with low levels of fecal contamination. Cryptosporidium
monitoring will only be required of small systems if they exceed the E.
coli trigger value. Because E. coli analysis is much cheaper than
Cryptosporidium analysis, the use of E. coli as a screen will
significantly reduce monitoring costs for the majority of small
systems. In order to allow EPA to review Cryptosporidium indicator
relationships in large system monitoring data, small systems will not
be required to initiate their monitoring until large system monitoring
has been completed. This will provide small systems with additional
time to become familiar with the rule and to prepare for monitoring and
other compliance activities.
Funding would be available from programs administered by EPA and
other Federal agencies to assist small public water systems (PWSs) in
complying with the LT2ESWTR. The Drinking Water State Revolving Fund
(DWSRF) assists PWSs with financing the costs of infrastructure needed
to achieve or maintain compliance with SDWA requirements. Through the
DWSRF, EPA awards capitalization grants to States, which in turn can
provide low-cost loans and other types of assistance to eligible PWSs.
Loans made under the program can have interest rates between 0 percent
and market rate and repayment terms of up to 20 years. States
prioritize funding based on projects that address the most serious
risks to human health and assist systems most in need. Congress
provided $1.275 billion for the DWSRF program in fiscal year 1997, and
has provided an additional $3.145 billion for the DWSRF program for
fiscal years 1998 through 2001.
The DWSRF places an emphasis on small and disadvantaged
communities. States must provide a minimum of 15% of the available
funds for loans to small communities. A State has the option of
providing up to 30% of the grant awarded to the State to furnish
additional assistance to State-defined disadvantaged communities. This
assistance can take the form of lower interest rates, principal
forgiveness, or negative interest rate loans. The State may also extend
repayment terms of loans for disadvantaged communities to up to 30
years. A State can set aside up to 2% of the grant to provide technical
assistance to systems serving communities with populations fewer than
10,000.
In addition to the DWSRF, money is available from the Department of
Agriculture's Rural Utility Service (RUS) and Housing and Urban
Development's Community Development Block Grant (CDBG) program. RUS
provides loans, guaranteed loans, and grants to improve, repair, or
construct water supply and distribution systems in rural areas and
towns of up to 10,000 people. In fiscal year 2002, RUS had over $1.5
billion of available funds for water and environmental programs. The
CDBG program includes direct grants to States, which in turn are
awarded to smaller communities, rural areas, and colon as in Arizona,
California, New Mexico, and Texas and direct grants to U.S. territories
and trusts. The CDBG budget for fiscal year 2002 totaled over $4.3
billion.
Although not required by the RFA to convene a Small Business
Advocacy Review (SBAR) Panel because EPA determined that this proposal
would not have a significant economic impact on a substantial number of
small entities, EPA did convene a panel to obtain advice and
recommendations from representatives of the small entities potentially
subject to this rule's requirements.
Before convening the SBAR Panel, EPA consulted with a group of 24
small entity stakeholders likely to be impacted by the LT2ESWTR and who
were asked to serve as Small Entity Representatives (SERs) after the
Panel was convened. The small entity stakeholders included small system
operators, local government representatives, and representatives of
small nonprofit organizations. The small entity stakeholders were
provided with background information on SDWA and potential alternatives
for the LT2ESWTR in preparation for teleconferences on January 28,
2000, February 25, 2000, and April 7, 2000. This information package
included data on preliminary unit costs for treatment enhancements
under consideration.
During these three conference calls, the information that had been
provided to the small entity stakeholders was discussed and EPA
responded to questions and recorded initial comments. Following the
three calls, the small entity stakeholders were asked to provide input
on the potential impacts of the rule from their perspective. Seven
small entity stakeholders provided written comments on these materials.
The SBAR Panel convened on April 25, 2000. The small entity
stakeholders comments were provided to the SBAR Panel when it convened.
After a teleconference between the SERs and the SBAR Panel on May 25,
2000, the SERs were invited to provide additional

[[Page 47761]]

comments on the information provided. Seven SERs provided additional
comments on the rule components.
The SBAR Panel's report, Final Report of the Small Business
Advocacy Review Panel on Stage 2 Disinfectants and Disinfection
Byproducts Rule (Stage 2 DBPR) and Long Term 2 Enhanced Surface Water
Treatment Rule (LT2ESWTR) (USEPA 2000f), the SERs comments on the
LT2ESWTR, and the background information provided to the SBAR Panel and
the SERs are available for review in the docket for today's proposal
(http://www.epa.gov/edocket/).
In general, the SERs who were consulted on the LT2ESWTR were
concerned about the impact of these proposed rules on small water
systems, the ability of small systems to acquire the technical and
financial capability to implement requirements while maintaining
flexibility to tailor the requirements to their needs, and the
limitations of small systems. The SBAR Panel evaluated information and
small-entity comments on issues related to the impact of the LT2ESWTR.
The LT2ESWTR takes into consideration the recordkeeping and
reporting concerns identified by the SBAR Panel and the SERs. The SBAR
Panel recommended that EPA evaluate ways to minimize the recordkeeping
and reporting burdens under the rule by ensuring that the States have
appropriate capacity for rule implementation, and that EPA provide as
much monitoring flexibility as possible to small systems. EPA believes
that the continuity with the IESWTR and LT1ESWTR was maintained to the
extent possible to ease the transition to the LT2ESWTR, especially for
small systems. The LT2ESWTR builds on the protection afforded under the
IESWTR and LT1ESWTR, while minimizing the impact on small systems by
using a risk-targeted approach (i.e., source water monitoring) to
identify systems that are still at risk from Cryptosporidium exposure.
The SBAR Panel noted the concern of several SERs that flexibility
be provided in the compliance schedule of the rule. SERs commented on
the technical and financial limitations of some small systems, the
significant learning curve for operators with limited experience, and
the need to continue providing uninterrupted service as reasons why
additional compliance time may be needed for small systems. The SBAR
Panel encouraged EPA to keep these limitations in mind in developing
the proposed rule and provide as much compliance flexibility to small
systems as is allowable under SDWA.
EPA has concluded that the proposed schedule for the LT2ESWTR
provides sufficient time for small systems to achieve compliance. The
schedule for small system monitoring and compliance with additional
treatment requirements lags behind the schedule for large systems. The
basis for the lagging schedule for small systems is that it allows EPA
to confirm or refine the E. coli screening criteria that small systems
will use to reduce monitoring costs. However, the lagging schedule also
provides greater time for small systems to become knowledgeable about
the LT2ESWTR, including the new monitoring requirements, and to become
familiar with innovative technologies, like UV, that may be used by
some small systems to meet additional treatment requirements.
Some SERs emphasized that EPA needs to maintain an appropriate
balance between control of known microbial risks through adequate
disinfection and for the more uncertain risks that may be associated
with DBPs. The SBAR Panel did not foresee any potential conflict
between rules regulating control of microbial contaminants and those
regulating DBPs. EPA also believes that today's proposal and the
accompanying proposed Stage 2 DBPR achieve an appropriate balance
between microbial and DBP risks. The profiling and benchmarking
requirements described in section IV.D of this preamble will ensure
that systems maintain protection against pathogens as they make
treatment changes to control the formation of DBPs.
The SBAR Panel considered a wide range of options and regulatory
alternatives for providing small businesses with flexibility in
complying with the LT2ESWTR. The SBAR Panel was concerned with the
option of an across-the-board additional Cryptosporidium inactivation
requirement because of the potential high cost to small systems and the
uncertainty regarding the extent to which implementation of the
LT1ESWTR will adequately address Cryptosporidium contamination at small
systems. The SBAR Panel noted that, at the time, the Stage 2 M-DBP
Federal Advisory Committee was exploring a targeted approach to
Cryptosporidium control based on limited monitoring and system
assessment, which would identify a subset of vulnerable systems to
provide additional treatment in the range of 0.5-to 2.5-log reduction.
Further, this approach would allow E. coli monitoring in lieu of
Cryptosporidium monitoring as a screening device for small systems. The
SBAR Panel was also encouraged by recent developments suggesting that
UV is a viable, cost-effective means of fulfilling any additional
inactivation requirements.
The SBAR Panel recommended that, in developing any additional
inactivation requirements based on a targeted approach, EPA carefully
consider the potential impacts on small systems and attempt to
structure the regulatory requirements in a way that would minimize
burden on this group. The SBAR Panel supported E. coli as an indicator
parameter if additional monitoring is required. The SBAR Panel further
recommended that, among the options EPA analyzes, the Agency also
evaluate the option of not imposing any additional Cryptosporidium
control requirements on small systems at this time, as it considers
various options to address microbial concerns. Under this option, EPA
would evaluate the effects of LT1ESWTR, once implemented, and then
consider whether to impose additional requirements during its next 6-
year review of the standard, as required by SDWA.
EPA considered these recommendations and has concluded that
available information on the health risk associated with
Cryptosporidium in drinking water warrant moving forward with today's
proposal to address higher risk systems. In developing the proposed
LT2ESWTR, EPA has implemented the Advisory Committee's recommendations
to minimize burden on small systems. Specifically, the risk-targeted
treatment requirements will substantially reduce overall costs for
small systems in comparison to requiring additional treatment by all
systems, and the use of E. coli screening will allow most small systems
to avoid the cost of Cryptosporidium monitoring. Consequently, the
Agency has concluded that today's proposal achieves an appropriate
balance between public health protection and limiting the economic
burden imposed on small entities.
We continue to be interested in the potential impacts of the
proposed rule on small entities and welcome comments on issues related
to such impacts.

D. 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 section 202 of UMRA,

[[Page 47762]]

EPA generally must prepare a written statement, including a cost-
benefit analysis, for proposed and final rules with ``Federal
mandates'' that may result in expenditures to State, local and Tribal
governments, in the aggregate, or to the private sector, of $100
million or more in any one year. Before promulgating an EPA rule for
which a written statement is needed, section 205 of the UMRA generally
requires EPA to identify and consider a reasonable number of regulatory
alternatives and adopt the least costly, most cost-effective or least
burdensome alternative that achieves the objectives of the rule. The
provisions of section 205 do not apply when they are inconsistent with
applicable law. Moreover, section 205 allows EPA to adopt an
alternative other than the least costly, most cost-effective or least
burdensome alternative if the Administrator publishes 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.
2. Written Statement for Rules With Federal Mandates of $100 Million or
More
EPA has determined that this rule contains a Federal mandate that
may result in expenditures of $100 million or more for State, local,
and Tribal governments, in the aggregate, or the private sector in any
one year. Accordingly, EPA has prepared under section 202 of the UMRA a
written statement which is summarized in this section. Table VII-3
illustrates the annualized public and private costs for the LT2ESWTR.

Table VII-3.--Public and Private Costs of the Proposed LT2ESWTR
----------------------------------------------------------------------------------------------------------------
Range of annualized costs
(Million $, 2000$)
-------------------------------- Percent of
3% Discount 7% Discount total cost
rate rate
----------------------------------------------------------------------------------------------------------------
PWS Costs....................................................... $45.7-69.0 $50.2-75.2 62.2-62.4
State Costs..................................................... 0.9-1.0 1.2-1.2 1.3-0.9
Tribal Costs.................................................... 0.1-0.2 0.1-0.2 0.1-0.1
-----------------
Total Public Costs.......................................... 46.7-70.1 51.5-76.6 63.6-63.4
Total Private Costs......................................... 26.8-40.4 29.4-44.1 36.4-36.6
-----------------
Total Costs............................................. 73.5-110.5 80.9-120.7 100.0-100.0
----------------------------------------------------------------------------------------------------------------
Note: The ranges represent the ICRSSL (lowest) and Information Collection Rule (highest) modeled Cryptosporidium
occurrence distributions. Detail may not add due to independent rounding.
Source: The LT2ESWTR Economic Analysis (USEPA 2003a).

A more detailed description of this analysis is presented in
Economic Analysis for the LT2ESWTR (USEPA 2003a).
a. Authorizing legislation. As noted in section II, today's
proposed rule is promulgated pursuant to section 1412 (b)(1)(A) of the
Safe Drinking Water Act (SDWA), as amended in 1996, which directs EPA
to promulgate a national primary drinking water regulation for a
contaminant if EPA determines that the contaminant may have an adverse
effect on the health of persons, occurs in public water systems with a
frequency and at levels of public health concern, and regulation
presents a meaningful opportunity for health risk reduction.
b. Cost-benefit analysis. Section VI of this preamble discusses the
cost and benefits associated with the LT2ESWTR. Details are presented
in the Economic Analysis for the LT2ESTWR (USEPA 2003a). For the
LT2ESWTR proposal, EPA quantified costs and benefits for four
regulatory alternatives. The four alternatives are described in section
VI. Table VII-4 summarizes the range of annual costs and benefits for
each alternative.

Table VII-4.--Annual Benefits and Costs of Rule Alternatives
[$Million]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Enhanced COI Traditional Enahnced COI Tradition COI
range of COI range of range of range of Range of Range of
Regulatory Alternative annualized annualized annualized annualized annualized annualized
benefits (3%) benefits (3%) benefits (7%) benefits (7%) costs (3%) costs (7%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alternative A1.......................................... $457-1,492 $305-989 $389-1,260 $260-845 $361 $388
Alternative A2.......................................... 397-1,461 268-977 338-1,243 229-834 100-134 108-145
Alternative A3.......................................... 374-1,445 253-967 318-1,230 216-826 73-111 81-121
(Preferred Alternative).................................
Alternative A4.......................................... 328-1,349 225-907 279-1,148 192-775 37-59 41-65
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: The LT2ESWTR Economic Analysis (USEPA 2003a).

c. Estimates of future compliance costs and disproportionate
budgetary effects. To meet the UMRA requirement in section 202, EPA
analyzed future compliance costs and possible disproportionate
budgetary effects. The Agency believes that the cost estimates,
indicated earlier and discussed in more detail in section VI of this
preamble,

[[Page 47763]]

accurately characterize future compliance costs of the proposed rule.
In analyzing disproportionate impacts, the Agency considered the
impact on (1) different regions of the United States, (2) State, local,
and Tribal governments, (3) urban, rural and other types of
communities, and (4) any segment of the private sector. This analysis
is presented in section 7 of Economic Analysis for the LT2ESWTR (USEPA
2003a).
EPA has concluded that the LT2ESWTR will not cause a
disproportionate budgetary effect. This rule imposes the same
requirements on systems nationally and does not disproportionately
affect any segment. This rule will treat similarly situated systems (in
terms of size, water quality, available data, installed technology, and
presence of uncovered finished storage facilities) in similar
(proportionate) ways, without regard to geographic location, type of
community, or segment of industry. The LT2ESWTR is a rule where
requirements are proportionate to risk. Although some groups may have
differing budgetary effects as a result of LT2ESWTR, those costs are
proportional to the need for greater information (monitoring) and risk
posed (degree of treatment required). The variation in cost between
large and small systems is due to economies of scale (a larger system
can distribute cost across more customers). Regions will have varying
impacts due to the number of affected systems.
d. Macro-economic effects. Under UMRA section 202, EPA is required
to estimate the potential macro-economic effects of the regulation.
These types of effects include those on productivity, economic growth,
full employment, creation of productive jobs, and international
competitiveness. Macro-economic effects tend to be measurable in
nationwide econometric models only if the economic impact of the
regulation reaches 0.25 percent to 0.5 percent of Gross Domestic
Product (GDP). In 2000, real GDP was $9,224 billion, so a rule would
have to cost at least $23 billion to have a measurable effect. A
regulation with a smaller aggregate effect is unlikely to have any
measurable impact unless it is highly focused on a particular
geographic region or economic sector.
The macro-economic effects on the national economy from the
LT2ESWTR should not have a measurable effect because the total annual
costs for the proposed option range from $73 million to $111 million
based on median Cryptosporidium occurrence distributions from the
ICRSSL and Information Collection Rule data sets and a discount rate of
3 percent ($81 to $121 million at a 7 percent discount rate). These
annualized figures will remain constant over the 25-year implementation
period that was evaluated, while GDP will probably continue to rise.
Thus, LT2ESWTR costs measures as a percentage of the national GDP will
only decline over time. Costs will not be highly focused on a
particular geographic region or sector.
e. Summary of EPA consultation with State, local, and Tribal
governments and their concerns. Consistent with the intergovernmental
consultation provisions of section 204 of UMRA, EPA has already
initiated consultations with the governmental entities affected by this
rule. 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 governments of regulatory requirements being
considered.
The Stage 2 M-DBP Federal Advisory Committee included
representatives from State government (Association of State Drinking
Water Administrators, Environmental Commissioners of States), local
government (National League of Cities), and Tribes (All Indian Pueblo
Council (AIPC)). Government and Tribal representatives on the Advisory
Committee were generally concerned with ensuring that drinking water
regulations are adequately protective of public health and that any
additional public health expenditures due to new regulations achieve
significant risk reduction. The proposed LT2ESWTR reflects the
consensus recommendations of the Advisory Committee, as stated in the
Agreement in Principle (65 FR 83015, December 29, 2000). Consequently,
EPA believes that the risk-targeted approach for additional
Cryptosporidium treatment requirements and other provisions in today's
proposal satisfies the concerns of the government and Tribal
representatives on the Advisory Committee.
As described in section VII.C of this preamble, the Agency convened
a Small Business Advocacy Review (SBAR) Panel in accordance with the
Regulatory Flexibility Act (RFA) as amended by the Small Business
Regulatory Enforcement Fairness Act to address the concerns of small
entities, including small local governments specifically. Small entity
representatives (SERs) to the SBAR panel, including representatives of
small local governments, were concerned about the cost of the rule, the
technical capability of small systems to implement requirements, and
flexibility in regulatory requirements and in the compliance schedule.
SERs also emphasized that EPA needs to balance the control of known
microbial risks with the risks associated with DBPs.
Today's proposal is responsive to these concerns, as stated in
section VII.C. The LT2ESWTR will impose costs for additional treatment
on only the fraction of systems identified through monitoring as being
at higher risk, and overall monitoring costs for small systems will be
greatly reduced through use of the E. coli screening to waive small
systems from Cryptosporidium monitoring. The microbial toolbox of
treatment options will provide significant flexibility to systems to
identify cost-effective solutions for meeting additional
Cryptosporidium treatment requirements. The compliance schedule for
small systems is delayed in relation to large systems, which will allow
small systems additional time to become knowledgeable about and prepare
to implement the LT2ESWTR. The intent of the proposed disinfection
profiling provisions is to ensure that when systems make treatment
changes to control DBP formation, they maintain protection against
pathogens.
EPA held a meeting on the LT2ESWTR in February 2001 with
representatives of State and local governments. Representatives of the
following organizations attended: Association of State Drinking Water
Administrators (ASDWA), the National Governors' Association (NGA), the
National Conference of State Legislatures (NCSL), the International
City/County Management Association (ICMA), the National League of
Cities (NLC), the County Executives of America, and health departments.
Representatives asked questions regarding how Cryptosporidium gets into
the water, whether EPA would add laboratory approval for
Cryptosporidium to State certification programs, the effectiveness of
ozone and UV, and the development of ambient water quality criteria for
Cryptosporidium.
EPA has largely addressed these questions in this preamble. Section
II characterizes sources of Cryptosporidium. As described in section
IV.K, EPA is currently carrying out a laboratory approval program for
Cryptosporidium analyses but expects that this will be included in
State laboratory certification programs in the future. In section
IV.C., EPA describes the effectiveness of ozone and UV for
Cryptosporidium inactivation and provides criteria for how these
technologies may be used to comply with the treatment requirements in

[[Page 47764]]

today's proposal. The Agency is currently exploring the development of
ambient water quality criteria for Cryptosporidium, but such criteria
are not available at this time and are not included in today's
proposal.
In addition to the Tribal representative on the Advisory Committee,
EPA conducted outreach and consultation with Tribal representatives on
a number of occasions regarding the LT2ESWTR. EPA presented the
LT2ESWTR at the following forums: the 16th Annual Consumer Conference
of the National Indian Health Board, which included over 900
representatives of Tribes across the nation; the annual conference of
the National Tribal Environmental Council, at which over 100 Tribes
were represented; and the 1999 EPA/Inter-Tribal Council of Arizona,
which included representatives from 15 Tribes. EPA also sent the
presentation materials used in the first two meetings and meeting
summaries to over 500 Tribes and Tribal organizations.
Fact sheets describing the requirements of the LT2ESWTR and
requesting Tribal input were distributed at an annual EPA Tribal
meeting in San Francisco and at a Native American Water Works
Association meeting in Scottsdale, Arizona. EPA also worked through its
Regional Indian Coordinators and the National Tribal Operations
Committee to raise awareness of the development of the proposed rule.
EPA mailed all Federal Tribes LT2ESWTR fact sheets in November 2000.
The Tribal representative to the Advisory Committee also presented the
Stage 2 Agreement in Principle prior to signature in at least one
political forum for various Tribes not affiliated with AIPC.
EPA held a teleconference in January 2002 with 12 Tribal
representatives and four Regional Tribal Program Coordinators. Prior to
the teleconference, EPA sent invitations to all Federal Tribes, along
with a fact sheet explaining the LT2ESWTR.
Through this consultation, Tribal representatives expressed concern
about implementing new regulations without additional funding sources.
However, they also stated that the LT2ESWTR would have a benefit, and
asserted that people served by small systems should receive equivalent
public health protection. Questions were asked regarding the impact of
the rule (e.g., number of Tribal surface water systems) and the date
for finalizing the rule. The Tribal representative to the M-DBP
Advisory Committee advocated that risk mitigation plans for uncovered
finished water storage facilities should account for cultural uses by
Tribes.
In response to the concerns expressed by Tribal representatives,
EPA noted that the LT2ESWTR proposal is designed to minimize costs by
targeting higher risk systems, and includes other provisions, described
earlier, to reduce burden. Moreover, the projected benefits of the rule
substantially exceed costs. EPA also explained that capital projects
related to the rule would be eligible for Federal funding sources, such
as the Drinking Water State Revolving Fund, due to the health risks
associated with Cryptosporidium. The LT2ESWTR Economic Analysis (USEPA
2003a) provides an analysis of the impact of the LT2ESWTR on Tribes.
EPA has identified 67 Tribal water systems that would be subject to the
LT2ESWTR.
In addition to these direct consultations with State, local, and
Tribal governments, EPA posted a pre-proposal draft of the LT2ESWTR
proposal on an EPA Internet site (http://www.epa.gov/safewater/) in
November 2001. EPA received comments on this pre-proposal draft from
ASDWA and six States, several public water systems owned by local
governments, as well as private water systems, laboratories, and other
stakeholders. Among the concerns raised by commenters representing
State and local governments were the following: early implementation of
monitoring by large systems; flexibility for States in awarding
treatment credits to different Cryptosporidium control technologies;
and the added burden of the rule on systems and States.
EPA has addressed these concerns in developing the LT2ESWTR
proposal. As described in section IV.J, EPA is planning to directly
implement the large system monitoring requirements that occur during
the first 2.5 years after promulgation. The planned approach is similar
to that used for the UCMR, including an electronic data reporting
system for storing monitoring results and tracking compliance. With
this approach, States will be able to access data reported by their
systems, thereby allowing States to exercise oversight of their systems
during early implementation if they chose. However, EPA will take
primary responsibility for providing technical assistance to systems
and assessing compliance with monitoring requirements.
In regard to treatment credit for Cryptosporidium control
technologies, the Agency has made substantial efforts to ensure that
the criteria in today's proposal are based on the best available data.
EPA has worked in partnership with industry and researchers to gather
information, and proposed criteria for several microbial toolbox
options reflect comments by the Science Advisory Board. In addition,
today's proposal gives flexibility to States by allowing them to award
different levels of Cryptosporidium treatment credit to their systems
based on site-specific demonstrations.
With respect to the burden the LT2ESWTR would place on water
systems and States, EPA has, as described previously in this preamble,
attempted to minimize overall costs under the proposed LT2ESWTR. This
is achieved through risk-targeting of additional treatment
requirements, allowing most small systems to avoid Cryptosporidium
monitoring costs through E. coli screening, and facilitating the use of
lower cost treatment technologies like UV.
In summary, EPA has concluded that the proposed option for the
LT2ESWTR is needed to provide a significant public health benefit by
reducing exposure to Cryptosporidium. While many public water systems
achieve adequate control of Cryptosporidium, additional treatment
should be required for filtered systems with elevated source water
pathogen levels and for unfiltered systems. The availability of
improved analytical methods allows additional treatment requirements to
be targeted to higher risk systems, and the development of technologies
like UV makes it feasible for systems to provide additional treatment.
The monetized benefits of today's proposal significantly exceed total
costs, and EPA believes there will be substantial unquantified benefits
as well.
f. Regulatory alternatives considered. As required under section
205 of UMRA, EPA considered several regulatory alternatives to address
systems at risk for contamination by microbial pathogens, specifically
including Cryptosporidium. A detailed discussion of these alternatives
can be found in section VI of the preamble and also in the Economic
Analysis for the LT2ESWTR (USEPA 2003a).
g. Selection of the least costly, most cost-effective, or least
burdensome alternative that achieves the objectives of the rule. Among
the regulatory alternatives considered for the LT2ESWTR, as described
in section VI, the Agency believes the proposed alternative is the most
cost-effective that achieves the objectives of the rule. The objective
of the LT2ESWTR is to reduce risk from Cryptosporidium and other
pathogens in systems where current regulations do not provide
sufficient protection.
The Agency evaluated a less costly and less burdensome alternative.

[[Page 47765]]

However, this alternative would provide no benefit to several thousand
consumers who, under the proposed alternative, would receive benefits
that most likely exceed their costs, based on Agency estimates. This is
illustrated in the LT2ESWTR Economic Analysis (USEPA 2003a). By failing
to reduce risk for consumers where additional treatment requirements
would be cost-effective, the less costly alternative does not appear to
achieve the objectives of the LT2ESWTR.
The other alternatives considered by the Agency achieve the
objectives of the rule, but are more costly, more burdensome, and
potentially less cost-effective. The proposed alternative targets
additional treatment requirements to systems with the highest
vulnerability to Cryptosporidium, and maximizes net benefits under a
broad range of conditions (USEPA 2003a). Consequently, the Agency has
found the proposed alternative to be the most cost-effective among
those that achieve the objectives of the rule.
3. Impacts on Small Governments
EPA has determined that this rule contains no regulatory
requirements that might significantly or uniquely affect small
governments. Thus, today's rule is not subject to the requirements of
section 203 of UMRA. As described in section VII.C, EPA has certified
that this proposed rule will not have a significant economic impact on
a substantial number of small entities. Estimated annual expenditures
by small systems for the LT2ESWTR range from $7.9 to $13.0 million at a
3% discount rate and $8.0 to $13.0 million at a 7% discount rate. While
the treatment requirements of the LT2ESWTR apply uniformly to both
small and large public water systems, large systems bear a majority of
the total costs of compliance with the rule. This is due to the fact
that large systems treat a majority of the drinking water that
originates from surface water sources.

E. Executive Order 13132: 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.''
Under Executive Order 13132, EPA may not issue a regulation that
has federalism implications, that imposes substantial direct compliance
costs, and that is not required by statute, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by State and local governments, or EPA consults with
State and local officials early in the process of developing the
proposed regulation.
EPA has concluded that this proposed rule may have federalism
implications, because it may impose substantial direct compliance costs
on State or local governments, and the Federal government will not
provide the funds necessary to pay those costs. The proposed rule may
result in expenditures by State, local, and Tribal governments, in the
aggregate of $100 million or more in any one year. Costs are estimated
to range from $73 to $111 million at a 3 percent discount rate and $81
to $121 million using a 7 percent discount rates based on the median
distribution modeled from ICRSSL and Information Collection Rule
Cryptosporidium occurrence data sets. Accordingly, EPA provides the
following federalism summary impact statement as required by section
6(b) of Executive Order 13132.
EPA consulted with representatives of State and local officials
early in the process of developing the proposed regulation to permit
them to have meaningful and timely input into its development. Section
VII.D.2.e describes EPA's consultation with representatives of State
and local officials. This consultation included State and local
government representatives on the Stage 2 M-DBP Federal Advisory
Committee, the representatives from small local governments to the SBAR
panel, a meeting with representatives from ASDWA, NGA, NCSL, ICMA, NLC,
the County Executives of America, and health departments, consultation
with Tribal governments at four meetings, and comments from State and
local governments on a pre-proposal draft of the LT2ESWTR.
Representatives of State and local officials were generally
concerned with ensuring that drinking water regulations are adequately
protective of public health and that any additional regulations achieve
significant health benefits in return for required expenditures. They
were specifically concerned with the burden of the proposed rule, both
in cost and technical complexity, giving flexibility to systems and
States, balancing the control of microbial risks and DBP risks, funding
for implementing new regulations, equal protection for small systems,
and early implementation of monitoring by large systems.
EPA has concluded that the proposed LT2ESWTR is needed to reduce
the public health risk associated with Cryptosporidium in drinking
water. Estimated benefits for the rule are significantly higher than
costs. Further, as described in this section and in section VII.D.2.e,
the Agency believes that today's proposal addresses many of the
concerns expressed by representatives of government officials.
Under the proposed LT2ESWTR, expenditures for additional treatment
are targeted to the fraction of systems with the highest vulnerability
to Cryptosporidium, thereby minimizing burden for the majority of
systems that will not be required to provide additional treatment. The
microbial toolbox of compliance options will provide flexibility to
systems in meeting additional treatment requirements, and States have
the flexibility to award treatment credits based on site-specific
demonstrations. Disinfection profiling provisions are intended to
ensure that systems do not reduce microbial protection as they take
steps to reduce exposures to DBPs.
The LT2ESWTR achieves equal public health protection for small
systems. However, the use of E. coli monitoring by small systems as a
screening analysis to determine the need for Cryptosporidium monitoring
will reduce monitoring costs for most small systems. Capital projects
related to the rule would be eligible for funding from the Drinking
Water State Revolving Fund, which includes specific funding for small
communities. EPA is planning to support the initial monitoring by large
systems that takes place within the first 2.5 years after promulgation.
This will substantially reduce the burden on States associated with
early implementation of monitoring requirements.
In the spirit of Executive Order 13132, and consistent with EPA
policy to promote communications between EPA and State and local
governments, EPA specifically solicits comment on this proposed rule
from State and local officials.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (59 FR 22951, November 9, 2000),
requires EPA

[[Page 47766]]

to develop ``an accountable process to ensure meaningful and timely
input by Tribal officials in the development of regulatory policies
that have Tribal implications.'' ``Policies that have Tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes.''
Under Executive Order 13175, EPA may not issue a regulation that
has Tribal implications, that imposes substantial direct compliance
costs, and that is not required by statute, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by Tribal governments, or EPA consults with Tribal
officials early in the process of developing the proposed regulation
and develops a Tribal summary impact statement.
EPA has concluded that this proposed rule may have Tribal
implications, because it may impose substantial direct compliance costs
on Tribal governments, and the Federal government will not provide the
funds necessary to pay those costs. EPA has identified 67 Tribal water
systems serving a total population of 78,956 that may be subject to the
LT2ESWTR. They will bear an estimated total annualized cost of $135,974
at a 3 percent discount rate ($138,910 at 7 percent) to implement this
rule as proposed. Estimated mean annualized cost per system ranges from
$792 to $23,979 at a 3 percent discount rate ($844 to $26,194 at 7
percent) depending on system size (see section 7 of the LT2ESWTR
Economic Analysis (USEPA 2003a) for details). Accordingly, EPA provides
the following Tribal summary impact statement as required by section
5(b) of Executive Order 13175.
EPA consulted with representatives of Tribal officials early in the
process of developing this regulation to permit them to have meaningful
and timely input into its development. Section VII.D.2.e describes
EPA's outreach and consultation with Tribes, which included
presentations on the LT2ESWTR at four Tribal conferences and meetings,
mailing fact sheets and presentation materials regarding the proposal
to Tribes on several occasions, and a teleconference with
representatives of Tribal officials to comment on the proposed rule.
As discussed in section VII.D.2.e, Tribal representatives stated
that protection of public health is important regardless of the number
of people a system is serving, and they recognized that the LT2ESWTR
would provide a public health benefit. However, Tribal representatives
were concerned about the availability of funding to implement the
regulation and asked about the projected impact on Tribes (e.g., number
of Tribal surface water systems that would be affected). Also, the
Tribal representative to the Federal Advisory Committee was concerned
that risk mitigation plans for uncovered finished water storage
facilities account for cultural uses by Tribes.
EPA has concluded that the proposed LT2ESWTR is needed to reduce
the risk associated with Cryptosporidium in public water systems using
surface water sources. Projected benefits for today's proposal are
substantially greater than costs. Moreover, as described in this
section and in section VII.D.2.e, today's proposal addresses many of
the concerns stated by Tribal representatives.
The LT2ESWTR will provide equivalent public health protection to
all system sizes, including Tribal systems. By targeting additional
treatment requirements to higher risk systems, the LT2ESWTR will
minimize overall burden in comparison with requiring additional
treatment by all systems. In addition, the provision in the proposal
allowing E. coli screening to determine if Cryptosporidium monitoring
is necessary will reduce monitoring costs for many small Tribal
systems. (EPA notes that 66 of the 67 Tribal systems identified by the
Agency as subject to the LT2ESWTR are small systems.) Due to the health
risks associated with Cryptosporidium, capital expenditures needed for
compliance with the rule will be eligible for Federal funding sources,
specifically the Drinking Water State Revolving Fund. EPA is developing
guidance that will address consideration of Tribal cultural uses of
uncovered finished water storage facilities.
In the spirit of Executive Order 13175, and consistent with EPA
policy to promote communications between EPA and Tribal governments,
EPA specifically solicits additional comment on this proposed rule from
Tribal officials.

G. Executive Order 13045: Protection of Children from Environmental
Health 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.
This proposed rule is subject to the Executive Order because it is
an economically significant regulatory action as defined in Executive
Order 12866, and we believe that the environmental health or safety
risk addressed by this action may have a disproportionate effect on
children. Accordingly, we have evaluated the environmental health or
safety effects of Cryptosporidium on children. The results of this
evaluation are contained in Cryptosporidium: Risk for Infants and
Children (USEPA 2001d) and described in this section of this preamble.
Further, while available information is not adequate to conduct a
quantitative risk assessment specifically on children, EPA has assessed
the risk associated with Cryptosporidium in drinking water for the
general population, including children. This assessment is described in
the Economic Analysis for the LT2ESWTR (USEPA 2003a) and is summarized
in section VI of this preamble. Copies of these documents and
supporting information are available in the public docket for today's
proposal.
Cryptosporidiosis in children is similar to adult disease (USEPA
2001d). Diarrhea is the most common symptom. Other common symptoms in
otherwise healthy (i.e., immunocompetent) children include anorexia,
vomiting, abdominal pain, fever, dehydration and weight loss.
The risk of illness and death due to cryptosporidiosis depends on
several factors, including age, nutrition, exposure, genetic
variability, disease and the immune status of the individual. Mortality
resulting from diarrhea generally occurs at a greater rate among the
very young and elderly (Gerba et al., 1996). During the 1993 Milwaukee
drinking water outbreak, associated mortalities in children were
reported. Also, children with laboratory-confirmed cryptosporidiosis
were more likely to have an underlying disease that altered their
immune status (Cicirello et al., 1997). In that study, the observed
association between increasing age of children and increased numbers of
laboratory-confirmed cryptosporidiosis suggested to the authors that
the data

[[Page 47767]]

are consistent with increased tap water consumption of older children.
However, due to data limitations, this observation could not be
adequately analyzed. Asymptomatic infection, especially in
underdeveloped communities, can have a substantial effect on childhood
growth (Bern et al., 2002).
Cryptosporidiosis appears to be more prevalent in populations, such
as children, that may not have established immunity against the disease
and may be in greater contact with environmentally contaminated
surfaces (DuPont et al., 1995). In the United States, children aged one
to four years are more likely than adults to have the disease. The most
recent reported data on cryptosporidiosis shows the occurrence rate
(for the year 1999) is higher in children ages one to four (3.03
incidence rate per 100,000) than in any adult age group (CDC, 2001).
Evidence from blood sera antibodies collected from children during the
1993 Milwaukee outbreak suggest that children had greater levels of
Cryptosporidium infection than predicted for the general community
(based on the random-digit dialing telephone survey method) (McDonald
et al., 2001).
Data indicate a lower incidence of cryptosporidiosis infection
during the first year of life. This is attributed to breast-fed infants
consuming less tap water and, hence, having less exposure to
Cryptosporidium, as well as the possibility that mothers confer short
term immunity to their children. 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 less than six months
(Casemore, 1990). Similarly, in the U.S., of 2,566 reported
Cryptosporidium illnesses in 1999, 525 occurred in ages one to four
(incidence rate of 3.03 per 100,000) compared with 58 cases in infants
under one year (incidence rate of 1.42 per 100,000) (CDC, 2001).
An infected child may spread the disease to other children or
family members (Heijbel et al., 1987, Osewe et al., 1996). Millard et
al. (1994) documented greater household secondary transmission of
cryptosporidiosis from children than from adults to household and other
close contacts. Children continued to shed oocysts for more than two
weeks (mean 16.5 days) after diarrhea cessation (Tangerman et al.,
1991).
While Cryptosporidium may have a disproportionate effect on
children, available data are not adequate to distinctly assess the
health risk for children resulting from Cryptosporidium-contaminated
drinking water. In assessing risk to children when evaluating
regulatory alternatives for the LT2ESWTR, EPA assumed the same risk for
children as for the population as a whole.
Section VI of this preamble presents the regulatory alternatives
that EPA evaluated for the proposed LT2ESWTR. Among the four
alternatives the Agency considered, three involved a risk-targeting
approach in which additional Cryptosporidium treatment requirements are
based on source water monitoring results. A fourth alternative involved
additional treatment requirements for all systems.
The alternative requiring additional treatment by all systems was
not selected because of concerns about feasibility and because it
imposed costs but provided few benefits to systems with high quality
source water (i.e., relatively low Cryptosporidium risk). The three
risk-targeting alternatives were evaluated based on several factors,
including costs, benefits, net benefits, feasibility of implementation,
and other specific impacts (e.g., impacts on small systems or sensitive
subpopulations).
The proposed alternative was recommended by the M-DBP Federal
Advisory Committee and selected by EPA as the Preferred Regulatory
Alternative because it was deemed feasible and provides significant
public health benefits in terms of avoided illnesses and deaths. EPA's
analysis of benefits and costs indicates that the proposed alternative
ranks highly among those evaluated with respect to maximizing net
benefits, as shown in the LT2ESWTR Economic Analysis (USEPA 2003a).
This document is available in the docket for this action.
The result of the LT2ESWTR 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 LT2ESWTR may,
therefore, result in greater risk reduction for children than for the
general population.
The public is invited to submit or identify peer-reviewed studies
and data, of which EPA may not be aware, that assessed results of early
life exposure to Cryptosporidium.

H. Executive Order 13211: Actions 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. This
determination is based on the following analysis.
The first consideration is whether the LT2ESWTR would adversely
affect the supply of energy. The LT2ESWTR does not regulate power
generation, either directly or indirectly. The public and private
utilities that the LT2ESWTR regulates do not, as a rule, generate
power. Further, the cost increases borne by customers of water
utilities as a result of the LT2ESWTR are a low percentage of the total
cost of water, except for a very few small systems that might install
advanced technologies and then need to spread that cost over a narrow
customer base. Therefore, the customers that are power generation
utilities are unlikely to face any significant effects as a result of
the LT2ESWTR. In sum, the LT2ESWTR does not regulate the supply of
energy, does not generally regulate the utilities that supply energy,
and is unlikely to affect significantly the customer base of energy
suppliers. Thus, the LT2ESWTR would not translate into adverse effects
on the supply of energy.
The second consideration is whether the LT2ESWTR would adversely
affect the distribution of energy. The LT2ESWTR does not regulate any
aspect of energy distribution. The utilities that are regulated by the
LT2ESWTR already have electrical service. As derived later in this
section, the proposed rule is projected to increase peak electricity
demand at water utilities by only 0.02 percent. Therefore, EPA
estimates that the existing connections are adequate and that the
LT2ESWTR has no discernable adverse effect on energy distribution.
The third consideration is whether the LT2ESWTR would adversely
affect the use of energy. Because some drinking water utilities are
expected to add treatment technologies that use electrical power, this
potential impact is evaluated in more detail. The analyses that
underlay the estimation of costs for the LT2ESWTR are national in scope
and do not identify specific plants or utilities that may install
treatment in response to the rule. As a result, no analysis of the
effect on specific energy suppliers is possible with the available

[[Page 47768]]

data. The approach used to estimate the impact of energy use,
therefore, focuses on national-level impacts. The analysis estimates
the additional energy use due to the LT2ESWTR, and compares that to the
national levels of power generation in terms of average and peak loads.
The first step in the analysis is to estimate the energy used by
the technologies expected to be installed as a result of the LT2ESWTR.
Energy use is not directly stated in Technologies and Costs for Control
of Microbial Contaminants and Disinfection By-Products (USEPA 2003c),
but the annual cost of energy for each technology addition or upgrade
necessitated by the LT2ESWTR is provided. An estimate of plant-level
energy use is derived by dividing the total energy cost per plant for a
range of flows by an average national cost of electricity of $0.076/kWh
(USDOE EIA, 2002). These calculations are shown in detail in Chapter 7
of the Economic Analysis for the LT2ESWTR (USEPA 2003a). The energy use
per plant for each flow range and technology is then multiplied by the
number of plants predicted to install each technology in a given flow
range. The energy requirements for each flow range are then added to
produce a national total. No electricity use is subtracted to account
for the technologies that may be replaced by new technologies,
resulting in a conservative estimate of the increase in energy use.
Results of the analysis are shown in Table VII-5 for each of the
modeled Cryptosporidium occurrence distributions. The results range
from an incremental national annual energy usage of 0.12 million
megawatt-hours (mW) for the modeled Information Collection Rule
occurrence distribution to 0.07 million mW for the modeled ICRSSL
occurrence distribution.

Table VII-5.--Total Increased Annual National Energy Usage Attributable to the LT2ESWTR
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICR ICRSSL ICRSSM
-------------------------------------------------------------------------------------------------
Total annual
Technology Plants Total annual Plants Total annual Plants energy
selecting energy required selecting energy required selecting required (kWh/
technology (kWh/yr) technology (kWh/yr) technology yr)
--------------------------------------------------------------------------------------------------------------------------------------------------------
A B C D E F
CIO₂.................................................. 77 343,297 61 268,861 70 312,036
UV.................................................... 998 86,827,218 490 52,212,046 632 64,515,863
O₃ (0.5 log).......................................... 26 12,524,670 19 10,328,359 21 11,467,703
O₃ (1.0 log).......................................... 24 12,456,132 12 6,119,824 21 10,759,696
O₃ (2.0 log).......................................... 9 7,324,561 0 35,259 2 1,787,144
MF/UF................................................. 10 5,691,144 8 4,507,577 5 2,790,401
Bag Filters........................................... 1,545 1,631,873 1,236 1,306,067 1,441 1,522,243
Cartridge Filters..................................... 190 76,793 17 6,254 52 19,686
-------------------------------------------------------
Total........................................... 2,878 126,875,687 1,844 74,784,249 2,244 93,174,772
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: The LT2ESWTR Economic Analysis (USEPA 2003a).

To determine if the additional energy required for systems to
comply with the rule would have a significant adverse effect on the use
of energy, the numbers in Table VII-5 are compared to the national
production figures for electricity. According to the U.S. Department of
Energy's Information Administration, electricity producers generated
3,800 million mW of electricity in 2001 (USDOE EIA, 2002). Therefore,
even using the highest assumed energy use for the LT2ESWTR, the rule
when fully implemented would result in only a 0.003 percent increase in
annual average energy use.
In addition to average energy use, the impact at times of peak
power demand is important. To examine whether increased energy usage
might significantly affect the capacity margins of energy suppliers,
their peak season generating capacity reserve was compared to an
estimate of peak incremental power demand by water utilities.
Both energy use and water use are highest in the summer months, so
the most significant effects on supply would be seen then. In the
summer of 2001, U.S. generation capacity exceeded consumption by 15
percent, or approximately 120,000 mW (USDOE EIA 2002). Assuming around-
the-clock operation of water treatment plants, the total energy
requirement can be divided by 8,760 hours per year to obtain an average
power demand of 15 mW for the modeled Information Collection Rule
occurrence distribution. A more detailed derivation of this value is
shown in Appendix P of the Economic Analysis for the LT2ESWTR (USEPA
2003a). Assuming that power demand is proportional to water flow
through the plant, and that peak flow can be as high as twice the
average daily flow during the summer months, about 30 mW could be
needed for treatment technologies installed to comply with the
LT2ESWTR. This is only 0.024 percent of the capacity margin available
at peak use.
Although EPA recognizes that not all areas have a 15 percent
capacity margin and that this margin varies across regions and through
time, this analysis reflects the effect of the rule on national energy
supply, distribution, or use. While certain areas, notably California,
have experienced shortfalls in generating capacity in the recent past,
a peak incremental power requirement of 30 mW nationwide is not likely
to significantly change the energy supply, distribution, or use in any
given area. Considering this analysis, EPA has concluded that LT2ESWTR
is not likely to have a significant adverse effect on the supply,
distribution, or use of energy.

I. National Technology Transfer and Advancement Act

Section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) of 1995, Public Law 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., material specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standard bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.

[[Page 47769]]

The proposed rulemaking involves technical standards. EPA proposes
to use several voluntary consensus standards (VCS) methods for
enumerating E. coli in surface waters. These methods are listed in
section IV.K.2, Table IV-37, and were developed or adopted by the
following organizations: American Public Health Association in Standard
Methods for the Examination of Water and Wastewater, 20th, 19th, and
18th Editions, the American Society of Testing Materials in Annual Book
of ASTM Standards--Water and Environmental Technology, and the
Association of Analytical Chemists in Official Methods of Analysis of
AOAC International, 16th Edition. These methods are available in the
docket for today's proposal. EPA has concluded that these methods have
the necessary sensitivity and specificity to meet the data quality
objectives of the LT2ESWTR.
The Agency conducted a search to identify potentially applicable
voluntary consensus standards for analysis of Cryptosporidium. However,
we identified no such standards. Therefore, EPA proposes to use the
following methods for Cryptosporidium analysis: Method 1622:
``Cryptosporidium in Water by Filtration/IMS/FA'' (EPA-821-R-01-026,
April 2001) (USEPA 2001e) and Method 1623: ``Cryptosporidium and
Giardia in Water by Filtration/IMS/FA'' (EPA 821-R-01-025, April 2001)
(USEPA 2001f).
EPA welcomes comments on this aspect of the proposed rulemaking
and, specifically, invites the public to identify additional
potentially applicable voluntary consensus standards, and to explain
why such standards should be used in this regulation.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations or Low-Income Populations

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.
Two aspects of the LT2ESWTR comply with the order that requires the
Agency to consider environmental justice issues in the rulemaking and
to consult with stakeholders representing a variety of economic and
ethnic backgrounds. These are: (1) The overall nature of the rule, and
(2) the convening of a stakeholder meeting specifically to address
environmental justice issues.
The Agency built on the efforts conducted during the development of
the IESWTR 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 might impact sensitive
subpopulations, minority populations, and low-income populations. This
meeting was a continuation of stakeholder meetings that started in 1995
to obtain input on the Agency's Drinking Water Programs. Topics
discussed included treatment techniques, costs and benefits, data
quality, health effects, and the regulatory process. Participants were
national, State, Tribal, municipal, and individual stakeholders. EPA
conducted the meeting by video conference call between eleven cities.
The major objectives for the March 12, 1998, meeting were the
following:

? Solicit ideas from stakeholders on known issues concerning
current drinking water regulatory efforts;
? Identify key areas of concern to stakeholders; and
? Receive suggestions from stakeholders concerning ways to
increase representation of communities in OGWDW regulatory efforts.
In addition, EPA developed a plain-English guide for this meeting
to assist stakeholders in understanding the multiple and sometimes
complex issues surrounding drinking water regulations.
The LT2ESWTR and other drinking water regulations promulgated or
under development are expected to have a positive effect on human
health regardless of the social or economic status of a specific
population. The LT2ESWTR serves to provide a similar level of drinking
water protection to all groups. Where water systems have high
Cryptosporidium levels, they must treat their water to achieve a
specified level of protection. Further, to the extent that levels of
Cryptosporidium in drinking water might be disproportionately high
among minority or low-income populations (which is unknown), the
LT2ESWTR will work to remove those differences. Thus, the LT2ESWTR
meets the intent of Federal policy requiring incorporation of
environmental justice into Federal agency missions.
The LT2ESWTR applies uniformly to CWSs, NTNCWSs, and TNCWSs that
use surface water or GWUDI as their source. Consequently, this rule
provides health protection from pathogen exposure equally to all income
and minority groups served by surface water and GWUDI systems.

K. Consultations with the Science Advisory Board, National Drinking
Water Advisory Council, and the Secretary of Health and Human Services

In accordance with sections 1412 (d) and (e) of SDWA, the Agency
has consulted with the Science Advisory Board (SAB), the National
Drinking Water Advisory Council (NDWAC), and will consult with the
Secretary of Health and Human Services regarding the proposed LT2ESWTR
during the public comment period. EPA charged the SAB panel with
reviewing the following aspects of the LT2ESWTR proposal:
? The analysis of Cryptosporidium occurrence, as described in
Occurrence and Exposure Assessment for the LT2ESWTR (USEPA 2003b);
? The pre- and post-LT2ESWTR Cryptosporidium risk assessment,
as described in Economic Analysis for the LT2ESWTR (USEPA 2003a); and
? The treatment credits for the following four microbial
toolbox components: raw water off-stream storage, pre-sedimentation,
lime softening, and lower finished water turbidity (described in
section IV.C of this preamble).
EPA met with the SAB to discuss the LT2ESWTR on June 13, 2001
(Washington, DC), September 25-26, 2001 (teleconference), and December
10-12, 2001 (Los Angeles, CA). Written comments from the December 2001
meeting of the SAB addressing the occurrence analysis and risk
assessment were generally supportive. EPA has responded to the SAB's
recommendations for Cryptosporidium occurrence analysis in the current
draft of Occurrence and Exposure Assessment for the LT2ESWTR (USEPA
2003b), and EPA has addressed the SAB's comments on risk assessment in
the current draft of Economic Analysis for the LT2ESWTR (USEPA 2003a).
Comments from the SAB on the microbial toolbox components and the
Agency's responses to those comments are described in section IV.C of
this preamble.
EPA met with the NDWAC on November 8, 2001, in Washington, DC, to
discuss the LT2ESWTR proposal. EPA specifically requested comments from
the NDWAC on the regulatory approach taken in the proposed microbial
toolbox (e.g., proposal of specific design and implementation criteria
for treatment credits). The Council was generally supportive of EPA
establishing criteria for awarding

[[Page 47770]]

treatment credit to toolbox components, but recommended that EPA
provide flexibility for States to address system specific situations.
EPA believes that the demonstration of performance credit, described in
section IV.C.17, provides this flexibility by allowing States to award
higher or lower levels of treatment credit for microbial toolbox
components based on site specific conditions. Minutes of the NDWAC and
SAB meetings are in the docket for today's proposal.

L. Plain Language

Executive Order 12866 encourages Federal agencies to write rules in
plain language. EPA invites comments on how to make this proposed rule
easier to understand. For example: Has EPA organized the material to
suit commenters' needs? Are the requirements in the rule clearly
stated? Does the rule contain technical language or jargon that is not
clear? Would a different format (grouping and ordering of sections, use
of headings, paragraphs) make the rule easier to understand? Could EPA
improve clarity by adding tables, lists, or diagrams? What else could
EPA do to make the rule easier to understand?

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Van Breemen, L., H. Ketelaars, W. Hoogenboezem, and G. Medema. 1998.
Storage reservoirs--a first barrier for pathogenic micro-organisms
in The Netherlands. Water Science and Technology. 37(2):253-260.
Wang, J., R. Song, and S. Hubbs. 2001. Particle removal through
riverbank filtration process, in W. Julich and J.

[[Page 47775]]

Schubert, eds., Proceedings of the Internation Riverbank Filtration
Conference, November 2-4, 2000, Dusseldorf, Germany, Internationale
Arbeitsgemeinschaft der Wasserwork im Rheineinzugsgebiet.
Wegelin, M., M. Boller, and R. Schertenleib. 1987. Particle Removal
by Horizontal-Flow Roughing Filtration. Aqua. 35(2): 115-125.
Wegelin, M. 1988. Rouging gravel filters for suspended solids
removal. Slow Sand Filtration: Recent Developments in Water
Treatment Technology, N.J.D. Graham (Ed.) Ellis Horwood Ltd.,
Chichester, UK: 103-122.
West, T., P. Daniel, P. Meyerhofer, A. DeGraca, S. Leonard, and C.
Gerba. 1994. Evaluation of Cryptosporidium Removal through High-Rate
Filtration. Proceedings, Annual Conference of the American Water
Works Association, Denver, CO.
Willocks, L., A. Crampin, L. Milne, C. Seng, M. Susman, R. Gair, M.
Moulsdale, S. Shafi, R. Wall, R. Wiggins, and N. Lightfoot. 1998. A
large outbreak of cryptosporidiosis associated with a public water
supply from a deep chalk borehole. Communicable Disease and Public
Health. 1(4):239-43.
Yates, R., K. Scott, J. Green, J. Bruno, and R. De Leon. 1998. Using
Aerobic Spores to Evaluate Treatment Plant Performance. Proceedings,
Annual Conference of the American Water Works Association, Denver,
CO.
Zheng, M., S. Andrews, and J. Bolton. 1999. Impacts of medium-
pressure UV on THM and HAA formation in pre-UV chlorinated drinking
water. Proceedings, Water Quality Technology Conference of the
American Water Works Association, Denver, CO.

List of Subjects

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: July 11, 2003.
Linda J. Fisher,
Acting Administrator.
For the reasons set forth in the preamble, title 40 chapter I of
the Code of Federal Regulations is proposed to be amended as follows:

PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS

1. 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.

2. Section 141.2 is amended by adding, in alphabetical order,
definitions for Bag filters, Bank filtration, Cartridge filters,
Flowing stream, Lake/reservoir, Membrane filtration, Off-stream raw
water storage, Plant intake, Presedimentation, and Two-stage lime
softening to read as follows:

Sec. 141.2 Definitions.

* * * * *
Bag filters are pressure-driven separation devices that remove
particulate matter larger than 1 [mu]m using an engineered porous
filtration media through either surface or depth filtration. Bag
filters are typically constructed of a non-rigid, fabric filtration
media housed in a pressure vessel in which the direction of flow is
from the inside of the bag to outside.
Bank filtration is a water treatment process that uses a pumping
well to recover surface water that has naturally infiltrated into
ground water through a river bed or bank(s). Infiltration is typically
enhanced by the hydraulic gradient imposed by a nearby pumping water
supply or other well(s).
* * * * *
Cartridge filters are pressure-driven separation devices that
remove particulate matter larger than 1 [mu]m using an engineered
porous filtration media through either surface or depth filtration.
Cartridge filters are typically constructed as rigid or semi-rigid,
self-supporting filter elements housed in pressure vessels in which
flow is from the outside of the cartridge to the inside.
* * * * *
Flowing stream is a course of running water flowing in a definite
channel.
* * * * *
Lake/reservoir refers to a natural or man made basin or hollow on
the Earth's surface in which water collects or is stored that may or
may not have a current or single direction of flow.
* * * * *
Membrane filtration is a pressure-driven or vacuum-driven
separation process in which particulate matter larger than 1 [mu]m is
rejected by an engineered barrier primarily through a size exclusion
mechanism, and which has a measurable removal efficiency of a target
organism that can be verified through the application of a direct
integrity test. This definition includes the common membrane
technologies of microfiltration (MF), ultrafiltration (UF),
nanofiltration (NF), and reverse osmosis (RO).
* * * * *
Off-stream raw water storage refers to an impoundment in which
water is stored prior to treatment and from which outflow is
controlled.
* * * * *
Plant intake refers to the works or structures at the head of a
conduit through which water is diverted from a source (e.g., river or
lake) into the treatment plant.
* * * * *
Presedimentation is a preliminary unit process used to remove
gravel, sand and other particulate material from the source water
through settling before it enters the main treatment plant.
* * * * *
Two-stage lime softening refers to a process for the removal of
hardness by the addition of lime and consisting of two distinct unit
clarification processes in series prior to filtration.
* * * * *
3. Appendix A to Subpart Q of part 141 is amended in section I,
Part A by adding entry number 10:
Subpart Q--Public Notification of Drinking Water Violations.

Appendix A to Subpart Q of Part 141--NPDWR Violations and Other Situations Requiring Public Notice \1\
----------------------------------------------------------------------------------------------------------------
MCL/MRDL/TT violations \2\ Monitoring and testing procedure
--------------------------------------- violations
--------------------------------------
Contaminant Tier of public Tier of public
notice Citation notice Citation
required required
----------------------------------------------------------------------------------------------------------------
I. Violations of National Primary
Drinking Water Regulations
(NPDWR) \3\:
A. Microbiological Contaminants

[[Page 47776]]

* * * * * * *
10. LT2ESWTR violations........... 2 141.720-141.729...... 3 141.701-141.707;
141.711-141.713;
141.730

* * * * * * *
----------------------------------------------------------------------------------------------------------------
\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 primary agency. Primary
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.

4. Part 141 is amended by adding a new subpart W to read as
follows:
Subpart W--Enhanced Filtration and Disinfection for Cryptosporidium

General Requirements

141.700 Applicability.
141.701 General requirements.

Source Water Monitoring Requirements

141.702 Source water monitoring.
141.703 Sampling schedules.
141.704 Sampling locations.
141.705 Analytical methods.
141.706 Requirements for use of an approved laboratory.
141.707 Reporting source water monitoring results.
141.708 Previously collected data.
141.709 Bin classification for filtered systems.

Disinfection Profiling and Benchmarking Requirements

141.710 [Reserved]
141.711 Determination of systems required to profile.
141.712 Schedule for disinfection profiling requirements.
141.713 Developing a profile.
141.714 Requirements when making a significant change in
disinfection practice.

Treatment Technique Requirements

141.720 Treatment requirements for filtered systems.
141.721 Treatment requirements for unfiltered systems.
141.722 Microbial toolbox options for meeting Cryptosporidium
treatment requirements.
141.723 [Reserved]
141.724 Requirements for uncovered finished water storage
facilities.

Requirements for Microbial Toolbox Components

141.725 Source toolbox components.
141.726 Pre-filtration treatment toolbox components.
141.727 Treatment performance toolbox components.
141.728 Additional filtration toolbox components.
141.729 Inactivation toolbox components.

Reporting and Recordkeeping Requirements

141.730 Reporting requirements.
141.731 Recordkeeping requirements.

Subpart W--Enhanced Filtration and Disinfection for Cryptosporidium

General Requirements

Sec. 141.700 Applicability.

The requirements of this subpart apply to all subpart H systems.
Failure to comply with any requirement of this subpart is a violation
and requires public notification.

Sec. 141.701 General requirements.

(a) All subpart H systems, including wholesale systems, must
characterize their source water to determine what (if any) additional
treatment is necessary for Cryptosporidium, unless they meet the
criteria in either paragraph (f) or (g) of this section.
(b) Systems serving at least 10,000 people that currently provide
filtration or that are unfiltered and required to install filtration
must conduct source water monitoring that includes Cryptosporidium, E.
coli, and turbidity sampling and comply with the treatment requirements
in Sec. 141.720.
(c) Systems serving fewer than 10,000 people that currently provide
filtration or that are unfiltered and required to install filtration
must conduct source water monitoring consisting of E. coli sampling or
sampling of an alternative indicator approved by the State. If the
annual mean concentration of E. coli exceeds the levels specified in
Sec. 141.702(b), or if the level of a State-approved alternate
indicator exceeds a State-approved alternative indicator trigger level,
systems must conduct Cryptosporidium monitoring to complete the source
water monitoring requirements and comply with the treatment
requirements in Sec. 141.720.
(d) Systems that are unfiltered and meet all the filtration
avoidance criteria of Sec. 141.71 must conduct source water monitoring
consisting of Cryptosporidium sampling and comply with the treatment
requirements in Sec. 141.721.
(e) Systems must comply with the requirements in this subpart based
on the schedule in the following table, except that systems are not
required to conduct source water monitoring if they meet the criteria
in paragraph (f) of this section for systems that currently provide
filtration or that are unfiltered and required to install filtration or
paragraph (g) of this section for systems that are unfiltered and meet
all the filtration avoidance criteria of Sec. 141.71:

[[Page 47777]]

Compliance Requirements Table
------------------------------------------------------------------------
Must perform . . And comply by . .
Systems that are . . . .\a,b\ .
------------------------------------------------------------------------
(1) Subpart H systems serving (i) 24 months of Submitting a
£=10,000 people that source water monthly report to
currently provide filtration or monitoring for EPA no later than
that are unfiltered and Cryptosporidium, ten days after
required to install filtration. E. coli and the end of the
turbidity at first month
least once each following the
month beginning month when the
no later than sample is taken.
[Date 6 Months
After Date of
Publication of
Final Rule in the
Federal Register].
(ii) Treatment Installing
technique treatment and
implementation, complying with
if necessary. the treatment
technique no
later than [Date
72 Months After
Date of
Publication of
Final Rule in the
Federal Register]
\c\.
(2) Subpart H systems serving (i) 24 months of Submitting a
£=10,000 people that source water monthly report to
are unfiltered and meet the monitoring for EPA no later than
filtration avoidance criteria Cryptosporidium ten days after
of Sec. 141.71. at least once the end of the
each month first month
beginning no following the
later than [Date month when the
6 Months After sample is taken.
Date of
Publication of
Final Rule in the
Federal Register].
(ii) Treatment Installing
technique treatment and
implementation, complying with
if necessary. the treatment
technique no
later than [Date
72 Months After
Date of
Publication of
Final rule in the
Federal Register]
\c\.
(3) Subpart H systems serving 12 months of Submitting a
<10,000 people that currently source water monthly report to
provide filtration or that are monitoring for E. the State no
unfiltered and required to coli at least later than ten
install filtration and are not once every two days after the
required to monitor for weeks beginning end of the first
Cryptosporidium based on E. no later than month following
coli or other indicator [Date 30 Months the month when
monitoring results \d\. After Date of the sample is
Publication of taken.
Final Rule in the
Federal Register].
(4) Subpart H systems serving (i) 12 months of Submitting a
<10,000 people that currently source water monthly report to
provide filtration or that are monitoring for E. the State no
unfiltered and required to coli at least later than ten
install filtration and must once every two days after the
perform Cryptosporidium weeks beginning end of the first
monitoring based on E. coli or no later than month following
other indicator monitoring [Date 30 Months the month when
results \d\. After Date of the sample is
Publication of taken.
Final Rule in the
Federal Register]
and 12 months of
source water
monitoring for
Cryptosporidium
at least twice
each month
beginning no
later than [Date
48 Months After
Date of
Publication of
Final Rule in the
Federal Register].
(ii) Treatment Installing
technique treatment and
implementation, complying with
if necessary. the treatment
technique no
later than [Date
102 Months After
Date of
Publication of
Final Rule in the
Federal Register]
\c\.
(5) Subpart H systems serving (i) 12 months of Submitting a
<10,000 people that are source water monthly report to
unfiltered and meet the monitoring for the State no
filtration avoidance criteria Cryptosporidium later than ten
of Sec. 141.71. at least twice days after the
each month end of the first
beginning no month following
later than [Date the month when
48 Months After the sample is
Date of taken.
Publication of
Final Rule in the
Federal Register].
(ii) Treatment Installing
technique treatment and
implementation, complying with
if necessary. the treatment
technique no
later than [Date
102 Months After
Date of
Publication of
Final Rule in the
Federal Register]
\c\.
------------------------------------------------------------------------
\a\ Any sampling performed more frequently than required must be evenly
distributed over the sampling period.
\b\ Systems may use data that meet the requirements in Sec. 141.708
collected prior to the monitoring start date to substitute for an
equivalent number of months at the end of the monitoring period.
\c\ States may allow up to an additional two years for complying with
the treatment technique requirement for systems making capital
improvements.
\d\ See Sec. 141.702(b) to determine if Cryptosporidium monitoring is
required.

(f) Systems that currently provide filtration or that are
unfiltered and required to install filtration are not required to
conduct source water monitoring under this subpart if the system
currently provides or will provide a total of at least 5.5 log of
treatment for Cryptosporidium, equivalent to meeting the treatment
requirements of Bin 4 in Sec. 141.720. Systems must notify the State
not later than the date the system is otherwise required to submit a
sampling schedule for monitoring under Sec. 141.703 and must install
and operate technologies to provide a total of at least 5.5 log of
treatment for Cryptosporidium by the applicable date in paragraph (e)
of this section.
(g) Systems that are unfiltered and meet all the filtration
avoidance criteria of Sec. 141.71 are not required to conduct source
water monitoring under this subpart if the system currently provides or
will provide a total of at least 3 log Cryptosporidium inactivation,
equivalent to meeting the treatment requirements for unfiltered systems
with a mean Cryptosporidium concentration of greater than 0.01 oocysts/
L in Sec. 141.721. Systems must notify the State not later than the
date the system is otherwise required to submit a sampling schedule for
monitoring under Sec. 141.703. Systems must install and operate
technologies to provide a total of at least 3 log Cryptosporidium
inactivation by the applicable date in paragraph (e) of this section.
(h) Systems must comply with the uncovered finished water storage
facility requirements in Sec. 141.724 no later than [Date 36 Months
After Date of Publication of Final Rule in the Federal Register].

[[Page 47778]]

Source Water Monitoring Requirements

Sec. 141.702 Source water monitoring.

(a) Systems must conduct initial source water monitoring as
specified in Sec. 141.701(b) through (f).
(b) Systems serving fewer than 10,000 people that provide
filtration or that are unfiltered and required to install filtration
must perform Cryptosporidium monitoring in accordance with Sec.
141.701(e) if they meet any of the criteria in paragraphs (b)(1)
through (4) of this section.
(1) For systems using lake/reservoir sources, an annual mean E.
coli concentration greater than 10 E. coli/100 mL, based on monitoring
conducted under this section, unless the State approves an alternative
indicator trigger.
(2) For systems using flowing stream sources, an annual mean E.
coli concentration greater than 50 E. coli/100 mL, based on monitoring
conducted under this section, unless the State approves an alternative
indicator trigger.
(3) If the State approves an alternative to the indicator trigger
in paragraph (b)(1) or (b)(2) of this section, an annual concentration
that exceeds a State-approved trigger level, including an alternative
E. coli level, based on monitoring conducted under this section.
(4) The system does not conduct E. coli or other State-approved
indicator monitoring as specified in Sec. 141.701(e).
(c) Systems may submit Cryptosporidium data collected prior to the
monitoring start date to meet the initial source water monitoring
requirements of paragraphs (a) through (b) of this section. Systems may
also use Cryptosporidium data collected prior to the monitoring start
date to substitute for an equivalent number of months at the end of the
monitoring period. All data submitted under this paragraph must meet
the requirements in Sec. 141.708.
(d) Systems must conduct a second round of source water monitoring
in accordance with the requirements in Sec. 141.701(b) through (e) of
this section, beginning no later than the dates specified in paragraphs
(d)(1) through (3) of this section, unless they meet the criteria in
either paragraph Sec. 141.701(f) or (g).
(1) Systems that serve at least 10,000 people must begin a second
round of source water monitoring no later than [Date 108 Months After
Date of Publication of Final Rule in the Federal Register].
(2) Systems serving fewer than 10,000 people that provide
filtration or that are unfiltered and required to install filtration
must begin a second round of source water monitoring no later than
[Date 138 Months After Date of Publication of Final Rule in the Federal
Register]
and, if required to monitor for Cryptosporidium under
paragraph (b) of this section, must begin Cryptosporidium monitoring no
later than [Date 156 Months After Date of Publication of Final Rule in
the Federal Register].
(3) Systems serving fewer than 10,000 people that are unfiltered
and meet the filtration avoidance requirements of Sec. 141.71 must
begin a second round of source water monitoring no later than [Date 156
Months After Date of Publication of Final Rule in the Federal
Register].

Sec. 141.703 Sampling schedules.

(a) Systems required to sample under Sec. Sec. 141.701 through
141.702 must submit a sampling schedule that specifies the calendar
dates that all required samples will be taken.
(1) Systems serving at least 10,000 people must submit their
sampling schedule for initial source water monitoring to EPA
electronically at [insert Internet address]
no later than [Date 3
Months After Date of Publication of Final Rule in the Federal
Register].
(2) Systems serving fewer than 10,000 people that are filtered or
that are unfiltered and required to install filtration must submit a
sampling schedule for initial source water monitoring of E. coli or an
alternative State-approved indicator to the State no later than [Date
27 Months After Date of Publication of Final Rule in the Federal
Register].
(3) Filtered systems serving fewer than 10,000 people that are
required to conduct Cryptosporidium monitoring and unfiltered systems
serving fewer than 10,000 people must submit a sampling schedule for
initial source water Cryptosporidium monitoring to the State no later
than [Date 45 Months After Date of Publication of Final Rule in the
Federal Register].
(4) Systems must submit a sampling schedule for the second round of
source water monitoring to the State no later than 3 months prior to
the date the system is required to begin the second round of monitoring
under Sec. 141.702(d).
(b) Systems must collect samples within two days of the dates
indicated in their sampling schedule.
(c) If extreme conditions or situations exist that may pose danger
to the sample collector, or which are unforeseen or cannot be avoided
and which cause the system to be unable to sample in the required time
frame, the system must sample as close to the required date as feasible
and submit an explanation for the alternative sampling date with the
analytical results.
(d) Systems that are unable to report a valid Cryptosporidium
analytical result for a scheduled sampling date due to failure to
comply with the analytical method requirements, including the quality
control requirements in Sec. 141.705, must collect a replacement
sample within 14 days of being notified by the laboratory or the State
that a result cannot be reported for that date and must submit an
explanation for the replacement sample with the analytical results.

Sec. 141.704 Sampling locations.

(a) Unless specified otherwise in this section, systems required to
sample under Sec. Sec. 141.701 through 141.702 must collect source
water samples from the plant intake prior to any treatment. Where
treatment is applied in an intake pipe such that sampling in the pipe
prior to treatment is not feasible, systems must collect samples as
close to the intake as is feasible, at a similar depth and distance
from shore.
(b) Presedimentation. Systems using a presedimentation basin must
collect source water samples after the presedimentation basin but
before any other treatment. Use of presedimentation basins during
monitoring must be consistent with routine operational practice and the
State may place reporting requirements to verify operational practices.
Systems collecting samples after a presedimentation basin may not
receive credit for the presedimentation basin under Sec. 141.726(a).
(c) Raw water off-stream storage. Systems using an off-stream raw
water storage reservoir must collect source water samples after the
off-stream storage reservoir. Use of off-stream storage during
monitoring must be consistent with routine operational practice and the
State may place reporting requirements to verify operational practices.
(d) Bank filtration. The required sampling location for systems
using bank filtration differs depending on whether the bank filtered
water is treated by subsequent filtration for compliance with Sec.
141.173(b) or Sec. 141.552(a), as applicable.
(1) Systems using bank filtered water that is treated by subsequent
filtration for compliance with Sec. 141.173(b) or Sec. 141.552(a), as
applicable, must collect source water samples from the well (i.e.,
after bank filtration), but before any other treatment. Use of bank
filtration during monitoring must be consistent with routine
operational practice and the State may place reporting

[[Page 47779]]

requirements to verify operational practices. Systems collecting
samples after a bank filtration process may not receive credit for the
bank filtration under Sec. 141.726(c).
(2) Systems using bank filtration as an alternative filtration
demonstration to meet their Cryptosporidium removal requirements under
Sec. 141.173(b) or Sec. 141.552(a), as applicable, must collect
source water samples in the surface water (i.e., prior to bank
filtration).
(3) Systems using a ground water source under the direct influence
of surface water that meet all the criteria for avoiding filtration in
Sec. 141.71 and that do not provide filtration treatment must collect
source water samples from the ground water (e.g., the well).
(e) Multiple sources. Systems with plants that use multiple water
sources at the same time, including multiple surface water sources and
blended surface water and ground water sources, must collect samples as
specified in paragraph (e)(1) or (2) of this section. The use of
multiple sources during monitoring must be consistent with routine
operational practice and the State may place reporting requirements to
verify operational practices.
(1) If a sampling tap is available where the sources are combined
prior to treatment, the sample must be collected from the tap.
(2) If there is not a sampling tap where the sources are combined
prior to treatment, systems must collect samples at each source near
the intake on the same day and must follow either paragraph (e)(2)(i)
or (e)(2)(ii) of this section for sample analysis.
(i) Composite samples from each source into one sample prior to
analysis. In the composite, the volume of sample from each source must
be weighted according to the proportion of the source in the total
plant flow at the time the sample is collected.
(ii) Analyze samples from each source separately as specified in
Sec. 141.705, and calculate a weighted average of the analysis results
for each sampling date. The weighted average must be calculated by
multiplying the analysis result for each source by the fraction the
source contributed to total plant flow at the time the sample was
collected, and then summing these values.

Sec. 141.705 Analytical methods.

(a) Cryptosporidium. Systems must use Method 1622 Cryptosporidium
in Water by Filtration/IMS/FA, EPA 821-R-01-026, April 2001, or Method
1623 Cryptosporidium and Giardia in Water by Filtration/IMS/FA, EPA
821-R-01-025, April 2001, for Cryptosporidium analysis.
(1) Systems are required to analyze at least a 10 L sample or a
packed pellet volume of at least 2 mL as generated by the methods
listed in paragraph (a) of this section. Systems unable to process a 10
L sample must analyze as much sample volume as can be filtered by two
filters approved by EPA for the methods listed in paragraph (a) of this
section, up to a packed pellet volume of 2 mL.
(2)(i) Matrix spikes (MS) samples as required by the methods in
paragraph (a) of this section must be spiked and filtered by a
laboratory approved for Cryptosporidium analysis under Sec. 141.706.
The volume of the MS sample must be within 10 percent of the volume of
the unspiked sample that is collected at the same time, and the samples
must be collected by splitting the sample stream or collecting the
samples sequentially. The MS sample and the associated unspiked sample
must be analyzed by the same procedure.
(ii) If the volume of the MS sample is greater than 10 L, the
system is permitted to filter all but 10 L of the MS sample in the
field, and ship the filtered sample and the remaining 10 L of source
water to the laboratory. In this case, the laboratory must spike the
remaining 10 L of water and filter it through the filter used to
collect the balance of the sample in the field.
(3) Each sample batch must meet the quality control criteria for
the methods listed in paragraph (a) of this section. Flow cytometer-
counted spiking suspensions must be used for MS samples and ongoing
precision and recovery (OPR) samples; recovery for OPR samples must be
11% to 100%; for each method blank, oocysts must not be detected.
(4) Total Cryptosporidium oocysts as detected by fluorescein
isothiocyanate (FITC) must be reported as determined by the color
(apple green or alternative stain color approved under Sec. 141.706(a)
for the laboratory), size (4-6 [mu]m) and shape (round to oval). This
total includes all of the oocysts identified, less any atypical
organisms identified by FITC, differential interference contrast (DIC)
or 4',6-diamindino-2-phenylindole (DAPI), including those possessing
spikes, stalks, appendages, pores, one or two large nuclei filling the
cell, red fluorescing chloroplasts, crystals, and spores.
(b) E. coli. Systems must use the following methods listed in this
paragraph for enumeration of E. coli in source water (table will be
replaced with CFR cite from Guidelines Establishing Test Procedures for
the Analysis of Pollutants; Analytical Methods for Biological
Pollutants in Ambient Water when finalized--expected 2003):

Methods for E. coli Enumeration \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
VCSB methods
Technique Method \1\ EPA ------------------------------------------------------------------
Standard methods ASTM AOAC
--------------------------------------------------------------------------------------------------------------------------------------------------------
Most Probable Number (MPN).......... LTB, EC-MUG............ ...................... 9221B.1/9221F
ONPG-MUG............... ...................... 9223B ...................... 991.15
ONPG-MUG............... ...................... 9223B
Membrane Filter (MF)................ mFC→NA-MUG..... ...................... 9222D/9222G
ENDO→NA-MUG.... ...................... 9222B/9222G
mTEC agar.............. 1103.1................ 9213D D5392-93
Modified mTEC agar..... Modified 1103.1
MI agar................ EPA-600-R-013
m-ColiBlue24 broth
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Tests must be conducted in a format that provides organism enumeration.

XXXXXXXXXXXXXXXXXXXXXX(1) The time from sample collection to
initiation of analysis may not exceed 24 hours. Systems must maintain
samples between 0[deg]C and 10[deg]C during transit.
(2) [Reserved]
(c) Turbidity. Systems must use methods for turbidity measurement
approved in Sec. 141.74.

[[Page 47780]]

Sec. 141.706 Requirements for use of an approved laboratory.

(a) Cryptosporidium. Systems must have Cryptosporidium samples
analyzed by a laboratory that has passed a quality assurance evaluation
under EPA's Laboratory Quality Assurance Evaluation Program for
Analysis of Cryptosporidium in Water or a laboratory that has been
certified for Cryptosporidium analysis by an equivalent State
laboratory certification program.
(b) E. coli. Any laboratory certified by the EPA, the National
Environmental Laboratory Accreditation Conference or the State for
total coliform or fecal coliform analysis in source water under Sec.
141.74 is deemed approved for E. coli analysis under this subpart when
the laboratory uses the same technique for E. coli that the laboratory
uses for source water in Sec. 141.74.
(c) Turbidity. Measurements of turbidity must be made by a party
approved by the State.

Sec. 141.707 Reporting source water monitoring results.

(a) All systems serving at least 10,000 people must submit the
results of all initial source water monitoring required under Sec.
141.702(a) to EPA electronically at [insert Internet address]. Systems
that do not have the ability to submit data electronically may use an
alternative format approved by EPA.
(b) Systems serving fewer than 10,000 people must submit the
results of all initial source water monitoring required under Sec.
141.702(a)-(b) to the State.
(c) All systems must submit the results from the second round of
source water monitoring required under Sec. 141.702(d) to the State.
(d) Source water monitoring analysis results must be submitted not
later than ten days after the end of first month following the month
when the sample is collected. The submission must include the
applicable information in paragraphs (e)(1) and (2) of this section.
(e)(1) Systems must report the following data elements for each
Cryptosporidium analysis:

(i) PWS ID
(ii) Facility ID
(iii) Sample collection point
(iv) Sample collection date
(v) Sample type (field or matrix spike)
(vi) Sample volume filtered (L), to nearest \1/4\ L
(vii) Was 100% of filtered volume examined
(viii) Number of oocysts counted
(i) For matrix spike samples, systems must also report the sample
volume spiked and estimated number of oocysts spiked. These data are
not required for field samples.
(ii) For samples in which less than 10 L is filtered or less than
100% of the sample volume is examined, systems must also report the
number of filters used and the packed pellet volume.
(iii) For samples in which less than 100% of sample volume is
examined, systems must also report the volume of resuspended
concentrate and volume of this resuspension processed through
immunomagnetic separation.
(2) Systems must report the following data elements for each E.
coli analysis:

(i) PWS ID
(ii) Facility ID
(iii) Sample collection point
(iv) Sample collection date
(v) Analytical method number
(vi) Method type
(vii) Source type
(viii) E. coli/100 mL
(ix) Turbidity (Systems serving fewer than 10,000 people that are not
required to monitor for turbidity under Sec. 141.701(c) are not
required to report turbidity with their E. coli results.)

Sec. 141.708 Previously collected data.

(a) Systems may comply with the initial monitoring requirements of
Sec. 141.702(a) using Cryptosporidium data collected before the system
is required to begin monitoring if the system meets the conditions in
paragraphs (b) through (h) of this section and EPA notifies the system
that the data are acceptable.
(b) To be accepted, previously collected Cryptosporidium data must
meet the conditions in paragraphs (b)(1) through (5) of this section.
(1) Samples were analyzed by laboratories using one of the
analytical methods in paragraphs (b)(1)(i) through (iv) of this
section.
(i) Method 1623: Cryptosporidium and Giardia in Water by
Filtration/IMS/FA, 2001, EPA-821-R-01-025.
(ii) Method 1622: Cryptosporidium in Water by Filtration/IMS/FA,
2001, EPA-821-R-01-026.
(iii) Method 1623: Cryptosporidium and Giardia in Water by
Filtration/IMS/FA, 1999, EPA-821-R-99-006.
(iv) Method 1622: Cryptosporidium in Water by Filtration/IMS/FA,
1999, EPA-821-R-99-001.
(2) Samples were collected no less frequently than each calendar
month on a regular schedule, beginning no earlier than January 1999.
(3) Samples were collected in equal intervals of time over the
entire collection period (e.g., weekly, monthly). Sample collection
interval may vary for the conditions specified in Sec. 141.703(c) and
(d) if the system provides documentation of the condition.
(4) Samples met the conditions for sampling location specified in
Sec. 141.704. The system must report the use of bank filtration,
presedimentation, and raw water off-stream storage during sampling.
(5) For each sample, the laboratory analyzed at least 10 L of
sample or at least 2 mL of packed pellet or as much volume as could be
filtered by 2 filters approved by EPA for the methods listed in
paragraph (b)(1) of this section, up to a packed pellet volume of 2 mL.
(c) The system must submit a letter to EPA concurrent with the
submission of previously collected data certifying that the data meet
the conditions in paragraphs (c)(1) and (2) of this section.
(1) The reported Cryptosporidium analysis results include all
results generated by the system during the time period beginning with
the first reported result and ending with the final reported result.
This applies to samples that were collected from the sampling location
specified for source water monitoring under this subpart, not spiked,
and analyzed using the laboratory's routine process for the analytical
methods listed in paragraph (a)(1) of this section.
(2) The samples were representative of a plant's source water(s)
and the source water(s) have not changed.
(d) For each sample, the system must report the data elements in
Sec. 141.707(e)(1).
(e) The laboratory or laboratories that generated the data must
submit a letter to EPA concurrent with the submission of previously
collected data certifying that the quality control criteria specified
in the methods listed in paragraph (b)(1) of this section were met for
each sample batch associated with the previously collected data.
Alternatively, the laboratory may provide bench sheets and sample
examination report forms for each field, matrix spike, IPR, OPR, and
method blank sample associated with the previously collected data.
(f) If a system has at least two years of Cryptosporidium data
collected before [Date of Publication of Final Rule in the Federal
Register]
and the system intends to use these data to comply with the
initial source water monitoring required under Sec. 141.702(a) in lieu
of conducting new monitoring, the system must submit to EPA, no later
than [Date 2 Months After Date of Publication of Final Rule in the
Federal Register], the previously collected data and the supporting
information specified in this section. EPA will notify the system by
[Date 4 Months After Date of Publication of Final Rule in the Federal
Register]
as to whether the data are acceptable. If EPA does not notify
the system that the

[[Page 47781]]

submitted data are acceptable, the system must carry out initial source
water as specified in Sec. Sec. 141.701 through 141.707 until EPA
notifies the system that it has at least two years of acceptable data.
(g) If a system has fewer than two years of Cryptosporidium data
collected before [Date of Publication of Final Rule in the Federal
Register]
and the system intends to use these data to meet, in part,
the initial source water monitoring required under Sec. 141.702(a),
the system must submit to EPA, no later than [Date 8 Months After Date
of Publication of Final Rule in the Federal Register], the previously
collected data and the supporting information specified in this
section. The system must carry out initial source water monitoring
according to the requirements in Sec. Sec. 141.701 through 141.707
until EPA notifies the system that it has at least two years of
acceptable data.
(h) If a system has two or more years of previously collected data
and the system intends to use these data to comply with the initial
source water monitoring required under Sec. 141.702(a), but the system
also intends to carry out additional initial source water monitoring in
order to base its determination of average Cryptosporidium
concentration under Sec. 141.709 or Sec. 141.721 on more than two
years of monitoring data, the system must submit to EPA, no later than
[Date 8 Months After Date of Publication of Final Rule in the Federal
Register], the previously collected data and the supporting information
specified in this section. The system must carry out initial source
water monitoring according to the requirements in Sec. Sec. 141.701
through 141.707 until EPA notifies the system that it has at least two
years of acceptable data.

Sec. 141.709 Bin classification for filtered systems.

(a) Following completion of the initial source water monitoring
required under Sec. 141.702(a), filtered systems and unfiltered
systems that are required to install filtration must calculate their
initial Cryptosporidium bin concentration using the Cryptosporidium
results reported under Sec. 141.702(a), along with any previously
collected data that satisfy the requirements of Sec. 141.708, and
following the procedures in paragraphs (b)(1) through (3) of this
section.
(b)(1) For systems that collect a total of at least 48 samples, the
Cryptosporidium bin concentration is equal to the arithmetic mean of
all sample concentrations.
(2) For systems that serve at least 10,000 people and collect a
total of at least 24 samples, but not more than 47 samples, the
Cryptosporidium bin concentration is equal to the highest arithmetic
mean of all sample concentrations in any 12 consecutive months during
which Cryptosporidium samples were collected.
(3) For systems that serve fewer than 10,000 people and take at
least 24 samples, the Cryptosporidium bin concentration is equal to the
arithmetic mean of all sample concentrations.
(c) Filtered systems and unfiltered systems that are required to
install filtration must determine their initial bin classification from
the following table and using the Cryptosporidium bin concentration
calculated under paragraph (a) of this section:

Bin Classification Table for Filtered Systems
------------------------------------------------------------------------
With a
Cryptosporidium bin The bin
For systems that are: concentration of . classification is
. .\1\ . . .
------------------------------------------------------------------------
* * * required to monitor for Cryptosporidium < Bin 1
Crypto[chyph]sporidium under 0.075 oocyst/L.
Sec. Sec. 141.701 to 141.702.
0.075 oocysts/L Bin 2
<=Cryptosporidium
< 1.0 oocysts/L.
1.0 oocysts/L <= Bin 3
Cryptosporidium <
3.0 oocysts/L.
Cryptosporidium Bin 4
£= 3.0
oocysts/L.
* * * serving fewer than 10,000 NA................. Bin 1
people and NOT required to
monitor for Cryptosporidium
under Sec. 142.702(b).
------------------------------------------------------------------------
\1\ Based on calculations in paragraph (a) or (d) of this section, as
applicable.

(d) Following completion of the second round of source water
monitoring required under Sec. 141.702(d), filtered systems and
unfiltered systems that are required to install filtration must
recalculate their Cryptosporidium bin concentration using the
Cryptosporidium results reported under Sec. 141.702(d) and following
the procedures in paragraphs (b)(1) through (3) of this section.
Systems must then determine their bin classification a second time
using this Cryptosporidium bin concentration and the table in paragraph
(c) of this section.
(e) Any filtered system or unfiltered system that is required to
install filtration that fails to complete the monitoring requirements
of Sec. Sec. 141.701 through 141.707 or choses not to monitor
pursuant to Sec. 141.701(f) must meet the treatment requirements for
Bin 4 under Sec. 141.720 by the date applicable under Sec.
141.701(e).

Disinfection Profiling and Benchmarking Requirements

Sec. 141.710 [Reserved].

Sec. 141.711 Determination of systems required to profile.

(a) Subpart H of this part community and nontransient noncommunity
water systems serving at least 10,000 people that do not have at least
5.5 log of Cryptosporidium treatment, equivalent to compliance with Bin
4 in Sec. 141.720, in place prior to the date when the system is
required to begin profiling in Sec. 141.712 are required to develop
Giardia lamblia and virus disinfection profiles.
(b) Subpart H community and nontransient noncommunity water systems
serving fewer than 10,000 people that do not have at least 5.5 log of
Cryptosporidium treatment, equivalent to compliance with Bin 4 in Sec.
141.720, in place prior to the date when the system is required to
begin profiling in Sec. 141.712 are required to develop Giardia
lamblia and virus disinfection profiles if any of the criteria in
paragraphs (b)(1) through (3) of this section apply.
(1) TTHM levels in the distribution system are at least 0.064 mg/L
as a locational running annual average (LRAA) at any monitoring site.
Systems must base their TTHM LRAA calculation on data collected for
compliance under subpart L of this part after [Date of Publication of
Final Rule in the Federal Register], or as determined by the State.

[[Page 47782]]

(2) HAA5 levels in the distribution system are at least 0.048 mg/L
as an LRAA at any monitoring site. Systems must base their HAA5 LRAA
calculation on data collected for compliance under subpart L of this
part after [Date of Publication of Final Rule in the Federal Register],
or as determined by the State.
(3) The system is required to monitor for Cryptosporidium under
Sec. 141.701(c).
(c) In lieu of developing a new profile, systems may use the
profile(s) developed under Sec. 141.172 or Sec. Sec. 141.530 through
141.536 if the profile(s) meets the requirements of Sec. 141.713(c).

Sec. 141.712 Schedule for disinfection profiling requirements.

(a) Systems must comply with the following schedule in the table in
this paragraph:

Schedule of Required Disinfection Profiling Milestones \1\
----------------------------------------------------------------------------------------------------------------
Date
--------------------------------------------------------------------------
Subpart H systems serving fewer than 10,000
Activity Subpart H systems people
serving at least 10,000 -------------------------------------------------
people Required to monitor for Not required to monitor
Cryptosporidium for Cryptosporidium
----------------------------------------------------------------------------------------------------------------
1. Report TTHM and HAA5 LRAA results NA..................... NA..................... [Date 42 Months After
to State. Date of Publication of
Final Rule in the
Federal Register].
2. Begin disinfection profiling \1,2\ [Date 24 Months After [Date 54 Months After [Date 42 Months After
Date of Publication of Date of Publication of Date of Publication of
Final Rule in the Final Rule in the Final Rule in the
Federal Register]. Federal Register]. Federal Register]
if
required \3\.
3. Complete disinfection profiling [Date 36 Months After [Date 66 Months After [Date 54 Months After
based on at least one year of data. Date of Publication of Date of Publication of Date of Publication of
Final Rule in the Final Rule in the Final Rule in the
Federal Register]. Federal Register]. Federal Register]
if
required \3\.
----------------------------------------------------------------------------------------------------------------
\1\ Systems with at least 5.5 log of Cryptosporidium treatment in place are not required to do disinfection
profiling.
\2\ Systems may use existing operational data and profiles as described in Sec. 141.713(c).
\3\ Systems serving fewer than 10,000 people are not required to conduct disinfection profiling if they are not
required to monitor for Cryptosporidium and if their TTHM and HAA5 LRAAs do not exceed the levels specified in
Sec. 141.711(b).

(b) [Reserved]

Sec. 141.713 Developing a profile.

(a) Systems required to develop disinfection profiles under Sec.
141.711 must follow the requirements of this section. Systems must
monitor at least weekly for a period of 12 consecutive months to
determeine the total log inactivation for Giardia lamblia and viruses.
Systems must determine log inactivation for Giardia lamblia through the
entire plant, based on CT_99.9 values in Tables 1.1 through
1.6, 2.1 and 3.1 of Sec. 141.74(b) as applicable. Systems must
determine log inactivation for viruses through the entire treatment
plant based on a protocol approved by the State.
(b) Systems with a single point of disinfectant application prior
to the entrance to the distribution system must conduct the monitoring
in paragraphs (b)(1) through (4) of this section. Systems with more
than one point of disinfectant application must conduct the monitoring
in paragraphs (b)(1) through (4) of this section for each disinfection
segment. Systems must monitor the parameters necessary to determine the
total inactivation ratio, using analytical methods in Sec. 141.74(a).
(1) For systems using a disinfectant other than UV, the temperature
of the disinfected water must be measured at each residual disinfectant
concentration sampling point during peak hourly flow or at an
alternative location approved by the State.
(2) For systems using chlorine, the pH of the disinfected water
must be measured at each chlorine residual disinfectant concentration
sampling point during peak hourly flow or at an alternative location
approved by the State.
(3) The disinfectant contact time(s) (T) must be determined during
peak hourly flow.
(4) The residual disinfectant concentration(s) (C) of the water
before or at the first customer and prior to each additional point of
disinfection must be measured during peak hourly flow.
(c) In lieu of conducting new monitoring under paragraph (b) of
this section, systems may elect to meet the requirements of paragrphs
(c)(1) or (2) of this section.
(1) Systems that have at least 12 consecutive months of existing
operational data that are substantially equivalent to data collected
under the provisions of paragraph (b) of this section may use these
data to develop disinfection profiles as specified in this section if
the system has neither made a significant change to its treatment
practice nor changed sources since the data were collected. Systems
using existing operational data may develop disinfection profiles for a
period of up to three years.
(2) Systems may use disinfection profile(s) developed under Sec.
141.172 or Sec. Sec. 141.530 through 141.536 in lieu of developing a
new profile if the system has neither made a significant change to its
treatment practice nor changed sources since the profile was developed.
Systems that have not developed a virus profile under Sec. 141.172 or
Sec. Sec. 141.530 through 141.536 must develop a virus profile using
the same monitoring data on which the Giardia lamblia profile is based.
(d) Systems must calculate the total inactivation ratio for Giardia
lamblia as specified in paragraphs (d)(1) through (3) of this section.
(1) Systems using only one point of disinfectant application may
determine the total inactivation ratio for the disinfection segment
based on either of the methods in paragraph (d)(1)(i) or (ii) of this
section.
(i) Determine one inactivation ratio (CTcalc/CT_99.9)
before or at the first customer during peak hourly flow.
(ii) Determine successive CTcalc/CT_99.9 values,
representing sequential inactivation ratios, between the point of
disinfectant application and a point before or at the first customer
during peak hourly flow. The system must calculate the total
inactivation ratio by determining (CTcalc/CT_99.9) for each
sequence and then adding the (CTcalc/CT_99.9) values together
to determine ([Sigma]
(CTcalc/CT_99.9)).
(2) Systems using more than one point of disinfectant application
before the first customer must determine the CT value of each
disinfection segment immediately prior to the next point of

[[Page 47783]]

disinfectant application, or for the final segment, before or at the
first customer, during peak hourly flow. The (CTcalc/CT_99.9)
value of each segment and ([Sigma](CTcalc/CT_99.9)) must be
calculated using the method in paragraph (d)(1)(ii) of this section.
(3) The system must determine the total logs of inactivation by
multiplying the value calculated in paragraph (d)(1) or (d)(2) of this
section by 3.0.
(4) Systems must calculate the log of inactivation for viruses
using a protocol approved by the State.
(5) Systems must retain the disinfection profile data in graphic
form, as a spreadsheet, or in some other format acceptable to the State
for review as part of sanitary surveys conducted by the State.

Sec. 141.714 Requirements when making a significant change in
disinfection practice.

(a) A system that is required to develop a disinfection profile
under the provisions of this subpart and that plans to make a
significant change to its disinfection practice must calculate a
disinfection benchmark and must notify the State prior to making such a
change. Significant changes to disinfection practice are defined in
paragraphs (a)(1) through (4) of this section.
(1) Changes to the point of disinfection;
(2) Changes to the disinfectant(s) used in the treatment plant;
(3) Changes to the disinfection process; and
(4) Any other modification identified by the State.
(5) Systems must use the procedures specified in paragraphs
(a)(5)(i) and (ii) of this section to calculate a disinfection
benchmark.
(i) For the year of profiling data collected and calculated under
Sec. 141.713, or for each year with profiles covering more than one
year, systems must determine the lowest mean monthly level of both
Giardia lamblia and virus inactivation. Systems must determine the mean
Giardia lamblia and virus inactivation for each calendar month for each
year of profiling data by dividing the sum of daily or weekly Giardia
lamblia and virus log inactivation by the number of values calculated
for that month.
(ii) The disinfection benchmark is the lowest monthly mean value
(for systems with one year of profiling data) or the mean of the lowest
monthly mean values (for systems with more than one year of profiling
data) of Giardia lamblia and virus log inactivation in each year of
profiling data.
(6) Systems must submit the information in paragraphs (a)(6)(i)
through (iii) of this section when notifying the State that they are
planning to make a significant change in disinfection practice.
(i) A description of the proposed change.
(ii) The disinfection profile and benchmark for Giardia lamblia and
viruses determined under Sec. Sec. 141.713 and 141.714.
(iii) An analysis of how the proposed change will affect the
current level of disinfection.

Treatment Technique Requirements

Sec. 141.720 Treatment requirements for filtered systems.

(a) Filtered systems or systems that are unfiltered and required to
install filtration must provide the level of treatment for
Cryptosporidium specified in this paragraph, based on their bin
classification as determined under Sec. 141.709 and their existing
treatment:

----------------------------------------------------------------------------------------------------------------
And the system uses the following filtration treatment in full compliance with
subpart H, P, and T of this section (as applicable), then the additional
treatment requirements are . . .
-------------------------------------------------------------------------------
If the system bin classification Conventional
is . . . filtration Slow sand or Alternative
treatment Direct filtration diatomaceous earth filtration
(including filtration technologies
softening)
----------------------------------------------------------------------------------------------------------------
(1) Bin 1....................... No additional No additional No additional No additional
treatment. treatment. treatment. treatment
(2) Bin 2....................... 1 log treatment... 1.5 log treatment. 1 log treatment... (\1\)
(3) Bin 3....................... 2 log treatment... 2.5 log treatment. 2 log treatment... (\2\)
(4) Bin 4....................... 2.5 log treatment. 3 log treatment... 2.5 log treatment. (\3\)
----------------------------------------------------------------------------------------------------------------
\1\ As determined by the State such that the total Cryptosporidium removal and inactivation is at least 4.0 log.

\2\ As determined by the State such that the total Cryptosporidium removal and inactivation is at least 5.0 log.

\3\ As determined by the State such that the total Cryptosporidium removal and inactivation is at least 5.5 log.

(b) Filtered systems must use one, or a combination, of the
management and treatment options listed in Sec. 141.722, termed the
microbial toolbox, to meet the additional Cryptosporidium treatment
requirements identified for each bin in paragraph (a) of this section.
(c) Systems classified in Bin 3 and Bin 4 must achieve at least 1
log of the additional treatment required under paragraph (a) of this
section using either one or a combination of the following: bag
filters, bank filtration, cartridge filters, chlorine dioxide,
membranes, ozone, and/or UV as specified in Sec. 141.722.

Sec. 141.721 Treatment requirements for unfiltered systems.

(a) Following completion of the initial source water monitoring
required under Sec. 141.702(a), unfiltered systems that meet all
filtration avoidance criteria of Sec. 141.71 must calculate the
arithmetic mean of all Cryptosporidium sample concentrations reported
under Sec. 141.702(a), along with any previously collected data that
satisfy the requirements of Sec. 141.708, and must meet the treatment
requirements in paragraph (b)(1) or (2) of this section, as applicable,
based on this concentration.
(b)(1) Unfiltered systems with a mean Cryptosporidium concentration
of 0.01 oocysts/L or less must provide at least 2 log Cryptosporidium
inactivation.
(2) Unfiltered systems with a mean Cryptosporidium concentration of
greater than 0.01 oocysts/L must provide at least 3 log Cryptosporidium
inactivation.
(c) Unfiltered systems must use chlorine dioxide, ozone, or UV as
specified in Sec. 141.722 to meet the Cryptosporidium inactivation
requirements of this section.
(1) Unfiltered systems that use chlorine dioxide or ozone and fail
to achieve the Cryptosporidium log inactivation required in paragraph
(b)(1) or (2) of this section, as applicable, on more than one day in
the calendar month are in violation of the treatment technique
requirement.
(2) Unfiltered systems that use UV light and fail to achieve the
Cryptosporidium log inactivation required in paragraph (b)(1) or (2) of
this section, as applicable, in at least 95% of the water that is
delivered to the public during each calendar month, based on monitoring
required under paragraph Sec. 141.729(d)(4), are in violation of the
treatment technique requirement.
(d) Unfiltered systems must meet the combined Cryptosporidium,
Giardia

[[Page 47784]]

lamblia, and virus inactivation requirements of this section and Sec.
141.72(a) using a minimum of two disinfectants, and each disinfectant
must separately achieve the total inactivation required for either
Cryptosporidium, Giardia lamblia, or viruses.
(e) Following completion of the second round of source water
monitoring required under Sec. 141.702(d), unfiltered systems that
meet all filtration avoidance criteria of Sec. 141.71 must calculate
the arithmetic mean of all Cryptosporidium sample concentrations
reported under Sec. 141.702(d) and must meet the treatment
requirements in paragraph (b)(1) or (2) of this section, as applicable,
based on this concentration.
(f) Any unfiltered system that meets all filtration avoidance
criteria of Sec. 141.71 and fails to complete the monitoring
requirements of Sec. Sec. 141.701 through 141.707 or choses not to
monitor pursuant to Sec. 141.701(g) must meet the treatment
requirements of paragraph (b)(2) of this section by the date applicable
under Sec. 141.701(e).

Sec. 141.722 Microbial toolbox options for meeting Cryptosporidium
treatment requirements.

(a) To meet the additional Cryptosporidium treatment requirements
of Sec. Sec. 141.720 and 141.721, systems must use microbial toolbox
options listed in this follwing table that are designed, implemented,
and operated in accordance with the requirements of this subpart.

Microbial Toolbox: Options, Credits and Criteria
------------------------------------------------------------------------
Proposed Cryptosporidium treatment
Toolbox option credit with design and
implementation criteria
------------------------------------------------------------------------
Source Toolbox Components
------------------------------------------------------------------------
(1) Watershed control program..... 0.5 log credit for State approved
program comprising EPA specified
elements. Specific criteria are in
Sec. 141.725(a).
(2) Alternative source/intake Bin classification based on
management. concurrent Cryptosporidium
monitoring. No presumptive credit.
Specific criteria are in Sec.
141.725(b).
-----------------------------------
Pre-Filtration Toolbox Components
------------------------------------------------------------------------
(3) Presedimentation basin with 0.5 log credit for new basins with
coagulation. continuous operation and coagulant
addition. No presumptive credit for
basins existing when monitoring is
required under Sec. 141.702.
Specific criteria are in Sec.
141.726(a).
(4) Two-stage lime softening...... 0.5 log credit for two-stage
softening with coagulant addition.
Specific criteria are in Sec.
141.726(b).
(5) Bank filtration............... 0.5 log credit for 25 foot setback;
1.0 log credit for 50 foot setback.
No presumptive credit for bank
filtration existing when monitoring
is required under Sec.
141.704(d)(1). Specific criteria
are in Sec. 141.726(c).
-----------------------------------
Treatment Performance Toolbox Components
------------------------------------------------------------------------
(6) Combined filter performance... 0.5 log credit for combined filter
effluent turbidity <= 0.15 NTU in
95% of samples each month. Specific
criteria are in Sec. 141.727(a).
(7) Individual filter performance. 1.0 log credit for individual filter
effluent turbidity <=0.1 NTU in 95%
of daily maximum samples each month
and no filter £0.3 NTU in
two consecutive measurements.
Specific criteria are in Sec.
141.727(b).
(8) Demonstration of performance.. Credit based on a demonstration to
the State through State approved
protocol. Specific criteria are in
Sec. 141.727(c).
-----------------------------------
Additional Filtration Toolbox Components
------------------------------------------------------------------------
(9) Bag filters................... 1 log credit with demonstration of
at least 2 log removal efficiency
in challenge test; Specific
criteria are in Sec. 141.728(a).
(10) Cartridge filters............ 2 log credit with demonstration of
at least 3 log removal efficiency
in challenge test; Specific
criteria are in Sec. 141.728(a).
(11) Membrane filtration.......... Log removal credit up to the lower
value of the removal efficiency
demonstrated during the challenge
test or verified by the direct
integrity test applied to the
system. Specific criteria are in
Sec. 141.728(b).
(12) Second stage filtration...... 0.5 log credit for a second separate
filtration stage in treatment
process following coagulation.
Specific criteria are in Sec.
141.728(c).
(13) Slow sand filers............. 2.5 log credit for second separate
filtration process. Specific
criteria are in Sec. 141.728(d).
-----------------------------------
Inactivation Toolbox Components
------------------------------------------------------------------------
(14) Chlorine dioxide............. Log credit based on demonstration of
compliance with CT table. Specific
criteria are in Sec. 141.729(b).
(15) Ozone........................ Log credit based on demonstration of
compliance with CT table. Specific
criteria are in Sec. 141.729(c).
(16) UV........................... Log credit based on demonstration of
compliance with UV dose table.
Specific criteria are in Sec.
141.729(d).
------------------------------------------------------------------------

(b) Failure to comply with the requirements of this section in
accordance with the schedule in Sec. 141.701(e) is a treatment
technique violation.

Sec. 141.723 [Reserved]

Sec. 141.724 Requirements for uncovered finished water storage
facilities.

(a) Systems using uncovered finished water storage facilities must
comply with the conditions of one of the paragraphs (a)(1) through (3)
of this section for each facility no later than the date specified in
Sec. 141.701(h).
(1) Systems must cover any uncovered finished water storage
facility.
(2) Systems must treat the discharge from the uncovered finished
water storage facility to the distribution system to achieve at least 4
log virus inactivation using a protocol approved by the State.
(3) Systems must have a State-approved risk mitigation plan for the
uncovered finished water storage facility that addresses physical
access and site security, surface water runoff, animal and bird waste,
and ongoing water quality assessment, and includes a schedule for plan
implementation. Systems must implement the risk

[[Page 47785]]

mitigation plan approved by the State. Systems must submit risk
mitigation plans to the State for approval no later than [Date 24
Months After Date of Publication of Final Rule in the Federal
Register].
(b) Failure to comply with the requirements of this section in
accordance with the schedule in Sec. 141.701(h) is a treatment
technique violation.

Requirements for Microbial Toolbox Components

Sec. 141.725 Source toolbox components.

(a) Watershed control program.
(1) Systems that intend to qualify for a 0.5 log credit for
Cryptosporidium removal for a watershed control program must notify the
State no later than one year after completing the source water
monitoring requirements of Sec. 141.702(b) that they intend to develop
a watershed control program and to submit it for State approval.
(2) Systems must submit a proposed initial watershed control plan
and a request for plan approval and 0.5 log Cryptosporidium removal
credit to the State no later than two years after completing the source
water monitoring requirements of Sec. 141.702(b). Based on a review of
the initial proposed watershed control plan, the State may approve,
reject, or conditionally approve the plan. If the plan is approved, or
if the system agrees to implement the State's conditions for approval,
the system is awarded a 0.5 log credit for Cryptosporidium removal to
apply against additional treatment requirements.
(3) The application to the State for initial program approval must
include elements in paragraphs (a)(3)(i) through (iii) of this section.
(i) An analysis of the vulnerability of each source to
Cryptosporidium. The vulnerability analysis must address the watershed
upstream of the drinking water intake and must include the following: a
characterization of the watershed hydrology, identification of an
``area of influence'' (the area to be considered in future watershed
surveys) outside of which there is no significant probability of
Cryptosporidium or fecal contamination affecting the drinking water
intake, identification of both potential and actual sources of
Cryptosporidium contamination, the relative impact of the sources of
Cryptosporidium contamination on the system's source water quality, and
an estimate of the seasonal variability of such contamination.
(ii) An analysis of control measures that could mitigate the
sources of Cryptosporidium contamination identified during the
vulnerability analysis. The analysis of control measures must address
their relative effectiveness in reducing Cryptosporidium loading to the
source water and their feasability and sustainability.
(iii) A plan that establishes goals and defines and prioritizes
specific actions to reduce source water Cryptosporidium levels. The
plan must explain how the actions are expected to contribute to
specific goals, identify watershed partners and their role(s), identify
resource requirements and commitments, and include a schedule for plan
implementation.
(4) Initial State approval of a watershed control plan and its
associated 0.5 log Cryptosporidium removal credit is valid until the
system completes the second round of Cryptosporidium monitoring
required under Sec. 141.702(d). Systems must complete the actions in
paragraphs (a)(4)(i) through (iv) of this section to maintain State
approval and the 0.5 log credit.
(i) Submit an annual watershed control program status report to the
State by a date determined by the State. The annual watershed control
program status report must describe the system's implementation of the
approved plan and assess the adequacy of the plan to meet its goals. It
must explain how the system is addressing any shortcomings in plan
implementation, including those previously identified by the State or
as the result of the watershed survey conducted under paragraph
(a)(4)(ii) of this section. If it becomes necessary during
implementation to make substantial changes in its approved watershed
control program, the system must notify the State and provide a
rationale prior to making any such changes. If any change is likely to
reduce the level of source water protection, the system must also
include the actions it will take to mitigate the effects in its
notification.
(ii) Conduct an annual watershed sanitary survey and submit the
survey report to the State for approval. The survey must be conducted
according to State guidelines and by persons approved by the State to
conduct watershed surveys. The survey must encompass the area of the
watershed that was identified in the State-approved watershed control
plan as the area of influence and, at a minimum, assess the priority
activities identified in the plan and identify any significant new
sources of Cryptosporidium.
(iii) Submit to the State a request for review and re-approval of
the watershed control program and for a continuation of the 0.5 log
removal credit for a subsequent approval period. The request must be
provided to the State at least six months before the current approval
period expires or by a date previously determined by the State. The
request must include a summary of activities and issues identified
during the previous approval period and a revised plan that addresses
activities for the next approval period, including any new actual or
potential sources of Cryptosporidium contamination and details of any
proposed or expected changes from the existing State-approved program.
The plan must address goals, prioritize specific actions to reduce
source water Cryptosporidium, explain how actions are expected to
contribute to achieving goals, identify partners and their role(s),
resource requirements and commitments, and the schedule for plan
implementation.
(iv) The annual status reports, watershed control plan and annual
watershed sanitary surveys must be made available to the public upon
request. These documents must be in a plain language style and include
criteria by which to evaluate the success of the program in achieving
plan goals. If approved by the State, the system may withhold portions
of the annual status report, watershed control plan, and watershed
sanitary survey based on security considerations.
(5) Unfiltered systems may not claim credit for Cryptosporidium
removal under this option.
(b) Alternative source. (1) If approved by the State, a system may
be classified in a bin under Sec. 141.709 based on monitoring that is
conducted concurrently with source water monitoring under Sec. 141.701
and reflects a different intake location (either in the same source or
for an alternate source) or a different procedure for managing the
timing or level of withdrawal from the source.
(2) Sampling and analysis of Cryptosporidium in the concurrent
round of monitoring must conform to the requirements for monitoring
conducted under this subpart to determine bin classification. Systems
must submit the results of all monitoring to the State, along with
supporting information documenting the operating conditions under which
the samples were collected.
(3) If the State classifies the system in a bin based on monitoring
that reflects a different intake location or a different procedure for
managing the timing or level of withdrawal from the source, the system
must relocate the intake or use

[[Page 47786]]

the intake management strategy, as applicable, no later than the
applicable date for treatment technique implementation in Sec.
141.701. The State may specify reporting requirements to verify
operational practices.

Sec. 141.726 Pre-filtration treatment toolbox components.

(a) Presedimentation. New presedimentation basins that meet the
criteria in paragraphs (a)(1) through (4) of this section are eligible
for 0.5 log Cryptosporidium removal credit. Systems with
presedimentation basins existing when the system is required to conduct
monitoring under Sec. 141.702(a) may not claim this credit and, during
periods when the basins are in use, must collect samples after the
basins for the purpose of determining bin classification under Sec.
141.709.
(1) The presedimentation basin must be in continuous operation and
must treat all of the flow reaching the treatment plant.
(2) The system must continuously add a coagulant to the
presedimentation basin.
(3) Presedimentation basin influent and effluent turbidity must be
measured at least once per day or more frequently as determined by the
State.
(4) The system must demonstrate on a monthly basis at least 0.5 log
reduction of influent turbidity through the presedimentation process in
at least 11 of the 12 previous consecutive months.
(i) The monthly demonstration of turbidity reduction must be based
on the mean of daily turbidity readings collected under paragraph
(a)(3) of this section and calculated as follows:
log₁₀(monthly mean of daily influent turbidity)--
log₁₀(monthly mean of daily effluent turbidity).
(ii) If the presedimentation process has not been in operation for
12 months, the system must verify on a monthly basis at least 0.5 log
reduction of influent turbidity through the presedimentation process,
calculated as specified in this paragraph, for at least all but any one
of the months of operation.
(b) Two-stage lime softening. Systems that operate a two-stage lime
softening plant are eligible for an additional 0.5 log Cryptosporidium
removal credit if there is a second clarification step between the
primary clarifier and filter(s) that is operated continuously. Both
clarifiers must treat all of the plant flow and a coagulant, which may
be excess lime or magnesium hydroxide, must be present in both
clarifiers.
(c) Bank filtration. New bank filtration that serves as
pretreatment to a filtration plant is eligible for either a 0.5 or a
1.0 log Cryptosporidium removal credit towards the requirements of this
subpart if it meets the design criteria specified in paragraphs (c)(1)
through (c)(5) of this section and the monitoring and reporting
criteria of paragraph (c)(6) of this section. Wells with a ground water
flow path of at least 25 feet are eligible for 0.5 log removal credit;
wells with a ground water flow path of at least 50 feet are eligible
for 1.0 log removal credit. The ground water flow path must be
determined as specified in paragraph (c)(5) of this section.
(1) Only horizontal and vertical wells are eligible for bank
filtration removal credit.
(2) Only wells in granular aquifers are eligible for bank
filtration removal credit. Granular aquifers are those comprised of
sand, clay, silt, rock fragments, pebbles or larger particles, and
minor cement. The aquifer material must be unconsolidated as
demonstrated by the aquifer characterization specified in paragraph
(c)(3) of this section, unless the system meets the conditions of
paragraph (c)(4) of this section. Wells located in consolidated
aquifers, fractured bedrock, karst limestone, and gravel aquifers are
not eligible for bank filtration removal credit.
(3) A system seeking removal credit for bank filtration must
characterize the aquifer at the well site to determine aquifer
properties. The aquifer characterization must include the collection of
relatively undisturbed continuous core samples from the surface to a
depth at least equal to the bottom of the well screen. The recovered
core length must be at least 90 percent of the total projected depth to
the well screen, and each sampled interval must be a composite of no
more than 2 feet in length. A well is eligible for removal credit if at
least 90 percent of the composited intervals from the aquifer contain
at least 10 percent fine grained material, which is defined as grains
less than 1.0 mm in diameter.
(4) Wells constructed in partially consolidated granular aquifers
are eligible for removal credit if approved by the State based on a
demonstraton by the system that the aquifer provides sufficient natural
filtration. The demonstration must include a characterization of the
extent of cementation and fractures present in the aquifer.
(5) For vertical wells, the ground water flow path is the measured
horizontal distance from the edge of the surface water body to the
well. This horzontal distance to the surface water must be determined
using the floodway boundary or 100 year flood elevation boundary as
delineated on Federal Emergency Management Agency (FEMA) Flood
Insurance Rate maps. If the floodway boundary or 100 year flood
elevation boundary is not delineated, systems must determine the
floodway or 100 year flood elevation boundary using methods
substantially equilvalent to those used in preparing FEMA Flood
Insurance Rate maps. For horizontal wells, the ground water flow path
is the closest measured distance from the bed of the river under normal
flow conditions to the closest horizontal well lateral intake.
(6) Turbidity measurements must be performed on representative
samples from each wellhead at least every four hours that the bank
filtration is in operation. Continuous turbidity monitoring at each
wellhead may be used if the system validates the continuous measurement
for accuracy on a regular basis using a protocol approved by the State.
If the monthly average of daily maximum turbidity values at any well
exceeds 1 NTU, the system must report this finding to the State within
30 days. In addition, within 30 days of the exceedance, the system must
conduct an assessment to determine the cause of the high turbidity
levels and submit that assessment to the State for a determination of
whether any previously allowed credit is still appropriate.
(7) Systems with bank filtration that serves as pretreatment to a
filtration plant and that exists when the system is required to conduct
monitoring under Sec. 141.702(a) may not claim this credit. During
periods when the bank filtration is in use, systems must collect
samples after the bank filtration for the purpose of determining bin
classification under Sec. 141.709.

Sec. 141.727 Treatment performance toolbox components.

(a) Combined filter performance. Systems using conventional
filtration treatment or direct filtration treatment may claim an
additional 0.5 log Cryptosporidium removal credit for any month at each
plant that demonstrates that combined filter effluent (CFE) turbidity
levels are less than or equal to 0.15 NTU in at least 95 percent of the
measurements taken each month, based on sample measurements collected
under Sec. Sec. 141.73,141.173(a) and 141.551. Systems may not claim
credit under this paragraph and paragraph (b) in the same month.
(b) Individual filter performance. Systems using conventional
filtration treatment or direct filtration treatment

[[Page 47787]]

may claim an additional 1.0 log Cryptosporidium removal credit for any
month at each plant that meets both the individual filter effluent
(IFE) turbidity requirements of paragraphs (b)(1) and (2) of this
section, based on monitoring conducted under Sec. Sec. 141.174(a) and
141.560.
(1) IFE turbidity must be less than 0.1 NTU in at least 95% of the
maximum daily values recorded at each filter in each month, excluding
the 15 minute period following return to service from a filter
backwash.
(2) No individual filter may have a measured turbidity greater than
0.3 NTU in two consecutive measurements taken 15 minutes apart.
(c)(1) Demonstration of performance. Systems may demonstrate to the
State, through the use of State-approved protocols, that a plant, or
unit process of a plant, achieves a mean Cryptosporidium removal
efficiency greater than any presumptive credit specified under Sec.
141.720 or Sec. Sec. 141.725 through 141.728. Systems are eligible
for an increased Cryptosporidium removal credit if the State determines
that the plant or process can reliably achieve such a removal
efficiency on a continuing basis and the State provides written
notification of its determination to the system. States may establish
ongoing monitoring and/or performance requirements the State determines
are necessary to demonstrate the greater credit and may require the
system to report operational data on a monthly basis to verify that
conditions under which the demonstration of performance was awarded are
maintained during routine operations. If the State determines that a
plant, or unit process of a plant, achieves an average Cryptosporidium
removal efficiency less than any presumptive credit specified under
Sec. 141.720 or Sec. Sec. 141.725 through 141.728, the State may
assign the lower credit to the plant or unit process.
(2) Systems may not claim presumptive credit for any toolbox box
component in Sec. Sec. 141.726, 141.727(a) and (b), or 141.728 if
that component is also included in the demonstration of performance
credit.

Sec. 141.728 Additional filtration toolbox components.

(a) Bag and cartridge filters. Systems are eligible for a 1 log
Cryptosporidium removal credit for bag filters and a 2 log
Cryptosporidium removal credit for cartridge filters by meeting the
criteria in paragraphs (a)(1) through (a)(10) of this section. The
request to the State for this credit must include the results of
challenge testing that meets the requirements of paragraphs (a)(2)
through (a)(9) of this section.
(1) To receive a 1 log Cryptosporidium removal credit for a bag
filter, the filter must demonstrate a removal efficiency of 2 log or
greater for Cryptosporidium. To receive a 2 log Cryptosporidium removal
credit for a cartridge filter, the filter must demonstrate a removal
efficiency of 3 log or greater for Cryptosporidium. Removal efficiency
must be demonstrated through challenge testing conducted according to
the criteria in paragraphs (a)(2) through (a)(9) of this section. The
State may accept data from challenge testing conducted prior to [Date
of Publication of Final Rule in the Federal Register]
in lieu of
additional testing if the prior testing was consistent with the
criteria specified in paragraphs (a)(2) through (a)(9) of this section.
(2) Challenge testing must be performed on full-scale bag or
cartridge filters that are identical in material and construction to
the filters proposed for use in full-scale treatment facilities for
removal of Cryptosporidium.
(3) Challenge testing must be conducted using Cryptosporidium
oocysts or a surrogate that is removed no more efficiently than
Cryptosporidium oocysts. The organism or surrogate used during
challenge testing is referred to as the challenge particulate. The
concentration of the challenge particulate must be determined using a
method capable of discreetly quantifying the specific organism or
surrogate used in the test; gross measurements such as turbidity may
not be used.
(4) The maximum feed water concentration that can be used during a
challenge test must be based on the detection limit of the challenge
particulate in the filtrate (i.e., filtrate detection limit) and must
be calculated using the equation in either paragraph (a)(4)(i) or
(a)(4)(ii) of this section as applicable.
(i) For cartridge filters: Maximum Feed Concentration = 3.16x10\4\
x (Filtrate Detection Limit).
(ii) For bag filters: Maximum Feed Concentration = 3.16x10\3\ x
(Filtrate Detection Limit).
(5) Challenge testing must be conducted at the maximum design flow
rate for the filter as specified by the manufacturer.
(6) Each filter evaluated must be tested for a duration sufficient
to reach 100 percent of the terminal pressure drop, which establishes
the maximum pressure drop under which the filter may be used to comply
with the requirements of this subpart.
(7) Each filter evaluated must be challenged with the challenge
particulate during three periods over the filtration cycle: within two
hours of start-up after a new bag or cartridge filter has been
installed; when the pressure drop is between 45 and 55 percent of the
terminal pressure drop; and at the end of the run after the pressure
drop has reached 100 percent of the terminal pressure drop.
(8) Removal efficiency of a bag or cartridge filter must be
determined from the results of the challenge test and expressed in
terms of log removal values using the following equation:

LRV = LOG₁₀(C_f)-LOG₁₀(C_p)

[[Page 47788]]

membrane filtration process under the conditions in paragraph (b)(3) of
this section.
(2) Challenge Testing. The membrane used by the system must undergo
challenge testing to evaluate removal efficiency, and the system must
submit the results of challenge testing to the State. Challenge testing
must be conducted according to the criteria in paragraphs (b)(2)(i)
through (b)(2)(vii) of this section. The State may accept data from
challenge testing conducted prior to [Date of Publication of Final Rule
in the Federal Register]
in lieu of additional testing if the prior
testing was consistent with the criteria in paragraphs (b)(2)(i)
through (b)(2) (vii) of this section.
(i) Challenge testing must be conducted on either a full-scale
membrane module, identical in material and construction to the membrane
modules used in the system's treatment facility, or a smaller-scale
membrane module, identical in material and similar in construction to
the full-scale module.
(ii) Challenge testing must be conducted using Cryptosporidium
oocysts or a surrogate that is removed no more efficiently than
Cryptosporidium oocysts. The organism or surrogate used during
challenge testing is referred to as the challenge particulate. The
concentration of the challenge particulate must be determined using a
method capable of discretely quantifying the specific challenge
particulate used in the test; gross measurements such as turbidity may
not be used.
(iii) The maximum feed water concentration that can be used during
a challenge test is based on the detection limit of the challenge
particulate in the filtrate and must be determined according to the
following equation:

Maximum Feed Concentration = 3.16x10\6\ x (Filtrate Detection Limit)

(iv) Challenge testing must be conducted under representative
hydraulic conditions at the maximum design flux and maximum design
process recovery specified by the manufacture for the membrane module.
Flux is defined as the rate of flow per unit of membrane area. Recovery
is defined as the ratio of filtrate volume produced by a membrane to
feed water volume applied to a membrane over the course of an
uninterrupted operating cycle. An operating cycle is bounded by two
consecutive backwash or cleaning events. For the purpose of challenge
testing in this section, recovery does not consider losses that occur
due to the use of filtrate in backwashing or cleaning operations.
(v) Removal efficiency of a membrane module during challenge
testing must be determined as a log removal using the following
equation:

LRV = LOG₁₀(C_f) - LOG₁₀(C_p)

where LRV = log removal value demonstrated during challenge testing;
C_f = the feed concentration used during the challenge test;
and C_p = the filtrate concentration observed during the
challenge test. Equivalent units must be used for the feed and filtrate
concentrations. If the challenge particulate is not detected in the
filtrate, the term C_p is set equal to the detection limit.
An LRV must be calculated for each membrane module evaluated during the
test.
(vi) The removal efficiency of a membrane filtration process
demonstrated during challenge testing must be expressed as a log
removal value (LRV_C-Test). If fewer than 20 modules are
tested, then LRV_C-Test is equal to the lowest of the
representative LRVs among the applicable modules tested. If 20 or more
modules are tested, then LRV_C-Test is equal to the 10th
percentile of the representative LRVs among the applicable modules
tested. The percentile is defined by (i/(n+1)) where i is the rank of n
individual data points ordered lowest to highest. If necessary, the
10th percentile may be calculated using linear interpolation.
(vii) The challenge test must establish a quality control release
value (QCRV) for a non-destructive performance test that demonstrates
the Cryptosporidium removal capability of the membrane filtration
process. This performance test must be applied to each production
membrane module used by the system that did not undergo a challenge
test in order to verify Cryptosporidium removal capability. Production
modules that do not meet the established QCRV are not eligible for the
removal credit demonstrated during the challenge test.
(viii) If a previously tested membrane is modified in a manner that
could change the removal efficiency of the membrane or the
applicability of the non-destructive performance test and associated
QCRV, addition challenge testing to demonstrate the removal efficiency
of, and determine a new QCRV for, the modified membrane must be
conducted and submitted to the State.
(3) Direct integrity testing. Systems must conduct direct integrity
testing in a manner that demonstrates a removal efficiency equal to or
greater than the removal credit awarded to the membrane filtration
process and meets the requirements described in paragraphs (b)(3)(i)
through (b)(3)(vi) of this section.
(i) The direct integrity test must be independently applied to each
membrane unit in service. A membrane unit is a group of membrane
modules that share common valving that allows the unit to be isolated
from the rest of the system for the purpose of integrity testing or
maintenance.
(ii) The direct integrity method must have a resolution of 3 [mu]m
or less, where resolution is defined as the smallest leak size that
contributes to a response from the direct integrity test.
(iii) The system must demonstrate that the direct integrity test
can verify the log removal credit awarded to the membrane filtration
process by the State using the approach in either paragraph
(b)(2)(iii)(A) or (b)(2)(iii)(B) of this section as applicable based on
the type of direct integrity test.
(A) For direct integrity tests that use an applied pressure or
vacuum, the maximum log removal value that can be verified by the test
must be calculated according to the following equation:

LRV_DIT = LOG₁₀(Q_p /(VCF x
Q_breach))

where LRV_DIT = maximum log removal value that can be
verified by a direct integrity test; Q_p = total design
filtrate flow from the membrane unit; Q_breach = flow of
water from an integrity breach associated with the smallest integrity
test response that can be reliably measured, and VCF = volumetric
concentration factor. The volumetric concentration factor is the ratio
of the suspended solids concentration on the high pressure side of the
membrane relative to that in the feed water.
(B) For direct integrity tests that use a particulate or molecular
marker, the maximum log removal value that can be verified by the test
must be calculated according to the following equation:

LRV_DIT = LOG₁₀(C_f)-
LOG₁₀(C_p)

where LRV_DIT = maximum log removal value that can be
verified by a direct integrity test; C_f = the typical feed
concentration of the marker used in the test; and C_p = the
filtrate concentration of the marker from an integral membrane unit.
(iv) Systems must establish a control limit for the direct
integrity test that is indicative of an integral membrane unit capable
of meeting the removal credit awarded by the State.
(v) If the result of a direct integrity test is outside the control
limit established under paragraphs (b)(3)(i) through (b)(3)(iv) of this
section, the membrane unit must be removed from service. A direct
integrity test must be

[[Continued on page 47789]]

Notices For
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
1998
1997
1996
1995
1994

National Primary Drinking Water Regulations: Long Term 2 Enhanced Surface Water Treatment Rule

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