EPA also received comments generally supporting the use of
alternative sites for repeat monitoring since they provide more
flexibility in determining the locations of the repeat samples,
allowing for better protection of public health on a site-specific
basis, subject to State review. One commenter disagreed, saying that
repeat samples should be near the original positive sample site so that
they can provide the necessary information to confirm the original
positive sample. A few commenters are against having within-five-
connections-upstream-and-downstream locations from the original
positive sample as the default locations for repeat monitoring. They
suggested that these default locations should be eliminated altogether
and that all PWSs be allowed to take the other two repeat samples at
alternative locations.
    EPA believes that not all systems will use the option of taking
repeat samples at alternative locations. Some PWSs, especially small
NCWSs, may not avail themselves of this option for reasons of
simplicity and lack of resources and expertise. They may elect to stick
with the set repeat monitoring locations of five connections upstream
and downstream of the original total coliform-positive sample, as it
will be less burdensome on them than locating alternative sites and
demonstrating that the alternative sites are more effective. Hence, EPA
is maintaining within-five-connections-upstream-and-downstream
locations as the default repeat sampling locations.
    While the prescribed locations may work for some systems, other
systems may find them too limiting. Taking repeat samples at the
prescribed locations of within five-connections-upstream-and-downstream
can be difficult for some systems to implement within the required 24
hours for a repeat sample because of issues such as access to the site.
Therefore, EPA is allowing PWSs to propose alternative repeat
monitoring locations, either as fixed locations or as criteria in an
SOP, to facilitate the identification of the source and extent of any
problem. EPA believes that both the within-five-connections-upstream-
and-downstream repeat sampling locations and the locations as
identified by an SOP can be used by the operator to better understand
the extent and duration of potential pathways of contamination into the
distribution system with the appropriate amount of State supervision.
    EPA requested comment on whether systems should be required to
obtain prior State approval for using repeat monitoring sites other
than the within-five-connections-upstream-and-downstream locations of
the original routine total coliform-positive site. Most of the
commenters were against requiring prior State approval for the use of
alternative repeat monitoring locations. They suggested that it is more
appropriate to include these sites (or the criteria to choose sites) in
the SOP or in the sample siting plan, which is then subject to State
review and revision. Some commenters also stated that requiring pre-
approval for each individual instance of using alternative sites is not
practical.
    EPA agrees that obtaining prior State approval to use alternative
repeat monitoring locations is not necessary since there is no
reduction in monitoring and EPA expects the SOP to be used only by
large systems with the technical resources to justify alternative
monitoring sites. Although State approval is not required, EPA requires
PWSs that are intending to use this option to submit their proposed
alternative sampling sites (as part of an SOP or the sample siting
plan) to the State. The PWS must be able to demonstrate to the State
that the alternative monitoring sites are appropriate to help
characterize the extent of the possible contamination. The State is
given the discretion to review and revise the alternative monitoring
locations consistent with their practice regarding sample siting plans.
EPA does not require that the State formally acknowledge and approve
the alternative monitoring locations. The alternative monitoring
locations are considered appropriate unless the State disapproves or
modifies them, which results in the requirement being self-
implementing.
    EPA received general support for allowing samples taken at the
ground water source to serve both as a triggered source sample under
the GWR and as one of the repeat samples under the RTCR (i.e., as dual
purpose samples). Some States said that this practice is already being
done in their States and therefore should continue under the RTCR. Most
commenters supported the provision with the understanding that the
practice would be subject to State approval. One commenter, however,
disagreed with the provision and thought the PWS would not be
collecting a sufficient number of repeat samples to represent the water
quality in the distribution system if one of the repeat samples is
taken at the source water. Another commenter suggested making the
option available for ground water systems of all sizes, as it will help
reduce labor and analytical costs, and will provide a clearer picture
as to the location and cause of the total coliform-positive sample.
    The preamble to the proposed RTCR discussed the drawbacks to
allowing dual purpose samples i.e., a reduction in the number of
repeats in the distribution system. By requiring State approval of the
use of dual purpose sampling, the RTCR ensures that this flexibility
will only be allowed where the State has determined it is appropriate.
EPA believes that PWSs with limited or no distribution systems are the
best candidates for approval since there is little to no chance of
contamination from the distribution system except from cross
connection. On the other hand, EPA believes that dual purpose samples
may not be appropriate for systems with extensive distribution systems
because the reduction in monitoring (i.e., one less repeat sample in a
distribution system that extends far from the source water sample site)
may not provide public health protection equivalent to taking separate
samples.
    EPA requested comment on whether the use of dual purpose samples
should be allowed by simply including it in the sample siting plan,
without prior State approval. As stated earlier, most of the comments
supported allowing dual purpose sampling with the understanding that it
will be approved by the State. Some commenters, on the other hand, said
that it should be allowed without prior State approval. One commenter
said that the State may not be able to review and approve the sample
siting plan until the next

sanitary survey, which maybe as long as five years after the RTCR
implementation. One commenter said that States should only be required
to say that dual purpose sampling is not allowed for specific systems.
Another commenter suggested allowing States to explain their process
for approval in their primacy application, rather than each situation
being handled on a case-by-case basis, thereby reducing administrative
burden.
    As discussed earlier, EPA believes that requiring State approval
for allowing dual purpose sampling limits the practice only to systems
that can avail themselves of it without compromising public health
protection. State approval is required because this constitutes a
reduction in monitoring (no separate triggered source water samples),
relative to requiring separate samples for compliance with the two
rules. EPA believes this reduction in monitoring is appropriate only if
the State determines that the dual purpose sample provides public
health protection equivalent to that provided by separate repeat and
source water samples.
    As part of the special primacy requirements for the RTCR in Sec.
142.16(q), States adopting the reduced monitoring provisions of the
RTCR, including dual purpose sampling, must describe how they will do
so in their primacy application package. States must include their
approval process for dual purpose sampling in their application. This
gives States the flexibility to determine how and when they want to
grant approval, i.e., whether on a case-by-case basis (whenever a total
coliform-positive occurs) or on a pre-approved basis (i.e., the system
has prior State approval to take a dual purpose sample whenever it is
triggered to do source water monitoring).

E. Coliform Treatment Technique

1. Coliform Treatment Technique Triggers
    a. Requirements. The non-acute MCL violation for total coliforms
under the 1989 TCR is replaced under the RTCR by a coliform treatment
technique involving monitoring for total coliforms and assessment and
corrective action when triggered. EPA is establishing an assessment
process in the RTCR to strengthen public health protection. Under the
1989 TCR, a system is not required to perform an assessment following a
monthly/non-acute MCL violation or an acute MCL violation. Under the
RTCR treatment technique framework, the presence of total coliforms is
used as an indicator of a potential pathway of contamination into the
distribution system. As discussed in section III.B of this preamble,
Rule Construct: MCLG and MCL for E. coli and Coliform Treatment
Technique, the RTCR eliminates the associated MCLG and MCL for total
coliforms. The RTCR specifies two levels of treatment technique
triggers, Level 1 and Level 2, and their corresponding levels of
response. The degree and depth to which a PWS must examine its system
and monitoring and operational practices, i.e., the difference between
a Level 1 or Level 2 assessment, depends on the degree of potential
pathway for contamination. A Level 2 assessment requires a more in-
depth and comprehensive review of the PWS compared to a Level 1. A
discussion of the levels of assessments is found later in section
III.E.2 of this preamble, Assessment.
    The system has exceeded the trigger immediately once any of the
following conditions have been met.
    Level 1 treatment technique triggers
     For systems taking 40 or more samples per month, the PWS
exceeds 5.0 percent total coliform-positive samples for the month; or
     For systems taking fewer than 40 samples per month, the
PWS has two or more total coliform-positive samples in the same month;
or
     The PWS fails to take every required repeat sample after
any single routine total coliform-positive sample.
    The first two treatment technique triggers were the conditions that
define a non-acute MCL violation under the 1989 TCR. The third trigger
provides incentive for systems to take their repeat samples to ensure
that they are assessing the extent of the total coliform contamination;
if they do not do so by repeat sampling, they must conduct an
assessment instead to ensure there are no pathways to contamination
(sanitary defects). Repeat monitoring is critical in identifying the
extent, source, and characteristics of fecal contamination in a timely
manner. EPA's analysis, as discussed in the preamble to the proposed
RTCR (see section III.A.4 of the preamble to the proposed RTCR, Repeat
samples), shows that the average percentage of repeat samples that are
positive is much higher than that of routine samples, demonstrating
that when operators are required to take a second look at their systems
following the positive routine sample, they find, on average, a higher
rate of coliform presence than during routine sampling. In other words,
the high repeat total coliform positive rate indicates the persistence
of total coliforms at such locations in the distribution system. Since
under the RTCR there is no additional routine monitoring for systems
that monitor at least monthly and the number of additional routine
monitoring and repeat monitoring samples for the smallest systems that
are not on monthly monitoring is decreased, the need to conduct repeat
monitoring is more crucial than ever in providing immediate and useful
information needed to protect public health.
    Level 2 treatment technique triggers:
     The PWS has an E. coli MCL violation (see section III.F of
this preamble, Violations, for a description of what constitutes an E.
coli MCL violation); or
     The PWS has a second Level 1 treatment technique trigger
within a rolling 12-month period, unless the initial Level 1 treatment
technique trigger was based on exceeding the allowable number of total
coliform-positive samples, the State has determined a likely reason for
the total coliform-positive samples that caused the initial Level 1
treatment technique trigger, and the State establishes that the system
has fully corrected the problem; or
     For PWSs with approved reduced annual monitoring, the
system has a Level 1 treatment technique trigger in two consecutive
years.
    b. Key issues raised. EPA received comments that disagreed with the
inclusion of the third Level 1 treatment technique trigger, i.e.,
failing to take every required repeat sample after any single routine
total coliform-positive sample triggers a Level 1 assessment. Some of
the commenters suggested that this does not pose a public health
concern and should remain a monitoring violation because if a system
does not conduct the required repeat monitoring, then it is doubtful
that it will conduct the assessment. One commenter was concerned that a
system might opt to conduct the assessment instead of taking the repeat
samples and just indicate in the assessment form that no sanitary
defect was found or the cause of the total coliform-positive sample
could not be identified. The system then avoids the possibility of the
repeat samples being total coliform- or E. coli-positive. They
commented that since the Level 1 assessment is done by the system,
doing the assessment will also be cheaper than taking the repeat
samples.
    EPA disagrees that the PWS will avoid taking repeat samples because
of economic reasons. EPA's analysis indicates that a Level 1 assessment
costs about four times as much as taking three repeat samples (see
Exhibits 3-12 and

4-7 of the Technology and Cost Document for the Final Revised Total
Coliform Rule (USEPA 2012b)). States also must review the assessment
form submitted by the PWS. If the assessment and/or corrective action
is/are not acceptable to the State, the State can require the PWS to
redo the assessment and submit a revised assessment form. EPA also
expects that in situations where the cause of the total coliform- or E.
coli-positive result cannot be identified, the PWS will arrive at this
conclusion only after due diligence on its part (i.e., the system
adheres to proper procedures and standards set by the State in
conducting the assessment). The State may require the PWS to provide
supporting documentation and analyses to back-up its finding. Because
of the cost and the effort involved in conducting a Level 1 assessment,
EPA expects that systems will want to ensure that assessments are
conducted only when potential problems may exist rather than for
failure to take repeat samples.
    One commenter suggested that EPA clarify that collecting samples
outside the 24-hour required time is not a Level 1 trigger as there are
instances when the repeat samples cannot be collected within 24 hours
of the routine total coliform-positive sample. EPA notes that there is
a provision in the RTCR, Sec.  141.858(a)(1), that allows the State to
extend the 24-hour limit on a case-by-case basis if the system has a
logistical problem in collecting the repeat samples within 24 hours
that is beyond its control. In such cases when the State allows the
system to collect the repeat samples beyond the 24 hours, the system
does not trigger a Level 1 assessment.
    One commenter suggested that EPA include an additional provision
that an assessment need not be triggered if the total coliform-positive
occurred when there are representative levels of disinfectant residual
in the distribution system, stating that historical total coliform-
positive results occurred with normal levels of chlorine residuals in
the distribution system and did not cause any waterborne disease. EPA
disagrees that there is no public health risk in this situation. The
fact that total coliforms can be detected even in the presence of a
disinfectant residual is an indication that there might be a bigger,
hidden problem that needs further investigation. An assessment is
warranted to determine if there exists a potential pathway of
contamination into the distribution system and corrective action is
warranted if a sanitary defect is identified.
    EPA received comments to eliminate the Level 2 treatment technique
trigger where a second Level 1 assessment is triggered within a rolling
12-month period, or for systems on annual monitoring, where two Level 1
assessments in two consecutive years trigger a Level 2 assessment. Some
of the commenters thought that many small systems will be triggered to
conduct a Level 2 assessment multiple times. EPA believes that although
the conditions (i.e., a second Level 1 trigger) that lead to the Level
2 trigger do not necessarily pose an immediate acute public health
threat, it may still pose a potential serious health impact because of
the persistence of the contamination and the failure of the system to
address it. EPA believes that a Level 2 assessment is warranted in this
case because a more in-depth examination of the system is needed to
determine the cause of the persistent occurrences of total coliforms.
EPA also notes that, ideally, a well-performed Level 1 assessment and
appropriate corrective action will prevent most systems from developing
conditions that lead to a Level 2 assessment.
2. Assessment
    a. Requirements. There are two levels of assessment based on the
associated treatment technique trigger: Level 1 assessment for a Level
1 treatment technique trigger and Level 2 assessment for a Level 2
treatment technique trigger. At a minimum, both Level 1 and 2
assessments must include review and identification of the following
elements:
     Atypical events that may affect distributed water quality
or indicate that distributed water quality was impaired;
     Changes in distribution system maintenance and operation
that may affect distributed water quality, including water storage;
     Source and treatment considerations that bear on
distributed water quality, where appropriate;
     Existing water quality monitoring data; and
     Inadequacies in sample sites, sampling protocol, and
sample processing.
    The system must conduct the assessment consistent with any State
directives that tailor specific assessment elements with respect to the
size and type of the system and the size, type, and characteristics of
the distribution system. The PWS must complete the assessment as soon
as practical after the PWS learns it has exceeded a treatment technique
trigger. Failure to conduct a triggered assessment is a treatment
technique violation. See section III.F.1.b of this preamble, Coliform
treatment technique violation.
Level 1 Assessment
    A Level 1 assessment must be conducted when a PWS exceeds one or
more of the Level 1 treatment technique triggers specified previously.
Under the rule, this self-assessment consists of a basic examination of
the source water, treatment, distribution system and relevant
operational practices. The PWS should look at conditions that could
have occurred prior to and caused the total coliform-positive sample.
Example conditions include treatment process interruptions, loss of
pressure, maintenance and operation activities, recent operational
changes, etc. In addition, the PWS should check the conditions of the
following elements: sample sites, distribution system, storage tanks,
source water, etc.
Level 2 Assessment
    A Level 2 assessment must be conducted when a PWS exceeds one or
more of the Level 2 treatment technique triggers specified previously.
It is a more comprehensive examination of the system and its monitoring
and operational practices than the Level 1 assessment. The level of
effort and resources committed to undertaking a Level 2 assessment is
commensurate with the more comprehensive investigation and review of
available information, and engages additional parties and expertise
relative to the Level 1 assessment. Level 2 assessments must be
conducted by a party approved by the State: the State itself, a third
party, or the PWS where the system has staff or management with the
required certification or qualifications specified by the State. If the
PWS or a third party conducts the Level 2 assessment, the PWS or third
party must follow the State requirements for conducting the Level 2
assessment. The PWS must also comply with any expedited actions or
additional actions required by the State in the case of an E. coli MCL
violation.
Assessment Forms
    The PWS must submit the completed assessment form for either a
Level 1 or Level 2 assessment to the State for review within 30 days
after the PWS learns that it has exceeded the trigger. Failure to
submit the completed assessment form after the PWS properly conducts
the assessment is a reporting violation (see section III.F.1.d of this
preamble, Reporting violation). If the State determines that the
assessment is insufficient, the State will consult with the PWS. If the
State requires revisions after consultation, the PWS must submit

a revised assessment to the State on an agreed-upon schedule not to
exceed 30 days from the date of the initial consultation.
    The completed assessment form must include assessments conducted,
all sanitary defects found (or a statement that no sanitary defects
were identified), corrective actions completed, and a proposed
timetable for any corrective actions not already completed. Upon
completion and submission of the assessment form by the PWS to the
State, the State must determine if the system has identified the likely
cause(s) for the Level 1 or Level 2 treatment technique trigger and, if
so, establish that the system has corrected the problem(s). Whether or
not the system has identified any sanitary defects or a likely cause
for the trigger, the State may determine whether or not the assessment
is sufficient, and if it is not, the State must discuss its concerns
with the system. The State may require revisions to the assessment
after the consultation.
    b. Key issues raised. The RTCR requires assessments to identify
whether potential pathways of contamination into the distribution
system exist after monitoring results indicate the system has exceeded
a trigger. However, some commenters disagreed that requiring
assessments will result in better public health protection. For one,
they stated that assessments are already occurring under the 1989 TCR;
hence, there is no need to formally require them. Second, assessments
conducted by small systems will not likely be adequate as these systems
usually do not have the resources and the capability to conduct a
proper assessment. The States will then have to perform the assessments
themselves (even the Level 1 assessments), thus adding to State burden.
Third, assessments will reduce follow-up sampling and will allow a PWS
to ``guess assess'' the cause of the positive sample.
    EPA agrees that there already is some level of assessment and
corrective action being performed voluntarily by proactive systems, and
accounted for this fact in the economic analyses for the final RTCR
(see chapter 7.4.5 of the RTCR EA (USEPA 2012a), Assessments). However,
not all systems are proactive in addressing the probable cause(s) of
the positive samples. Under the 1989 TCR, when a system has an MCL
violation and any subsequent sampling did not detect total coliforms,
the problem may persist despite the subsequent negative samples due to
the intermittent nature of microbial contamination and may remain
unaddressed. By requiring PWSs to assess their systems when they are
triggered to do so, the RTCR aims to build and strengthen the
capability of PWSs in ensuring that their systems maintain their
integrity and that barriers are in place and are effective. These
actions will better protect public health than the additional
monitoring with no assessment and corrective action that is allowed
under the 1989 TCR.
    EPA acknowledges that small systems, especially small NCWSs may not
have the knowledge and the resources that other systems, like CWSs,
have. However, most small NCWSs are simple systems that often consist
of just the source water and a limited distribution system. EPA
anticipates then that the level of effort and expertise needed to
conduct a Level 1 assessment at these systems will not be considerable.
At a minimum, the Level 1 assessment should be conducted or managed by
a responsible party of the PWS. While EPA does not expect the Level 1
assessor to be an expert in the requirements of SDWA, the assessor
should be someone familiar enough with the system to answer the
questions in the Level 1 assessment form or to gather correct
information from others who work for the system.
    To help in the implementation of the assessment, a PWS may conduct
a Level 1 assessment while it consults with the State by phone. This is
in lieu of having the State physically perform the assessment when the
PWS needs assistance. Generally, the PWS would still need to fill-out
the assessment form and submit it to the State. The State would still
need to review the form but the process will not take as much effort as
previously anticipated since the State would already be familiar with
that particular assessment. It is also permissible that the State fill
out the form while the PWS consults with the State by phone when doing
the assessment. The State may also want to set up alternative methods
for the PWS to submit the assessment form, such as via an online
submission or email. The State should document its process in the
primacy application.
    EPA disagrees that the assessment requirements will reduce follow-
up sampling. PWSs are still required to take repeat samples following a
routine total coliform-positive sample. PWSs on quarterly or annual
monitoring must conduct additional routine monitoring the month
following the total coliform-positive sample. In addition, nothing in
the treatment technique requirements precludes a PWS from taking
additional compliance samples or special purpose samples such as those
taken to determine whether disinfection practices are sufficient
following pipe replacement or repairs (see Sec.  141.853(b) of the
RTCR).
    EPA disagrees that PWSs conducting the assessment will ``guess
assess'' the cause of the positive samples. Conducting an assessment is
a methodical process that requires a PWS to evaluate the different
elements of its operation and distribution system (Sec.  141.859(b)(2)
of the RTCR specifies the minimum elements that an assessment must
have, keeping in mind that some of the elements may not be applicable
to some PWSs like small NCWSs). The RTCR requires that an assessment
form be completed. The assessment form should help and guide the PWS in
conducting the assessment by laying out the different elements the PWS
must look into. EPA provides examples of assessment forms that States
and PWSs can use to help them in conducting the assessment (these
examples are given in Appendix X of the AIP (USEPA 2008c) and in
Appendix A of the Proposed Revised Total Coliform Rule Assessments and
Corrective Actions Guidance Manual--Draft (USEPA 2010d)). EPA also
acknowledges that an assessment will not always identify sanitary
defects or find a reason or cause for the presence of total coliforms
and/or E. coli. In such cases, the PWS must document that fact in the
completed assessment form. This, however, is not ``guess assessing'' as
EPA expects that only PWSs that adhere to proper procedures and
standards set by the State are eligible to arrive at this
determination. It is then the responsibility of the State to determine
if the assessment was acceptable.
    Some commenters suggested that for systems with limited
distribution systems that have a first Level 1 trigger, the Level 1
assessment should be delayed and the focus of the evaluation should be
on the source water, and the Level 1 assessment should only be
conducted if there is another Level 1 trigger.
    The system may conduct an integrated assessment that meets the
requirements of all applicable rules, such as the GWR and the RTCR, as
long as the assessment is consistent with any State directives that
tailor specific assessment elements with respect to the size and type
of the system and the size, type, and characteristics of the
distribution system, as required under Sec.  141.859(b)(2) of the RTCR.
EPA further notes that source water issues are one of the elements that
need to be considered in a Level 1 (or 2) assessment where they may be
a contributing factor to a coliform exceedance or other trigger. EPA
expects that assessments at PWSs

with limited or no distribution systems will be relatively simple
assessments and can be tailored to meet applicable requirements of both
the GWR and the RTCR. EPA will address this in the revised Revised
Total Coliform Rule Assessment and Corrective Actions Guidance Manual
that is being developed.
    EPA received comments both in support and against having two levels
of assessment. The commenters in the second category concluded that
both levels of assessment would involve the same effort. There were
comments to eliminate the Level 1 assessment and emphasize the Level 2
assessment, as the Level 1 assessment will not lead to any meaningful
evaluation and will only take up the State's resources. EPA disagrees
that there is no need for two levels of assessment. The RTCR requires
two levels of assessment to recognize that a higher level of effort to
diagnose a problem should be applied to situations of greater potential
public health concern such as repeated Level 1 triggers or an E. coli
MCL violation. A Level 1 assessment is not as comprehensive as Level 2
assessment. This however, does not negate the importance of a Level 1
assessment. Triggers that lead to a Level 1 assessment may indicate the
possibility of a breach of the barriers in place. It is important that
PWSs ensure that these barriers remain intact by performing the
assessment.
    EPA received comments that the qualifications of assessors are not
clear in the rule. The commenters suggested including the
qualifications in the rule or referencing the qualifications described
in the Proposed RTCR Assessment and Corrective Actions Guidance
Manual--Draft (USEPA 2010d). Some commenters concluded that the Level 2
assessment will require a whole new certification program for
assessors. Others concluded that the States will end up doing the Level
2 assessment because of what is expected and required of a Level 2
assessment. On the other hand, one commenter suggested that a system
operator should be certified to perform an assessment of their own
system. Another suggested that States be allowed to set mechanisms in
place to ensure that a Level 2 assessment is performed more
comprehensively than a Level 1 assessment.
    EPA does not require that a separate certification program be
established to determine who can perform a Level 2 assessment. Instead
of being prescriptive on who can conduct a Level 2 assessment, EPA is
allowing the State to determine its criteria and process for approval
of Level 2 assessors and to determine who is appropriate to conduct the
assessment given the State's knowledge of the complexity of the system
and the knowledge and policies of the State. Although the rule allows
that certified operators may perform a Level 2 assessment if approved
by the State, EPA recommends that States consider whether having the
assessment done by someone from outside the system can provide a fresh
perspective. Qualified certified operators can be allowed to conduct
assessments at other systems.
    EPA requested comments on how to ensure that a Level 2 assessment
is more comprehensive than a Level 1 assessment (e.g., by possibly
including asset management and capacity development). EPA asked in the
proposed rule whether EPA should provide more detail in guidance or
rule language, on the elements and differences between a Level 1 and
Level 2 assessment. A majority of the commenters were against the
inclusion of asset management and capacity development in the Level 2
assessment. EPA received comments stating that the proposed rule
language regarding the two levels of assessment was adequate and that
additional discussion about the differences between the two should
instead be addressed in guidance. One commenter, on the other hand,
said that there was no difference in the scope between the two
assessments based on the way the proposed rule language was written.
    EPA defined in Sec.  141.2 both a Level 1 assessment and a Level 2
assessment to provide a better distinction between the two levels of
assessment and facilitate the implementation of the RTCR. See section
III.A.1 of this preamble, Assessment, for the definitions of a Level 1
and Level 2 assessment. EPA is also requiring States to describe in
their primacy application how they will ensure that a Level 2
assessment is more comprehensive than a Level 1 assessment; thus,
giving the States more flexibility in implementing the rule. EPA
released the Proposed Revised Total Coliform Rule Assessments and
Corrective Actions Guidance Manual--Draft (USEPA 2010d) in August 2010
to help stakeholders understand the difference between the two levels
of assessment. EPA will revise this guidance manual based on the
comments received and release it soon after the final RTCR is published
in the Federal Register.
    EPA received comments to allow the extension of the assessment
period beyond 30 days. A commenter suggested that intermediate
deadlines for a Level 2 assessment triggered by the presence of E. coli
be included because of the acute nature of the threat.
    EPA expects that the PWS will conduct an assessment as soon as
practical after the PWS receives notice or becomes aware that the
system has exceeded a trigger. EPA imposes a 30-day limit because the
possible occurrence of contamination, as indicated by the conditions
that trigger the assessment, must be addressed immediately. The system
has 30 days from the time it learns of exceeding the trigger to conduct
the assessment and complete the corrective action. EPA believes that
the 30-day period is sufficient time for problem identification and
potential remediation of the problem in conjunction with the follow-up
assessment in most cases. The system can work out a schedule with the
State to complete the corrective action if more time is needed. It is
very important, however, that the assessment is conducted as soon as
possible within those 30 days. In the case of an E. coli MCL violation,
the system must comply with any expedited actions or additional actions
required by the State (see Sec.  141.859(b)(4) of the RTCR). EPA also
encourages PWSs to submit their completed assessment forms as soon as
possible and not wait until the end of the 30-days to do so.
3. Corrective Action
    a. Requirements. Under the RTCR, PWSs are required to correct
sanitary defects found through either a Level 1 or Level 2 assessment.
Systems should ideally be able to correct any sanitary defects found in
the assessment within 30 days and report that correction on the
assessment form. This is especially important when E. coli has been
detected in samples collected from the distribution system, indicating
that a potential health hazard exists. However, EPA recognizes that
correcting sanitary defects within 30 days may not always be possible
due to the extent and cost of the corrective action, and that some
systems therefore may not be able to fix sanitary defects before
submitting the completed assessment form within the 30-day interval.
When the correction of sanitary defects is not completed by the time
the PWS submits the completed assessment form to the State, EPA
encourages the State and PWS to work together to determine the
appropriate schedule for corrective actions (which may include
additional or more detailed assessment or engineering studies) to be
completed as soon as possible. The schedule, which is approved by the
State, must include when the corrective action will be completed and
any

necessary milestones and temporary public health protection measures.
The PWS must comply with this schedule and notify the State when each
scheduled corrective action is completed.
    At any time during the assessment or corrective action phase,
either the PWS or the State may request a consultation with the other
entity to discuss and determine the appropriate actions to be taken.
The system may consult with the State on all relevant steps that the
system is considering to complete the corrective action, including the
method of accomplishment, an appropriate timeframe, and other relevant
information. EPA is not requiring this to be a mandatory consultation
to provide ease of implementation for States. In many cases,
consultation may not be necessary because the type of corrective action
for the sanitary defect will be clear and can be implemented right away
(e.g., replacement of a missing screen).
    b. Key issues raised. EPA received comments that not all sanitary
defects should have to be corrected unless it can be determined the
defect directly correlates to the trigger or if the defect is otherwise
regulated. Similarly, commenters suggested that EPA clarify that any
requirement to correct sanitary defects found during the assessment be
limited only to issues that are within the system's control. In
contrast, one commenter encouraged EPA to provide authority to States
to require broader corrective actions beyond fixing specific sanitary
defects (e.g., requiring development and implementation of a storage
tank inspection and maintenance plan).
    EPA acknowledges that it may or may not be possible to conclusively
link the total coliform-E. coli-positive sample to a given sanitary
defect due to the complexity of the distribution system configuration
and transport of contaminants throughout the system. That being the
case, the PWS must still correct all sanitary defects found through the
assessment even if the defect cannot be proven to be the likely cause
of the positive sample, to prevent the defect from providing a pathway
for future contamination. The RTCR takes a more preventive approach to
protect public health by requiring that systems perform an assessment
of their system when their monitoring results indicate a potential
pathway of contamination into the distribution system, or a breach in
the barriers that are in place, and correct all identified sanitary
defects, regardless of whether the defect is directly related to the
positive sample or not. This is because EPA believes that correcting
only sanitary defects that are correlated to the positive sample is not
sufficiently protective of public health. Uncorrected sanitary defects
may provide a pathway for future incidences of contamination.
    The RTCR requires that sanitary defects be corrected but does not
mandate how the defects are to be corrected. States and PWSs may have
other authorities under local ordinances and State laws that they may
use to address the problem. For example, in cases where the location of
the sanitary defect is outside the normal control of the PWS (e.g.,
cross connection occurring on private property), community water
systems that are part of the local government may have some authority
to address the problem under the public health code if the issue is
affecting the water in the distribution system (AWWA 2010) or through
other local ordinances such as plumbing codes. EPA encourages States
and PWSs to work together to determine the best course of action when
correcting sanitary defects.
    Some commenters said that it is unclear how a water utility should
demonstrate that it has corrected a sanitary defect and how the primacy
agency would take enforcement action on any defects identified by the
system. One commenter suggested that EPA clarify whether a sanitary
defect would be considered corrected if subsequent samples are total
coliform-negative. EPA notes that because of the intermittent nature of
microbial contamination, it may not be adequate to just rely on follow-
up samples to verify that the problem has been corrected or has gone
away. Depending on the nature of the sanitary defect, States may
require additional measures to ensure that the integrity of the
distribution system has been restored (e.g., pressure monitoring,
follow-up inspection of tanks, etc.). States have discretion on how to
determine that defects have been corrected (e.g., site visits, sanitary
surveys, etc.). Failure to correct identified sanitary defects is a
treatment technique violation and States are expected to use their
legal authority to take enforcement action to return the system to
compliance.

F. Violations

1. Requirements
    EPA is establishing the definition of the following violations--MCL
violation, treatment technique violation, monitoring violation, and
reporting violation--consistent with the proposed RTCR. Each type of
violation requires public notice, the level of which depends on the
severity of the violation (see section III.G of this preamble,
Providing Notification and Information to the Public, for information
on public notification), and may trigger a system on reduced monitoring
to increase its monitoring frequency (see section III.C of this
preamble, Monitoring, for information on monitoring frequency). In
addition to these violations, systems are required to comply with all
the requirements of the RTCR, e.g., to use an approved analytic method
to test for total coliforms and E. coli, to monitor according to a
sample siting plan, etc. EPA also would like to clarify that exceeding
a trigger and being required to conduct an assessment is not a
violation by itself; as described later in this section, a violation
occurs when a system exceeds the trigger but does not complete the
required assessment and corrective action in response.
    a. E. coli MCL violation. A system incurs an E. coli MCL violation
if any of the following occurs:
     A routine sample is total coliform-positive and one of its
associated repeat samples is E. coli-positive.
     A routine sample is E. coli-positive and one of its
associated repeat samples is total coliform-positive.
     A system fails to take all required repeat samples
following a routine sample that is positive for E. coli.
     A system fails to test for E. coli when any repeat sample
tests positive for total coliforms.
    b. Coliform treatment technique violation. A system incurs a
coliform treatment technique violation when any of the following
occurs:
     A system fails to conduct a required assessment within 30
days of notification of the system exceeding the trigger (see section
III.E of this preamble, Coliform Treatment Technique, for conditions
under which monitoring results trigger a required assessment).
     A system fails to correct any sanitary defect found
through either a Level 1 or 2 assessment within 30 days (see also
section III.E of this preamble, Coliform Treatment Technique) or in
accordance with State-derived schedule.
     A seasonal system fails to complete a State-approved
start-up procedure prior to serving water to the public. This is
further discussed later on in the Key issues raised part of this
section.
    There is no treatment technique violation associated solely with a
system exceeding one or more action triggers (Level 1 or Level 2
triggers).
    c. Monitoring violation. A system incurs a monitoring violation
when any of the following occurs:

     A system fails to take every required routine or
additional routine sample in a compliance period.
     A system fails to test for E. coli following a routine
sample that is total coliform-positive.
    d. Reporting violation. A system incurs a reporting violation when
any of the following occurs:
     A system fails to timely submit a monitoring report or a
correctly completed assessment form after it properly monitors or
conducts an assessment by the required deadlines. The PWS is
responsible for reporting this information to the State regardless of
any arrangement with a laboratory.
     A system fails to timely notify the State following an E.
coli-positive sample. See section III.H.1.a of this preamble,
Reporting, for reporting requirements in the case of an E. coli-
positive sample.
     A seasonal system fails to submit certification of
completion of State-approved start-up procedure. This is further
discussed in the Key issues raised part of this section.
2. Key Issues Raised
    EPA received comments that supported the proposed definition of the
violations. Others offered suggestions to ease implementation burden.
For example, one commenter recommended that only one violation be
generated for each compliance situation (i.e., if an MCL violation is
determined, then neither treatment technique, nor monitoring, nor
reporting violation can be generated; if a treatment technique
violation is determined, then neither monitoring nor reporting
violation can be generated). However, EPA believes that it is important
to track each of these situations individually so that the State can be
aware of the system's progress resolving situations and complying with
all rule requirements. Each situation is also accompanied by public
notification requirements so that consumers can be aware of problems at
the water system and the progress and efforts to correct them. EPA
believes it is important to continue to notify the public of each
situation.
    Some commenters were uncertain about when failure to take all
repeat samples triggers the associated Tier 1 PN (i.e., when the 24-
hour clock starts). Some questioned how the State will know when the
failure to collect these repeats has occurred in such a way to assure
timely Tier 1 PN when the sample results do not need to be reported
until the 10th day of the month following the month in which the
samples were collected. EPA believes that State programs have been
designed to address timely response to follow-up requirements such as
the need to take repeat samples, through education, compliance
assistance, and tracking and enforcement programs. The time limit is
established to assure that systems act promptly to investigate positive
samples. Some States require direct electronic reporting of results,
which provides for more timely notification, and EPA encourages such
practice. In the situations where it is not possible for the system to
take the repeat samples within 24 hours, States have the discretion to
waive the requirement (see section III.D of this preamble, Repeat
Samples).
    Other commenters suggested adding to the list of violations. EPA
received comment that there should be a violation when a seasonal
system fails to perform the start-up procedure. EPA agrees and is
designating such failure as a treatment technique violation. EPA is
also requiring seasonal systems to certify that they have completed the
start-up procedure and submit this certification to the State. Failure
to do so is a reporting violation. EPA believes that performing start-
up procedures is very important to mitigate the possible risks
resulting from the seasonal system being shutdown, depressurized, or
drained. Designating such failure as a violation will compel seasonal
systems to make sure that they take the necessary steps to mitigate
public health risks before serving water to the public.
    Other commenters, on the other hand, suggested deleting the MCL
violation resulting from failure to take all required repeat samples
following a routine E. coli-positive sample. One commenter suggested
that instead of an MCL violation, this should be considered a sanitary
defect that requires corrective action. EPA considers E. coli as an
indicator of a potential pathway of fecal contamination that should be
taken seriously. A system needs to follow up with repeat samples to
characterize the extent and source of such contamination. Failure to
take the required repeat samples following an initial E. coli-positive
sample is not protective of public health and is a serious violation.
Making such failure an E. coli violation prevents a system from
incurring only a monitoring violation when there is an indication of
fecal contamination.
    Some commenters do not agree with the treatment technique violation
because they do not agree that the treatment technique requirements of
the RTCR are appropriate. For a discussion on the treatment technique,
see section III.E of this preamble, Coliform Treatment Technique. One
commenter asked for clarification on whether failure to submit the
assessment form within 30 days is a treatment technique violation. As
stated previously, this is a reporting violation, not a treatment
technique violation, if the assessment has in fact been completed and
the only failure was in submitting the required form. A treatment
technique violation occurs when a potential pathway of contamination
into the distribution system is unexplored and/or uncorrected. A system
that neglects to perform the prescribed assessment or corrective action
within schedule is in violation of the treatment technique requirement.
    Commenters also supported EPA's proposal of separating the combined
monitoring and reporting violation under the 1989 TCR into two separate
violations. One commenter noted that it has been difficult to determine
the significance of a violation when two types of violations--
monitoring and reporting--are captured and reported under only one
heading. It is, therefore, difficult to develop performance measures
and ensure data quality when the two violations are combined.

G. Providing Notification and Information to the Public

1. Requirements
    EPA is promulgating changes to the public notification (PN)
requirements contained in 40 CFR part 141 subpart Q to correspond to
the violation provisions of the RTCR (see section III.F of this
preamble, Violations). EPA is requiring a Tier 1 PN for an E. coli MCL
violation, Tier 2 PN for a treatment technique violation for failure to
conduct assessments or corrective actions, and a Tier 3 PN for a
monitoring violation or a reporting violation.
    Tier 1 PN is required for NPDWR violations and situations with
significant potential to have serious adverse effects on human health
as a result of short-term exposure, such as could occur with exposure
to fecal pathogens. Tier 1 PN is required as soon as possible but no
later than 24 hours after the system learns of the violation. An E.
coli MCL violation indicates possible exposure to pathogens in drinking
water that can possibly result in serious, acute health effects, such
as diarrhea, cramps, nausea, headaches, or other symptoms and possible
greater health risks for infants, young children, the elderly, and
people with severely compromised immune systems.
    In the 1989 TCR, if a system has an acute MCL violation, which is
based on

the presence of fecal coliforms or E. coli, or the system's failure to
test for fecal coliforms or E. coli following a total coliform-positive
repeat sample, the system is required to publish Tier 1 PN. Under the
RTCR, a system is required to publish Tier 1 PN when it has an E. coli
MCL violation. (See section III.F of this preamble, Violations, for a
discussion of MCL violations.) In addition, the system will continue to
be required to notify the State after learning of an E. coli-positive
sample, as required under the 1989 TCR. As mentioned earlier in section
III.B of this preamble, Rule Construct: MCLG and MCL for E. coli and
Coliform Treatment Technique, EPA is eliminating the MCL for fecal
coliforms. Under the RTCR, the standard health effects language, which
is required to be included in all public notification actions, is
modified to delete the reference to the fecal coliform MCL and fecal
coliforms. The language for a non-acute violation under the 1989 TCR is
modified to apply to a violation of the assessments and corrective
action requirements of the coliform treatment technique.
    Tier 2 PN is required for all NPDWR violations and situations with
potential to have serious adverse effects on human health not requiring
Tier 1 PN. The system must provide public notice as soon as practical,
but no later than 30 days after the system learns of the violation. A
treatment technique violation under the RTCR meets these criteria
because it is an indication that the public water system failed to
protect public health when the system failed to conduct an assessment
or complete corrective action following identification of sanitary
defects. Sanitary defects indicate that a pathway may exist in the
distribution system that has potential to cause public health concern.
    In the 1989 TCR, a system is required to publish a Tier 2 PN when
the system has a non-acute MCL violation, which is based on total
coliform presence. Under the RTCR, a system is required to publish a
Tier 2 PN if the system violates the coliform treatment technique
requirements. Also, EPA is modifying the standard health effects
language for coliform to emphasize the assessment and corrective action
requirements of the RTCR.
    Tier 3 PN is required for all other NPDWR violations and situations
not included in Tier 1 or Tier 2. The existing Tier 3 PN requires a
system to provide public notice no later than one year after the system
learns of the violation or situation or begins operating under a
variance or exemption. Monitoring and reporting violations have
historically been designated as Tier 3 PN unless an immediate public
health concern has been identified (e.g., failure to monitor for E.
coli after a total coliform-positive sample requires a Tier 1
notification.) Where no such immediate public health concern has been
identified, EPA believes that a public notice given at least annually
for monitoring and reporting violations fulfills the public's right-to-
know about these violations.
    In the 1989 TCR, a system is required to publish a Tier 3 PN when
the system has a monitoring and reporting violation. In the RTCR,
monitoring violations are considered distinct from reporting
violations. Both types of violations require Tier 3 PN.
    Consumer confidence report (CCR) requirements are also modified.
Health effects language for the CCR for total coliforms and E. coli,
which is identical to the health effects language required for PN, is
updated in the same way as described for PN. In addition, the RTCR
removes the CCR requirements for the inclusion of total numbers of
positive samples, or highest monthly percentage of positive samples for
total coliforms as well as total number of positive samples for fecal
coliforms. These provisions are replaced by requirements to include the
number of Level 1 and Level 2 assessments required and completed, the
number of corrective actions required and completed, and the total
number of positive samples for E. coli. A system that fails to complete
all the required assessments or correct all identified sanitary defects
has a treatment technique violation and must identify it in the CCR as:
(1) Failure to conduct all of the required assessment(s); and/or (2)
failure to correct all identified sanitary defects. A system that has
an MCL violation must also include the condition that resulted in the
MCL violation (see section III.B.1 of this preamble, MCLG and MCL, and
Sec.  141.860(a) of the RTCR). Unchanged and consistent with the
provisions under the 1989 TCR, a CWS may provide Tier 3 PN using the
annual CCR.
    CCR requirements are updated to reflect the advisory committee's
recommendations that total coliforms be used as an indicator to start
an evaluation process that, where necessary, will require the PWS to
correct sanitary defects. EPA believes it is most appropriate to inform
the public about actions taken, in the form of assessments and
corrective actions, since failure to conduct these activities lead to
treatment technique violations under the RTCR. Because the RTCR no
longer includes the total coliform MCL but now includes a trigger, EPA
believes that systems no longer need to report the number of total
coliform-positive samples via the CCR, since that could cause confusion
or inappropriate changes in behavior among consumers. In addition, the
CCR requirements will also reflect the removal of fecal coliform.
2. Key Issues Raised
    In general, EPA received comments in support of the PN requirements
of the RTCR. The commenters stated that the changes are consistent with
the intent and recommendations of the TCRDSAC. However, there were a
few commenters who disagreed on certain aspects of the requirements.
These comments are discussed in detail in the following paragraphs.
    EPA requested comment on whether the elimination of the PN
associated with the presence of total coliforms (i.e., the Tier 2 PN
associated with the non-acute MCL violation under the 1989 TCR) will
result in a loss of information to consumers. Although the majority of
the commenters said that it would not result in a loss of information,
some commenters said that it would. One commenter said that the PN
associated with the presence of total coliforms has been an effective
tool to motivate PWSs to take corrective actions; to eliminate such PN
and replace it with a PN associated with treatment technique violations
is not ``equal to or better'' public health protection. One commenter
believed that if the non-acute PN requirement is eliminated, then NCWSs
would not have the tool to communicate to the public the possible
health risk as these PWSs are not required to send out a CCR.
    As EPA discussed in section III.B of this preamble, Rule Construct:
MCLG and MCL for E. coli and Coliform Treatment Technique, the presence
of total coliforms is not, by itself, a public health threat. EPA
agrees with comments received that suggest that the Tier 2 PN for a
non-acute MCL violation under the 1989 TCR is sometimes unnecessarily
alarming as it attributes greater public health significance to the
presence of total coliforms than is warranted. EPA believes the removal
of the Tier 2 PN for a non-acute MCL violation will help prevent public
confusion.
    EPA received comments that under the 1989 TCR some States require a
Tier 1 PN when a NCWS has a non-acute MCL violation. EPA would like to
note that the 1989 TCR requires a Tier 2 PN for a non-acute MCL
violation, not a Tier 1 PN. Some States using their own authority have
chosen to elevate the PN

level to Tier 1 for a non-acute MCL in some or all cases. In certain
circumstances, some States use this elevated PN in association with
other follow-up actions involving agreements with other State and local
agencies, to provide a more comprehensive and immediate response to
potential public health threats, or to make the most efficient use of
their existing authorities to protect public health. It is not EPA's
intent to take this discretion away from the States, or to undermine
these cooperative agreements with other State and local agencies. If a
State deems that a given situation calls for a more elevated level of
PN, or requires a more immediate action to ensure that public health is
protected, then they can do so under their own discretion and
authority. For example, the Level 2 assessment requirements in Sec.
141.859(b)(4) allow States to require expedited actions or additional
actions to ensure that public health is protected.
    EPA notes that NCWSs are required, like CWSs, to publish a PN,
either a Tier 1, Tier 2, or Tier 3, depending on the violation. Even if
they are not required to issue a CCR, NCWS must provide PN in other
forms or methods consistent with the requirements of 40 CFR 141.153.
States can also direct the PWS to perform additional public health
measures (e.g., boil water orders, elevated PNs, etc.) as allowed under
SDWA and the authority granted to them by their own legislation similar
to EPA's authority under section 1431 of SDWA.
    EPA requested comment on whether to require special notice to the
public of sanitary defects similar to the special notice requirements
for significant deficiencies under the GWR. Most commenters were
against including such provision. They stated that it would cause
confusion and unnecessary alarm to customers. Several commenters noted
that it is not appropriate for sanitary defects under the RTCR to have
similar notice requirements as that of significant deficiencies under
the GWR. The special notice requirement for significant deficiencies
under the GWR only applies to NCWSs since they are not required to send
out a CCR. EPA agrees that no special notice of sanitary defects is
necessary and is not including such provision in the RTCR.
    EPA received comments suggesting modifications to the standard PN
and CCR health effects language regarding total coliforms and the
treatment technique violations included in the proposed RTCR. EPA has
modified the standard health effects language found in Subpart O and
Subpart Q of part 141 to make the language consistent with the use of
total coliforms in the RTCR as an indicator of a potential pathway
through which a contamination can enter the distribution system.

H. Reporting and Recordkeeping

1. Requirements
    a. Reporting. In addition to the existing general reporting
requirements provided in 40 CFR 141.31, the RTCR requires a PWS to:
     Notify the State no later than the end of the next
business day after it learns of an E. coli-positive sample.
     Report an E. coli MCL violation to the State no later than
the end of the next business day after learning of the violation. The
PWS must also notify the public in accordance with 40 CFR part 141
subpart Q.
     Report a treatment technique violation to the State no
later than the end of the next business day after it learns of the
violation. The PWS must also notify the public in accordance with 40
CFR part 141 subpart Q.
     Report monitoring violations to the State within ten days
after the system discovers the violation, and notify the public in
accordance with 40 CFR part 141 subpart Q.
     Submit completed assessment form to the State within 30
days after determination that the coliform treatment technique trigger
has been exceeded.
     Notify the State when each scheduled corrective action is
completed for corrections not completed by the time of the submission
of the assessment form.
     A seasonal system must certify that it has completed a
State-approved start-up procedure prior to serving water to the public.
    EPA is adding the submission of the assessment form and the
certification of completion of start-up procedure to the reporting
requirements under Sec.  141.861 of the RTCR for better clarity and
ease of tracking compliance. In the proposed rule, the submission of
the assessment form is found only in Sec.  141.859, Coliform treatment
technique requirements for protection against potential fecal
contamination. The inclusion of the submission of the assessment form
in Sec.  141.861 does not impose additional requirements beyond those
that are imposed by the treatment technique requirements (see section
III.E of this preamble, Coliform Treatment Technique, for discussion on
the treatment technique requirements). Failure to submit the assessment
form or the certification is a reporting violation as discussed in
section III.F.1.d of this preamble, Reporting violation.
    b. Recordkeeping. EPA is maintaining the requirements regarding the
retention of sample results and records of decisions related to
monitoring schedules found in 40 CFR 141.33, and including provisions
that address the new requirements of the RTCR pertaining to reduced and
increased monitoring, treatment technique, etc. In addition, systems
are required to maintain on file for State review the assessment form
or other available summary documentation of the sanitary defects and
corrective actions taken. Systems are required to maintain these
documents for a period not less than five years after completion of the
assessment or corrective action. Since systems have to maintain these
files no less than five years, which is the maximum period allowed
between sanitary surveys (i.e., five years; see 40 CFR 142.16(b)(3) and
40 CFR 142.16(o)(2)), States have the opportunity to review these files
during sanitary surveys and/or annual visits. The five-year period is
also consistent with the recordkeeping requirements for microbiological
analyses under 40 CFR 141.33(a).
    The system must also maintain a record of any repeat sample taken
that meets State criteria for an extension of the 24-hour period for
collecting repeat samples.
2. Key Issues Raised
    EPA received comments that support the reporting and recordkeeping
requirements proposed by EPA. Most commenters said that the timeframes
are appropriate and are consistent with EPA's practice regarding
reporting and recordkeeping requirements in other regulations under
SDWA. One commenter, however, said that EPA should standardize the
recordkeeping requirements in all its rules, including the RTCR, for a
period equal to the compliance cycle (i.e., nine years). The commenter
adds that by standardization and being consistent with the compliance
cycle, all monitoring and compliance records including corrective
actions will be easily maintained, tracked, and available for State's
inspections without the confusion of varying recordkeeping durations
with different regulations. However, EPA's suite of drinking water
regulations addresses different kinds of contaminants with different
inherent characteristics, occurrence, and health effects. Because of
these differences, monitoring of these contaminants occurs at different
frequencies; hence, different reporting and recordkeeping requirements.
The reporting and recordkeeping requirements specific to a

drinking water regulation are therefore meant to support the
implementation of that regulation. If possible, EPA makes every effort
to ensure consistency of requirements across the drinking water
regulations.

I. Analytical Methods

1. AIP-Related Method Issues
    a. Evaluation of currently approved methods. The AIP recommended
that the Agency conduct a reevaluation of all the approved methods to
ensure continued approval was warranted. In the proposed rule, the
Agency identified the Environmental Technology Verification (ETV)
program as the preferred mechanism for conducting such an evaluation
and solicited comments on the approach.
    Key issues raised. While several commenters expressed support for a
method reevaluation study conducted through the ETV program, some
commenters expressed concern regarding the use of this program. One
commenter stated that the reevaluation study should meet criteria
established by EPA, not an EPA-contractor, who would receive financial
benefit from the method manufacturers for conducting the testing. This
commenter further expressed concern with using the ETV program because
``the intent of the ETV program was never to certify, approve,
guarantee, or warrantee analytical technologies.'' This commenter also
suggested that the ETV program does not have the resources to develop
the protocol for the method re-evaluation study.
    A second commenter expressed concern that the ETV program was
established to facilitate incorporation of commercially-ready test kits
into the market, which differs from the task of determining what are
appropriate performance criteria for SDWA compliance methods. This
commenter also expressed concern that the ETV program has not generated
rigorous enough product evaluations adequate to support approval of
alternative analytical procedures.
    Lastly, this commenter also suggested that the ETV studies do not
have the same level of independence in protocol development as other
third party studies, stating that in ETV studies, reviewers modify the
protocol at the beginning of each study, and that for the recent
verification study, there was not a clear discussion between the study
organizers and the technical review panel regarding development of the
final test protocol.
    EPA will take the comments concerning the ETV program into
consideration as the Agency develops a final approach to the
reevaluation of methods. EPA notes that ETV work is accomplished
through cooperative agreements between EPA and private non-profit
testing and evaluation organizations. ETV partners verify performance
claims but do not endorse, certify or approve technologies. EPA has the
regulatory authority and the responsibility to approve/disapprove
methods and typically does so based on a review of method performance
data generated by third party laboratories. Testing under the ETV
program is typically paid for by participating vendors.
    ETV expert panels typically include representatives from industry,
academia, EPA, and other stakeholders and collaborators. The rigor of
an ETV study is determined by the objectives of the study and the
resources available. If such a study is conducted, EPA, by virtue of
participation in the expert panel, would ensure that the study is
rigorous enough to meet the Agency's needs.
    EPA held a series of three open technical webinars in fall 2010.
Participants recommended the development of a coliform strain library.
The Water Research Foundation has funded a project to accomplish this
task and the Agency will be monitoring the progress of that work as it
considers the appropriate course of action.
    b. Review of the ATP protocol. The AIP recommended that the Agency
engage stakeholders in a technical dialogue in its review of the
Alternate Test Procedure (ATP) microbiological protocol. The proposed
rule described how EPA could use the study plan development from the
aforementioned method reevaluation study as a starting point for
discussions with stakeholders regarding the basis for evaluating new
methods. The proposed rule also explained that the study plan, along
with ``lessons learned'' from the reevaluation study, could be used as
a model for a revised ATP protocol.
    Key issues raised. One commenter suggested that the protocol used
in the method reevaluation study should be used as the revised ATP
protocol. EPA intends to consider this recommendation as it decides how
to move forward on revising the microbial test protocol.
    c. Approval of ``24-hour'' methods. The AIP recommended that EPA
consider the approval of analytical methods that allow more timely
(e.g., on the order of 24 hours) results. As expressed in the rule
proposal, EPA has concern that the more rapid ``24-hour'' methods may
not have the same recovery rates, especially for stressed or injured
organisms, as the historic methods that allow for longer incubation
times.
    Key issues raised. One commenter suggested that the Agency withdraw
approval for the older approved methods that can require longer times
to obtain results. EPA intends to consider this recommendation as it
decides how to move forward.
    d. Elimination of fecal coliforms. As explained in the rule
proposal, EPA plans to eliminate all provisions for fecal coliform
monitoring under this regulation. No comments were received on this
issue. As such, all provisions relating to fecal coliforms are removed
in this final rule.
    e. Request for comment on other AIP-related method issues. i.
Expedited results notification process. The proposed rule requested
comment on whether the RTCR should include provisions to ensure a more
expedited notification process. The RTCR could, for example, include
language requiring that PWSs arrange to be notified of a positive
result by their laboratory within 24 hours.
    Key issues raised. The Agency received many comments regarding this
element of the proposed rule. Many commenters expressed support for
this provision, with some States reporting that this provision is an
existing component of their State regulations. Several commenters
expressed that given the widespread availability of electronic
communication it would be easy for a laboratory to notify the public
water system quickly of the results of the sample analyses.
    Many comments expressed concern over the ability of the States to
enforce such a provision. Additionally, several commenters noted that
this provision would hold the water system accountable for the actions
of the laboratory, which the public water system does not have
immediate control over.
    EPA believes that the public is well served by timely reporting of
results but recognizes some of the challenges associated with
addressing this via regulation. Accordingly, the Agency intends to use
guidance documents associated with this regulation to address this
issue. Through the guidance documents, the Agency expects to urge
public water systems to establish language in their contract with the
laboratories requiring that the water system be notified by the
laboratory within 24 hours of any positive results.
    Additionally, the Agency plans to encourage the certified
laboratory community to ensure that laboratories

are aware of the importance of timely notification of any positive
results to their clients.
    ii. Taking repeat samples within 24 hours. During the Advisory
Committee meetings, the factors impacting the timeframe between a
coliform detection and the collection of the repeat sample were
discussed. It was noted that in some cases, repeat samples are not
collected for several days after notification of a coliform detection.
EPA requested comment in the proposed rule whether the RTCR should
require repeat samples be taken within 24 hours of a total coliform-
positive with no (or limited) exceptions.
    Key issues raised. While some commenters expressed support for such
a provision in the final rule, most commenters noted that the final
RTCR should retain flexibility around this requirement, as allowed in
the 1989 TCR.
    Several commenters noted that including such a provision in the
final RTCR would create a hardship on systems, with many mentioning
that weekend sample collection is a challenge for many small systems.
Concern was expressed that this provision in the final rule would
result in more monitoring violations but not necessarily change repeat
sample collection practice.
    Based on consideration of the concerns expressed, EPA is not
changing the provision that States may extend the 24-hour limit if the
system has a logistical problem in collecting the repeat samples within
24 hours that is beyond its control. See sections III.D of this
preamble, Repeat Samples, for additional discussion.
2. Other Method Issues
    a. Holding time. In the proposed rule, EPA clarified the language
defining when the sample holding time ends. The 1989 TCR states ``the
time from sample collection to initiation of analysis may not exceed 30
hours,'' and this language was clarified in the proposed rule to state
``The time from sample collection to initiation of test medium
incubation may not exceed 30 hours.''
    Key issues raised. Two comments were received on this rule
provision, with one commenter explaining that some water systems have a
difficult time meeting the 30-hour hold time, and this provision may
further impact their ability to meet the holding time. The second
commenter stated that the number of coliforms does not likely change in
``a 30 minute window'' and that this provision will not improve public
health.
    As explained in the proposed rule, EPA recognizes that this
provision may slightly decrease the amount of time that a water system
has to get the sample to the lab, by approximately 30 minutes or less.
EPA believes the impact of this provision is minimal, as a well managed
laboratory will be able to recognize a sample that is received near the
end of the holding time and make this sample a priority for analysis.
    The inclusion of this provision in the final rule serves to ensure
consistency in the analyses of the compliance samples on a national
basis and will have a minimal impact on water systems. As such, the
provision is included in the final rule.
    b. Dechlorinating agent. The proposed rule included a provision
that would require the use of a dechlorinating agent when samples of
chlorinated water are collected.
    Key issues raised. The Agency did not receive any adverse comment
to this provision of the proposed regulation. Accordingly, this
provision has been included in the final rule. EPA notes that the
wording of this provision in the final rule differs slightly from that
included in the proposed rule. The wording was changed to clarify that
the use of a dechlorinating agent is applicable to water systems that
use any type of chlorination (including chloramines) to disinfect their
drinking water supplies. The proposed rule did not include language
that was specific enough to ensure that this point was clear.
    c. Filtration funnels. In the proposed rule, EPA added a footnote
to the methods table that clarifies that the funnels used in the
membrane filtration procedure should be sterilized by autoclaving, not
by using ultraviolet (UV) light. The addition of this provision to the
rule makes the rule requirements consistent with what is recommended by
the Agency in the Manual for the Certification of Laboratories
Analyzing Drinking Water (EPA 815-R-05-004, 5th Edition, 2005).
    Key issues raised. The Agency only received one comment on this
provision, requesting clarification that would allow the use of
disposable filtration units that are purchased pre-sterilized by the
manufacturer. EPA believes that these units can be appropriate for use
in drinking water sample analyses, and therefore has modified the
provision to reflect usage of such units. The provision now reads as
follows:

    All filtration series must begin with membrane filtration
equipment that has been sterilized by autoclaving. Exposure of
filtration equipment to UV light is not adequate to ensure
sterilization. Subsequent to the initial autoclaving, exposure of
the filtration equipment to UV light may be used to sanitize the
funnels between filtrations within a filtration series.
Alternatively, disposable membrane filtration equipment that is pre-
sterilized by the manufacturer (i.e., disposable funnel units) may
be used.

    d. Analytical methods table changes. The proposed rule reflected
many modifications to the table of analytical methods to clarify which
methods were approved for use under this regulation.
    No comments were received on the following changes to the methods
table. Accordingly these modifications have been incorporated into the
final rule.
     The table is organized by methodology.
     E. coli methods are included in the analytical methods
table.
     The 18th and 19th editions of Standard Methods for the
Examination of Water and Wastewater are no longer approved and are not
included in the final rule.
     The references to Standard Methods 9221A and 9222A are
removed.
     The reference to Standard Methods 9221B is changed to
9221B.1, B.2.
     The reference to Standard Methods 9221D is changed to
9221D.1, D.2.
     The citation for MI agar is changed to EPA Method 1604.
     The table clarifies that Standard Methods 9221 F.1 and
9222 G.1c(1), and 9222 G.1c(2) may be used for E. coli analysis.
     The table clarifies the correct formulation for E. coli
medium with 4-methylumbelliferyl-Beta-D-glucuronide (EC-MUG) broth,
when used in conjunction with Standard Methods 9222G.1c(2), through the
addition of the following footnote: The following changes must be made
to the EC broth with MUG (EC-MUG) formulation: Potassium dihydrogen
phosphate, KH2PO4 must be 1.5g and 4-methylumbelliferyl-Beta-D-
glucuronide must be 0.05 g.
     The table reflects the approval of a modified Colitag
method for the simultaneous detection of E. coli and other total
coliforms.
    The proposed rule also contained a provision to allow the use of
Standard Methods 9221D in an enumerative format, specifically, in the
multiple tube format as described in Standard Methods 9221B.
    Key issues raised. One comment was received, stating that the use
of Standard Methods 9221D in an enumerative (multiple tube) format
should be evaluated through an Alternate Test Procedure (ATP) study or
be added to the proposed method reevaluation study. Given that this

method is a part of Standard Methods 9221, entitled ``Multiple-Tube
Fermentation Technique for Members of the Coliform Group,'' the Agency
believes it is appropriate for this method to be used in an
enumerative, multiple tube format. Additionally, as explained in the
proposed rule, there have been publications demonstrating that this
method is effective in a multiple tube format.
    Since use of this method in a multiple-tube format does not change
the formulation of the medium, nor the volume of sample analyzed, the
Agency has determined that an ATP evaluation is not necessary.
Therefore, the provision is included in the final rule.
    e. Holding temperature. In the proposed rule, the Agency requested
comment as to whether the RTCR should require the samples to be held at
10 degrees Celsius (C) or less during transit.
    Key issues raised. Several commenters expressed support for this
provision stating that it would improve the integrity of the data
collected under this rule. However, many commenters expressed concern
that the addition of this provision would cause a hardship, especially
to small systems, as it would increase the cost of the sample shipment.
Additionally, concern was expressed that this provision would increase
the number of ``failure to monitor'' violations, thereby imposing an
enforcement burden on the States.
    Based on further consideration of the potential additional burden
on both the PWSs and the States, EPA has determined that the provision
in the 1989 TCR will stay as is: ``Systems are encouraged but not
required to hold samples below 10 deg. C during transit.''
    Finally, in this final rule, there have been some further changes
to the analytical methods table to improve its clarity. Such changes
include the addition of the approved online versions of Standard
Methods in the analytical methods table and correction of some clerical
errors.

J. Systems Under EPA Direct Implementation

    Systems falling under direct oversight of EPA (e.g., Tribal
systems, PWSs in Wyoming, and PWSs in States that have not yet obtained
primacy for the RTCR) where EPA acts as the State, must comply with
decisions made by EPA for implementation of the RTCR. Under Sec.
142.16(q), to obtain primacy for the RTCR, States/Tribes are required
to demonstrate how they intend to implement the various requirements of
the rule; States/Tribes may do so in a manner that maximizes the
efficiency of the rule for the States/Tribes and the PWSs while
maintaining or increasing the effectiveness of the rule to protect
public health. EPA has the same responsibilities when the Agency acts
as the State in directly implementing the RTCR. In the proposed RTCR,
EPA requested comment on whether to make this explicit in the final
RTCR. All commenters who responded to this request for comment were in
support of such action. EPA already has such authority or flexibility
in direct implementation situations, both in the 1989 TCR and in all
other NPDWRs, but solicited comment and has added this provision to the
final rule for the sake of clarity in situations where EPA directly
implements the RTCR.

K. Compliance Date

    Consistent with SDWA section 1412(b)(10), States and PWSs are given
three years after the promulgation of the RTCR to prepare for
compliance with the rule. PWSs must begin compliance with the
requirements of the RTCR on April 1, 2016, a compliance effective date
that is just over three years from promulgation and coincides with
quarterly monitoring schedules applicable to many water systems. EPA
believes that capital improvements generally are not necessary to
ensure compliance with the RTCR. However, a State may allow individual
systems up to two additional years to comply with the RTCR if the State
determines that additional time is necessary for capital improvements,
in accordance with SDWA section 1412(b)(10).

IV. Other Elements of the Revised Total Coliform Rule

A. Best Available Technology

1. Requirements
    EPA is making three modifications to the 1989 TCR provisions
regarding the best technology, treatment techniques, or other means
available for achieving compliance with the MCL for E. coli under the
RTCR. EPA has re-designated these provisions from 40 CFR 141.63(d) to
141.63(e) and is making the following modifications.
     ``Coliforms'' in 40 CFR 141.63(d)(1) under the 1989 TCR is
replaced with ``fecal contaminants'' in 40 CFR 141.63(e)(1).
     ``Cross connection control'' is added to the list of
proper maintenance practices for the distribution system in 40 CFR
141.63(e)(3) (formerly 40 CFR 141.63(d)(3)).
     Subparts P, T, and W (filtration and/or disinfection of
surface water), and subpart S (disinfection of ground water), are added
in 40 CFR 141.63(e)(4) (formerly 40 CFR 141.63(d)(4)).
    The Agency is listing the same technology, treatment techniques, or
other means available for achieving compliance with the MCL for E. coli
as provided in Sec.  141.63(e), for small PWSs serving 10,000 or fewer
people, as required by SDWA section 1412(b)(4)(E)(ii).
2. Key Issues Raised
    EPA received comments that supported the modifications to the list
of best available technologies (BATs). The Agency also received
comments suggesting the addition of other items to the list, such as
the optional barriers that may qualify systems for reduced monitoring,
unidirectional flushing, storage tank inspection, maintenance, and
cleaning, and re-pressurization. EPA heard from a few commenters who
are against the inclusion of cross connection control in the list of
BATs. They stated that it is not appropriate to do so because EPA has
not defined cross connection control, and risks associated with cross
connection and backflow are being addressed in the research efforts of
the Research and Information Collection Partnership (see http://water.epa.gov/lawsregs/rulesregs/sdwa/tcr/regulation_revisions_tcrdsac.cfm#ricp for additional information about the Partnership);
hence, they concluded it is premature to include it in the RTCR.
    The methods for achieving compliance listed in 40 CFR 141.63(e)
represent the technology, treatment technique, and other means which
EPA finds to be feasible for purposes of meeting the MCL for E. coli,
in accordance with section 1412(b)(4)(E) of SDWA. The RTCR however, is
not imposing additional requirements (e.g., disinfection, filtration,
etc.) beyond those already addressed by other microbial drinking water
regulations such as the Ground Water Rule and the Surface Water
Treatment Rules; nor is it imposing specific requirements regarding the
use of the other methods such as main flushing programs, cross
connection control, etc. PWSs are given the discretion to use the
methods in 40 CFR 141.63(e) (if they are not already required to do
so), or other methods of their choice (provided they are acceptable to
the State), as they see fit for their own systems.
    EPA believes that the inclusion of cross connection control to the
list of BATs is appropriate given the public health risk associated
with unprotected cross connection. Several States already require that
PWSs implement a cross connection control program. As

discussed in the previous paragraph, the inclusion of cross connection
control in 40 CFR 141.63(e) does not impose specific requirements on
PWSs to implement a cross connection control program. Rather, it
acknowledges that cross connection control can be one of the tools PWSs
can use to comply with the E. coli MCL.

B. Variances and Exemptions

1. Requirements
    EPA is not allowing variances or exemptions to the E. coli MCL in
Sec.  141.4(a). EPA believes that water that exceeds the MCL for E.
coli poses an unreasonable risk to public health. Therefore, EPA is not
allowing any variances or exemptions to the E. coli MCL. EPA is also
eliminating the variance provisions in Sec.  141.4(b) under the 1989
TCR that allow systems to demonstrate to the State that the violation
of the monthly/non-acute total coliform MCL is due to biofilm and not
fecal or pathogenic contamination. This change also results in a
parallel change in Sec.  142.63(b). Since the MCL for total coliforms
is eliminated and replaced by a treatment technique, the variance for
the presence of biofilms is no longer applicable and allowed under
SDWA. Instead, the presence of biofilm is addressed through the
assessment and corrective action requirements of the RTCR.
    EPA is adding a note to the provision in Sec.  141.4(a) to clarify
that small system variances or exemptions for treatment technique
requirements in this rule and other rules that control microbial
contaminants may not be granted under SDWA section 1415(e)(6)(B) and
Sec.  142.304(a). This action reflects the statutory provision within
EPA's regulations and adds no new requirements or limitations to any of
these rules.
2. Key Issues Raised
    Most commenters support these changes. However, EPA also received
comment that supported the retention of the variance for the presence
of biofilms. The commenter said that the retention of the biofilm
variance would require PWSs to have a biofilm control program in place
that will require ongoing assessment and research to determine and
address the cause of the biofilms, thereby providing valuable
information. Some commenters suggested that if the biofilm variance is
removed, EPA should make it clear that the finding of biofilms as the
cause of the positive sample during an assessment is not a sanitary
defect which requires correction.
    As discussed previously in section IV.B.1 of this preamble,
Requirements, EPA is not allowing variances to the E. coli MCL because
EPA believes that water which exceeds the MCL for E. coli poses an
unreasonable risk to public health. Furthermore, retention of the
variance for total coliforms is not allowed under SDWA because the MCL
for total coliforms is eliminated and replaced by a treatment
technique. EPA believes that additional research and information
collection will be valuable to learning about the magnitude of the
risks from biofilms. However, research available to date indicates that
biofilms can harbor pathogens and result in accumulation of
contaminants (Brown and Barker 1999; Szewzyk et al. 2000; Berry et al.
2006; L[aring]ngmark et al. 2007), and considering it a sanitary defect
is warranted in some cases. Also, persistent biofilms that cause
continued total coliform presence compromises the value of total
coliforms as an indicator of potential pathways of contamination. If
biofilm is determined to be the cause of the total coliform-positive
samples that triggered an assessment, the PWS is encouraged to work
with the State to determine the right course of action to address the
biofilms. Under the RTCR, States have the discretion to determine if
the completed assessment and corrective action are adequate. The State
can use this discretion in addressing instances of biofilm presence and
determining the extent of biofilm problems in the distribution system
and the need to address them. When a system has an ongoing biofilm
problem that continues to cause total coliform-positive samples, the
system and the State can continue to take action until the biofilm
problem is resolved.

C. Revisions to Other NPDWRs as a Result of the RTCR

    EPA recognizes that there are linkages among monitoring
requirements between the 1989 TCR and other NPDWRs. For instance, under
the Surface Water Treatment Rule (SWTR) (USEPA 1989b, 54 FR 27486, June
29, 1989) and the Stage 1 Disinfectants and Disinfection Byproducts
Rule (Stage 1 DBPR) (USEPA 1998a, 63 FR 69389, December 16, 1998), the
residual disinfectant monitoring must be conducted at the same time and
location at which total coliform samples are taken, as required. Under
the SWTR, high measurements of turbidity in an unfiltered subpart H
system (i.e., a system using surface water or ground water under the
influence of surface water) trigger additional total coliform samples;
and compliance with the total coliform MCL under the 1989 TCR is one of
the criteria for a PWS to avoid filtration. Under the GWR, 1989 TCR
distribution system monitoring results determine whether a system is
required to conduct source water monitoring.
    For the criteria for avoiding filtration in the SWTR (Sec.
141.71(b)(5)), the Agency is clarifying that unfiltered systems must
continue to meet the E. coli MCL promulgated with the final RTCR at
Sec.  141.63(c) in order to remain unfiltered. The changes to Sec.
141.71(b)(5) provides for replacement of the (acute) total coliform MCL
at Sec.  141.63(b) with the E. coli MCL at Sec.  141.63(c) at the
compliance date of the RTCR. Although the name of the MCL has changed,
the determination of the E. coli MCL remains basically the same as that
for the (acute) total coliform MCL in Sec.  141.63(c), with the only
changes being those that were made to address the advisory committee
recommendations and the public comments.
    After considering other possible linkages between the RTCR and the
SWTR, GWR, Stage 1 DBPR, Stage 2 DBPR (USEPA 2006e, 71 FR 388, January
4, 2006), and Airline Drinking Water Rule (USEPA 2009), EPA has
concluded that the only other necessary revision to these NPDWRs is to
update the references to the 1989 TCR at 40 CFR 141.21, which is
superseded by 40 CFR part 141 subpart Y beginning April 1, 2016. The
monitoring requirements themselves are not changing as a result of the
RTCR. Residual disinfectant samples must still be taken at the same
time and location at which total coliform samples are taken under the
RTCR. High measurements of turbidity under the SWTR would still result
in additional total coliform samples. Results of total coliform
monitoring under the RTCR would still be a trigger for the GWR.
Although there are changes to the dual-purpose sampling requirement
(i.e., one sample to satisfy both the repeat monitoring requirement of
the RTCR and the triggered source water monitoring requirement of the
GWR), these changes are addressed in the RTCR and not in the GWR (see
section III.D of this preamble, Repeat Samples, for further discussion
on dual-purpose sampling). Comments received on dual-purpose sampling
are also discussed in section III.D of this preamble, Repeat Samples.
    EPA also received comments regarding the relationship between
source water evaluations under the GWR and assessments under RTCR;
those comments are addressed in section III.E.2 of this preamble,
Assessment.
    The RTCR is also not changing the existing sanitary survey
requirements

established under the IESWTR and the GWR. However, the RTCR is adding
the special monitoring evaluation that States must conduct at systems
serving 1,000 or fewer people during the sanitary survey. These
evaluations are not expected to significantly increase the burden to
conduct sanitary surveys because of the relatively simple nature of
these systems and their monitoring requirements.
    EPA did not receive any other substantial comments regarding the
relationships between RTCR and other NPDWRs.
    EPA recognizes that there are sections of part 141 that will no
longer be applicable after the RTCR compliance effective date. EPA
intends to review and update these sections in the future.

D. Storage Facility Inspection

    In the proposed RTCR, EPA discussed the potential public health
implications associated with poorly maintained storage facilities (such
as those associated with significant sediment accumulation inside the
tank and the presence of breaches). EPA requested comment and
supporting information regarding the current status of storage tanks
and their inspection as implemented by individual States and PWSs. Some
of the information EPA requested comment on included the state and
condition of tanks that have been cleaned and inspected, costs of
storage tank inspection and cleaning, the frequency of inspection and
cleaning, and how public health can be better protected. Based on the
comments and information that EPA received, the Agency is considering
the need for inspection requirements for finished water storage
facilities that would help mitigate potential public health risks if
PWSs do not inspect their storage facilities as recommended by industry
guidance (e.g., American Water Works Association (AWWA) Manual 42). EPA
plans to provide further information on the results of its
consideration of this issue in a future notice.

V. State Implementation

    SDWA establishes requirements that States or eligible Indian Tribes
must meet to assume and maintain primary enforcement responsibility
(primacy) to implement national primary drinking water regulations.
This section describes the requirements that States must meet to
maintain primacy under the RTCR, including adoption of drinking water
regulations that are no less stringent than the RTCR and meeting
recordkeeping and reporting requirements. This section also provides an
update on the Safe Drinking Water Information System (SDWIS) revisions
that EPA is developing to facilitate the implementation of RTCR.

A. Primacy

1. Requirements
    States are required to adopt or maintain requirements that are at
least as stringent as all of the sections of 41 CFR part 141that are
revised or added by the RTCR. SDWA provides two years after
promulgation of the RTCR (plus up to two more years if the
Administrator approves) for the State to adopt their regulations.
States may adopt more stringent requirements (e.g., requiring all
systems to conduct routine monthly monitoring). Many States have used
this authority in the past to improve public health protection and/or
simplify implementation.
    EPA grants interim primary enforcement authority for a new or
revised regulation during the period in which EPA is making a
determination with regard to primacy for that new or revised
regulation. States that have primacy (including interim primacy) for
every existing NPDWR already in effect may obtain interim primacy for
the RTCR, beginning on the date that the State submits the application
for this rule to EPA, or the effective date of its revised regulations,
whichever is later. A State that wishes to obtain interim primacy for
future NPDWRs must obtain primacy for this rule.
    EPA regulations at 40 CFR part 142 contain the program
implementation requirements for States to obtain primacy for the public
water supply supervision program as authorized under SDWA section 1413.
In addition to adopting rule requirements that are at least as
stringent as the requirements of the RTCR, and basic primacy
requirements specified in 40 CFR part 142, States are required to adopt
special primacy provisions pertaining to each specific regulation where
State implementation of the rule involves activities beyond general
primacy provisions. States must include these regulation-specific
provisions in their application for approval of any program revision.
States must also continue to meet all other conditions of primacy for
all other rules in 40 CFR part 142.
    The RTCR provides States with flexibility to implement the
requirements of the rule in a manner that maximizes the efficiency of
the rule for the States and water systems while increasing the
effectiveness of the rule to protect public health. To ensure an
effective and enforceable program under the RTCR, the State primacy
application for RTCR must include a description of how the State will
meet the following special primacy provisions contained in the RTCR at
40 CFR part 142:
     Baseline and Reduced Monitoring Provisions--The State
primacy application must indicate what baseline and reduced monitoring
provisions of the RTCR the State will adopt and describe how the State
will implement the RTCR in these areas so that EPA can be assured that
implementation plans meet the minimum requirements of the rule.
     Sample Siting Plans--States must describe the frequency
and process used to review and revise sample siting plans in accordance
with 40 CFR part 141, subpart Y to determine adequacy.
     Reduced Monitoring Criteria--The primacy application must
indicate whether the State will adopt the reduced monitoring provisions
of the RTCR (e.g., reduced monitoring provisions for ground water
systems serving 1,000 or fewer people, including provisions on dual
purpose sampling). If the State adopts the reduced monitoring
provisions, it must describe the specific types or categories of water
systems that will be covered by reduced monitoring and whether the
State will use all or a reduced set of the optional criteria. For each
of the reduced monitoring criteria, both mandatory and optional, the
State must describe how the criteria will be evaluated to determine
when systems qualify.
     Assessments and Corrective Actions--States must describe
their process to implement the new assessment and corrective action
phase of the rule. The description must include how the State will
ensure that Level 2 assessments are more comprehensive than Level 1
assessments, examples of sanitary defects, examples of assessment forms
or formats, and methods that systems may use to consult with the State
on appropriate corrective actions.
     Invalidation of routine and repeat samples collected under
the RTCR--States must describe their criteria and process to invalidate
total coliform-positive and E. coli-positive samples under the RTCR.
This includes criteria to determine if a sample was improperly
processed by the laboratory, reflects a domestic or other non-
distribution system plumbing problem or reflects circumstances or
conditions that do not reflect water quality in the distribution
system.
     Approval of individuals allowed to conduct RTCR Level 2
assessments--States must describe their criteria and process for
approval of individuals allowed to conduct RTCR Level 2 assessments.

     Special monitoring evaluation--States must describe how
they will perform special monitoring evaluations during sanitary
surveys for ground water systems serving 1,000 or fewer people to
determine whether systems are on an appropriate monitoring schedule.
     Seasonal systems--States must describe how they will
identify seasonal systems, how they will determine when systems on less
than monthly monitoring must monitor, and what will be the seasonal
system start-up provisions.
     Additional criteria for reduced monitoring--States must
describe how they will require systems on reduced monitoring to
demonstrate, where appropriate:

--Continuous disinfection entering the distribution system and a
residual in the distribution system.
--Cross connection control.
--Other enhancements to water system barriers.

     Criteria for extending the 24-hour period for collecting
repeat samples--If the State elects to use a set of criteria in lieu of
case-by-case decisions, they must describe the criteria they will use
to waive the 24-hour time limit for collecting repeat samples after a
total coliform-positive routine sample, or to extend the 24-hour limit
for collection of samples following invalidation. If the State elects
to use only case-by-case waivers, the State does not need to develop
and submit criteria.
2. Key Issues Raised
    Commenters generally supported the inclusion of these activities in
the primacy application and emphasized the importance of the
flexibility and discretion that this approach provides for States to
build on existing authorities of the 1989 TCR and focus on systems with
the greatest need. They suggested that EPA allow States as much
flexibility and discretion as possible to design their approach to
implementing the RTCR, including how to address seasonal water systems,
qualifications of assessors, the content of sample siting plans, and
compliance with multiple rules (e.g., coordination between 1989 TCR/
RTCR and GWR compliance), and how to consider multiple Level 1
assessments where the cause of the first Level 1 assessment has been
identified and corrected. However, some commenters suggested removal of
some of the special primacy requirements, such as those regarding
seasonal system startup procedures and how the States will review
sample siting plans, implement the assessment and corrective action
phase, and determine who is approved to conduct Level 2 assessments.
EPA is maintaining these primacy requirements in the RTCR because they
provide the States with the flexibility to design their programs to fit
their own needs without prescriptive, one-size-fits-all requirements.
Describing how the State will accomplish them in the primacy
application assures that consumers nationwide are receiving adequate
and comparable public health protection under the rule.
    EPA also requested comment on whether it is appropriate to have
States describe their criteria for waiving or extending the 24-hour
limit to collect repeat samples as a special primacy condition, or
instead have States keep records of decisions to waive and/or extend
the 24-hour limit. The majority of the commenters supported the former
option as it reduces paperwork burden and adds flexibility to the
implementation of the RTCR. EPA concurs and added the waiver or
extension of the 24-hour limit to the special primacy requirements as
an option for States that would rather describe their criteria for
waiving or extending the 24-hour limit in their primacy application,
instead of having to make the decision on a case-by-case basis. States
that elect to use only case-by-case waivers do not need to develop and
submit criteria.

B. State Recordkeeping and Reporting and SDWIS

1. Recordkeeping
    The current regulations in 40 CFR 142.14 require States with
primacy to keep records, including: analytical results to determine
compliance with MCLs, maximum residual disinfectant levels (MRDLs), and
treatment technique requirements; PWS inventories; State approvals;
enforcement actions; and the issuance of variances and exemptions.
Consistent with the recordkeeping requirements of the current
regulations, the RTCR requires States to keep records and supporting
information for each of the following decisions or activities for five
years:
     Any case-by-case decision to waive the 24-hour time limit
for collecting repeat samples after a total coliform-positive routine
sample, or to extend the 24-hour limit for collection of samples
following invalidation.
     Any decision to allow a system to waive the requirement
for three routine samples the month following a total coliform-positive
sample. The record of the waiver decision must contain all the items
listed in Sec. Sec.  141.854(j) and 141.855(f) of the RTCR.
     Any decision to invalidate a total coliform-positive
sample. If the State decides to invalidate a total coliform-positive
sample as provided in Sec.  141.853(c)(1) of the RTCR, the record of
the decision must contain all the items listed in that paragraph.
    Also, consistent with the recordkeeping requirements of the current
regulations, under the RTCR States must retain records of each of the
following decisions in such a manner that each system's current status
may be determined at any time:
     Any decision to reduce the total coliform monitoring
frequency for a community water system serving 1,000 or fewer people to
less than once per month, as provided in Sec.  141.855(d) of the RTCR;
and what the reduced monitoring frequency is. A copy of the reduced
monitoring frequency must be provided to the system.
     Any decision to reduce the total coliform monitoring
frequency for a non-community water system using only ground water and
serving 1,000 or fewer people to less than once per quarter, as
provided in Sec.  141.854(e) of the RTCR, and what the reduced
monitoring frequency is. A copy of the reduced monitoring frequency
must be provided to the system.
     Any decision to reduce the total coliform monitoring
frequency for a non-community water system using only ground water and
serving more than 1,000 persons during any month the system serves
1,000 or fewer people, as provided in Sec.  141.857(d) of the RTCR. A
copy of the reduced monitoring frequency must be provided to the
system.
     Any decision to waive the 24-hour limit for taking a total
coliform sample for a public water system that uses surface water, or
ground water under the direct influence of surface water, and that does
not practice filtration in accordance with part 141, subparts H, P, T,
and W, and that measures a source water turbidity level exceeding 1
nephelometric turbidity unit (NTU) near the first service connection.
     Any decision to allow a public water system to forgo E.
coli testing on a total coliform-positive sample if that system assumes
that the total coliform-positive sample is E. coli-positive.
    The RTCR also adds the following new recordkeeping requirement:
     States must keep records and supporting information
regarding completed and approved RTCR assessments, including reports
from the system that corrective action has been completed, for five
years.

2. Reporting
    EPA currently requires at 40 CFR 142.15 that States report to EPA
information such as violations, variance and exemption status, and
enforcement actions. The RTCR requires States to develop and maintain a
list of public water systems that the State is allowing to monitor less
frequently than once per month for community water systems or less
frequently than once per quarter for non-community water systems,
including the compliance date (the date that reduced monitoring was
approved) of the reduced monitoring requirement for each system.
3. SDWIS
    EPA has begun to plan and develop the next version of SDWIS, SDWIS
Next Gen, which will provide improved capabilities to update the system
when there are new rule requirements and that enables more efficient
data sharing among systems, laboratories, States, and EPA. EPA has
established a governance structure to allow States to provide input on
SDWIS Next Gen and begin identifying and prioritizing necessary system
functions. Developing the portions of the system that are needed for
implementing RTCR is a high priority. EPA remains committed to
completing revisions to SDWIS that will facilitate implementation of
RTCR and to completing them well in advance of the effective date of
the rule.
4. Key Issues Raised
    Many commenters emphasized the importance of developing revisions
to SDWIS sufficiently in advance of the effective date of the rule to
allow for efficient, effective, and consistent implementation,
tracking, recordkeeping, and reporting. As indicated above, EPA has
already begun planning and development of SDWIS Next Gen to incorporate
changes necessary to implement RTCR. EPA plans to complete the
revisions necessary to implement RTCR well in advance of the RTCR
effective date. Commenters also noted the advisory committee
recommendation to develop metrics for evaluating the effectiveness of
RTCR. Identifying metrics and incorporating them into SDWIS Next Gen
will be part of the process completed by the governance structure with
the input of stakeholders.
    Some commenters objected to the requirement for States to maintain
lists of systems on reduced monitoring and information on decisions on
sample invalidations and waivers of time limits. EPA notes that these
requirements also existed under the 1989 TCR and are not new under the
RTCR. These requirements, and the requirements to maintain other
information such as regarding assessments and review of seasonal system
startup procedures, will be considered in the design of SDWIS Next Gen
and incorporated to the extent possible to help States efficiently
manage their implementation requirements.
    Commenters also expressed the need for guidance to help States
implement rule requirements regarding annual site visits for systems on
annual monitoring, review of system RTCR monitoring frequency during
sanitary surveys, review of seasonal system startup procedures, and
identification of qualified assessors for Level 2 assessments. EPA
plans to work with States to develop the necessary changes in
implementation guidance well before the effective date of the RTCR.

VI. Economic Analysis (Health Risk Reduction and Cost Analysis)

    This section summarizes the economic analysis (EA) for the final
RTCR. The EA is an assessment of the benefits, both health and non-
health-related, and costs to the regulated community of the final
regulation, along with those of regulatory alternatives that the Agency
considered. EPA developed the EA for the RTCR to meet the requirement
of SDWA section 1412(b)(3)(C) for a Health Risk Reduction and Cost
Analysis (HRRCA), as well as the requirements of Executive Order 12866,
Regulatory Planning and Review, and Executive Order 13563, Improving
Regulation and Regulatory Review, under which EPA must estimate the
costs and benefits of the rule. The full EA for the final RTCR (RTCR
EA) (USEPA 2012a) includes additional details and discussion on the
topics presented throughout this section of the preamble. It is
available in the docket (Docket ID No. EPA-HQ-OW-2008-0878) and is also
published on the government's Web site at http://www.regulations.gov.
    SDWA section 1412(b)(3)(C) requires that the HRRCA for a NPDWR take
into account the following seven elements: (1) Quantifiable and
nonquantifiable health risk reduction benefits; (2) quantifiable and
nonquantifiable health risk reduction benefits from reductions in co-
occurring contaminants; (3) quantifiable and nonquantifiable costs that
are likely to occur solely as a result of compliance; (4) incremental
costs and benefits of rule options; (5) effects of the contaminant on
the general population and sensitive subpopulations including infants,
children, pregnant women, elderly, and individuals with a history of
serious illness; (6) any increased health risks that may occur as a
result of compliance, including risks associated with co-occurring
contaminants; and (7) other relevant factors such as uncertainties in
the analysis and factors with respect to the degree and nature of risk.
A summary of these elements is provided in this section of the
preamble, and a complete discussion can be found in the RTCR EA.
    Both benefit and cost measures are adjusted using social
discounting. In social discounting, future values of a rule's or
policy's effects are multiplied by discount factors. The discount
factors reflect both the amount of time between the present and the
point at which these events occur and the degree to which current
consumption is more highly valued than future consumption (USEPA
2000a). This process allows comparison of cost and benefit streams that
are variable over a given time period. EPA uses social discount rates
of both three percent and seven percent to calculate present values
from the stream of benefits and costs and also to annualize the present
value estimates. Historically, the use of three percent is based on
after tax rates of return to consumers on relatively risk-free
financial instruments, while seven percent is an estimate of average
economy-wide before-tax rate of return to incremental private
investment generally. For further information, see USEPA 2000a and OMB
1996.
    The time frame used for both benefit and cost comparisons in this
rule is 25 years. This time interval accounts for rule implementation
activities occurring soon after promulgation (e.g., States adopting the
criteria of the regulation) and the time for different types of
compliance actions (e.g., assessments and corrective actions) to be
realized up through the 25th year following rule promulgation. In the
RTCR EA, EPA also presents the undiscounted stream of benefits and
costs over the 25-year time frame in constant 2007 dollars (2007$).
    The benefits described in this section are discussed qualitatively,
and reductions in occurrence of total coliforms and E. coli and in
Level 2 assessments are used as indicators of positive benefits. EPA
was unable to quantify health benefits for the RTCR because there are
insufficient data reporting the co-occurrence in a single sample of
fecal indicator E. coli and pathogenic organisms. In addition, the
available fecal indicator E. coli data from the Six-Year Review 2
dataset (USEPA 2012a) described in this preamble were limited to
presence-

absence data because the 1989 TCR requires only the reporting of
presence or absence of fecal indicator E. coli using EPA-approved
standard methods. However, as discussed in chapter 6 of the RTCR EA,
even though health benefits could not be directly quantified, the
potential benefits from the RTCR include avoidance of a full range of
health effects from the consumption of fecally contaminated drinking
water, including the following: acute and chronic illness, endemic and
epidemic disease, waterborne disease outbreaks, and death. Since fecal
contamination may contain waterborne pathogens including bacteria,
viruses, and parasitic protozoa, in general, a reduction in fecal
contamination should reduce the risk from all of these contaminants.
    The net costs of the rule stem mostly from the new assessment and
corrective action requirements as well as the revised monitoring
provisions described earlier in this preamble. The costs discussed in
this section are presented as annualized present values in constant
2007$.
    This section of the preamble includes elements as follows: (A)
Regulatory Options Considered, (B) Major Sources of Data and
Information Used in Supporting Analyses, (C) Occurrence and Predictive
Modeling, (D) Baseline Profiles, (E) Anticipated Benefits of the RTCR,
(F) Anticipated Costs of the RTCR, (G) Potential Impact of the RTCR on
Households, (H) Incremental Costs and Benefits, (I) Benefits from
Simultaneous Reduction of Co-occurring Contaminants, (J) Change in Risk
from Other Contaminants, (K) Effects of Fecal Contamination and/or
Waterborne Pathogens on the General Population and Sensitive
Subpopulations, (L) Uncertainties in the Benefit and Cost Estimates for
the RTCR, (M) Benefit Cost Determination for the RTCR, (N) Comments
Received in Response to EPA's Requests for Comment, and (O) Other
Comments Received by EPA.

A. Regulatory Options Considered

    EPA evaluated the following three regulatory options as part of
this revised rule: (1) The 1989 TCR option, (2) the RTCR option
(today's final rule), and (3) an Alternative option. EPA discusses the
three regulatory options briefly in this preamble and in greater detail
in chapter 3 of the RTCR EA.
    First, the 1989 TCR option reflects EPA's understanding of how the
1989 TCR is currently being implemented. That is, the 1989 TCR option
is assumed to include ``status quo'' PWS and State implementation
practices. Next, the RTCR option is based on the provisions of this
final rule as described in detail in section III of this preamble,
Requirements of the Revised Total Coliform Rule. Third, the Alternative
option parallels the RTCR in most ways but includes variations of some
of the provisions that were discussed by the advisory committee before
they reached consensus on the recommendations in their AIP, which
served as the basis for the proposed and final rules.
    The Alternative option differs from the RTCR option in two ways.
First, under the Alternative option, at the compliance date all PWSs
are required to sample monthly for an initial period until they meet
the eligibility criteria for reduced monitoring. EPA assumes that
eligibility for reduced monitoring is determined during the next
sanitary survey following the RTCR compliance date. This more stringent
approach differs from the RTCR option that allows PWSs to continue to
monitor at their current frequencies (with an additional annual site
visit or voluntary Level 2 assessment requirement for PWSs wishing to
remain on annual monitoring) until they are triggered into an increased
sampling frequency. Second, under the Alternative option, no PWSs are
allowed to reduce monitoring to an annual basis. EPA defined the
Alternative option this way and included it in the RTCR EA to assess
the relative impacts of a more stringent rule and to better understand
the balance between costs and public health protection. EPA wishes to
emphasize that it is not adopting the Alternative Option, but is
providing cost and benefit information on it as a point of comparison
with the final rule as promulgated.
    To understand the relative impacts of the options, EPA gathered
available data and information to develop and provide input into an
occurrence and predictive model. EPA estimated both baseline conditions
and changes to these conditions anticipated to occur over time as a
result of these revised rule options. The analysis is described in more
detail in the RTCR EA.

B. Major Sources of Data and Information Used in Supporting Analyses

    This section of the preamble briefly discusses the data sources
that EPA used in its supporting analyses for the RTCR. For a more
detailed discussion, see chapter 4 of the RTCR EA.
1. Safe Drinking Water Information System Federal Version Data
    Safe Drinking Water Information System Federal Version (SDWIS/FED)
is EPA's national regulatory compliance database for the drinking water
program and is the main source of PWS inventory and violation data for
the RTCR baseline. SDWIS/FED contains information on each of the
approximately 155,000 active PWSs as reported by primacy agencies, EPA
Regions, and EPA headquarters personnel. SDWIS/FED includes records of
MCL violations and monitoring and reporting violations (both routine
and repeat and minor and major). It does not include sample results. It
also contains information to characterize the US inventory of PWSs
including system name and location, retail population served, source
water type (ground water (GW), surface water (SW), or ground water
under the direct influence of surface water (GWUDI)), disinfection
status, and PWS type (community water system (CWS), transient non-
community water system (TNCWS), and non-transient non-community water
system (NTNCWS)).
    To create the PWS and population baseline, EPA used the fourth
quarter of SDWIS/FED 2007 (USEPA 2007b), which was the most current PWS
inventory data available when EPA began developing the RTCR EA. These
data represent all current, active PWSs and the population served by
these systems.
    EPA also used the MCL violation data from SDWIS/FED to validate
model predictions for systems serving 4,100 or fewer people and to
predict E. coli (or ``acute,'' under the 1989 TCR) MCL violations (1989
TCR, RTCR, and Alternative option), total coliform (non-acute or
monthly) MCL violations (1989 TCR), and Level 1 and Level 2 assessment
triggers (RTCR and Alternative option) for systems serving more than
4,100 people.
2. Six-Year Review 2 Data
    Through an Information Collection Request (ICR) (USEPA 2006b),
States voluntarily submitted electronically available 1989 TCR
monitoring data \1\ (sample results) that were collected between
January 1998 and December 2005. EPA requested the 1989 TCR monitoring
results with the intent of conducting analyses and developing models to
assess the potential impacts of changes to the 1989 TCR. EPA received
data from 46 States, Tribes, and territories. A Data Quality Report
(USEPA 2010c) describes how the 1989 TCR monitoring data were obtained,
evaluated, and modified where

necessary to make the database internally consistent and usable for
analysis. Exhibit 2.1 in the Data Quality Report provides a complete
list of States or territories that submitted data and a description of
the use of these data.
---------------------------------------------------------------------------

    \1\ This refers to results of monitoring conducted pursuant to
the 1989 TCR, not results from the year 1989.
---------------------------------------------------------------------------

    In this EA, EPA included data from 37 primacy agencies (35 States
and 2 Tribes). Records included data for:
     PWS information (system type, population served, source
water type)
     Sample type (routine, repeat, special purpose)
     Analytical result
     Sampling location--entry point, distribution system and,
for repeat samples, original location, downstream, upstream, and other
     Analytical method
     Disinfectant residual data collected at TCR monitoring
sites
    As discussed in greater detail in section <IP_ADDRESS> of the RTCR EA,
EPA used 2005 data exclusively in the analyses supporting the RTCR
because the 2005 data set was the most complete year of data among the
Six-Year Review 2 data. The 2005 data was also the most recent data
available suggesting that it may be the most representative of present
conditions.
    The Six-Year Review 2 data also informed EPA's assumptions
regarding the proportions of ground water systems serving 1,000 or
fewer people that sample monthly, quarterly, or annually.
3. Other Information Sources
    Additional data and information sources included the Economic
Analysis for the Ground Water Rule (GWR EA) (USEPA 2006a), the
Technology and Cost Document for the Revised Total Coliform Rule (RTCR
T&C document) (USEPA 2012b), the US Census data, and the knowledge and
experience of stakeholders representing industry, States, small
systems, and the public.
    The GWR EA provided occurrence information on E. coli in the source
water of ground water PWSs for modeling the triggered monitoring
component of GWR and informed the assumptions on the distribution of
corrective actions taken in response to the presence of E. coli in the