Final Regulatory Flexibility Analysis for the Final Ground Water Rule

I  Background

The Regulatory Flexibility Act (RFA) as amended by the Small Business
Regulatory Enforcement Fairness Act (SBREFA), generally requires an
agency to prepare a regulatory flexibility analysis of any rule subject
to notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial number
of small entities. Small entities include small businesses, small
organizations, and small governmental jurisdictions.

In accordance with Section 604 of the RFA, EPA is preparing a final
regulatory flexibility analysis (FRFA) that examines the impact of the
Ground Water Rule (GWR) on small entities along with regulatory
alternatives that could reduce that impact.

	1 Description of Regulatory Options

As a result of the input received from stakeholders, EPA workgroups, and
other interested parties, EPA constructed four regulatory options: the
sanitary survey and corrective action option, the risk-targeted option,
the multi-barrier option, and the across-the-board disinfection option.
These options are described in more detail below.

The first regulatory option, sanitary survey and corrective actions,
requires States and other primacy agencies to conduct regular
comprehensive sanitary surveys of community ground water systems once
every three years and of non-community water systems once every five
years.  Most states already perform sanitary surveys but with variation
in frequency and stringency. This requirement increases their frequency
in some cases and specifies the following eight critical components for
evaluation: (1) source; (2) treatment; (3) distribution system; (4)
finished water storage; (5) pumps, pump facilities, and controls; (6)
monitoring and reporting, and data verification; (7) system management
and operation; and (8) operator compliance with State requirements.  If
a significant deficiency is identified, corrective action is required to
correct all significant deficiencies or a treatment technique violation
is incurred.  Furthermore, the system is required to notify the public
served by the water system of any significant deficiencies and/or source
water contamination. 

The second regulatory option, referred to as the risk-targeted approach,
incorporates all of the sanitary survey components required under the
first option with triggered source water monitoring. This requirement
only applies to systems that do not currently provide 4-log inactivation
or removal of viruses.  Triggered monitoring applies specifically to
systems that are notified that a Total Coliform Rule (TCR) routine
sample is total colifom-positive.  Within 24 hours of receiving a total
coliform-positive notice, systems must collect a source water sample and
test it for the presence of the State-specified fecal indicator. Unless
the State requires immediate corrective action, systems must take five
repeat samples within 24 hours and test them for the same fecal
indicator.  If the State requires immediate corrective action or if any
of the repeat samples are positive, Systems must implement at least one
of the following corrective actions:  provide alternate source water;
eliminate the source of contamination; or provide treatment that
reliably achieves at least 99.99 percent (4-log) inactivation or removal
of viruses before or at the first customer.  To better evaluate at risk
systems, the State also has the option of requiring assessment
monitoring (twelve monthly samples) of a system’s source water and
requiring corrective action if a positive indicator is found.

The third regulatory option, referred to as the multi-barrier approach,
combines the components of the first two options with a one-time
hydrogeologic sensitivity assessment (HSA), and assessment monitoring of
sources that are sensitive to fecal contamination. Similar to triggered
monitoring, assessment monitoring only applies to systems that do not
currently provide 4-log inactivation or removal of viruses. Systems must
conduct assessment monitoring unless the State performs an HSA and
determines that they do not draw water from a hydrogeologically
sensitive setting.  An HSA is a tool used to identify those systems in
aquifers where water can move quickly through the subsurface, thereby
increasing the possibility of fecal contamination.  The State will
assess the sensitivity of a system based on the hydrogeologic condition
of the aquifer.  States consider wells in karst, gravel, and fractured
bedrock aquifers to be sensitive unless there is a hydrogeologic barrier
present that prevents the movement of microbial contamination. 
Sensitive systems must collect and test a total of 12 ground water
source water samples within 7 years from the promulgation date of the
GWR for CWSs, and 9 years from the promulgation date for NCWSs, unless
the State notifies the system to complete source water sampling by an
earlier date.  Once this baseline has been established, systems are not
required to continue assessment monitoring. If any of these tests are
positive for the fecal indicator organism, the system is required to
eliminate the contamination, obtain a new source of water, or to provide
disinfection treatment that can achieve 4-log inactivation or removal of
viruses in the source water.

The fourth regulatory option, across-the-board disinfection, requires
all ground water systems to disinfect their source waters regardless of
the potential risk of fecal contamination. The systems would be required
to achieve 4-log inactivation or removal of viruses. As required under
the first three options, States would be required to conduct sanitary
surveys.  However, additional emphasis in the survey would be placed
upon ensuring the disinfection treatment is being properly operated and
maintained.

II Requirements for the Final Regulatory Flexibility Analysis

The RFA requires EPA to complete a FRFA addressing the following areas:

(1) The need for, and objectives of, the rule;

(2) A summary of the significant issues raised by the public comments in
response to the initial regulatory flexibility analysis, a summary of
the assessment of the agency of such issues, and a statement of any
changes made in the proposed rule as a result of such comments;

(3) A description of and an estimate of the number of small entities to
which the rule will apply or an explanation of why no such estimate is
available;

(4) A description of the projected reporting, recordkeeping and other
compliance requirements of the rule, including an estimate of the
classes of small entities which will be subject to the requirement and
the type of professional skills necessary for preparation of the report
or record; and

(5) A description of the steps the agency has taken to minimize the
significant economic impact on small entities consistent with the stated
objectives of applicable statutes, including a statement of the factual,
policy, and legal reasons for selecting the alternative adopted in the
final rule and why each one of the other significant alternatives to the
rule considered by the agency which affect the impact on small entities
was rejected.



The Need for, and Objectives of, the Rule

The GWR is promulgated pursuant to Section 1412(6)(8) of the SDWA, as
amended in 1996, which directs EPA to “promulgate national primary
drinking water regulations requiring disinfection as a treatment
technique for all public water systems, including surface water systems
and, as necessary, ground water systems.”

The Reasons the Agency is Considering This Action

EPA believes that there is a substantial likelihood that fecal
contamination of ground water supplies is occurring at frequencies and
levels that present public health concern. Fecal contamination refers to
the contaminants, particularly the microorganisms, contained in human or
animal feces. These microorganisms may include bacterial and viral
pathogens that can cause illnesses in the individuals that consume them.

Fecal contamination is introduced to ground water from a number of
sources including septic systems, leaking sewer pipes, landfills, sewage
lagoons, land application of wastewater sludge, cesspools, and storm
water runoff. Microorganisms can be transported with the ground water as
it moves through an aquifer. The distance that the microorganisms can be
transported through a ground water aquifer depends upon a number of
factors including the nature of the microorganism, temperature, and soil
properties. For example, protozoan organisms are much larger in size
than bacteria and viruses and are therefore much less likely to be able
to move through the soil matrix. The transport of microorganisms to
wells or other ground water system sources can also be affected by poor
well construction (e.g., improper well seals) that can result in large,
open conduits for fecal contamination to pass unimpeded into the water
supply.  Detailed information on studies used to characterize the
baseline level of fecal contamination in public water system (PWS)
supply wells is provided in Chapter 4 of the GWR Economic Analysis (EA).

Waterborne pathogens in fecally contaminated water can result in a
variety of illnesses that range in the severity of their outcomes from
mild diarrhea to kidney failure or heart disease. Exhibit 1 presents a
list of the illnesses that are caused by pathogenic viruses and bacteria
in fecally contaminated ground water. The populations that are
particularly sensitive to waterborne and other pathogens include
infants, young children, pregnant and lactating women, the elderly, and
the chronically ill.  These individuals may be more likely to become ill
as a result of exposure to the pathogens and are likely to have more
severe illnesses.

Exhibit 1 Illnesses Caused by Waterborne Pathogens 

Viral Waterborne Illnesses	Bacterial Waterborne Illnesses

Gastroenteritis (diarrhea, stomach cramps, etc.)	Gastroenteritis
(diarrhea, stomach cramps, etc.)

Myocarditis (heart disease)	Hemolytic uremic syndrome(kidney failure)

Meningitis	Cholera

Diabetes	Legionnaires Disease

Hepatitis

	Paralysis

	

 Objectives of the GWR

  SEQ CHAPTER \h \r 1 The GWR will address the human risks of illness
and death due to fecal contamination of ground water.  The reduction in
risk will be accomplished through implementation of the GWR’s
risk-targeted approach.  Because of the difficulties involved in
monitoring for the wide range of specific pathogenic bacteria and
viruses that could occur in ground water, one of the key provisions of
the risk-targeted approach is monitoring for a more easily measured
bacterial or viral fecal indicator microorganism.  Based on source water
sampling results, as well as implementation of the other GWR provisions,
PWSs will be required to take action to minimize the possible presence
of pathogenic bacteria and viruses that pose threats to human health.

Summary of Significant Issues Raised by the Public Comments In Response
to the Initial

	Regulatory Flexibility Analysis (IRFA). 

 Summary of Significant Issues Raised by SBAR Panel

	Prior to proposing the GWR and as discussed in the IRFA, EPA convened
an SBAR Panel for the proposed rule.  All SBAR comments on potential
small entity impacts continued to be evaluated through final
promulgation of the GWR.  The discussion below summarizes the SBAR
comments on potential small system impacts in terms of final GWR
requirements. 	 

2.1.1  Number of Small Entities Affected by the Rule

The SBAR Panel recommended that given the number of systems that could
be affected by the rule, EPA consider focusing compliance requirements
on those systems most at risk of fecal contamination. From this
perspective, the Panel suggested that EPA evaluate whether it would be
appropriate to establish different rule requirements for systems based
on system type, size or location. The Panel also suggested providing
States with maximum flexibility, consistent with ensuring an appropriate
minimum level of public health protection, to tailor specific
requirements to individual system needs and resources. The GWR addresses
this issue and is designed to target the systems at highest risk. Risk
characterization is based on system-specific circumstances.  For
example, a system is not required to perform source water microbial
monitoring until the State has cause to believe the system is at risk
based on a positive TCR routine sample.

Recordkeeping and Reporting

Because small systems frequently have minimal staff and resources,
including data on the underlying hydrogeology of the system, the SBAR
Panel recommended that EPA focus the recordkeeping, reporting, and
compliance requirements on those systems at greatest risk of fecal
contamination. The Panel also recommended that EPA consider tailoring
the requirements based on system size (e.g., the smaller systems would
not have to monitor as frequently or perform sanitary surveys on the
same schedule.)

The GWR employs a risk-targeted approach. The monitoring requirements
are based on system characteristics and circumstances and are not
directly related to system size. The only basic requirement consistent
across options is for sanitary surveys, but the implementation schedule
is staggered (e.g., every 3 years for CWS and every 5 years for NCWS)
which should provide some relief for small systems because there are
proportionately more NCWSs classified as small systems. Because many
small systems may not have easy access to the records that would ideally
be available for an HSA or a sanitary survey, EPA, after consulting with
stakeholders and the SBAR Panel, has determined that it will not use the
lack of adequate well records, the lack of a cross connection program,
or intermittent pressure fluctuations as automatic triggers to indicate
risk of potential contamination. These factors may be considered along
with others that more definitively demonstrate risk.

With respect to the potential cost of additional monitoring for small
systems, particularly if the rule requires viral monitoring, the SBAR
Panel offered several recommendations. First, the Panel suggested that,
to the extent possible, the GWR should build on the existing monitoring
framework in the TCR. Given the low cost of the total coliform test, the
Panel noted that an increase in the frequency and the locations for TCR
monitoring or additional samples in the source water if the system has a
total coliform-positive sample would be preferable given the current
cost of a viral test. However, the Panel also recommended that the EPA
continue to develop a lower cost, more accurate test to identify viral
and bacterial contamination in drinking water.

The GWR does build on the existing TCR monitoring framework by using the
results of the routine TCR monitoring to determine if source water
monitoring is required.  A system is required to test for the presence
of E. coli, coliphage, or enterococci in the source water within 24
hours of a total coliform-positive sample in the distribution system.
Hydrogeologic sensitivity assessments and additional assessment
(routine) monitoring  for sensitive systems were mandatory requirements
under the preferred regulatory alternative in the proposed GWR.  Under
the final rule, assessment monitoring is now optional at the State’s
discretion and HSAs are no longer a regulatory requirement.  HSAs are
considered to be one of several optional tools that States can use to
evaluate systems’ risks.  Making assessment monitoring an optional
State provision provides further flexibility to target only those
systems most at risk for contamination. Also, if a system does not have
a distribution system, any sample taken for TCR compliance is
effectively a source water sample so an additional triggered source
water sample would not be required. In both cases, however, if the
system has an E.coli, coliphage, or fecal coliform positive sample, the
system is required to conduct the necessary follow-up actions.

The SBAR Panel recommended that States be provided with flexibility when
implementing the rule. For example, while States must have the authority
to require the correction of significant deficiencies identified in a
sanitary survey, States should also have the flexibility to determine
which deficiencies are "significant" from a public health perspective.
When a State determines that corrective action is necessary, it should
have the flexibility to determine what actions a system should take,
including but not limited to disinfection. Similarly, States should also
have the flexibility to require disinfection across-the-board for all or
a subset of the public water supply systems in their State.
Additionally, States should also be given the flexibility to choose from
the full range of disinfection technologies that will meet the public
health goals of the rule.

The GWR provides States with considerable flexibility when implementing
the rule. This flexibility will allow States to work effectively within
their existing programs. Similarly, the rule allows States to consider
the characteristics of individual systems when determining an
appropriate corrective action. States have the flexibility to use any
disinfection treatment technology, provided it achieves 4-log
inactivation or removal of pathogens.

Because systems are highly variable the SBAR Panel recommended that
States be given the flexibility to determine appropriate maintenance or
cross connection control measures for each system and to the extent
practicable maintenance measures should be performance based.  EPA
recognizes that systems' characteristics are highly variable. States
have considerable flexibility when working with systems to address
significant deficiencies and take corrective action. Cross connection
control will be considered under future rulemaking efforts.

Significant Alternatives

Because the SBREFA consultation was conducted early in the regulatory
development process before there was a draft proposal, few comments were
received on specific regulatory alternatives. In general, the SERs
supported the approach described in the outreach materials while at the
same time commenting on particular aspects of the approach that might be
burdensome or otherwise problematic. Their concerns echo the comments
received on other parts of the IRFA.

From this perspective, the SBAR Panel reiterated their suggestion that
compliance requirements be tailored to the system size. In particular,
if the minimum monitoring frequency and the frequency for sanitary
surveys for the smallest systems (e.g., those serving less than 500
people) could be reduced, it would reduce both the resources necessary
to comply with the rule and record keeping required by the system.

EPA has structured the GWR as a risk-targeted approach to reducing fecal
contamination. Aside from implementation activities, the only
requirement applicable to all systems is sanitary surveys.  The State
may reduce the frequency of sanitary surveys for CWSs to at least once
every five years if the water system has an outstanding performance
record as determined by the State (e.g., no significant deficiencies
documented in previous assessments and no history of total coliform
maximum contaminant level (MCL) or monitoring violations under the TCR;
the system maintains 4-log treatment of viruses using inactivation,
removal, or State-approved combination of virus inactivation and
removal).  The required frequency for sanitary surveys is once every
five years for noncommunity systems. The majority of the small systems
are noncommunity systems so the majority of systems will only have a
sanitary survey once every five years. At this frequency, EPA believes
that the requirements will not be burdensome for even the smallest
systems.

Similarly, the only additional mandatory monitoring requirements are for
systems that do not treat their source water or treat to <4-log
inactivation or removal of viruses that have a total coliform-positive
routine sample in the distribution system under the TCR. More burdensome
assessment monitoring is optional and expected to be implemented by the
State only for systems that are at the highest risk for fecal
contamination of their ground water sources.

Finally, the SBAR Panel noted that disinfection of public water supplies
may result in an increase in other contaminants of concern, depending on
the characteristics of the source water and the distribution system. Of
particular concern were disinfection byproducts, lead, copper, and
arsenic.  EPA believes that these issues, when they occur, will be very
localized and transitory. However, the Agency considered these risk/risk
tradeoffs in the GWR EA and will provide guidance on how to address
these issues.

Other Comments

The panel could not reach consensus regarding the use of occurrence data
to support the rule. Several panel members expressed the concern that
the occurrence estimates discussed by EPA with the SERs overestimated
the actual occurrence of fecal contamination and the studies used did
not provide a true picture of national occurrence. EPA recognizes and
understands the concerns about the available data expressed by some
panel members. However, the Agency believes, after consulting with
experts in the field, that the available data may underestimate the
extent of ground water contamination because of limitations with
sampling methods and frequency. EPA believes that a central issue for
all participants and stakeholders in this rulemaking is how to interpret
the available data. EPA agrees that the GWR must be based on the best
available data, good science, and sound analysis. The studies described
in the materials presented to the SERs and SBAR Panel during the SBREFA
process were conducted at different times and for different reasons;
each requires careful analysis to ensure its proper use and to avoid
misuse.

2.2  Modifications Made to the Final GWR Regulatory Alternative
(Risk-Targeted Approach)

	 Based on Public Comments to the IRFA

  SEQ CHAPTER \h \r 1 	 

On May 10, 2000 EPA published the proposed GWR in the Federal Register. 
EPA proposed the multi-barrier approach described in Section I.1 as the
preferred option, and requested comment upon a number of other issues
including  EPA’s  Initial Regulatory Flexibility Analysis (IRFA) for
the Proposed Ground Water Rule.   Following publication of the proposed
GWR, EPA accepted public comments for 90 days.  EPA received
approximately 3,300 comments from over 250 individuals representing a
wide range of stakeholders, including public water systems, States,
Tribes, other organizations, and private citizens.  Each comment was
read and considered as part of the process for selecting and, where
appropriate, modifying the final GWR regulatory alternative.  A record
of every comment received on the proposal, as well as EPA’s response
to each, can be found in the Public Comment and Response Summary for the
Final Ground Water Rule (USEPA, 2006a).  Copies of individual comments
are also available as part of the public record and can be accessed
through the EPA’s Water Docket.

Many comments addressing the IRFA for the proposed GWR generally stated
concern over the impacts upon small water systems.  . Two significant
issues were raised in comments on the IRFA for the proposed rule.  First
several commentors wrote that small water systems lack the customer base
to defray the costs of installing new treatment, or the costs of the a
new source.    The second significant issue raised in comments on the
IRFA was a recommendation that EPA allow States flexibility to consider
competing fiscal impacts on small systems when implementing the rule.

	After considering the public comments, EPA re-evaluated the assumptions
and data underlying the GWR proposal.  This process led to the selection
of the risk-targeted approach (the second option described in Section
I.I, with slight modifications from the proposal,) as the final
regulatory approach. The selection of the risk-targeted approach
represents a significant reduction in burden from the proposed 
multi-barrier approach. Modifications to the risk-targeted approach as
described in the GWR proposal resulted in even further reduction in
burden for small systems.  These modifications also increased
flexibility to States to determine the most appropriate actions to
identify and address risks of microbial contamination in ground water
systems.  Key modifications from the proposed rule to the final GWR that
reduced burden to small water systems and increased State flexibility
include:

A change in the requirements for performing assessment monitoring to
make it an optional activity at the State’s discretion.

HSAs are not part of the regulatory framework. They are still considered
to be a useful tool that States can employ when evaluating a system’s
risk for contamination and trying to determine whether to require
assessment monitoring.

A change in the triggered monitoring requirements for certain small
systems was made in the final GWR, thus further reducing the burden to
some small systems.  For systems serving 1,000 people or fewer, a repeat
sample collected from a ground water source to meet the requirements of
the TCR will satisfy the triggered ground water source monitoring
requirements of this section for that ground water source if the State
approves the use of E. coli as a fecal indicator for source water
monitoring.



EPA believes these modifications will reduce the burden upon small
systems and provide flexibility to States and systems to undertake
targeted actions to identify and address microbial risks in ground water
systems.  EPA recognizes the challenges small systems face in defraying
the costs of modifications such as treatment or new sources.  This final
rule provides flexibility to States to work with the system to undertake
the most appropriate corrective actions to address microbial risks.  EPA
also notes that financial assistance is available to small systems
through programs such as the Drinking Water State Revolving Fund, the
Loan and Grant program of the U.S. Department of Agriculture’s Rural
Utilities Services (RUS) and the Community Development Block Grant
Program of the Department of Housing, A description of all final
regulatory requirements under the final GWR risk-targeted approach is
presented in Chapter 3 of the GWR EA.  



3 	Number of Small Entities Affected

According to the December 2003 data from EPA's Safe Drinking Water
Information System (SDWIS), there are 147,330 community water systems
(CWSs) and non-community water supplies providing potable ground water
to the public, of which 145,580 (99 percent) are classified by EPA as
small entities. EPA estimates that these small ground water systems
serve a population of more than 47 million.  Twenty eight percent of
these systems are estimated to be CWSs serving fixed populations on a
year-round basis.

Under the final GWR, all community and non-community water systems are
affected by at least one requirement; the sanitary survey provision. The
other GWR components are estimated to affect different numbers of
systems. Exhibit 2 shows the estimates of the number of small public and
private systems affected by each component of the final GWR.

4 	Small Entity Impacts

4.1 Reporting and Recordkeeping for the Final GWR

Under the final GWR, there are a number of recordkeeping and reporting
requirements for all ground water systems (including small systems). To
minimize the burden with these provisions, the EPA is implementing a
risk-targeted regulatory strategy for the GWR whereby the monitoring
requirements are based on system characteristics and circumstances and
are not directly related to system size. In this manner, the
risk-targeted approach takes a system-specific approach to regulation,
although a sanitary survey is required of all water systems. However,
the implementation schedule for this requirement is staggered (e.g.,
every three to five years for CWSs and every five years for NCWSs),
which should provide some relief for small systems because there are
proportionately more NCWSs classified as small systems.

To address the commentors concerns regarding the burden upon small water
systems and SBAR’s concern for the potential cost of additional
monitoring for small systems, the final GWR leverages the existing TCR
monitoring framework to the extent possible (e.g., by using the results
of the routine TCR monitoring to determine if source water monitoring is
required).  Under the final GWR systems are required to test for the
presence of E.coli, coliphage, or enterococci in the source water within
24 hours of a total coliform-positive sample in the distribution system.

Under the final rule, assessment monitoring is now optional at the
State’s discretion and HSAs are no longer a regulatory requirement. 
HSAs are considered to be one of several optional tools that States can
use to evaluate systems’ risks.  Making assessment monitoring an
optional State provision provides further flexibility to target only
those systems most at risk for contamination.

 Estimate of the Classes of Small Entities Subject to the GWR

The RFA provides default definitions for each type of small entity. It
also authorizes an agency to use alternative definitions for each
category of small entity, "which are appropriate to the activities of
the agency" after proposing the alternative definition(s) in the Federal
Register and taking comment 5 U.S.C. secs. 601(3) - (5). In addition to
the above, to establish an alternative small business definition,
agencies must consult with SBA's Chief Counsel for Advocacy.

For purposes of assessing the impacts of the GWR on small entities, EPA
considers small entities to be PWSs serving fewer than 10,000 people. 
This is the cut-off level specified by Congress in the 1996 Amendments
to the Safe Drinking Water Act for small system flexibility provisions. 
As required by this RFA, EPA proposed using this alternative definition
in the Federal Register (63 FR 7620; February 13, 1998), requested
public comment, consulted with the SBA, and finalized the alternative
definition for all future drinking water regulations in the Consumer
Confidence Reports regulation (63 FR 44511; August 19, 1998).

 Estimate of the Professional Skills Necessary for Preparation of Report
or Record

Section 1420(d)(3) of the SDWA, as amended, requires that, in
promulgating a NPDWR, the Administrator shall include an analysis of the
likely effect of compliance with the regulation on the technical,
managerial, and financial (TMF) capacity of PWSs.  The following
analysis fulfills this statutory obligation by identifying the
incremental impact that the GWR will have on the TMF of regulated water
systems.  This analysis reflects only the impact of new or revised
requirements, as established by the GWR; the impacts of previously
established requirements on system capacity are not considered.

Overall water system capacity is defined in Guidance on Implementing the
Capacity Development Provisions of the Safe Drinking Water Act
Amendments of 1996 (USEPA 1998a) as the ability to plan for, achieve,
and maintain compliance with applicable drinking water standards. 
Capacity encompasses three components: technical, managerial, and
financial.  Technical capacity is the operational ability of a water
system to meet those SDWA requirements. Managerial capacity is the
ability of a water system’s managers to make financial, operating, and
staffing decisions that enable the system to achieve and maintain
compliance with SDWA requirements.   Financial capacity is a water
system’s ability to acquire and manage sufficient financial resources
to allow the system to achieve and maintain compliance with SDWA
requirements. 

  

  SEQ CHAPTER \h \r 1 Small systems will likely face only a minimal
challenge to their technical and managerial capacity as a result of
efforts to familiarize themselves with the GWR and aid the State in
conducting sanitary surveys.  Total coliform sampling is already
required under the TCR and, therefore, it is not expected to pose any
new technical or managerial capacity issues for systems.  EPA estimates
that PWSs serving fewer than 10,000 people (i.e., all small systems)
will only need to take an average of between 0 and 3 triggered samples a
year, and small systems serving fewer than 1,000 people will be able to
use one of their required TCR repeat samples to satisfy assessment
monitoring requirements, eliminating any extra burden or cost. 

	Assessment monitoring for E. coli, enterococci, or coliphage, if
required by the State, is expected to have a greater impact on the
technical and managerial capacity of small systems than the triggered
monitoring requirements.  However, as with triggered monitoring, the
types of sampling required are not new to systems, although some system
operators may need additional training to understand the rule-specific
monitoring requirements.  

	Small system technical and managerial capacity may be affected by
requirements to monitor the effectiveness and reliability of their
disinfection or removal, especially systems not currently using
disinfection.  Ground water systems serving 3,300 people or fewer and
using disinfection can conduct daily grab samples to measure
disinfection levels instead of installing more costly continuous
monitoring equipment.  However, this may also require the system to
increase staffing levels in addition to providing training to ensure
that system staff understands the compliance monitoring requirements. 
Reporting, record-keeping, and data administration requirements will
also affect the managerial capacity of small systems.  

Small systems that are required to take corrective action are expected
to experience the most significant financial challenge since many
corrective actions consist of a large, one-time capital expenditure to
resolve the problem.  Changes in treatment may also significantly impact
the managerial and technical capacity of the system.



	5 Minimization of Economic Burden on Small Systems

	From the beginning of the rulemaking process, EPA has actively sought
out public comments on the GWR, and has made efforts to incorporate
flexibility in the requirements of the GWR to specifically minimize the
economic burden on small systems.  Sections 5.1 and 5.2 summarize
EPA’s efforts to minimize economic burden to small systems.

		5.1   Small Entity Outreach and Small Business Advocacy Review Panel

As required by section 609(b) of the RFA, as amended by SBREFA, EPA also
conducted outreach to small entities and convened a Small Business
Advocacy Review (SBAR) Panel to obtain advice and recommendations of
representatives of the small entities that potentially would be subject
to the rule's requirements. The SBAR Panel members for the GWR were the
Small Business Advocacy Chair of the Environmental Protection Agency,
the Director of the Standards and Risk Management Division in the Office
of Ground Water and Drinking Water (OGWDW) within EPA's Office of Water,
the Administrator for the Office of Information and Regulatory Affairs
of the Office of Management and Budget (OMB), and the Chief Counsel for
Advocacy of the SBA. The Panel convened on April 10, 1998 and met seven
times before the end of the 60-day period on June 8, 1998. The SBAR
Panel's report Final Report of the SBREFA Small Business Advocacy Review
Panel on EPA's Planned Proposed Rule for National Primary Drinking Water
Regulations: Ground Water, the SERs comments on components of the GWR,
and the background information provided to the SBAR Panel and the SERs
are available for review in the water docket.

Prior to convening the SBAR Panel, OGWDW consulted with a group of 22
SERs likely to be impacted by a GWR. The SERs included small system
operators, local government officials, small business owners (e.g., a
bed and breakfast with its own water supply), and small nonprofit
organizations (e.g., a church with its own water supply for the
congregation). The SERs were provided with background information on the
rule, on the need for the rule and the potential requirements. The SERs
were asked to provide input on the potential impacts of the rule from
their perspective. All 22 SERs commented on the information provided in
the IRFA. These comments were provided to the SBAR Panel when the Panel
convened. After a teleconference between the SERs and the Panel, the
SERs were invited to provide additional comments on the information
provided. Three SERs provided additional comments on the rule components
after the teleconference.

In general, the SERs consulted on the GWR were concerned about the
impact of the rule on small water systems (because of their small staff
and limited budgets), the additional monitoring that might be required,
and the data and resources necessary to conduct a hydrogeologic
sensitivity assessment or sanitary survey. A summary of the Panel's
recommendations to address the SER’s GWR concerns, as well as The
Agency's response to these concerns, are described in Section 2 of this
document.

 Economic Burden on Small Systems

On an annual basis, the cost of the final rule ranges from $61.8 million
to $62.3 million, using a three and seven percent discount rate.  System
costs make up 81 percent of the total rule costs. As described in
Section 5.1, in developing the GWR, EPA considered the recommendations
of the SBAR to minimize the cost impact to small systems. The
risk-targeted approach was designed to achieve maximum public health
protection while avoiding excessive compliance costs associated with
across-the-board disinfection regulatory compliance requirements.

To mitigate the associated compliance cost increases across water
systems, the GWR also provides States with considerable flexibility when
implementing the rule. This flexibility, recommended also by the SBAR,
will allow States to work more effectively within their existing
program.  Similarly, the rule allows States to consider the
characteristics and circumstances of individual systems when determining
an appropriate corrective action. For example, States have the
flexibility to allow systems to obtain a new source, or use any
disinfection treatment technology, provided it achieves 4-log treatment
of viruses using inactivation, removal, or State approved combination of
these technologies before or at the first customer.

To determine the costs and benefits of the final Rule, EPA considered
the full range of potential costs and benefits for the rule. The
flexibility in the rule is designed to reduce the cost of compliance
with the rule, particularly for small systems. While determining the
costs of the various technologies, EPA estimated the percentage of
systems in consultation with the States that will choose between the
different technologies, in part based on system size. EPA also
considered a range of benefits from reduction in illness and mortality
to avoided outbreak costs and possibly, reduced uncertainty and averting
behavior. However, only reductions in acute viral illnesses and
mortality from virus are monetized.  Depending on the discount rate and
cost of illness (COI) used the annual average monetized benefits of the
risk-targeted approach ranges between $8.6 million and $19.7 million.
More detailed cost and benefit information can be found in the final GWR
EA, which is available for review in the water docket.

EPA further recognized that the operational characteristics of water
systems are highly variable. In the GWR, States have considerable
flexibility when working with systems to address significant
deficiencies and take corrective action.

Statement of Factual, Policy, and Legal Reasons for Choosing the
Risk-Targeted Approach

EPA is issuing this final rule to comply with Section 1412(b)(8) of the
Safe Drinking Water Act, which directs EPA to “promulgate national
primary water regulations requiring disinfection as treatment technique
for all public water systems, including surface water systems and, as
necessary, ground water systems.”  EPA selected the Risk-Targeted
approach because it a cost effective approach for reducing the risk of
fecal contamination reaching people consuming water from ground water
systems. EPA also selected the Risk Targeted alternative because it is
more flexible, targeted and protective.   

  

Reasoning Behind Choosing the Risk-Targeted Approach as the Preferred
Alternative

  SEQ CHAPTER \h \r 1 The nonquantified benefits of this rule are large
and support the basis for selecting the risk-targeted approach over
other alternatives. Thus, the usual economic tests used to establish
that the final rule passes key threshold economic criteria and compares
favorably to other rule alternatives must be interpreted with care. A
detailed comparison of the quantified benefits and costs of each
regulatory alternative is presented in Chapter 8 of the GWR EA.  

	The GWR is cost-effective no other alternative achieves greater
benefits at the same cost or the same benefits at lower cost.   SEQ
CHAPTER \h \r 1 The economic analysis for this rule, considering
quantified and nonquantified benefits, supports the basis for selecting
the final GWR over other alternatives.  However, the distinction between
Alternative 2 and 3 on an economic basis, is not great.  

	

		EPA chose the final GWR because EPA believes it is more flexible,
targeted, and cost-effectively protective than Alternative 3.  Optional
assessment monitoring allows States to most effectsystems at greatest
risk and minimize unnecessary monitoring.  EPA took the following
considerations into account in making this judgment:

						

	1)  	Under Alternative 3, some States may not be able to conduct HSAs
and thereby require systems in nonsensitive aquifers to conduct
assessment monitoring unnecessarily. For systems not at risk this
additional monitoring would provide no benefit.

 

	2)  	Systems with frequent TC positives in the distributions system
(and subsequent frequent triggered monitoring) would benefit little from
assessment monitoring regardless if they were sensitive or not because
the source water would already be thoroughly evaluated.  Under
Alternative 3, such systems in sensitive (or undetermined) aquifers
would be required to do assessment monitoring.

 

	3) 	Systems identified as having significant risk factors pertaining to
potential fecal contamination at their source (e.g., aquifer condition,
well characteristics, proximity to sewage or septic), but infrequent
triggered monitoring source water samples, would benefit from assessment
monitoring.  States will be able to identify such systems on an ongoing
basis through a variety of tools and information readily available to
them.

	

	As a result of all of these considerations, EPA has determined that the
final GWR will provide important protection against illnesses and deaths
attributable to fecally contaminated ground water. EPA also believes
that the GWR will provide a desired level of protection from ground
water pathogen contamination at a justifiable cost.

 The terminology describing this rule component was changed. In the
proposal, assessment monitoring was referred to as “routine
monitoring.”

 PAGE   16 

Final Regulatory Flexibility Analysis							October 2006

 for the Final Ground Water Rule

