expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9. In addition, EPA is
amending the table in 40 CFR part 9 of currently approved OMB control
numbers for various regulations to list the regulatory citations for
the information requirements contained in this final rule.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis for any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    The RFA provides default definitions for each type of small entity.
Small entities are defined as: (1) a small business as defined by the
Small Business Administrations's (SBA) regulations at 13 CFR 121.201;
(2) a small governmental jurisdiction that is a government of a city,
county, town, school district or special district with a population of
less than 50,000; and (3) a small organization that is any ``not-for-
profit enterprise which is independently owned and operated and is not
dominant in its field.'' However, the RFA also authorizes an agency to
use alternative definitions for each category of small entity, ``which
are appropriate to the activities of the agency'' after proposing the
alternative definition(s) in the Federal Register and taking comment. 5
U.S.C. 601(3)-(5). In addition, to establish an alternative small
business definition, agencies must consult with SBA's Chief Counsel for
Advocacy.
    For purposes of assessing the impacts of today's rule on small
entities, EPA considered small entities to be public water systems
serving 10,000 or fewer persons. As required by the RFA, EPA proposed
using this alternative definition in the Federal Register (63 FR 7620,
February 13, 1998), requested public comment, consulted with the Small
Business Administration (SBA), and finalized the alternative definition
in the Consumer Confidence Reports regulation (63 FR 44511, August 19,
1998). As stated in that Final Rule, the alternative definition is
applied to this regulation as well.

    After considering the economic impacts of today's final rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. The small
entities directly regulated by this final rule are PWSs serving fewer
than 10,000 people. We have determined that 152 of the 6,574 small
PWSs, or 2.3 percent, regulated by the LT2ESWTR will experience an
impact of 1 percent or greater of average annual revenues; further, 18
PWSs, which are 0.3 percent of the small PWSs regulated by this rule,
will experience an impact of 3 percent or greater of average annual
revenues (see Table VII.C-1).

                            Table VII.C-1.--Annualized Compliance Cost as a Percentage of Revenues for Small Entities (2003$)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average     Systems experiencing      Systems experiencing
                                                                                annual     costs of >=1% of their    costs of >=3% of their
                                                                Number of    Percent of   estimated           revenues                  revenues
            PWSs by ownership type and system size                small        small       revenues  ---------------------------------------------------
                                                                 systems      systems        per       Number of    Percent of   Number of    Percent of
                                                                                system($)     systems      systems      systems      systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         A            B            C        D=A*E            E        F=A*G            G
--------------------------------------------------------------
Small Government PWSs........................................        2,827           43    2,649,186           65          2.3            8          0.3
Small Business PWSs..........................................        2,452           37    2,555,888           57          2.3            7          0.3
Small Organization PWSs......................................        1,295           20    4,750,838            5          0.4            2          0.1
                                                              --------------
    All Small Entity PWSs....................................        6,574          100    2,981,331          152          2.3           18         0.3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Detail may not add due to independent rounding. Data are based on the means of the highest modeled distributions using Information Collection Rule
  occurrence data set. Costs are discounted at 3 percent, summed to present value, and annualized over 25 years. Source: Chapter 7 and Appendix H of the
  LT2ESWTR EA (USEPA 2005a).

    Although this final rule will not have a significant economic
impact on a substantial number of small entities, EPA nonetheless has
tried to reduce the impact of this rule on small entities. The LT2ESWTR
contains a number of provisions to minimize the impact of the rule on
PWSs generally, and on small PWSs in particular. The risk-targeted
approach of the LT2ESWTR will impose additional treatment requirements
only on the subset of PWSs with the highest vulnerability to
Cryptosporidium, as indicated by source water pathogen levels. This
approach will spare the majority of PWSs from the cost of installing
additional treatment. Also, development of the microbial toolbox under
the LT2ESWTR will provide both large and small PWSs with broad
flexibility in selecting cost-effective compliance options to meet
additional treatment requirements.
    Small PWSs will monitor for E. coli as a screening analysis for
source waters with low levels of fecal contamination. Cryptosporidium
monitoring will only be required of small PWSs if they exceed the E.
coli trigger value. Because E. coli analysis is much cheaper than
Cryptosporidium analysis, the use of E. coli as a screen will
significantly reduce monitoring costs for the majority of small PWSs.
Further, small PWSs will not be required to initiate their monitoring
until large PWS monitoring has been completed. This will provide small
PWSs with additional time to become familiar with the rule and to
prepare for monitoring and other compliance activities.
    Funding may be available from programs administered by EPA and
other Federal agencies to assist small PWSs in complying with the
LT2ESWTR. The Drinking Water State Revolving Fund (DWSRF) assists PWSs
with financing the costs of infrastructure needed to achieve or
maintain compliance with SDWA requirements. Through the DWSRF, EPA
awards capitalization grants to States, which in turn can provide low-
cost loans and other types of assistance to eligible PWSs. Loans made
under the program can have interest rates between 0 percent and market
rate and repayment terms of up to 20 years. States prioritize funding
based on projects that address the most serious risks to human health
and assist PWSs most in need. Congress provided $1.275 billion for the
DWSRF program in fiscal year 1997, and has provided an additional
$4.113 billion for the DWSRF program for fiscal years 1999 through
2003.
    The DWSRF places an emphasis on small and disadvantaged
communities. States must provide a minimum of 15% of the available
funds for loans to small communities. A State has the option of
providing up to 30% of the grant awarded to the State to furnish
additional assistance to State-defined disadvantaged communities. This
assistance can take the form of lower interest rates, principal
forgiveness, or negative interest rate loans. The State may also extend
repayment terms of loans for disadvantaged communities to up to 30
years. A State can set aside up to 2% of the grant to provide technical
assistance to PWSs serving communities with populations fewer than
10,000.
    In addition to the DWSRF, money is available from the Department of
Agriculture's Rural Utility Service (RUS) and Housing and Urban
Development's Community Development Block Grant (CDBG) program. RUS
provides loans, guaranteed loans, and grants to improve, repair, or
construct water supply and distribution systems in rural areas and
towns of up to 10,000 people. In fiscal year 2003, RUS had over $1.5
billion of available funds for water and environmental programs. The
CDBG program includes direct grants to States, which in turn are
awarded to smaller communities, rural areas, and colo[ntilde]as in
Arizona, California, New Mexico, and Texas and direct grants to U.S.
territories and trusts. The CDBG budget for fiscal year 2003 totaled
over $4.4 billion.
    Although not required by the RFA to convene a Small Business
Advocacy Review (SBAR) Panel because EPA determined that the proposed
rule would not have a significant economic impact on a substantial
number of small entities, EPA did convene a panel to obtain advice and
recommendations from representatives of the small entities potentially
subject to this rule's requirements. For a description of the SBAR
Panel and stakeholder recommendations, please see the proposed rule
(USEPA 2003a).

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local,

and Tribal governments and the private sector. Under section 202 of the
UMRA, EPA generally must prepare a written statement, including a cost-
benefit analysis, for proposed and final rules with ``Federal
mandates'' that may result in expenditures to State, local and Tribal
governments, in the aggregate, or to the private sector, of $100
million or more in any one year. Before promulgating an EPA rule for
which a written statement is needed, section 205 of the UMRA generally
requires EPA to identify and consider a reasonable number of regulatory
alternatives and adopt the least costly, most cost-effective or least
burdensome alternative that achieves the objectives of the rule. The
provisions of section 205 do not apply when they are inconsistent with
applicable law. Moreover, section 205 allows EPA to adopt an
alternative other than the least costly, most cost-effective or least
burdensome alternative if the Administrator publishes with the final
rule an explanation why that alternative was not adopted.
    Before EPA establishes any regulatory requirements that may
significantly or uniquely affect small governments, including Tribal
governments, it must have developed under section 203 of the UMRA a
small government agency plan. The plan must provide for notifying
potentially affected small governments, enabling officials of affected
small governments to have meaningful and timely input in the
development of EPA regulatory proposals with significant Federal
intergovernmental mandates, and informing, educating, and advising
small governments on compliance with the regulatory requirements.
    EPA has determined that this rule contains a Federal mandate that
may result in expenditures of $100 million or more for State, local,
and Tribal governments, in the aggregate, or the private sector in any
one year. Accordingly, EPA has prepared under section 202 of the UMRA a
written statement which is summarized below.
    Table VII.D-1 illustrates the annualized public and private costs
for the LT2ESWTR.
[GRAPHIC] [TIFF OMITTED] TR05JA06.017

    A more detailed description of this analysis is presented in
Economic Analysis for the LT2ESWTR (USEPA 2005a).
    As noted in section III, today's final rule is promulgated pursuant
to section 1412 (b)(1)(A) of the Safe Drinking Water Act (SDWA), as
amended in 1996, which directs EPA to promulgate a national primary
drinking water regulation for a contaminant if EPA determines that the
contaminant may have an adverse effect on the health of persons, occurs
in PWSs with a frequency and at levels of public health concern, and
regulation presents a meaningful opportunity for health risk reduction.
    Section VI of this preamble discusses the cost and benefits
associated with the LT2ESWTR. Details are presented in the Economic
Analysis for the LT2ESTWR (USEPA 2005a). EPA quantified costs and
benefits for four regulatory alternatives. The four alternatives are
described in section VI. Table VII.D-2 summarizes the range of annual
costs and benefits for each alternative.

[GRAPHIC] [TIFF OMITTED] TR05JA06.018

    To meet the UMRA requirement in section 202, EPA analyzed future
compliance costs and possible disproportionate budgetary effects. The
Agency believes that the cost estimates, indicated earlier and
discussed in more detail in section VI of this preamble, accurately
characterize future compliance costs of today's rule.
    In analyzing disproportionate impacts, EPA considered the impact on
(1) different regions of the United States, (2) State, local, and
Tribal governments, (3) urban, rural and other types of communities,
and (4) any segment of the private sector. This analysis is presented
in Chapter 7 of Economic Analysis for the LT2ESWTR (USEPA 2005a).
    EPA has concluded that the LT2ESWTR will not cause a
disproportionate budgetary effect. This rule imposes the same
requirements on PWSs nationally and does not disproportionately affect
any segment. This rule will treat similarly situated PWSs (in terms of
size, water quality, available data, installed technology, and presence
of uncovered finished storage facilities) in similar (proportionate)
ways, without regard to geographic location, type of community, or
segment of industry. The LT2ESWTR is a rule where requirements are
proportionate to risk. Although some groups may have differing
budgetary effects as a result of the LT2ESWTR, those costs are
proportional to the need for greater information (monitoring) and risk
posed (degree of treatment required). The variation in cost between
large and small PWSs is due to economies of scale (a larger PWS can
distribute cost across more customers). Regions will have varying
impacts due to the number of affected PWSs.
    Under UMRA section 202, EPA is required to estimate the potential
macro-economic effects of the regulation. These types of effects
include those on productivity, economic growth, full employment,
creation of productive jobs, and international competitiveness. Macro-
economic effects tend to be measurable in nationwide econometric models
only if the economic impact of the regulation reaches 0.25 percent to
0.5 percent of Gross Domestic Product (GDP). In 2003, real GDP was
$10,398 billion, so a rule would have to cost at least $26 billion to
have a measurable effect. A regulation with a smaller aggregate effect
is unlikely to have any measurable impact unless it is highly focused
on a particular geographic region or economic sector.
    The macro-economic effects on the national economy from the
LT2ESWTR should not have a measurable effect because the total annual
costs for today's rule range from $93 million to $133 million based on
median Cryptosporidium occurrence distributions from the ICRSSL and
Information Collection Rule data sets and a discount rate of 3 percent
($107 to $150 million at a 7 percent discount rate). These annualized
figures will remain constant over the 25-year implementation period
that was evaluated, while GDP will probably continue to rise. Thus, the
LT2ESWTR costs as a percentage of the national GDP will only decline
over time. Costs will not be highly focused on a particular geographic
region or sector.
    Consistent with the intergovernmental consultation provisions of
section 204 of the UMRA, EPA initiated consultations with the
governmental entities affected by this rule prior to the proposal. A
description of the consultations is found in the proposed rule (USEPA
2003a).
    As required under section 205 of UMRA, EPA considered several
regulatory alternatives to address PWSs at risk for contamination by
microbial pathogens, specifically including Cryptosporidium. A detailed
discussion of these alternatives can be found in section VI of the
preamble and also in the Economic Analysis for the LT2ESWTR (USEPA
2005a).
    Among the regulatory alternatives considered for the LT2ESWTR, as
described in section VI, EPA believes the alternative in today's rule
is the most cost-effective that achieves the objectives of the rule.
The objective of the LT2ESWTR is to achieve feasible risk reduction
from Cryptosporidium and other pathogens in vulnerable PWSs where
current regulations do not provide sufficient protection.
    EPA evaluated a less costly and less burdensome alternative.
However, that alternative would provide no benefit to several thousand
consumers who, under the alternative in today's final rule, will
receive benefits that most likely exceed their costs, based on EPA
estimates. This is illustrated in the LT2ESWTR Economic Analysis (USEPA
2005a). By failing to reduce risk for consumers where additional
treatment requirements would be cost-effective, the less costly
alternative does not appear to achieve the objectives of the LT2ESWTR.
    The other alternatives considered by the Agency achieve the
objectives of the rule, but are more costly, more burdensome, and
potentially less cost-effective. The alternative in today's rule
targets additional treatment requirements to PWSs with the highest
vulnerability to Cryptosporidium and maximizes net benefits under a
broad range of conditions (USEPA 2005a). Consequently, EPA has found
the alternative in today's rule to be the most cost-effective among
those that achieve the objectives of the rule.
    EPA has determined that this rule contains no regulatory
requirements that might significantly or uniquely affect small
governments. Thus, today's rule is not subject to the requirements of
section 203 of UMRA. As described in section VII.C, EPA has certified
that today's rule will not have a significant economic impact on a
substantial number of small entities. Average annual expenditures for
small PWSs to comply with the LT2ESWTR range from

$8.1 to $13.4 million at a 3% discount rate and $8.3 to $13.5 million
at a 7% discount rate. While the treatment requirements of the LT2ESWTR
apply uniformly to both small and large PWSs, large PWSs bear a
majority of the total costs of compliance with the rule. This is due to
the fact that large PWSs treat a majority of the drinking water that
originates from surface water sources.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
    Under Executive Order 13132, EPA may not issue a regulation that
has federalism implications, that imposes substantial direct compliance
costs, and that is not required by statute, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by State and local governments, or EPA consults with
State and local officials early in the process of developing the
regulation.
    EPA has concluded that this final rule may have federalism
implications, because it may impose substantial direct compliance costs
on State or local governments, and the Federal government will not
provide the funds necessary to pay those costs. The final rule may
result in expenditures by State, local, and Tribal governments, in the
aggregate of $100 million or more in any one year. Costs are estimated
to range from $93 to $133 million at a 3 percent discount rate and $107
to $150 million using a 7 percent discount rate based on the median
distribution modeled from ICRSSL and Information Collection Rule
Cryptosporidium occurrence data sets. Accordingly, EPA provides the
following federalism summary impact statement as required by section
6(b) of Executive Order 13132.
    EPA consulted with representatives of State and local officials
early in the process of developing today's rule to permit them to have
meaningful and timely input into its development. As described in the
proposed rule (USEPA 2003a), this consultation included State and local
government representatives on the Stage 2 M-DBP Federal Advisory
Committee (whose recommendations were largely adopted in today's rule),
the representatives from small local governments to the SBAR panel, a
meeting with representatives from the Association of State Drinking
Water Administrators, the National Governors' Association, the National
Conference of State Legislatures, the International City/County
Management Association, the National League of Cities, the County
Executives of America, and health departments, consultation with Tribal
governments at four meetings and through the Advisory Committee
process, and comments from State and local governments on a pre-
proposal draft of the LT2ESWTR.
    Representatives of State and local officials were generally
concerned with ensuring that drinking water regulations are adequately
protective of public health and that any additional regulations achieve
significant health benefits in return for required expenditures. They
were specifically concerned with the burden of the rule, both in cost
and technical complexity, giving flexibility to PWSs and States,
balancing the control of microbial risks and DBP risks, funding for
implementing new regulations, equal protection for small PWSs, and
early implementation of monitoring by large PWSs.
    EPA has concluded that the LT2ESWTR is needed to reduce the public
health risk associated with Cryptosporidium in drinking water. As shown
in section VI, estimated benefits for the rule are significantly higher
than costs. Further, EPA believes that today's rule addresses many of
the concerns expressed by representatives of government officials.
    Under the LT2ESWTR, expenditures for additional treatment are
targeted to the fraction of PWSs with the highest vulnerability to
Cryptosporidium, thereby minimizing burden for the majority of PWSs,
which will not be required to provide additional treatment. The
microbial toolbox of compliance options will provide flexibility to
PWSs in meeting additional treatment requirements, and States have the
flexibility to award treatment credits based on site-specific
demonstrations. Disinfection profiling provisions are intended to
ensure that PWSs do not reduce microbial protection as they take steps
to reduce exposures to DBPs.
    The LT2ESWTR achieves equal public health protection for small
PWSs. However, the use of E. coli monitoring by small PWSs as a
screening analysis to determine the need for Cryptosporidium monitoring
will reduce monitoring costs for most small PWSs. Capital projects
related to the rule will be eligible for funding from the Drinking
Water State Revolving Fund, which includes specific funding for small
communities. EPA is planning to support the initial monitoring by large
PWSs that takes place within the first few years after rule
promulgation. This will substantially reduce the burden on States
associated with early implementation of monitoring requirements.
    In the spirit of Executive Order 13132, and consistent with EPA
policy to promote communications between EPA and State and local
governments, EPA specifically solicited comment on the proposed rule
from State and local officials.
    As required by section 8(a) of Executive Order 13132, EPA included
a certification from its Federalism Official stating that EPA had met
the Executive Order's requirements in a meaningful and timely manner,
when it sent the draft of this final rule to OMB for review pursuant to
Executive Order 12866. A copy of this certification has been included
in the public version of the official record for this final rule.

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

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop ``an accountable process to ensure meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' Under Executive Order 13175,
EPA may not issue a regulation that has Tribal implications, that
imposes substantial direct compliance costs, and that is not required
by statute, unless the Federal government provides the funds necessary
to pay the direct compliance costs incurred by Tribal governments, or
EPA consults with Tribal officials early in the process of developing
the proposed regulation and develops a Tribal summary impact statement.
    EPA has concluded that this final rule may have Tribal
implications, because it may impose substantial direct compliance costs
on Tribal governments, and the Federal government will not provide the
funds necessary to pay those costs. EPA has identified 93 Tribal water
systems serving a total population of 82,216 that may be subject to the
LT2ESWTR. They will bear an estimated total annualized cost of $207,105
at a 3 percent discount rate ($309,583 at 7 percent) to

implement this rule. Estimated mean annualized cost per system ranges
from $1,944 to $7,068 at a 3 percent discount rate ($2,905 to $10,681
at 7 percent) depending on PWS size (see Chapter 7 of the LT2ESWTR
Economic Analysis (USEPA 2005a) for details). Accordingly, EPA provides
the following Tribal summary impact statement as required by section
5(b).
    EPA consulted with Tribal officials early in the process of
developing this regulation to permit them to have meaningful and timely
input into its development. This consultation is described in the
proposed rule (USEPA 2003a). Tribal officials were represented on the
M-DBP Advisory Committee.
    As required by section 7(a), EPA's Tribal Consultation Official has
certified that the requirements of the Executive Order have been met in
a meaningful and timely manner. A copy of this certification is
included in the docket for this rule.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    Executive Order 13045: ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that: (1) is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
    This final rule is subject to the Executive Order because it is an
economically significant regulatory action as defined in Executive
Order 12866, and we believe that the environmental health or safety
risk addressed by this action may have a disproportionate effect on
children. Accordingly, we have evaluated the environmental health or
safety effects of Cryptosporidium on children. The results of this
evaluation are contained in Cryptosporidium: Risk for Infants and
Children (USEPA 2001d), which is available in the public docket for
this action, and are summarized in this section of the preamble.
Further, while available information is not adequate to conduct a
quantitative risk assessment specifically for children, EPA has
assessed the risk associated with Cryptosporidium in drinking water for
the general population, including children. This assessment is
described in the Economic Analysis for the LT2ESWTR (USEPA 2005a) and
is summarized in section VI of this preamble.

Children's Environmental Health

    Cryptosporidiosis in children is similar to adult disease (USEPA
2001d). Diarrhea is the most common symptom. Other common symptoms in
otherwise healthy (i.e., immunocompetent) children include anorexia,
vomiting, abdominal pain, fever, dehydration and weight loss.
    The risk of illness and death due to cryptosporidiosis depends on
several factors, including age, nutrition, exposure, genetic
variability, disease and the immune status of the individual. Mortality
resulting from diarrhea generally occurs at a greater rate among the
very young and elderly (Gerba et al., 1996). During the 1993 Milwaukee
drinking water outbreak, associated mortalities in children were
reported. Also, children with laboratory-confirmed cryptosporidiosis
were more likely to have an underlying disease that altered their
immune status (Cicirello et al., 1997). In that study, the observed
association between increasing age of children and increased numbers of
laboratory-confirmed cryptosporidiosis suggested to the authors that
the data are consistent with increased tap water consumption of older
children. Asymptomatic infection can have a substantial effect on
childhood growth (Bern et al., 2002).
    Cryptosporidiosis appears to be more prevalent in populations, such
as children, that may not have established immunity against the disease
and may be in greater contact with environmentally contaminated
surfaces (DuPont et al., 1995). In the United States, children aged one
to four years are more likely than adults to have the disease. The most
recent reported data on cryptosporidiosis shows the occurrence rate
(for the year 1999) is higher in children ages one to four (3.03
incidence rate per 100,000) than in any adult age group (CDC, 2001).
Evidence from blood sera antibodies collected from children during the
1993 Milwaukee outbreak suggest that children had greater levels of
Cryptosporidium infection than predicted for the general community
(based on the random-digit dialing telephone survey method) (McDonald
et al., 2001).
    Data indicate a lower incidence of cryptosporidiosis infection
during the first year of life. This is attributed to breast-fed infants
consuming less tap water and, hence, having less exposure to
Cryptosporidium, as well as the possibility that mothers confer short
term immunity to their children. For example, in a survey of over
30,000 stool sample analyses from different patients in the United
Kingdom, the one to five year age group suffered a much higher
infection rate than individuals less than one year of age. For children
under one year of age, those older than six months of age showed a
higher rate of infection than individuals aged less than six months
(Casemore, 1990). Similarly, in the U.S., of 2,566 reported
Cryptosporidium illnesses in 1999, 525 occurred in ages one to four
(incidence rate of 3.03 per 100,000) compared with 58 cases in infants
under one year (incidence rate of 1.42 per 100,000) (CDC, 2001).
    An infected child may spread the disease to other children or
family members (Heijbel et al., 1987, Osewe et al., 1996). Millard et
al. (1994) documented greater household secondary transmission of
cryptosporidiosis from children than from adults to household and other
close contacts. Children continued to shed oocysts for more than two
weeks (mean 16.5 days) after diarrhea cessation (Tangerman et al.,
1991).
    While Cryptosporidium may have a disproportionate effect on
children, available data are not adequate to distinctly assess the
health risk for children resulting from Cryptosporidium-contaminated
drinking water. In assessing risk to children when evaluating
regulatory alternatives for the LT2ESWTR, EPA assumed the same risk for
children as for the population as a whole.
    Section VI of this preamble presents the regulatory alternatives
that EPA evaluated for the proposed LT2ESWTR. Among the four
alternatives the Agency considered, three involved a risk-targeting
approach in which additional Cryptosporidium treatment requirements are
based on source water monitoring results. A fourth alternative involved
additional treatment requirements for all PWSs. The alternative
requiring additional treatment by all PWSs was not selected because of
concerns about feasibility and because it imposed costs but provided
few benefits to PWSs with high quality source water (i.e., relatively
low Cryptosporidium risk). The three risk-targeting alternatives were
evaluated based on several factors, including costs, benefits, net
benefits, feasibility of implementation, and other specific impacts
(e.g., impacts on small PWSs or sensitive subpopulations).

    The alternative that today's final rule establishes was recommended
by the M-DBP Federal Advisory Committee and selected by EPA as the
Preferred Regulatory Alternative because it was deemed feasible and
provides significant public health benefits in terms of avoided
illnesses and deaths. EPA's analysis of benefits and costs indicates
that this alternative ranks highly among those evaluated with respect
to maximizing net benefits, as shown in the LT2ESWTR Economic Analysis
(USEPA 2005a). This document is available in the docket for this
action.
    The result of the LT2ESWTR will be a reduction in the risk of
illness for the entire population, including children. Because
available evidence indicates that children may be more vulnerable to
cryptosporidiosis than the rest of the population, the LT2ESWTR may,
therefore, result in greater risk reduction for children than for the
general population.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This rule is not a ``significant energy action'' as defined in
Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355
(May 22, 2001)) because it is not likely to have a significant adverse
effect on the supply, distribution, or use of energy. This
determination is based on the following analysis.
    The first consideration is whether the LT2ESWTR would adversely
affect the supply of energy. The LT2ESWTR does not regulate power
generation, either directly or indirectly. The public and private
utilities that the LT2ESWTR regulates do not, as a rule, generate
power. Further, the cost increases borne by customers of water
utilities as a result of the LT2ESWTR are a low percentage of the total
cost of water, except for a very few small PWSs that might install
advanced technologies and then need to spread that cost over a narrow
customer base. Therefore, the customers that are power generation
utilities are unlikely to face any significant effects as a result of
the LT2ESWTR. In sum, the LT2ESWTR does not regulate the supply of
energy, does not generally regulate the utilities that supply energy,
and is unlikely to affect significantly the customer base of energy
suppliers. Thus, the LT2ESWTR would not translate into adverse effects
on the supply of energy.
    The second consideration is whether the LT2ESWTR would adversely
affect the distribution of energy. The LT2ESWTR does not regulate any
aspect of energy distribution. The utilities that are regulated by the
LT2ESWTR already have electrical service. As derived later in this
section, the final rule is projected to increase peak electricity
demand at water utilities by only 0.036 percent. Therefore, EPA
estimates that the existing connections are adequate and that the
LT2ESWTR has no discernable adverse effect on energy distribution.
    The third consideration is whether the LT2ESWTR would adversely
affect the use of energy. Because some drinking water utilities are
expected to add treatment technologies that use electrical power, this
potential impact is evaluated in more detail. The analyses that
underlay the estimation of costs for the LT2ESWTR are national in scope
and do not identify specific plants or utilities that may install
treatment in response to the rule. As a result, no analysis of the
effect on specific energy suppliers is possible with the available
data. The approach used to estimate the impact of energy use,
therefore, focuses on national-level impacts. The analysis estimates
the additional energy use due to the LT2ESWTR, and compares that to the
national levels of power generation in terms of average and peak loads.
    The first step in the analysis is to estimate the energy used by
the technologies expected to be installed as a result of the LT2ESWTR.
Energy use is not directly stated in Technologies and Costs for Control
of Microbial Contaminants and Disinfection By-Products (USEPA 2003c),
but the annual cost of energy for each technology addition or upgrade
necessitated by the LT2ESWTR is provided. An estimate of plant-level
energy use is derived by dividing the total energy cost per plant for a
range of flows by an average national cost of electricity of $0.070/kWh
(USDOE 2004a). These calculations are shown in detail in Chapter 7 of
the Economic Analysis for the LT2ESWTR (USEPA 2005a). The energy use
per plant for each flow range and technology is then multiplied by the
number of plants predicted to install each technology in a given flow
range. The energy requirements for each flow range are then added to
produce a national total. No electricity use is subtracted to account
for the technologies that may be replaced by new technologies,
resulting in a conservative estimate of the increase in energy use.
Results of the analysis are shown in Table VII.H-1 for each of the
modeled Cryptosporidium occurrence distributions. The incremental
national annual energy usage is estimated at 165 million megawatt-hours
(mW) based on the modeled Information Collection Rule occurrence
distribution.

[GRAPHIC] [TIFF OMITTED] TR05JA06.019

    To determine if the additional energy required for PWSs to comply
with the rule would have a significant adverse effect on the use of
energy, the numbers in Table VII.H-1 are compared to the national
production figures for electricity. According to the U.S. Department of
Energy's Information Administration, electricity producers generated
3,848 million mW of electricity in 2003 (USDOE 2004b). Therefore, even
using the highest assumed energy use for the LT2ESWTR, the rule when
fully implemented would result in only a 0.004 percent increase in
annual average energy use.
    In addition to average energy use, the impact at times of peak
power demand is important. To examine whether increased energy usage
might significantly affect the capacity margins of energy suppliers,
their peak season generating capacity reserve was compared to an
estimate of peak incremental power demand by water utilities.
    Both energy use and water use are highest in the summer months, so
the most significant effects on supply would be seen then. In the year
of 2003, U.S. generation capacity exceeded consumption by 15 percent,
or approximately 160,00 mW (USDOE EIA 2004b). Assuming around-the-clock
operation of water treatment plants, the total energy requirement can
be divided by 8,760 hours per year to obtain an average power demand of
19 mW for the modeled Information Collection Rule occurrence
distribution. A more detailed derivation of this value is shown in
Chapter 7 of the Economic Analysis for the LT2ESWTR (USEPA 2005a).
Assuming that power demand is proportional to water flow through the
plant, and that peak flow can be as high as twice the average daily
flow during the summer months, about 38 mW could be needed for
treatment technologies installed to comply with the LT2ESWTR. This is
only 0.024 percent of the capacity margin available at peak use.
    Although EPA recognizes that not all areas have a 15 percent
capacity margin and that this margin varies across regions and through
time, this analysis reflects the effect of the rule on national energy
supply, distribution, or use. While certain areas, notably California,
have experienced shortfalls in generating capacity in the recent past,
a peak incremental power requirement of 38 mW nationwide is not likely
to significantly change the energy supply, distribution, or use in any
given area. Considering this analysis, EPA has concluded that LT2ESWTR
is not likely to have a significant adverse effect on the supply,
distribution, or use of energy.

I. National Technology Transfer and Advancement Act

    As noted in the proposed rule, Section 12(d) of the National
Technology Transfer and Advancement Act (``NTTAA'') of 1995, Public Law
104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use
voluntary consensus standards in its regulatory activities unless to do
so would be inconsistent with applicable law or otherwise impractical.
Voluntary consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, and business
practices) that are developed or adopted by voluntary consensus
standard bodies. The NTTAA directs EPA to provide Congress, through
OMB, explanations when the Agency decides not to use available and
applicable voluntary consensus standards.
    This rulemaking involves technical standards. EPA has decided to
use methods previously approved in 40 CFR 136.3 for the analysis of E.
coli in surface waters. These include several voluntary consensus
methods that were developed or adopted by the following organizations:
American Public Health Association in Standard Methods for the
Examination of Water and Wastewater, 20th, 19th, and 18th Editions, the
American Society of Testing Materials in Annual Book of ASTM
Standards--Water and Environmental Technology, and the Association of
Analytical Chemists in Official Methods of Analysis of AOAC
International, 16th Edition. EPA has concluded that these methods have
the necessary sensitivity and specificity to meet the data quality
objectives of the LT2ESWTR.
    The Agency conducted a search to identify potentially applicable
voluntary consensus standards for analysis of Cryptosporidium. However,
we identified no such standards. Therefore,

EPA approves the use of the following methods for Cryptosporidium
analysis: Method 1623: Cryptosporidium and Giardia in Water by
Filtration/IMS/FA, 2004, United States Environmental Protection Agency,
EPA-815-R-05-002 or Method 1622: Cryptosporidium in Water by
Filtration/IMS/FA, 2004, United States Environmental Protection Agency,
EPA-815-R-05-001.

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

    Executive Order 12898 establishes a Federal policy for
incorporating environmental justice into Federal agency missions by
directing agencies to identify and address disproportionately high and
adverse human health or environmental effects of its programs,
policies, and activities on minority and low-income populations. EPA
has considered environmental justice related issues concerning the
potential impacts of this action and consulted with minority and low-
income stakeholders. A description of this consultation can be found in
the proposed rule (USEPA 2003a).

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

    In accordance with Section 1412 (d) and (e) of the SDWA, the Agency
did consult with the Science Advisory Board, the National Drinking
Water Advisory Council (NDWAC), and the Secretary of Health and Human
Services on today's rule.
    EPA charged the SAB panel with reviewing the following aspects of
the LT2ESWTR proposal:
     The analysis of Cryptosporidium occurrence;
     The pre- and post-LT2ESWTR Cryptosporidium risk
assessment; and
     The treatment credits for the following four microbial
toolbox components: raw water off-stream storage, pre-sedimentation,
lime softening, and lower finished water turbidity.
    EPA met with the SAB to discuss the LT2ESWTR on June 13, 2001
(Washington, DC), September 25-26, 2001 (teleconference), and December
10-12, 2001 (Los Angeles, CA). The SAB issued its final report for this
review, Disinfection Byproducts and Surface Water Treatment: A EPA
Science Advisory Board Review of Certain Elements of the Stage 2
Regulatory Proposals, in May 2003.
    Comments from the SAB were generally supportive of EPA's analysis
of Cryptosporidium occurrence and the Cryptosporidium risk assessment
for today's rule. The SAB recommended some additional quality assurance
checks for statistical models, improved descriptions of underlying data
sets, and better characterization of uncertainty for key parameters.
USEPA 2005a and 2005b provide information on revisions EPA made in
response to these comments.
    SAB comments on microbial toolbox options and the Agency's
responses to those comments are described in section IIII.D of this
preamble. In general, the SAB supported treatment credit for two-stage
softening, recommended additional performance criteria to award
treatment credit to presedimentation basins, recommended modifications
to the treatment credit for combined and individual filter performance,
and opposed treatment credit for off-stream raw water storage.
    EPA met with the NDWAC on November 8, 2001, in Washington, DC, to
discuss the LT2ESWTR proposal. EPA specifically requested comments from
the NDWAC on the regulatory approach taken in the proposed microbial
toolbox (e.g., proposal of specific design and implementation criteria
for treatment credits). The Council was generally supportive of EPA
establishing criteria for awarding treatment credit to toolbox
components, but recommended that EPA provide flexibility for States to
address PWS specific situations. EPA believes that the demonstration of
performance credit, described in section IV.D.9 provides this
flexibility by allowing States to award higher or lower levels of
treatment credit for microbial toolbox components based on site
specific conditions.
    EPA has consulted with the U.S. Department of Health and Human
Services (HHS) regarding Cryptosporidium health effects and has
provided HHS with today's rule.

L. Plain Language

    Executive Order 12866 requires each agency to write its rules in
plain language. Readable regulations help the public find requirements
quickly and understand them easily. They increase compliance,
strengthen enforcement, and decrease mistakes, frustration, phone
calls, appeals, and distrust of government. EPA made every effort to
write this preamble to the final rule in as clear, concise, and
unambiguous manner as possible.

M. Analysis of the Likely Effect of Compliance With the LT2ESWTR on the
Technical, Financial, and Managerial Capacity of Public Water Systems

    Section 1420(d)(3) of SDWA, as amended, requires that in
promulgating an NPDWR, the Administrator shall include an analysis of
the likely effect of compliance with the regulation on the technical,
managerial, and financial capacity of public water systems. This
analysis can be found in the LT2ESWTR Economic Analysis (USEPA 2005a).
Analyses reflect only the impact of new or revised requirements, as
established by the LT2ESWTR; the impacts of previously established
requirements on system capacity are not considered.
    EPA has defined overall water system capacity 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 physical and
operational ability of a water system to meet SDWA requirements. This
refers to the physical infrastructure of the water system, including
the adequacy of source water and the adequacy of treatment, storage,
and distribution infrastructure. It also refers to the ability of
system personnel to adequately operate and maintain the system and to
otherwise implement requisite technical knowledge. Managerial capacity
is the ability of a water system to conduct its affairs to achieve and
maintain compliance with SDWA requirements. Managerial capacity refers
to the system's institutional and administrative capabilities.
Financial capacity is a water system's ability to acquire and manage
sufficient financial resources to allow the system to achieve and
maintain compliance with SDWA requirements. Technical, managerial, and
financial capacity can be assessed through key issues and questions,
including the following:

------------------------------------------------------------------------

------------------------------------------------------------------------
                           Technical Capacity
------------------------------------------------------------------------
Source water adequacy.............  Does the system have a reliable
                                     source of water with adequate
                                     quantity? Is the source generally
                                     of good quality and adequately
                                     protected?

Infrastructure adequacy...........  Can the system provide water that
                                     meets SDWA standards? What is the
                                     condition of its infrastructure,
                                     including wells or source water
                                     intakes, treatment and storage
                                     facilities, and distribution
                                     systems? What is the
                                     infrastructure's life expectancy?
                                     Does the system have a capital
                                     improvement plan?
Technical knowledge and             Are the system's operators
 implementation.                     certified? Do the operators have
                                     sufficient knowledge of applicable
                                     standards? Can the operators
                                     effectively implement this
                                     technical knowledge? Do the
                                     operators understand the system's
                                     technical and operational
                                     characteristics? Does the system
                                     have an effective O&M program?
-----------------------------------
                           Managerial Capacity
------------------------------------------------------------------------
Ownership accountability..........  Are the owners clearly identified?
                                     Can they be held accountable for
                                     the system?
Staffing and organization.........  Are the operators and managers
                                     clearly identified? Is the system
                                     properly organized and staffed? Do
                                     personnel understand the management
                                     aspects of regulatory requirements
                                     and system operations? Do they have
                                     adequate expertise to manage water
                                     system operations (i.e., to conduct
                                     implementation, monitor for E. coli
                                     and Cryptosporidium, install
                                     treatment, and cover or disinfect
                                     reservoir discharge to meet the
                                     LT2ESWTR requirements)? Do
                                     personnel have the necessary
                                     licenses and certifications?
Effective external linkages.......  Does the system interact well with
                                     customers, regulators, and other
                                     entities? Is the system aware of
                                     available external resources, such
                                     as technical and financial
                                     assistance?
-----------------------------------
                           Financial Capacity
------------------------------------------------------------------------
Revenue sufficiency...............  Do revenues cover costs?
Creditworthiness..................  Is the system financially healthy?
                                     Does it have access to capital
                                     through public or private sources?
Fiscal management and controls....  Are adequate books and records
                                     maintained? Are appropriate
                                     budgeting, accounting, and
                                     financial planning methods used?
                                     Does the system manage its revenues
                                     effectively?
------------------------------------------------------------------------

    After determining the type and number of systems to which each
requirement applies, EPA evaluated the capacity impact of each rule
requirement on large and small systems affected by that particular
requirement. EPA determined that the overall impacts on small systems'
technical, managerial, and financial capacity will vary. Monitoring and
familiarization with new rules will have no significant effects on
small systems, with the exception of moderate revenue constraints on
those systems that need to implement monitoring for Cryptosporidium.
The largest impacts will occur as a result of attaining 2.5 log
treatment levels, covering uncovered reservoirs, or disinfecting
reservoir discharge. EPA assumed that large systems will have the
technical, financial, and managerial capacity to implement LT2ESWTR
requirements based on the scale and complexity of their operations. The
nature of their operations generally assures that they have access to
the technical and managerial expertise to carry out all activities
required by the LT2ESWTR. It is also generally easier for large systems
to fund capital improvements than small systems, since costs can be
spread over a larger customer base, making them smaller on a per-
household basis.
    To meet challenges posed by rule requirements, it is likely that
some small and medium systems will need to develop or enhance linkages
with technical and financial assistance providers (including State
extension agents). Technical and financial assistance providers can
help systems analyze their needs as well as the trade-offs between cost
and health protection. In addition, they may be able to assist systems
in finding the funding necessary to install and operate new equipment.
The Safe Drinking Water Act, as amended in 1996, established the
Drinking Water State Revolving Fund to make funds available to drinking
water systems to finance infrastructure improvements. EPA also works
closely with organizations such as the National Rural Water Association
and the American Water Works Association to develop technical and
managerial tools, materials, and assistance to aid small systems.

N. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A Major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective March 6, 2006.

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IMS/FA. EPA 815-R-05-001.
USEPA. 2005d. Method 1623: Cryptosporidium and Giardia in Water by
Filtration/IMS/FA. EPA 815-R-05-002.
USEPA. 2005e. Valuing Time Losses Due to Illness under the 1996
Amendments to the Safe Drinking Water Act. EPA Office of Water.
Prepared by IEC Consultants.
Wang, J., R. Song, and S. Hubbs. 2001. Particle removal through
riverbank filtration process, in W. Julich and J. Schubert, eds.,
Proceedings of the Internation Riverbank Filtration Conference,
November 2-4, 2000, Dusseldorf, Germany, Internationale
Arbeitsgemeinschaft der Wasserwork im Rheineinzugsgebiet.
Ware and Schaefer. 2005. The effects of time and temperature on flow
cytometry enumerated live Cryptosporidium parvum oocysts. Letters in
Applied Microbiology 41:385-389.
Yang, S., S.K. Benson, C. Du, and M.C. Healey. 2000. Infection of
immunosuppressed C57BL/6N adult mice with a single oocyst of
Cryptosporidium parvum. J Parasitol. 86(4):884-7.
Yates, R., K. Scott, J. Green, J. Bruno, and R. De Leon. 1998. Using
Aerobic Spores to Evaluate Treatment Plant Performance. Proceedings,
Annual Conference of the American Water Works Association, Denver,
CO.

List of Subjects

40 CFR Part 9

    Reporting and recordkeeping.

40 CFR Part 141

    Environmental protection, Chemicals, Indians-lands, Incorporation
by reference, Intergovernmental relations, Radiation protection,
Reporting and recordkeeping requirements, Water supply.

40 CFR Part 142

    Environmental protection, Administrative practice and procedure,
Chemicals, Indians-lands, Radiation protection, Reporting and
recordkeeping requirements, Water supply.

    Dated: December 15, 2005.
Stephen L. Johnson,
Administrator.

0
For the reasons set forth in the preamble, title 40 chapter I of the
Code of Federal Regulations is amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; Executive Order 11735, 38 FR
21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246,
300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1,
300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-
7671q, 7542, 9601-9657, 11023, 11048.

0
2. In Sec.  9.1 the table is amended as follows:
0
a. Under the heading ``National Primary Drinking Water Regulations
Implementation'' by adding entries in numerical order for ``Sec.
141.706-141.710, 141.713-141.714, 141.716-141.723''.
0
b. Under the heading ``National Primary Drinking Water Regulations
Implementation'' by removing entries Sec.  142.15(c), 142.15(c)(6)-(7)
and adding entries in numerical order for ``142.14(a)(9), 142.15(c)(6),
and 142.16(n)'' as follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                   40 CFR citation                      OMB control No.
------------------------------------------------------------------------

                              * * * * * * *
------------------------------------------------------
               National Primary Drinking Water Regulations
------------------------------------------------------------------------

                              * * * * * * *
141.706-141.710......................................          2040-0266
141.713-141.714......................................          2040-0266
141.716-141.723......................................          2040-0266
------------------------------------------------------
       National Primary Drinking Water Regulations Implementation
------------------------------------------------------------------------

                              * * * * * * *
142.14(a)(9).........................................          2040-0266

                              * * * * * * *
142.15(c)(6).........................................          2040-0266

                              * * * * * * *
142.16(n)............................................          2040-0266

                              * * * * * * *
------------------------------------------------------------------------

PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS

0
3. The authority citation for Part 141 continues to read as follows:

    Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-
5, 300g-6, 300j-4, 300j-9, and 300j-11.

0
4. Section 141.2 is amended by adding, in alphabetical order,
definitions for ``Bag filters'', ``Bank filtration'', ``Cartridge
filters'', ``Flowing stream'', ``Lake/reservoir'', ``Membrane
filtration'', ``Plant intake'', ``Presedimentation'', and ``Two-stage
lime softening'', and revising the definition for ``Uncovered finished
water storage facility'' to read as follows:

Sec.  141.2  Definitions.

* * * * *
    Bag filters are pressure-driven separation devices that remove
particulate matter larger than 1 micrometer using an engineered porous
filtration media. They are typically constructed of a non-rigid, fabric
filtration media housed in a pressure vessel in which the direction of
flow is from the inside of the bag to outside.
    Bank filtration is a water treatment process that uses a well to
recover surface water that has naturally infiltrated into ground water
through a river bed or bank(s). Infiltration is typically enhanced by
the hydraulic gradient imposed by a nearby pumping water supply or
other well(s).
* * * * *
    Cartridge filters are pressure-driven separation devices that
remove particulate matter larger than 1 micrometer using an engineered
porous filtration media. They are typically constructed as rigid or
semi-rigid, self-supporting filter elements housed in pressure vessels
in which flow is from the outside of the cartridge to the inside.
* * * * *
    Flowing stream is a course of running water flowing in a definite
channel.
* * * * *
    Lake/reservoir refers to a natural or man made basin or hollow on
the Earth's surface in which water collects or is stored that may or
may not have a current or single direction of flow.
* * * * *
    Membrane filtration is a pressure or vacuum driven separation
process in which particulate matter larger than 1 micrometer is
rejected by an engineered barrier, primarily through a size-exclusion
mechanism, and which has a measurable removal efficiency of a target
organism that can be verified through the application of a direct
integrity test. This definition includes the common membrane
technologies of microfiltration, ultrafiltration, nanofiltration, and
reverse osmosis.
* * * * *
    Plant intake refers to the works or structures at the head of a
conduit through which water is diverted from a source (e.g., river or
lake) into the treatment plant.
* * * * *
    Presedimentation is a preliminary treatment process used to remove
gravel, sand and other particulate material from the source water
through settling before the water enters the primary clarification and
filtration processes in a treatment plant.
* * * * *
    Two-stage lime softening is a process in which chemical addition
and hardness precipitation occur in each of two distinct unit
clarification processes in series prior to filtration.
    Uncovered finished water storage facility is a tank, reservoir, or
other facility used to store water that will undergo no further
treatment to reduce microbial pathogens except residual disinfection
and is directly open to the atmosphere.
* * * * *

0
5. Subpart Q of part 141 is amended by adding Sec.  141.211 to read as
follows:

Sec.  141.211  Special notice for repeated failure to conduct
monitoring of the source water for Cryptosporidium and for failure to
determine bin classification or mean Cryptosporidium level.

    (a) When is the special notice for repeated failure to monitor to
be given? The owner or operator of a community or non-community water
system that is required to monitor source water under Sec.  141.701
must notify persons served by the water system that monitoring has not
been completed as specified no later than 30 days after the system has
failed to collect any 3 months of monitoring as specified in Sec.
141.701(c). The notice must be repeated as specified in Sec.
141.203(b).
    (b) When is the special notice for failure to determine bin
classification or mean Cryptosporidium level to be given? The owner or
operator of a community or non-community water system that is required
to determine a bin classification under Sec.  141.710, or to determine
mean Cryptosporidium level under Sec.  141.712, must notify persons
served by the water system that the determination has not been made as
required no later than 30 days after the system has failed report the
determination as specified in Sec.  141.710(e) or Sec.  141.712(a),
respectively. The notice must be repeated as specified in Sec.
141.203(b). The notice is not required if the system is complying with
a State-approved schedule to address the violation.
    (c) What is the form and manner of the special notice? The form and
manner of the public notice must follow the requirements for a Tier 2
public notice prescribed in Sec.  141.203(c). The public notice must be
presented as required in Sec.  141.205(c).
    (d) What mandatory language must be contained in the special
notice? The notice must contain the following language, including the
language necessary to fill in the blanks.
    (1) The special notice for repeated failure to conduct monitoring
must contain the following language:

    We are required to monitor the source of your drinking water for
Cryptosporidium. Results of the monitoring are to be used to
determine whether water treatment at the (treatment plant name) is
sufficient to adequately remove Cryptosporidium from your drinking
water. We are required to complete this monitoring and make this
determination by (required bin determination date). We ``did not
monitor or test'' or ``did not complete all monitoring or testing''
on schedule and, therefore, we may not be able to determine by the
required date what treatment modifications, if any, must be made to
ensure adequate Cryptosporidium removal. Missing this deadline may,
in turn, jeopardize our ability to have the required treatment
modifications, if any, completed by the deadline required, (date).
    For more information, please call (name of water system contact)
of (name of water system) at (phone number).

    (2) The special notice for failure to determine bin classification
or mean Cryptosporidium level must contain the following language:

    We are required to monitor the source of your drinking water for
Cryptosporidium in order to determine by (date) whether water
treatment at the (treatment plant name) is sufficient to adequately
remove Cryptosporidium from your drinking water. We have not made
this determination by the required date. Our failure to do this may
jeopardize our ability to have the required treatment modifications,
if any, completed by the required deadline of (date). For more
information, please call (name of water system contact) of (name of
water system) at (phone number).

    (3) Each special notice must also include a description of what the
system is doing to correct the violation and when the system expects to
return to compliance or resolve the situation.

0
6. Appendix A to Subpart Q of part 141 is amended by adding entry
number 10 under I.A. to read as follows:

Subpart Q--Public Notification of Drinking Water Violations

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

                                                  * * * * * * *
    10. LT2ESWTR violations............            2    141.710-141.720    \22\ 2, 3  141.701-141.705 and
                                                                                141.708-141.709.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Violations and other situations not listed in this table (e.g., failure to prepare Consumer Confidence
  Reports) do not require notice, unless otherwise determined by the primary agency. Primacy agencies may, at
  their option, also require a more stringent public notice tier (e.g., Tier 1 instead of Tier 2 or Tier 2
  instead of Tier 3) for specific violations and situations listed in this Appendix, as authorized under Sec.
  141.202(a) and Sec.   141.203(a).
\2\ MCL--Maximum contaminant level, MRDL--Maximum residual disinfectant level, TT--Treatment technique.
\3\ The term Violations of National Primary Drinking Water Regulations (NPDWR) is used here to include
  violations of MCL, MRDL, treatment technique, monitoring, and testing procedure requirements.
* * * * * * *
\22\ Failure to collect three or more samples for Cryptosporidium analysis is a Tier 2 violation requiring
  special notice as specified in Sec.   141.211. All other monitoring and testing procedure violations are Tier
  3.

0
7. Part 141 is amended by adding a new subpart W to read as follows:

Subpart W--Enhanced Treatment for Cryptosporidium

General Requirements

Sec.
141.700 General requirements.

Source Water Monitoring Requirements

141.701 Source water monitoring.
141.702 Sampling schedules.
141.703 Sampling locations.
141.704 Analytical methods.
141.705 Approved laboratories.
141.706 Reporting source water monitoring results.
141.707 Grandfathering previously collected data.

Disinfection Profiling and Benchmarking Requirements

141.708 Requirements when making a significant change in
disinfection practice.
141.709 Developing the disinfection profile and benchmark.

Treatment Technique Requirements

141.710 Bin classification for filtered systems.
141.711 Filtered system additional Cryptosporidium treatment
requirements.
141.712 Unfiltered system Cryptosporidium treatment requirements.
141.713 Schedule for compliance with Cryptosporidium treatment
requirements.
141.714 Requirements for uncovered finished water storage
facilities.

Requirements for Microbial Toolbox Components

141.715 Microbial toolbox options for meeting Cryptosporidium
treatment requirements.
141.716 Source toolbox components.
141.717 Pre-filtration treatment toolbox components.
141.718 Treatment performance toolbox components.
141.719 Additional filtration toolbox components.
141.720 Inactivation toolbox components.

Reporting and Recordkeeping Requirements

141.721 Reporting requirements.
141.722 Recordkeeping requirements.

Requirements for Sanitary Surveys Performed by EPA

141.723 Requirements to respond to significant deficiencies
identified in sanitary surveys performed by EPA.

Subpart W--Enhanced Treatment for Cryptosporidium

General Requirements

Sec.  141.700  General requirements.

    (a) The requirements of this subpart W are national primary
drinking water regulations. The regulations in this subpart establish
or extend treatment technique requirements in lieu of maximum
contaminant levels for Cryptosporidium. These requirements are in
addition to requirements for filtration and disinfection in subparts H,
P, and T of this part.
    (b) Applicability. The requirements of this subpart apply to all
subpart H systems, which are public water systems supplied by a surface
water source and public water systems supplied by a ground water source
under the direct influence of surface water.
    (1) Wholesale systems, as defined in Sec.  141.2, must comply with
the requirements of this subpart based on the population of the largest
system in the combined distribution system.
    (2) The requirements of this subpart for filtered systems apply to
systems required by National Primary Drinking Water Regulations to
provide filtration treatment, whether or not the system is currently
operating a filtration system.
    (3) The requirements of this subpart for unfiltered systems apply
only to unfiltered systems that timely met and continue to meet the
filtration avoidance criteria in subparts H, P, and T of this part, as
applicable.
    (c) Requirements. Systems subject to this subpart must comply with
the following requirements:
    (1) Systems must conduct an initial and a second round of source
water monitoring for each plant that treats a surface water or GWUDI
source. This monitoring may include sampling for Cryptosporidium, E.
coli, and turbidity as described in Sec. Sec.  141.701 through 141.706,
to determine what level, if any, of additional Cryptosporidium
treatment they must provide.
    (2) Systems that plan to make a significant change to their
disinfection practice must develop disinfection profiles and calculate
disinfection benchmarks, as described in Sec. Sec.  141.708 through
141.709.
    (3) Filtered systems must determine their Cryptosporidium treatment
bin classification as described in Sec.  141.710 and provide additional
treatment for Cryptosporidium, if required, as described in Sec.
141.711. All unfiltered systems must provide treatment for
Cryptosporidium as described in Sec.  141.712. Filtered and unfiltered
systems must implement Cryptosporidium treatment according to the
schedule in Sec.  141.713.

    (4) Systems with uncovered finished water storage facilities must
comply with the requirements to cover the facility or treat the
discharge from the facility as described in Sec.  141.714.
    (5) Systems required to provide additional treatment for
Cryptosporidium must implement microbial toolbox options that are
designed and operated as described in Sec. Sec.  141.715 through
141.720.
    (6) Systems must comply with the applicable recordkeeping and
reporting requirements described in Sec. Sec.  141.721 through 141.722.
    (7) Systems must address significant deficiencies identified in
sanitary surveys performed by EPA as described in Sec.  141.723.

Source Water Monitoring Requirements

Sec.  141.701  Source water monitoring.

    (a) Initial round of source water monitoring. Systems must conduct
the following monitoring on the schedule in paragraph (c) of this
section unless they meet the monitoring exemption criteria in paragraph
(d) of this section.
    (1) Filtered systems serving at least 10,000 people must sample
their source water for Cryptosporidium, E. coli, and turbidity at least
monthly for 24 months.
    (2) Unfiltered systems serving at least 10,000 people must sample
their source water for Cryptosporidium at least monthly for 24 months.
    (3)(i) Filtered systems serving fewer than 10,000 people must
sample their source water for E. coli at least once every two weeks for
12 months.
    (ii) A filtered system serving fewer than 10,000 people may avoid
E. coli monitoring if the system notifies the State that it will
monitor for Cryptosporidium as described in paragraph (a)(4) of this
section. The system must notify the State no later than 3 months prior
to the date the system is otherwise required to start E. coli
monitoring under Sec.  141.701(c).
    (4) Filtered systems serving fewer than 10,000 people must sample
their source water for Cryptosporidium at least twice per month for 12
months or at least monthly for 24 months if they meet one of the
following, based on monitoring conducted under paragraph (a)(3) of this
section:
    (i) For systems using lake/reservoir sources, the annual mean E.
coli concentration is greater than 10 E. coli/100 mL.
    (ii) For systems using flowing stream sources, the annual mean E.
coli concentration is greater than 50 E. coli/100 mL.
    (iii) The system does not conduct E. coli monitoring as described
in paragraph (a)(3) of this section.
    (iv) Systems using ground water under the direct influence of
surface water (GWUDI) must comply with the requirements of paragraph
(a)(4) of this section based on the E. coli level that applies to the
nearest surface water body. If no surface water body is nearby, the
system must comply based on the requirements that apply to systems
using lake/reservoir sources.
    (5) For filtered systems serving fewer than 10,000 people, the
State may approve monitoring for an indicator other than E. coli under
paragraph (a)(3) of this section. The State also may approve an
alternative to the E. coli concentration in paragraph (a)(4)(i), (ii)
or (iv) of this section to trigger Cryptosporidium monitoring. This
approval by the State must be provided to the system in writing and
must include the basis for the State's determination that the
alternative indicator and/or trigger level will provide a more accurate
identification of whether a system will exceed the Bin 1
Cryptosporidium level in Sec.  141.710.
    (6) Unfiltered systems serving fewer than 10,000 people must sample
their source water for Cryptosporidium at least twice per month for 12
months or at least monthly for 24 months.
    (7) Systems may sample more frequently than required under this
section if the sampling frequency is evenly spaced throughout the
monitoring period.
    (b) Second round of source water monitoring. Systems must conduct a
second round of source water monitoring that meets the requirements for
monitoring parameters, frequency, and duration described in paragraph
(a) of this section, unless they meet the monitoring exemption criteria
in paragraph (d) of this section. Systems must conduct this monitoring
on the schedule in paragraph (c) of this section.
    (c) Monitoring schedule. Systems must begin the monitoring required
in paragraphs (a) and (b) of this section no later than the month
beginning with the date listed in this table:

              Source Water Monitoring Starting Dates Table
------------------------------------------------------------------------
                                                     And must begin the
                              Must begin the first     second round of
                                 round of source        source water
  Systems that serve . . .     water monitoring no   monitoring no later
                              later than the month     than the month
                                 beginning . . .       beginning . . .
------------------------------------------------------------------------
(1) At least 100,000 people.  (i) October 1, 2006.  (ii) April 1, 2015.
(2) From 50,000 to 99,999     (i) April 1, 2007...  (ii) October 1,
 people.                                             2015.
(3) From 10,000 to 49,999     (i) April 1, 2008...  (ii) October 1,
 people.                                             2016.
(4) Fewer than 10,000 and     (i) October 1, 2008.  (ii) October 1,
 monitor for E. coli \a\.                            2017.
(5) Fewer than 10,000 and     (i) April 1, 2010...  (ii) April 1, 2019.
 monitor for Cryptosporidium
 \b\.
------------------------------------------------------------------------
\a\ Applies only to filtered systems.
\b\ Applies to filtered systems that meet the conditions of paragraph
  (a)(4) of this section and unfiltered systems.

    (d) Monitoring avoidance. (1) Filtered systems are not required to
conduct source water monitoring under this subpart if the system will
provide a total of at least 5.5-log of treatment for Cryptosporidium,
equivalent to meeting the treatment requirements of Bin 4 in Sec.
141.711.
    (2) Unfiltered systems are not required to conduct source water
monitoring under this subpart if the system will provide a total of at
least 3-log Cryptosporidium inactivation, equivalent to meeting the
treatment requirements for unfiltered systems with a mean
Cryptosporidium concentration of greater than 0.01 oocysts/L in Sec.
141.712.
    (3) If a system chooses to provide the level of treatment in
paragraph (d)(1) or (2) of this section, as applicable, rather than
start source water monitoring, the system must notify the State in
writing no later than the date the system is otherwise required to
submit a sampling schedule for monitoring under Sec.  141.702.
Alternatively, a system may choose to stop sampling at any point after
it has initiated monitoring if it notifies the State in writing that it
will provide this level of treatment. Systems must install and operate
technologies to provide this level of treatment by the

applicable treatment compliance date in Sec.  141.713.
    (e) Plants operating only part of the year. Systems with subpart H
plants that operate for only part of the year must conduct source water
monitoring in accordance with this subpart, but with the following
modifications:
    (1) Systems must sample their source water only during the months
that the plant operates unless the State specifies another monitoring
period based on plant operating practices.
    (2) Systems with plants that operate less than six months per year
and that monitor for Cryptosporidium must collect at least six
Cryptosporidium samples per year during each of two years of
monitoring. Samples must be evenly spaced throughout the period the
plant operates.
    (f)(1) New sources. A system that begins using a new source of
surface water or GWUDI after the system is required to begin monitoring
under paragraph (c) of this section must monitor the new source on a
schedule the State approves. Source water monitoring must meet the
requirements of this subpart. The system must also meet the bin
classification and Cryptosporidium treatment requirements of Sec. Sec.
141.710 and 141.711 or Sec.  141.712, as applicable, for the new source
on a schedule the State approves.
    (2) The requirements of Sec.  141.701(f) apply to subpart H systems
that begin operation after the monitoring start date applicable to the
system's size under paragraph (c) of this section.
    (3) The system must begin a second round of source water monitoring
no later than 6 years following initial bin classification under Sec.
141.710 or determination of the mean Cryptosporidium level under Sec.
141.712, as applicable.
    (g) Failure to collect any source water sample required under this
section in accordance with the sampling schedule, sampling location,
analytical method, approved laboratory, and reporting requirements of
Sec. Sec.  141.702 through 141.706 is a monitoring violation.
    (h) Grandfathering monitoring data. Systems may use (grandfather)
monitoring data collected prior to the applicable monitoring start date
in paragraph (c) of this section to meet the initial source water
monitoring requirements in paragraph (a) of this section. Grandfathered
data may substitute for an equivalent number of months at the end of
the monitoring period. All data submitted under this paragraph must
meet the requirements in Sec.  141.707.

Sec.  141.702  Sampling schedules.

    (a) Systems required to conduct source water monitoring under Sec.
141.701 must submit a sampling schedule that specifies the calendar
dates when the system will collect each required sample.
    (1) Systems must submit sampling schedules no later than 3 months
prior to the applicable date listed in Sec.  141.701(c) for each round
of required monitoring.
    (2)(i) Systems serving at least 10,000 people must submit their
sampling schedule for the initial round of source water monitoring
under Sec.  141.701(a) to EPA electronically at https://intranet.epa.gov/lt2/
.

    (ii) If a system is unable to submit the sampling schedule
electronically, the system may use an alternative approach for
submitting the sampling schedule that EPA approves.
    (3) Systems serving fewer than 10,000 people must submit their
sampling schedules for the initial round of source water monitoring
Sec.  141.701(a) to the State.
    (4) Systems must submit sampling schedules for the second round of
source water monitoring Sec.  141.701(b) to the State.
    (5) If EPA or the State does not respond to a system regarding its
sampling schedule, the system must sample at the reported schedule.
    (b) Systems must collect samples within two days before or two days
after the dates indicated in their sampling schedule (i.e., within a
five-day period around the schedule date) unless one of the conditions
of paragraph (b)(1) or (2) of this section applies.
    (1) If an extreme condition or situation exists that may pose
danger to the sample collector, or that cannot be avoided and causes
the system to be unable to sample in the scheduled five-day period, the
system must sample as close to the scheduled date as is feasible unless
the State approves an alternative sampling date. The system must submit
an explanation for the delayed sampling date to the State concurrent
with the shipment of the sample to the laboratory.
    (2)(i) If a system is unable to report a valid analytical result
for a scheduled sampling date due to equipment failure, loss of or
damage to the sample, failure to comply with the analytical method
requirements, including the quality control requirements in Sec.
141.704, or the failure of an approved laboratory to analyze the
sample, then the system must collect a replacement sample.
    (ii) The system must collect the replacement sample not later than
21 days after receiving information that an analytical result cannot be
reported for the scheduled date unless the system demonstrates that
collecting a replacement sample within this time frame is not feasible
or the State approves an alternative resampling date. The system must
submit an explanation for the delayed sampling date to the State
concurrent with the shipment of the sample to the laboratory.
    (c) Systems that fail to meet the criteria of paragraph (b) of this
section for any source water sample required under Sec.  141.701 must
revise their sampling schedules to add dates for collecting all missed
samples. Systems must submit the revised schedule to the State for
approval prior to when the system begins collecting the missed samples.

Sec.  141.703  Sampling locations.

    (a) Systems required to conduct source water monitoring under Sec.
141.701 must collect samples for each plant that treats a surface water
or GWUDI source. Where multiple plants draw water from the same
influent, such as the same pipe or intake, the State may approve one
set of monitoring results to be used to satisfy the requirements of
Sec.  141.701 for all plants.
    (b)(1) Systems must collect source water samples prior to chemical
treatment, such as coagulants, oxidants and disinfectants, unless the
system meets the condition of paragraph (b)(2) of this section.
    (2) The State may approve a system to collect a source water sample
after chemical treatment. To grant this approval, the State must
determine that collecting a sample prior to chemical treatment is not
feasible for the system and that the chemical treatment is unlikely to
have a significant adverse effect on the analysis of the sample.
    (c) Systems that recycle filter backwash water must collect source
water samples prior to the point of filter backwash water addition.
    (d) Bank filtration. (1) Systems that receive Cryptosporidium
treatment credit for bank filtration under Sec.  141.173(b) or Sec.
141.552(a), as applicable, must collect source water samples in the
surface water prior to bank filtration.
    (2) Systems that use bank filtration as pretreatment to a
filtration plant must collect source water samples from the well (i.e.,
after bank filtration). Use of bank filtration during monitoring must
be consistent with routine operational practice. Systems collecting
samples after a bank filtration process may not receive treatment
credit for the bank filtration under Sec.  141.717(c).

    (e) Multiple sources. Systems with plants that use multiple water
sources, including multiple surface water sources and blended surface
water and ground water sources, must collect samples as specified in
paragraph (e)(1) or (2) of this section. The use of multiple sources
during monitoring must be consistent with routine operational practice.
    (1) If a sampling tap is available where the sources are combined
prior to treatment, systems must collect samples from the tap.
    (2) If a sampling tap where the sources are combined prior to
treatment is not available, systems must collect samples at each source