National Primary Drinking Water Regulations: Long
Term 2 Enhanced Surface Water Treatment Rule
[Federal Register: January 5, 2006 (Volume 71, Number 3)]
[Rules and Regulations]
[Page 753-786]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ja06-7]
[[pp. 753-786]]
National Primary Drinking Water Regulations: Long Term 2 Enhanced
Surface Water Treatment Rule
[[Continued from page 752]]
[[Page 753]]
time losses in the Enhanced COI estimate is appropriate only for
marginal changes in time use; it is not appropriate for the types of
lifetime changes considered in the comparison.
The Enhanced COI estimates are based on an approach developed in
the EPA report, Valuing Time Losses Due to Illness under the 1996
Amendments to the Safe Drinking Water Act (USEPA 2005e). This report
has been subject to two rounds of independent peer review. In
conclusion, EPA believes that including the Enhanced COI in conjunction
with the Traditional COI is justified theoretically and that including
both measures increases EPA's ability to understand the impacts of the
rule.
VII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
Under Executive Order 12866, [58 FR 51735, (October 4, 1993)]
the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to OMB review and the requirements of the
Executive Order. The Order defines ``significant regulatory action'' as
one that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or Tribal governments or communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
Pursuant to the terms of Executive Order 12866, it has been
determined that this rule is a ``significant regulatory action''
because it may have an annual effect on the economy of $100 million or
more (estimated annual costs are $93 to 133 million and $107 to 150
million at 3 and 7 percent discount rates, respectively). As such, this
action was submitted to OMB for review. Changes made in response to OMB
suggestions or recommendations are documented in the public record.
B. Paperwork Reduction Act
The Office of Management and Budget (OMB) has approved the
information collection requirements contained in this rule under the
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and
has assigned OMB control number 2040-0266.
The information collected as a result of this rule will allow the
States and EPA to determine appropriate requirements for specific PWSs
and to evaluate compliance with the rule. For the first 3 years after
LT2ESWTR promulgation, the major information requirements concern
monitoring activities and compliance tracking. The information
collection requirements are mandatory (40 CFR part 141) and the
information collected is not confidential.
The estimate of annual average burden hours for the LT2ESWTR during
the first three years following promulgation is 141,295 hours. The
annual average cost estimate is $4.4 million for labor and $7 million
per year for operation and maintenance including lab costs (which is a
purchase of service). The burden hours per response is 0.63 hours and
the cost per response is $50.35. The frequency of response (average
responses per respondent) is 90.3, annually. The estimated number of
likely respondents is 2,503 (the product of burden hours per response,
frequency, and respondents does not total the annual average burden
hours due to rounding). Note that the burden hour estimates for the
first 3-year cycle include some large PWS but not small PWS monitoring.
Conversely, burden estimate for the second 3-year cycle will include
remaining monitoring for large systems (those serving between 10,000
and 49,999 people) and small PWS monitoring, but not for large PWS
serving 50,000 or more, which will have been completed by then.
Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology 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.
[[Page 754]]
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,
[[Page 755]]
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.
[[Page 756]]
[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
[[Page 757]]
$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'' (59 FR 22951, 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
[[Page 758]]
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).
[[Page 759]]
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.
[[Page 760]]
[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,
[[Page 761]]
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?
[[Page 762]]
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.
VIII. References
Aboytes, Ramon, G. Di Giovanni, F. Abrams, C. Rheinecker, W.
McElroy, N. Shaw, and M.W. LeChevallier. 2004. Detection of
Infectious Cryptosporidium in Filtered Drinking Water. Journal of
AWWA 96(9):88-97.
APHA. 1992. Standard Methods for the Examination of Water and
Wastewater; 18th Edition. American Public Health Association, Washington D.C.
Arora, H., M. LeChevallier, R. Aboytes, E. Bouwer, C. O'Melia, W.
Ball, W. Weiss, and T. Speth. 2000. Full-scale evaluation of
riverbank filtration at three Midwest water treatment plants.
Proceedings of the Water Quality Technology Conference, Salt Lake
City, Utah, American Water Works Association, Denver, Colorado.
Arrowood, M.J. 1997. Diagnosis. In: Cryptosporidium and
cryptosporidiosis, R. Fayer, ed. CRC Press, New York.
ASTM. 2001. Standard test method for on-line measurement of
turbidity below 5 NTU in water. D-6698-01.
ASTM. 2003. Standard test method for determination of turbidity
below 5 NTU in static mode. D-6855-03.
Battigelli, D. and M. Sobsey. 1993. The inactivation of Hepatitis A
virus, poliovirus, and coliphage MS2 by lime softening and chlorine/
monochloramine disinfection. Proceedings of the Water Quality
Technology Conference of the American Water Works Association, Denver, CO.
Bern, C., Y. Ortega, W. Checkley, J. Roberts, A. Lescano, L.
Cabrera, M. Verastegui, E. Black, C. Sterling, and H. Gilman. 2002.
Epidemiologic differences between cyclosporiasis and
cryptosporidiosis in Peruvian children. Emerging Infectious
Diseases. 8:6:581-5.
Bukhari, Z., T. Hargy, J. Bolton, B. Dussert, and J. Clancy. 1999.
Medium-pressure UV for oocyst inactivation. J. AWWA. 91:3:86-94.
Carey, C.M., H. Lee, and J.T. Trevors. 2004. Biology, persistence
and detection of Cryptosporidium parvum and Cryptosporidium hominis
oocyst. Wat. Res. 38: 818-862.
Casemore, D. 1990. Epidemiological aspects of human
cryptosporidiosis. Epidemiol. Infect. 104:1-28.
[[Page 763]]
CDC. 1993. Surveillance for Waterborne-Disease Outbreaks--United
States, 1991-1992. MMWR. 42/SS-5:1-22.
CDC. 1996. Surveillance for Waterborne-Disease Outbreaks--United
States, 1993-1994. MMWR. 45/SS-1:1-33.
CDC. 1998. Surveillance for Waterborne-Disease Outbreaks--United
States, 1995-1996. MMWR. 47/SS-5:1-33.
CDC. 2000. Surveillance for Waterborne-Disease Outbreaks--United
States, 1997-1998. MMWR. 49/SS-4:1-36.
CDC. 2001. Preliminary FoodNet Data on the Incidence of Foodborne
Illnesses--Selected Sites, United States, 2000. MMWR. 50(13):241-246.
CDC. 2002. Surveillance for Waterborne-Disease outbreaks: United
States, 1999-2000. MMWR 51(SS-8):1-47.
Chappell, C., P. Okhuysen, C. Sterling, C. Wang, W. Jakubowski and
H. Dupont. 1999. Infectivity of Cryptosporidium parvum in healthy
adults with pre-existing anti-C. Parvum serum immunoglobulin G. Am.
J. Trop. Med. Hyg. 60:157-164.
Ciardelli, C. 1996a. Giardia and Cryptosporidium challenge of the
HIF-14 vessel and PP-D-1 cartridges. Analytical Services, Inc.,
Williston, VT.
Ciardelli, C. 1996b. Giardia and Cryptosporidium challenge of the
HUR-170-HP filter. Analytical Services, Inc., Williston, VT.
Cicirello, H., K. Kehl, D. Addiss, M. Chusid, R. Glass, J. Davis,
and P. Havens. 1997. Cryptosporidiosis in children during a massive
waterborne outbreak in Milwaukee, Wisconsin: Clinical, laboratory
and epidemiologic findings. Epidemiol. Infect. 119 (1): 53-60.
Clancy, J., Z. Bukhari, T. Hargy, M. Thomas, J. Bolton, B. Dussert.
1998. Inactivation of Cryptosporidium parvum Oocysts Using Medium-
Pressure Ultraviolet Light in Bench and Pilot Scale Studies.
Proceedings 1998 American Water Works Association Water Quality
Technology Conference, San Diego, CA, November 1-4:
Clancy, J., Z. Bukhari, T. Hargy, J. Bolton, B. Dussert, and M.
Marhsall. 2000. Using UV to inactivate Cryptosporidium. J. AWWA.
92(9):97-104.
Clancy, J., T. Hargy, D. Battigelli, M. Marshall, D. Korich, and W.
Nicholson. 2002. Susceptibility of multiple strains of C. parvum to
UV light. AWWA Research Foundation, Denver, CO
Clark, S.C., M. Morabbi, T. Hargy, J. Chandler, and J. Wiginton.
2001. Softening: The Ultimate Microbial Tool?. Proceedings of the
Water Quality Technology Conferenc, Nashville, TN, November 11-15.
Publisher: American Water Works Association, Denver, CO.
Clark, R., M. Sivagensan, E. Rice, and J. Chen. 2002a. Development
of a CT equation for the inactivation of Cryptosporidium oocysts
with ozone. Wat. Res. 36: 3141-3149.
Clark, R., M. Sivagensan, E. Rice, and J. Chen. 2002b. Development
of a CT equation for the inactivation of Cryptosporidium oocysts
with chlorine dioxide. Wat. Res. (in press).
Connell, K, C. Rodgers, H. Shank-Givens, J. Scheller, M. Pope, and
K. Miller. 2000. Building a better protozoa data set. J. AWWA.
92(10):30-43.
Cornwell, D.A., M.J. MacPhee, N.E. McTigue, H. Arora, G. DiGiovanni,
M. LeChevallier, and J.S. Taylor. 2001. Treatment options for
Giardia, Cryptosporidium, and other contaminants in recycled
backwash water. AWWA Research Foundation, Denver, CO.
Cornwell, D. and M. LeChevallier (2002). Treatment options for
removal of Giardia, Cryptosporidium, and other contaminants in
recycled backwash water. American Water Works Association Research
Foundation, Denver, CO.
Corso, P., M. Kramer, K. Blair, D. Addiss, J. Davis, A. Haddix.
2003. The cost of illness associated with the massive waterborne
outbreak of Cryptosporidium infections in 1993 in Milwaukee,
Wisconsin. Emerging Infectious Diseases. 9:4:426-31.
Craik, S., G. Finch, J. Bolton, and M. Belosevic, 2000. Inactivation
of Giardia muris cysts using medium-pressure ultraviolet radiation
in filtered drinking water. Wat. Res. 34:18:4325-32.
Craik, S., D. Weldon, G. Finch, J. Bolton, and M. Belosevic. 2001.
Inactivation of Cryptosporidium parvum oocysts using medium- and
low-pressure ultraviolet radiation. Wat. Res. 35:1387-98
Craun, F., and R. Calderon. 1996. Microbial risks in groundwater
systems: Epidemiology of waterborne outbreaks. Under the Microscope:
Examining microbes in groundwater. Proceedings of the Groundwater
Foundation's 12th Annual Fall Symposium, Boston. September.
Current, W. 1986. Cryptosproridium: Its biology and potential for
environmental transmission. Crit. Rev. in Env. Control. 17:1:21-51.
Driedger, A.M., J.L. Rennecker, and B.J. Marinas. 2001. Inactivation
of Cryptosporidium parvum oocysts with ozone and monochloramine at
low temperature. Wat. Res. 35(1)41-48.
Dugan, N., K. Fox, J. Owens, and R. Miltner. 2001. Controlling
Cryptosporidium oocysts using conventional treatment. J. AWWA.
93:12::64-76.
DuPont, H., C. Chappell, C. Sterling, P. Okhuysen, J. Rose, and W.
Jakubowski. 1995. The Infectivity of Cryptosporidium parvum in
healthy volunteers. New Eng. J. Med. 332(13):855-859.
Dwyer, P., M. Collins, A. Margolin, and Hogan. 1995. Assessment of
MS2 Bacteriophage Giardia Cysts Cryptosporidium Oocysts and Organic
Carbon Removals by Hollow Fiber Ultrafiltration. AWWA Membrane
Technology Conference Proceedings, Reno NV, pp. 487.
Edzwald, J. and M. Kelly. 1998. Control of Cryptosporidium from
reservoirs to clarifiers to filters. Wat. Sci. Technol. 37(2):1-8.
Embrey, M. 1999. Adenovirus in drinking water, literature summary.
Final report. Prepared by The George Washington University School of
Public Health and Health Services, Department of Environmental and
Occupational Health, Washington, DC.
Emelko, M., P. Huck, and R. Slawson. 1999. Design and Operational
Strategies for Optimizing Cryptosporidium Removal by Filters.
Proceedings of 1999 Water Quality Technology Conference, American
Water Works Association, Denver, CO.
Emelko, M., P. Huck, and II. Douglas, and J. van den Oever. 2000.
Cryptosporidium and Microsphere Removal During Low Turbidity End-of-
Run and Early Breakthrough Filtration. Proceeding Of Water Quality
Technology Conference, American Water Works Association, Denver, CO.
Enriquez, C. and C. Greba. 1999. Evaluation of the Osmonics Water
Purification Filters FGF, FAP and SXE in their Ability to Remove
Cryptosporidium parvum Oocysts. Final Report. University of Arizona,
Tuscon, AZ.
Farthing M.J. 2000. Clinical aspects of human cryptosporidiosis. In:
Cryptosporidiosis and microsporidiosis,vol. 6,1st ed., F. Petry,
editor. S. Kargar AG, New York. 50-74.
Fayer, R., and B. Ungar. 1986. Cryptosporidium spp. and
cryptosporidiosis. Microbial Review. 50(4):458-483.
Fayer, R. and T. Nerad. 1996. Effects of low temperatures on
viability of Cryptosporidium parvum oocysts. Appl. Environ.
Microbiol., 62:4:1431-1433.
Fayer, R., L. Gasbarre, P. Pasquali, A. Canals, S. Almeria, and D.
Zarlenga. 1998a. Cryptosporidium parvum infection in bovine
neonates-dynamic clinical, parasitic, and immunologic patterns. Int.
J. Parasitol., 28:1:49-56.
Fayer, R., J.M. Trout, and M.C. Jenkins. 1998b. Infectivity of
Cryptosporidium parvum oocysts stored in water at environmental
temperatures. J. Parasitol. 84(6)1165-1169.
Finch, G.R., L.L. Gyurek, L.R. Liyanage, and M. Belosevic. 1997.
Effects of various disinfection methods on the inactivation of
Cryptosporidium. AWWA Research Foundation, Denver, CO.
Fogel, D., J. Isaac-Renton, R. Guasparini, W. Moorehead, and J.
Ongerth. 1993. Removing Giardia and Cryptosporidium by slow sand
filtration. J. AWWA. 85:11:77-84.
Francy et al. 2004. Effects of seeding procedures and water quality
on recovery of Cryptosporidium oocysts from stream water by using
U.S. Environmental Protection Agency Method 1623. Applied and
Environmental Microbiology. 70(7):4118-4128.
Frisby, H.R., D.G. Addiss, W.J. Reiser, B. Hancock, J.M. Vergeront,
N.J. Hoxie, J.P. Davis. 1997. Clinical and epidemiologic features of
a massive waterborne outbreak of cryptosporidiosis in persons with
HIV infection. J. AIDS and Hum. Retrovirology 16:367-373.
Frost, F.J., T. Muller, G.F. Craun, R.L. Calderon, and P.A. Roeffer.
2001. Paired
[[Page 764]]
city Cryptosporidium serosurvey in the southwest USA, Epidemiol.
Infect. 126:301-307.
Frost, F.J., T. Muller, G.F. Craun, W.B. Lockwood, R.L. Calderon.
2002. Serological evidence of endemic waterborne Cryptosporidium
infections. Annals of Epidemiology 12:222-227.
Geldreich, E.E., and S. Shaw. 1993. New York City Water Supply
Microbial Crisis. U.S. Environmental Protection Agency.
Gerba, C., J. Rose, and C. Haas. 1996. Sensitive populations: who is
at the greatest risk? International Journal of Food Microbiology:
30(1-2), 10pp.
Goodrich, J., S. Li, and B. Lykins. 1995. Cost and Performance
Evaluations of Alternative Filtration Technologies for Small
Communities. Proceedings of the Annual Conference of the American
Water Works Association, Denver, CO.
Graczyk, T.K. Cranfield, M.R., Fayer, R. and Anderson, M.S. 1996.
Viability and Infectivity of Cryptosporidium parvum Oocysts are
Retained Upon Intestinal Passage Through a Refractory Avian Host.
Applied and Environmental Microbiology 62(9):3234-3237.
Great Lakes Instruments, 1992. Analytical Method for Turbidity
Measurement: Great Lakes Instrument Method 2, GLI, Milwaukee, WI. 8pp.
Gregory, R. and T. Zabel. 1990. Sedimentation and Flotation in Water
Quality and Treatment: A Handbook of Community Water Supplies. F.W.
Pontious, ed. American Water Works Assoc. 4th ed. New York: McGraw
Hill. 427-444.
Hagen, K. 1998. Removal of Particles, Bacteria and Parasites With
Ultrafiltration for Drinking Water Treatment. Desalination: The
International Journal on the Science and Technology of Desalting and
Water Purification. 1(3): 85-91.
Hall T., J. Pressdee, and E. Carrington. 1994. Removal of
Cryptosporidium oocysts by water treatment processes. Report No.
FR0457, Foundation for Water Research, Bucks, UK.
Harrington W., A. Krupnick, and W. Spofford. 1985. The benefits of
preventing an outbreak of giardiasis due to drinking water
contamination. Resources for the Future Report.
Harrington, G., H. Chen, A. Harris, II. Xagoraraki, D. Battigelli,
and J. Standridge. 2001. Removal of Emerging Waterborne Pathogens.
American Water Works Association Research Foundation, Denver, CO.
Harter, T., S. Wagner and E. Atwill. 2000. Colloid transport and
filtration of Cryptosporidium parvum in sandy soils and aquifer
sediments. Environ. Sci. Technol. 34:62-70.
Havelaar, A., M. van Olphen, and J. Schijven. 1995. Removal and
inactivation of viruses by drinking water treatment processes under
full scale conditions, Wat. Sci. Technol. 31:55062.
Heijbel, H., K. Slaine, B. Seigel, P. Wall, S. McNabb, W. Gibbons,
and G. Istre. 1987. Outbreak of diarrhea in a day care center with
spread to household members: The role of Cryptosporidium. Pediatr.
Infect. Dis. J. 6(6):532-535.
Hoxie, N., J. Davis, J. Vergeront, R. Nashold, and K. Blair. 1997.
Cryptosporidiosis-associated mortality following a massive
waterborne outbreak in Milwaukee, Wisconsin. Amer. J. Publ. Health.
87(12):2032-2035.
Huck, P.M., B. Coffey, C. O'Melia, and M. Emelko. 2000. Removal of
Cryptosporidium by Filtration Under Conditions of Process Challenge.
Proceedings from the Water Quality Technology Conference of the
American Water Works Association, Denver, CO.
Jacangelo, J.G, M.E. Aeita, K.E. Carns, E.W. Cummings, and J.
Mallevialle. 1989. Assessing Hollow-Fiber Ultrafiltration for
Particle Removal. J. AWWA, 81:11:68.
Jacangelo, J., S. Adham and J. Laine. 1995. Mechanism of
Cryptosporidium, Giardia, and MS2 virus removal by MF and UF. J.
AWWA 87(9):107-21.
Jacangelo, J., S. Adham, and J-M Laine. 1997. Membrane Filtration
for Microbial Removal, Report No. 90715, American Water Works
Association Research Foundation, Denver, CO.
Kachalesky, L.A., and T. Masterson. 1995. Membrane Filtration of
Sewage Treatment Plant Effluent. AWWA Membrane Technology Conference
Proceedings, Reno NV, pp. 517.
Kato, S., M. Jenkins, W. Ghiorse, E. Fogarty, and D. Bowman. 2001.
Inactivation of Cryptosporidium parvum oocysts in field soil.
Southeast Asian J. Trop. Med. Public Health. 32(2):183-9.
Kelley, M., P. Warrier, J. Brokaw, K. Barrett, and S. Komisar. 1995.
A study of two U.S. Army installation drinking water sources and
treatment systems for the removal of Giardia and Cryptosporidium.
Proceedings of the Annual Conference of the American Water Works
Association, Denver, CO.
Korich, D.G., J.R. Mead, M.S. Madore, N.A. Sinclair, and C.R.
Sterling. 1990. Effects of ozone, chlorine dioxide, chlorine, and
monochloramine on Cryptosporidium parvum oocyst viability. Appl.
Environ. Microbiol. 56(5)1423-1428.
Landis, H., J. Thompson, J. Robinson, and E. Bltachley. 2000.
Inactivation responses of Cryptosporidium parvum to UV radiation and
gamma radiation. Proceedings AWWA Water Quality Technical
Conference, Salt Lake City, UT, November 5-9.
LeChevallier, M., W. Norton, and R. Lee. 1991. Giardia and
Cryptosporidium spp. in filtered drinking water supplies. Appl.
Environ. Microbial. 57(9):2617-2621.
LeChevallier, M. and W. Norton. 1992. Examining relationships
between particle counts and Giardia, Cryptosporidium and turbidity.
J. AWWA. 84(120):52-60.
LeChevallier, M. and W. Norton. 1995. Giardia and Cryptosporidium in
raw and finished water. J. AWWA. 87(9):54-68.
LeChevallier, M., W. Norton, and T. Atherholt. 1997. Protozoa in
open reservoirs. J. AWWA. 89(9):84-96.
LeChevallier, M.W., G. D. Di Giovanni, J.L. Clancy, Z. Bukhari, S.
Bukhari, J.S. Rosen, J. Sobrinho, M.M. Frey. 2003. Comparison of
Method 1623 and Cell Culture-PCR for Deterction of Cryptosporidium
spp. in Source Waters. J. Appl. Environ. Microbiol. 69:2:971-979.
Letterman R., C. Johnson, S. Viswanathan, and J. Dwarakanathan.
2001. A study of low level turbidity measurements. Published by the
American Water Works Association Research Foundation, Denver, CO.
Li, S., J. Goodrich, J. Owens, G. Willeke, F. Schaefer and R. Clark.
1997. Reliability of surrogates for determining Cryptosporidium
removal. J. AWWA. 89(5):90.
Li, H., G. Finch, D. Smith, and M. Belosevic. 2001. Sequential
Disinfection Desgin Criteria for Inactivation of Cryptosporidium
Oocysts in Drinking Water. American Water Works Association Research
Foundation, Denver, CO.
Logsdon, G., M. Frey, T. Stefanich, S. Johnson, D. Feely, J. Rose,
and M. Sobsey. 1994. The removal and disinfection efficiency of lime
softening processes for Giardia and viruses. American Water Works
Association Research Foundation, Denver, CO.
Long, W.R. 1983. Evaluation of Cartridge Filters for the Removal of
Giardia lamblia Cyst Models from Drinking Water Systems. Journal of
Environmental Health. 45(5):220.
MacKenzie, W R and N J Hoxie, M E Proctor, M S Gradus, K A Blair, D
E Peterson, J J Kazmierczak, D A Addiss, K R Fox, J B Rose, and J P
Davis. 1994. A massive outbreak of Cryptosporidium infection
transmitted through the public water supply. New England Journal of
Medicine 331(3): 161-167.
Mazounie, P., F. Bernazeau, and P. Alla. 2000. Removal of
Cryptosporidium by High Rate Contact Filtration: The Performance of
the Prospect Water Filtration Plant During the Sydney Water Crisis.
Water Science and Technology. 41(7):93-101.
McDonald, A., W. MacKenzie, D. Addiss, M. Gradus, G. Linke, E.
Zembrowski, M. Hurd, M. Arroweed, P. Lammie, and J. Priest. 2001.
Cryptosporidium parvum-specific antibody responses among children
residing in Milwaukee during the 1993 waterborne outbreak. Jour.
Infectious Diseases 183:1373-1379.
McTigue, N., M. LeChevallier, H. Arora, and J. Clancy. 1998.
National assessment of particle removal by filtration. American
Water Works Association Research Foundation, Denver, CO.
Mead, P.S., Slutsker, L., Dietz, V., McCaig, L.F., Bresee, J.S.,
Shapiro, C., Griffin, P.M., and Tauxe, R.V. 1999. Food-Related
Illness and Death in the United States. Center for Disease Control
and Prevention 5(5):607-625.
Medema, G., M. Juhasz-Hoterman, and J. Luitjen. 2000. Removal of
micro-organisms by bank filtration in a gravel-sand soil.
Proceedings of the International Riverbank Filtration Conference,
November 2-4, D[uuml]sseldorf,
[[Page 765]]
W. Julich and J. Schubert, eds., Internationale Arbeitgemeinschaft
der Wasserwerke im Rheineinzugsgebiet, Amsterdam.
Messner, M. 2003. Estimating lot variability (Chlorine dioxide CT
table). USEPA Report. April 30, 2003.
Millard, P., K. Gensheimer, D. Addiss, D. Sosin, G. Beckett, A.
Houck-Jankoski, and A. Hudson. 1994. An outbreak of
cryptosporidiosis from fresh-pressed apple cider. JAMA. 272:1592-1596.
Morgan-Ryan, U., A. Fall, L. Ward, N. Hijjawi, II. Sulaiman, R.
Fayer, R. Thompson, M. Olson, A. Lal, and L. Xiao. 2002.
Cryptosporidium hominis n. sp. (Apicomplexa: Cryptosporidiidae) from
Homo sapiens. Jounal of Eukaryotic Microbiology. 49:6:443-440.
National Research Council. 1997. Safe water from every tap. National
Academy Press, Washington, DC.
Nichols et al. 2004. Survival of Cryptosporidium parvum oocysts
after prolonged exposure to still natural mineral waters. Journal of
Food Protection 67(3):517-523.
Nieminski, E. and J. Ongerth. 1995. Removing Giardia and
Cryptosporidium by conventional treatment and direct filtration. J.
AWWA 87(9):96-106.
Nieminski, E. and W. Bellamy. 2000. Application of Surrogate
Measures to Improve Treatment Plant Performance. AWWA Research
Foundation, Denver, CO.
NSF International. 2000a. Environmental Technology Verification
Report: Physical Removal of Cryptosporidium oocysts and Giardia
cysts in Drinking Water, Aquasource North America, Ultrafiltration
System Model A35, Pittsburgh, PA.
NSF International. 2000b. Environmental Technology Verification
Report: Physical Removal of Cryptosporidium oocysts and Giardia
cysts in Drinking Water, Pall Corporation, WPM-1 Microfiltration
Pilot System, Pittsburgh, PA.
NSF International. 2000c. Environmental Technology Verification
Report: Physical Removal of Cryptosporidium oocysts and Giardia
cysts in Drinking Water, Leopold Membrane Systems, Ultrabar
Ultrafiltration System with 60 Inch Mark III Membrane Element,
Pittsburgh, PA.
NSF International. 2000d. Environmental Technology Verification
Report: Physical Removal of Cryptosporidium oocysts and Giardia
cysts in Drinking Water, Zenon, ZeeWeed ZW-500 Ultrafiltration
Membrane System, Pittsburgh, PA.
NSF International. 2000e. Environmental Technology Verification
Report: Physical Removal of Microbiological and Particulate
Contaminants in Drinking Water, Ionics, UF-1-7T Ultrafiltration
Membrane System, Escondido, CA.
NSF International. 2000f. Environmental Technology Verification
Report: Physical Removal of Microbiological and Particulate
Contaminants in Drinking Water, Zenon, Enhanced Coagulation ZeeWeed
ZW-500 Ultrafiltration Membrane System, Escondido, CA.
NSF International. 2000g. Environmental Technology Verification
Report: Physical Removal of Microbiological and Particulate
Contaminants in Drinking Water, Hydranautics, Hydracap
Ultrafiltration Membrane System, Escondido, CA.
NSF International. 2001a. Environmental technology verification
report, physical removal of Giardia- and Cryptosporidium-sized
particles in drinking water: Rosedale Products, Inc. Bag and
Cartridge Filter System Model GFS-302P2-150S-ESBB. (01/08/PEADW395),
Ann Arbor, MI.
NSF International. 2001b. Environmental technology verification
report, physical removal of Giardia- and Cryptosporidium-sized
particles in drinking water: Lapoint Industries Aqua-Rite Potable
Water Filtration System. (01/08/PEADW395), Ann Arbor, MI.
NSF International. 2002a. Proposed Modification to ETV Protocol for
Equipment Verification Testing for Physical Removal of
Microbiological and Particulate Contaminants, Test Plan for Membrane
Filtration. Ann Arbor, MI.
NSF International. 2002b. Environmental Technology Verification
Protocol for Equipment Verification Testing for Physical Removal of
Microbiological and Particulate Contaminants. (40CFR35.6450), Ann
Arbor, MI.
Okhuysen, P.C., C.L. Chappell, C.R. Sterling, W. Jakubowski, and
H.L. DuPont. 1998. Susceptibility and Serologic Response of Healthy
Adults to Reinfection with Cryptosporidium parvum. American Society
for Microbiology. 66:2:441-443.
Okhuysen, P.C., C.L. Chappell, J.H. Crabb, C.R. Sterling, and H.L.
DuPont. 1999. Virulence of three distinct Cryptosporidium parvum
isolates for healthy adults. Journal of Infectious Diseases.
180:4:1275-1281.
Okhuysen, P.C., S.M. Rich, C.L. Chappell, K.A. Grimes, G. Widmer, X.
Feng, S. Tzipori. 2002. Infectivity of a Cryptosporidium parvum
isolate of cervine origin for healthy adults and interferon-gamma
knockout mice. J Infect Dis. 185(9):1320-5.
Oliveri, V., G. Willinghan, J. Vickers, and C. McGahey. 1991.
Continuous Microfiltration of Secondary Wastewater Effluent. AWWA
Membrane Technology Conference Proceedings, Orlando, FL.
Ongerth, J. and J. Pecoraro. 1995. Removing Cryptosporidium using
multimedia filters. J. AWWA. 87(12):83-89.
Ongerth, J. and P. Hutton. 1997. DE filtration to remove
Cryptosporidium. J. AWWA. 89(12):39-46.
Ongerth, J. and P. Hutton. 2001. Testing of diatomaceous earth
filtration for removal of Cryptosporidium oocysts. J. AWWA. 93(12): 54-63.
Oppenheimer J., E. Aieta, R. Trussell, J. Jacangelo, and N. Najim.
2000. Evaluation of Cryptosporidium inactivation in natural waters.
American Water Works Association Research Foundation, Denver, CO.
Oppenheimer, J., T. Gillogly, G. Stolarik, and R. Ward. 2002.
Comparing the efficiency of low and medium pressure UV light for
inactivating Giardia muris and Cryptosporidium parvum in waters with
low and high levels of turbidity. Proceedings of the Annual
Conference of the American Water Works Association, Denver, CO.
Osewe, P, D. Addis, K. Blair, A. Hightower, M. Kamb, and J. Davis.
1996. Cryptosporidiosis in Wisconsin: A case-control study of post-
outbreak transmission. Epidemiol. Infect. 117:297-304.
Owens J., R. Miltner, T. Slifko, and J. Rose. 1999. In vitro
excystation and infectivity in mice and cell culture to assess
chlorine dioxide inactivation of Cryptosporidium oocysts, in
Proceedings of the Water Quality Technology Conference of the
American Water Works Association, Denver, CO.
Owens J., R. Miltner, E. Rice, C. Johnson, D. Dahling, F. Schaefer,
and H. Shukairy 2000. Pilot-scale ozone inactivation of
Cryptosporidium and other microorganisms in natural water. Ozone
Sci. Eng. 22:5:501-517.
Pang, L., M. Close and M. Noonan. 1998. Rhodamine WT and Bacillus
subtilis transport through an alluvial gravel aquifer. Ground Water.
36:112-122.
Patania, N., Jacangelo, J., Cummings, L., Wilczak, A., Riley, K.,
and Oppenheimer, J. 1995. Optimization of Filtration for Cyst
Removal. AWWARF. Denver, CO. 178pp.
Patania, N., P. Mazounie, F. Bernazeau, G. Maclean, and P. Alla.
1999. Removal of Cryptosporidium by contact filtration: The Sydney
experience. Proceedings of the Annual Conference of the American
Water Works Association, Denver, CO.
Payment, P. and E. Franco. 1993. Clostridium perfringens and somatic
coliphages as indicators of the efficiency of drinking water
treatment for viruses and protozoan cysts. Appl. Environ. Micro.
59(8):2418-2424.
Plummer, J.D., J.K. Edzwald, and M.B. Kelly. 1995. Removing
Cryptosporidium by dissolved-air flotation. J. AWWA. 87(9):85-95.
Pope, M., M. Bussen, M. Feige, L. Shadix, S. Gonder, C. Rodgers, Y.
Chambers, J. Pulz, K. Miller, K. Connell, and J. Standridge. 2003.
Assessment of the effects of holding time and temperature on E. coli
densities in surface water samples. Appl. Environ. Micro.
69(10):6201-7.
Pokorny, N.J., S.C. Weir, R.A. Carreno, J.T. Trevors, H. Lee. 2002.
Influence of temperature on Cryptosporidium parvum oocyst
infectivity in river water samples as detected by tissue culture
assay. J Parasitol. 88(3):641-3.
Qian, S., M. Donnelly, D. Schmelling, M. Messner, K. Linden, and C.
Cotton. 2004. Ultraviolet light inactivation of protozoa in drinking
water: a Bayesian meta-analysis. Wat. Res. 38(2) 317-326
Ransome, M.E., T.N. Whitmore, and E.G. Carrington. 1993. Effects of
Disinfectants on the Viability of Cryptosporidium parvum oocysts.
Water Supply. 11:75-89.
Rennecker J., B. Marinas, J. Owens and E. Rice. 1999. Inactivation
of Cryptosporidium parvum oocysts with ozone. Wat. Res. 33(11):2481-2488.
[[Page 766]]
Rennecker, J.L., A.M. Driedger, S.A. Rubin, and B.J. Marinas. 2000.
Synergy in sequential inactivation of Cryptosporidium parvum with
ozone/free chlorine and ozone/monochloramine. Wat. Res. 34(17):4121-4130.
Rice, E., K. Fox, R. Miltner, D. Lytle, and C. Johnson. 1996.
Evaluating Plant Performance with Endospores. J. AWWA. 88(9):122-130.
Robertson, L.J., A.T. Campbell, and H.V Smith. 1992. Survival of
Cryptosporidium parvum oocysts under various environmental
pressures. Appl. Env. Microbiol., 58:11:3494-3500.
Roessler, N. 1998. Control of Cryptosporidium in bottled water using
cartridge filtration systems. Filtration & Separation. 35(1):37-39.
Rossignol J.F., H. Hidalgo, M. Feregrino, F. Higuera, W.H. Gomez,
J.L. Romero, J. Padierna, A. Geyne, M.S. Ayers. 1998. A double-
`blind' ``placebo controlled study of nitazoxanide in the treatment
of cryptosporidial diarrhoea in AIDS patients in Mexico. Trans R Soc
Trop Med Hyg 92(6):663-6.
Ruffell K., J. Rennecker, and B. Marinas. 2000. Inactivation of
Cryptosporidium parvum oocysts with chlorine dioxide. Wat. Res.
34(3):868-876.
SAB (EPA Science Advisory Board). 2003. Disinfection Byproducts and
Surface Water Treatment: A EPA Science Advisory Board Review of
Certain Elements of the Stage 2 Regulatory Proposals. A Review by
the Drinking Water Committee of the EPA Science Advisory Board
Executive Committee. EPA-SAB-DWC-03-005.
Sadar, M. 1999. Turbidimeter Instrument Comparison: Low-level Sample
Measurements Technical Information Series. Hach Company. ap/dp 4/99
1ed rev1 D90.5 Lit No. 7063.
Schaub, S., H. Hargett, M. Schmidt and W. Burrows. 1993. Reverse
osmosis water purification unit: Efficacy of cartridge filters for
removal of bacteria and protozoan cysts when RO elements are
bypassed. U.S. Army Biomedical Research and Development Laboratory,
Fort Detrick, Frederick, MD.
Scheller, J, K. Connell, H. Shank-Givens, and C. Rodgers. 2002.
Design, Implementation, and Results of USEPA's 70-utility ICR
Laboratory Spiking Program. Information Collection Rule Data
Analysis. McGuire, M, J. McLain, and A. Obolensky, eds.
Schuler, P. and M. Ghosh. 1990. Diatomaceous earth filtration of
cysts and other particulates using chemical additives. J. AWWA
82(12):67-75.
Schuler, P. and M. Ghosh. 1991. Slow sand filtration of cysts and
other particulates. Proceedings of the annual conference of the
American Water Works Association, Denver, CO.
Shin, G., K. Linden, M. Arrowood, and M. Sobsey. 2001. Low-Pressure
UV Inactivation and DNA Repair Potential of Cryptosporidium parvum
Oocysts. Appl. Environ. Microbiol. 67(7):3029-3032.
Silverman, G., L. Nagy, and B. Olson. 1983. Variations in
particulate matter, algae, and bacteria in an uncovered finished-
drinking-water reservoir. J. AWWA. 75(4):191-5.
Sivaganesan, M. 2003. Estimating lot variability for development of
ozone CT table. USEPA Report. February 24, 2003.
Solo-Gabriele, H. and S. Neumeister. 1996. U.S. outbreaks of
cryptosporidiosis. J. AWWA. 88:76-86.
Sommer, R., S. Appelt, W. Pribil, and T. Slifko. 2001. UV
Irradiation in a Standard Laboratory Batch Apparatus (Wavelength
253.7 nm). Draft Report.
States, S., K. Stadterman, L. Ammon, p. Vogel, J. Baldizar, D.
Wright, L. Conley, and J. Sykora. 1997. Protozoa in river water:
sources, occurrence, and treatment. J. AWWA. 89:(9)74-83.
Tangerman, R., S. Gordon, P. Wiesner, and L. Kreckmanet. 1991. An
outbreak of cryptosporidiosis in a day-care center in Georgia,
American Jour. of Epidemiology. 133:471-476.
Timms, S., J. Slade, and C. Fricker. 1995. Removal of
Cryptosporidium by slow sand filtration. Wat. Sci. Technol. 31(5-
6):81-84.
Trussel, R., P. Gagliardo, S. Adham, amd A. Olivieri. 1998.
Membranes as an Alternate to Disinfection. Microfiltration II
Conference of the National Water Research Institute Proceedings,
November 12-13, San Diego, CA.
USDOE. 2004a. Table ES1.A. Total Electric Power Industry Summary
Statistics, 2004 and 2003. http://www.eia.doe.gov/cneaf/electricity/epm/
tablees1a.html. USDOE 2004b. Table 7.1. Electricity Overview (Billion
Kilowatthours). http://www.eia.doe.gov/emeu/mer/txt/mer7-1.
USEPA 1989a. National Primary Drinking Water Regulations;
Filtration, Disinfection; Turbidity, Giardia lamblia, Viruses,
Legionella, and Heterotrophic Bacteria; Final Rule. Part III.
Federal Register, 54:124:27486. (June 29, 1989).
USEPA. 1989b. National Interim Primary Drinking Water Regulations;
Total Coliform Rule; Final Rule. Part III. Federal Register,
54:124:27544. (June 29, 1989).
USEPA. 1991a. Optimizing Water Treatment Plant Performance Using the
Composite Correction Program. EPA 625-6-91-027.
USEPA. 1991b. Guidance Manual for Compliance with the Filtration and
Disinfection Requirements for Public Water Systems Using Surface
Water Sources. Published by American Water Works Assoc. Denver, CO.
USEPA. 1993. EPA Method 180.1. Nephelometric Method. EPA 600/R-93-100.
USEPA. 1994. National Primary Drinking Water Regulations; Enhanced
Surface Water Treatment Requirements. 59 FR 38832; July 29, 1994.
USEPA. 1997. National Primary Drinking Water Regulations: Interim
Enhanced Surface Water Treatment Rule Notice of Data Availability;
Proposed Rule. 62 FR 59486, November 3, 1997.
USEPA. 1998a. National Primary Drinking Water Regulations; Interim
Enhanced Surface Water Treatment Rule. 63 FR 69477, December 16, 1998.
USEPA. 1998b. National Primary Drinking Water Regulations; Stage 1
Disinfectants and Disinfection Byproducts Rule. 63 FR 69389;
December 16, 1998.
USEPA. 1998c. Revisions to State Primacy Requirements To Implement
Safe Drinking Water Act Amendments. 63 FR 23362, April 28, 1998.
USEPA. 1999a. Method 1622: Cryptosporidium in Water by Filtration/
IMS/FA. EPA-821-R-99-001.
USEPA. 1999b. Method 1623: Cryptosporidium and Giardia in Water by
Filtration/IMS/FA. EPA-821-R-99-006.
USEPA. 1999c. Guidance Manual for Compliance with the Interim
Enhanced Surface Water Treatment Rule: Turbidity Provisions. EPA-
815-R-99-010.
USEPA. 1999d. Disinfection Profiling and Benchmarking Guidance
Manual. EPA 815-R-99-013.
USEPA. 1999e. Uncovered Finished Water Reservoirs Guidance Manual.
EPA 815-R-99-011.
USEPA. 2000a. Stage 2 Microbial and Disinfection Byproducts Federal
Advisory Committee Agreement in Principle. 65 FR 83015; December 29, 2000.
USEPA. 2000b. National Primary Drinking Water Regulations: Public
Notification Rule; Final Rule. 65 FR 25982; May 4, 2000.
USEPA. 2000c. U.S. Environmental Protection Agency. Guidelines for
Preparing Economic Analyses. Washington, DC. EPA 240-R-00-003,
September 2000.
USEPA. 2000d. SAB Report from the Environmental Economics Advisory
Committee on EPA's White Paper ``Valuing the Benefits of Fatal
Cancer Risk Reduction.'' EPA-SAB-EEAC-00-013.
USEPA. 2001a. National Primary Drinking Water; Filter Backwash
Recycling Rule; Final Rule. 66 FR 31086; June 8, 2001. EPA-815-Z-01-001.
USEPA. 2001b. Cryptosporidium: Human Health Criteria Document. EPA-
822-K-94-001.
USEPA. 2001c. Cryptosporidium: Drinking Water Advisory. EPA-822-R-01-009.
USEPA. 2001d. Cryptosporidium: Risk for Infants and Children.
February 23, 2001.
USEPA. 2001e. Method 1622: ``Cryptosporidium in Water by Filtration/
IMS/FA'' EPA-821-R-01-026, April 2001.
USEPA. 2001f. Method 1623: ``Cryptosporidium and Giardia in Water by
Filtration/IMS/FA'' EPA 821-R-01-025, April 2001.
USEPA. 2001g. Low-Pressure Membrane Filtration for Pathogen Removal:
Application, Implementation and Regulatory Issues. EPA 815-C-01-001.
USEPA. 2001h. Guidelines Establishing Test Procedures for the
Analysis of Pollutants; Analytical Methods for Biological Pollutants
in Ambient Water; Proposed Rule. Federal Register. August 30, 2001.
USEPA. 2002a. National Primary Drinking Water Regulations: Long Term 1
[[Page 767]]
Enhanced Surface Water Treatment Rule; Final Rule. Federal Register.
January 14, 2002. 67 FR 1812. EPA 815-Z-02-001.
USEPA. 2002b. Process for Designing a Watershed Initiative. 67 FR
36172, May 23, 2002.
USEPA. 2002c. Method 1103.1: Escherichia coli (E. coli) In Water By
Membrane Filtration Using membrane-Thermotolerant Escherichia coli
Agar (mTEC). U.S. Environmental Protection Agency, Office of Water,
Washington, DC. EPA-821-R-02-020.
USEPA. 2002d. Laboratory Quality Assurance Evaluation Program for
Analysis of Cryptosporidium Under the Safe Drinking Water Act;
Agency Information Collection: Proposed Collection; Comment Request.
Federal Register: March 4, 2002. 67 FR 9731.
USEPA. 2003a. National Primary Drinking Water Regulations: Long Term
2 Enhanced Surface Water Treatment Rule; Proposed Rule. 68 FR 47640,
August 11, 2003.
USEPA. 2003b. Guidelines Establishing Test Procedures for the
Analysis of Pollutants; Analytical Methods for Biological Pollutants
in Ambient Water. 68 FR 43272, July 21, 2003.
USEPA. 2005a. Economic Analysis for the Long Term 2 Enhanced Surface
Water Treatment Rule. U.S. Environmental Protection Agency, Office
of Water, Washington, DC. EPA-821-R-06-001.
USEPA. 2005b. Occurrence and Exposure Assessment for the Long Term 2
Enhanced Surface Water Treatment Rule. U.S. Environmental Protection
Agency, Office of Water, Washington, DC. EPA-821-R-06-002.
USEPA. 2005c. Method 1622: Cryptosporidium in Water by Filtration/
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.
? For the reasons set forth in the preamble, title 40 chapter I of the
Code of Federal Regulations is amended as follows:
PART 9--[AMENDED]
? 1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; Executive Order 11735, 38 FR
21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246,
300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1,
300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-
7671q, 7542, 9601-9657, 11023, 11048.
? 2. In Sec. 9.1 the table is amended as follows:
? 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''.
? 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
* * * * * * *
-----------------------------------------------------------------------
[[Page 768]]
PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS
? 3. The authority citation for Part 141 continues to read as follows:
Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-
5, 300g-6, 300j-4, 300j-9, and 300j-11.
? 4. Section 141.2 is amended by 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.
* * * * *
? 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.
? 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
[[Page 769]]
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.
? 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.
[[Page 770]]
(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
[[Page 771]]
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).
[[Page 772]]
(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
near the intake on the same day and must follow either paragraph
(e)(2)(i) or (ii) of this section for sample analysis.
(i) Systems may composite samples from each source into one sample
prior to analysis. The volume of sample from each source must be
weighted according to the proportion of the source in the total plant
flow at the time the sample is collected.
(ii) Systems may analyze samples from each source separately and
calculate a weighted average of the analysis results for each sampling
date. The weighted average must be calculated by multiplying the
analysis result for each source by the fraction the source contributed
to total plant flow at the time the sample was collected and then
summing these values.
(f) Additional Requirements. Systems must submit a description of
their sampling location(s) to the State at the same time as the
sampling schedule required under Sec. 141.702. This description must
address the position of the sampling location in relation to the
system's water source(s) and treatment processes, including
pretreatment, points of chemical treatment, and filter backwash
recycle. If the State does not respond to a system regarding sampling
location(s), the system must sample at the reported location(s).
Sec. 141.704 Analytical methods.
(a) Cryptosporidium. Systems must analyze for Cryptosporidium using
Method 1623: Cryptosporidium and Giardia in Water by Filtration/IMS/FA,
2005, United States Environmental Protection Agency, EPA-815-R-05-002
or Method 1622: Cryptosporidium in Water by Filtration/IMS/FA, 2005,
United States Environmental Protection Agency, EPA-815-R-05-001, which
are incorporated by reference. The Director of the Federal Register
approves this incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may obtain a copy of these methods online
from http://www.epa.gov/safewater/disinfection/lt2 or from the United
States Environmental Protection Agency, Office of Ground Water and
Drinking Water, 1201 Constitution Ave., NW, Washington, DC 20460
(Telephone: 800-426-4791). You may inspect a copy at the Water Docket
in the EPA Docket Center, 1301 Constitution Ave., NW, Washington, DC,
(Telephone: 202-566-2426) or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html. 
(1) Systems must analyze at least a 10 L sample or a packed pellet
volume of at least 2 mL as generated by the methods listed in paragraph
(a) of this section. Systems unable to process a 10 L sample must
analyze as much sample volume as can be filtered by two filters
approved by EPA for the methods listed in paragraph (a) of this
section, up to a packed pellet volume of at least 2 mL.
(2)(i) Matrix spike (MS) samples, as required by the methods in
paragraph (a) of this section, must be spiked and filtered by a
laboratory approved for Cryptosporidium analysis under Sec. 141.705.
(ii) If the volume of the MS sample is greater than 10 L, the
system may filter all but 10 L of the MS sample in the field, and ship
the filtered sample and the remaining 10 L of source water to the
laboratory. In this case, the laboratory must spike the remaining 10 L
of water and filter it through the filter used to collect the balance
of the sample in the field.
(3) Flow cytometer-counted spiking suspensions must be used for MS
samples and ongoing precision and recovery (OPR) samples.
(b) E. coli. Systems must use methods for enumeration of E. coli in
source water approved in Sec. 136.3(a) of this title.
(1) The time from sample collection to initiation of analysis may
not exceed 30 hours unless the system meets the condition of paragraph
(b)(2) of this section.
(2) The State may approve on a case-by-case basis the holding of an
E. coli sample for up to 48 hours between sample collection and
initiation of analysis if the State determines that analyzing an E.
coli sample within 30 hours is not feasible. E. coli samples held
between 30 to 48 hours must be analyzed by the Colilert reagent version
of Standard Method 9223B as listed in Sec. 136.3(a) of this title.
(3) Systems must maintain samples between 0[deg]C and 10[deg]C
during storage and transit to the laboratory.
(c) Turbidity. Systems must use methods for turbidity measurement
approved in Sec. 141.74(a)(1).
Sec. 141.705 Approved laboratories.
(a) Cryptosporidium. Systems must have Cryptosporidium samples
analyzed by a laboratory that is approved under EPA's Laboratory
Quality Assurance Evaluation Program for Analysis of Cryptosporidium in
Water or a laboratory that has been certified for Cryptosporidium
analysis by an equivalent State laboratory certification program.
(b) E. coli. Any laboratory certified by the EPA, the National
Environmental Laboratory Accreditation Conference or the State for
total coliform or fecal coliform analysis under Sec. 141.74 is approved
for E. coli analysis under this subpart when the laboratory uses the
same technique for E. coli that the laboratory uses for Sec. 141.74.
(c) Turbidity. Measurements of turbidity must be made by a party
approved by the State.
Sec. 141.706 Reporting source water monitoring results.
(a) Systems must report results from the source water monitoring
required under Sec. 141.701 no later than 10 days after the end of the
first month following the month when the sample is collected.
(b)(1) All systems serving at least 10,000 people must report the
results from the initial source water monitoring required under Sec.
141.701(a) to EPA electronically at https://intranet.epa.gov/lt2/.
(2) If a system is unable to report monitoring results
electronically, the system may use an alternative approach for
reporting monitoring results that EPA approves.
(c) Systems serving fewer than 10,000 people must report results
from the initial source water monitoring required under Sec.
141.701(a) to the State.
(d) All systems must report results from the second round of source
water monitoring required under Sec. 141.701(b) to the State.
(e) Systems must report the applicable information in paragraphs
(e)(1) and (2) of this section for the source water monitoring required
under Sec. 141.701.
(1) Systems must report the following data elements for each
Cryptosporidium analysis:
Data element.
1. PWS ID.
2. Facility ID.
[[Page 773]]
3. Sample collection date.
4. Sample type (field or matrix spike).
5. Sample volume filtered (L), to nearest \1/4\ L.
6. Was 100% of filtered volume examined.
7. Number of oocysts counted.
(i) For matrix spike samples, systems must also report the sample
volume spiked and estimated number of oocysts spiked. These data are
not required for field samples.
(ii) For samples in which less than 10 L is filtered or less than
100% of the sample volume is examined, systems must also report the
number of filters used and the packed pellet volume.
(iii) For samples in which less than 100% of sample volume is
examined, systems must also report the volume of resuspended
concentrate and volume of this resuspension processed through
immunomagnetic separation.
(2) Systems must report the following data elements for each E.
coli analysis:
Data element.
1. PWS ID.
2. Facility ID.
3. Sample collection date.
4. Analytical method number.
5. Method type.
6. Source type (flowing stream, lake/reservoir, GWUDI).
7. E. coli/100 mL.
8. Turbidity.\1\
\1\ Systems serving fewer than 10,000 people that are not required to
monitor for turbidity under Sec. 141.701 are not required to report
turbidity with their E. coli results.
Sec. 141.707 Grandfathering previously collected data.
(a)(1) Systems may comply with the initial source water monitoring
requirements of Sec. 141.701(a) by grandfathering sample results
collected before the system is required to begin monitoring (i.e.,
previously collected data). To be grandfathered, the sample results and
analysis must meet the criteria in this section and the State must approve.
(2) A filtered system may grandfather Cryptosporidium samples to
meet the requirements of Sec. 141.701(a) when the system does not have
corresponding E. coli and turbidity samples. A system that grandfathers
Cryptosporidium samples without E. coli and turbidity samples is not
required to collect E. coli and turbidity samples when the system
completes the requirements for Cryptosporidium monitoring under Sec.
141.701(a).
(b) E. coli sample analysis. The analysis of E. coli samples must
meet the analytical method and approved laboratory requirements of
Sec. Sec. 141.704 through 141.705.
(c) Cryptosporidium sample analysis. The analysis of
Cryptosporidium samples must meet the criteria in this paragraph.
(1) Laboratories analyzed Cryptosporidium samples using one of the
analytical methods in paragraphs (c)(1)(i) through (vi) of this
section, which are incorporated by reference. The Director of the
Federal Register approves this incorporation by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy of these
methods on-line from the United States Environmental Protection Agency,
Office of Ground Water and Drinking Water, 1201 Constitution Ave, NW,
Washington, DC 20460 (Telephone: 800-426-4791). You may inspect a copy
at the Water Docket in the EPA Docket Center, 1301 Constitution Ave.,
NW, Washington, DC, (Telephone: 202-566-2426) or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(i) Method 1623: Cryptosporidium and Giardia in Water by
Filtration/IMS/FA, 2005, United States Environmental Protection Agency,
EPA-815-R-05-002.
(ii) Method 1622: Cryptosporidium in Water by Filtration/IMS/FA,
2005, United States Environmental Protection Agency, EPA-815-R-05-001.
(iii) Method 1623: Cryptosporidium and Giardia in Water by
Filtration/IMS/FA, 2001, United States Environmental Protection Agency,
EPA-821-R-01-025.
(iv) Method 1622: Cryptosporidium in Water by Filtration/IMS/FA,
2001, United States Environmental Protection Agency, EPA-821--R-01-026.
(v) Method 1623: Cryptosporidium and Giardia in Water by
Filtration/IMS/FA, 1999, United States Environmental Protection Agency,
EPA-821-R-99-006.
(vi) Method 1622: Cryptosporidium in Water by Filtration/IMS/FA,
1999, United States Environmental Protection Agency, EPA-821-R-99-001.
(2) For each Cryptosporidium sample, the laboratory analyzed at
least 10 L of sample or at least 2 mL of packed pellet or as much
volume as could be filtered by 2 filters that EPA approved for the
methods listed in paragraph (c)(1) of this section.
(d) Sampling location. The sampling location must meet the
conditions in Sec. 141.703.
(e) Sampling frequency. Cryptosporidium samples were collected no
less frequently than each calendar month on a regular schedule,
beginning no earlier than January 1999. Sample collection intervals may
vary for the conditions specified in Sec. 141.702(b)(1) and (2) if the
system provides documentation of the condition when reporting
monitoring results.
(1) The State may approve grandfathering of previously collected
data where there are time gaps in the sampling frequency if the system
conducts additional monitoring the State specifies to ensure that the
data used to comply with the initial source water monitoring requirements
of Sec. 141.701(a) are seasonally representative and unbiased.
(2) Systems may grandfather previously collected data where the
sampling frequency within each month varied. If the Cryptosporidium
sampling frequency varied, systems must follow the monthly averaging
procedure in Sec. 141.710(b)(5) or Sec. 141.712(a)(3), as applicable,
when calculating the bin classification for filtered systems or the
mean Cryptosporidium concentration for unfiltered systems.
(f) Reporting monitoring results for grandfathering. Systems that
request to grandfather previously collected monitoring results must
report the following information by the applicable dates listed in this
paragraph. Systems serving at least 10,000 people must report this
information to EPA unless the State approves reporting to the State
rather than EPA. Systems serving fewer than 10,000 people must report
this information to the State.
(1) Systems must report that they intend to submit previously
collected monitoring results for grandfathering. This report must
specify the number of previously collected results the system will
submit, the dates of the first and last sample, and whether a system
will conduct additional source water monitoring to meet the
requirements of Sec. 141.701(a). Systems must report this information
no later than the date the sampling schedule under Sec. 141.702 is
required.
(2) Systems must report previously collected monitoring results for
grandfathering, along with the associated documentation listed in
paragraphs (f)(2)(i) through (iv) of this section, no later than two
months after the applicable date listed in Sec. 141.701(c).
(i) For each sample result, systems must report the applicable data
elements in Sec. 141.706.
(ii) Systems must certify that the reported monitoring results
include all results the system generated during the time period
beginning with the first reported result and ending with the final
reported result. This applies to samples that were collected from the
[[Page 774]]
sampling location specified for source water monitoring under this
subpart, not spiked, and analyzed using the laboratory's routine
process for the analytical methods listed in this section.
(iii) Systems must certify that the samples were representative of
a plant's source water(s) and the source water(s) have not changed.
Systems must report a description of the sampling location(s), which
must address the position of the sampling location in relation to the
system's water source(s) and treatment processes, including points of
chemical addition and filter backwash recycle.
(iv) For Cryptosporidium samples, the laboratory or laboratories
that analyzed the samples must provide a letter certifying that the
quality control criteria specified in the methods listed in paragraph
(c)(1) of this section were met for each sample batch associated with
the reported results. Alternatively, the laboratory may provide bench
sheets and sample examination report forms for each field, matrix
spike, IPR, OPR, and method blank sample associated with the reported
results.
(g) If the State determines that a previously collected data set
submitted for grandfathering was generated during source water
conditions that were not normal for the system, such as a drought, the
State may disapprove the data. Alternatively, the State may approve the
previously collected data if the system reports additional source water
monitoring data, as determined by the State, to ensure that the data
set used under Sec. 141.710 or Sec. 141.712 represents average source
water conditions for the system.
(h) If a system submits previously collected data that fully meet
the number of samples required for initial source water monitoring
under Sec. 141.701(a) and some of the data are rejected due to not
meeting the requirements of this section, systems must conduct
additional monitoring to replace rejected data on a schedule the State
approves. Systems are not required to begin this additional monitoring
until two months after notification that data have been rejected and
additional monitoring is necessary.
Disinfection Profiling and Benchmarking Requirements
Sec. 141.708 Requirements when making a significant change in
disinfection practice.
(a) Following the completion of initial source water monitoring
under Sec. 141.701(a), a system that plans to make a significant
change to its disinfection practice, as defined in paragraph (b) of
this section, must develop disinfection profiles and calculate
disinfection benchmarks for Giardia lamblia and viruses as described in
Sec. 141.709. Prior to changing the disinfection practice, the system
must notify the State and must include in this notice the information
in paragraphs (a)(1) through (3) of this section.
(1) A completed disinfection profile and disinfection benchmark for
Giardia lamblia and viruses as described in Sec. 141.709.
(2) A description of the proposed change in disinfection practice.
(3) An analysis of how the proposed change will affect the current
level of disinfection.
(b) Significant changes to disinfection practice are defined as
follows:
(1) Changes to the point of disinfection;
(2) Changes to the disinfectant(s) used in the treatment plant;
(3) Changes to the disinfection process; or
(4) Any other modification identified by the State as a significant
change to disinfection practice.
Sec. 141.709 Developing the disinfection profile and benchmark.
(a) Systems required to develop disinfection profiles under Sec.
141.708 must follow the requirements of this section. Systems must
monitor at least weekly for a period of 12 consecutive months to
determine the total log inactivation for Giardia lamblia and viruses.
If systems monitor more frequently, the monitoring frequency must be
evenly spaced. Systems that operate for fewer than 12 months per year
must monitor weekly during the period of operation. Systems must
determine log inactivation for Giardia lamblia through the entire
plant, based on CT99.9 values in Tables 1.1 through 1.6, 2.1
and 3.1 of Sec. 141.74(b) as applicable. Systems must determine log
inactivation for viruses through the entire treatment plant based on a
protocol approved by the State.
(b) Systems with a single point of disinfectant application prior
to the entrance to the distribution system must conduct the monitoring
in paragraphs (b)(1) through (4) of this section. Systems with more
than one point of disinfectant application must conduct the monitoring
in paragraphs (b)(1) through (4) of this section for each disinfection
segment. Systems must monitor the parameters necessary to determine the
total inactivation ratio, using analytical methods in Sec. 141.74(a).
(1) For systems using a disinfectant other than UV, the temperature
of the disinfected water must be measured at each residual disinfectant
concentration sampling point during peak hourly flow or at an
alternative location approved by the State.
(2) For systems using chlorine, the pH of the disinfected water
must be measured at each chlorine residual disinfectant concentration
sampling point during peak hourly flow or at an alternative location
approved by the State.
(3) The disinfectant contact time(s) (t) must be determined during
peak hourly flow.
(4) The residual disinfectant concentration(s) (C) of the water
before or at the first customer and prior to each additional point of
disinfectant application must be measured during peak hourly flow.
(c) In lieu of conducting new monitoring under paragraph (b) of
this section, systems may elect to meet the requirements of paragraphs
(c)(1) or (2) of this section.
(1) Systems that have at least one year of existing data that are
substantially equivalent to data collected under the provisions of
paragraph (b) of this section may use these data to develop
disinfection profiles as specified in this section if the system has
neither made a significant change to its treatment practice nor changed
sources since the data were collected. Systems may develop disinfection
profiles using up to three years of existing data.
(2) Systems may use disinfection profile(s) developed under Sec.
141.172 or Sec. Sec. 141.530 through 141.536 in lieu of developing a
new profile if the system has neither made a significant change to its
treatment practice nor changed sources since the profile was developed.
Systems that have not developed a virus profile under Sec. 141.172 or
Sec. Sec. 141.530 through 141.536 must develop a virus profile using
the same monitoring data on which the Giardia lamblia profile is based.
(d) Systems must calculate the total inactivation ratio for Giardia
lamblia as specified in paragraphs (d)(1) through (3) of this section.
(1) Systems using only one point of disinfectant application may
determine the total inactivation ratio for the disinfection segment
based on either of the methods in paragraph (d)(1)(i) or (ii) of this
section.
(i) Determine one inactivation ratio (CTcalc/CT99.9)
before or at the first customer during peak hourly flow.
(ii) Determine successive CTcalc/CT99.9 values,
representing sequential inactivation ratios, between the point of
disinfectant application and a point before or at the first customer
during peak hourly flow. The system must
[[Page 775]]
calculate the total inactivation ratio by determining (CTcalc/
CT99.9) for each sequence and then adding the (CTcalc/
CT99.9) values together to determine ([Sigma]
(CTcalc/
CT99.9)).
(2) Systems using more than one point of disinfectant application
before the first customer must determine the CT value of each
disinfection segment immediately prior to the next point of
disinfectant application, or for the final segment, before or at the
first customer, during peak hourly flow. The (CTcalc/CT99.9)
value of each segment and ([Sigma]
(CTcalc/CT99.9)) must be
calculated using the method in paragraph (d)(1)(ii) of this section.
(3) The system must determine the total logs of inactivation by
multiplying the value calculated in paragraph (d)(1) or (d)(2) of this
section by 3.0.
(4) Systems must calculate the log of inactivation for viruses
using a protocol approved by the State.
(e) Systems must use the procedures specified in paragraphs (e)(1)
and (2) of this section to calculate a disinfection benchmark.
(1) For each year of profiling data collected and calculated under
paragraphs (a) through (d) of this section, systems must determine the
lowest mean monthly level of both Giardia lamblia and virus
inactivation. Systems must determine the mean Giardia lamblia and virus
inactivation for each calendar month for each year of profiling data by
dividing the sum of daily or weekly Giardia lamblia and virus log
inactivation by the number of values calculated for that month.
(2) The disinfection benchmark is the lowest monthly mean value
(for systems with one year of profiling data) or the mean of the lowest
monthly mean values (for systems with more than one year of profiling
data) of Giardia lamblia and virus log inactivation in each year of
profiling data.
Treatment Technique Requirements
Sec. 141.710 Bin classification for filtered systems.
(a) Following completion of the initial round of source water
monitoring required under Sec. 141.701(a), filtered systems must
calculate an initial Cryptosporidium bin concentration for each plant
for which monitoring was required. Calculation of the bin concentration
must use the Cryptosporidium results reported under Sec. 141.701(a)
and must follow the procedures in paragraphs (b)(1) through (5) of this
section.
(b)(1) For systems that collect a total of at least 48 samples, the
bin concentration is equal to the arithmetic mean of all sample
concentrations.
(2) For systems that collect a total of at least 24 samples, but
not more than 47 samples, the bin concentration is equal to the highest
arithmetic mean of all sample concentrations in any 12 consecutive
months during which Cryptosporidium samples were collected.
(3) For systems that serve fewer than 10,000 people and monitor for
Cryptosporidium for only one year (i.e., collect 24 samples in 12
months), the bin concentration is equal to the arithmetic mean of all
sample concentrations.
(4) For systems with plants operating only part of the year that
monitor fewer than 12 months per year under Sec. 141.701(e), the bin
concentration is equal to the highest arithmetic mean of all sample
concentrations during any year of Cryptosporidium monitoring.
(5) If the monthly Cryptosporidium sampling frequency varies,
systems must first calculate a monthly average for each month of
monitoring. Systems must then use these monthly average concentrations,
rather than individual sample concentrations, in the applicable
calculation for bin classification in paragraphs (b)(1) through (4) of
this section.
(c) Filtered systems must determine their initial bin
classification from the following table and using the Cryptosporidium
bin concentration calculated under paragraphs (a)-(b) of this section:
Bin Classification Table for Filtered Systems
------------------------------------------------------------------------
With a Cryptosporidium The bin
For systems that are: bin concentration of . classification
. .\1\ is . . .
------------------------------------------------------------------------
. . . required to monitor for Cryptosporidium < 0.075 Bin 1.
Cryptosporidium under Sec. oocyst/L.
141.701.
0.075 oocysts/L Bin 2.
< =Cryptosporidium
< 1.0 oocysts/L.
1.0 oocysts/L Bin 3.
< =Cryptosporidium
< 3.0 oocysts/L.
Cryptosporidium >=3.0 Bin 4.
oocysts/L.
. . . serving fewer than NA.................... Bin 1.
10,000 people and NOT
required to monitor for
Cryptosporidium under Sec.
141.701(a)(4).
------------------------------------------------------------------------
\1\ Based on calculations in paragraph (a) or (d) of this section, as
applicable.
(d) Following completion of the second round of source water
monitoring required under Sec. 141.701(b), filtered systems must
recalculate their Cryptosporidium bin concentration using the
Cryptosporidium results reported under Sec. 141.701(b) and following
the procedures in paragraphs (b)(1) through (4) of this section.
Systems must then redetermine their bin classification using this bin
concentration and the table in paragraph (c) of this section.
(e)(1) Filtered systems must report their initial bin
classification under paragraph (c) of this section to the State for
approval no later than 6 months after the system is required to
complete initial source water monitoring based on the schedule in Sec.
141.701(c).
(2) Systems must report their bin classification under paragraph
(d) of this section to the State for approval no later than 6 months
after the system is required to complete the second round of source
water monitoring based on the schedule in Sec. 141.701(c).
(3) The bin classification report to the State must include a
summary of source water monitoring data and the calculation procedure
used to determine bin classification.
(f) Failure to comply with the conditions of paragraph (e) of this
section is a violation of the treatment technique requirement.
Sec. 141.711 Filtered system additional Cryptosporidium treatment
requirements.
(a) Filtered systems must provide the level of additional treatment
for Cryptosporidium specified in this paragraph based on their bin
classification as determined under Sec. 141.710 and according to the
schedule in Sec. 141.713.
[[Page 776]]
----------------------------------------------------------------------------------------------------------------
And the system uses the following filtration treatment in full compliance with subparts
H, P, and T of this part (as applicable), then the additional Cryptosporidium treatment
If the system bin requirements are . . .
classification is . . -----------------------------------------------------------------------------------------
. Conventional Slow sand or Alternative
filtration treatment Direct filtration diatomaceous earth filtration
(including softening) filtration technologies
----------------------------------------------------------------------------------------------------------------
Bin 1................. No additional No additional No additional No additional
treatment. treatment. treatment. treatment.
Bin 2................. 1-log treatment...... 1.5-log treatment.... 1-log treatment..... (\1\)
Bin 3................. 2-log treatment...... 2.5-log treatment.... 2-log treatment..... (\2\)
Bin 4................. 2.5-log treatment.... 3-log treatment...... 2.5-log treatment... (\3\)
----------------------------------------------------------------------------------------------------------------
\1\ As determined by the State such that the total Cryptosporidium removal and inactivation is at least 4.0-log.
\2\ As determined by the State such that the total Cryptosporidium removal and inactivation is at least 5.0-log.
\3\ As determined by the State such that the total Cryptosporidium removal and inactivation is at least 5.5-log.
(b)(1) Filtered systems must use one or more of the treatment and
management options listed in Sec. 141.715, termed the microbial
toolbox, to comply with the additional Cryptosporidium treatment
required in paragraph (a) of this section.
(2) Systems classified in Bin 3 and Bin 4 must achieve at least 1-
log of the additional Cryptosporidium treatment required under
paragraph (a) of this section using either one or a combination of the
following: bag filters, bank filtration, cartridge filters, chlorine
dioxide, membranes, ozone, or UV, as described in Sec. Sec. 141.716
through 141.720.
(c) Failure by a system in any month to achieve treatment credit by
meeting criteria in Sec. Sec. 141.716 through 141.720 for microbial
toolbox options that is at least equal to the level of treatment
required in paragraph (a) of this section is a violation of the
treatment technique requirement.
(d) If the State determines during a sanitary survey or an
equivalent source water assessment that after a system completed the
monitoring conducted under Sec. 141.701(a) or Sec. 141.701(b),
significant changes occurred in the system's watershed that could lead
to increased contamination of the source water by Cryptosporidium, the
system must take actions specified by the State to address the
contamination. These actions may include additional source water
monitoring and/or implementing microbial toolbox options listed in
Sec. 141.715.
Sec. 141.712 Unfiltered system Cryptosporidium treatment requirements.
(a) Determination of mean Cryptosporidium level. (1) Following
completion of the initial source water monitoring required under Sec.
141.701(a), unfiltered systems must calculate the arithmetic mean of
all Cryptosporidium sample concentrations reported under Sec.
141.701(a). Systems must report this value to the State for approval no
later than 6 months after the month the system is required to complete
initial source water monitoring based on the schedule in Sec. 141.701(c).
(2) Following completion of the second round of source water
monitoring required under Sec. 141.701(b), unfiltered systems must
calculate the arithmetic mean of all Cryptosporidium sample
concentrations reported under Sec. 141.701(b). Systems must report
this value to the State for approval no later than 6 months after the
month the system is required to complete the second round of source
water monitoring based on the schedule in Sec. 141.701(c).
(3) If the monthly Cryptosporidium sampling frequency varies,
systems must first calculate a monthly average for each month of
monitoring. Systems must then use these monthly average concentrations,
rather than individual sample concentrations, in the calculation of the
mean Cryptosporidium level in paragraphs (a)(1) or (2) of this section.
(4) The report to the State of the mean Cryptosporidium levels
calculated under paragraphs (a)(1) and (2) of this section must include
a summary of the source water monitoring data used for the calculation.
(5) Failure to comply with the conditions of paragraph (a) of this
section is a violation of the treatment technique requirement.
(b) Cryptosporidium inactivation requirements. Unfiltered systems
must provide the level of inactivation for Cryptosporidium specified in
this paragraph, based on their mean Cryptosporidium levels as
determined under paragraph (a) of this section and according to the
schedule in Sec. 141.713.
(1) Unfiltered systems with a mean Cryptosporidium level of 0.01
oocysts/L or less must provide at least 2-log Cryptosporidium inactivation.
(2) Unfiltered systems with a mean Cryptosporidium level of greater
than 0.01 oocysts/L must provide at least 3-log Cryptosporidium
inactivation.
(c) Inactivation treatment technology requirements. Unfiltered
systems must use chlorine dioxide, ozone, or UV as described in Sec.
141.720 to meet the Cryptosporidium inactivation requirements of this
section.
(1) Systems that use chlorine dioxide or ozone and fail to achieve
the Cryptosporidium inactivation required in paragraph (b) of this
section on more than one day in the calendar month are in violation of
the treatment technique requirement.
(2) Systems that use UV light and fail to achieve the
Cryptosporidium inactivation required in paragraph (b) of this section
by meeting the criteria in Sec. 141.720(d)(3)(ii) are in violation of
the treatment technique requirement.
(d) Use of two disinfectants. Unfiltered systems must meet the
combined Cryptosporidium inactivation requirements of this section and
Giardia lamblia and virus inactivation requirements of Sec. 141.72(a)
using a minimum of two disinfectants, and each of two disinfectants
must separately achieve the total inactivation required for either
Cryptosporidium, Giardia lamblia, or viruses.
Sec. 141.713 Schedule for compliance with Cryptosporidium treatment
requirements.
(a) Following initial bin classification under Sec. 141.710(c),
filtered systems must provide the level of treatment for
Cryptosporidium required under Sec. 141.711 according to the schedule
in paragraph (c) of this section.
(b) Following initial determination of the mean Cryptosporidium
level under Sec. 141.712(a)(1), unfiltered systems must provide the
level of treatment for Cryptosporidium required under Sec. 141.712
according to the schedule in paragraph (c) of this section.
(c) Cryptosporidium treatment compliance dates.
[[Page 777]]
Cryptosporidium Treatment Compliance Dates Table
------------------------------------------------------------------------
Must comply with
Cryptosporidium treatment
Systems that serve . . . requirements no later than .
. . \a\
------------------------------------------------------------------------
(1) At least 100,000 people............... (i) April 1, 2012.
(2) From 50,000 to 99,999 people.......... (i) October 1, 2012.
(3) From 10,000 to 49,999 people.......... (i) October 1, 2013.
(4) Fewer than 10,000 people.............. (i) October 1, 2014.
------------------------------------------------------------------------
a States may allow up to an additional two years for complying with the
treatment requirement for systems making capital improvements.
(d) If the bin classification for a filtered system changes
following the second round of source water monitoring, as determined
under Sec. 141.710(d), the system must provide the level of treatment
for Cryptosporidium required under Sec. 141.711 on a schedule the
State approves.
(e) If the mean Cryptosporidium level for an unfiltered system
changes following the second round of monitoring, as determined under
Sec. 141.712(a)(2), and if the system must provide a different level
of Cryptosporidium treatment under Sec. 141.712 due to this change,
the system must meet this treatment requirement on a schedule the State
approves.
Sec. 141.714 Requirements for uncovered finished water storage facilities.
(a) Systems using uncovered finished water storage facilities must
comply with the conditions of this section.
(b) Systems must notify the State of the use of each uncovered
finished water storage facility no later than April 1, 2008.
(c) Systems must meet the conditions of paragraph (c)(1) or (2) of
this section for each uncovered finished water storage facility or be
in compliance with a State-approved schedule to meet these conditions
no later than April 1, 2009.
(1) Systems must cover any uncovered finished water storage facility.
(2) Systems must treat the discharge from the uncovered finished
water storage facility to the distribution system to achieve
inactivation and/or removal of at least 4-log virus, 3-log Giardia
lamblia, and 2-log Cryptosporidium using a protocol approved by the State.
(d) Failure to comply with the requirements of this section is a
violation of the treatment technique requirement.
Requirements for Microbial Toolbox Components
Sec. 141.715 Microbial toolbox options for meeting Cryptosporidium
treatment requirements.
(a)(1) Systems receive the treatment credits listed in the table in
paragraph (b) of this section by meeting the conditions for microbial
toolbox options described in Sec. Sec. 141.716 through 141.720.
Systems apply these treatment credits to meet the treatment
requirements in Sec. 141.711 or Sec. 141.712, as applicable.
(2) Unfiltered systems are eligible for treatment credits for the
microbial toolbox options described in Sec. 141.720 only.
(b) The following table summarizes options in the microbial toolbox:
Microbial Toolbox Summary Table: Options, Treatment Credits and Criteria
------------------------------------------------------------------------
Cryptosporidium treatment credit with
Toolbox Option design and implementation criteria
------------------------------------------------------------------------
Source Protection and Management Toolbox Options
------------------------------------------------------------------------
(1) Watershed control program 0.5-log credit for State-approved program
comprising required elements, annual
program status report to State, and
regular watershed survey. Unfiltered
systems are not eligible for credit.
Specific criteria are in Sec.
141.716(a).
(2) Alternative source/intake No prescribed credit. Systems may conduct
management. simultaneous monitoring for treatment
bin classification at alternative intake
locations or under alternative intake
management strategies. Specific criteria
are in Sec. 141.716(b).
------------------------------
Pre Filtration Toolbox Options
------------------------------------------------------------------------
(3) Presedimentation basin 0.5-log credit during any month that
with coagulation. presedimentation basins achieve a
monthly mean reduction of 0.5-log or
greater in turbidity or alternative
State-approved performance criteria. To
be eligible, basins must be operated
continuously with coagulant addition and
all plant flow must pass through basins.
Specific criteria are in Sec.
141.717(a).
(4) Two-stage lime softening. 0.5-log credit for two-stage softening
where chemical addition and hardness
precipitation occur in both stages. All
plant flow must pass through both
stages. Single-stage softening is
credited as equivalent to conventional
treatment. Specific criteria are in Sec.
141.717(b).
(5) Bank filtration.......... 0.5-log credit for 25-foot setback; 1.0-
log credit for 50-foot setback; aquifer
must be unconsolidated sand containing
at least 10 percent fines; average
turbidity in wells must be less than 1
NTU. Systems using wells followed by
filtration when conducting source water
monitoring must sample the well to
determine bin classification and are not
eligible for additional credit. Specific
criteria are in Sec. 141.717(c).
------------------------------
Treatment Performance Toolbox Options
------------------------------------------------------------------------
(6) Combined filter 0.5-log credit for combined filter
performance. effluent turbidity less than or equal to
0.15 NTU in at least 95 percent of
measurements each month. Specific
criteria are in Sec. 141.718(a).
(7) Individual filter 0.5-log credit (in addition to 0.5-log
performance. combined filter performance credit) if
individual filter effluent turbidity is
less than or equal to 0.15 NTU in at
least 95 percent of samples each month
in each filter and is never greater than
0.3 NTU in two consecutive measurements
in any filter. Specific criteria are in
Sec. 141.718(b).
(8) Demonstration of Credit awarded to unit process or
performance. treatment train based on a demonstration
to the State with a State- approved
protocol. Specific criteria are in Sec.
141.718(c).
------------------------------
[[Page 778]]
Additional Filtration Toolbox Options
------------------------------------------------------------------------
(9) Bag or cartridge filters Up to 2-log credit based on the removal
(individual filters). efficiency demonstrated during challenge
testing with a 1.0-log factor of safety.
Specific criteria are in Sec.
141.719(a).
(10) Bag or cartridge filters Up to 2.5-log credit based on the removal
(in series). efficiency demonstrated during challenge
testing with a 0.5-log factor of safety.
Specific criteria are in Sec.
141.719(a).
(11) Membrane filtration..... Log credit equivalent to removal
efficiency demonstrated in challenge
test for device if supported by direct
integrity testing. Specific criteria are
in Sec. 141.719(b).
(12) Second stage filtration. 0.5-log credit for second separate
granular media filtration stage if
treatment train includes coagulation
prior to first filter. Specific criteria
are in Sec. 141.719(c)
(13) Slow sand filters....... 2.5-log credit as a secondary filtration
step; 3.0-log credit as a primary
filtration process. No prior
chlorination for either option. Specific
criteria are in Sec. 141.719(d).
------------------------------
Inactivation Toolbox Options
------------------------------------------------------------------------
(14) Chlorine dioxide........ Log credit based on measured CT in
relation to CT table. Specific criteria
in Sec. 141.720(b)
(15) Ozone................... Log credit based on measured CT in
relation to CT table. Specific criteria
in Sec. 141.720(b).
(16) UV...................... Log credit based on validated UV dose in
relation to UV dose table; reactor
validation testing required to establish
UV dose and associated operating
conditions. Specific criteria in Sec.
141.720(d).
------------------------------------------------------------------------
Sec. 141.716 Source toolbox components.
(a) Watershed control program. Systems receive 0.5-log
Cryptosporidium treatment credit for implementing a watershed control
program that meets the requirements of this section.
(1) Systems that intend to apply for the watershed control program
credit must notify the State of this intent no later than two years
prior to the treatment compliance date applicable to the system in
Sec. 141.713.
(2) Systems must submit to the State a proposed watershed control
plan no later than one year before the applicable treatment compliance
date in Sec. 141.713. The State must approve the watershed control
plan for the system to receive watershed control program treatment
credit. The watershed control plan must include the elements in
paragraphs (a)(2)(i) through (iv) of this section.
(i) Identification of an ``area of influence'' outside of which the
likelihood of Cryptosporidium or fecal contamination affecting the
treatment plant intake is not significant. This is the area to be
evaluated in future watershed surveys under paragraph (a)(5)(ii) of
this section.
(ii) Identification of both potential and actual sources of
Cryptosporidium contamination and an assessment of the relative impact
of these sources on the system's source water quality.
(iii) An analysis of the effectiveness and feasibility of control
measures that could reduce Cryptosporidium loading from sources of
contamination to the system's source water.
(iv) A statement of goals and specific actions the system will
undertake to reduce source water Cryptosporidium levels. The plan must
explain how the actions are expected to contribute to specific goals,
identify watershed partners and their roles, identify resource
requirements and commitments, and include a schedule for plan
implementation with deadlines for completing specific actions
identified in the plan.
(3) Systems with existing watershed control programs (i.e.,
programs in place on January 5, 2006) are eligible to seek this credit.
Their watershed control plans must meet the criteria in paragraph
(a)(2) of this section and must specify ongoing and future actions that
will reduce source water Cryptosporidium levels.
(4) If the State does not respond to a system regarding approval of
a watershed control plan submitted under this section and the system
meets the other requirements of this section, the watershed control
program will be considered approved and 0.5 log Cryptosporidium
treatment credit will be awarded unless and until the State
subsequently withdraws such approval.
(5) Systems must complete the actions in paragraphs (a)(5)(i)
through (iii) of this section to maintain the 0.5-log credit.
(i) Submit an annual watershed control program status report to the
State. The annual watershed control program status report must describe
the system's implementation of the approved plan and assess the
adequacy of the plan to meet its goals. It must explain how the system
is addressing any shortcomings in plan implementation, including those
previously identified by the State or as the result of the watershed
survey conducted under paragraph (a)(5)(ii) of this section. It must
also describe any significant changes that have occurred in the
watershed since the last watershed sanitary survey. If a system
determines during implementation that making a significant change to
its approved watershed control program is necessary, the system must
notify the State prior to making any such changes. If any change is
likely to reduce the level of source water protection, the system must
also list in its notification the actions the system will take to
mitigate this effect.
(ii) Undergo a watershed sanitary survey every three years for
community water systems and every five years for noncommunity water
systems and submit the survey report to the State. The survey must be
conducted according to State guidelines and by persons the State approves.
(A) The watershed sanitary survey must meet the following criteria:
encompass the region identified in the State-approved watershed control
plan as the area of influence; assess the implementation of actions to
reduce source water Cryptosporidium levels; and identify any
significant new sources of Cryptosporidium.
(B) If the State determines that significant changes may have
occurred in the watershed since the previous watershed sanitary survey,
systems must undergo another watershed sanitary survey by a date the
State requires, which may be earlier than the regular date in paragraph
(a)(5)(ii) of this section.
(iii) The system must make the watershed control plan, annual
status reports, and watershed sanitary survey reports available to the
public upon
[[Page 779]]
request. These documents must be in a plain language style and include
criteria by which to evaluate the success of the program in achieving
plan goals. The State may approve systems to withhold from the public
portions of the annual status report, watershed control plan, and
watershed sanitary survey based on water supply security considerations.
(6) If the State determines that a system is not carrying out the
approved watershed control plan, the State may withdraw the watershed
control program treatment credit.
(b) Alternative source. (1) A system may conduct source water
monitoring that reflects a different intake location (either in the
same source or for an alternate source) or a different procedure for
the timing or level of withdrawal from the source (alternative source
monitoring). If the State approves, a system may determine its bin
classification under Sec. 141.710 based on the alternative source
monitoring results.
(2) If systems conduct alternative source monitoring under
paragraph (b)(1) of this section, systems must also monitor their
current plant intake concurrently as described in Sec. 141.701.
(3) Alternative source monitoring under paragraph (b)(1) of this
section must meet the requirements for source monitoring to determine
bin classification, as described in Sec. Sec. 141.701 through 141.706.
Systems must report the alternative source monitoring results to the
State, along with supporting information documenting the operating
conditions under which the samples were collected.
(4) If a system determines its bin classification under Sec.
141.710 using alternative source monitoring results that reflect a
different intake location or a different procedure for managing the
timing or level of withdrawal from the source, the system must relocate
the intake or permanently adopt the withdrawal procedure, as
applicable, no later than the applicable treatment compliance date in
Sec. 141.713.
Sec. 141.717 Pre-filtration treatment toolbox components.
(a) Presedimentation. Systems receive 0.5-log Cryptosporidium
treatment credit for a presedimentation basin during any month the
process meets the criteria in this paragraph.
(1) The presedimentation basin must be in continuous operation and
must treat the entire plant flow taken from a surface water or GWUDI source.
(2) The system must continuously add a coagulant to the
presedimentation basin.
(3) The presedimentation basin must achieve the performance
criteria in paragraph (3)(i) or (ii) of this section.
(i) Demonstrates at least 0.5-log mean reduction of influent
turbidity. This reduction must be determined using daily turbidity
measurements in the presedimentation process influent and effluent and
must be calculated as follows: log10(monthly mean of daily
influent turbidity)-log10(monthly mean of daily effluent
turbidity).
(ii) Complies with State-approved performance criteria that
demonstrate at least 0.5-log mean removal of micron-sized particulate
material through the presedimentation process.
(b) Two-stage lime softening. Systems receive an additional 0.5-log
Cryptosporidium treatment credit for a two-stage lime softening plant
if chemical addition and hardness precipitation occur in two separate
and sequential softening stages prior to filtration. Both softening
stages must treat the entire plant flow taken from a surface water or
GWUDI source.
(c) Bank filtration. Systems receive Cryptosporidium treatment
credit for bank filtration that serves as pretreatment to a filtration
plant by meeting the criteria in this paragraph. Systems using bank
filtration when they begin source water monitoring under Sec.
141.701(a) must collect samples as described in Sec. 141.703(d) and
are not eligible for this credit.
(1) Wells with a ground water flow path of at least 25 feet receive
0.5-log treatment credit; wells with a ground water flow path of at
least 50 feet receive 1.0-log treatment credit. The ground water flow
path must be determined as specified in paragraph (c)(4) of this section.
(2) Only wells in granular aquifers are eligible for treatment
credit. Granular aquifers are those comprised of sand, clay, silt, rock
fragments, pebbles or larger particles, and minor cement. A system must
characterize the aquifer at the well site to determine aquifer
properties. Systems must extract a core from the aquifer and
demonstrate that in at least 90 percent of the core length, grains less
than 1.0 mm in diameter constitute at least 10 percent of the core material.
(3) Only horizontal and vertical wells are eligible for treatment
credit.
(4) For vertical wells, the ground water flow path is the measured
distance from the edge of the surface water body under high flow
conditions (determined by the 100 year floodplain elevation boundary or
by the floodway, as defined in Federal Emergency Management Agency
flood hazard maps) to the well screen. For horizontal wells, the ground
water flow path is the measured distance from the bed of the river
under normal flow conditions to the closest horizontal well lateral screen.
(5) Systems must monitor each wellhead for turbidity at least once
every four hours while the bank filtration process is in operation. If
monthly average turbidity levels, based on daily maximum values in the
well, exceed 1 NTU, the system must report this result to the State and
conduct an assessment within 30 days to determine the cause of the high
turbidity levels in the well. If the State determines that microbial
removal has been compromised, the State may revoke treatment credit
until the system implements corrective actions approved by the State to
remediate the problem.
(6) Springs and infiltration galleries are not eligible for
treatment credit under this section, but are eligible for credit under
Sec. 141.718(c).
(7) Bank filtration demonstration of performance. The State may
approve Cryptosporidium treatment credit for bank filtration based on a
demonstration of performance study that meets the criteria in this
paragraph. This treatment credit may be greater than 1.0-log and may be
awarded to bank filtration that does not meet the criteria in
paragraphs (c)(1)-(5) of this section.
(i) The study must follow a State-approved protocol and must
involve the collection of data on the removal of Cryptosporidium or a
surrogate for Cryptosporidium and related hydrogeologic and water
quality parameters during the full range of operating conditions.
(ii) The study must include sampling both from the production
well(s) and from monitoring wells that are screened and located along
the shortest flow path between the surface water source and the
production well(s).
Sec. 141.718 Treatment performance toolbox components.
(a) Combined filter performance. Systems using conventional
filtration treatment or direct filtration treatment receive an
additional 0.5-log Cryptosporidium treatment credit during any month
the system meets the criteria in this paragraph. Combined filter
effluent (CFE) turbidity must be less than or equal to 0.15 NTU in at
least 95 percent of the measurements. Turbidity must be measured as
described in Sec. 141.74(a) and (c).
(b) Individual filter performance. Systems using conventional
filtration treatment or direct filtration treatment receive 0.5-log
Cryptosporidium treatment credit, which can be in
[[Page 780]]
addition to the 0.5-log credit under paragraph (a) of this section,
during any month the system meets the criteria in this paragraph.
Compliance with these criteria must be based on individual filter
turbidity monitoring as described in Sec. 141.174 or Sec. 141.560, as
applicable.
(1) The filtered water turbidity for each individual filter must be
less than or equal to 0.15 NTU in at least 95 percent of the
measurements recorded each month.
(2) No individual filter may have a measured turbidity greater than
0.3 NTU in two consecutive measurements taken 15 minutes apart.
(3) Any system that has received treatment credit for individual
filter performance and fails to meet the requirements of paragraph
(b)(1) or (2) of this section during any month does not receive a
treatment technique violation under Sec. 141.711(c) if the State
determines the following:
(i) The failure was due to unusual and short-term circumstances
that could not reasonably be prevented through optimizing treatment
plant design, operation, and maintenance.
(ii) The system has experienced no more than two such failures in
any calendar year.
(c) Demonstration of performance. The State may approve
Cryptosporidium treatment credit for drinking water treatment processes
based on a demonstration of performance study that meets the criteria
in this paragraph. This treatment credit may be greater than or less
than the prescribed treatment credits in Sec. 141.711 or Sec. Sec.
141.717 through 141.720 and may be awarded to treatment processes that
do not meet the criteria for the prescribed credits.
(1) Systems cannot receive the prescribed treatment credit for any
toolbox box option in Sec. Sec. 141.717 through 141.720 if that
toolbox option is included in a demonstration of performance study for
which treatment credit is awarded under this paragraph.
(2) The demonstration of performance study must follow a State-
approved protocol and must demonstrate the level of Cryptosporidium
reduction the treatment process will achieve under the full range of
expected operating conditions for the system.
(3) Approval by the State must be in writing and may include
monitoring and treatment performance criteria that the system must
demonstrate and report on an ongoing basis to remain eligible for the
treatment credit. The State may designate such criteria where necessary
to verify that the conditions under which the demonstration of
performance credit was approved are maintained during routine operation.
Sec. 141.719 Additional filtration toolbox components.
(a) Bag and cartridge filters. Systems receive Cryptosporidium
treatment credit of up to 2.0-log for individual bag or cartridge
filters and up to 2.5-log for bag or cartridge filters operated in
series by meeting the criteria in paragraphs (a)(1) through (10) of
this section. To be eligible for this credit, systems must report the
results of challenge testing that meets the requirements of paragraphs
(a)(2) through (9) of this section to the State. The filters must treat
the entire plant flow taken from a subpart H source.
(1) The Cryptosporidium treatment credit awarded to bag or
cartridge filters must be based on the removal efficiency demonstrated
during challenge testing that is conducted according to the criteria in
paragraphs (a)(2) through (a)(9) of this section. A factor of safety
equal to 1-log for individual bag or cartridge filters and 0.5-log for
bag or cartridge filters in series must be applied to challenge testing
results to determine removal credit. Systems may use results from
challenge testing conducted prior to January 5, 2006 if the prior
testing was consistent with the criteria specified in paragraphs (a)(2)
through (9) of this section.
(2) Challenge testing must be performed on full-scale bag or
cartridge filters, and the associated filter housing or pressure
vessel, that are identical in material and construction to the filters
and housings the system will use for removal of Cryptosporidium. Bag or
cartridge filters must be challenge tested in the same configuration
that the system will use, either as individual filters or as a series
configuration of filters.
(3) Challenge testing must be conducted using Cryptosporidium or a
surrogate that is removed no more efficiently than Cryptosporidium. The
microorganism or surrogate used during challenge testing is referred to
as the challenge particulate. The concentration of the challenge
particulate must be determined using a method capable of discreetly
quantifying the specific microorganism or surrogate used in the test;
gross measurements such as turbidity may not be used.
(4) The maximum feed water concentration that can be used during a
challenge test must be based on the detection limit of the challenge
particulate in the filtrate (i.e., filtrate detection limit) and must
be calculated using the following equation:
Maximum Feed Concentration = 1 x 10 4 x (Filtrate Detection
Limit)
(5) Challenge testing must be conducted at the maximum design flow
rate for the filter as specified by the manufacturer.
(6) Each filter evaluated must be tested for a duration sufficient
to reach 100 percent of the terminal pressure drop, which establishes
the maximum pressure drop under which the filter may be used to comply
with the requirements of this subpart.
(7) Removal efficiency of a filter must be determined from the
results of the challenge test and expressed in terms of log removal
values using the following equation:
LRV = LOG10(Cf)-LOG10(Cp)
Where:
LRV = log removal value demonstrated during challenge testing;
Cf = the feed concentration measured during the challenge
test; and Cp = the filtrate concentration measured during
the challenge test. In applying this equation, the same units must be
used for the feed and filtrate concentrations. If the challenge
particulate is not detected in the filtrate, then the term
Cp must be set equal to the detection limit.
(8) Each filter tested must be challenged with the challenge
particulate during three periods over the filtration cycle: within two
hours of start-up of a new filter; when the pressure drop is between 45
and 55 percent of the terminal pressure drop; and at the end of the
cycle after the pressure drop has reached 100 percent of the terminal
pressure drop. An LRV must be calculated for each of these challenge
periods for each filter tested. The LRV for the filter
(LRVfilter) must be assigned the value of the minimum LRV
observed during the three challenge periods for that filter.
(9) If fewer than 20 filters are tested, the overall removal
efficiency for the filter product line must be set equal to the lowest
LRVfilter among the filters tested. If 20 or more filters
are tested, the overall removal efficiency for the filter product line
must be set equal to the 10th percentile of the set of
LRVfilter values for the various filters tested. The
percentile is defined by (i/(n+1)) where i is the rank of n individual
data points ordered lowest to highest. If necessary, the 10th
percentile may be calculated using linear interpolation.
(10) If a previously tested filter is modified in a manner that
could change the removal efficiency of the filter product line,
challenge testing to demonstrate the removal efficiency of
[[Page 781]]
the modified filter must be conducted and submitted to the State.
(b) Membrane filtration. (1) Systems receive Cryptosporidium
treatment credit for membrane filtration that meets the criteria of
this paragraph. Membrane cartridge filters that meet the definition of
membrane filtration in Sec. 141.2 are eligible for this credit. The
level of treatment credit a system receives is equal to the lower of
the values determined under paragraph (b)(1)(i) and (ii) of this section.
(i) The removal efficiency demonstrated during challenge testing
conducted under the conditions in paragraph (b)(2) of this section.
(ii) The maximum removal efficiency that can be verified through
direct integrity testing used with the membrane filtration process
under the conditions in paragraph (b)(3) of this section.
(2) Challenge Testing. The membrane used by the system must undergo
challenge testing to evaluate removal efficiency, and the system must
report the results of challenge testing to the State. Challenge testing
must be conducted according to the criteria in paragraphs (b)(2)(i)
through (vii) of this section. Systems may use data from challenge
testing conducted prior to January 5, 2006 if the prior testing was
consistent with the criteria in paragraphs (b)(2)(i) through (vii) of
this section.
(i) Challenge testing must be conducted on either a full-scale
membrane module, identical in material and construction to the membrane
modules used in the system's treatment facility, or a smaller-scale
membrane module, identical in material and similar in construction to
the full-scale module. A module is defined as the smallest component of
a membrane unit in which a specific membrane surface area is housed in
a device with a filtrate outlet structure.
(ii) Challenge testing must be conducted using Cryptosporidium
oocysts or a surrogate that is removed no more efficiently than
Cryptosporidium oocysts. The organism or surrogate used during
challenge testing is referred to as the challenge particulate. The
concentration of the challenge particulate, in both the feed and
filtrate water, must be determined using a method capable of discretely
quantifying the specific challenge particulate used in the test; gross
measurements such as turbidity may not be used.
(iii) The maximum feed water concentration that can be used during
a challenge test is based on the detection limit of the challenge
particulate in the filtrate and must be determined according to the
following equation:
Maximum Feed Concentration = 3.16 x 106 x (Filtrate
Detection Limit)
(iv) Challenge testing must be conducted under representative
hydraulic conditions at the maximum design flux and maximum design
process recovery specified by the manufacturer for the membrane module.
Flux is defined as the throughput of a pressure driven membrane process
expressed as flow per unit of membrane area. Recovery is defined as the
volumetric percent of feed water that is converted to filtrate over the
course of an operating cycle uninterrupted by events such as chemical
cleaning or a solids removal process (i.e., backwashing).
(v) Removal efficiency of a membrane module must be calculated from
the challenge test results and expressed as a log removal value
according to the following equation:
LRV = LOG10(Cf) x LOG10(Cp)
Where:
LRV = log removal value demonstrated during the challenge test;
Cf = the feed concentration measured during the challenge
test; and Cp = the filtrate concentration measured during
the challenge test. Equivalent units must be used for the feed and
filtrate concentrations. If the challenge particulate is not detected
in the filtrate, the term Cp is set equal to the detection
limit for the purpose of calculating the LRV. An LRV must be calculated
for each membrane module evaluated during the challenge test.
(vi) The removal efficiency of a membrane filtration process
demonstrated during challenge testing must be expressed as a log
removal value (LRVC-Test). If fewer than 20 modules are
tested, then LRVC-Test is equal to the lowest of the
representative LRVs among the modules tested. If 20 or more modules are
tested, then LRVC-Test is equal to the 10th percentile of
the representative LRVs among the modules tested. The percentile is
defined by (i/(n+1)) where i is the rank of n individual data points
ordered lowest to highest. If necessary, the 10th percentile may be
calculated using linear interpolation.
(vii) The challenge test must establish a quality control release
value (QCRV) for a non-destructive performance test that demonstrates
the Cryptosporidium removal capability of the membrane filtration
module. This performance test must be applied to each production
membrane module used by the system that was not directly challenge
tested in order to verify Cryptosporidium removal capability.
Production modules that do not meet the established QCRV are not
eligible for the treatment credit demonstrated during the challenge test.
(viii) If a previously tested membrane is modified in a manner that
could change the removal efficiency of the membrane or the
applicability of the non-destructive performance test and associated
QCRV, additional challenge testing to demonstrate the removal
efficiency of, and determine a new QCRV for, the modified membrane must
be conducted and submitted to the State.
(3) Direct integrity testing. Systems must conduct direct integrity
testing in a manner that demonstrates a removal efficiency equal to or
greater than the removal credit awarded to the membrane filtration
process and meets the requirements described in paragraphs (b)(3)(i)
through (vi) of this section. A direct integrity test is defined as a
physical test applied to a membrane unit in order to identify and
isolate integrity breaches (i.e., one or more leaks that could result
in contamination of the filtrate).
(i) The direct integrity test must be independently applied to each
membrane unit in service. A membrane unit is defined as a group of
membrane modules that share common valving that allows the unit to be
isolated from the rest of the system for the purpose of integrity
testing or other maintenance.
(ii) The direct integrity method must have a resolution of 3
micrometers or less, where resolution is defined as the size of the
smallest integrity breach that contributes to a response from the
direct integrity test.
(iii) The direct integrity test must have a sensitivity sufficient
to verify the log treatment credit awarded to the membrane filtration
process by the State, where sensitivity is defined as the maximum log
removal value that can be reliably verified by a direct integrity test.
Sensitivity must be determined using the approach in either paragraph
(b)(3)(iii)(A) or (B) of this section as applicable to the type of
direct integrity test the system uses.
(A) For direct integrity tests that use an applied pressure or
vacuum, the direct integrity test sensitivity must be calculated
according to the following equation:
LRVDIT = LOG10 (Qp /(VCF x
Qbreach))
Where:
LRVDIT = the sensitivity of the direct integrity test;
Qp = total design filtrate flow from the membrane unit;
Qbreach = flow of water from an
[[Page 782]]
integrity breach associated with the smallest integrity test response
that can be reliably measured, and VCF = volumetric concentration
factor. The volumetric concentration factor is the ratio of the
suspended solids concentration on the high pressure side of the
membrane relative to that in the feed water.
(B) For direct integrity tests that use a particulate or molecular
marker, the direct integrity test sensitivity must be calculated
according to the following equation:
LRVDIT = LOG10(Cf)-
LOG10(Cp)
Where:
LRVDIT = the sensitivity of the direct integrity test;
Cf = the typical feed concentration of the marker used in
the test; and Cp = the filtrate concentration of the marker
from an integral membrane unit.
(iv) Systems must establish a control limit within the sensitivity
limits of the direct integrity test that is indicative of an integral
membrane unit capable of meeting the removal credit awarded by the State.
(v) If the result of a direct integrity test exceeds the control
limit established under paragraph (b)(3)(iv) of this section, the
system must remove the membrane unit from service. Systems must conduct
a direct integrity test to verify any repairs, and may return the
membrane unit to service only if the direct integrity test is within
the established control limit.
(vi) Systems must conduct direct integrity testing on each membrane
unit at a frequency of not less than once each day that the membrane
unit is in operation. The State may approve less frequent testing,
based on demonstrated process reliability, the use of multiple barriers
effective for Cryptosporidium, or reliable process safeguards.
(4) Indirect integrity monitoring. Systems must conduct continuous
indirect integrity monitoring on each membrane unit according to the
criteria in paragraphs (b)(4)(i) through (v) of this section. Indirect
integrity monitoring is defined as monitoring some aspect of filtrate
water quality that is indicative of the removal of particulate matter.
A system that implements continuous direct integrity testing of
membrane units in accordance with the criteria in paragraphs (b)(3)(i)
through (v) of this section is not subject to the requirements for
continuous indirect integrity monitoring. Systems must submit a monthly
report to the State summarizing all continuous indirect integrity
monitoring results triggering direct integrity testing and the
corrective action that was taken in each case.
(i) Unless the State approves an alternative parameter, continuous
indirect integrity monitoring must include continuous filtrate
turbidity monitoring.
(ii) Continuous monitoring must be conducted at a frequency of no
less than once every 15 minutes.
(iii) Continuous monitoring must be separately conducted on each
membrane unit.
(iv) If indirect integrity monitoring includes turbidity and if the
filtrate turbidity readings are above 0.15 NTU for a period greater
than 15 minutes (i.e., two consecutive 15-minute readings above 0.15
NTU), direct integrity testing must immediately be performed on the
associated membrane unit as specified in paragraphs (b)(3)(i) through
(v) of this section.
(v) If indirect integrity monitoring includes a State-approved
alternative parameter and if the alternative parameter exceeds a State-
approved control limit for a period greater than 15 minutes, direct
integrity testing must immediately be performed on the associated
membrane units as specified in paragraphs (b)(3)(i) through (v) of this
section.
(c) Second stage filtration. Systems receive 0.5-log
Cryptosporidium treatment credit for a separate second stage of
filtration that consists of sand, dual media, GAC, or other fine grain
media following granular media filtration if the State approves. To be
eligible for this credit, the first stage of filtration must be
preceded by a coagulation step and both filtration stages must treat
the entire plant flow taken from a surface water or GWUDI source. A
cap, such as GAC, on a single stage of filtration is not eligible for
this credit. The State must approve the treatment credit based on an
assessment of the design characteristics of the filtration process.
(d) Slow sand filtration (as secondary filter). Systems are
eligible to receive 2.5-log Cryptosporidium treatment credit for a slow
sand filtration process that follows a separate stage of filtration if
both filtration stages treat entire plant flow taken from a surface
water or GWUDI source and no disinfectant residual is present in the
influent water to the slow sand filtration process. The State must
approve the treatment credit based on an assessment of the design
characteristics of the filtration process. This paragraph does not
apply to treatment credit awarded to slow sand filtration used as a
primary filtration process.
Sec. 141.720 Inactivation toolbox components.
(a) Calculation of CT values. (1) CT is the product of the
disinfectant contact time (T, in minutes) and disinfectant
concentration (C, in milligrams per liter). Systems with treatment
credit for chlorine dioxide or ozone under paragraph (b) or (c) of this
section must calculate CT at least once each day, with both C and T
measured during peak hourly flow as specified in Sec. Sec. 141.74(a)
through (b).
(2) Systems with several disinfection segments in sequence may
calculate CT for each segment, where a disinfection segment is defined
as a treatment unit process with a measurable disinfectant residual
level and a liquid volume. Under this approach, systems must add the
Cryptosporidium CT values in each segment to determine the total CT for
the treatment plant.
(b) CT values for chlorine dioxide and ozone. (1) Systems receive
the Cryptosporidium treatment credit listed in this table by meeting
the corresponding chlorine dioxide CT value for the applicable water
temperature, as described in paragraph (a) of this section.
CT Values (mg[middot]min/L) for Cryptosporidium Inactivation by Chlorine Dioxide \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Water Temperature, [deg]C
Log credit ---------------------------------------------------------------------------------------
< =0.5 1 2 3 5 7 10 15 20 25 30
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 0.25........................................................ 159 153 140 128 107 90 69 45 29 19 12
(ii) 0.5........................................................ 319 305 279 256 214 180 138 89 58 38 24
(iii) 1.0....................................................... 637 610 558 511 429 360 277 179 116 75 49
(iv) 1.5........................................................ 956 915 838 767 643 539 415 268 174 113 73
(v) 2.0......................................................... 1275 1220 1117 1023 858 719 553 357 232 150 98
(vi) 2.5........................................................ 1594 1525 1396 1278 1072 899 691 447 289 188 122
[[Page 783]]
(vii) 3.0....................................................... 1912 1830 1675 1534 1286 1079 830 536 347 226 147
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Systems may use this equation to determine log credit between the indicated values: Log credit = (0.001506 x (1.09116) Temp) x CT.
(2) Systems receive the Cryptosporidium treatment credit listed in
this table by meeting the corresponding ozone CT values for the
applicable water temperature, as described in paragraph (a) of this
section.
CT Values (mg[middot]min/L) for Cryptosporidium Inactivation by Ozone \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Water Temperature, [deg]C
Log credit ---------------------------------------------------------------------------------------
< =0.5 1 2 3 5 7 10 15 20 25 30
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 0.25........................................................ 6.0 5.8 5.2 4.8 4.0 3.3 2.5 1.6 1.0 0.6 0.39
(ii) 0.5........................................................ 12 12 10 9.5 7.9 6.5 4.9 3.1 2.0 1.2 0.78
(iii) 1.0....................................................... 24 23 21 19 16 13 9.9 6.2 3.9 2.5 1.6
(iv) 1.5........................................................ 36 35 31 29 24 20 15 9.3 5.9 3.7 2.4
(v) 2.0......................................................... 48 46 42 38 32 26 20 12 7.8 4.9 3.1
(vi) 2.5........................................................ 60 58 52 48 40 33 25 16 9.8 6.2 3.9
(vii) 3.0....................................................... 72 69 63 57 47 39 30 19 12 7.4 4.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Systems may use this equation to determine log credit between the indicated values: Log credit = (0.0397 x (1.09757)Temp) x CT.
(c) Site-specific study. The State may approve alternative chlorine
dioxide or ozone CT values to those listed in paragraph (b) of this
section on a site-specific basis. The State must base this approval on
a site-specific study a system conducts that follows a State-approved
protocol.
(d) Ultraviolet light. Systems receive Cryptosporidium, Giardia
lamblia, and virus treatment credits for ultraviolet (UV) light
reactors by achieving the corresponding UV dose values shown in
paragraph (d)(1) of this section. Systems must validate and monitor UV
reactors as described in paragraphs (d)(2) and (3) of this section to
demonstrate that they are achieving a particular UV dose value for
treatment credit.
(1) UV dose table. The treatment credits listed in this table are
for UV light at a wavelength of 254 nm as produced by a low pressure
mercury vapor lamp. To receive treatment credit for other lamp types,
systems must demonstrate an equivalent germicidal dose through reactor
validation testing, as described in paragraph (d)(2) of this section.
The UV dose values in this table are applicable only to post-filter
applications of UV in filtered systems and to unfiltered systems.
UV Dose Table for Cryptosporidium, Giardia lamblia, and Virus Inactivation Credit
----------------------------------------------------------------------------------------------------------------
Cryptosporidium Giardia lamblia
Log credit UV dose (mJ/ UV dose (mJ/ Virus UV dose
cm\2\) cm\2\) (mJ/cm\2\)
----------------------------------------------------------------------------------------------------------------
(i) 0.5................................................ 1.6 1.5 39
(ii) 1.0............................................... 2.5 2.1 58
(iii) 1.5.............................................. 3.9 3.0 79
(iv) 2.0............................................... 5.8 5.2 100
(v) 2.5................................................ 8.5 7.7 121
(vi) 3.0............................................... 12 11 143
(vii) 3.5.............................................. 15 15 163
(viii) 4.0............................................. 22 22 186
----------------------------------------------------------------------------------------------------------------
(2) Reactor validation testing. Systems must use UV reactors that
have undergone validation testing to determine the operating conditions
under which the reactor delivers the UV dose required in paragraph
(d)(1) of this section (i.e., validated operating conditions). These
operating conditions must include flow rate, UV intensity as measured
by a UV sensor, and UV lamp status.
(i) When determining validated operating conditions, systems must
account for the following factors: UV absorbance of the water; lamp
fouling and aging; measurement uncertainty of on-line sensors; UV dose
distributions arising from the velocity profiles through the reactor;
failure of UV lamps or other critical system components; and inlet and
outlet piping or channel configurations of the UV reactor.
(ii) Validation testing must include the following: Full scale
testing of a reactor that conforms uniformly to the UV reactors used by
the system and inactivation of a test microorganism whose dose response
characteristics have been quantified with a low pressure mercury vapor
lamp.
(iii) The State may approve an alternative approach to validation
testing.
(3) Reactor monitoring. (i) Systems must monitor their UV reactors
to determine if the reactors are operating within validated conditions,
as determined under paragraph (d)(2) of this section. This monitoring
must include UV intensity as measured by a UV sensor, flow rate, lamp
status, and other parameters the State designates
[[Page 784]]
based on UV reactor operation. Systems must verify the calibration of
UV sensors and must recalibrate sensors in accordance with a protocol
the State approves.
(ii) To receive treatment credit for UV light, systems must treat
at least 95 percent of the water delivered to the public during each
month by UV reactors operating within validated conditions for the
required UV dose, as described in paragraphs (d)(1) and (2) of this
section. Systems must demonstrate compliance with this condition by the
monitoring required under paragraph (d)(3)(i) of this section.
Reporting and Recordkeeping Requirements
Sec. 141.721 Reporting requirements.
(a) Systems must report sampling schedules under Sec. 141.702 and
source water monitoring results under Sec. 141.706 unless they notify
the State that they will not conduct source water monitoring due to
meeting the criteria of Sec. 141.701(d).
(b) Systems must report the use of uncovered finished water storage
facilities to the State as described in Sec. 141.714.
(c) Filtered systems must report their Cryptosporidium bin
classification as described in Sec. 141.710.
(d) Unfiltered systems must report their mean source water
Cryptosporidium level as described in Sec. 141.712.
(e) Systems must report disinfection profiles and benchmarks to the
State as described in Sec. Sec. 141.708 through 141.709 prior to
making a significant change in disinfection practice.
(f) Systems must report to the State in accordance with the
following table for any microbial toolbox options used to comply with
treatment requirements under Sec. 141.711 or Sec. 141.712.
Alternatively, the State may approve a system to certify operation
within required parameters for treatment credit rather than reporting
monthly operational data for toolbox options.
Microbial Toolbox Reporting Requirements
----------------------------------------------------------------------------------------------------------------
Systems must submit the
Toolbox option following information On the following schedule
----------------------------------------------------------------------------------------------------------------
(1) Watershed control program (WCP).......... (i) Notice of intention to No later than two years before
develop a new or continue an the applicable treatment
existing watershed control compliance date in Sec.
program. 141.713
(ii) Watershed control plan..... No later than one year before
the applicable treatment
compliance date in Sec.
141.713.
(iii) Annual watershed control Every 12 months, beginning one
program status report. year after the applicable
treatment compliance date in
Sec. 141.713.
(iv) Watershed sanitary survey For community water systems,
report. every three years beginning
three years after the
applicable treatment
compliance date in Sec.
141.713. For noncommunity
water systems, every five
years beginning five years
after the applicable treatment
compliance date in Sec.
141.713.
(2) Alternative source/intake management..... Verification that system has No later than the applicable
relocated the intake or adopted treatment compliance date in
the intake withdrawal procedure Sec. 141.713.
reflected in monitoring results.
(3) Presedimentation......................... Monthly verification of the Monthly reporting within 10
following: (i) Continuous basin days following the month in
operation (ii) Treatment of which the monitoring was
100% of the flow (iii) conducted, beginning on the
Continuous addition of a applicable treatment
coagulant (iv) At least 0.5-log compliance date in Sec.
mean reduction of influent 141.713.
turbidity or compliance with
alternative State-approved
performance criteria.
(4) Two-stage lime softening................. Monthly verification of the Monthly reporting within 10
following: (i) Chemical days following the month in
addition and hardness which the monitoring was
precipitation occurred in two conducted, beginning on the
separate and sequential applicable treatment
softening stages prior to compliance date in Sec.
filtration (ii) Both stages 141.713.
treated 100% of the plant flow.
(5) Bank filtration.......................... (i) Initial demonstration of the No later than the applicable
following: (A) Unconsolidated, treatment compliance date in
predominantly sandy aquifer (B) Sec. 141.713.
Setback distance of at least 25
ft. (0.5-log credit) or 50 ft.
(1.0-log credit).
(ii) If monthly average of daily Report within 30 days following
max turbidity is greater than 1 the month in which the
NTU then system must report monitoring was conducted,
result and submit an assessment beginning on the applicable
of the cause.. treatment compliance date in
Sec. 141.713.
(6) Combined filter performance.............. Monthly verification of combined Monthly reporting within 10
filter effluent (CFE) turbidity days following the month in
levels less than or equal to which the monitoring was
0.15 NTU in at least 95 percent conducted, beginning on the
of the 4 hour CFE measurements applicable treatment
taken each month. compliance date in Sec.
141.713.
(7) Individual filter performance............ Monthly verification of the Monthly reporting within 10
following: (i) Individual days following the month in
filter effluent (IFE ) which the monitoring was
turbidity levels less than or conducted, beginning on the
equal to 0.15 NTU in at least applicable treatment
95 percent of samples each compliance date in Sec.
month in each filter (ii) No 141.713.]
individual filter greater than
0.3 NTU in two consecutive
readings 15 minutes apart.
(8) Demonstration of performance............. (i) Results from testing No later than the applicable
following a State approved treatment compliance date in
protocol. Sec. 141.713.
(ii) As required by the State, Within 10 days following the
monthly verification of month in which monitoring was
operation within conditions of conducted, beginning on the
State approval for applicable treatment
demonstration of performance compliance date in Sec.
credit. 141.713.
[[Page 785]]
(9) Bag filters and cartridge filters........ (i) Demonstration that the No later than the applicable
following criteria are met: (A) treatment compliance date in
Process meets the definition of Sec. 141.713.
bag or cartridge filtration;
(B) Removal efficiency
established through challenge
testing that meets criteria in
this subpart.
(ii) Monthly verification that Within 10 days following the
100% of plant flow was filtered. month in which monitoring was
conducted, beginning on the
applicable treatment
compliance date in Sec.
141.713.
(10) Membrane filtration..................... (i) Results of verification No later than the applicable
testing demonstrating the treatment compliance date in
following: (A) Removal Sec. 141.713.
efficiency established through
challenge testing that meets
criteria in this subpart; (B)
Integrity test method and
parameters, including
resolution, sensitivity, test
frequency, control limits, and
associated baseline.
(ii) Monthly report summarizing Within 10 days following the
the following: (A) All direct month in which monitoring was
integrity tests above the conducted, beginning on the
control limit; (B) If applicable treatment
applicable, any turbidity or compliance date in Sec.
alternative state-approved 141.713.
indirect integrity monitoring
results triggering direct
integrity testing and the
corrective action that was
taken.
(11) Second stage filtration................. Monthly verification that 100% Within 10 days following the
of flow was filtered through month in which monitoring was
both stages and that first conducted, beginning on the
stage was preceded by applicable treatment
coagulation step. compliance date in Sec.
141.713.
(12) Slow sand filtration (as secondary Monthly verification that both a Within 10 days following the
filter). slow sand filter and a month in which monitoring was
preceding separate stage of conducted, beginning on the
filtration treated 100% of flow applicable treatment
from subpart H sources.. compliance date in Sec.
141.713.
(13) Chlorine dioxide........................ Summary of CT values for each Within 10 days following the
day as described in Sec. month in which monitoring was
141.720.. conducted, beginning on the
applicable treatment
compliance date in Sec.
141.713.
(14) Ozone................................... Summary of CT values for each Within 10 days following the
day as described in Sec. month in which monitoring was
141.720.. conducted, beginning on the
applicable treatment
compliance date in Sec.
141.713.
(15) UV...................................... (i) Validation test results No later than the applicable
demonstrating operating treatment compliance date in
conditions that achieve Sec. 141.713.
required UV dose. Within 10 days following the
(ii) Monthly report summarizing month in which monitoring was
the percentage of water conducted, beginning on the
entering the distribution applicable treatment
system that was not treated by compliance date in Sec.
UV reactors operating within 141.713.
validated conditions for the
required dose as specified in
141.720(d)..
----------------------------------------------------------------------------------------------------------------
Sec. 141.722 Recordkeeping requirements.
(a) Systems must keep results from the initial round of source
water monitoring under Sec. 141.701(a) and the second round of source
water monitoring under Sec. 141.701(b) until 3 years after bin
classification under Sec. 141.710 for filtered systems or
determination of the mean Cryptosporidium level under Sec. 141.710 for
unfiltered systems for the particular round of monitoring.
(b) Systems must keep any notification to the State that they will
not conduct source water monitoring due to meeting the criteria of
Sec. 141.701(d) for 3 years.
(c) Systems must keep the results of treatment monitoring
associated with microbial toolbox options under Sec. Sec. 141.716
through 141.720 and with uncovered finished water reservoirs under
Sec. 141.714, as applicable, for 3 years.
Requirements for Sanitary Surveys Performed by EPA
Sec. 141.723 Requirements to respond to significant deficiencies
identified in sanitary surveys performed by EPA.
(a) A sanitary survey is an onsite review of the water source
(identifying sources of contamination by using results of source water
assessments where available), facilities, equipment, operation,
maintenance, and monitoring compliance of a PWS to evaluate the
adequacy of the PWS, its sources and operations, and the distribution
of safe drinking water.
(b) For the purposes of this section, a significant deficiency
includes a defect in design, operation, or maintenance, or a failure or
malfunction of the sources, treatment, storage, or distribution system
that EPA determines to be causing, or has the potential for causing the
introduction of contamination into the water delivered to consumers.
(c) For sanitary surveys performed by EPA, systems must respond in
writing to significant deficiencies identified in sanitary survey
reports no later than 45 days after receipt of the report, indicating
how and on what schedule the system will address significant
deficiencies noted in the survey.
(d) Systems must correct significant deficiencies identified in
sanitary survey reports according to the schedule approved by EPA, or
if there is no approved schedule, according to the schedule reported
under paragraph (c) of this section if such deficiencies are within the
control of the system.
PART 142--NATIONAL PRIMARY DRINKING WATER REGULATIONS IMPLEMENTATION
? 8. The authority citation for part 142 continues to read as follows:
Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-
5, 300g-6, 300j-4, 300j-9 and 300j-11.
? 9. Section 142.14 is amended by adding paragraph (a)(9) to read as
follows:
Sec. 142.14 Records kept by States.
* * * * *
(a) * * *
[[Page 786]]
(9) Any decisions made pursuant to the provisions of part 141,
subpart W of this chapter.
(i) Results of source water E. coli and Cryptosporidium monitoring.
(ii) The bin classification after the initial and after the second
round of source water monitoring for each filtered system, as described
in Sec. 141.710 of this chapter.
(iii) Any change in treatment requirements for filtered systems due
to watershed assessment during sanitary surveys, as described in Sec.
141.711(d) of this chapter.
(iv) The determination of whether the mean Cryptosporidium level is
greater than 0.01 oocysts/L after the initial and after the second
round of source water monitoring for each unfiltered system, as
described in Sec. 141.712(a) of this chapter.
(v) The treatment processes or control measures that systems use to
meet their Cryptosporidium treatment requirements under Sec. 141.711
or Sec. 141.712 of this chapter.
(vi) A list of systems required to cover or treat the effluent of
an uncovered finished water storage facility, as specified in Sec.
141.714 of this chapter.
* * * * *
? 10. Section 142.15 is amended by adding paragraph (c)(6) to read as
follows:
Sec. 142.15 Reports by States.
(c) * * *
(6) Subpart W. (i) The bin classification after the initial and
after the second round of source water monitoring for each filtered
system, as described in Sec. 141.710 of this chapter.
(ii) Any change in treatment requirements for these systems due to
watershed assessment during sanitary surveys, as described in Sec.
141.711(d) of this chapter.
(iii) The determination of whether the mean Cryptosporidium level
is greater than 0.01 oocysts/L both after the initial and after the
second round of source water monitoring for each unfiltered system, as
described in Sec. 141.712(a) of this chapter.
* * * * *
? 11. Section 142.16 is amended by adding paragraph (n) to read as follows:
Sec. 142.16 Special primacy conditions.
* * * * *
(n) Requirements for States to adopt 40 CFR part 141, subpart W. In
addition to the general primacy requirements elsewhere in this part,
including the requirements that State regulations be at least as
stringent as Federal requirements, an application for approval of a
State program revision that adopts 40 CFR part 141, subpart W, must
contain a description of how the State will accomplish the following
program requirements where allowed in State programs.
(1) Approve an alternative to the E. coli levels that trigger
Cryptosporidium monitoring by filtered systems serving fewer than
10,000 people, as described in Sec. 141.701(a)(5).
(2) Assess significant changes in the watershed and source water as
part of the sanitary survey process and determine appropriate follow-up
action for systems, as described in Sec. 141.711(d) of this chapter.
(3) Approve watershed control programs for the 0.5-log treatment
credit in the microbial toolbox, as described in Sec. 141.716(a) of
this chapter.
(4) Approve protocols for demonstration of performance treatment
credits in the microbial toolbox, as allowed under Sec. 141.718(c) of
this chapter.
(5) Approve protocols for alternative ozone and chlorine dioxide CT
values in the microbial toolbox, as allowed under Sec. 141.720(c) of
this chapter.
(6) Approve an alternative approach to UV reactor validation
testing in the microbial toolbox, as allowed under Sec.
141.720(d)(2)(iii) of this chapter.
* * * * *
[FR Doc. 06-4 Filed 1-4-06; 8:45 am]
BILLING CODE 6560-50-P
![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}