v>EPA
United States
Environmental Protection
Agency
Guidance on Generation and
Submission of Grandfathered
Cryptosporidium Data for Bin
Classification Under the Long Term 2
Enhanced Surface Water Treatment
Rule
April 2003
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Office of Water (4607)
EPA815-R-03-009
www.epa.gov/safewater
April 2003
Printed on Recycled Paper
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Disclaimer
The Standards and Risk Management Division, of the Office of Ground Water and Drinking Water, has
reviewed and approved this guidance for publication. Neither the United States Government nor any of its
employees, contractors, or their employees make any warranty, expressed or implied, or assumes any
legal liability or responsibility for any third party's use of or the results of such use of any information,
apparatus, product, or process discussed in this report, or represents that its use by such party would not
infringe on privately owned rights. Mention of trade names or commercial products does not constitute
endorsement or recommendation for use.
Questions concerning this report or its application should be addressed to:
Dan Schmelling
U.S. EPA Office of Ground Water and Drinking Water
EPA East Building
Mail Code 4607, Room 2209J
1201 Constitution Avenue, NW
Washington, DC 20004
schmelling.dan@epa.gov
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Guidance on Generation and Submission of Grandfathered
Cryptosporidium Data for Bin Classification Under the Long Term 2
Enhanced Surface Water Treatment Rule
1.0 Purpose
The purpose of this guidance is to assist public water systems (PWSs) that elect to monitor for
Cryptosporidium prior to fmalization of the Long Term 2 Enhanced Surface Water Treatment Rule
(LT2ESWTR). The U.S. Environmental Protection Agency (EPA) is developing the LT2ESWTRto
address risk from Cryptosporidium in drinking water. This guidance reflects recommendations by the
Stage 2 Microbial and Disinfection Byproducts Advisory Committee (the Committee) to the EPA
Administrator for the LT2ESWTR. The Committee's recommendations are set forth in an Agreement in
Principle (Agreement) (65 FR 83015, December 29, 2000).
The Agreement recommends that under the LT2ESWTR, PWSs using surface water conduct source water
Cryptosporidium monitoring for a specified period. The monitoring results would determine a risk bin
classification, which would dictate what, if any, additional Cryptosporidium treatment would be required.
Under the Agreement, PWSs could use previously collected (i.e., grandfathered) Cryptosporidium
monitoring results to determine their LT2ESWTR bin classification in lieu of additional monitoring under
the rule. However, to be used for bin classification, previously collected data should be equivalent in
sample number, frequency, and data quality to data that would be collected during LT2ESWTR
implementation.
This guidance describes how PWSs can perform grandfathered Cryptosporidium monitoring such that the
results should be equivalent to data generated under the LT2ESWTR and, therefore, acceptable for use in
bin classification. This guidance does not address the potential use under the LT2ESWTR of previously
collected Cryptosporidium data that are determined not to be equivalent to the data generated under the
LT2ESWTR; EPA plans to solicit comment on this issue in the proposed rule.
This document constitutes EPA's guidance for PWSs that choose to monitor for Cryptosporidium prior to
EPA's issuance of the final LT2ESWTR and seek to have the data accepted for use ("grandfathered") when
the LT2ESWTR is promulgated. This document does not substitute for the Safe Drinking Water Act or EPA
regulations, nor is it a regulation itself. This guidance cannot impose legally binding requirements on the
EPA, States, authorized tribes, or the regulated community, and might not apply to a particular situation
based on the circumstances. As with all guidance, EPA may change this guidance in the future to reflect
new information.
This guidance addresses the following topics:
1.0 Purpose
2.0 Background
3.0 General Guidelines for Generating Cryptosporidium Data
3.1 Sample Collection Location
3.2 Sample Collection Schedule
3.3 Cryptosporidium Analytical Methods for Grandfathered Data
3.4 Cryptosporidium Laboratories for Grandfathered Data
3.5 E. coll and Turbidity Measurements
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4.0 Reporting Grandfathered Data
4.1 Data Package Contents
4.2 Schedule for Submission of Grandfathered Data
4.3 Procedures for Submission of Grandfathered Data
5.0 Contact Information
6.0 Checklists for Grandfathering Cryptosporidium Data
2.0 Background
"Grandfathered" Cryptosporidium data are results generated before monitoring under the LT2ESWTR starts
and that a PWS intends to use in determining its bin classification under the rule (for an initial discussion of
bin classification, see http://www.epa.gov/safewater/lt2/st2eswtr.html). Under the Agreement,
grandfathered data may be used in lieu of, or in addition to, results generated during LT2ESWTR
implementation.
EPA plans to establish detailed, standardized requirements for Cryptosporidium sample collection, analysis,
laboratory performance, and data reporting under the final LT2ESWTR to ensure that data will be of
satisfactory quality for bin classification. These requirements will be published in the proposed
LT2ESWTR and will be subject to public comment. Related information and guidance will be provided
through laboratory and utility guidance manuals for the rule, the Cryptosporidium Laboratory Quality
Assurance Evaluation Program, EPA Methods 1622 and 1623, and the LT2 Data Collection System.
Grandfathered Cryptosporidium data will be generated before LT2ESWTR requirements are established.
The purpose of these guidelines is to assist PWSs in producing grandfathered data that should be equivalent
to the data collected during LT2ESWTR implementation and, therefore, eligible for use in bin
classification. The final LT2ESWTR will establish requirements for reporting and acceptance of
grandfathered monitoring results.
3.0 General Guidelines for Generating Cryptosporidium Data
Under the Agreement, a PWSs' grandfathered Cryptosporidium data package should meet the following
general conditions:
Samples were collected from the appropriate location(s) (see details below)
• Samples were representative of a plant's source water(s) and the source water(s) have not changed
• Samples were collected no less frequently than each calendar month on a regular schedule, beginning
no earlier than January 1999 (when EPA Method 1622 was first released as an interlaboratory-validated
method)
Samples were collected in equal intervals of time over the entire collection period (e.g., weekly, twice-
per-month, monthly)
• The data set includes all source water Cryptosporidium monitoring results generated during the
grandfathered data monitoring period (see details below—data from monitoring not directed towards
LT2ESWTR binning will not be a component of the binning data set)
Sample volumes of at least 10 L were analyzed or, in cases where 10 L were not analyzed, at least 2 mL
of packed pellet volume were analyzed (additional details below)
• The data were generated using the validated versions of EPA Methods 1622 or 1623
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• The data are fully compliant with the QA/QC criteria specified in the version of Method 1622 or
Method 1623 used to generate the data, including analysis of matrix spike (MS) samples at a frequency
of at least 5% (1 MS sample for every 20 monitoring samples)
The following sections discuss these recommendations in more detail.
3.1 Sample Collection Location
Under the Agreement, LT2ESWTR monitoring is intended to assess the mean Cryptosporidium level in the
influent to drinking water plants that treat surface water or ground water under the direct influence
(GWUDI) of surface water. Generally, monitoring should be performed for each plant that treats a surface
water or GWUDI source. However, where multiple plants receive all of their water from the same influent
(e.g., multiple plants draw water from the same pipe), the same set of monitoring results may be applicable
to each plant.
Cryptosporidium samples intended for grandfathering under the LT2ESWTR should be collected at a
location that is representative of the treatment plant influent and prior to any treatment (with exceptions
noted below). Additional information for specific situations is provided as follows:
3.1.1 Plants That Do Not Have a Sampling Tap Located Prior to Any Treatment
Plants in this situation should pursue one of the following options:
• Establish a sampling location prior to treatment
• Discontinue chemical addition for a period of 6 to 12 hours (or when determined by the plant to be
chemical-free as indicated by appropriate analytical methods for the chemical additive) before sample
collection
• Manually collect source water samples as close to the intake as is feasible, at a similar depth and
distance from shore
3.1.2 Plants That Use Different Water Sources at the Same Time
This includes multiple surface water sources and blended surface water and groundwater sources. Plants in
this situation should pursue one of the following options:
• If there is a sampling tap where the sources are combined prior to treatment, the sample should be
collected from the tap.
• If the sampling tap is located after treatment, discontinue chemical addition for a period of 6 to 12 hours
(or when determined by the plant to be chemical-free) before sample collection.
• Samples can be manually collected at each source near the intake on the same day and composited into
one sample. The volume of sample from each source should be weighted according to the proportion of
that source used by the plant. For example, if a plant has two sources and 75% of the drinking water is
from Source A and 25% is from Source B, then for a 10 L sample, 7.5 L would be collected from
Source A and combined with 2.5 L collected from Source B. Compositing of samples should reflect
plant operation at the time the sample is collected and may change during the monitoring period.
3.1.3 Plants That Use Presedimentation
PWSs with plants using a presedimentation basin should take source water samples after the
presedimentation basin but before any other treatment. Use of presedimentation basins during monitoring
should be consistent with routine operational practice and should be documented.
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3.1.4 Plants That Use Raw Water Off-Stream Storage
PWSs with plants using an off-stream raw water storage reservoir should take source water samples after
the off-stream storage reservoir but before any other treatment. Use of off-stream storage during monitoring
should be consistent with routine operational practice and should be documented.
3.1.5 Plants That Use Bank Filtration
The correct sampling location for PWSs with plants using bank filtration differs depending on whether the
bank filtered water is treated by subsequent filtration for compliance with the Surface Water Treatment
Rule (SWTR) (i.e., compliance with 40 CFR 141.73).
• PWSs using bank filtered water that is treated by subsequent filtration for compliance with the SWTR
should collect source water samples from the well (i.e., after bank filtration) but before any other
treatment. Use of bank filtration during monitoring should be consistent with routine operational
practice and should be documented.
• PWSs using bank filtered water without additional filtration (e.g., PWSs complying with the SWTR
using an alternative filtration demonstration under 40 CFR 141.73(d)) should take source water samples
in the surface water source (e.g., the river). Use of bank filtration during monitoring should be
consistent with routine operational practice and should be documented.
If the PWS does not collect samples as recommended in this section, the data may not be acceptable for
grandfathering.
3.2 Sample Collection Schedule
The Agreement recommends that during LT2ESWTR monitoring, PWSs should collect samples at least
monthly and in accordance with a schedule established by the PWS prior to initiation of monitoring. PWSs
may collect samples more frequently (e.g., twice-per-month, weekly) provided the same frequency is
maintained throughout the monitoring period. Sampling for grandfathered data should follow these same
criteria.
EPA recommends that prior to initiation of grandfathered monitoring, PWSs develop a schedule listing the
calendar date on which each Cryptosporidium sample will be collected and include this schedule when
submitting the grandfathered data package to EPA. PWSs that have begun grandfathered monitoring
without establishing a sampling schedule should develop a schedule for the collection of remaining
samples. PWSs should collect samples within 2 days before or after the dates indicated in their sampling
schedules. Exceptions to the sampling schedule are noted as follows:
• If extreme conditions or situations exist that may pose danger to the sampler, or which are unforeseen
or cannot be avoided and which cause the system to be unable to sample in the required time frame, the
PWS should sample as close to the scheduled date as feasible and submit an explanation for the
alternative sampling date with the analytical results.
• PWSs that are unable to report a valid Cryptosporidium analytical result for a scheduled sampling date
due to failure to comply with the analytical method quality control standards (e.g., sample is lost or
contaminated; laboratory exceeds an analytical method holding time) should collect a replacement
sample within 14 days of being notified by the laboratory that a result cannot be reported for that date.
PWSs should submit an explanation for the replacement sample with the analytical results.
Alternative sample collection dates should be timed so as not to coincide with another scheduled
Cryptosporidium sample collection date. Documentation of alternate sample collection, including the
reason, should be provided with the grandfathered data package.
Water treatment plants that use surface water or GWUDI but are operated only seasonally (e.g., during
times of high-water demand) should monitor at least monthly during the period when the plant is in
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operation. EPA plans to solicit comment in the LT2ESWTR proposal on whether a minimum number of
samples should be required for seasonally operated plants.
The Agreement recommends that if PWSs collect a total of at least 48 samples (regardless of whether all of
the samples were collected before LT2ESWTR promulgation or some were collected before and some after
rule promulgation), the Cryptosporidium bin concentration will be equal to the arithmetic mean of all
sample concentrations. For PWSs that serve at least 10,000 people and collect a total of at least 24 samples,
but not more than 47 samples, the Cryptosporidium bin concentration will be equal to the highest arithmetic
mean of all sample concentrations in any 12 consecutive months during which Cryptosporidium samples
were collected.
3.3 Cryptosporidium Analytical Methods for Grandfathered Data
The Agreement recommends that Methods 1622 or 1623 be used for Cryptosporidium analyses for the
LT2ESWTR. The following are EPA validated versions of Methods 1622 and 1623:
• Method 1623: Cryptosporidium and Giardia in Water by Filtration/IMS/FA. U.S. Environmental
Protection Agency, Office of Water. 2001. EPA-821-R-01-025
• Method 1622: Cryptosporidium in Water by Filtration/IMS/FA. U.S. Environmental Protection Agency,
Office of Water. 2001. EPA-821-R-01-026
• Method 1623: Cryptosporidium and Giardia in Water by Filtration/IMS/FA. U.S. Environmental
Protection Agency, Office of Water. 1999. EPA-821-R-99-006 (Note: The 2001 version of the method
should be used to generate data after January 1, 2002.)
• Method 1622: Cryptosporidium in Water by Filtration/IMS/FA. U.S. Environmental Protection Agency,
Office of Water. 1999. EPA-821-R-99-001 (Note: The 2001 version of the method should be used to
generate data after January 1, 2002.)
Notable differences between the 1999 and 2001 versions of EPA Method 1622/1623 include the following:
• Nationwide approval of modified versions of the methods using the following components:
- Whatman Nuclepore CrypTest™ filter
- IDEXX Filta-Max™ filter
- Waterborne Aqua-Glo™ G/C Direct FL antibody stain
- Waterborne Crypt-a-Glo™ and Giardi-a-Glo™ antibody stains
• Clarified sample acceptance criteria
• Modified capsule filter elution procedure
• Modified concentrate aspiration procedure
• Modified IMS acid dissociation procedure
• Updated QC acceptance criteria for IPR and OPR tests
• Addition of a troubleshooting section for QC failures
• Modified holding times
• Inclusion of flow cytometry-sorted spiking suspensions (required for spiked samples analyzed during
LT2 monitoring)
Since release of the 2001 versions of Methods 1622/1623, EPA also has approved a modified version of the
methods using the Pall Gelman Envirochek™ HV filter and has approved the use of irradiated, flow
cytometer-sorted spiking suspensions for routine QC sample spiking.
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Laboratories that analyze Cryptosporidium samples using other modified procedures, as allowed under the
performance criteria of Methods 1622/1623, should be approved to use the modified procedures under the
Lab QA Program discussed in section 3.4.
3.3.1 Minimum Sample Volume and Subsampling Analysis
The Agreement recommends a sample volume of at least 10 L for Cryptosporidium analyses and, in
addition, recommends that EPA provide guidelines for those cases where it is not possible to process a 10 L
sample. The following are guidelines for minimum sample and subsample volume for Cryptosporidium
analyses under the LT2ESWTR.
• 10 L of sample, or
• 2 mL of packed pellet volume, or
• As much volume as two filters can accommodate before clogging (this condition applies only to filters
that have been approved by EPA for nationwide use with Methods 1622/1623—the Pall Gelman
Envirochek™ and Envirochek™ HV filters, the IDEXX FiltaMax™ foam filter, and the Whatman
CrypTest™ cartridge filter).
The Agreement would allow PWSs to analyze larger volumes. EPA recommends that PWSs analyze similar
sample volumes throughout the monitoring period. However, data sets including different samples volumes
would be acceptable under the Agreement, provided the PWS analyzes at least the minimum sample
volume, as given in this section, for each sample.
3.3.2 Analysis of Matrix Spike Samples
Method 1622 and 1623 require matrix spike (MS) samples to be analyzed at a frequency of 1 MS sample
for every 20 monitoring samples from each plant. The MS sample and the associated unspiked sample must
be analyzed by the same procedure and the MS sample must be the same volume as the associated
monitoring sample. If the volume of the MS sample is greater than 10 L, the system is permitted to filter all
but 10 L of the MS sample in the field, and ship the filtered sample and the remaining 10 L of source water
to the laboratory to have the laboratory spike the remaining 10 L of water and filter it through the filter used
to collect the balance of the sample in the field.
Utilities collecting and shipping bulk water samples for filtration and analysis at the laboratory should split
their sample stream and collect the monitoring sample volume and MS sample volume simultaneously.
• The sample stream should be split using flow controllers on both sides of the split to regulate the
pressure difference between the side being subjected to filtration (resulting in higher pressure) and the
side flowing into a bulk sample container. A mixing chamber (filter housing without filter) can be
added immediately upstream from the Y to aid in equalizing the distribution of sample particulates to
either side.
• If splitting the sample stream is not practical, the utility should collect the MS sample immediately
before or after the monitoring sample.
Under the Agreement, MS sample results would not be used to adjust Cryptosporidium recoveries at any
individual source water; but MS results would be used collectively to assess overall recovery and variability
for EPA Method 1622/1623 in source water. No resampling would be necessary for MS samples that do not
meet Method 1622/1623 recovery guidelines.
3.4 Cryptosporidium Laboratories for Grandfathered Data
EPA has established the Laboratory Quality Assurance Evaluation Program for the Analysis of
Cryptosporidium in Water (Lab QA Program) to approve laboratories to perform Cryptosporidium analyses
under the LT2ESWTR (see http://www.epa.gov/safewater/lt2/cla final.html). EPA recognizes that some
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PWSs could begin generating grandfathered Cryptosporidium data prior to when the Lab QA Program is
fully implemented (e.g., before EPA is able to evaluate all laboratories that will participate in the program).
Consequently, PWSs should ensure that their grandfathered Cryptosporidium samples are analyzed by
laboratories that will be evaluated under the Lab QA Program before the data are submitted to EPA. Note
that PWSs will not submit grandfathered data packages until after the LT2ESWTR is final, currently
scheduled for mid- or late 2004. Samples analyzed by laboratories that do not meet the criteria for approval
under the LT2ESWTR may not be accepted for grandfathering.
Laboratories should also participate in the EPA Protozoa PT Program. EPA does not expect there to be
restrictions on the number of laboratories involved in the generation of a PWS's grandfathered data.
3.5 E. co/i and Turbidity Measurements
The Agreement recommends that PWSs serving at least 10,000 people should collect E. coll and turbidity
samples along with Cryptosporidium samples when monitoring under the LT2ESWTR. EPA recommends
that PWSs conducting early (i.e., grandfathered) monitoring collect and analyze E. coli samples with each
Cryptosporidium sample and measure turbidity during each sampling event. However, the Agreement
would not exclude the use of previously collected Cryptosporidium data if E. coli and turbidity samples are
not collected.
4.0 Reporting Grandfathered Data
The final LT2ESWTR will establish reporting requirements for grandfathered data. The following
recommendations are intended to give PWSs an indication of potential reporting requirements for
consideration when establishing their grandfathered data monitoring programs.
For consideration of grandfathered data, PWSs should submit to EPA a complete data package as described
below.
4.1 Data Package Contents
The grandfathered data package should include the following:
1. A signed cover letter from the PWS certifying that the data represent the plant's current source water
and that all source water Cryptosporidium monitoring results collected during the LT2ESWTR
monitoring period (defined below) are included in the package
2. Sample collection schedule established before beginning monitoring
3. Where applicable, documentation addressing the dates and reason(s) for re-sampling, as well as the use
of presedimentation, off stream storage, or bank filtration during monitoring
4. A list of the field and MS samples submitted in the data package (see Section 4.1.1, below, for details),
identified by sample ID and collection date
5. Sample results for all field and MS samples (see Section 4.1.2, below, for details) and
6. Documentation that all method-required quality control requirements were acceptable for every field
and MS sample submitted with the package (see Section 4.1.3, below, for details).
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4.1.1 Sample Results to be Reported
PWSs that conduct monitoring for grandfathering should submit results for all source water
Cryptosporidium samples analyzed during the LT2ESWTR monitoring period, as defined below. This will
include all samples that were:
• Collected from the sampling location used for LT2ESWTR monitoring,
Not spiked, and
Analyzed using the laboratory's routine process for Method 1622/1623 analyses, including analytical
technique and QA/QC.
EPA plans that the LT2ESWTR monitoring period for a specific PWS will begin with the collection of the
first sample submitted for LT2ESWTR binning and end with the collection of the final sample submitted
for LT2ESWTR binning (as long as a minimum of 2 years of acceptable data have been submitted). With
the use of grandfathered data, the final sample may be collected before the end of the LT2ESWTR
implementation schedule. Sample results generated after the last sample result in the PWS's data package
would be considered outside the PWS's LT2ESWTR monitoring period and would not need to be submitted
to EPA for LT2ESWTR binning purposes. However, these results may be subject to reporting requirements
under other federal or State regulations.
4.1.2 Data Elements to be Reported for Each Sample Result
The following data elements, at a minimum, should be submitted for each Cryptosporidium monitoring
sample and MS sample:
• PWS ID
• Facility ID
• Sample collection point
• Sample collection date
• Sample type (field or MS)
• Sample volume filtered (L), to nearest % L
• Number of oocysts counted
• For samples in which less than 10 L is filtered or less than 100% of the sample volume is examined,
PWSs should also report the number of filters used and the packed pellet volume.
• For samples in which less than 100% of sample volume is examined, PWSs should also report the
volume of resuspended concentrate and volume of this resuspension processed through
immunomagnetic separation.
• For matrix spike samples, PWSs should also report the sample volume spiked and estimated number of
oocysts spiked. These data are not applicable to monitoring samples.
EPA recommends that these data elements be reported by submitting a completed sample collection form,
laboratory bench sheet, and Cryptosporidium report form for each sample. Example bench sheets and report
forms can be found at http://www.epa.gov/microbes/bnchjuO 1 .pdf and
http://www.epa.gov/microbes/cptojuO 1 .pdf Sample documentation forms that are different from these
examples, but that contain the minimum required data elements listed above, may be acceptable.
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4.1.3 Supporting Quality Control Information
The data package should include a signed letter from the laboratory certifying that all method-required
quality control elements (including sample temperature upon receipt, ongoing precision and recovery and
method blank results, holding times, and positive and negative staining controls) were performed at the
required frequency, and were acceptable for every monitoring and MS sample submitted with the package.
The letter should include a list of the applicable monitoring and MS samples, and the corresponding OPR
and method blank sample ID for each.
Alternately, the PWS may include the bench sheet and Cryptosporidium report form (or comparable
detailed data reporting forms) for each OPR and method blank sample associated with the field and MS
samples in the grandfathered data package. If this option is selected, the letter from the laboratory still
should certify that sample temperature upon receipt, holding times, and positive and negative staining
controls were acceptable for all samples. (The letter is not necessary if detailed data reporting forms
containing this information are submitted for the field and MS sample results.)
4.2 Schedule for Submission of Grandfathered Data
EPA's current intent is that PWSs with at least 2 years of grandfathered data at the time of LT2ESWTR
promulgation and that intend to use these data in lieu of monitoring under the LT2ESWTR (/. e., do NOT
intend to conduct additional monitoring) should submit these data to EPA within 2 months following
LT2ESWTR promulgation (currently planned for mid- or late 2004). EPA plans to notify these PWSs
within 4 months following LT2ESWTR promulgation as to whether their data are sufficient for bin
classification. PWSs with fewer than 2 years of grandfathered data at the time of LT2ESWTR
promulgation, or that have at least 2 years of grandfathered data but intend to conduct monitoring under the
LT2ESWTR, should submit these data to EPA within 8 months of LT2ESWTR promulgation. Under the
Agreement, PWSs should conduct monitoring under the LT2ESWTR unless notified in writing by EPA that
they have 2 years of acceptable data.
4.3 Procedures for Submission of Grandfathered Data
EPA does not intend to formally accept grandfathered Cryptosporidium data until the LT2ESWTR is
finalized. The final rule will include procedures for submission of grandfathered data.
5.0 Contact Information
For general questions regarding the LT2ESWTR, please contact Dan Schmelling, EPA Office of Ground
Water and Drinking Water, at schmelling.dan(giepa.gov or (202) 564-5281. For specific questions regarding
Cryptosporidium analytical methods, data QA/QC issues, and the Cryptosporidium Lab QA Program,
please contact Mary Ann Feige, EPA Office of Ground Water and Drinking Water, Technical Support
Center at feige.maryann@,epa.gov or (513) 569-7944.
6.0 Checklists for Grandfathering Cryptosporidium Data
To help PWSs interested in monitoring for Cryptosporidium before LT2ESWTR apply the information
provided in this guidance, two checklists have been developed and are provided below. The "Checklist for
Beginning Grandfathered Cryptosporidium Monitoring" is designed to be used by PWSs to check their
monitoring plans against the this guidance document before proceeding with monitoring. The "Checklist for
Submitting Grandfathered Cryptosporidium Data" is designed to be used by PWSs to check their data
package against the information in this guidance document before submitting the data package to EPA for
review.
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Checklist for Beginning Srandfathered Cryptosporidium Monitoring
Sampling location. Does the intended sample collection location comply with the guidance
provided in Section 3.1 of this guidance document?
Sampling schedule. Is the sample collection schedule designed to monitor for Cryptosporidium
at least monthly, and in accordance with the guidance provided in Section 3.2 of this guidance
document?
Laboratory coordination. Have you verified that your intended sample collection schedule can
be accommodated by the Cryptosporidium laboratory (to avoid holding time problems)?
Matrix spikes. Does the sampling schedule include collection of extra volume for matrix spike
samples every 20 field samples?
Method version. Will the April 2001 version of EPA Method 1622 or EPA Method 1623 be used
to analyze samples?
Sample volume issues. Have you consulted with your Cryptosporidium laboratory to determine
whether your samples are likely to clog filters or require additional "subsample" analyses?
Cryptosporidium laboratory qualifications. Is your Cryptosporidium sample analysis laboratory
approved, or seeking approval, under EPA's Lab QA Program?
£ co//' laboratory qualifications. Is your utility laboratory certified under the drinking water
certification program to perform the technique that the laboratory will be using to analyze £
co/i samples during Cryptosporidium monitoring (techniques include multiple-well, membrane
filtration, and multiple tube)? If the analyses will be performed by a commercial laboratory, is
the commercial laboratory certified to perform the technique?
Turbidity measurements. Will turbidity measurements be made for each sample?
Data reporting. Will your Cryptosporidium laboratory be recording all data elements specified
in Section 4.1.2 of this document?
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Checklist for Submitting Srandfathered Cryptosporidium Data
Cover letter. Does the data package include a signed cover letter certifying that the data
represent the plant's current source water and that all source water Cryptosporidium
monitoring results collected during the LT2ESWTR monitoring period are included in the
package?
Sampling schedule. Does the data package include a sample collection schedule established
before beginning monitoring?
Additional documentation. Have you included any additional documentation required regarding
resampling, the use of presedimentation, and/or off stream storage during routine plant
operation?
List of samples. Does the data package include a list of the field and matrix spike (MS)
samples submitted in the data package, identified by sample ID and collection date?
Number of field samples. Does the data package include at least 24 field samples collected
over 2 years?
Completeness of results. Are all applicable field sample results from the monitoring period
included?
MS sample results. Is the number of MS results submitted equivalent to at least 5% of the
number of field sample results?
Sample data. Are the minimum data elements (specified in Section 4.1.2 of this document)
provided for each field and MS sample?
Sample volumes. Are the volume analyzed for all field samples at least 10 L? For samples in
which less than 10 L was examined, were at least 2 ml of packed pellet volume analyzed or did
two filters clog?
Quality control (QC) certification. Does the data package include a letter from the
laboratory certifying that all method-required QC requirements were acceptable for every
field and MS sample submitted with the package?
Detailed quality control information. If bench sheets and report forms with QC information
are included, rather than a laboratory letter, are the following requirements met?
D Sample temperature requirements. Was the temperature of all monitoring samples
between 0°C and 8°C upon receipt?
D Ongoing precision and recovery (OPR) recovery. Do All OPR sample results meet QC
acceptance criteria of the method version used for the analysis?
D OPR frequency. Is an acceptable OPR sample associated with every field sample?
D Method blank results. Are all method blank sample results acceptable?
D Method blank frequency. Is an acceptable method blank sample associated with every
field sample?
D Spike levels. Were spike levels of 500 oocysts or less used for all OPR and MS samples?
D Holding times. Were all holding times met for all field and QC samples for composite
samples (holding times start when collection of the first sample begins)?
D Staining control frequency. Are positive and negative staining controls associated with all
field and QC samples?
D Staining control results. Were positive and negative staining controls acceptable for all
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Office of Water (4607)
EPA815-R-03-009
www.epa.gov/safewater
April 2003
Printed on Recycled Paper
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