[Code of Federal Regulations]
[Title 40, Volume 22]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR141.40]
[Page 426-435]
TITLE 40--PROTECTION OF ENVIRONMENT
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
PART 141_NATIONAL PRIMARY DRINKING WATER REGULATIONS--Table of Contents
Subpart E_Special Regulations, Including Monitoring Regulations and
Sec. 141.40 Monitoring requirements for unregulated contaminants.
Prohibition on Lead Use
(a) General applicability. This section specifies the monitoring and
quality control requirements that must be followed if you own or operate
a public water system (PWS) that is subject to the Unregulated
Contaminant Monitoring Regulation (UCMR), as specified in paragraphs
(a)(1) and (2) of this section. In addition, this section specifies the
UCMR requirements for State and Tribal participation. For the purposes
of this section, PWS ``population served,'' ``State,'' `` PWS
Official,'' ``PWS Technical Contact,'' and ``finished water'' apply as
defined in Sec. 141.35(a). The determination of whether a PWS is
required to monitor under this rule is based on the type of system
(e.g., community water system, non-transient non-community water system,
etc.); whether the system purchases all of its water, as finished water,
from another system; and its population served as of June 30, 2005.
(1) Applicability to transient non-community systems. If you own or
operate a transient non-community water system, you do not have to
monitor that system for unregulated contaminants.
(2) Applicability to community water systems and non-transient non-
community water systems.
(i) Large systems. If you own or operate a wholesale or retail PWS
(other than a transient non-community system) that serves more than
10,000 people, and do not purchase your entire water supply as finished
water from another PWS, you must monitor according to the specifications
in this paragraph (a)(2)(i). If you believe that your applicability
status is different than EPA has specified in the notification letter
that you received, or if you are subject to UCMR requirements and you
have not been notified by either EPA or your State, you must report to
EPA, as specified in Sec. 141.35(b)(2) or (c)(4).
(A) Assessment Monitoring. You must monitor for the unregulated
contaminants on List 1 of Table 1, UCMR Contaminant List, in paragraph
(a)(3) of this section. If you serve a population of more than 10,000
people, you are required to perform this monitoring regardless of
whether you have been notified by the State or EPA.
(B) Screening Survey. You must monitor for the unregulated
contaminants on List 2 (Screening Survey) of Table 1, as specified in
paragraph (a)(3) of this section, if your system serves 10,001 to
100,000 people and you are notified by EPA or your State that you are
part of the State Monitoring Plan for Screening Survey testing. If your
system serves more than 100,000 people, you are required to conduct this
Screening Survey testing regardless of whether you have been notified by
the State or EPA.
(C) Pre-Screen Testing. You must monitor for the unregulated
contaminants on List 3 of Table 1, in paragraph (a)(3) of this section,
if notified by your State or EPA that you are part of the Pre-Screen
Testing.
(ii) Small systems. Small PWSs, as defined in this paragraph, will
not be selected to monitor for any more than one of the three monitoring
lists provided in Table 1, UCMR Contaminant List, in paragraph (a)(3) of
this section.
[[Page 427]]
EPA will provide sample containers, provide pre-paid air bills for
shipping the sampling materials, conduct the laboratory analysis, and
report and review monitoring results for all small systems selected to
conduct monitoring under paragraphs (a)(2)(ii)(A) through (C) of this
section. If you own or operate a PWS (other than a transient system)
that serves 10,000 or fewer people and do not purchase your entire water
supply from another PWS, you must monitor as follows:
(A) Assessment Monitoring. You must monitor for the unregulated
contaminants on List 1 of Table 1, in paragraph (a)(3) of this section,
if you are notified by your State or EPA that you are part of the State
Monitoring Plan for Assessment Monitoring.
(B) Screening Survey. You must monitor for the unregulated
contaminants on List 2 of Table 1, in paragraph (a)(3) of this section,
if notified by your State or EPA that you are part of the State
Monitoring Plan for the Screening Survey.
(C) Pre-Screen Testing. You must monitor for the unregulated
contaminants on List 3 of Table 1, in paragraph (a)(3) of this section,
if you are notified by your State or EPA that you are part of the State
Monitoring plan for Pre-Screen Testing.
(3) Analytes to be monitored. Lists 1, 2, and 3 of unregulated
contaminants are provided in the following table:
Table 1--UCMR Contaminant List
[List 1: Assessment Monitoring Chemical Contaminants]
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2--CAS 6--Period during
1--Contaminant registry 3--Analytical methods 4--Minimum reporting 5--Sampling location which monitoring to
number \a\ level \b\ \c\ be completed
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Dimethoate........................... 60-51-5 EPA 527 \d\............. 0.7 [mu]g/L............. EPTDS.................. 1/1/2008-12/31/2010
Terbufos sulfone..................... 56070-16-7 EPA 527 \d\............. 0.4 [mu]g/L............. EPTDS.................. 1/1/2008-12/31/2010
2,2[min],4,4[min]-tetrabromodiphenyl 5436-43-1 EPA 527 \d\............. 0.3 [mu]g/L............. EPTDS.................. 1/1/2008-12/31/2010
ether (BDE-47).
2,2[min],4,4[min],5- 60348-60-9 EPA 527 \d\............. 0.9 [mu]g/L............. EPTDS.................. 1/1/2008-12/31/2010
pentabromodiphenyl ether (BDE-99).
2,2[min],4,4[min],5,5[min]- 59080-40-9 EPA 527 \d\............. 0.7 [mu]g/L............. EPTDS.................. 1/1/2008-12/31/2010
hexabromobiphenyl (HBB).
2,2[min],4,4[min],5,5[min]- 68631-49-2 EPA 527 \d\............. 0.8 [mu]g/L............. EPTDS.................. 1/1/2008-12/31/2010
hexabromodiphenyl ether (BDE-153).
2,2[min],4,4[min],6- 189084-64-8 EPA 527 \d\............. 0.5 [mu]g/L............. EPTDS.................. 1/1/2008-12/31/2010
pentabromodiphenyl ether (BDE-100).
1,3-dinitrobenzene................... 99-65-0 EPA 529 \e\............. 0.8 [mu]g/L............. EPTDS.................. 1/1/2008-12/31/2010
2,4,6-trinitrotoluene (TNT).......... 118-96-7 EPA 529 \e\............. 0.8 [mu]g/L............. EPTDS.................. 1/1/2008-12/31/2010
Hexahydro-1,3,5-trinitro-1,3,5- 121-82-4 EPA 529 \e\............. 1 [mu]g/L............... EPTDS.................. 1/1/2008-12/31/2010
triazine (RDX).
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Table 1--UCMR Contaminant List
[List 2: Screening Survey Chemical Contaminants
--------------------------------------------------------------------------------------------------------------------------------------------------------
2--CAS 6--Period during
1--Contaminant registry 3--Analytical methods 4--Minimum reporting 5--Sampling location which monitoring to
number \a\ level \b\ \c\ be completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acetanilide Pesticide Degradation Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acetochlor ESA....................... 187022-11-3 EPA 535 \f\............. 1 [mu]g/L............... EPTDS.................. 1/1/2008-12/31/2010
Acetochlor OA........................ 184992-44-4 EPA 535 \f\............. 2 [mu]g/L............... EPTDS.................. 1/1/2008-12/31/2010
Alachlor ESA......................... 142363-53-9 EPA 535 \f\............. 1 [mu]g/L............... EPTDS.................. 1/1/2008-12/31/2010
Alachlor OA.......................... 171262-17-2 EPA 535 \f\............. 2 [mu]g/L............... EPTDS.................. 1/1/2008-12/31/2010
Metolachlor ESA...................... 171118-09-5 EPA 535 \f\............. 1 [mu]g/L............... EPTDS.................. 1/1/2008-12/31/2010
Metolachlor OA....................... 152019-73-3 EPA 535 \f\............. 2 [mu]g/L............... EPTDS.................. 1/1/2008-12/31/2010
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acetanilide Pesticide Parent Compounds
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acetochlor........................... 34256-82-1 EPA 525.2 \g\........... 2 [mu]g/L............... EPTDS.................. 1/1/2008-12/31/2010
Alachlor............................. 15972-60-8 EPA 525.2 \g\........... 2 [mu]g/L............... EPTDS.................. 1/1/2008-12/31/2010
Metolachlor.......................... 51218-45-2 EPA 525.2 \g\........... 1 [mu]g/L............... EPTDS.................. 1/1/2008-12/31/2010
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[[Page 428]]
Nitrosamines
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N-nitrosodiethylamine (NDEA)......... 55-18-5 EPA 521 \h\............. 0.005 [mu]g/L........... DSMRT and EPTDS........ 1/1/2008-12/31/2010
N-nitroso-dimethylamine (NDMA)....... 62-75-9 EPA 521 \h\............. 0.002 [mu]g/L........... DSMRT and EPTDS........ 1/1/2008-12/31/2010
N-nitroso-di-n-butylamine (NDBA)..... 924-16-3 EPA 521 \h\............. 0.004 [mu]g/L........... DSMRT and EPTDS........ 1/1/2008-12/31/2010
N-nitroso-di-n-propylamine (NDPA).... 621-64-7 EPA 521 \h\............. 0.007 [mu]g/L........... DSMRT and EPTDS........ 1/1/2008-12/31/2010
N-nitroso-methylethylamine (NMEA).... 10595-95-6 EPA 521 \h\............. 0.003 [mu]g/L........... DSMRT and EPTDS........ 1/1/2008-12/31/2010
N-nitrosopyrrolidine (NPYR).......... 930-55-2 EPA 521 \h\............. 0.002 [mu]g/L........... DSMRT and EPTDS........ 1/1/2008-12/31/2010
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 1--UCMR Contaminant List
[List 3: Pre-Screen Testing to be Sampled After Notice of Analytical Methods Availability]
--------------------------------------------------------------------------------------------------------------------------------------------------------
2--CAS 6--Period during
1--Contaminant registry 3--Analytical methods 4--Minimum reporting 5--Sampling location which monitoring to
number \a\ level \b\ \c\ be completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reserved \i\......................... Reserved \i\ Reserved \i\............ Reserved \i\............ Reserved \i\........... Reserved \i\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Column headings are:
1--Contaminant: The name of the contaminant to be analyzed.
2--CAS (Chemical Abstract Service) Registry Number or Identification Number: A unique number identifying the chemical contaminants.
3--Analytical Methods: method numbers identifying the methods that must be used to test the contaminants.
4--Minimum Reporting Level: The value and unit of measure at or above which the concentration of the contaminant must be measured using the approved
analytical methods.
5--Sampling Location: The locations within a PWS at which samples must be collected.
6--Period During Which Monitoring to Be Completed: The dates during which the sampling and testing are to occur for the indicated contaminant.
The analytical procedures shall be performed in accordance with the documents associated with each method (per the following footnotes). The
incorporation by reference of the following documents listed in footnotes d--h was approved by the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. Information on how to obtain these documents can be provided by the Safe Drinking Water Hotline at (800) 426-4791.
Documents may be inspected at EPA's Drinking Water Docket, 1301 Constitution Avenue, NW., EPA West, Room B102, Washington, DC 20460, Telephone: (202)
566-2426; or at the National Archives and Records Administration (NARA). For information on availability of this material at NARA, call 202-741-6030,
or go to:http://www.archives.gov/federal-register/index.html.
\a\ The version of the EPA methods which you must follow for this Regulation are listed in d--h as follows.
\b\ The Minimum Reporting Level (MRL) was established by EPA by adding the mean of the Lowest Concentration Minimum Reporting Levels (LCMRL) determined
according to the procedure detailed in ``Statistical Protocol for the Determination of The Single-Laboratory Lowest Concentration Minimum Reporting
Level (LCMRL) and Validation of the Minimum Reporting Level (MRL)'' by the primary and secondary laboratories conducting the development and
validation of the analytical method to three times the difference of the LCMRLs. If LCMRL data from three or more laboratories were available, the MRL
was established by EPA by adding three times the standard deviation of the LCMRLs to the mean of the LCMRLs. Note that EPA Method 525.2 was developed
prior to UCMR 2, hence the LCMRLs were not determined for analytes determined by this method.
\c\ Sampling must occur at entry points to the distribution system (EPTDSs) after treatment is applied that represent each non-emergency water source in
routine use over the 12-month period of monitoring. See 40 CFR 141.35(c)(3) for an explanation of the requirements related to use of representative
EPTDSs. Sampling for nitrosamines on List 2 must also occur at the disinfection byproduct distribution system maximum residence time (DSMRT) sampling
locations as defined in 40 CFR 141.132(b)(1)(i) and at EPTDS sampling locations. If a treatment plant/water source is not subject to the sampling
required in 40 CFR 141.132(b)(1), then the samples for nitrosamines must be collected only at the EPTDS location(s).
\d\ EPA Method 527 ``Determination of Selected Pesticides and Flame Retardants in Drinking Water by Solid Phase Extraction and Capillary Column Gas
Chromatography/Mass Spectrometry (GC/MS),'' Revision 1.0, April 2005 is available at http://www.epa.gov/safewater/methods/sourcalt.html.
\e\ EPA Method 529 ``Determination of Explosives and Related Compounds in Drinking Water by Solid Phase Extraction and Capillary Column Gas
Chromatography/Mass Spectrometry (GC/MS),'' Revision 1.0, September 2002 is available at http://www.epa.gov/nerlcwww/ordmeth.htm.
\f\ EPA Method 535 `` Measurement of Chloroacetanilide and Other Acetamide Herbicide Degradates in Drinking Water by Solid Phase Extraction and Liquid
Chromatography/Tandem Mass Spectrometry (LC/MS/MS),'' Version 1.1, April 2005 is available at http://www.epa.gov/nerlcwww/ordmeth.htm.
\g\ EPA Method 525.2 ``Determination of Organic Compounds in Drinking Water by Liquid-Solid Extraction and Capillary Column Gas Chromatography/Mass
Spectrometry,'' Revision 2.0, 1995 is available at http://www.NEMI.gov.
\h\ EPA Method 521 ``Determination of Nitrosamines in Drinking Water by Solid Phase Extraction and Capillary Column Gas Chromatography with Large Volume
Injection and Chemical Ionization Tandem Mass Spectrometry (MS/MS),'' Version 1.0, September 2004 is available at http://www.epa.gov/nerlcwww/
ordmeth.htm.
\i\ To be determined at a later time.
[[Page 429]]
(4) Sampling requirements--(i) Large systems. If you serve more than
10,000 people and meet the UCMR applicability criteria specified in
paragraph (a)(2)(i) of this section, you must comply with the
requirements specified in paragraphs (a)(4)(i)(A) through (I) of this
section. Your samples must be collected according to the schedule that
you are assigned by EPA or your State, or the schedule that you revised
using EPA's electronic data reporting system on or before August 2,
2007. Your schedule must follow both the timing and frequency of
monitoring specified in Tables 1 and 2 of this section.
(A) Monitoring period. You must collect the samples in one
continuous 12-month period for List 1 Assessment Monitoring, and, if
applicable, for List 2 Screening Survey, or List 3 Pre-Screen Testing,
during the time frame indicated in column 6 of Table 1, in paragraph
(a)(3) of this section. EPA or your State will specify the month(s) and
year(s) in which your monitoring must occur. As specified in Sec.
141.35(c)(5), you must contact EPA if you believe you cannot conduct
monitoring according to your schedule.
(B) Frequency. You must collect the samples within the time frame
and according to the frequency specified by contaminant type and water
source type for each sampling location, as specified in Table 2, in this
paragraph, with the following exception. For the second round of ground
water sampling, if a sample location is non-operational for more than
one month before and one month after the scheduled sampling month (i.e.,
it is not possible for you to sample within the five to seven month
window specified the Table 2, in this paragraph), you must notify EPA as
specified in Sec. 141.35(c)(5).
Table 2--Monitoring Frequency by Contaminant and Water Source Types
----------------------------------------------------------------------------------------------------------------
Contaminant type Water source type Time frame Frequency
----------------------------------------------------------------------------------------------------------------
Chemical........................... Surface water or ground 12 months............. You must monitor for 4
water under the direct consecutive quarters.
influence of surface water Sample events must
(GWUDI) (includes all occur 3 months apart.
sampling locations for
which some or all of the
water comes from a surface
water or GWUDI source at
any time during the 12
month monitoring period).
Ground water............... 12 months............. You must monitor twice
in a consecutive 12-
month period. Sample
events must occur 5-7
months apart.
----------------------------------------------------------------------------------------------------------------
(C) Location. You must collect samples for each List 1 Assessment
Monitoring contaminant, and, if applicable, for each List 2 Screening
Survey, or List 3 Pre-Screen Testing contaminant, as specified in Table
1, in paragraph (a)(3) of this section. Samples must be collected at
each sample point that is specified in column 5 of Table 1, in paragraph
(a)(3) of this section. If you are a ground water system with multiple
EPTDSs, and you request and receive approval from EPA or the State for
sampling at representative EPTDS(s), as specified in Sec. 141.35(c)(3),
you must collect your samples from the approved representative sampling
location(s). Systems conducting Screening Survey monitoring must also
sample for nitrosamines at the disinfection byproduct distribution
system maximum residence time (DSMRT) sampling location(s) if they are
subject to sampling requirements in Sec. 141.132(b)(1).
(D) Sampling instructions. For each List 1 Assessment Monitoring
contaminant, and, if applicable, for each List 2 Screening Survey, or
List 3 Pre-Screen Testing contaminant, you must follow the sampling
procedure for the method specified in column 3 of Table 1, in paragraph
(a)(3) of this section. In addition, you must not composite (that is,
combine, mix, or blend) the samples; you must collect and preserve each
sample separately. Samples collected
[[Page 430]]
for the analysis of Acetanilide ``parent'' pesticides and their
degradation products (Methods 525.2 and 535) must be collected at the
same sampling point, at the same time.
(E) Sample collection and shipping time. If you must ship the
samples for analysis, you must collect the samples early enough in the
day to allow adequate time to send the samples for overnight delivery to
the laboratory. You should not collect samples on Friday, Saturday, or
Sunday because sampling on these days may not allow samples to be
shipped and received at the laboratory at the required temperature,
unless you have made special arrangements with your laboratory to
receive the samples.
(F) Analytical methods. For each contaminant, you must use the
respective analytical methods for List 1, and, if applicable, for List
2, or List 3 that are specified in column 3 of Table 1, in paragraph
(a)(3) of this section; report values at or above the minimum reporting
levels for List 1, and, if applicable, for List 2 Screening Survey, or
List 3 Pre-Screen Testing, that are specified in column 4 of Table 1, in
paragraph (a)(3) of this section; and conduct the quality control
procedures specified in paragraph (a)(5) of this section.
(G) Laboratory errors or sampling deviations. If the laboratory data
do not meet the required QC criteria, as specified in paragraph (a)(5)
of this section, or you do not follow the required sampling procedures,
as specified in paragraphs (a)(4) of this section, you must resample
within 30 days of being informed or becoming aware of these facts. This
resampling is not for the purpose of confirming previous results, but to
correct the sampling or laboratory error. All systems must report the
results obtained from the first sampling for each sampling period,
except for cases of sampling or laboratory errors. For the purposes of
this rule, no samples are to be recollected for the purposes of
confirming the results observed in a previous sampling.
(H) Analysis. For the List 1 contaminants, and, if applicable, List
2 Screening Survey, or List 3 Pre-Screen Testing contaminants,
identified in Table 1, paragraph (a)(3) of this section, you must
arrange for testing by a laboratory that has been approved by EPA
according to requirements in paragraph (a)(5)(ii) of this section.
(I) Review and reporting of results. After you have received the
laboratory results, you must review, approve, and submit the system
information, and sample collection data and test results. You must
report the results as provided in Sec. 141.35(c)(6).
(ii) Small systems. If you serve 10,000 or fewer people and are
notified that you are part of the State Monitoring Plan for Assessment
Monitoring, Screening Survey or Pre-Screen monitoring, you must comply
with the requirements specified in paragraphs (a)(4)(i)(A) through (H)
of this section. If EPA or the State informs you that they will be
collecting your UCMR samples, you must assist them in identifying the
appropriate sampling locations and in collecting the samples.
(A) Monitoring period and frequency. You must collect samples at the
times specified for you by the State or EPA. Your schedule must follow
both the timing of monitoring specified in Table 1, List 1, and, if
applicable, List 2, or List 3, and the frequency of monitoring in Table
2 of this section.
(B) Location. You must collect samples at the locations specified
for you by the State or EPA.
(C) Sample kits. You must store and maintain the sample collection
kits sent to you by the UCMR Sampling Coordinator in accordance with the
kit's instructions. The sample kit will include all necessary
containers, packing materials and cold packs, instructions for
collecting the sample and sample treatment (such as dechlorination or
preservation), report forms for each sample, contact name and telephone
number for the laboratory, and a prepaid return shipping docket and
return address label. If any of the materials listed in the kit's
instructions are not included in the kit or arrive damaged, you must
notify the UCMR Sampling Coordinator who sent you the sample collection
kits.
(D) Sampling instructions. You must comply with the instructions
sent to you by the State or EPA concerning the use of containers,
collection (how to fill the sample bottle),
[[Page 431]]
dechlorination and/or preservation, and sealing and preparation of
sample and shipping containers for shipment. You must not composite
(that is, combine, mix, or blend) the samples. You also must collect,
preserve, and test each sample separately. You must also comply with the
instructions sent to you by the UCMR Sampling Coordinator concerning the
handling of sample containers for specific contaminants.
(E) Sampling deviations. If you do not collect a sample according to
the instructions provided to you for a listed contaminant, you must
report the deviation within 7 days of the scheduled monitoring on the
sample reporting form, as specified in Sec. 141.35(d)(2). You must
resample following instructions that you will be sent from the UCMR
Sampling Coordinator or State. A copy of the form must be sent to the
laboratory with the recollected samples, and to the UCMR Sampling
Coordinator.
(F) Duplicate samples. EPA will select a subset of systems in the
State Monitoring Plan that must collect duplicate samples for quality
control. If your system is selected, you will receive two sample kits
for an individual sampling location that you must use. You must use the
same sampling protocols for both sets of samples, following the
instructions in the duplicate sample kit.
(G) Sampling forms. You must completely fill out each of the
sampling forms and bottles sent to you by the UCMR Sampling Coordinator,
including data elements listed in Sec. 141.35(e) for each sample. If
you are conducting Assessment Monitoring, you must include elements 1
through 5, and 7; and if you are conducting Screening Survey, you must
include elements 1 through 7. You must sign and date the sampling forms.
(H) Sample collection and shipping. You must collect the samples
early enough in the day to allow adequate time to send the samples for
overnight delivery to the laboratory. You should not collect samples on
Friday, Saturday, or Sunday because sampling on these days may not allow
samples to be shipped and received at the laboratory at the required
temperature unless you have made special arrangements with EPA for the
laboratory to receive the samples. Once you have collected the samples
and completely filled in the sampling forms, you must send the samples
and the sampling forms to the laboratory designated on the air bill.
(5) Quality control requirements. If your system serves more than
10,000 people, you must ensure that the quality control requirements
listed below are met during your sampling procedures and by the
laboratory conducting your analyses. You must also ensure that all
method quality control procedures and all UCMR quality control
procedures are followed.
(i) Sample collection/preservation. You must follow the sample
collection and preservation requirements for the specified method for
each of the contaminants in Table 1, in paragraph (a)(3) of this
section. These requirements specify sample containers, collection,
dechlorination, preservation, storage, sample holding time, and extract
storage and/or holding time that you must assure that the laboratory
follow.
(ii) Laboratory approval for Lists 1, List 2 and List 3. To be
approved to conduct UCMR testing, the laboratory must be certified under
Sec. 141.28 for one or more compliance analyses; demonstrate for each
analytical method it plans to use for UCMR testing that it can meet the
Initial Demonstration of Capability (IDC) requirements detailed in the
analytical methods specified in column 3 of Table 1, in paragraph (a)(3)
of this section; and successfully participate in the UCMR Proficiency
Testing (PT) Program administered by EPA for each analytical method it
plans to use for UCMR testing. UCMR laboratory approval decisions will
be granted on an individual method basis for the methods listed in
column 3 of Table 1 in paragraph (a)(3) of this section for List 1, List
2, and List 3 contaminants. Laboratory approval is contingent upon the
capability of the laboratory to post monitoring data to the EPA
electronic data reporting system. To participate in the UCMR Laboratory
Approval Program, the laboratory must complete and submit the necessary
registration forms by April 4, 2007. Correspondence must be addressed
to: UCMR 2 Laboratory Approval Coordinator, USEPA, Technical Support
Center, 26 West Martin Luther King Drive (MS 140), Cincinnati, OH 45268;
or e-mailed to
[[Page 432]]
EPA at UCMR--Sampling--Coordinator@epa.gov.
(iii) Minimum Reporting Level. The MRL is the lowest analyte
concentration for which future recovery is predicted to fall, with high
confidence (at least 99%), between 50% and 150% recovery.
(A) Validation of laboratory performance. Your laboratory must be
capable of quantifying each contaminant listed in Table 1, at or below
the MRL specified in column 4 of Table 1, in paragraph (a)(3) of this
section. You must ensure that the laboratory completes and has on file
and available for your inspection, records of two distinct procedures.
First, your laboratory must have conducted an IDC involving replicate
analyses at or below the MRL as described in this paragraph. Second, for
each day that UCMR analyses are conducted by your laboratory, a
validation of its ability to quantify each contaminant, at or below the
MRL specified in column 4 of Table 1, in paragraph (a)(3) of this
section, following the procedure listed in paragraph (a)(5)(iii)(B) of
this section, must be performed. The procedure for initial validation of
laboratory performance at or below the MRL is as follows:
(1) All laboratories using EPA drinking water methods under UCMR
must demonstrate that they are capable of meeting data quality
objectives (DQOs) at or below the MRL listed in Table 1, column 4, in
paragraph (a)(3) of this section.
(2) The MRL, or any concentration below the MRL, at which
performance is being evaluated, must be contained within the range of
calibration. The calibration curve regression model and the range of
calibration levels that are used in these performance validation steps
must be used in all routine sample analyses used to comply with this
regulation. Only straight line or quadratic regression models are
allowed. The use of either weighted or unweighted models is permitted.
The use of cubic regression models is not permitted.
(3) Replicate analyses of at least seven (7) fortified samples in
reagent water must be performed at or below the MRL for each analyte,
and must be processed through the entire method procedure (i.e.,
including extraction, where applicable, and with all preservatives).
(4) A prediction interval of results (PIR), which is based on the
estimated arithmetic mean of analytical results and the estimated sample
standard deviation of measurement results, must be determined by
Equation 1:
[GRAPHIC] [TIFF OMITTED] TR04JA07.000
Where:
t is the Student's t value with df degrees of freedom and confidence
level (1-[alpha]),
s is the sample standard deviation of n replicate samples fortified at
the MRL,
n is the number of replicates.
(5) The values needed to calculate the PIR using Equation 1 are:
Number of replicates (n); Student's t value with a two-sided 99%
confidence level for n number of replicates; the average (mean) of at
least seven replicates; and the sample standard deviation. Factor 1 is
referred to as the Half Range PIR (HRPIR).
[GRAPHIC] [TIFF OMITTED] TR04JA07.001
For a certain number of replicates and for a certain confidence level in
Student's t, this factor
[GRAPHIC] [TIFF OMITTED] TR04JA07.002
is constant, and can be tabulated according to replicate number and
confidence level for the Student's t. Table 3 in this paragraph lists
the constant factor (C) for replicate sample numbers
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7 through 10 with a confidence level of 99% for Student's t.
(6) The HRPIR is calculated by Equation 2:
[GRAPHIC] [TIFF OMITTED] TR04JA07.003
(7) The PIR is calculated by Equation 3:
[GRAPHIC] [TIFF OMITTED] TR04JA07.004
Table 3--The Constant Factor (C) to be Multiplied by the Standard Deviation to Determine the Half Range Interval
of the PIR (Student's t 99% Confidence Level) \a\
----------------------------------------------------------------------------------------------------------------
Constant factor (C) to be multiplied
Replicates Degrees of freedom by the standard deviation
----------------------------------------------------------------------------------------------------------------
7 6 3.963
----------------------------------------------------------------------------------------------------------------
8 7 3.711
----------------------------------------------------------------------------------------------------------------
9 8 3.536
----------------------------------------------------------------------------------------------------------------
10 9 3.409
----------------------------------------------------------------------------------------------------------------
\a\ The critical t-value for a two-sided 99% confidence interval is equivalent to the critical t-value for a one-
sided 99.5% confidence interval, due to the symmetry of the t-distribution. PIR = Prediction Interval of
Results.
(8) The lower and upper result limits of the PIR must be converted
to percent recovery of the concentration being tested. To pass criteria
at a certain level, the PIR lower recovery limits cannot be lower than
the lower recovery limits of the QC interval (50%), and the PIR upper
recovery limits cannot be greater than the upper recovery limits of the
QC interval (150%). When either of the PIR recovery limits falls outside
of either bound of the QC interval of recovery (higher than 150% or less
than 50%), laboratory performance is not validated at the concentration
evaluated. If the PIR limits are contained within both bounds of the QC
interval, laboratory performance is validated for that analyte.
(B) Quality control requirements for validation of laboratory
performance at or below the MRL.
(1) You must ensure that the calibration curve regression model and
that the range of calibration levels that are used in these performance
validation steps are used in future routine sample analysis. Only
straight line or quadratic regression models are allowed. The use of
either weighted or unweighted models is permitted. The use of cubic
regression models is not permitted.
(2) You must ensure, once your laboratory has performed an IDC as
specified in each analytical method (demonstrating that DQOs are met at
or below an MRL), that a daily performance check is performed for each
analyte and method. A single laboratory blank, fortified at or below the
MRL for each analyte, must be processed through the entire method
procedure. The measured concentration for each analyte must be converted
to a percent recovery, and if the recovery is within 50%-150%
(inclusive), the daily performance of the laboratory has been validated.
The results for any analyte for which 50%-150% recovery cannot be
demonstrated during the daily check are not valid. Laboratories may
elect to re-run the daily performance check sample if the performance
for any analyte or analytes cannot be validated. If performance is
validated for these analytes, the laboratory performance is considered
validated. Alternatively, the laboratory may re-calibrate and repeat the
performance validation process for all analytes.
(iv) Laboratory fortified sample matrix and laboratory fortified
sample matrix duplicate. You must ensure that your laboratory prepares
and analyzes the Laboratory Fortified Sample Matrix (LFSM) sample for
accuracy and Laboratory Fortified Sample Matrix Duplicate (LFSMD)
samples for precision to determine method accuracy and precision for all
contaminants in Table 1, in paragraph (a)(3) of this section. LFSM/LFSMD
samples must be prepared using a sample collected and analyzed
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in accordance with UCMR 2 requirements and analyzed at a frequency of 5%
(or 1 LFSM/LFSMD set per every 20 samples) or with each sample batch,
whichever is more frequent. In addition, the LFSM/LFSMD fortification
concentrations must be alternated between a low-level fortification and
mid-level fortification approximately 50% of the time. (For example: A
set of 40 samples will require preparation and analysis of 2 LFSM/LFSMD
sets. The first set must be fortified at either the low-level or mid-
level, and the second set must be fortified with the other standard,
either the low-level or mid-level, whichever was not used for the
initial LFSM/LFSMD set.) The low-level LFSM/LFSMD fortification
concentration must be within 50% of the MRL for
each contaminant (e.g., for an MRL of 1 [mu]g/L the acceptable
fortification levels must be between 0.5 [mu]g/L and 1.5 [mu]g/L). The
mid-level LFSM/LFSMD fortification concentration must be within 20% of the mid-level calibration standard for each
contaminant, and should represent, where possible and where the
laboratory has data from previously analyzed samples, an approximate
average concentration observed in previous analyses of that analyte.
There are no acceptance criteria specified for LFSM/LFSMD analyses. All
LFSM/LFSMD data are to be reported.
(v) Method defined quality control. You must ensure that your
laboratory performs Laboratory Fortified Blanks and Laboratory
Performance Checks, as appropriate to the method's requirements, for
those methods listed in Table 1, column 3, in paragraph (a)(3) of this
section. Each method specifies acceptance criteria for these QC checks.
(vi) Reporting. You must ensure that your laboratory reports the
analytical results and other data, with the required data listed in
Table 1, in Sec. 141.35(e). You must require your laboratory to submit
these data electronically to the State and EPA using EPA's electronic
data reporting system, accessible at (http://www.epa.gov/safewater/ucmr/
ucmr2/reporting.html), within 120 days from the sample collection date.
You then have 60 days from when the laboratory posts the data to review,
approve, and submit the data to the State and EPA, via EPA's electronic
data reporting system. If you do not electronically approve and submit
the laboratory data to EPA within 60 days of the laboratory's posting to
EPA's electronic reporting system, the data will be considered approved
and final for State and EPA review.
(6) Violation of this rule--(i) Monitoring violations. Any failure
to monitor in accordance with Sec. 141.40(a)(3)-(5) is a monitoring
violation.
(ii) Reporting violations. Any failure to report in accordance with
Sec. 141.35 is a reporting violation.
(b) Petitions and Waivers by States--(1) Governors' petition for
additional contaminants. The Safe Drinking Water Act allows Governors of
seven (7) or more States to petition the EPA Administrator to add one or
more contaminants to the UCMR Contaminant List in paragraph (a)(3) of
this section. The petition must clearly identify the reason(s) for
adding the contaminant(s) to the monitoring list, including the
potential risk to public health, particularly any information that might
be available regarding disproportional risks to the health and safety of
children, the expected occurrence documented by any available data, any
analytical methods known or proposed to be used to test for the
contaminant(s), and any other information that could assist the
Administrator in determining which contaminants present the greatest
public health concern and should, therefore, be included on the UCMR
Contaminant List in paragraph (a)(3) of this section.
(2) State-wide waivers. A State can waive monitoring requirements
only with EPA approval and under very limited conditions. Conditions and
procedures for obtaining a waiver are as follows:
(i) Application. A State may apply to EPA for a State-wide waiver
from the unregulated contaminant monitoring requirements for PWSs
serving more than 10,000 people. To apply for such a waiver, the State
must submit an application to EPA that includes the following
information: The list of contaminants on the UCMR Contaminant List for
which a waiver is requested, along with documentation for each
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contaminant in the request demonstrating that the contaminants or their
parent compounds do not occur naturally in the State, and certifying
that during the past 15 years they have not been used, applied, stored,
disposed of, released, or detected in the source waters or distribution
systems in the State.
(ii) Approval. EPA will review State applications and notify the
State whether it accepts or rejects the request. The State must receive
written approval from EPA before issuing a State-wide waiver.
[72 FR 393, Jan. 4, 2007; 72 FR 3916, Jan. 26, 2007]