Expedited Approval of Alternative Test Procedures for the Analysis of Contaminants Under the Safe Drinking Water Act: Analysis and Sampling Procedures
Federal Register: November 10, 2009 (Volume 74, Number 216)
Rules and Regulations
Page 57908-57918
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr10no09-10
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 141
EPA-HQ-OW-2009-0707; FRL-8979-5
Expedited Approval of Alternative Test Procedures for the
Analysis of Contaminants Under the Safe Drinking Water Act; Analysis and Sampling Procedures
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This action announces the Environmental Protection Agency's
(EPA's) approval of alternative testing methods for use in measuring the levels of contaminants in drinking water and determining compliance with national primary drinking water regulations. The Safe Drinking
Water Act (SDWA) authorizes EPA to approve the use of alternative testing methods through publication in the Federal Register. EPA is using this streamlined authority to make 25 additional methods available for analyzing drinking water samples required by regulation.
This expedited approach provides public water systems, laboratories, and primacy agencies with more timely access to new measurement techniques and greater flexibility in the selection of analytical methods, thereby reducing monitoring costs while maintaining public health protection.
DATES: This action is effective November 10, 2009.
FOR FURTHER INFORMATION CONTACT: Safe Drinking Water Hotline: (800) 426-4791
Page 57909
or Patricia Snyder Fair, Technical Support Center, Office of Ground
Water and Drinking Water (MS 140), Environmental Protection Agency, 26
West Martin Luther King Drive, Cincinnati, OH 45268; telephone number:
(513) 569-7937; e-mail address: fair.pat@epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
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Does This Action Apply to Me?
Public water systems are the regulated entities required to measure contaminants in drinking water samples. In addition, EPA Regions as well as States and Tribal governments with authority to administer the regulatory program for public water systems under SDWA may also measure contaminants in water samples. When EPA sets a monitoring requirement in its national primary drinking water regulations for a given contaminant, the Agency also establishes in the regulations standardized test procedures for analysis of the contaminant. This action makes alternative testing methods available for particular drinking water contaminants beyond the testing methods currently established in the regulations. EPA is providing public water systems required to test water samples with a choice of using either a test procedure already established in the existing regulations or an alternative test procedure that has been approved in this action.
Categories and entities that may ultimately be affected by this action include:
Examples of potentially regulated
Category
entities
NAICS \1\
State, Local, & Tribal Governments...................... States, local and Tribal governments
924110 that analyze water samples on behalf of public water systems required to conduct such analysis; States, local and Tribal governments that themselves operate community and non- transient non-community water systems required to monitor.
Industry................................................ Private operators of community and non-
221310 transient non-community water systems required to monitor.
Municipalities.......................................... Municipal operators of community and
924110 non-transient non-community water systems required to monitor.
\1\ North American Industry Classification System.
This table is not exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. This table lists the types of entities that EPA is now aware could potentially be affected by this action. Other types of entities not listed in the table could also be impacted. To determine whether your facility is affected by this action, you should carefully examine the applicability language at 40 CFR 141.2 (definition of public water system). If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.
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How Can I Get Copies of This Document and Other Related Information?
Docket. EPA established a docket for this action under Docket ID
No. EPA-HQ-OW-2009-0707. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy at the Water Docket in the EPA Docket Center, (EPA/DC) EPA
West, Room 3334, 1301 Constitution Ave., NW., Washington, DC.
Copyrighted materials are available only in hard copy. The EPA Docket
Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is (202) 566-1744, and the telephone number for the
Water Docket is (202) 566-2426.
Abbreviations and Acronyms Used in This Action
CFR: Code of Federal Regulations.
DOC: Dissolved Organic Carbon.
DPD: N,N-Diethyl-p-phenylenediamine.
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coli: Escherichia coli.
EPA: Environmental Protection Agency.
HAA5: Haloacetic Acids (five); Sum of Monochloroacetic Acid,
Dichloroacetic Acid, Trichloroacetic Acid, Monobromoacetic Acid, and
Dibromoacetic Acid.
IC: Ion Chromatography.
IC-ESI-MS/MS: Ion Chromatography Electrospray Ionization Tandem Mass
Spectrometry.
LED: Light Emitting Diode. mg/L: Milligrams/Liter.
MRL: Minimum Reporting Level.
NEMI: National Environmental Methods Index. nm: Nanometers.
QC: Quality Control.
SDWA: Safe Drinking Water Act.
SUVA: Specific Ultraviolet Absorbance.
TOC: Total Organic Carbon.
UV254: Ultraviolet Absorbance at 254 nanometers.
Table of Contents
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General Information
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Does This Action Apply to Me?
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How Can I Get Copies of This Document and Other Related
Information?
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Background
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What Is the Purpose of This Action?
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What Is the Basis for This Action?
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Summary of Approvals
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Methods Developed by EPA
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Methods Developed by Voluntary Consensus Standard Bodies
(VCSB)
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Methods Developed by Vendors
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Statutory and Executive Order Reviews
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References
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Background
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What Is the Purpose of This Action?
In this action, EPA is approving 25 analytical methods for determining contaminant concentrations in samples collected under SDWA.
Regulated parties required to sample and monitor may use either the testing methods already established in existing regulations or the alternative testing methods being approved in this action. The new methods are listed in Appendix A to Subpart C in 40 CFR 141 and on
EPA's drinking water methods Web site at http://www.epa.gov/safewater/ methods/analyticalmethods_expedited.html.
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What Is the Basis for This Action?
When EPA determines that an alternative analytical method is
``equally effective'' (i.e., as effective as a method that has already been promulgated in the regulations), SDWA allows EPA to approve the use of the alternative method through publication in the Federal
Register. (See Section 1401(1) of SDWA.) EPA is using this streamlined approval authority to make 25 additional methods available for determining contaminant concentrations in samples collected under SDWA.
EPA has determined that, for each contaminant or group of contaminants listed in Section III, the additional testing methods being approved in this action are equally effective as one or more of the testing methods already established in the regulations for those contaminants.
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Section 1401(1) states that the newly approved methods ``shall be treated as an alternative for public water systems to the quality control and testing procedures listed in the regulation.'' Accordingly, this action makes these additional (and optional) 25 analytical methods legally available for meeting EPA's monitoring requirements.
This action does not add regulatory language, but does, for informational purposes, update an appendix to the regulations at 40 CFR part 141 that lists all methods approved under Section 1401(1) of SDWA.
Accordingly, while this action is not a rule, it is updating CFR text and therefore is being published in the ``Final Rules'' section of this
Federal Register.
EPA described this expedited methods approval process in an April 10, 2007, Federal Register notice (72 FR 17902) (USEPA 2007) and announced its intent to begin using the process. EPA published the first set of approvals in a June 3, 2008, Federal Register notice (73
FR 31616) (USEPA 2008) and added Appendix A to 40 CFR Part 141, Subpart
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Six additional methods were added to Appendix A to Subpart C in an
August 3, 2009, Federal Register notice (74 FR 38348) (USEPA 2009a).
Future approvals using this process are anticipated.
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Summary of Approvals
EPA is approving 25 methods that are equally effective relative to methods previously promulgated in the regulations. By means of this notice, these 25 methods are added to Appendix A of 40 CFR Part 141,
Subpart C.
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Methods Developed by EPA 1. EPA Method 334.0, ``Determination of Residual Chlorine in
Drinking Water Using an On-line Chlorine Analyzer'' (USEPA 2009b) establishes quality control (QC) criteria for on-line chlorine analyzers such that the analyzers provide data equivalent to the grab sample methodologies that are already approved in the regulations. The on-line chlorine analyzer is calibrated using aqueous standards or the results from grab samples that are collected at the same sample point as used by the analyzer. The grab samples are analyzed for chlorine using a method that is approved for drinking water compliance monitoring. The accuracy of the on-line chlorine analyzer is periodically verified (and adjustments made when necessary) based on results from grab sample analyses.
Previously approved methods for determining free and total chlorine residuals in drinking water are listed in the tables at 40 CFR 141.74(a)(2) and 40 CFR 141.131(c)(1). All of the methods are designed for grab sample analyses. The regulation at 40 CFR 141.74(a)(2) also states, ``Free and total chlorine residuals may be measured continuously by adapting a specified chlorine residual method for use with a continuous monitoring instrument provided the chemistry, accuracy, and precision remain the same. Instruments used for continuous monitoring must be calibrated with a grab sample measurement at least every five days, or with a protocol approved by the State.''
Continuous monitoring instruments that use N,N-Diethyl-p-phenylene diamine (DPD) chemistry are the only on-line chlorine analyzers that, prior to this action, met the drinking water regulatory requirement to use the same chemistry as an approved method. The instruments perform chlorine residual measurements on a frequent basis using an automated version of Standard Method 4500-Cl G (APHA 1998), which is listed in the tables at 40 CFR 141.74(a)(2) and 40 CFR 141.131(c)(1). Since the instruments use an approved method, they have the capability to provide the same accuracy and precision as the approved method (Standard Method 4500-Cl G), if they are properly installed and maintained. The performance characteristics of the instruments are periodically checked by comparing the instrumental results to grab sample measurements according to a protocol approved by the State.
EPA Method 334.0 now allows the use of on-line chlorine analyzers based on chemistry different from that of approved methods. It is a
``performance based'' method, which means it establishes QC criteria to bench-mark the performance of the on-line chlorine analyzer against the performance of approved grab sample methods. As long as the on-line analyzer meets the QC criteria in EPA Method 334.0, the data are deemed equivalent to data obtained using the approved grab sample methods. EPA
Method 334.0 can be used with any type of on-line chlorine analyzer.
Data from 38 drinking water treatment facilities (EE&T, Inc. 2009) were used as the basis for establishing the on-line chlorine analyzer
QC criteria in EPA Method 334.0. Chlorine residual measurements from on-line amperometric chlorine analyzers were compared to the results from grab sample analyses performed using either Standard Method 4500-
Cl D (amperometric titration) (APHA 1998) or Standard Method 4500-Cl G
(DPD colorimetric). Both Standard Methods are approved for drinking water compliance monitoring analyses and are listed in the tables at 40
CFR 141.74(a)(2) and 40 CFR 141.131(c)(1). The data from the 38 facilities demonstrate that on-line amperometric chlorine analyzers can provide data that are equivalent to approved methods.
EPA Method 334.0 requires that the analyst demonstrate that the grab sample method provides reliable data prior to using it to verify the performance of an on-line chlorine analyzer. This QC requirement is consistent with the QC requirements in the approved grab sample methods. Aqueous standards are analyzed to demonstrate the accuracy and precision of the measurements. EPA recommends that the grab sample QC requirements in EPA Method 334.0 be used with all on-line chlorine analyzers, including those that are originally approved under the provisions of 40 CFR 141.74.
A preliminary draft of EPA Method 334.0 was provided to the
Association of State Drinking Water Administrators, the American Water
Works Association, and the Water and Wastewater Equipment Manufacturers
Association. A revised draft was reviewed by persons from two State agencies and two drinking water utilities. The final method reflects changes made in response to review comments. The public docket for this action includes the comments from these organizations and the Agency's response to comments (USEPA 2009c).
EPA has determined that EPA Method 334.0 is equally effective for measuring free and total chlorine residuals as the methods that are promulgated in the regulations at 40 CFR 141.74(a)(2) and 40 CFR 141.131(c)(1). The basis for this determination is discussed in Fair and Wendelken 2009. EPA is therefore approving use of EPA Method 334.0 for on-line analyses of free and total chlorine. A copy of the method can be accessed and downloaded directly on-line at http://epa.gov/ safewater/methods/analyticalmethods_ogwdw.html. 2. EPA Method 302.0, ``Determination of Bromate in Drinking Waters using Two-Dimensional Ion Chromatography with Suppressed Conductivity
Detection'' (USEPA 2009d) is a large volume (1.0 mL), two-dimensional ion chromatography (IC) method that uses suppressed conductivity detection for the determination of bromate in raw and finished drinking waters. Because this method utilizes two dissimilar IC columns it does not require second column confirmation. Detection and quantitation are accomplished in the second dimension by suppressed conductivity measurement. Bromate
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concentration is calculated using the integrated peak area and the external standard technique.
EPA Method 302.0 offers increased bromate specificity without the complexity of post column reactors.
The approved methods for bromate are listed at 40 CFR 141.131(b)(1). The performance characteristics of EPA Method 302.0 were compared to the characteristics of approved EPA Methods 300.1 (USEPA 2000), 317.0, Revision 2.0 (USEPA 2001), and 326.0 (USEPA 2002). EPA has determined that EPA Method 302.0 is equally effective for measuring bromate concentrations as these approved methods. EPA Method 302.0 can also meet the minimum reporting limit (MRL) requirements necessary for methods that are used to support the reduced bromate monitoring specified at 40 CFR 141.132(b)(3)(ii)(B). The basis for these determinations is discussed in Munch 2009a. EPA is therefore approving
EPA Method 302.0 for the routine determination of bromate in drinking water and also allowing its use for reduced bromate monitoring. A copy of the method can be accessed and downloaded directly on-line at http:/
/epa.gov/safewater/methods/analyticalmethods_ogwdw.html. 3. EPA Method 557, ``Determination of Haloacetic Acids, Bromate, and Dalapon in Drinking Water by Ion Chromatography Electrospray
Ionization Tandem Mass Spectrometry (IC-ESI-MS/MS)'' (USEPA 2009e) is a direct-injection, ion chromatography, negative-ion electrospray ionization, tandem mass spectrometry (IC-ESI-MS/MS) method for the determination of nine haloacetic acids in finished drinking waters.
Each method analyte is qualitatively identified via a unique mass transition, and the concentration is calculated using the integrated peak area and the internal standard technique.
Bromate may be measured concurrently with the haloacetic acids.
Real time, chromatographic separation of common anions in drinking water (matrix elimination) is a key feature of this method. Acceptable method performance has been demonstrated for matrix ion concentrations of 320 milligrams/Liter (mg/L) chloride, 250 mg/L sulfate, 150 mg/L bicarbonate and 20 mg/L nitrate.
EPA Method 557 eliminates the labor intensive sample preparation steps (extraction and derivatization) that are required in the current methods that are approved for haloacetic acid determinations. It also reduces the use of solvents and potentially hazardous chemicals. The development work for this method is described in the method research summary (Zaffiro and Zimmerman 2009).
The sum of five haloacetic acids (monochloroacetic acid, dichloroacetic acid, trichloroacetic acid, monobromoacetic acid, and dibromoacetic acid) is regulated as HAA5. The approved methods for HAA5 are listed at 40 CFR 141.131(b)(1). The performance characteristics of
EPA Method 557 for each of the five haloacetic acids were compared to the characteristics of approved EPA Methods 552.2 (USEPA 1995) and 552.3, Revision 1.0 (USEPA 2003) for the same compounds. EPA has determined that EPA Method 557 is equally effective for measuring HAA5 relative to approved EPA Methods 552.2 and 552.3. The basis for this determination is discussed in Munch 2009b. Therefore, EPA is approving
EPA Method 557 for determining HAA5 in drinking water.
The performance characteristics of EPA Method 557 were also compared to the bromate-measurement characteristics of approved EPA
Methods 300.1 (USEPA 2000), 317.0 Revision 2.0 (USEPA 2001), and 326.0
(USEPA 2002). EPA has determined that EPA Method 557 is equally effective for measuring bromate concentrations as these approved methods. EPA Method 557 can also meet the MRL requirements necessary for methods that are used to support the reduced bromate monitoring specified at 40 CFR 141.132(b)(3)(ii)(B). The basis for these determinations is discussed in Munch 2009b. EPA is therefore approving
EPA Method 557 for the routine determination of bromate in drinking water and also allowing its use for reduced bromate monitoring.
A copy of EPA Method 557 can be accessed and downloaded directly on-line at http://epa.gov/safewater/methods/analyticalmethods_ ogwdw.html. 4. EPA Method 415.3, Revision 1.2, ``Determination of Total Organic
Carbon and Specific UV Absorbance at 254 nanometers (nm) in Source
Water and Drinking Water'' (USEPA 2009f) is a slightly modified version of the currently approved EPA Method 415.3, Revision 1.1 (USEPA 2005).
Revision 1.1 is listed as an approved method for determining total organic carbon (TOC), dissolved organic carbon (DOC), ultraviolet absorbance at 254 nm (UV254), and specific ultraviolet absorbance (SUVA) concentrations at 40 CFR 141.131(d). Determination of
UV254can only be done using a double beam spectrophotometer if the instrument is zeroed according to the directions in the approved method. Since many water system laboratories use single beam spectrophotometers, the method was revised to allow for their use by modifying the zeroing procedure. This modification did not result in any change in the performance of the method. Therefore, EPA finds that
Method 415.3, Revision 1.2 is equally effective as Revision 1.1.
Revision 1.2 also corrects some typographical errors that are present in Revision 1.1. The modifications are documented in Wimsatt 2009. EPA is approving EPA Method 415.3, Revision 1.2 for determining TOC, DOC,
UV254, and SUVA in source water and drinking water.
A copy of EPA Method 415.3, Revision 1.2 can be accessed and downloaded directly on-line at http://www.epa.gov/nerlcwww/ordmeth.htm.
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Methods Developed by Voluntary Consensus Standard Bodies (VCSB) 1. Standard Methods for the Examination of Water and Wastewater.
Standard Methods 9223 B-97 and 9223 B (20th and 21st Edition) can be used to detect Escherichia coli (E. coli). Approved methods for E. coli are listed at 40 CFR 141.21(f)(6). The Minimal Medium ONPG-MUG (MMO-
MUG) Test is listed as an approved method for E. coli and the reference cited for the procedure is a journal article (Edberg et al. 1989).
Standard Methods used the same research documented in the journal article to write Standard Method 9223 B, which is published in the 20th and 21st Edition of Standard Methods for the Analysis of Water and
Wastewater (APHA 1998, 2005). The same method is also available on-line as Standard Method 9223 B-97 (APHA 1997). Since Standard Methods 9223 B
(20th and 21st Edition) and 9223 B-97 are the same procedure as that documented in the Edberg et al. article, they are equally effective as the approved Edberg method for determining E. coli (Best 2009).
Therefore, EPA is approving the use of Standard Methods 9223 B (20th
Edition), 9223 B (21st Edition) and 9223 B-97 for determining E. coli as specified at 40 CFR 141.21(f)(6). The 20th and 21st editions can be obtained from American Public Health Association (APHA), 800 I Street,
NW., Washington, DC 20001-3710. Standard Method 9223 B-97 is available at http://www.standardmethods.org. 2. ASTM International. EPA compared the most recent versions of 14
ASTM International methods to the versions of those methods cited in 40
CFR 141 and 143. Changes between the approved version and the most recent version of each method are summarized
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in Fair 2009. The revisions primarily involve editorial changes (i.e., updated references, reorganization, and corrections of errors). Data generated using the revised methods are comparable to data obtained using the previous versions because the chemistry, sample-handling protocols, and QC are unchanged. The new versions are equally effective relative to the version cited in the regulation (Fair 2009). Therefore,
EPA is approving the use of the 14 updated ASTM methods for the contaminants and regulations listed in the following table.
The revised ASTM method for bromate and chlorite analyses (D 6581- 08) is split into two techniques. Method A uses chemically suppressed ion chromatography and is the same as the approved Method D 6581-00, which is listed in the regulation at 40 CFR 141.131(b)(1); ASTM D 6581- 08 A is one of the 14 methods previously discussed. Method B uses electrolytically suppressed ion chromatography and represents a new method. EPA compared the bromate and chlorite performance data for
Method B to the data in the approved Method D 6581-00 and determined that Method B is equally effective as the currently approved method
(Fair 2009). Therefore, EPA is approving ASTM D 6581-08 B for the determination of bromate and chlorite in routine drinking water compliance samples.
The ASTM methods that are approved in this action are listed in the following table:
ASTM method
Contaminant
Regulation
D511-09 A (ASTM International
Calcium.............................. 40 CFR 141.23(k)(1). 2009a).
Magnesium............................ 40 CFR 141.23(k)(1).
D511-09 B (ASTM International
Calcium.............................. 40 CFR 141.23(k)(1). 2009a).
Magnesium............................ 40 CFR 141.23(k)(1).
D1688-07 A (ASTM International
Copper............................... 40 CFR 141.23(k)(1). 2009b).
D1688-07 C (ASTM International
Copper............................... 40 CFR 141.23(k)(1). 2009b).
D2972-08 B (ASTM International
Arsenic.............................. 40 CFR 141.23(k)(1). 2009c).
D2972-08 C (ASTM International
Arsenic.............................. 40 CFR 141.23(k)(1). 2009c).
D3559-08 D (ASTM International
Lead................................. 40 CFR 141.23(k)(1). 2009d).
D3645-08 B (ASTM International
Beryllium............................ 40 CFR 141.23(k)(1). 2009e).
D3697-07 (ASTM International 2009f) Antimony............................. 40 CFR 141.23(k)(1).
D3859-08 A (ASTM International
Selenium............................. 40 CFR 141.23(k)(1). 2009g).
D3859-08 B (ASTM International
Selenium............................. 40 CFR 141.23(k)(1). 2009g).
D1253-08 (ASTM International 2009h) Free Chlorine........................ 40 CFR 141.74(a)(2). 40 CFR 141.131(c)(1)
Total Chlorine....................... 40 CFR 141.74(a)(2). 40 CFR 141.131(c)(1).
Combined Chlorine.................... 40 CFR 141.131(c)(1).
D516-07 (ASTM International 2009i). Sulfate.............................. 40 CFR 143.4(b).
D6581-08 A (ASTM International
Bromate.............................. 40 CFR 141.131(b)(1). 2009j).
Chlorite............................. 40 CFR 141.131(b)(1).
D6581-08 B (ASTM International
Bromate.............................. 40 CFR 141.131(b)(1). 2009j).
Chlorite............................. 40 CFR 141.131(b)(1).
The 15 ASTM methods are available from ASTM International, 100 Barr
Harbor Drive, West Conshohocken, PA 19428-2959 or http://www.astm.org.
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Methods Developed by Vendors 1. AMI Turbiwell Method (SWAN Analytische Instrumente AG 2009a) uses light emitting diode (LED) nephelometry to continuously measure turbidity in drinking water. The turbidimeter utilizes a non-contact light source design to avoid fouling of optical surfaces. The LED has an emission range of 415 nm to 780 nm with a peak spectral radiance of 562nm. The light beam from the emission LED impinges the water surface and is refracted. The detector measures the scattered light at an angle of 90[deg]. A light barrier avoids measurement errors due to light reflections. The instrument is equipped with an internal data logger, or the data can be downloaded to a personal computer or central data system with appropriate computer software.
The approved methods for turbidity are listed at 40 CFR 141.74(a)(1). The performance characteristics of the AMI Turbiwell turbidimeter were compared to the performance characteristics of approved EPA Method 180.1 (USEPA 1993). The validation study report
(SWAN Analytische Instrumente AG 2009b) summarizes the results obtained from the turbidimeters placed in series at three different public water systems. One water system used ground water and the other two plants used surface water sources. Measurements included at least one filter backwash at each of the surface water plants.
EPA has determined that the AMI Turbiwell Method is equally effective as approved EPA Method 180.1. The basis for this determination is discussed in the validation study report (SWAN
Analytische Instrumente AG 2009b). Therefore, EPA is approving the AMI
Turbiwell Method for determining turbidity in drinking water. A copy of the method can be downloaded from the National Environmental Methods
Index (NEMI) at http://www.nemi.gov or obtained by contacting Markus
Bernasconi, SWAN Analytische Instrumente AG, Studbachstrasse 13, CH- 8340 Hinwil, Switzerland. 2. ChloroSense (Palintest Ltd 2009a) is an electrochemical sensor method that measures free and total chlorine using disposable sensors.
Free and combined available chlorine react with proprietary reagents on the sensor to create intermediate reaction products. These products are then detected electrochemically. The current that flows in each case is proportional to the amount of free available chlorine or total available chlorine in the sample. The sensors are pre-calibrated, and free and total chlorine concentrations are displayed upon completion of the analysis.
Approved methods for determining free and total chlorine residuals in drinking water are listed in the tables at 40 CFR 141.74(a)(2) and 40 CFR 141.131(c)(1). The performance characteristics of ChloroSense were compared to the performance characteristics of approved Standard
Methods 4500-Cl D (amperometric titration)(APHA 1998) and 4500-Cl G
(DPD colorimetric)(APHA 1998). A variety of samples, including drinking water samples from both surface and
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ground water sources, were fortified with known chlorine concentrations and then analyzed by each method. The results are summarized in the validation study report (Palintest Ltd 2009b).
EPA has determined that the ChloroSense Method is equally effective as approved Standard Methods 4500-Cl D and 4500-Cl G. The basis for this determination is discussed in the validation study report
(Palintest Ltd 2009b). Therefore, EPA is approving the ChloroSense
Method for determining free and total chlorine residuals in drinking water. A copy of the method can be downloaded from NEMI at http:// www.nemi.gov or obtained by contacting Palintest Ltd, 21 Kenton Lands
Road, P.O. Box 18395, Erlanger, KY 41018. 3. Modified ColitagTM(CPI International 2009).
ColitagTM(CPI International 2001) is a presence/absence method approved for use under the Total Coliform Rule. It uses enzymatic cleavage of a chromogenic substance to detect total coliforms and enzymatic cleavage of a fluorogenic substance to detect E. coli in a 100 mL sample of drinking water. Detection of total coliforms and E. coli are performed simultaneously by this method. ColitagTM may also be used in a most-probable-number format provided that the sum of all individual portions of the sample total 100 mL. Modified
ColitagTMhas a different formulation from the originally approved ColitagTM. The purpose of the formula change is to achieve greater selectivity for total coliforms and E. coli.
Additionally, the Modified ColitagTMprovides flexibility in the incubation period (16 to 48 hours), while the approved
ColitagTMrequires a 24 hour incubation time.
Approved methods for total coliforms are listed at 40 CFR 141.21(f)(3) and approved methods for E. coli are listed at 40 CFR 141.21(f)(6). The performance characteristics of Modified
ColitagTMwere compared to Standard Methods 9221 B (LTB/
BGLB) for total coliforms and 9222 G (LTB/EC-MUG) for E. coli (APHA 1998). The comparison study involved analyses of twenty replicate drinking water samples that were inoculated with very low densities of chlorine stressed total coliforms or E. coli obtained from ten geographically dispersed waste waters. Method specificity was evaluated using 100 positive and 100 negative cultures as determined from analyses by the reference methods.
EPA has determined that the Modified ColitagTMMethod is equally effective as approved Standard Methods 9221 B for total coliforms and 9222 G for E. coli, which are already promulgated in the regulations at 40 CFR 141.21(f)(3) and 40 CFR 141.21(f)(6), respectively. The basis for this determination is discussed in the study report (USEPA 2009g). Therefore, EPA is approving the Modified
ColitagTMMethod for determining total coliforms and E. coli in drinking water. A copy of the method can be downloaded from NEMI at http://www.nemi.gov or obtained by contacting CPI International, 580
Skylane Boulevard, Santa Rosa, CA 95403.
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Statutory and Executive Order Reviews
As noted in Section II, under the terms of SDWA Section 1401(1), this streamlined method approval action is not a rule. Accordingly, the
Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement Fairness Act of 1996, does not apply because this action is not a rule for purposes of 5 U.S.C. 804(3).
Similarly, this action is not subject to the Regulatory Flexibility Act because it is not subject to notice and comment requirements under the
Administrative Procedure Act or any other statute. In addition, because this approval action is not a rule but simply makes alternative
(optional) testing methods available for monitoring under SDWA, EPA has concluded that other statutes and executive orders generally applicable to rulemaking do not apply to this approval action.
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References
American Public Health Association (APHA). 1997. Standard Method 9223-97. Enzyme Substrate Coliform Test. Approved by Standard
Methods Committee 1997. Standard Methods Online. (Available at http://www.standardmethods.org.)
American Public Health Association (APHA). 1998. 20th Edition of
Standard Methods for the Examination of Water and Wastewater,
American Public Health Association, 800 I Street, NW., Washington,
DC 20001-3710.
American Public Health Association (APHA). 2005. 21st Edition of
Standard Methods for the Examination of Water and Wastewater,
American Public Health Association, 800 I Street, NW., Washington,
DC 20001-3710.
ASTM International. 2009a. ASTM D 511-09. Standard Test Methods for
Calcium and Magnesium in Water. ASTM International, 100 Barr Harbor
Drive, West Conshohocken, PA 19428-2959. (Available at http:// www.astm.org.)
ASTM International. 2009b. ASTM D 1688-07. Standard Test Methods for
Copper in Water. ASTM International, 100 Barr Harbor Drive, West
Conshohocken, PA 19428-2959. (Available at http://www.astm.org.)
ASTM International. 2009c. ASTM D 2972-08. Standard Test Methods for
Arsenic in Water. ASTM International, 100 Barr Harbor Drive, West
Conshohocken, PA 19428-2959. (Available at http://www.astm.org.)
ASTM International. 2009d. ASTM D 3559-08. Standard Test Methods for
Lead in Water. ASTM International, 100 Barr Harbor Drive, West
Conshohocken, PA 19428-2959. (Available at http://www.astm.org.)
ASTM International. 2009e. ASTM D 3645-08. Standard Test Methods for
Beryllium in Water. ASTM International, 100 Barr Harbor Drive, West
Conshohocken, PA 19428-2959. (Available at http://www.astm.org.)
ASTM International. 2009f. ASTM D 3697-07. Standard Test Methods for
Antimony in Water. ASTM International, 100 Barr Harbor Drive, West
Conshohocken, PA 19428-2959. (Available at http://www.astm.org.)
ASTM International. 2009g. ASTM D 3859-08. Standard Test Methods for
Selenium in Water. ASTM International, 100 Barr Harbor Drive, West
Conshohocken, PA 19428-2959. (Available at http://www.astm.org.)
ASTM International. 2009h. ASTM D 1253-08. Standard Test Method for
Residual Chlorine in Water. ASTM International, 100 Barr Harbor
Drive, West Conshohocken, PA 19428-2959. (Available at http:// www.astm.org.)
ASTM International. 2009i. ASTM D 516-07. Standard Test Method for
Sulfate Ion in Water. ASTM International, 100 Barr Harbor Drive,
West Conshohocken, PA 19428-2959. (Available at http:// www.astm.org.)
ASTM International. 2009j. ASTM D 6581-08. Standard Test Methods for
Bromate, Bromide, Chlorate, and Chlorite in Drinking Water by
Suppressed Ion Chromatography. ASTM International, 100 Barr Harbor
Drive, West Conshohocken, PA 19428-2959. (Available at http:// www.astm.org.)
Best, J. 2009. Memo to the record describing basis for expedited approval of Standard Methods 9223 B (20th Edition), 9223 B (21st
Edition) and 9223 B-97 for determining E. coli as specified at 40
CFR 141.21(f)(6). August 31, 2009.
CPI International. 2001. Colitag\TM\ Test. Colitag\TM\ Product as a
Test for Detection and Identification of Coliforms and Escherichia coli Bacteria in Drinking Water and Source Water as Required in
National Primary Drinking Water Regulations. August 2001. 580
Skylane Boulevard, Santa Rosa, CA 95403.
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Modified ColitagTMTest Method for the Simultaneous
Detection of E. coli and other Total Coliforms in Water (ATP D05- 0035). August 28, 2009. 5580 Skylane Boulevard, Santa Rosa, CA 95403.
Edberg, S.C. et al. 1989. ``National Field Evaluation of a Defined
Substrate Method for the Simultaneous Detection of Total Coliforms and Escherichia coli from Drinking Water: Comparison with
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Presence-Absence Techniques.'' Applied Environmental Microbiology,
Vol. 55, pp. 1003-1008, April 1989.
Environmental Engineering & Technology, Inc. (EE&T, Inc.).
Memorandum No. 4 to AWWA. Final Analysis of Online Amperometric
Data. EE&T Project No. 5318, February 27, 2009. EE&T, Inc., 712 Gum
Rock Court, Newport News, VA 23606.
Fair, P. 2009. Memo to the record describing basis for approval of updated ASTM methods. September 30, 2009.
Fair, P. and Wendelken, S. 2009. Memo to the record describing basis for expedited approval of EPA Method 334.0. September 30, 2009.
Munch, D. 2009a. Memo to the record describing basis for expedited approval of EPA Method 302.0 for bromate. September 30, 2009.
Munch, D. 2009b. Memo to the record describing basis for expedited approval of EPA Method 557 for HAA5 and bromate. October 6, 2009.
Palintest Ltd. 2009a. ChloroSense Method, Rev. 1.0. Measurement of
Free and Total Chlorine in Drinking Water by Palintest ChloroSense,
August 10, 2009, Palintest Ltd, 21 Kenton Lands Road, PO Box 18395,
Erlanger, KY 41018. (Available at http://www.nemi.gov.)
Palintest Ltd. 2009b. ATP Evaluation of Palintest ChloroSense for the Measurement of Free and Total Chlorine, August 10, 2009.
Palintest Ltd, 21 Kenton Lands Road, PO Box 18395, Erlanger, KY 41018.
SWAN Analytische Instrumente AG. 2009a. AMI Turbiwell Method, Rev. 1.0. Continuous Measurement of Turbidity Using a SWAN AMI Turbiwell
Turbidimeter, August 10, 2009, Markus Bernasconi, SWAN Analytische
Instrumente AG, Studbachstrasse 13, CH-8340 Hinwil, Switzerland.
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AMI Turbiwell Turbidimeter for Measurement of Turbidity, August 10, 2009. Studbachstrasse 13, CH-8340 Hinwil, Switzerland.
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Reagent for Trace Bromate Analysis, EPA 815-R-03-007, June 2002.
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Dalapon in Drinking Water by Liquid-Liquid Microextraction,
Derivatization, and Gas Chromatography with Electron Capture
Detection, EPA 815-B-03-002, July 2003. (Available at http:// www.epa.gov/safewater/methods/analyticalmethods_ogwdw.html).
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Organic Carbon and Specific UV Absorbance at 254 nm in Source Water and Drinking Water. EPA/600/R-05/055, February 2005. (Available at http://www.epa.gov/nerlcwww/ordmeth.htm.)
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Sampling Procedures. 72 FR 17902. April 10, 2007.
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Analysis and Sampling Procedures. 73 FR 31616. June 3, 2008.
USEPA. 2009a. Expedited Approval of Alternative Test Procedures for the Analysis of Contaminants Under the Safe Drinking Water Act;
Analysis and Sampling Procedures. 74 FR 38348. August 3, 2009.
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Electrospray Ionization Tandem Mass Spectrometry (IC-ESI-MS/MS), EPA 815-B-09-012, August 2009. (Available at http://epa.gov/safewater/ methods/analyticalmethods_ogwdw.html.)
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Organic Carbon and Specific UV Absorbance at 254 nm in Source Water and Drinking Water. EPA/600/R-09/122, September 2009. (Available at http://www.epa.gov/nerlcwww/ordmeth.htm.)
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September 30, 2009.
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Summary, Shaw Environmental Inc., Cincinnati OH. March 2009.
List of Subjects in 40 CFR Part 141
Chemicals, Environmental protection, Indians--lands,
Intergovernmental relations, Radiation protection, Reporting and recordkeeping requirements, Water supply.
Dated: October 29, 2009.
Peter S. Silva,
Assistant Administrator, Office of Water. 0
For the reasons stated in the preamble, 40 CFR part 141 is amended as follows:
PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS 0 1. The authority citation for part 141 continues to read as follows:
Authority: 42 U.S.C. 300f, 300g-l, 300j-4, and 300j-9. 0 2. Appendix A to subpart C of part 141 is amended as follows: 0 a. By revising the entry in the table entitled ``Alternative testing methods for contaminants listed at 40 CFR 141.21(f)(3).'' 0 b. By adding the table entitled ``Alternative testing methods for contaminants listed at 40 CFR 141.21(f)(6)'' after the table entitled
``Alternative testing methods for contaminants listed at 40 CFR 141.21(f)(3).'' 0 c. By revising the entries for ``Antimony,'' ``Arsenic,''
``Beryllium,'' ``Calcium,'' ``Copper,'' ``Lead,'' ``Magnesium,'' and
``Selenium'' in the table entitled ``Alternative testing methods for contaminants listed at 40 CFR 141.23(k)(1).'' 0 d. By revising the entry for ``Turbidity'' in the table entitled
``Alternative testing methods for contaminants listed at 40 CFR 141.74(a)(1).'' 0 e. By revising the entries for ``Free Chlorine'' and ``Total Chlorine'' in the
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table entitled ``Alternative testing methods for disinfectant residuals listed at 40 CFR 141.74(a)(2).'' 0 f. By revising the entry for ``HAA5'' and adding the entries for
``Bromate'' and ``Chlorite'' after the entry for ``HAA5'' in the table entitled ``Alternative testing methods for contaminants listed at 40
CFR 141.131(b)(1).'' 0 g. By revising the entries for ``Free Chlorine,'' ``Combined Chlorine'' and ``Total Chlorine'' in the table entitled ``Alternative testing methods for disinfectant residuals listed at 40 CFR 141.131(c)(1).'' 0 h. By revising all the entries in the table entitled ``Alternative testing methods for parameters listed at 40 CFR 141.131(d).'' 0 i. By adding the table entitled ``Alternative testing methods with MRL
