EPA Approves Alternative Test Procedures for Analysis of Contaminants Under Safe Drinking Water Act

Targeted News Service

WASHINGTON, June 20 -- The U.S. Environmental Protection Agency published the following rule in the Federal Register:

Expedited Approval of Alternative Test Procedures for the Analysis of Contaminants Under the Safe Drinking Water Act; Analysis and Sampling Procedures

A Rule by the Environmental Protection Agency on 06/19/2014

Publication Date: Thursday, June 19, 2014

Agency: Environmental Protection Agency

Dates: This action is effective June 19, 2014.

Effective Date: 06/19/2014

Entry Type: Rule

Action: Final rule.

Document Citation: 79 FR 35081

Page: 35081 -35096 (16 pages)

CFR: 40 CFR 141

Agency/Docket Numbers:EPA-HQ-OW-2014-0408

FRL-9912-52-OW

Document Number: 2014-14369

Shorter URL: https://federalregister.gov/a/2014-14369

Action

Final Rule.

Summary

This action announces the U.S. 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 21 additional methods available for analyzing drinking water samples. 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 June 19, 2014.

FOR FURTHER INFORMATION CONTACT:

Safe Drinking Water Hotline (800) 426-4791 or Glynda Smith, Technical Support Center, Standards and Risk Management Division, Office of Ground Water and Drinking Water (MS 140), Environmental Protection Agency, 26 West Martin Luther King Drive, Cincinnati, OH 45268; telephone number: (513) 569-7652; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. 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 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 or in prior expedited approval actions. Categories and entities that may ultimately be affected by this action include:

Category .....Examples of potentially regulated entities .....NAICS1

State, Local, & Tribal Governments .....States, local and Tribal governments 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 .....924110

Industry .....Private operators of community and non-transient non-community water systems required to monitor .....221310

Municipalities .....Municipal operators of community and non-transient non-community water systems required to monitor .....924110

1North 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 in the Code of Federal Regulations (CFR) 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. B. 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-2014-0408. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the Water Docket in the EPA Docket Center, (EPA/DC) William Jefferson Clinton West Building, Room 3334, 1301 Constitution Ave. NW., Washington, DC. Copyrighted materials are available only in hard copy. The EPA DC 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

APHA: American Public Health Association

ATP: Alternate Test Procedure

CFR: Code of Federal Regulations

DPD: N,N-diethyl-p-phenylenediamine

EPA: United States Environmental Protection Agency

GWR: Ground Water Rule

NAICS: North American Industry Classification System

NEMI: National Environmental Methods Index

PRFC: Planar Reagent-Filled Cuvette(s)

QC: Quality Control

RTCR: Revisions to the Total Coliform Rule

SDWA: The Safe Drinking Water Act

TCR: Total Coliform Rule

VCSB: Voluntary Consensus Standard Bodies

II. Background

A. What is the purpose of this action?

In this action, EPA is approving 21 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 or in prior expedited approval actions. The new methods are listed along with other methods similarly approved through previous expedited actions in 40 CFR Part 141 Appendix A to Subpart C and on EPA's drinking water methods Web site at http://water.epa.gov/scitech/drinkingwater/labcert/analyticalmethods_expedited.cfm.

B. 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 21 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 as effective as one or more of the testing methods already approved in the regulations for those contaminants. Section 1401(1) of SDWA 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 21 analytical methods legally available as options 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 the Federal Register.

III. Summary of Approvals

EPA is approving 21 methods that are equally effective relative to methods previously promulgated in the regulations. By means of this rule, these 21 methods are added to Appendix A to Subpart C of 40 CFR Part 141.

A. Methods Developed by Voluntary Consensus Standard Bodies (VCSB)

1. Standard Methods for the Examination of Water and Wastewater (Standard Methods). EPA compared the most recent online versions of 14 Standard Methods to earlier versions of those methods that are currently approved in 40 CFR parts 141 and 143. Changes between the approved version and the most recent version of each method are summarized in Smith and Wendelken (2013a). The revisions primarily involve editorial changes (e.g., corrections of errors, procedural clarifications, and reorganization of text). The updated online versions listed in the following table are the same as the earlier approved versions with respect to the chemistry and microbiology, sample handling protocols, and method performance data. For all of these reasons, EPA has concluded that the updated online versions are equally effective relative to those that are currently approved in the regulations. Therefore, EPA is approving the use of the 14 updated Standard Methods for the contaminants and their respective regulations listed in the following table:

Standard method revised version .....Approved method .....Contaminant .....Regulation

2550-10, online version (APHA 2010a) .....2550-00, online version (APHA 2000a) .....Temperature .....40 CFR 141.23(k)(1).

3113 B-10, online version (APHA 2010b) .....3113 B-99, online version (APHA 1999) .....Antimony, arsenic, barium, beryllium, cadmium, chromium, copper, lead, nickel, selenium, aluminum, iron, manganese, silver .....40 CFR 141.23(k)(1); 40 CFR 143.4(b).

5910 B-11, online version (APHA 2011) .....5910 B-00, online version (APHA 2000b) .....UV Absorption at 254 nm .....40 CFR 141.131(d).

6251 B-07, online version (APHA 2007) .....6251 B-94, online version (APHA 1994) .....HAA5 .....40 CFR 141.131(b)(1).

6640 B-06, online version (APHA 2006a) .....EPA Method 515.4, Rev. 1.0 (USEPA 2000) .....2,4-D; 2,4,5-TP; Dalapon; Dinoseb; Pentachlorophenol; Picloram .....40 CFR 141.24(e)(1).

6651 B-05, online version (APHA 2005a) .....6651 B, 20th Edition (APHA 1998) .....Glyphosate .....40 CFR 141.24(e)(1).

9221 A-06, online version (APHA 2006b) .....9221 A, 20th Edition (APHA 1998) .....Total Coliforms .....40 CFR 141.21(f)(3); 40 CFR 141.74(a)(1).

9221 B-06, online version (APHA 2006c) .....9221 B, 20th Edition (APHA 1998) .....Total Coliforms .....40 CFR 141.21(f)(3); 40 CFR 141.74(a)(1).

9221 B.1, B.2-06, online version (APHA 2006c) .....9221 B.1, B.2, 20th Edition (APHA 1998) .....Total Coliforms .....40 CFR 141.852(a)(5).

9221 C-06, online version (APHA 2006d) .....9221 C, 20th Edition (APHA 1998) .....Total Coliforms .....40 CFR 141.74(a)(1).

9221 E-06, online version (APHA 2006e) .....9221 E, 20th Edition (APHA 1998) .....Fecal Coliforms .....40 CFR 141.21(f)(5); 40 CFR 141.74(a)(1).

9221 F-06, online version (APHA 2006f) .....9221 F, 20th Edition (APHA 1998) .....E. coli .....40 CFR 141.402(c)(2).

9221 F.1-06, online version (APHA 2006f) .....9221 F.1, 20th Edition (APHA 1998) .....E. coli .....40 CFR 141.852(a)(5).

9222 D-06, online version (APHA 2006g) .....9222 D, 20th Edition (APHA 1998) .....Fecal Coliforms .....40 CFR 141.74(a)(1).

9223 B-04, online version (APHA 2004a) .....9223, 20th Edition (APHA 1998) .....Total Coliforms .....40 CFR 141.21(f)(3); 40 CFR 141.74(a)(1); 40 CFR 141.852(a)(5).

9223 B-04, online version (APHA 2004a) .....9223 B, 20th Edition (APHA 1998) .....E. coli .....40 CFR 141.21(f)(6); 40 CFR 141.402(c)(2); 40 CFR 141.852(a)(5).

9215 B-04, online version (APHA 2004b) .....9215 B, 20th Edition (APHA 1998) .....Heterotrophic Bacteria .....40 CFR 141.74(a)(1).

The online versions of Standard Methods are available at http://www.standardmethods.org.

2. ASTM International. EPA compared the most recent versions of three ASTM International methods (ASTM Methods D512-12 B, D3223-12, and D4327-11) to the earlier versions of those methods that are currently approved in 40 CFR 141 and 143. Changes between the earlier approved version and the most recent version of each method are summarized in Smith (2013). The revisions primarily involve editorial changes (e.g., updated references, definitions, terminology, procedural clarifications, and reorganization of text). The revised methods are the same as the approved versions with respect to sample collection and handling protocols, sample preparation, analytical methodology, and method performance data; thus, EPA finds they are equally effective relative to the approved methods.

EPA is thus approving the use of the following ASTM methods for the contaminants and their respective regulations listed in the following table:

ASTM Revised version .....Approved method .....Contaminant .....Regulation

D512-12 B (ASTM 2012a) .....D512-89 B (reapproved 1999) (ASTM 1989) .....Chloride .....40 CFR 143.4(b).

D3223-12 (ASTM 2012b) .....D3223-02 (ASTM 2002) .....Mercury .....40 CFR 141.23(k)(1).

D4327-11 (ASTM 2011) .....D4327-03 (ASTM 2003) .....Fluoride, nitrate, nitrite, orthophosphate, chloride, sulfate .....40 CFR 141.23(k)(1); 40 CFR 143.4(b).

The ASTM methods are available from ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959 or http://www.astm.org.

B. Methods Developed by Vendors

1. IDEXX Laboratories, Inc. Colilert-18(TM). Colilert-18(TM) is an approved commercial medium capable of simultaneous detection of total coliform and Escherichia coli bacteria. The use of this medium is described in Standard Method 9223 B, 21st edition of Standard Methods for the Examination of Water and Wastewater (APHA 2005b). Standard Method 9223 B is approved for determination of total coliform bacteria and E. coli under the Revisions to the Total Coliform Rule (RTCR) (USEPA 2013) as cited at 40 CFR 141.852(a)(5). Colilert-18(TM) is a minor variation of an already approved medium, and was determined to be applicable to the Total Coliform Rule (TCR) (Dougherty 1996). EPA is using today's action to clarify that Colilert-18(TM) is itself an approved medium when used as described in Standard Method 9223 B for determining total coliform bacteria and E. coli in drinking water under the RTCR. Accordingly, EPA is adding the Colilert-18(TM) medium and methodology as described in Standard Method 9223 B to the list of alternative testing methods in Appendix A to Subpart C of Part 141. Colilert-18(TM) is available from IDEXX Laboratories, Inc., One IDEXX Drive, Westbrook, ME 04092, and also at http://www.idexx.com.

2. Hach Company Method 10260--Determination of Chlorinated Oxidants (Free and Total) in Water using Disposable Planar Reagent-Filled Cuvettes and Mesofluidic Channel Colorimetry (Hach Company 2013a). The Hach Company Method 10260 uses disposable planar reagent-filled cuvettes (PRFC) to measure free, total and combined chlorine as an optional alternate test procedure to Standard Method 4500-Cl G (APHA 1998) which is approved in the drinking water regulations at 40 CFR 141.74(a)(2) for determination of free and total chlorine, and at 40 CFR 141.131(c)(1) for determination of free, total and combined chlorine. In this method, a mesofluidic pump system draws a water sample through a cuvette that is prefilled with the reagents required to perform DPD (N,N-diethyl-p-phenylenediamine) colorimetric chlorine tests. The sample is then drawn to an optical channel where the chlorine level is measured at a wavelength between 490 and 530 nm. Automation of the DPD determination relative to the manual procedure described in the approved method reduces errors associated with reagent addition, mixing and color development. Three laboratories analyzed a variety of drinking water matrices (e.g., low ionic strength, high ionic strength, and tap water samples derived from both surface water and ground water sources). The performance characteristics of the Hach Method 10260 were compared to the performance characteristics of the approved method. The validation study report (Hach 2013b) summarizes the results obtained from the multi-laboratory study and indicates that Hach Method 10260 is equally as effective as Standard Method 4500-Cl G for the colorimetric determination of free and total chlorine in drinking water. The basis for this determination is discussed in Smith and Wendelken (2013b). EPA is thus approving Hach Method 10260 as an alternate method to Standard Method 4500-Cl G for the analysis of free and total chlorine in drinking water. Hach Method 10260 is available from Hach Company, 5600 Lindbergh Drive, P.O. Box 389, Loveland, CO 80539, and also at www.hach.com.

3. Palintest Ltd ChlordioX Plus Method--Chlorine Dioxide and Chlorite in Drinking Water by Amperometry using Disposable Sensors (Palintest Ltd 2013). The Palintest Ltd ChlordioX Plus uses recyclable disposable sensors for amperometric detection of chlorine dioxide and the disinfection byproduct, chlorite, in drinking water. Standard Method 4500-ClO 2 E (APHA 1998) is an amperometric titration method that is currently approved in the regulations at 40 CFR 141.74(a)(2) and 40 CFR 141.131(c)(1) for determination of chlorine dioxide in drinking water; it is also cited in the regulations at 40 CFR 141.131(b)(1) for routine daily monitoring of chlorite. The approved method requires experienced analysts and is not portable, which limits options for field and site testing. The ChlordioX Plus method is associated with a portable sensor driven instrument and chlorine dioxide standards are available, which can be used with the instrument. Chlorine dioxide is reduced at the surface of the sensor and the current produced is directly proportional to the chlorine dioxide level in the sample. The chlorite level can be determined from a sample duplicate by oxidation of iodide to iodine. The method performance of the ChlordioX Plus method was compared to the performance of Standard Method 4500-ClO 2 E at three public drinking water utilities that use chlorine dioxide for primary disinfection. A variety of samples, including drinking water samples from both surface and ground water sources, were fortified with known chlorine dioxide and chlorite concentrations and then analyzed by each method. The results of the validation study are summarized in Smith and Wendelken (2013c). EPA has determined that the ChlordioX Plus method is equally as effective as the approved method, Standard Method 4500-ClO 2 E. The basis for this determination is discussed in Smith and Wendelken (2013c). Therefore, EPA is approving the ChlordioX Plus method for determining chlorine dioxide and chlorite in drinking water. A copy of the method can be obtained by contacting Palintest Ltd, 1455 Jamike Avenue (Suite 100), Erlanger, KY 41018.

4. Veolia Water Solutions and Technologies Tecta EC/TC Method--Presence/Absence Method for the Simultaneous Detection of Total Coliforms and Escherichia coli (E. coli) in Drinking Water (Veolia 2014a). Tecta EC/TC is a microbiological method for the simultaneous detection of total coliforms and E. coli in drinking water by broth enrichment of samples. Total coliforms and E. coli are detected as being present or absent in 100 mL samples of drinking water by enzymatic cleavage of fluorogenic substances with the formation of fluorescent compounds after incubation. Approved drinking water methods for total coliforms are listed at 40 CFR 141.21(f)(3) under the Total Coliform Rule (TCR) and at 40 CFR 141.852(a)(5) under the Revisions to the Total Coliform Rule (RTCR). Methods approved for E. coli in drinking water are listed at 40 CFR 141.21(f)(6) under the TCR, at 40 CFR 141.402(c)(2) under the Ground Water Rule (GWR), and at 40 CFR 141.852(a)(5) under the RTCR. Tecta EC/TC is similar to other approved drinking water methods except that it uses hydrophobic fluorogens for total coliforms and E. coli which adhere to a hydrophobic plastic stub. These fluorogens emit fluorescent light into the interior of the stub when illuminated by ultraviolet light. The fluorescence from the fluorogens is detected by a photometer adjacent to the stub. The incubation temperature maintenance, incubation timing, and fluorescence detection and results recording are all performed by an automated instrument. Tecta EC/TC is able to detect total coliforms and E. coli in 18 hours. Reagents and sample incubation containers are available, which can be used with the Tecta EC/TC incubator/detector. An Alternative Test Procedure (ATP) study was conducted to compare the method performance of Tecta EC/TC to the performance of the approved methods Standard Methods 9221 B (LTB/BGLB for total coliforms) and 9221 F (LTB/EC-MUG for E. coli) (APHA 1998). The comparison study involved analyses of 200 drinking water samples--20 replicate samples that were inoculated with very low densities of chlorine-stressed total coliforms or E. coli obtained from 10 geographically dispersed waste waters. Method specificity was evaluated using approximately 100 positive and 100 negative cultures as determined from analyses by the reference methods. The ATP validation study report (Veolia 2014b) details the study design and method data evaluation. EPA has determined that Tecta EC/TC is equally effective relative to the approved Standard Method 9221 B for total coliforms under the TCR and RTCR, and Standard Method 9221 F for E. coli under the TCR, GWR, and RTCR. The basis for this determination is discussed in Sinclair (2014). Therefore, EPA is approving the Tecta EC/TC method for determining total coliforms and E. coli in drinking water. Tecta EC/TC is an automated and self-contained method, but is subject to the requirements for certified laboratories described in CFR 141.28.

A copy of the Tecta EC/TC method is available from Veolia Water Solutions and Technologies, Suite 4697, Biosciences Complex, 116 Barrie Street, Kingston, Ontario, Canada K7L 3N6.

[*Federal RegisterVJ 2014-06-19]

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