NSF ANSI_61_watemarked.pdf

NSF International Standard / American National Standard

NSF/ANSI 61 - 2016

Drinking Water System Components - Health Effects

Not for Distribution or Sale

NSF International, an independent, not-for-profit, non-governmental organization, is dedicated to being the leading global provider of public health and safety-based risk management solutions while serving the interests of all stakeholders.

This Standard is subject to revision.

Contact NSF to confirm this revision is current.

Users of this Standard may request clarifications and interpretations, or propose revisions by contacting:

Chair, Joint Committee on Drinking Water Additives c/o NSF International 789 North Dixboro Road, P.O. Box 130140

Ann Arbor, Michigan 48113-0140 USA Phone: (734) 769-8010 Telex: 753215 NSF INTL

FAX: (734) 769-0109

E-mail: info@nsf.org

Web: http://www.nsf.org or Sale i

NSF/ANSI 61 – 2016

International Standard/ American National Standard for Drinking Water Additives ―

Drinking water system components ― Health effects

Standard Developer

NSF International

NSF International Board of Directors

Designated an ANSI Standard January 05, 2016

American National Standards Institute ii

Prepared by The NSF Joint Committee on Drinking Water Additives

Recommended for Adoption by The NSF Council of Public Health Consultants

Adopted by The NSF Board of Directors June 1988

Revised October 1988 Revised November 1999 Addendum October 2007 Revised May 1990 Revised September 2000 Revised December 2008 Revised May 1991 Revised February 2001 Revised August 2009 Revised May 1992 Addendum September 2001 Revised February 2010 Revised September 1994 Revised July 2002 Revised October 2010 Revised January 1995 Addendum August 2002 Revised June 2011 Revised July 1996 Editorial Revision February 2002 Addendum March 2012 Revised September 1996 Revised September 2003 Revised July 2012 Revised November 1996 Editorial Revision October 2003 Addendum March 2013 Revised January 1997 Revised November 2004 Revised January 2014 Revised March 1997 Addendum March 2005 Revised September 2014 Revised July 1997 Revised October 2005 Revised February 2015 Revised November 1998 Revised March 2007 Revised October 2015 Revised January 1999 Revised July 2007 Revised July 2016

Published by

NSF International PO Box 130140, Ann Arbor, Michigan 48113-0140, USA

For ordering copies or for making inquiries with regard to this Standard, please reference the designation

“NSF/ANSI 61 – 2016.”

Copyright 2016 NSF International Previous editions © 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, 2007, 2005, 2004, 2003, 2002, 2001, 2000, 1999, 1998, 1997, 1996, 1995, 1994, 1992, 1991, 1990, 1988

Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from NSF International.

Printed in the United States of America.

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Disclaimers1

NSF, in performing its functions in accordance with its objectives, does not assume or undertake to discharge any responsibility of the manufacturer or any other party. The opinions and findings of NSF represent its professional judgment. NSF shall not be responsible to anyone for the use of or reliance upon this Standard by anyone. NSF shall not incur any obligation or liability for damages, including consequential damages, arising out of or in connection with the use, interpretation of, or reliance upon this Standard.

NSF Standards provide basic criteria to promote sanitation and protection of the public health. Provisions for mechanical and electrical safety have not been included in this Standard because governmental agencies or other national standards-setting organizations provide safety requirements.

Participation in NSF Standards development activities by regulatory agency representatives (federal, local, state) shall not constitute their agency's endorsement of NSF or any of its Standards.

Preference is given to the use of performance criteria measurable by examination or testing in NSF Standards development when such performance criteria may reasonably be used in lieu of design, materials, or construction criteria.

The illustrations, if provided, are intended to assist in understanding their adjacent standard requirements.

However, the illustrations may not include all requirements for a specific product or unit, nor do they show the only method of fabricating such arrangements. Such partial drawings shall not be used to justify improper or incomplete design and construction.

Unless otherwise referenced, the annexes are not considered an integral part of NSF Standards. The annexes are provided as general guidelines to the manufacturer, regulatory agency, user, or certifying organization.

1 The information contained in this Disclaimer is not part of this American National Standard (ANS) and has not been processed in accordance with ANSI’s requirements for an ANS. As such, this Disclaimer may contain material that has not been subjected to public review or a consensus process. In addition, it does not contain requirements necessary for conformance to the Standard.

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Contents

1 Purpose, scope, and normative references

1.1 Purpose

1.2 Scope

1.3 Normative references

1.4 Limitations

1.5 Alternate products or materials

1.6 Significant figures and rounding

2 Definitions

3 General requirements

3.1 General 6

3.2 Information and formulation requirements

3.3 Identification of analytes

3.4 Products manufactured from Annex C acceptable materials

3.5 Restriction on use of lead containing materials

3.6 Weighted average lead content of products

4 Pipes and related products

4.1 Scope

4.2 Definitions

4.3 General requirements

4.4 Sample requirements

4.5 Extraction procedures

4.6 Analysis

4.7 Normalization of contaminant concentrations

4.8 Evaluation of contaminant concentrations

5 Barrier materials

5.1 Scope

5.2 Definitions

5.3 General requirements

5.4 Sample requirements

5.5 Extraction procedures

5.6 Analysis of extraction water

5.7 Normalization

5.8 Evaluation of contaminant concentrations

6 Joining and sealing materials

6.1 Coverage

6.2 Definitions

6.3 Material and extraction testing requirements

6.4 Items of special significance

7 Process media

7.1 Scope

7.2 Definitions

7.3 General requirements

7.4 Sample requirements

7.5 Extraction procedures

7.6 Analysis

7.7 Normalization

7.8 Evaluation of contaminant concentrations

8 Mechanical devices

8.1 Coverage

8.2 Definitions

8.3 Device, component, or material requirements

8.4 In-line devices, components, and materials

8.5 Point-of-entry systems, components, and media

8.6 Chemical feeders and generators

8.7 Other mechanical devices, components, and materials

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9 Mechanical plumbing devices

9.1 Coverage

9.2 Definitions

9.3 Device, component, or material requirements

9.4 Exposure and normalization

9.5 Evaluation of normalized contaminant concentrations

10 Instructions and information

Annex A ................................................................................................................................................. A1

Annex B ................................................................................................................................................. B1

Annex C .................................................................................................................................................C1

Annex D .................................................................................................................................................D1

Annex E ................................................................................................................................................. E1

Annex F ................................................................................................................................................. F1

Annex G ................................................................................................................................................ G1

Interpretations Annex .......................................................................................................... Interpretations - 1 or Sale vii

Foreword2

In response to a competitive request for proposals from the U. S. Environmental Protection Agency (USEPA), a Consortium led by NSF International (NSF) agreed to develop voluntary third-party consensus standards and a certification program for all direct and indirect drinking water additives. Other members of the Consortium include the American Water Works Association Research Foundation, the Association of State Drinking Water Administrators, the Conference of State Health and Environmental Managers, and the American Water Works Association. (COSHEM has since become inactive as an organization.) Each organization was represented on a steering committee with oversight responsibility for the administration of the cooperative agreement. The Steering Committee provides guidance on overall administration and management of the cooperative agreement. Currently, the member organizations remain active in an oversight role.

Two standards for additives products were developed. NSF/ANSI 60: – Drinking water treatment chemicals ― Health effects covers many of the water treatment chemicals, also known as direct additives. This Standard, NSF/ANSI 61: Drinking water system components ― Health effects, covers all indirect additives products and materials. Testing to determine the potential of a product to impart taste and/or odor to drinking water is not included in this Standard.

NSF/ANSI 61 was developed to establish minimum requirements for the control of potential adverse human health effects from products that contact drinking water. It does not attempt to include product performance requirements that are currently addressed in other voluntary consensus standards established by such organizations as the American Water Works Association, the American Society for Testing and Materials, and the American National Standards Institute. Because this Standard complements the performance standards of these organizations, it is recommended that products also meet the appropriate performance requirements specified in the standards of such organizations.

NSF/ANSI 61, and subsequent product certification against it, has replaced the USEPA Additives Advisory Program for drinking water system components. USEPA terminated its advisory role in April 1990. For more information with regard to USEPA's actions, refer to the July 7, 1988 Federal Register

(53FR25586).

Water age can be a major factor in the deterioration of water quality within plumbing systems affecting issues of both public health and aesthetic concerns. With increased water age is an increased potential for the formation of disinfection by-products, increased corrosion, and an increased potential for microbial regrowth. It can also lead to a loss in the effectiveness of corrosion control measures and an increased potential for nitrification of the water.

Within NSF/ANSI 61, most extraction protocols result in exposure periods between 12 to 24 hours. While these are appropriate for typical drinking water system use, they can be significantly less than in others.

Examples of where high water age can occur include:

— Water storage tanks in rain water catchment systems where the duration may be weeks or months,

— Plumbing system designs in green buildings which result of overall reduction in water usage without a change in piping design to minimize stagnation,

— Buildings where stagnant periods occur due to non-use such as schools between semesters, vacation homes, or seasonal buildings, and

2 The information contained in this Foreword is not part of this American National Standard (ANS) and has not been processed in accordance with ANSI’s requirements for an ANS. As such, this Foreword may contain material that has not been subjected to public review or a consensus process. In addition, it does not contain requirements necessary for conformance to the Standard.

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— Products on isolated lines with either long or oversized piping resulting low water turnover.

NSF/ANSI 61 compliant products are often specified in these applications yet the potential accumulation of leachates over extended periods of exposure may or may not be addressed though this standard. It is important that the design of drinking water plumbing systems take into account potentials for extended aging of water. This may include the flushing of the water piping system after extended periods of nonuse. It is also important for managers of the drinking systems in buildings be aware of the potential for high water age and proactively manage the system to minimize it.

This Standard and the accompanying text are intended for voluntary use by certifying organizations, utilities, regulatory agencies, and/or manufacturers as a basis of providing assurances that adequate health protection exists for covered products. Product certification issues, including frequency of testing and requirements for follow-up testing, evaluation, enforcement, and other policy issues, are not addressed by this Standard.

It is the intent of the Joint Committee to eliminate the extraction water specified in Table B3a from the Standard after August 2020, or a period of five years from the adoption of Table B3b. Use of either Table B3a or B3b provides for transition during this period. Certification bodies and other users of this standard are strongly encouraged to perform periodic assessments of the effects of this change and provide feedback to the Joint Committee.

All references to gallons (gal) are in U.S. gallons.

This version includes the following revisions:

Issue 110:

This revision excluded fire sprinklers from the restriction of use of lead containing materials under section 3.5.

Issue 123:

The requirement of providing the expected service life of a product under the information and formulation requirements under section 3.2 was removed.

Issue 128:

This revision extended the use of section 9 water when evaluating lead and copper release from brass and bronze devices.

Issue 129:

Criteria and a method were added for evaluating in-line copper silver ion generators under section 8.

Issue 130:

This revision added material specific analyses under Table 3.2.

Issue 131:

This revision harmonized language regarding testing of copper and copper alloy pipe, tubing, and fittings under section 4.

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Issue 132:

The hot water exposure protocols under sections 4 and 8 were harmonized.

Suggestions for improvement of this Standard are welcome. This Standard is maintained on a Continuous Maintenance schedule and can be opened for comment at any time. Comments should be sent to Chair, Joint Committee on Drinking Water Additives – System Components at standards@nsf.org, or NSF International, Standards Department, P.O. Box 130140, Ann Arbor, Michigan 48113-0140, USA.

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Consortium Organizations

NSF International

Popularly referred to as NSF, NSF International is a noncommercial agency. It is incorporated under the laws of Michigan as a not-for-profit organization devoted to research, education, and service. It seeks to solve problems involving man and his environment. It wishes to promote health and enrich the quality of life through conserving and improving that environment. Its fundamental principle of operation is to serve as a neutral medium in which business and industry, official regulatory agencies, and the public come together to deal with problems involving products, equipment, procedures, and services related to health and the environment. It is conceived and administered as a public service organization.

NSF is perhaps best known for its role in developing standards and criteria for equipment, products, and services that bear upon health. NSF was the lead organization in the Consortium responsible for developing this Standard. NSF conducts research; tests and evaluates equipment, products, and services for compliance with standards and criteria; and grants and controls the use of NSF registered Marks.

NSF offers product certification (Listing Services) for all products covered by its standards. Each program has established policies governing the associated product evaluation, Listing Services, follow-up, and enforcement activities. The NSF Listing Mark is widely recognized as a sign that the product or service to which it relates complies with the applicable NSF standard(s).

AWWA Research Foundation

The mission of the American Water Works Association Research Foundation (now the Water Research Foundation), is to sponsor practical, applied research on behalf of the drinking water industry of North America. The scope of the research program embraces all aspects of water supply operation, from development and maintenance of water resources to treatment technologies and water quality issues, from storage and distribution system operations to health effects studies and utility planning and management activities. Water Research Foundation (WRF) serves as the centralized industry institution for planning, managing, and funding cooperative research and development in drinking water, including the subsequent transfer of technology and results for practical application by the water utility community.

WRF's purpose in this cooperative program is to provide a communication link with the water utilities throughout North America and serve as the focal point for identification of research needs of the water supply industry with respect to the additives program.

The Association of State Drinking Water Administrators

The Association of State Drinking Water Administrators (ASDWA) is a nonprofit organization whose eligible membership is comprised of drinking water program administrators in each of the 50 states and seven U. S. territories. Through the organization, representatives speak with a collective voice to Congressional committees, the United States Environmental Protection Agency (EPA), professional and trade associations, water utilities, and the general public on issues related to state drinking water programs. With its mission of protecting the public health through assurance of high-quality drinking water, and promoting responsible, reasonable, and feasible drinking water programs at the state and federal levels, the Association is a valued contributor to the consortium, and to the program. It provides the link between the additives program and the state drinking water programs.

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The Conference of State Health and Environmental Managers

The Conference of State Health and Environmental Managers (COSHEM), known formerly as the Conference of State Sanitary Engineers (CSSE), is currently inactive as an organization. It brought to the consortium expertise and involvement of state health and environmental program managers. The Conference was the focal point for health concerns of all state environmental programs, including drinking water, wastewater, air, solid and hazardous wastes, radiology, occupational health, and food. A standing committee on water supply focused on drinking water issues and kept the membership informed. The Conference played an important role early in the program through two-way communication with state health and environmental program decisionmakers.

American Water Works Association

The purpose of the American Water Works Association (AWWA) is to promote public health, safety, and welfare by improving the quality and increasing the quantity of water delivered to the public, and to developing and furthering an understanding of the problems relating thereto by:

— advancing the knowledge of the design, construction, operation, water treatment, and management of water utilities;

— developing standards for procedures, equipment, and materials used by public water supply systems;

— advancing the knowledge of problems involved in the development of resources, production, and distribution of safe and adequate water supplies;

— educating the public on the problems of water supply and promoting a spirit of cooperation between consumers and suppliers in solving these problems; and

— conducting research to determine the causes of problems with providing a safe and adequate water supply, and proposing solutions thereto in an effort to improve the quality and quantity of the water supply provided to the public.

AWWA brings to the Consortium its established position as the largest public drinking water association in North America, with a broad membership that includes utilities, consultants, manufacturers/distributors/ agents, contractors, and other organizations with a direct interest in drinking water.

© 2016 NSF NSF/ANSI 61 – 2016

NSF/ANSI Standard for Drinking Water Additives ―

Drinking water system components ― Health effects

1 Purpose, scope, and normative references

1.1 Purpose

This Standard establishes minimum health effects requirements for the chemical contaminants and impurities that are indirectly imparted to drinking water from products, components, and materials used in drinking water systems. This Standard does not establish performance, taste and odor, or microbial growth support requirements for drinking water system products, components, or materials.

1.2 Scope

1.2.1 This Standard is intended to cover specific materials or products that come into contact with:

drinking water, drinking water treatment chemicals, or both. The focus of the Standard is evaluation of contaminants or impurities imparted indirectly to drinking water. The products and materials covered include, but are not limited to, process media (e.g., carbon, sand), protective materials (e.g., coatings, linings, liners), joining and sealing materials (e.g., solvent cements, welding materials, gaskets), pipes and related products (e.g., pipes, tanks, fittings), mechanical devices used in treatment/transmission/distribution systems (e.g., valves, chlorinators, separation membranes, point-of-entry drinking water treatment systems), and mechanical plumbing devices (e.g., faucets, endpoint control valves).

1.2.2 Point-of-use drinking water treatment devices are not covered by the scope of this Standard.

1.3 Normative references

The following documents contain requirements that, by reference in this text, constitute requirements of this Standard. At the time this Standard was balloted, the editions listed below were valid. All documents are subject to revision, and parties are encouraged to investigate the possibility of applying the recent editions of the documents indicated below. The most recent published edition of the document shall be used for undated references.

21 CFR 58, Good Laboratory Practice for Non-Clinical Laboratory Studies3

40 CFR Part 136, Guidelines Establishing Test Procedures for the Analysis of Pollutants4

40 CFR Part 141, National Primary Drinking Water Regulations4

40 CFR Part 160, Good Laboratory Practice Standards4

3 USFDA, 5600 Fishers Lane, Rockville, MD 20857 <www.fda.gov>

4 Superintendent of Documents, U. S. Government Printing Office, Washington, DC 20402 <www.gpo.gov> or Sale

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40 CFR Part 798, Health Effects Testing Guidelines4

APHA, AWWA, WEF, Standard Methods for the Examination of Water and Wastewater, twenty-second edition5,6,7

ASTM A240/A240M-05. Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications8

ASTM A269-04. Standard Specification for Seamless and Welded Austenitic Stainless Steel Tubing for General Service8

ASTM A312/A312M-05. Standard Specification for Seamless, Welded, and Heavily Cold Worked Austenitic Stainless Steel Pipes8

ASTM A789/A789M-05. Standard Specification for Seamless and Welded Ferritic/Austenitic Stainless Steel Tubing for General Service8

ASTM A790/A790M-05. Standard Specification for Seamless and Welded Ferritic/Austenitic Stainless Steel Pipe8

ASTM A815/A815M-04. Standard Specification for Wrought Ferritic, Ferritic/Austenitic, and Martensitic Stainless Steel Piping Fittings8

ASTM C31/C31M-00e1. Standard Practice for Making and Curing Concrete Test Specimens in the Field8

ASTM C109/C109M-99. Standard Test Method for Compressive Strength of Hydraulic Cement Mortars8

ASTM C 183-02. Standard Practice for Sampling and the Amount of Testing of Hydraulic Cement8

ASTM C192/C192M-00. Standard Practice for Making and Curing Concrete Test Specimens in the Laboratory8

ASTM C511-98. Standard Specification for Moist Cabinets, Moist Rooms, and Water Storage Tanks Used in the Testing of Hydraulic Cements and Concretes8

ASTM C778-00. Standard Specification for Standard Sand8

ASTM D2855-96. Standard Practice for Making Solvent-Cemented Joints with Poly(Vinyl Chloride) (PVC) Pipe and Fittings8

ASTM D3182-89 (1994). Standard Practice for Rubber – Materials, Equipment, and Procedures for Mixing Standard Compounds and Preparing Standard Vulcanized Sheets8

ASTM E29-02 Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications8

ASTM F493-97. Standard Specification for Solvent Cements for Chlorinated Poly(Vinyl Chloride) (CPVC) Plastic Pipe and Fittings8

5 American Public Health Association (APHA), 800 I Street, NW, Washington, DC 20001 <www.apha.gov>

6 American Water Works Association (AWWA), 6666 Quincy Avenue, Denver, CO 80235-9913 <www.awwa.org>

7 Water Environment Federation (WEF), 601 Wythe Street, Alexandria, VA <www.wef.org>

8 ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2859 <www.astm.org> or Sale

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ANSI/AWWA B100-96. AWWA Standard for Filtering Material6

ANSI/AWWA C652-92. AWWA Standard for Disinfection of Water-Storage Facilities6

NSF/ANSI 60 – Drinking water treatment chemicals – Health effects

NSF/ANSI 372 – Drinking water system components – Lead content

OECD, OECD Guidelines for the Testing of Chemicals, May 19969

SSPC-PA2– 2004 Steel Structures Painting Manual Volume 2. Paint Application Specification10

The Society for Protective Coatings, Steel Structures Painting Manual. Volume 2. Reference Paint Application Specification No. 2 (SSPC-PA2)10

USEPA-570-9-82-002. Manual for the Certification of Laboratories Analyzing Drinking Water, October 198211

USEPA-600/4-79-020. Methods for the Chemical Analysis of Water and Wastes, March 198311

USEPA-600/4-80-032. Prescribed Procedures for Measurement of Radioactivity in Drinking Water11

USEPA-600/4-84-053. Methods for Organic Chemical Analysis of Municipal and Industrial Wastewater, June 198411

USEPA-600/R-05/054. 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), September 200411

USFDA, Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives in Food3

1.4 Limitations

The requirements of this Standard are limited to addressing potential health effects, except where specific application and performance standards are referenced. This Standard does not establish taste and odor requirements for drinking water system products and materials. The criteria set forth in this Standard cover products created by good manufacturing practices and generally recognized manufacturing processes. As the presence of unusual or unexpected impurities is frequently dependent upon the method of manufacture and the quality of raw material used, products prepared by other than recognized methods of manufacture or with unusual raw materials shall be fully evaluated in accordance with 3 of this Standard (general requirements). Products that have been evaluated and found to meet other NSF standards having health requirements equivalent to this Standard as indicated in each section shall be acceptable for drinking water applications without separate evaluation under this Standard.12

9 Organization for Economic Cooperation and Development (OECD), 2 Rue Andre-Pascal, 75775 Paris Cedex 16, France <www.oecd.org>

10 The Society for Protective Coatings (SSPC), 40 24th Street, 6th Floor, Pittsburgh, PA 15222-4656 <www.sspc.org>

11 USEPA, Environmental Monitoring and Support Laboratory, Cincinnati, OH 45268 <www.epa.gov>

12 Final acceptance of a product for drinking water application is the responsibility of the appropriate federal, state, or local regulatory agent.

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1.5 Alternate products or materials

While specific materials are stipulated in this Standard, drinking water system products or components that incorporate alternate materials shall be acceptable when it is verified that the product or component meets the applicable requirements of the Standard based on its end use.

1.6 Significant figures and rounding

For determining conformance with the specifications in this standard, the Absolute Method in ASTM E29 Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications shall be used. When rounding data, the Rounding Procedure in section 6.4 of ASTM E29 shall be used.

2 Definitions

Terms used in this Standard that have a specific technical meaning are defined here.

2.1 analytical summary: A list of the analytes and analytical procedures, both chemical and microbiological, that are selected to determine whether a product is conformant to the requirements of the Standard; analytes may be either product-specific or formulation-dependent.

2.2 at the tap: Referring to the point of delivery or point of use for drinking water.

2.3 cold water application: A product application that is not intended to result in exposure for extended periods to water in excess of ambient water temperature.

2.4 contaminant: A physical, chemical, biological, or radiological substance or matter in water.

NOTE – Consistent with the definition in the Federal Safe Drinking Water Act, a contaminant can have either a beneficial or detrimental effect on the potability of water.

2.5 diluted surface area (DSA): The surface area/volume ratio of a product, component, or material calculated using its actual wetted surface area, the field static and/or field flow volumes directed by the standard for the end use for which the product is being evaluated. The calculation shall use the normalization equation specific to that end use. The values for lab surface area and lab volume in the normalization equation shall be entered as 1 for the purposes of this determination causing the DSA ratio to equal the calculated NF factor. The volume of chemical generated or water treated shall be for a 24 hour period.

Example calculation: For a component of a chemical generator that has an actual surface area of 5 in2 and the unit treats a minimum daily water volume of 500,000 liters per day. (Refer to Annex B for definition of normalization terms):

DSA (

in2

L

) = NF = N1 × N2 × N4

SAF

SAL

VL

VF(static)

VF(static)

VF(flowing)

VTC

VWT

500,000

= 0.00001 in

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where:

SAF = surface area exposed in the field;

SAL = 1 (per DSA definition);

VL = 1 (per DSA definition);

VF(static) cancels out of the equation for this example;

VF(flowing) = VTC and the two cancel out of the equation in this example (i.e. The volume of solution leaving the chemical generator (VF(flowing) ) is the same as that being used to treat the water (VTC))

VWT = volume of raw water treated with the concentrated chemical when dosed at the prescribed feed rate during a 24-h period.

2.6 direct additives: A treatment chemical and its contaminants directly added to water during the production of drinking water.

2.7 distribution system: The system of conduits or the network of pipelines (located primarily in the streets) through which a primary domestic water supply is distributed to consumers. In plumbing codes, this term is applied to all the hot and cold water piping installed in buildings.

2.8 drinking water: Water intended for human consumption.

2.9 drinking water treatment unit system: A complete water treatment device, including all components needed to connect the device to a potable water supply.

2.10 free available chlorine: The sum of hypochlorous acid and hypochlorite ions.

2.11 good manufacturing practices: The practice of maximizing the purity of products and materials by maintaining and practicing appropriate quality control and quality assurance procedures.

2.12 hot water application: A product application that is intended to result in exposure for extended periods to water that has been raised from ambient temperature.

2.13 indirect additives: Contaminants that are extracted into drinking water through contact with the surfaces of materials, components, or products used for its treatment, storage, transmission, or distribution.

2.14 manufacturer: A corporation, company, or individual that produces, formulates, packages, or repackages products, components, and materials that are intended to be in contact with drinking water.

2.15 maximum contaminant level (MCL): The maximum concentration of a regulated contaminant that is permitted in a public drinking water supply, as defined under the Federal Safe Drinking Water Act.

NOTE — If the manufacturer requests review to relevant alternate regulatory requirements, the certifying agency can consider alternative regulatory levels, e.g., Canadian Maximum Acceptable Concentrations (MACs).

2.16 normalization: The process of adjusting laboratory extraction results by accounting for differences between laboratory and field surface area-to-volume ratios to reflect the contaminant concentration at the tap.

2.17 normalized concentration: A value for a contaminant concentration from a laboratory extraction test that has been adjusted to reflect the potential contaminant concentration at the tap.

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2.18 point-of-entry (POE) system: A system with a minimum initial clean-system flow rate of no less than 15 L/min at 103 kilopascals pressure drop and 18 ± 5 °C water temperature (not less than 4 gal/min at 15 psig pressure drop and 65 ± 10 °F water temperature) used to treat the water supply at a building or facility for drinking, washing, and flushing or for other non-consumption water supply purposes.

2.19 point-of-use (POU) system: A plumbed-in or faucet-mounted system used to treat the drinking and/or cooking water at a single tap or multiple taps but not used to treat the majority of water used for washing and flushing or other non-consumption purposes at a building or facility. Any batch system or device not connected to the plumbing system is considered a point-of-use system.

2.20 short-term exposure level (STEL): A maximum concentration of a contaminant that is permitted in drinking water for an acute exposure calculated in accordance with Annex A of this Standard.

2.21 single product allowable concentration (SPAC): The maximum concentration of a contaminant in drinking water that a single product is allowed to contribute as defined by Annex A of this Standard.

2.22 total allowable concentration (TAC): The maximum concentration of a nonregulated contaminant allowed in a public drinking water supply as defined by Annex A of this Standard.

2.23 transmission system: A system of conduits through which a primary water supply is transmitted to the distribution system.

2.24 unit void volume: Total water-holding volume with the medium (media) and internal components in place.

3 General requirements

3.1 General

3.1.1 Product and material information described in 3.2 shall be used to determine the specific section (4 through 9) under which a product or material shall be evaluated.

3.1.2 Products or materials whose intended uses fall under more than one section of this Standard shall be evaluated under the section with the most rigorous evaluation conditions.

NOTE — Rigorous conditions are typically associated with shorter conditioning periods, longer exposure periods, higher surface-area-to-volume ratios, and higher exposure temperatures.

3.2 Information and formulation requirements

The following information shall be obtained and reviewed for all materials with a water contact surface to determine the appropriate analytical testing and to ensure that the potential health effects of products and materials are accurately and adequately identified:

— the product section(s) under which the product, component, or material is covered and the intended function or end use of the product or the material;

— for assemblies, sub-assemblies, products or components, a list of all materials and their corresponding surface areas that come into direct contact with water;

— when appropriate, the total volume of water that the product can hold when filled to capacity;

— the anticipated minimum, maximum, and average volumes of water that come into contact with the product, component, or material during a 24-h period;

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— complete formulation information (equal to 100.0%) for each water contact material. This shall include:

— a complete formulation shall result in the identity by CAS# or chemical name of each component of the formulation including but not limited to the activators, antioxidants, antimicrobials, co-solvents, fillers, initiators, peroxides, pigments, plasticizers, process aids, solvents, stabilizer, surfactants and terminators;

— percent or parts by weight for each chemical in the formulation or reference to a national or international standardized material specification for metallic materials (e.g. UNS copper alloy specifications);

NOTE 1 — The complete formulation information may be omitted for a component material if:

— the generic material type is contained in Table 3.1 and its diluted surface area in the application is less than or equal to 0.001 in2/L or 0.0001 in2/L for static or flowing conditions respectively; or

— the generic material type is contained in Table 3.1 and if the material is in a high flow device and used exclusively at public water treatment facilities. For the purposes of this section high flow devices are limited to chemical feeders, disinfectant generators (e.g. chlorine dioxide, hypochlorite, ozone and ultraviolet), electrodialysis technologies, microfiltration technologies, nanofiltration technologies, reverse osmosis and ultrafiltration technologies; or

— the generic material type is contained in Table 3.1 and if (1) used in a mechanical device or mechanical plumbing device and (2) the material is not a coating, and (3) the component is not a process media; or

— if (1) the material is not listed in Table 3.1, and (2) it is used in a mechanical device or mechanical plumbing device and (3) the material is not a coating, and (4) the component is not a process media, and the material is tested to the requirements of Table 3.2.

If the product is to be considered compliant to a lead content standard, the lead content (percent by weight) and wetted surface area of each component that comes into contact with the direct flow of water under the normal operation of the product is required. Complete documentation shall be submitted in accordance with NSF/ANSI 372 – Drinking water system components – Lead content.

NOTE 2 — A material is defined as a combination of ingredients used to manufacture (mold, extrude, stamp, cast, machine, mix etc.) a part or component used in the assembly of a device. To include but not be limited to plastics, elastomers, metallic components, media, lubricants, adhesives, process aid, preservatives, coatings and surface treatments.

— when the chemical composition of an ingredient or component cannot be determined based on the information submitted by the material supplier, the information shall be obtained by the certifier from the ingredient supplier prior to determining all formulation dependant analytes;

— the composition of the materials ingredients and their components shall be known to determine the identity of formulation specific analytes.

— the maximum temperature to which the product, component, or material is exposed during its intended end use;

— a description/classification of the manner in which the product or material is manufactured (including any process parameters that affect product surface areas in direct contact with water), handled, and packaged. The manufacturing process variability shall be verified by the manufacturer as to its effect on contaminant leachate levels, and the manufacturer shall establish and demonstrate appropriate ongoing process controls to ensure ongoing product conformance with this Standard;

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NOTE — The methods used to alter the water contact surfaces of product components during manufacturing, either mechanically (e.g., metal cutting, molding, stamping) or chemically (e.g., washing, coating, plating, brite-dip cleaning), may have a significant effect upon contaminant leachate performance.

— when available, a list of the known or suspected impurities within the product or material and the maximum percent or parts by weight of each impurity;

— when available, the solubility, hydrolysis products, and extraction rates of chemicals within the product or material; and

— when available, a list of published and unpublished toxicological studies relevant to the chemicals and impurities present in the product, component, or material.

3.2.1 Information and formulation requirements for regenerated/reactivated media

In addition to the information formulation requirements of 3.2, the following information is required for the formulation review and preparation of the analytical summary for regenerated and reactivated media.

— A description of the regeneration/reactivation process and process controls, such as time, temperature, chemical regenerants, and any QC tests associated with the regeneration/reactivation process to ensure contaminants are removed from the spent media so that it complies with the requirements of this standard.

— A copy of the procedure detailing the evaluation, and conclusion associated with the review of data from spent media sources identifying all regulated contaminants, or other contaminants of concern that are removed from water and any contaminant spills or unusual water conditions.

— A copy of the data, and a copy of the documentation associated with the evaluation of the data from the spent media source(s) associated with a specific lot of reactivated or regenerated media for which a retained sample is available for testing.

3.2.1.1 Incoming shipments of media to be regenerated/reactivated

The following information shall be provided by the water system and maintained by the processing plant for each shipment of spent media received for regeneration/reactivation:

— Identification of the type of the spent media, spent media source, and application of use (e.g. production of drinking water);

— Identification of the original media, including manufacturer or previous regeneration/reactivation facility, trade designation, mesh size and compliance with this standard for each spent media source;

— Regulated contaminants or other contaminants of concern removed from water, including any contaminant spills or unusual water quality conditions;

— Statement as to whether the spent media has been knowingly exposed to:

— Activated carbon: polychlorinated biphenyls (PCBs), or dioxins;

— Other media: herbicides, pesticides, PCBs, dioxins or 1,2 dibromo-3chloropropane (DBCP);

— Statement to verify that the spent media source is from a public water system (publicly or privately owned) as defined by US EPA regulations (40 CFR 141.2), or equivalent regulations in Canada and other countries where applicable.

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3.3 Identification of analytes

For all products and materials, the formulation information required in 3.2 shall be reviewed for completeness (e.g., all formulations total 100.0%), and to determine whether a minimum test battery has been established for each water contact material (see Table 3.1). In addition to selecting the minimum testing parameters decribed in Table 3.1, a formulation review to identify any formulation-dependent analytes shall be performed for all water contact materials (see 3.3.1).

In instances where the complete formulation has not been obtained for a material that is used in a component of a mechanical device or mechanical plumbing device as allowed through Note 1 of 3.2, testing shall include the material specific analyses in Table 3.1, or as directed in Table 3.2.

3.3.1 Formulation-dependent analysis selection

For all water contact materials, the formulation information described in 3.2 shall be reviewed, and formulation-dependent analytes shall be identified for each water contact material. The criteria for selection of a formulation-dependent analyte shall include, but not be limited to, the following:

— known or suspected toxicity of the substance or its byproduct(s);

— high water solubility of the substance;

— monomer(s) of polymeric ingredients;

— solvents and co-solvents used in the polymerization process or those used in the material formulation;

— antioxidants, antimicrobials, curing agents, initiators, peroxides, pigments, plasticizers, process aids, stabilizer and terminators and their impurities, degradation and hydrolysis products;

— high probability of extraction of a substance or its byproduct(s) at toxicologically significant concentrations; and

— extraction or migration information for the substance provided by the manufacturer or that present in the public literature.

3.3.2 Established minimum test batteries

The materials listed in Table 3.1 or Table 3.2 shall be tested for the indicated analyses and any formulation-dependent analyses identified during the formulation-dependent analyte selection. Products, components, or materials made exclusively from materials in Table 3.1 shall not require testing if:

— their diluted surface area in the application is less than or equal to 0.001 or 0.0001 for static or flowing conditions respectively, or

— the material is in a high flow device and used exclusively at public water treatment facilities. For the purposes of this section, high flow devices are limited to chemical feeders, disinfection generators (e.g. chlorine dioxide, hypochlorite, ozone and ultraviolet), electrodialysis technologies, microfiltration technologies, nanofiltration technologies, reverse osmosis and ultrafiltration technologies.

3.4 Products manufactured from Annex C acceptable materials

Products manufactured entirely from Annex C materials shall not be required to undergo extraction testing for material-specific analytes of interest. However, extraction testing for contaminants contributed by processes specific to a production site shall be considered formulation-dependent analytes. Annex C contains the evaluation requirements for qualification as an acceptable material.

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Table 3.1 – Material-specific analyses

Material type Required analyses

Pipe/fitting/device materials

Aluminum regulated metals2, aluminum Aluminum oxide ceramics regulated metals2, aluminum

Asphaltic-coated ductile iron

GC/MS base/neutral scan (specific for carbonyls and non-aromatic hydrocarbons)1, volatile organic chemicals (VOCs), polynuclear aromatic hydrocarbons (PNAs), regulated metals2, molybdenum, vanadium, manganese

Brass regulated metals2, zinc, nickel, bismuth15 Carbon graphite non-impregnated

GC/MS1, VOCs, polynuclear hydrocarbons (PNAs), regulated metals2

Carbon graphite (phenol formaldehyde impregnated)

GC/MS1, VOCs, polynuclear hydrocarbons (PNAs), formaldehyde, regulated metals2, Carbon Steel regulated metals2 Cast Iron regulated metals2 Chrome/nickel plating regulated metals2, nickel Concrete regulated metals2, Copper regulated metals2 Ductile iron regulated metals2 Galvanized steel regulated metals2, zinc, nickel Magnets Metals14,15 Nickel based alloys regulated metals2, nickel Platinum regulated metals2, platinum Quartz regulated metals2 Ruby or sapphire (natural and synthetic aluminum oxide gemstones) regulated metals2, aluminum

Silicon carbide ceramics regulated metals2, silicon Silver regulated metals2, silver Stainless steel regulated metals2, nickel Titanium regulated metals2, titanium Tungsten Carbide regulated metals2, tungsten Zirconium oxide ceramics regulated metals2, zirconium Plastic materials

Acetal (AC)/polyoxymethylene

(POM)

formaldehyde, VOCs, regulated metals2, phenolics (by GC/MS base/acid scan)1, acetal oligomers (by GC/MS base/acid scan)1

Acrylonitrile-butadiene-styrene

(ABS)

Acrylonitrile-styrene (SAN) acrylonitrile, 1,3-butadiene, styrene, regulated metals,2,, VOCs, phenolics (by GC/MS base/acid scan)1

Cross linked polyethylene

(PEX)

GC/MS1, VOCs, regulated metals2, phenolics (by GC/MS base/acid scan)1, methanol, tert-butyl alcohol3

Nylon 6 caprolactam, nitrogen-containing extractants (by GC/MS base/neutral scan)1, VOCs, regulated metals2, phenolics (by GC/MS base/acid scan)1

Other nylons nitrogen-containing extractants (by GC/MS base/neutral scan)1, VOCs, regulated metals2,, phenolics (by GC/MS base/acid scan)1, nylon monomers

Polybutylene (PB) VOCs, regulated metals2, phenolics (by GC/MS base/acid scan)1

Polycarbonate (PC) Bisphenol A, VOCs, regulated metals2, phenolics (by GC/MS base/acid scan)1

Polyethylene (PE) VOCs, regulated metals2, phenolics (by GC/MS base/acid scan)1 or Sale

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Polyphenylene oxide (PPO) dimethyl phenol, VOCs, regulated metals2, phenolics (by GC/MS base/acid scan)1

Polyphthalamide (PPA) hexamethylene diamine, terephthalic acid, isophthalic acid, VOCs, regulated metals2 , phenolics (by GC/MS base/acid scan)1

Polypropylene (PP) VOCs, regulated metals2, phenolics (by GC/MS base/acid scan)1 Polysulphone including poly[phenylene sulphone]

(PPSU)

sulphone monomer, VOCs, regulated metals2, phenolics (by GC/MS base/acid scan)1

Polyurethane (PUR) GC/MS1, VOCs, regulated metals2 , phenolics (by GC/MS base/acid scan)1

Polyvinyl chloride (PVC) and chlorinated polyvinyl chloride

(CPVC)

regulated metals2, phenolics1, VOCs, tin4, antimony5, residual vinyl chloride monomer (RVCM)6

Polyvinyl chloride (flexible) VOCs, regulated…