Standard establishes minimum requirements for health effects testing, monitoring
By Blake Stark
Through the Safe Drinking Water Act, the U.S. EPA establishes standards for drinking water quality and, with its partners, implements various technical and financial programs to ensure drinking water safety. U.S. state drinking water regulatory agencies enforce drinking water regulations and monitor water supply operations in each state.
One key resource to help facilitate this is NSF/ANSI/CAN 60: Drinking Water Treatment Chemicals–Health Effects. First developed in 1988, this standard establishes minimum requirements to control potential adverse human health effects from products used in the treatment, storage and distribution of drinking water.
Product monitoring requirements and evaluation frequencies of treatment chemicals can vary widely, based on the policies and practices of third-party certification organizations. Prompted by concerns that some certification bodies require annual retesting of treatment chemicals while others allow up to five years between product retests, a new standard was developed. This standard, NSF/ANSI 223: Conformity Assessment Requirements for Certification Bodies that Certify Products Pursuant to NSF/ANSI/CAN 60: Drinking Water Treatment Chemicals-Health Effects, sets minimum requirements to be used by conformity assessment organizations when testing and certifying products to NSF/ANSI/CAN 60.
Currently, 49 states require drinking water treatment chemicals to comply with NSF/ANSI/CAN 60. In 40 of these states, drinking water treatment chemicals are required to be certified through a third-party product certifier accredited by the American National Standards Institute (ANSI). In Canada, most provincial drinking water regulatory agencies require treatment chemicals to be certified through an organization accredited by the Standards Council of Canada (SCC).
Responding to concerns that five years may be too long between retesting, the California Code of Regulations (CCR) was updated in 2008 to require annual monitoring/evaluation of drinking water treatment chemicals to NSF/ANSI/CAN 60.
In 2009, a Conformity Assessment Task Group, a sub-group of the Drinking Water Treatment Chemicals Joint Committee, which oversees NSF/ANSI/CAN 60, began working to establish a standard to contain minimum criteria for certifiers of treatment chemicals. The task group was comprised of water utility personnel, drinking water supply regulators and ANSI-accredited Standard 60 product certifiers, as well as manufacturers and distributors of water treatment chemicals.
As an immediate step, a conformity assessment section containing minimum product testing and facility inspection requirements was added to NSF/ANSI/CAN 60. This was followed for several years until a separate standard containing requirements for third-party certifiers of treatment chemical products was developed.
Purpose and Scope of NSF/ANSI 223
First published in 2012, NSF/ANSI 223 sets minimum requirements to be used by conformity assessment organizations when testing and certifying products to NSF/ANSI/CAN 60. These requirements are supplemental to those contained in ISO/IEC 17065 and do not replace the requirements of the ISO standard. NSF/ANSI 223 requirements include documentation reviews, product testing and facility inspections conducted during surveillance. Minimum facility inspection requirements are also defined. In addition, an informative annex has been included to provide examples of conformity assessment activities drawn from the experiences of accredited NSF/ANSI/CAN 60 product certifiers. Two major sections of NSF/ANSI 223 cover product testing and facility audits.
Each chemical product certified to NSF/ANSI/CAN 60 must be sampled and tested at least once per calendar year. This required analysis includes the chemistry-specific parameters identified in NSF/ANSI/CAN 60 as well as any additional parameters (if applicable) assigned during the product’s formulation review. Within each chemical family, the product with the highest concentration may be tested as the representative of a series of analogous lower-concentration products. Also, for a facility that blends, dilutes, dissolves, repackages or transfers products (where each of the original/incoming source products is certified on its own), at least one product sample per facility will be tested on an annual basis.
NSF/ANSI 223 establishes minimum audit content/scope criteria including validation of product formulations, review of production records and product sampling. It also establishes minimum audit frequencies for certified facilities. Each certified chemical production or distribution facility must be audited at least once per calendar year. Facilities with severe and/or repeated non-compliances related to NSF/ANSI/CAN 60 certification must be audited at least once per quarter for 36 months. In addition, NSF/ANSI 223 prescribes an increased audit frequency for many facilities internationally. Transparency International’s Corruption Perceptions Index (TI CPI, see sidebar) is used as a baseline for establishing the audit frequencies of NSF/ANSI/CAN 60 certified facilities.
Facilities located in countries that have a score of less than 50 on the TI CPI, or that lack a score on this index, must be audited at least twice per calendar year. The facility may reduce this to an annual audit frequency if:
- It has demonstrated and maintained 36 consecutive months of no NSF/ANSI/CAN 60-related audit deficiencies; or
- It is registered to one of the following quality or environmental management standards by a third-party registrar (that is accredited by an International Accreditation Forum signatory): ISO 9001, ISO 14000/14001, American Chemistry Council’s Responsible Care Management System® or the National Association of Chemical Distributors’ Code of Management Practice; or
- It is part of a wholly-owned global business entity or joint venture where all parties are operating under a quality management plan as described above.
Facilities that repackage/distribute material supplied by a facility located in a country with a TI CPI score under 50 must be audited at least twice per calendar year. The certification body has the option to reduce the inspection frequency to once per calendar year if the supplying facility meets one of the following criteria:
- The supplier to the facility receives audits from a certification body accredited by an International Accreditation Forum signatory.
- The chemical repackager/distributor has an alternate method acceptable to the certification body, which provides a mechanism to verify that no changes have been made to the supplied product.
The public deserves a uniform approach to the evaluation of drinking water treatment chemicals for health effects. All states are encouraged to require compliance to the NSF/ANSI 223 conformity assessment standard for NSF/ANSI/CAN 60 product certification organizations. This ensures that minimum compliance activities are followed in the evaluation of drinking water treatment chemicals during the initial certification process and during future monitoring and surveillance of these products. WW
About the Author: Blake Stark is general manager of chemicals and media in the water division at NSF International, a global public health organization based in Ann Arbor, Mich. For more information or to request a copy of NSF/ANSI 223, contact him at [email protected].