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General Questions on NSF/ANSI Standard 61 | TEVA Energy

General Questions on NSF/ANSI Standard 61Image of Water Filling Glass

  • What is NSF/ANSI Standard 61?NSF/ANSI Standard 61 – Drinking Water System Components was published in 1988 to establish minimum requirements for the control of potential adverse human health effects from products that contact drinking water.NSF/ANSI Standard 61 includes criteria for testing and evaluating products to ensure they do not leach contaminants into the water that would be a health concern. These contaminants include those regulated by the United States Environmental Protection Agency (USEPA) and Health Canada, as well as any other non-regulated compounds that may be of concern.
  • What products are covered under NSF/ANSI Standard 61?
    • Pipes and Related Products (including pipe, hose, fittings)
    • Protective and Barrier Materials (including cements/coatings)
    • Joining and Sealing Materials (including gaskets, adhesives, lubricants)
    • Process Media (including carbon, sand, zeolite, ion exchange media)
    • Mechanical Devices (including water meters, in-line valves, filters, process equipment)
    • Mechanical Plumbing Devices (faucets, drinking fountains, and components)
    • Potable Water Materials (non-metallic materials)
  • What is involved in the NSF/ANSI Standard 61 Certification process?The NSF Certification process has seven basic steps, as follows:
    1. Application – NSF/ANSI Standard 61 requires a disclosure by the manufacturer of all water contact materials in the product and a disclosure by the manufacturer’s material suppliers of all chemical ingredients in the materials.
    2. Formulation, toxicology and product use information – Client and suppliers complete and submit NSF’s Product Information Form. This provides formulation, toxicology and product use information.
    3. NSF formulation review – NSF toxicologists perform a formulation review for each water contact material to determine any possible ingredients, contaminants, or reaction by-products that may potentially leach from the material into drinking water. This formulation review then determines the battery of chemical analyses that will be performed on a particular material.
    4. Plant audit and sample collection – NSF then conducts an inspection of the production facility to verify the product formulation and production process and to ensure adequate quality control procedures are in place to prevent the use of unauthorized materials. Product samples are collected during the inspection and sent to NSF laboratories to be tested to the appropriate exposure protocol of NSF/ANSI Standard 61.
    5. Laboratory testing – Devices or materials are evaluated according to the exposure and analysis methods in Annex B of NSF/ANSI Standard 61. Most products undergo a 3-week exposure process where the products are exposed to various formulated waters designed to extract specific types of contaminants. Contaminant concentrations are determined from chemical analyses of the exposure water samples.
    6. Toxicology evaluation – These contaminant concentrations are then evaluated by a toxicologist to the pass/fail criteria in Annex D and E of NSF/ANSI Standard 61. Products that meet the requirements of the standard are then certified and appear in the NSF Listings. If products fail to meet the requirements of the standard, the manufacturer may identify the source of the failure and resubmit a reformulated product for certification.
    7. Certification grantedFollow-up program- Once products are certified and listed by NSF they are inspected and reviewed on an annual basis.Listed production facilities are then subjected to unannounced annual inspections by NSF auditors to ensure that certified products are made according to the authorized formulations and processes. Products are collected on a routine basis (typically once annually) for retesting.Occasionally, certified products will fail an annual retest. When this happens, NSF immediately notifies the manufacturer. NSF requires the manufacturer to stop shipment of noncompliant product and to fully investigate the cause of the failure. An NSF field auditor inspects the facility to ensure the manufacturer has taken these steps. If the manufacturer is able to identify and correct the cause of the failure, they may resubmit the product for certification. If the reformulated product meets the requirements of NSF/ANSI Standard 61, the manufacturer may again mark and sell the products as NSF certified.
  • How was NSF/ANSI Standard 61 developed? How is it maintained?
    NSF/ANSI Standard 61 is overseen by the NSF Drinking Water Additives Image of Advisory Board Conference Room TableJoint Committee. This committee has a balance of 1/3 public health regulatory members, 1/3 product manufacturer members, and 1/3 product user representatives. Any proposal to revise the standard is typically assigned to a task group composed of joint committee members and external experts. Task group members are assigned by the chairman of the joint committee.One standing group is the Health Advisory Board. This group consists of toxicologists from USEPA, Health Canada, state and provincial agencies, as well as toxicologists from industry, and private consulting firms. This group is responsible for reviewing and approving all allowable contaminant concentrations that are published in NSF/ANSI Standard 61.Any revision that is proposed by a task group must receive majority approval from the joint committee. Any negative ballots from the joint committee must be circulated to all committee members and adjudicated, according to the guidelines of the American National Standards Institute (ANSI).Once a revision is approved by the joint committee, the proposal passes to the NSF Council of Public Health Consultants, which consists of regulatory officials from public health agencies across North America.Revisions to NSF/ANSI Standard 61 are also circulated for public comment and any concerns addressed through the guidelines of the American National Standards Institute. ANSI gives final approval to each revision of the standard.Anyone may submit a proposed change to the standard, as well as other issues for discussion by the joint committee, by submitting an issue paper to the chairman of the joint committee. All meetings of the joint committee are open and may be attended by requesting an invitation from the secretary of the joint committee. Contact standards@nsf.org for further information.

If you have additional questions relating to NSF/ANSI Standard 61, or NSF’s certification services, contact Dave Purkiss at 734.827.6855 or purkiss@nsf.org.

 

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