NSF/ANSI Standards 60, 61, And 372

NSF/ANSI Standards 60, 61, and 372B.B. Singh, NSF International,June 26, 2018

AgendaAbout NSF InternationalNSF’s Mission, Capabilities, and ServicesNSF/ANSI Standard 60Health Effects for Drinking WaterTreatment ChemicalsNSF/ANSI Standard 61Health Effects for Drinking Water SystemComponentsNSF/ANSI Standard 372Lead Content for Drinking Water SystemComponents2

Our MissionNSF International is dedicated to being the leadingglobal provider of public health and safety-based riskmanagement solutions while serving the interests of allstakeholders, namely the public, the businesscommunity and government agencies.NSF International is a global, independent,public health and safety organization.Our mission and focus has always beenprotecting and improving human health.3

NSF helps people live safer.We carry out this human health and safety mission by:STANDARDSTESTINGCERTIFICATIONAUDITINGWriting standardsto promote food,drinking water,indoor air, dietarysupplements,consumerproducts andenvironmentalsafetyTesting productsto these andother standardsCertifyingproducts to thesestandardsConducting safetyaudits for thefood, water andconsumer goodsindustriesCONSULTINGTRAININGProviding strategicand technicalconsulting for thedietarysupplement,pharmaceutical,medical device,food and beverageindustriesDevelopingtraining andeducationprograms4

Bringing Industry, Regulatory and Consumers TogetherIndustryRegulatorsConsumersAerospace, Automotive,Building and Construction,Food, Chemical, ConsumerProducts, Pharmaceutical,Medical Device, DietarySupplement, WaterDistribution and Treatment,Sustainability.USDA, EPA, FDA, CPHC,HC, and International,National, State, LocalGovernment AgenciesEducators andConsumer Groups5

Our FoundingIn 1944,NSF was foundedas the NationalSanitationFoundation in theUniversity ofMichigan’s Schoolof Public Health.Today,we are nowNSF International,with corporateheadquarters inAnn Arbor, MI,USA, and 51 officeand lab locationsworldwide.6

Today, NSF is a Global Leader in Public Health andSafetyDeveloper of over 90 nationalconsensus standardsSteadfast ties with key associationsand government agencies.NSF works closely with international, federal,state and local regulators : FDA, USDA, EPA , U.S.Government & LegislaturePan American Health Organization/World HealthOrganization Collaborating Center on FoodSafety, Water Quality and Indoor EnvironmentService provider to thousands of organizationsin 168 countries7

NSFAroundthe GlobeNSF providesservices in168 countrieswith 51office andlaboratorylocations.8

NSF International Accreditations and CertificationsISO 17025United StatesCanadaEuropeChinaISO 14001

NSF Standards Process10

Development of NSF 60 & 61YearItem1972-1990EPA operates registration program for some treatment and distributionproducts.1984EPA issues a RFP to develop product standards and a certificationprogram.1985NSF led consortium (AWWA, AwwaRF, ASDWA, COSHEM) is awardedcontract.1988NSF Standards 60 & 61 are published.1989NSF begins certifying products to NSF-60 and NSF-61 .

Joint Committee on Drinking Water AdditivesManufacturers Public HealthProducersTrade AssociationsEPACDCHealth CanadaAcademiaStateLocalUsersConsumersWater UtilitiesSpecifiersCertifiersTesting LabsRetailersNGOs Developed in 1988 One committee oversees 61 and aseparate committee oversees 60 Meets regularly to revise standard Functions via equal 3-part votingand consists of 33 members

Council of Public Health Consultants NSF advisory body for standards development and program implementation Ensure public health issues addressed Review & ballot all standards or revisions Elects its own membership of 50 Regulators and User Representatives– Leaders in public health, environment and academics Technical Committee Role– Conduct review of proposed revisions utilizing technical expertise in thefield or area covered by the ballot

ANSI American National Standards Institute Approves Standards– NSF/ANSI Standard 60– NSF/ANSI Standard 61 ANSI accredits certification organizationsUnited States

NSF Global Water ServicesNSF developed many publichealth standards adopted bythe U.S. EPA to protectdrinking water; and standardspromoting pool/spa safety.NSF tests and certifiesproducts to these and otherindustry standards.Municipal Water ProductsNSF/ANSI 60, 61, 372 and 419Plumbing ProductsNSF/ANSI 14 and 61-Section 9;NSF/ANSI 372; UPC ; IPC ; ICC;ASTM; ASSE; ASMEOnsite Wastewater Treatmentand Reuse DevicesNSF/ANSI 40, 41, 46, 245 and 350Recreational Water SafetyFiltration ProductsNSF/ANSI 42, 44, 53, 55, 58, 62, 177,401 and 419; NSF Protocols P231,P248 and P477NSF/ANSI 50: Pumps, drains, pool covers,filters and pool chemicals15

NSF/ANSI 60 for DrinkingWater TreatmentChemicals16

Purpose of NSF/ANSI 60Establishes minimum health effects requirements for the chemicals, the chemicalcontaminants, and the impurities that are directly added to drinking water from drinkingwater treatment chemicals

Scope of NSF/ANSI 60 Applies to drinking water treatment chemicals thatare directly added to water and intended to bepresent in the finished drinking water.(Example: chlorine, fluoride) Also applies to chemical products that are directlyadded to water but not intended to be present inthe finished water.(Example: Reverse Osmosis Antiscalants)

Parameters excluded from NSF/ANSI 60 Taste and Odor Performance Contaminants produced as by-productsthrough reaction of the treatment chemicalwith a constituent of the treated water orsurface water

I 60 RequirementsWhat contaminants can enter the waterthrough dosing of the treatment chemical?AuditingAre they below the maximum allowable level?Certification andListingComplianceMonitoring20

InformationRequirementsNSF/ANSI 60 RequirementsExact ingredients and suppliersQualificationTestingA proposed maximum use level for the productThe manufacturing processAuditingA list of known or suspected impuritiesCertification andListingA Certificate of AnalysisProduct Use InstructionsComplianceMonitoring21

gCertification andListingNSF/ANSI 60 RequirementsProduct is typically dosed into water at 10X maximum use level,and then analyzed for contaminants of concern.Contaminants of concern Metals Organics Formulation specific and usually will include scansfor VOCs, residual monomers, and others.ComplianceMonitoring Copyright NSF International22

InformationRequirementsQualificationTesting60 RequirementsTechnical Evaluation – Contaminant concentrations are calculated toreflect in-the-field (at-the-tap) exposure levels.Normalized concentration is compared to pass/failcriteria of the standard.AuditingCertification andListingComplianceMonitoring Copyright NSF InternationalNormalization Normalized contaminant concentrations arecompared to Single Product AllowableConcentrations (SPACs).– SPACs 1/10 of Total Allowable Concentration (TAC)of a contaminant in drinking water.23

gCertification andListingComplianceMonitoring60 RequirementsManufacturing Facility Inspection Inspection typically includes: Production Area Walk Through Verification of ingredients and sources used Review of batch sheets for blended products Review of production quality control processes Identification of possible sources of contamination Review product labeling (traceability) and packaging24

60 RequirementsInformationRequirementsOnce all requirements are met:QualificationTesting Products are Certified by NSF and entitled to bearthe NSF MarkAuditing Certified Products appear in NSF listingsCertification andListing Listings may include restrictions on use of theproduct in the field NSF Listings are available on the Internet mplianceMonitoring Copyright NSF International

60 stingChemicals Certified to NSF 60 are retested and auditedon an annual basis in order to ensure continuedcompliance to the standardAuditingCertification andListingComplianceMonitoring26

Product Failures under NSF/ANSI 60 If NSF Certified products fail monitoring tests, production is put onhold NSF retests the product Non-compliant product is destroyed If public health concern, product can be recalled and public noticecan be given In some cases, compliance may be achieved by reduction of theaffected product’s maximum use level

NSF/ANSI 61 for MunicipalWater Products

Scope of NSF/ANSI Standard 61Standard 61 establishes minimum health effectsrequirements for the chemical contaminants andimpurities that are directly imparted to drinkingwater from products, components, and materialsused in drinking water systems. Covers all products with drinking water contact from source to tap. Scope of NSF/ANSI 61 does not include performance, taste and odor, microbial growth supportrequirements, or point of use drinking water treatment devices.

InformationRequirementsQualificationTesting61 RequirementsWhat contaminants migrate or extract intowater?AuditingAre they below the maximum allowable level?Certification andListingMonitor Testing

61 stingAuditingProduct manufacturer is required to disclose exactmaterials and suppliers used for each wettedcomponent of their productNSF reviews material formulations and determinesappropriate analytical testing to perform Certification andListingMonitor TestingMay include metals testing and/or organics testing

InformationRequirementsQualificationTesting61 Requirements Product is flushed according to manufacturer’s instructions Product is exposed to formulated water for a number of daysspecified by the standard Most municipal products are “conditioned” with water for 17 daysWater storage tanks are conditioned with water for 5 daysAuditingCertification andListingMonitor Testing32

InformationRequirements61 Requirements QualificationTestingAuditing Certification andListing Monitor TestingProduct exposed to formulated exposure waterspH 5pH 6.5pH 8pH 10Water Contact Temperatures Cold (23C)Domestic Hot (60C)Commercial Hot (82C)Exposure Sequence Varies based on Product Type 1 hour for process media5 days for water storage tanks and tank coatings17 days for most products19 days for faucets and endpoint devices33

InformationRequirements61 Requirements Example in-vessel exposureQualificationTestingAuditingCertification andListingMonitor Testing Copyright NSF International34

61 RequirementsInformationRequirements Example in-product exposureQualificationTestingAuditingCertification andListingMonitor Testing Copyright NSF International35

InformationRequirements61 RequirementsExtraction water is analyzed for ion andListingMonitor Testing Copyright NSF International

InformationRequirementsQualificationTesting61 RequirementsAnalytical Testing is Formulation DependentExamples:Material TypeAuditingCertification andListingPortland and Hydraulic CementsRegulated metals, dioxins and furans,radionuclides, glycols andethanolamines (or specific grinding aidused), BNA GC/MS organics analysisEPDMBNA GC/MS organics analysis, VOCs,phenolics, phthalates, nitrosaminesEpoxy CoatingsBNA GC/MS organics analysis, VOCs,bisphenol A and derivatives,epichlorohydrin, solvent and reactantadditivesBrassRegulated Metals(Al, Sb, As, Ba, Be, Bi, Cd, Cr, Cu, Pb, Hg,Ni, Se, Ag, Ti, Sn, Zn)Monitor Testing Copyright NSF InternationalTypical Analysis37

InformationRequirementsQualificationTesting61 RequirementsToxicology evaluation is performed to compare results toacceptable limitsAuditingCertification andListingMonitor Testing38

61 stingTechnical evaluation is performed to compare results toacceptable limits AuditingCertification andListingNormalization- Contaminant concentrations are calculated to reflectin-the-field (at-the-tap) exposure levels based on field useassumptions using one of two end use conditions:– Static conditions- typically worst-case for service line andresidential products.– Flowing conditions-typically worst-case for water treatmentand distribution (water main) products. Normalized concentration is compared to pass/fail criteria of thestandardMonitor Testing39