NSF/ANSI Standards 60/61 Pass/Fail Criteria Updates Kevin Cox Senior Research Toxicologist NSF International

Goals of Presentation Review the types and sources of pass/fail criteria –EPA, Health Canada, JPRSC, NSF International, etc. Provide an update on new and updated pass/fail criteria that will be balloted for addition to the Annex –HAB Peer-Reviewed Risk Assessments –JPRSC reconciled values

Pass/Fail Criteria – Annex A NSF/ANSI Standard 60/61 TAC = Total Allowable Concentration –The maximum concentration of a non-regulated contaminant allowed in a public drinking water supply SPAC = Single Product Allowable Concentration –The maximum concentration of a contaminant in drinking water that a single product is allowed to contribute –Generally 1/10 th of the TAC value STEL = Short-term Exposure Level –A maximum concentration of a contaminant that is permitted in drinking water for an acute exposure

Sources of Pass/Fail Criteria US EPA & Health Canada Regulatory Values –Maximum Contaminant Levels (MCL) – EPA –Maximum Acceptable Concentration (MAC) – Health Canada US EPA Integrated Risk Information System (IRIS) Assessments Other U.S. or International Regulatory Values –U.S. EPA, U.S. FDA, WHO, etc. Risk Assessments Peer Reviewed by the NSF Health Advisory Board (HAB) JPRSC (Joint Peer Review Steering Committee) Reconciliations Threshold of Evaluation Assessments

NSF International Health Advisory Board (HAB) Mission and Charge To provide expert peer review, advice and guidance on human health effects issues to the NSF Council of Public Health Consultants To provide consensus peer review of documents supporting derivation of NSF drinking water action levels To review and accept defined methods for performing scientifically-sound human health risk assessments for inclusion in NSF/ANSI 60 and 61, Annex A

Current HAB Membership Edward Ohanian, U.S. EPA, Chair Michael Dourson, TERA, Vice-Chair David Blakey, Health Canada Steven Bursian, Michigan State University Craig Farr, Craig Farr Consulting Helen Goeden, State of Minnesota Robert Hinderer, Lubrizol Corporation Gene McConnell, ToxPath, Inc. Martin Philbert, University of Michigan Elaine Francis, Sandcastle Toxicology Associates

FALL 2014 HAB MEETING (Oct 21-22, 2014) Chemical NameCAS# Current TAC/SPAC/STEL (µg/L) Updated TAC/SPAC/STEL (µg/L) Mercaptobenzothiazole / 4 / 4020 / 2 / 20 Dichloropropanols / 9 / 30 (total)10 / 4 / 10 (total) Dimethylphthalate / 0.3 / 1050 / 50 / 50 Alkyl Dimethyl Benzyl Ammonium Chloride (multiple)900 / 90 / / 300 / 5000 Triclosan / 50 / / 30 / 700

SPRING 2015 HAB MEETING (May 5-6, 2015) Chemical NameCAS# Current TAC/SPAC/STEL (µg/L) Updated TAC/SPAC/STEL (µg/L) Nonylphenol isomers / 2 (total)70 / 7 / 300 (total) 1-Hexanol Not Listed2000 / 200 / Potassium Peroxymonosulfate Not Listed5000 / 5000 / m-Cresol p-Cresol Not Listed 400 / 40 / 1000 (total) (tentative) Diethylene Glycol Dibenzoate / 0.3 / / 500 / 8000 (tentative) Tripropylene glycol diacrylate / 0.3 / / 8 / 1000 (tentative)

Joint Peer Review Steering Committee Established to consolidate efforts among ANSI accredited certification bodies to nominate/prioritize risk assessment documents for review by the NSF HAB Intended to reduce duplication in effort and to harmonize risk values when products are being certified to NSF/ANSI Standards Membership includes the Chairman of the NSF HAB and representatives from participating ANSI accredited certification bodies

Joint Peer Review Steering Committee Established to consolidate efforts among ANSI accredited certification bodies to nominate/prioritize risk assessment documents for review by the NSF HAB Intended to reduce duplication in effort and to harmonize risk values when products are being certified to NSF/ANSI Standards Membership includes the Chairman of the NSF HAB and representatives from participating ANSI accredited certification bodies

Yes Yes NoNo NoNo YesYes Unanimous agreement on action levels by JPRSC? Is an OC expert panel-approved risk assessment available? NoNo Group 4: New document(s) presented to HAB Yes Action levels based on Authoritative Body peer reviewed assessment? Yes Is a more recent peer reviewed risk assessment available? No Group 1: Certifiers adopt Authoritative Body values (FYI to HAB) Group 3: Certifiers adopt action levels reconciled by HAB No Decision Process for Reconciling Action Levels START Key: OC = Other Certifiers; JPRSC = Joint Peer Review Steering Committee; HAB = NSF Health Advisory Board YesYes Is there an NSF risk assessment approved by the HAB? Yes Is new information the basis for an OC risk assessment? No Group 2: Certifiers adopt NSF action levels Group 5: FYI to HAB

Joint Peer Review Steering Committee JPRSC has continued its reconciliation efforts –Reconciled values through June 2014 were incorporated in recently accepted ballot to combine Annex D and Annex E in NSF/ANSI Standards 60 and 61 –Reconciliation efforts have continued with ~50 new values reconciled between certifying organizations. –32 new or updated values will be added to the combined Annex if the next ballot is successful None of the updated pass/fail criteria have been reduced

JPSRC Reconciled Values Chemical NameCAS# Current TAC/SPAC/STEL (µg/L) Updated TAC/SPAC/STEL (µg/L) 2,5-Dichlorobenzoic acid / 0.3 / 1010 / 10 3,5-Dichlorobenzoic acid Not Listed10 / 10 Glycerol Not Listed2000 / 200 Hexadecanoic acid Not Listed500 / 500 Octadecanoic acid Not Listed500 / 500 Cholesterol Not Listed10 / 10

JPSRC Reconciled Values Chemical NameCAS# Current TAC/SPAC/STEL (µg/L) Updated TAC/SPAC/STEL (µg/L) α-Tocopherol acetate Not Listed20 / 20 1,2-Propanediol, 3-(2- methylphenoxy) / 0.3 / 1010 / 10 Indole, 3-(2- (diethylamino)ethyl) Not Listed3 / 0.3 / 10 Formic acid Not Listed10 / 10 Hexanal / 0.3 / 1010 / 10 Isopropyl alcohol Not Listed50 / 50 / 40000

JPSRC Reconciled Values Chemical NameCAS# Current TAC/SPAC/STEL (µg/L) Updated TAC/SPAC/STEL (µg/L) Benzenesulfonamide, 4- methyl / 0.3 / 1010 / 10 1,4-Benzenediamine, N,N'- diphenyl / 0.3 / 1010 / 10 Propane Not Listed10 / 10 Propane, 2-methyl Not Listed20 / 20 Citric acid, tributyl ester / 0.3 / 1010 / 10 1,3-Propanediol, 2-ethyl-2- (hydroxymethyl) Not Listed10 / 10

JPSRC Reconciled Values Chemical NameCAS# Current TAC/SPAC/STEL (µg/L) Updated TAC/SPAC/STEL (µg/L) Peroxide, bis(1-methyl-1- phenylethyl) Not Listed50 / 10 Phenol, 4-(1,1- dimethylpropyl) Not Listed10 / 10 Saccharin Not Listed3 / 0.3 / 10 Acetophenone, 4'-tert- butyl-2',6'-dimethyl-3',5'- dinitro Not Listed10 / 10 1H-Inden-1-one, 2,3- dihydro / 0.3 / 1010 / 10 Phthalic acid / 0.3 / / 1000

JPSRC Reconciled Values Chemical NameCAS# Current TAC/SPAC/STEL (µg/L) Updated TAC/SPAC/STEL (µg/L) Phenol, 3-(phenylamino) / 0.3 / 1010 / 10 Triallyl cyanurate / 0.3 / 1050 / 50 1-Butanamine,N,N-dibutyl / 0.3 / 1010 / 10 alpha-Cadinol Not Listed10 / 10 Tetradecanoic acid Not Listed500 / 500 Butane, 2-methoxy-2- methyl Not Listed3 / 0.3 / 10

JPSRC Reconciled Values Chemical NameCAS# Current TAC/SPAC/STEL (µg/L) Updated TAC/SPAC/STEL (µg/L) Ethanone, 1-(4-(1- methylethenyl)phenyl) / 0.3 / 1010 / 10 tau-Cadinol Not Listed10 / 10

Future Efforts JPRSC will continue to make progress towards harmonization of pass/fail criteria Ballot to add new and updated pass/fail criteria to Annex anticipated for Summer 2015 Removing toxicology Annex from Standards 60/61 into a separate reference Standard still under consideration

Questions?