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

NSF/ANSI Standards 60/61Pass/Fail Criteria Updates

Kevin CoxSenior 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 1/10th 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 Name CAS#Current

TAC/SPAC/STEL(µg/L)

UpdatedTAC/SPAC/STEL

(µg/L)

Mercaptobenzothiazole 149-30-4 40 / 4 / 40 20 / 2 / 20

Dichloropropanols96-23-1

616-23-926545-73-3

30 / 9 / 30 (total) 10 / 4 / 10 (total)

Dimethylphthalate 131-11-3 3 / 0.3 / 10 50 / 50 / 50

Alkyl Dimethyl Benzyl Ammonium Chloride (multiple) 900 / 90 / 1000 3000 / 300 / 5000

Triclosan 3380-34-5 500 / 50 / 8000 300 / 30 / 700

SPRING 2015 HAB MEETING (May 5-6, 2015)

Chemical Name CAS#Current

TAC/SPAC/STEL(µg/L)

UpdatedTAC/SPAC/STEL

(µg/L)

Nonylphenol isomers 25154-52-384852-15-3 20 / 2 (total) 70 / 7 / 300 (total)

1-Hexanol 111-27-3 Not Listed 2000 / 200 / 30000

Potassium Peroxymonosulfate 70693-62-8 Not Listed 5000 / 5000 / 20000

m-Cresolp-Cresol

108-39-4106-44-5 Not Listed 400 / 40 / 1000 (total)

(tentative)

Diethylene Glycol Dibenzoate 120-55-8 3 / 0.3 / 10 5000 / 500 / 8000

(tentative)

Tripropylene glycol diacrylate 42978-66-5 3 / 0.3 / 10 80 / 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

No

No

Yes

Unanimous agreement on

action levels by JPRSC?

Is an OC expert panel-approved risk assessment

available?No

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

Yes

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 Name CAS#Current

TAC/SPAC/STEL(µg/L)

UpdatedTAC/SPAC/STEL

(µg/L)

2,5-Dichlorobenzoic acid 50-79-3 3 / 0.3 / 10 10 / 10

3,5-Dichlorobenzoic acid 51-36-5 Not Listed 10 / 10

Glycerol 56-81-5 Not Listed 2000 / 200

Hexadecanoic acid 57-10-3 Not Listed 500 / 500

Octadecanoic acid 57-11-4 Not Listed 500 / 500

Cholesterol 57-88-5 Not Listed 10 / 10

JPSRC Reconciled Values

Chemical Name CAS#Current

TAC/SPAC/STEL(µg/L)

UpdatedTAC/SPAC/STEL

(µg/L)

α-Tocopherol acetate 58-95-7 Not Listed 20 / 20

1,2-Propanediol, 3-(2-methylphenoxy)- 59-47-2 3 / 0.3 / 10 10 / 10

Indole, 3-(2-(diethylamino)ethyl)- 61-51-8 Not Listed 3 / 0.3 / 10

Formic acid 64-18-6 Not Listed 10 / 10

Hexanal 66-25-1 3 / 0.3 / 10 10 / 10

Isopropyl alcohol 67-63-0 Not Listed 50 / 50 / 40000

JPSRC Reconciled Values

Chemical Name CAS#Current

TAC/SPAC/STEL(µg/L)

UpdatedTAC/SPAC/STEL

(µg/L)

Benzenesulfonamide, 4-methyl- 70-55-3 3 / 0.3 / 10 10 / 10

1,4-Benzenediamine, N,N'-diphenyl- 74-31-7 3 / 0.3 / 10 10 / 10

Propane 74-98-6 Not Listed 10 / 10

Propane, 2-methyl- 75-28-5 Not Listed 20 / 20

Citric acid, tributyl ester 77-94-1 3 / 0.3 / 10 10 / 10

1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)- 77-99-6 Not Listed 10 / 10

JPSRC Reconciled Values

Chemical Name CAS#Current

TAC/SPAC/STEL(µg/L)

UpdatedTAC/SPAC/STEL

(µg/L)

Peroxide, bis(1-methyl-1-phenylethyl)- 80-43-3 Not Listed 50 / 10

Phenol, 4-(1,1-dimethylpropyl)- 80-46-6 Not Listed 10 / 10

Saccharin 81-07-2 Not Listed 3 / 0.3 / 10

Acetophenone, 4'-tert-butyl-2',6'-dimethyl-3',5'-

dinitro-81-14-1 Not Listed 10 / 10

1H-Inden-1-one, 2,3-dihydro- 83-33-0 3 / 0.3 / 10 10 / 10

Phthalic acid 88-99-3 3 / 0.3 / 10 10000 / 1000

JPSRC Reconciled Values

Chemical Name CAS#Current

TAC/SPAC/STEL(µg/L)

UpdatedTAC/SPAC/STEL

(µg/L)

Phenol, 3-(phenylamino)- 101-18-8 3 / 0.3 / 10 10 / 10

Triallyl cyanurate 101-37-1 3 / 0.3 / 10 50 / 50

1-Butanamine,N,N-dibutyl- 102-82-9 3 / 0.3 / 10 10 / 10

alpha-Cadinol 481-34-5 Not Listed 10 / 10

Tetradecanoic acid 544-63-8 Not Listed 500 / 500

Butane, 2-methoxy-2-methyl- 994-05-8 Not Listed 3 / 0.3 / 10

JPSRC Reconciled Values

Chemical Name CAS#Current

TAC/SPAC/STEL(µg/L)

UpdatedTAC/SPAC/STEL

(µg/L)

Ethanone, 1-(4-(1-methylethenyl)phenyl)- 5359-04-6 3 / 0.3 / 10 10 / 10

tau-Cadinol 5937-11-1 Not Listed 10 / 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?