Upload
rodger-mosley
View
225
Download
4
Tags:
Embed Size (px)
Citation preview
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?