NSF/ANSI Standards 60/61 NSF/ANSI Standards 60/61

Issue Paper #1 – Combining Annex D and EIssue Paper #1 – Combining Annex D and E

Issue Paper #2 – Additional Pass/Fail CriteriaIssue Paper #2 – Additional Pass/Fail Criteria

December 2013

COMBINING ANNEX D AND COMBINING ANNEX D AND ANNEX EANNEX E

IntroductionIntroduction

• Drinking water pass/fail criteria in NSF/ANSI Standards 60/61 are currently located in two separate annexes

• Annex D (normative) and Annex E (informative)

• In each annex, there are multiple tables (D1-D4 and E1-E2)

• As the annexes are currently maintained separately for Standard 60 and Standard 61, pass/fail criteria for chemicals may be listed in one Standard but not the other and duplicative entries are more challenging to identify

• Maintaining multiple tables in two Standards makes it difficult for users to locate pass/fail criteria

RecommendationsRecommendations

• Consolidate the drinking water criteria currently in Annex D and Annex E into a single annex

• Combined annex would be identical and appear in NSF/ANSI Standard 60 and Standard 61

• Recommendation is supported the Joint Peer Review Steering Committee (JPRSC)

Joint Peer Review Steering CommitteeJoint Peer Review Steering Committee

• Established to consolidate efforts among ANSI accredited certification bodies to prioritize risk assessments for review by the HAB and reconcile action levels derived from duplicate risk assessment efforts

• Membership includes HAB chair and representatives from five certification bodies

• Officially reached agreement to harmonize efforts in April 2013

Recommended Format for Combined AnnexRecommended Format for Combined Annex

• The current recommendation is to have the chemicals organized by both CAS# and alphabetically

Contaminant CAS # Drinking Water Regulatory Level

(MCL/MAC) or Total Allowable

Concentration (TAC) (mg/L)

Single Product Allowable

Concentration (SPAC) (mg/L)

Short Term Exposure

Level (STEL) (mg/L)

Source of Supporting

Documentation 1, 2, 3, 4, 5, 6

Previous Annex

Location

carbon disulfide 75-15-0 0.7 0.07 Derived from the oral RfD on the USEPA IRIS database with a default 20% relative source contribution for drinking water. Verification date: 08/05/1985

Std. 61 D3

carbon tetrachloride 56-23-5 0.005 0.0005 40 CFR §141.60, 40 CFR §141.61

Std. 60 D1, Std. 61 D1

carbonic acid, diisopropyl ester 6482-34-4 0.003 0.0003 TOE Std. 60 D4, Std. 61 D4

castor oil, hydrogenated, ethoxylated 61788-85-0 0.003 0.0003 TOE Std. 60 D4, Std. 61 D4

cerium 7440-45-1 0.003 0.0003 TOE Std. 60 D4, Std. 61 D4

chloral hydrate 302-17-0 0.7 0.07 Derived from the oral RfD on the USEPA IRIS database with a default 20% relative source contribution for drinking water. Agency Consensus Date: 11/16/1999

Std. 60 D3, Std. 61 D3

chloramines (total as Cl2) 10599-90-3 411 0.4 40 CFR §141.54 Std. 60 D1, Std. 61 D1

chlorate 14866-68-3 1 0.2 Std. 60 D1 chlordane 57-74-9 0.002 0.0002 40 CFR §141.60, 40

CFR §141.61 Std. 60 D1, Std. 61 D1

Format ChallengesFormat Challenges

• Chemical names – There is not a currently unified chemical naming approach between certifiers which limits the benefits of the alphabetical listing

– May be possible to address through JPRSC

• Length – The proposed format results in a 199 page document

– This does not include substantial future additions

– Solution may be to remove annexes containing pass/fail criteria from Standards into a separate stand alone document

Normative/InformativeNormative/Informative

• Currently, NSF/ANSI Standards 60/61 distinguish between normative and informative pass/fail criteria

• Normative Criteria

– Under Annex D, pass/fail values listed are to be used in the determination of product compliance with the Standard

• Informative Criteria

– Under Annex E, a chemical that exceeds the informative criteria should be subject to a complete toxicity data review and risk assessment prior to using the informational evaluation criteria to determine compliance with the Standard

• A consensus among the JPRSC membership was that no distinction is currently made between normative and informative values when evaluating compliance

ADDITION/UPDATES OF ADDITION/UPDATES OF PASS/FAIL CRITERIAPASS/FAIL CRITERIA

New Pass/Fail CriteriaNew Pass/Fail Criteria

- Based on reconciliation efforts and development of new risk assessments, NSF International, along with the remainder of the JPRSC membership, is recommending the addition (or update) of 541 pass/fail criteria to Annex D/E of both Standards

- A footnote referencing to the activities of the JPRSC would be included

Sources of New CriteriaSources of New Criteria

• NSF International – Peer Reviewed Risk Assessments

– Peer reviewed in 2012 or 2013 by the Health Advisory Board

• NSF International – Threshold of Evaluation Chemicals

• NSF International – Other Additions

• JPRSC – Initial List of Reconciled Values

• JPRSC – Threshold of Evaluation Chemicals

Questions for the Joint CommitteeQuestions for the Joint Committee

• Should Annex D and Annex E be combined into a single Annex?

• Is it appropriate to have the newly formatted annex be considered normative?

• Are two separate tables necessary (one organized by CAS# and the other alphabetically by chemical name)?

• Should the annex of pass/fail criteria be removed from the Standards into separate stand alone document?