The NELAC Institute

1. The NELAC Institute Accreditation Body Committee (ABC) Jeff Flowers, Ph.D., Chair

2. Committee Members • Jeff Flowers, Flowers Chemical Laboratories,Chair • Sharon Mertens, Milwaukee Metro Sewerage Dist. • Stephen Arms, FL DOH • Daniel Dickinson, NY DOH • Linda Geddes MWH Laboratories • Steve Stubbs TX TCEQ • Lynn Bradley USEPA OEI • Joe Aiello NJ DEP

3. Mission • The mission of the TNI Accreditation Body Committee is to develop and support accreditation standards by engaging industry experts in a consensus-based standards development process. • To improve the quality and consistency of environmental data throughout the United States. • To foster the mutual recognition of laboratory accreditation by Accreditation Bodies.

4. Strategies - ABC • Assist TNI NELAP board and TNI LASC as needed with review of existing NELAC policies • Develop policies and procedures to assist TNI NELAP board in implementing new standards

5. Accomplishment • Volume 2, Module 1 was adopted by TNI members • Continued mutual recognition of AB’s • LASC Recommends Adoption • (once a guidance document has been produced, editorial changes made and a TIA has been used to change the standard.)

6. Current Assignment • Respond to LASC Comments • Prepared 2 TIAs • Obtained CSDB affirmative vote for TIA advancement • In Public Comment Period for TIA Now • Address to jeff@flowerslabs.com

7. Current Assignment (cont.) • Develop Affiliate/Associate TNI recognitions • Progression Model of Attainment • Grant additional rights as program matures • Ask TNI Board to consider new membership category

8. When to use a Tentative Interim Amendment (TIA) • The amendment appears to be of an emergency nature requiring prompt action • Will be used infrequently and only in cases where the amendment is expected to be non-controversial. • Determination of an emergency nature shall include, but not be limited to, one or more of the following factors:

9. Why use a Tentative Interim Amendment (TIA) • The standard contains an error or an omission that was overlooked during the regular standard development or revision process; • The standard contains a conflict with other language; • The proposed amendment intends to respond to a new Federal regulation or other development; and/or • The proposed amendment intends to correct a circumstance that has resulted in an adverse impact that was overlooked during the regular standard development or revision process, or • Was without adequate technical justification for the action.

10. How are Tentative Interim Amendments (TIA) used • Requires 15 day public notice • Effective 20 days after vote of Expert Committee • May remain in effect for no more than two years

11. TIA 1 ABC TIA One The section(s) of the standard that should be amended; V2M1 4.3.5 The rationale for the Tentative Interim Amendment: Several states (both large and small; KN, NY, NH, FL…) will not be able to comply with the existing standard as written. Specifically; they in fact do not comply with the requirement to have “a person(s) or committee(s) different from those who carried out the assessment”. These existing NELAP states will need to lose their existing NELAP recognized status if the language remains as is. The factor(s) that would determine whether the amendment qualifies as a Tentative Interim Amendment: It has been determined by the ABC that it is of an emergency nature and that the committee missed the change originally. The proposed change to the standard, including suggested wording. The ABC proposes to add to the existing language to the end of the sentence; “ unless the responsible government authority allows otherwise.”

12. TIA 2 ABC TIA Two The section(s) of the standard that should be amended; V2M1 5.7.3b The rationale for the Tentative Interim Amendment: Several states (both large and small; KN, NY, NH, FL…) will not be able to comply with the existing standard as written. Specifically; they in fact do not comply with the requirement to have “a person(s) or committee(s) different from those who carried out the assessment”. These existing NELAP states will need to lose their existing NELAP recognized status if the language remains as is. The factor(s) that would determine whether the amendment qualifies as a Tentative Interim Amendment: It has been determined by the ABC that it is of an emergency nature and that the committee missed the change originally. The proposed change to the standard, including suggested wording. The ABC proposes to add to the existing language to the end of the sentence; “ unless the responsible government authority allows otherwise.”

13. TIA Comments • TIA allows AB assessor to be judge and Jury. • Counter to ISO17011 theme • Some ABs will need to drop TIN requirements if TIA is not adopted • Let states with problem use third party assessment committee, to perform their statutory authority to approve/deny accreditation. • Can not change ISO language, need different phrasing. • Labs are expected to change to comply with the standard, why could we not require the same from an AB • Let the standard be adopted as is, then let the ABs then tell us that they will not or cannot meet the standard

14. TIA Discussion NewLanguage • Section 4.3.5NOTE: The decision may be made by person(s) or committee(s) not different from those who carried out the assessment if the responsible government authority allows it. • Section 5.7.3bNOTE: Internal audits may be conducted by personnel who perform the activity to be audited if the responsible government authority allows it.

15. Associate/Affiliate

16. Future Plans? • Produce SOPs and Model Polices to allow implementation by TNI Board and TNI LASC to: • Establish an effective system for the recognition of accreditation bodies. • Develop an effective system for having states participate in the program without having to become Accreditation Bodies • Monthly conference calls, 3rd Tuesday, 12 AM EST