Paul Mills Enabling Technologies Division Computer Sciences Corporation Federal Sector

1. The Evolution of NELAC30th National Energy andEnvironmental Conference ProgramSeptember 14–17, 2003 at the Rio Hotel, Las Vegas, NevadaSession T-41 Paul Mills Enabling Technologies Division Computer Sciences Corporation Federal Sector

2. What were the problems? • Inconsistent / nonexistent inspections • No reciprocity among states • Loss of accreditation in one state does not affect status in another • Accreditation in all areas is not available • Customers have no access to information • Accreditation not recognized in foreign markets • Programs generally viewed as inadequate

3. What was needed? Standardized lab requirements Uniform audits Reciprocity

4. Elements of Accreditation Analysis of Proficiency Testing samples On-site assessment Data audit Quality system

5. Background • Report to Congress 1986 • Committee on National Accreditation of Environmental Laboratories (CNAEL) 7/91-7/92 • State-EPA Focus Group 1/93-9/94 • National Environmental Laboratory Accreditation Conference (NELAC) 2/95 - ongoing

6. Vision • States and EPA develop consensus standards that are voluntarily adopted by the states (the NELAC role) • EPA oversees accrediting authorities to assure uniformity • State grants accreditation, which is unconditionally recognized by other participating authorities • Laboratories can voluntarily apply to any approved authority if their home state does not participate

7. NELAC Oversight Structure

8. Regulatory Authorities’ Benefits • Multi-State/Agency Endorsement. • Multi-Program Applicability--SDWA, CWA, CAA, RCRA,and CERCLA • Comparable and Defensible Environmental Data • Reduced Cost through shared access to laboratory data and assessments • More Effective Use of Resources and Project Dollars • Multi-sector Wisdom and Expertise from multiple agencies, states and various groupsin the private sector • DoD Recognized and Endorsed

9. The Benefits to Regulatory Authorities, cont. • Public and Private Representation for standards development and review, and consensus adoption • Analytical testing of environmental samples • Federal (EPA) recognition of state and federalAccrediting Authorities • Laboratory on site assessmentProficiency testingField testing

10. NELAC--The Goal • The goal of NELAC is to foster the generation of environmentallaboratory data of known and acceptable quality onwhich to base public health and environmental managementdecisions. • Implies lab audits, PT/PE samples, database of providers and results, accredited labs and auditors and agencies.

11. NELAC Provides a National Forum To: • Establish consensus • Encourage uniformity • Foster cooperation among States by adoption of uniform standards

12. The NELAC Work Product • The NELAC Standards • A Publication • Constitution and Bylaws • Seven Chapters

13. Initial NELAC Structure EnvironmentalLaboratoryAdvisory Board AccreditingAuthorityReview Board Board of Directors Voting Members (Regulatory) Contributors (Stakeholders) Standing Committees Administrative Committees Ad Hoc Committees

14. NELAC Participants Voting Members EPA Officials Federal Officials State Officials Board of Directors NELAC Director Exec. Secretary Chair Chair Elect Past Chair Members-at-large (6) Contributors General Public Laboratories Regulated Industry Environmental Groups Lab/Industry Associations Assessor Bodies Retired Voting Members

15. NELAC Committees

16. Environmental Laboratory Advisory Board (ELAB) • Private sector group established in compliance with the Federal Advisory Committee Act to solicit consensus advice on the NELAC process and standards. • Duties/Scope • recommendations on standards of accreditation • advice on requirements for accrediting authorities • analyses, reviews, reports, and activities to support recommendations • Reports to EPA

17. Accrediting Authority Review Board • Monitors NELAP to assure that EPA is following the NELAC standards for recognizing accrediting authorities. • Serves as a review board for accrediting authorities whose recognition has been denied or revoked. • Conducts an annual audit of the NELAP process and reports its findings. • Provides advice on issues referred by the NELAP Director.

18. NELAC Track Record • Proposed Standards - FRN 12/94 • 1: Adopted Constitution & Bylaws • 2: Adopted complete set of standards • 3: Minor revisions to standards • 4: Glossary and expanded PT program • 5: Field Activities Committee • 6: ISO 17025 and Restructuring

19. Implementation • Not a function of NELAC! • States adopt standards voluntarily: • Select scope of accreditation • Select voluntary or mandatory nature of program • Select types of laboratories to be accredited • May use third party assessors • May assess fees • States must comply with NELAC: • Accept reciprocity • Apply all NELAC standards to laboratories • Refrain from adding supplemental requirements

20. NELAP—The Program • Coordinate implementation of NELAC standards • NELAP recognizes state and federal agencies as AccreditingAuthorities and will accredit at least one state laboratory instates applying to NELAP • Requires reciprocal recognition of accreditation amongstate and federal NELAP Accrediting Authorities • In addition, many states and agencies currently outsidethe program recognize NELAP accredited laboratories

21. Some Cautions Accreditation does not guarantee reliable data were generated, only that the lab is capable Accreditation does not address service issues

22. Why Change? • Advantages of Current Structure • Balanced representation of stakeholders on committees • All stakeholders can provide input • Highly efficient standards development and adoption process (approx. one year in most cases) • Limitations • Private sector involvement is limited (can comment, but cannot debate or vote • EPA wants NELAC to pursue self-sufficiency • NELAC cannot perform all functions needed

23. NELAC Standard-Setting Process (NOW) Standing Committees write/modify standards States implement standards Approved standardspublished Proposed standardspublished and discussedat interim meetings Final standardspublished and proposed for adoptionat annual meetings Standards approved, often with modifications, at Annual Meetings

24. NELAC Standard-Setting Process (after restructuring) States implement standards Consensus Organizations write/modify standards Approved standardspublished Proposed standardspublished and discussedat “interim” meetings Standards approved for use in NELAP program at Annual Meetings Final standardspublished and proposed to NELAC for adoptionat annual meetings

25. Restructuring of NELAC • New constitution and bylaws approved • Most committees will cease operation in July 2003 • NELAC continues as an organization of government officials only • New organization INELA formed to continue standards development work

26. The “New” NELAC • Government only participation • EPA retains sponsorship • Members adopt standards for use by NELAC accrediting authorities • NELAC may consider standards from any voluntary consensus standards development organization • NELAP remains as an EPA program to approve state accrediting authorities

27. Consensus Standards Development Organizations Consensus (from OMB 119): “….defined as general agreement, but not necessarily unanimity, and includes a process for attempting to resolve objections by interested parties, as long as all comments have been fairly considered, each objector is advised of the disposition of his or her objection(s) and the reasons why, and the consensus body members are given an opportunity to change their votes after reviewing the comments.” • INELA, ASQ, ASTM and others may provide standards for NELAC consideration

28. The NELAC Standards Adoption Process Consensus Standards Development Organization Standard submitted Rejected Standards Review Committee 6 month time frame? Recommended for acceptance Rejected Vote by NELAC Accepted Implementation of the Standard by NELAP AAs Adoption of The Standard

29. The Proposed Structure STANDARDS DEVELOPMENT ORGANIZATION (INELA) STANDARDS ADOPTION ORGANIZATION (NELAC) Board of Directors Program Policy & Structure (CHAPTER 1) Proficiency Testing (CHAPTER 2) On-Site Assessment (CHAPTER 3) Accreditation Process (CHAPTER 4) Quality Systems (CHAPTER 5) Accrediting Authority (CHAPTER 6) Field Activities (CHAPTER 7) Membership & Outreach Committee Nominating Committee standards Standards Review Committee standards VOTING

30. Constitution and Bylaws • Significantly changed in July 2002 • Scope of NELAC • Organization • Committees • 2001 – ten Committees • 2002 – three Committees : Nominating, Membership & Outreach, and Standards Review

31. Groups Covered • National Environmental Laboratory Accreditation Program (NELAP) • Accrediting Authority Review Board (AARB) • Proficiency Testing (PT) Board • EPA • Other

32. NELAP • Recognition and Oversight of Accrediting Authorities (AA’s) • Administration of Boards: • AARB • PT Board • Publish Tables: • Fields of Accreditation (FOA) Tables • Proficiency Testing (PT) Tables

33. NELAP (continued) • Website Maintenance for NELAC • Organize NELAC Annual Meetings • Marketing and Communication • Reporting to NELAC • EPA Liaison

34. AARB • Review of AA Recognition Process • Conflict Resolution • Reporting: • On NELAP • To NELAC

35. PT Board • Recommend Proficiency Testing Oversight Body/Proficiency Test Provider Accreditor (PTOB/PTPA) • Oversight for PTPA • Recommendation of PT Providers • Complaint Resolution for PT Issues • Collect PT Data for Purposes of Setting Quality Control Limits

36. PT Board, cont. • Hold PT Caucus • Reporting: • To NELAP • Annual Report to NELAC on PT Program • Annual Public Report on Statistics of PT Process

37. EPA • Staff NELAP • Administrative Support for NELAC • Publish Standards • Funding Support • Coordination and Outreach: • Internally • Externally • Designated Federal Official (DFO) for Environmental Laboratory Advisory Board (ELAB)

38. Other • No Change: • AA’s/States • Other Federal Agencies • Laboratories • Unresolved: • EPA as an Accrediting Authority • National Database

39. Progress and Next Steps (NELAC) • Progress • A standards-adoption process has been developed • Timelines related to standards development have been set • AA Reps for Standards Review Committee established • Next Steps • Form and/or restructure new NELAC committees • Develop operating policies for Committees (especially the Standards Review Committee) • Modify existing and/or develop new NELAC policies, as necessary

40. Institute for National Environmental Laboratory Accreditation (INELA) • INELA established in 2001 as non-profit voluntary consensus organization to support NELAC • Active work began in May 2002 • INELA committee structure parallels existing NELAC committees • INELA also can provide auxiliary support functions • Members can be anyone interested in laboratory accreditation • Primary goal of organization is development of laboratory accreditation standards

41. INELA’s Vision • An efficient and cooperative relationship between INELA and NELAC • A system that will retain the strengths of the “old” NELAC and add new strengths (especially improved self-sufficiency) • A full partnership between government and the private sector

42. Goals of New Organization • Develop environmental laboratory accreditation standards using expert committee structure • Host semi-annual meetings to share information • Achieve fiscal self-sufficiency • Include greater participation of private sector • Take on new activities • PTOB, training, hotline, etc. • Meet OMB Circular 119-A definition • openness, balance of interest, due process, and an appeals process

43. INELA Organization

44. Organizational Framework • Approved as 501c3 tax-exempt organization • 275 members; including 14 organizations • Website operational www.inela.org • Monthly newsletter -- The Institute Review

45. 2-Year Standards-Development Cycle Jul ’03 Committees develop standards Dec ’03 Draft standards discussed at Winter Meeting Jan ’04 Electronic vote by all INELA members Committees deals with objections Jun ’04 Objections & mods discussed at Summer Meeting Jul ’04 Electronic vote by all INELA members Sep ’04 Standards submitted to NELAC Jan ’05 Committees refine standards (if needed) Mar ’05 Electronic vote on refined standards by all INELA members May ’05 Refined stds submitted to NELAC for June vote

46. 1-Year Standards-Development Cycle Jun ’04 Draft standards presented and discussed at Summer Meeting Jul ’04 Electronic vote by all INELA members Sep ’04 Standards submitted to NELAC for discussion at Interim Meeting (Winter Meeting) Jun ’05 NELAC vote at Annual Meeting (Summer Meeting)

47. What’s the Same? • Committee structure and operation • Consensus process • Experts involved in standards development • Interim and annual meetings

48. What’s Different? • Greater private sector participation • Board • Committees • Individual and organizational membership • Broader-based financial support to foster sustainability • Every member has a vote

49. INELA Operating Principles • Work by consensus • Provide unrestricted access to use of accreditation standards • Use the best of NELAC as an organizational model • Establish reasonable fees (not for profit) • Maintain low operating costs

50. Planned Activities • Establish committees (admin and technical) • Develop policies for standards development • Host Meetings • Development of laboratory accreditation standards • Conduct communication and outreach activities • Establish contractor support • Secure long-term fiscal viability