Methods and Data Comparability Board

1. Methods and Data Comparability Board Accreditation of Federal Laboratories for Water Quality Monitoring Advisory Committee on Water Information April 3, 2002

2. Accreditation Workgroup Presentation • Herb Brass -- USEPA • Bart Simmons -- CA Department of Toxic Substances Control (Workgroup Co-Chair) • Cliff Annis -- Merck & Co., Inc. • Jerry Parr -- Catalyst Information Resources, Inc. • Jerry Diamond -- Tetra Tech

3. USGS USEPA US DOD (Corps of Engineers and Navy) CA Dept of Toxic Substances Association of Public Health Laboratories ME Health and Env. Testing Laboratory AZ Dept. of Health VA DEQ American Chemistry Council Merck and Co., Inc. Catalyst Information Resources Standard Methods Montgomery Watson Harza IDEXX Laboratories Tetra Tech Organizations Represented inAccreditation Workgroup

4. Lab Performance Field Performance Mission of the Accreditation Workgroup Develop and promote a Board position on laboratory accreditation and field certification. Coordinate with external accreditation standard-setting organizations (e.g., NELAC).

5. There has been the notion that “following the method” ensures accurate data. A method is simply one key component of generating reliable data. Consider an analogy…two chefs, in two kitchens, using the same recipe… The same recipe in the hands of an inexperienced cook with less-than-terrific equipment is a riskier proposition. Why Accreditation? In the hands of a skilled, experienced cook, using fresh ingredients and with all the right equipment, a wonderful outcome will result. Both cooks, however, may be following the same “method”.

6. Accreditation Workgroup accomplishments • White Paper on the value of accreditation • Issue Paper on the need for federal lab accreditation • Coordination with NELAC and ELAB • Diverse representation on the workgroup was key to achieving consensus on recommendations

7. Revised Recommendations for Federal Laboratories (2002) 1 All federal agencies (and commercial laboratories employed by federal agencies) performing analytical water testing, as part of compliance or ambient monitoring programs, be accredited under a recognized program, in order to better establish comparability of data and to meet the needs of specific federal agency programs. Each agency should evaluate the cost of implementing this recommendation as it applies to their individual situation.

8. Revised Recommendations for Federal Laboratories (2002) 2 The National Environmental Laboratory Accreditation Program (NELAP -- full program) is the Board’s recommended program, because NELAP adequately meets (or is taking measures tothat meet) the broad needs of the majority of federal laboratories performing water testing. Specifically, it is focused on uniform accreditation requirements across states (and therefore, potentially reduces accreditation costs for labs operating in several states), and allows Federal as well as state accrediting authorities.

9. Revised Recommendations for Federal Laboratories (2002) 2 • For NELAP to serve as a satisfactory • accrediting program for federal laboratories, • NELAP needs to continue its efforts to: • Obtain more state participation and reciprocity • Address standards for ambient monitoring, • field sample collection, and field measurements • Promote the development of PBMS implementation

10. Revised Recommendations for Federal Laboratories (2002) New 3 The MDCB (and its parent organization, the NWQMC) will periodically re-evaluate NELAP’s suitability to serve as a national accreditation program in order: (1) to review the status of their progress in the aforementioned efforts, and (2) to encourage state, federal, and private participation in NELAP

11. Revised Recommendations for Federal Laboratories (2002) 4 Federal agencies should consider seeking to become an accrediting authority for their own laboratories under NELAP Recommendation deleted

12. Accreditation of Federal Laboratories for Water Quality MonitoringComments Received • ACWI -- May 2001 • EPA -- August 2001 • ACWI – March 2002

13. ACWI Comments – May, 2001 Concern about federal agencies becoming accrediting authorities for their own laboratories -- conflict of interest. Response -- Delete recommendation 4 and add text stating that Council and Board will track progress by EPA and other agencies.

14. ACWI Comments-- May, 2001 Concern about recommending a specific accrediting program Response -- Further explanation added in text to strengthen NELAP as recommended accreditation program. Added recommendation that MDCB and NWQMC will periodically review NELAP progress. Combined original recommendations 2 and 3

15. Major EPA Comments Costs of implementing recommendations not specified Response -- Recommendation 1 modified to state that federal organizations should consider cost impact. Comments added in text including results of an analysis that suggests that cost should be reduced under a national accreditation program

16. Major EPA Comments Need to note that recommendations are to be adopted on a voluntary basis. Response – Text of position paper changed to reflect this point.

17. Major EPA Comments Concern about accreditation of research laboratories performing projects, such as methods development Response -- Text changed to reflect that research labs need not be accredited under such circumstances

18. Major EPA Comments Needs to be a better presentation of the problem (including relevant history) and background to the paper in the Introduction section. Those unfamiliar with the word “accreditation” and its benefits will have difficulty grasping the issues and ideas expressed in the paper. Need to define reciprocity. Response -- Introductory section added that defines accreditation, its benefits, its importance in monitoring, and relevant discussion of the problem being addressed in the paper. Taken from Value of Accreditation write-up. Reciprocity defined.

19. Major EPA Comments Definition of terms needs to be added for clarity Response -- a table was added early in the text to define terms

20. Major EPA Comments The paper needs to present more supportive materials for NELAP justifying it as the recommended program Response -- More information was added that brings out several advantages or “Merits” of NELAP including their relatively comprehensive accreditation standards, open-forum approach to participation, and focus on state reciprocity issues. Relevant information concerning NELAC has also been incorporated in this section. Text has been added explaining recent improvements in state and laboratory participation in NELAP, which further demonstrates NELAP as a feasible and preferred option

21. ACWI Comments-- March, 2002 Smaller labs may find accreditation to be resource prohibitive (NOAA) Response -- Cost studies show that national accreditation is cost effective, if laboratories have quality systems in place. Under NELAP, options are available for tiering, so that some requirements are reduced for smaller laboratories.

22. ACWI Comments-- March, 2002 Research laboratories must be required to meet accreditation standards, because their data may be used to establish baseline contamination levels, and should be of suitable quality to compare to compliance and other monitoring data. (LWVUS) Response -- Opinions regarding accreditation of research laboratories varied from full accreditation to none. Position taken is a compromise that recommends that laboratories not gathering monitoring data have “documented quality systems in place to ensure that appropriate data are collected.”

23. ACWI Comments-- March, 2002 “The Quality Assurance Officer for Illinois EPA-Bureau of Water and I… whole-heartedly agree with the position expressed. Illinois and many other state’s labs are NELAP accredited and also provide NELAP accreditation to other private and government labs. NELAP is now the most wide spread accreditation program in the USA, and it allows reciprocity between states and other entities. NELAP accreditation provides a basic level of quality assurance for analytical laboratories.” (Gregg Good, Mike Henebry)

24. ACWI Comments-- March, 2002 NELAP is not recognized on an international basis as is A2LA. If we have federally recognized accreditation, it should operate on a global basis. Response -- There is a fundamental difference between the US and other countries. Environmental laboratory accreditation is viewed by states (and EPA) as an inherently governmental function. This comes from the delegation of the SDWA program to the states by EPA. However, integration with international standards is important. Note -- while A2LA is recognized internationally, it has not been embraced by the states.

26. Status of NELAP • Most accredited labs are wastewater, drinking water, or commercial labs • Over 1,200 accredited labs in 45 states, Puerto Rico and three foreign countries • New York Dept of Health accredits the most labs

27. Current NELAP Issues • Re-restructuring to satisfy legal concerns and to potentially to use a non-profit organization • Revising standards to comply with ISO 17025 • Revising standards to incorporate performance-based testing

28. Future Methods Board Accreditation Tasks • Transmit public version of NEMI to the NELAC Board, ELAB, and NELAC Quality Systems Committee • Review proposed language on performance-based standards and recommend changes to NELAC Quality Systems Committee • Recommend changes to NELAC standards to conform with Water Quality Data Elements • Pursue the option of taxonomy standards with NELAC