Florida Pilot Initiative for the Performance Approach to Measurement Systems Stephen Arms Florida Department of Health

The Concerns Adequacy and efficiency of the current alternate test procedure (ATP) approval process in EPA’s Clean Water Act (CWA) NPDES permit program and the Safe Drinking Water Act (SDWA) Difficulty and length of time needed to promulgate Federal Register changes in CWA and SDWA approved methods Even after a new method is accepted by the community as a good approach, getting the approvals in a timely fashion has been a problem

The Concerns The importance of the State programs receiving reliable monitoring data from laboratories Impact of a Performance Approach (PA) on the regulatory programs Impact of a PA pilot project on laboratory accreditation

The Concerns FDEP has a very workable Alternate Test Procedure for its own promulgated methods ( But runs into a problem when the test involves data to be reported to the federal level under the CWA and SDWA

We held a PA Pilot Kickoff Meeting on March 8, 2006

The Proposal A flexible, yet scientifically rigorous approach for the approval of laboratory analytical methods for regulatory and non-regulatory use

Operational Components and Issues EPA Delegation of Method Approval Authority Coordination with FDOH Environmental Laboratory Certification Program (ELCP) Coordination with FDEP Programs Technical Review and Approval of Methods Performance Criteria for Cross-Program Use of Methods FDEP Universal Method Database

Delegation of Method Approval Authority FDEP would assume authority for approval of non- regulatory methods. FDEP would ensure that all approved methods are appropriate for the intended application and consistent with the compliance objectives of the applicable state or federal rule. FDEP would apply due diligence to assure that the precision, accuracy, and sensitivity of the method is equivalent or superior to existing methods.

Coordination with FDOH ELCP FDEP would consult and advise FDOH about increasing the flexibility of the laboratory certification process to allow accreditation of all matrix-method-analyte combinations approved by FDEP FDOH would notify FDEP of requests from laboratories for accreditation of new methods

Coordination with FDEP Programs The FDEP Bureau of Laboratories would consult and advise the FDEP Water and Waste programs concerning the most effective way to formalize this streamlined approach to the approval of methods for existing and new permits, orders, contracts and projects. This could involve a revision of administrative procedures for the processing of permits and orders.

Technical Review and Approval of Methods FDEP would develop a more flexible process for the technical review of methods, based on the intended use. Existing methods would be reviewed and accepted for approval based on several criteria  history of use  their citation in regulations  because they have a successful track record throughout the environmental laboratory community

For new and alternative techniques, the availability of published methods by government, industry groups, vendors and others will be considered when establishing the approved standard operating procedure that will be the basis of the approved method. Any relevant performance data will be evaluated for its application to the intended uses of the method. Technical Review and Approval of Methods

Laboratories would be required to adhere to all NELAC standards for demonstrating method and laboratory performance. FDEP would require method validation using established state protocols for proposed methods where no other information is available. All methods would be evaluated for consistency with performance criteria to be established for cross-program use. Technical Review and Approval of Methods

Performance Criteria for Cross- Program Use of Methods The FDEP Bureau of Laboratories would establish technology-based performance criteria for basic DQOs (selectivity, sensitivity, precision, and accuracy) by:  Designating a reference method as the standard for all calibration and QC performance for the technology and matrix, or  Establishing performance criteria in whole or in part for a specific regulatory or programmatic application, either as a supplement to a reference method or as independent criteria applied to the technology

FDEP Universal Method Database The Bureau of Laboratories would develop a universal database of matrix-method-analyte combinations for use by all FDEP programs. This database would replace existing approved method lists cited in other FDEP rules, permits, orders and guidance documents. Methods would be selected for specific uses consistent with the concerns outlined above.

First Steps Formulate plans for a proposed pilot initiative Define the scope of such a program Identify the resources needed to implement an initiative Investigate the regulatory and legal basis for implementing the initiative within the EPA

Some time passed…

And we held a second meeting on November 9, 2006

Outcome EPA has legal obstacles to delegation of method approval authority to the State Other approaches were considered

Short-Term Alternatives EPA and FDEP partner on ATP approval process, particularly evaluation Identify new methods FDEP has approved to include in mid-2007 rule Identify additional performance criteria

Interim Actions – DEP Programs Drinking Water Matrix  Certified in Drinking Water Matrix  Certified for Method/Analyte Combination  Report only Certified Matrix/Method/Analyte Combinations Non-Potable Water Matrix  Certified in Non-Potable Water Matrix  Certified for at least one Equivalent Technology/Analyte Combination May Still Report Withdrawn Method until QA Rule Finalized  Report Program-Required Method Cannot report SW 846 Methods for Wastewater Compliance Certification and Reporting Requirements

Equivalent Methods

Where Do We Go From Here? EPA should continue to explore creative ways to overcome legal barriers to good science and technological progress. The Forum on Environmental Measurements must aggressively fast-track the Performance Approach. Florida will continue to work within its authority to implement the Performance Approach.  Continue to identify benefits/advantages  Get buy-in/support from FDEP program management

Hope from EPA EPA Office of Air has presented criteria for method modification New 40 CFR Part offers criteria for NPDES method modification New DW methods build in some additional flexibility DW can speed up method approvals  Shorten evaluation of method  Use authority to delegate approval down to the AA level

Recent Developments Half-day meeting of the Forum on Environmental Measurements (FEM) in April 2007  Very senior level individuals in EPA  Performance Approach is not “one-size-fits- all” Renewed interest and commitment

Work to be Done New Definition drafted with:  Regional and Enforcement involvement  Consideration of diverse program office needs The Performance Approach has a proposed new name FEM commitment of immediate change, but overall implementation within 2 years Involvement with states and industry in implementation and complete scoping a must  Open invitation for partnerships and participation in new pilot project opportunities

Keep Striving Toward the Goal! Prescriptive Methods Performance Approach