Panel Discussion on Method Development and Approval in the 21st Century

Panel Discussion on Method Development and Approval in the 21st Century
Oral Presentation

Prepared by J. Parr1, L. Phelps2, J. Morgan3
1 - The NELAC Institute, , , United States
2 - USEPA, , , United States
3 - Pace Analytical, , , United States


Contact Information: jerry.parr@nelac-institute.org;


ABSTRACT

Historically, EPA program offices have had widely varying approaches to validating and approving test methods for regulatory data. Some EPA program offices have had a very prescriptive philosophy regarding test methods, only allowing methods developed by the Agency or, if developed by others, only approved after an extensive validation effort and, notice and comment in the Federal Register. Other EPA offices have published methods with little or no validation data to support the premise that the method is appropriate for its intended purpose. In virtually all cases, the current approaches have resulted in a slow and tedious process for introducing innovative new technologies for environmental monitoring.

ISO/IEC 17025 and the laboratory accreditation standard developed by The NELAC Institute focus on a laboratory's ability to provide data appropriate for its intended purpose and states that "methods published ... in national standards shall preferably be used." EPA's Performance Based Measurement Systems (PBMS) approach had limited success, and much more flexibility now exists across all EPA programs through flexible approaches to environmental measurement. Although in some cases new methods are approved rather quickly, much more can be done, especially since the current process is sometimes constrained by political realities.

The purpose of this session is to explore options for a new process to ensure that methods are appropriated validated before use and approved in a transparent and effective process.