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

EPA's Role in Approving Methods
Oral Presentation

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


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.