Perspective of the NELAC Institute

Plenary Session
Oral Presentation

Prepared by J. Parr1, J. Morgan2
1 - The NELAC Institute, 210 S. Lamar St., 210 South Lamar Street, WEATHERFORD, Texas, 76086, United States
2 - Pace Analytical Services, , , United States


Contact Information: [email protected]; 817-308-0449

ABSTRACT

For over 50 years, some EPA program offices have believed if they write, validate, and approve the “perfect” method data quality will be assured. This belief has been shown to be wrong numerous times. By the time EPA goes through this process, the technology has changed. No matter how much detail is in the method, there is always room for interpretation and mistakes by laboratories that do not have the expertise. Furthermore, just like a good recipe, a method cannot guarantee the result will be good. In Daubert vs Merril Dow the US Supreme Court set forth five foundational principles relating to data admissibility:
• Whether a theory or technique can be (and has been) tested,
• Whether it has been subjected to peer review and publication,
• Whether there is a high known or potential rate of error,
• Whether there are standards controlling the technique’s operation, and
• Whether the technique has been accepted within the scientific community.
While the current EPA process addresses some of these, it does not get to the key issue of professional standards. However, the laboratory accreditation standard developed by the NELAC Institute (TNI) does. The TNI Standard is based on ISO/IEC 17025 but contains additional specificity relating to issues such as data integrity, proficiency testing, method validation and verification, instrument calibration, and much, much more.
EPA does have a key role in ensuring a validated test method exists for regulatory purposes. However, laboratories should be able to modify this method, or develop and validate a completely new method, without EPA’s approval as long as they are accredited to the TNI standard. This new approach will require changes to the current regulations in 40 CFR Parts 136 and 141 and may require laboratory assessors to be trained on how to evaluate new/modified methods.