Establishing Laboratory Analysis Procedure for EPA FIFRA Enforcement Samples to Meet the ISO/IEC 17025:2005 Requirements using Flexible Scope Approach

Yoko Shibuya Johnson, Gareth Horvath

Abstract


An ISO/IEC 17025:2005 accredited laboratory procedure that quantifies analytes and validates an analytical method used simultaneously was established for analyzing pesticide misuse samples. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the U.S. Environmental Protection Agency (EPA) grants the authority over regulating pesticide use to each state. Samples for pesticide misuse cases such as drift complaints are analyzed by state laboratories (state FIFRA labs). State FIFRA labs receive samples that require quick turnaround with a variety of unique matrix/analyte combinations. The majority of the samples are analyzed by non-standard methods that are developed by the laboratory. It is impractical to pre-validate such non-standard methods. Yet, the forensic nature of pesticide misuse investigation samples demands legally defensible analytical data. The author's laboratory developed an expedited validation procedure that is conducted simultaneously with analyte quantitation by using the standard addition technique. The procedure received ISO/IEC 17025:2005 accreditation from the American Association for Laboratory Accreditation under their Flexible Scope Policy. The developed validation protocol and associated procedural changes made to the daily operations are supported by several laboratory documents that are unique to the Flexible Scope option.

Keywords


ISO/IEC 17025:2005 accreditation, pesticide misuse, FIFRA, state, Flexible Scope Policy

Full Text:

PDF

References


Akingbade, D., Phillips, T., Thiex, N., Klein, R., Mangione, C., Salfinger, Y., & Shea, S. (2014). Building an Integrated Laboratory System to Advance the Safety of Food and Animal Feed. Journal of Regulatory Science, 2, 1-6.

American Association for Laboratory Accreditation. (2011). C226 - Specific Checklist: NELAC TNI Standard Module 4 - Quality Systems for Chemical Testing. Retrieved from https://www.a2la.org/appsweb/appdocs.cfm?certno=0.32&title=

American Association for Laboratory Accreditation. (2011). P112 -- Flexible Scope Policy. Retrieved December 29, 2016 from https://www.a2la.org/policies/A2LA_P112.pdf

Analytical Laboratory of Accreditation Criteria Committee of AOAC International. (2010). AOAC INTERNATIONAL Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals An Aid to Interpretation of ISO/IEC 17025:2005. Retrieved from http://www.aoac.org/aoac_prod_imis/aoac/AOAC_Member/BS/11543.aspx

Dai, S. Y. (2016). Producing Quality Laboratory Data: A Systems Approach. Journal of Regulatory Science, 4, 19-21.

Kaml, C., Weiss, C. C., Dezendorf, P., Ishida, M., Rice, D. H., Klein, R., & Salfinger, Y. (2014). Developing a Competency Framework for U.S. State Food and Feed Testing Laboratory Personnel. Journal of AOAC International, 97, 768-772.

Paya, P., Anastassiades, M., Mack, D., Sigalova, I., Tasdelen, B., Oliva, J., & Barba, A. (2007). Analysis of pesticide residues using the Quick Easy Cheap Effective Rugged and Safe (QuEChERS) pesticide multiresidue method in combination with gas and liquid chromatography and tandem mass spectrometric detection. Analytical and Bioanalytical Chemistry, 389, 1697-1714.

U.S. Environmental Protection Agency. (n.d.). Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Federal Facilities. Retrieved December 29, 2016 from https://www.epa.gov/enforcement/federal-insecticide-fungicide-and-rodenticide-act-fifra-and-federal-facilities