T1-01 Laboratory Accreditation – Progress Towards the Nation’s Integrated Food/Feed Safety System

Monday, August 1, 2016: 8:30 AM
240 (America's Center - St. Louis)
Yvonne Salfinger, Association of Public Health Laboratories, Denver, CO
Shari Shea, Association of Public Health Laboratories, Silver Spring, MD
Kirsten Larson, Association of Public Health Laboratories, Silver Spring, MD
Robyn Pyle, Association of Public Health Laboratories, Silver Spring, MD
Ruiqing Pamboukian, U.S. Food and Drug Administration, Rockville, MD
Introduction: Laboratory accreditation attests to the competency and technical capability of a laboratory, leading to results which are defensible to a recognized standard, and supports the traceability and accountability of results generated by a laboratory that may be made available for consideration by federal agencies for enforcement actions.  ISO/IEC 17025 is an accreditation standard utilized by laboratories throughout the world.

Purpose: The Food Safety Modernization Act of 2011 stresses the importance of quality testing standards and directs FDA to establish a program for laboratory accreditation. This work furthers that effort through collaboration with three national associations and their member governmental laboratories.

Methods: In 2012, FDA entered into five-year cooperative agreements with 31 state food-testing laboratories to either attain ISO/IEC 17025:2005 accreditation (23 laboratories/$300,000/year) or expand and maintain existing accreditation (8 laboratories/$150,000/year). At the same time, FDA awarded a five-year cooperative agreement to APHL to support accreditation in collaboration with AFDO and AAFCO. In 2015, an additional cohort of 6 food and 20 feed testing laboratories was awarded funding to obtain accreditation.

Results: The first cohort of laboratories (N=23) will be accredited by the end of 2017.  Among other support, APHL, AFDO and AAFCO have provided these laboratories with a Discussion Board, >200 documents posted to a resource website, >15 webinars posted providing training to >800 participants, targeted assistance to 16 unfunded laboratories, development of a Laboratory Curriculum Framework for Governmental Food and Feed Testing Laboratories, and publication of GOODSamples (Guidance for Obtaining Defensible Samples).

Significance: Investment in governmental laboratory accreditation for the nation’s regulatory food and feed testing laboratories will provide added value towards the mission of protecting the public health. Accreditation leads to greater laboratory capacity and improved quality of data submitted to regulatory food agencies. With all of the efforts above, the number of accredited laboratories performing regulatory testing will be significantly increased.