FSMA’s Missing Puzzle Piece

Departments - From the Advisory Board

August 14, 2017

ROGER BRAUNINGER, Biosafety Program, Manager, A2LA

It has been more than six years since President Obama signed into law the landmark Food Safety Modernization Act (FSMA). While there has been a significant amount of progress in many respects, one area of importance has yet to be acted upon. The missing piece of the FSMA puzzle, which was to have been implemented not later than two years after the date of the Act’s enactment, is the establishment of a program for the testing of food by accredited laboratories. Title II, Sec. 202 (Improving Capacity to Detect and Respond to Food Safety Problems; Laboratory Accreditation for Analyses of Foods) gives FDA the authority to develop a laboratory accreditation program (presumably based on ISO/IEC 17025).

It includes the establishment of a publicly available registry of accreditation bodies recognized by the secretary and laboratories accredited by a recognized accreditation body. The registry may include independent private labs (foreign and domestic) and those run and operated by a federal agency, state, or locality with a demonstrated capability to conduct sampling and analytical testing methodologies on foods.

To help encourage FDA to act upon this crucial element of FSMA, on May 18, members of the Food Laboratory Alliance, including myself for A2LA, Heather Jordan (API), Rob Debbout (Cherney), David Bryant (Eurofins), and Mark Hammersla (NSI Lab Solutions) ventured to Capitol Hill. Our goal was to visit members of Congress to request that they urge FDA to move forward on the creation of the accreditation program.

While FSMA authorizes FDA to develop a program for the accreditation of laboratories, it is for a specific narrow band of activities. Thus, a careful reading of the legislative language reveals the use of these laboratories is limited to the purpose of determining the need for a national recall or other compliance and enforcement activities. Stated another way: For routine quality control testing, food manufacturers will not be required to use these “FDA-recognized” accredited labs. But, it appears that the writing is on the wall: that routine testing results are to be taken seriously and will need to carry the same authority as a test report from an accredited laboratory.