The Dialog Continues - FDA FSMA Clarifications

Brian Sharp
Contributing Writer

In the continuous pursuit of keeping up-to-date with all things FSMA, as well as being an avid reader of Food Safety Magazine, I felt a recent letter to the editor by Hal King, Ph. D. & Gary Ades Ph. D. was worth sharing.  It continues the dialog of an excellent article King & Ades wrote in Food Safety Magazine’s October/November issue titled, “The New GMP for Food Manufacturing.” 

After the article was published, they received a comment from Jenny Scott, a senior advisor from the Office of Food Safety, FDA Center for Food Safety and Nutrition. She provided a succinct yet useful list of clarifications that the FDA had put out regarding the final FSMA rules, after the article was published. If you missed it, the FDA clarification list included these points:  

  • The rules require that manufacturers have a program that would verify what their suppliers were doing rather than the rules require a supplier approval and verification program

  • FDA does not approve or disapprove a food safety plan. They will have access to plans and records as part of the inspection process

  • The validation of each HARPC plan for each facility is to be done by a qualified individual within 90 days, not before, the plan is implemented

  • HARPC is part of the total food safety plan, as a process, not to be confused with being the food safety plan

  • Processing controls must be validated, not preventive controls

As follow-up, King & Ades provide further insights on each of these above items in this month’s Food Safety Magazine issue – definitely a worthy (but quick!) read - click here.

And the education, interpretation and dialog of FSMA shall continue!  Be sure to save the date for our 2016 kick-off FSMA Fridays session January 29 with Dr. David Acheson and The Acheson Group. 

FSMA webinar series