Training options available in anticipation of upcoming human HARPC compliance date.

  • Under FDA’s hazard analysis and risk-based preventive control (HARPC) requirements  for human food and animal food, a food facility’s compliance strategy must be overseen by a “preventive controls qualified individual.”  Under both rules, a preventive controls qualified individual is defined as someone who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or who must be otherwise qualified through job experience to develop and apply a food safety system.  In Fall 2015, FDA announced its FSMA Training Strategy, indicating the Agency’s plan to facilitate industry training and thus promote effective FSMA implementation.  As the September 2016 general compliance date for the human HARPC requirements approaches, companies have been seeking training opportunities for their potential preventive controls qualified individuals.
  • FDA has collaborated with the Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH) to create the “Food Safety Preventive Controls Alliance” (FSPCA) to develop training courses that will help regulated industry comply with the HARPC rule in the months ahead.  In particular, the Alliance represents that its course entitled “FSPCA Preventive Controls for Human Food” is the “standardized curriculum” recognized by FDA, and that successfully completing this course is one way to meet the requirements for a preventive controls qualified individual.  The curriculum for animal HARPC training is still in development, with courses expected to begin in June.
  • Although the HARPC requirements do not require a preventive controls qualified individual to be qualified on the basis of training, many companies likely will find such training useful and instructive as they continue to develop and implement their FSMA compliance strategies.