It is in the spirit of collaboration that we at FDA have invested much time and energy over the last year in outreach to the food industry and other stakeholders to gain input prior to proposing rules for implementing FSMA. And it is in the spirit of collaboration that I am here today, with a focus on the role public-private collaboration – and particularly accredited third party certification – can play in providing the food safety assurances consumers seek.
We’ve discussed this topic before, but our dialogue is about to reach a critical new phase as FDA moves down the pathway of implementing FSMA. We will soon be publishing proposed rules that will establish the basic regulatory framework for the new food safety system, as it will operate with respect to both domestic and imported food. This means we will be getting down to some of the crucial details of how FSMA will work in practice.
To facilitate our collaboration in getting the rules right, I’ll briefly review the five highest priority framework rules, so you can be prepared to provide further input. I’ll also flag some of the challenges we must work on together to fulfill the promise of accredited third-party certification.
Key FSMA Framework Rules
Three of the forthcoming proposed rules relate to establishing the basic regulatory framework for prevention that Congress mandated for those who grow and pack fresh produce and process food and animal feed. While Congress recognized that prevention is a shared responsibility of all participants in the food system, it also recognized the differences among facilities that manufacture or pack food and animal feed, and farms that grow produce. That is why we are proposing three separate rules to establish the basic framework of prevention standards.
Facilities that process human food will be required to establish modern preventive controls that are consistent with internationally recognized principles of Hazard Analysis and Critical Control Points (HACCP) and address supplier verification activities that relate to the safety of food. Congress used some different terms in mandating preventive controls in all types of food facilities, but these proposed rules will seem familiar to those who are currently following Codex principles and guidelines for HACCP.