The past two years have been a challenge for both food processors and the FDA in understanding and implementing FSMA. In the June/July 2017 issue of Food Safety Magazine, at the start of FSMA compliance for most processors, we asked processors in the US, Canada and around the world about their plans for FSMA compliance, how they saw the regulations changing their operations, how they were preparing for FDA inspections, and anything else that they saw that they would be facing.
Now that it’s 2019 and processors have had (up to) 2 years of experience with FSMA, we wanted to get an update on how they were dealing with the new rules, what changes they’ve made, what’s working and what’s not, and what they’ve learned about this new regulatory environment. Our findings have been published in the April/May 2019 issue of Food Safety Magazine – in the Food Safety Insights column.
We found out that many processors have been dealing with the changes with the changes relatively well, considering the scope of the impacts. While many of their concerns still revolve around some of the same issues – interpretation of the regulations and managing conflicts from different requirements – their concerns and fears about onerous FDA inspections seems to have seems to have faded. In 2017, 60% of US/Canadian processors disagreed that the FDA will “educate before they regulate” and they expressed concern that FDA FSMA inspections would be difficult. In our current survey, 72% said that they found that indeed the FDA is educating before they regulate – and impressive turnaround in only two years! (Which has been recognized by FDA Officials – https://twitter.com/FrankYiannasFDA/status/1118989658573234176
Many of the processors who have had an inspection have said the inspections have been going very well, the FDA inspectors are better trained and more open to listening to the processors, and some processors also said their most recent inspections have been the “best ever.” It seems that we have found out that something is going quite well with FSMA inspections.
In Part Two of this investigation, which will be published in the June/July issue of Food Safety Magazine, we will present more findings about the changes in sampling, testing and environmental monitoring that processors have been making for FSMAS compliance and we will also hear directly from the FDA on their response to the survey findings.