What is new and interesting with the release of the FDA’s Preventive Controls for Human Foods?

Obviously, it would be very difficult to boil down all the content of the new Food Safety Modernization Act’s Preventive Controls for Human Foods into a few key points. But after having participated in the three webinars that the FDA conducted last week on Preventive Controls for Human and Animals Foods ( the definition of a farm is still quite confusing and will be further defined in the future through guidance documents), Preventive Controls for Human Foods and Preventive Controls for Animal Food, I will give it a go. These presentations are available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247546.htm. The recordings of the webinars are coming soon as well.

For me there are a couple of the requirements that will be more challenging for some companies in the future comply with due to the leap from present preventive control to the new ones. The requirement for assessing and controlling pathogens in the production environment for Ready to Eat Foods and the firming up of allergen control program. A more detailed approach with an understanding of how these program extended into the overall food safety plan will be needed. Potentially greater visibility into ingredient statements and process testing for allergens to enhance detection may be required for compliance. Non traditional testing of areas other than the processing lines could be included to detect hidden allergen cross contamination sites.

The creation of a binding requirement for education and training of employees. The standard of compliance will be much higher now.

Supply Chain Quality/Food Safety Control will also become much more complex. The days of collecting audit certificates as evidence of compliance are over. A more detailed understanding of a suppliers food safety program will be required and any hazards that the ingredients may contain and these hazards need to be included in the finished goods hazard analysis. The trick is how you do manage this additional complexity without creating multiple new programs. The supplier has to notify the customer of the hazards present in an ingredient and obtain verification that the customer has processes in place to control/prevent the hazard. This is an interesting new component, in the past, the due dilgence was heavily on the customer to dig out the details. This new higher level of communication and document exchange will require a streamlined supply chain management program with high visibility of information and metrics.

The FDA is working on many new guidance document to help the industry understand the new regulations. The FDA has set up a forum in which questions may be asked for further clarification.