• The Acheson Group

In the Midst of FSMA Guidance Issuance, FDA Discusses "What's Next"


While the arrival of the first of the FSMA compliance deadlines brings with it the need for enforcement, FDA's discussion of "What's Next" is much more heavily focused on cooperation and education. That is, statements by three FDA officials – Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, Deputy Commissioner for Global Regulatory Operations and Policy Howard Sklamberg, and Director of FDA’s Food and Feed Program in the Office of Regulatory Affairs Joann Givens – note that the Agency's focus will be on providing compliance support for industry through education, training and technical assistance.


Acknowledging that the FSMA rules bring new territory for the Agency as well as for food companies, a top priority for FDA is providing the framework for industry's implementation of preventive controls and cGMP requirements. As such, FDA has begun issuing draft guidance (as we have been discussing in many of our recent newsletters), and it plans to issue about two dozen more over the next few years.


The agency also stated that it intends to continue dialogue and collaboration with industry "to ensure that everyone understands and engages in their respective roles in food safety." It will continue conversations with stakeholders and seek public feedback on the guidance, implementing changes if necessary and fine-tuning aspects of the rule, stating, "This first wave of compliance dates is important to the entire spectrum of FSMA implementation; the lessons learned will be invaluable in the years ahead when smaller food facilities are held to the new standards."


However, food facilities need to take care to not let the Agency's acknowledgement of new territory and cooperation lull them into complacency. The rules are the rules, and the first of them are now effective for many food facilities. As such, the FDA statements make it clear that with its "mandate to protect public health," it will be looking at how facilities are working to comply with the new food safety standards, and will "act swiftly" to protect public health when it becomes necessary to do so.


So what should you be doing now? According to FDA, "The best thing that people in the food industry can do is take the measures required by the new rules – not just the letter of the law but what it represents in terms of transforming the food safety system."  But what does that really mean? I think where the FDA is going to make it clear is that food companies need to adopt the philosophy of preventive controls. As we have noted many times in the past, this is not just having a HACCP plan, rather it requires a more holistic approach.


Look at the big picture – think prevention and be proactive in potentially vulnerable areas; promptly correct problems, even if they aren’t yet violations; set up a thorough system for documenting what you do "The better the records, the more a company can demonstrate that it is meeting the legal standard"; and put processes and procedures in place to prevent problems, utilizing some redundancy so if a measure fails, another can take its place.

Food facilities should also be prepared to answer questions about problems that federal (or state) inspectors could find, such as:

  • When the problem(s) first came to your attention, what did you do?

  • Were you proactive in looking for the problems?

  • If you could not find a solution, did you get the right expertise?

  • Did you educate your employees?

The proactive approach to compliance represented by these questions is the approach facilities should be taking toward all aspects of FSMA. That is, creating a culture of food safety initiated by management, and being prepared to demonstrate what you are doing to meet the new requirements no matter when FDA may show up at your door.


As FDA sates, "These compliance dates aren’t the beginning of the end of our work to make FSMA a reality. They’re the end of the beginning." The ultimate goal is to see all food facilities doing the best they can: continuing to learn and improve and create a preventive, food safety system that is self-sustaining – with everyone in a food facility systematically operating in a way that complies with the law.


Thus FDA appears to be taking a soft approach right now to FSMA compliance. I suspect this is more due to the lack of training of FDA inspectors. Don’t be lulled into a false sense of security. Every other aspect of FDA’s behavior toward the food industry is aggressive, so it is only a matter of time before FSMA bites at the inspectional level.

About The Acheson Group (TAG)

Led by former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain.  With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. Learn more at: www.achesongroup.com

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