According to the U.S. Food and Drug Administration (FDA), 15 percent of the U.S. food supply is imported from other countries. And that number is increasing, which raises new kinds of food safety concerns—especially when products originate from countries with regulatory systems that don’t adhere to the same standards as the FDA’s Food Safety Modernization Act (FSMA). For this reason, the FDA has been on a global voyage, visiting Canada, China and Mexico over the last few months in an effort to create a united food safety movement.
The agency is also embarking upon the next phase of FSMA, which addresses importers of food for humans and animals here in the United States. Through the month of June, the FDA held public meetings in an effort to educate the importer community on the FDA safety programs, which includes establishing an operational framework and plans for guidance documents, training, education and technical assistance.
The strategic objectives are to reduce food safety problems in the foreign supply chain, apply more effective interdiction of unsafe food at the port of entry, and provide more rapid and effective post-entry response to unsafe imports. In addition to that, the FDA recently released the “FSMA’s Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration,” and presented a webinar on food defense measures that an owner/operator of a manufacturing facility is required to implement to protect against intentional contamination of food.
I know your next question: “What now?”
First, understand that food defense is different from food safety as it addresses how someone could intentionally contaminate food, thereby looking at physical access to a facility, which is different from food safety analysis that prevents bacteria from getting into food.
The FDA’s food defense plan requires a vulnerability assessment, mitigation strategies, procedures in place for food defense monitoring, food defense corrective action, food defense verification, records documenting written procedures, and training. In the vulnerability assessment, for each step in a procedure, manufacturers must consider the potential for public health impact, the degree of physical access to a product and the ability of an attacker to successfully contaminate a product. This means that you have to consider an “inside job” too.
And, all of this must be reanalyzed at least every three years, or whenever there is a significant change that creates a new vulnerability. For most manufacturers, they will need to be compliant with this new rule by July 26, 2019. Small businesses (with fewer than 500 employees) have until 2020.
What’s interesting about the new rule is that the FDA doesn’t offer any suggestions on the types of tools and technologies that could help manufacturers with compliance other than providing access to its Food Defense Mitigation Strategies Database, which, upon further investigation, I found to be a very high level checklist of things to do. For example, the “bottle cleaner/soaker” category includes a long list of bulleted items ranging from “accompany unauthorized persons to restricted areas” to “use Clean in Place (CIP) equipment,” and “use automated equipment to restrict access to a product.” Figuring out how to implement all that stuff is up to you.
It’s clear the FDA wants food and beverage manufacturers to implement automation to meet FSMA preventive measures, but they don’t offer any advice on specific technologies that can help. So I will.
First, leverage technologies that are already in place, like a historian database, and make sure it is capturing all of the parameters of the process to track if something is out of spec. To that end, trend time and temperature of processes and automate recipe management. In addition, consider implementing an enterprise resource planning (ERP) system to maintain genealogy records and respond to document requests.
Now more than ever it is time to think about connecting the enterprise with the plant floor in order to have information that monitors everything from raw materials to the retail shelves. And, since the FDA food defense rule emphasizes physical access to production, perhaps the most obvious solution is to install a security surveillance system.
Of course, there is so much more to think about, so it may be time to call in the professionals. Turn to your automation supplier or systems integrator to make technology recommendations that can help with compliance. And do that soon because the clock is ticking.