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The US Food and Drug Administration (FDA) said this week that it has finalized a new rule under the dictates of the Food Safety Modernization Act (FSMA) that requires both domestic and foreign food facilities "to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm."

According to FDA, "Facilities now have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to these areas receive appropriate training and maintain certain records."

It is the first time such a mandate has been imposed by FDA, which says that it "will help to prevent wide-scale public health harm by requiring companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply. While such acts are unlikely to occur, the new rule advances mitigation strategies to further protect the food supply."

Food manufacturers are required to comply with the new regulation within three to five years after publication of the final rule, depending on the size of the business.
KC's View:
One of the most important components of all new new FSMA rules is the notion of preventive controls. Companies can no longer just be reactive to problems ... they have to be ahead of the wave, with detailed plans for how to deal with issues and extensive, accessible records that can be provided to FDA almost on a moment's notice.

And yet, there is considerable evidence that a lot of companies aren't ready, aren't convinced that FSMA regulations will make the food system safer, and are ignorant to the possibility that senior executives can be held personally culpable if things go south. In this case, ignorance ain't bliss ... and, to coin a phrase, resistance is futile.

Full disclosure: In the interest of transparency, I need to point out here that ReposiTrak - which has created automated information management technology that allows companies to do the things necessary to comply with evolving FSMA regulations - is a longtime MNB sponsor, and I've produced a number of videos for them on the subject. Those videos - largely with senior food industry executives with a great deal of objectivity and knowledge - have convinced me about the seriousness of the situation and the need for retailers to get with the program.