Food Safety Modernization Act (FSMA) and its Impact on Packaging

Posted on 6/29/2012 9:33:04 AM By Jeff Timm

Late last year the Federal Government passed the Food Safety Modernization Act (FSMA).  The final regulations are still being written by the FDA so the full impact of the law is still not known; however, some aspects that will require the immediate attention of the packaging industry are clear.  The Act is focused on improving and guaranteeing the safety of the food itself,  but since packaging plays such a vital role in protecting food and is part of the broader food industry supply chain that includes  ‘facilities that manufacture, process, pack, or hold foods’ packaging will ultimately be part of the three main sections of the FSMA:

First the law represents a shift from ‘reactive’ compliance to ‘proactive’ steps geared toward preventing contamination rather than responding to it.  In the simplest of situations this means that heat seals and flexible lidding must seal, flexible packaging films must provide barrier protection and puncture resistance as advertised, closures must close and rigid packaging must not crack due to environmental stress cracking (ESCR).
Next the law will require in some form stricter record keeping throughout the whole supply chain to improve traceability of materials used to make packaging.  Easy record access by the Food and Drug Administration (FDA) will also be a requirement.  I envision something akin to the tighter requirements now in play in the pharmaceutical packaging industry.  Along with traceability back to lot numbers, raw material certification data and various other manufacturing details, the law is favoring continuous inspection rather than spot inspection techniques.  This may require the incorporation of new automated control equipment on line or other new procedures that need to be implemented to assure a safer food supply. 
One other important note is that the FSMA will also require the same level of compliance on imported food and packaging as is required on domestically produced food and packaging.  This has ramifications not only for those food suppliers that are strictly importers, but also on multinational companies that sometimes use the flexibility of their supply chain to source food from multiple countries including the U.S. depending on demand, seasonality and other factors.
So what does all this mean for a packaging company?

  • At a minimum be prepared to receive multiple requests from your food manufacturing customers to be able to provide easy access to certification and traceability of your materials and all the components that you use to make your materials.  
  • Be prepared for new or increased FDA inspections of your facilities.
  • It is better to understand your responsibilities now rather than have to comply in a short period of time without much preparation.
  • Train your sales, customer service and marketing organizations to be able to address customer inquiries on this topic.
  • Make sure your own Regulatory Affairs & Compliance staff is geared up for this and can translate the final requirements when issued to those in your organization that need to put practices in place to comply.

As the Act directs, be proactive not reactive.  Living in this new regulatory environment will be a lot easier and less costly if your entire organization follows the same direction.

comments powered by Disqus