In his piece,
Blue Bell and the Very Real Impact of the Food Safety Modernization Act, FDA’s Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, discusses how FSMA will help prevent (not eliminate) foodborne outbreaks such as those associated with
ice cream sold by Blue Bell.The coming change with an implemented FSMA regulation that can be taken from this article is that companies will need 'real' controls in place for hazards that have been determined for their product and operation. Real controls are ones that are well planned, implemented and verifiable. This not only covers process-related controls, but those that had been considered as part of the prerequisite programs...sanitation for example.
In the Blue Bell case, Listeria monitoring was in place, but all their program was really able to do was show that Listeria was showing up, but beyond that, questions could be easily raised - was it in product, was it on food contact surfaces, what was the source and was anything done to eliminate that source. In the FDA's 2008 draft guidance document,
Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods; Draft Guidance, recommendations for environmental and product sampling are made. However, FSMA differs in that it will ask....'how do you know?'. So instead of recommending testing, the question is 'how do you know you are controlling Listeria?'. It is now on the that processor to be able to provide proof of control...which in this case, is most likely testing of the environment as well as product. Along with that, verification, documentation, and corrective action.
So in the build-up to FSMA, challenge the controls by asking 'how do you really know' whether the controls you have identified are working. How do you know whether the corrective actions taken eliminated the hazard from occurring and prevented suspect product from reaching the consumer.
FDA Voice http://blogs.fda.gov/fdavoice/index.php/2015/05/blue-bell-and-the-very-real-impact-of-the-food-safety-modernization-act/Blue Bell and the Very Real Impact of the Food Safety Modernization ActPosted on
May 20, 2015 by
FDA VoiceBy: Michael R. Taylor
Could the deadly outbreak of illnesses tied to contaminated ice cream have been prevented? It’s an important question, one that is on the minds of many in the wake of the multi-state outbreak of Listeria monocytogenes tied to ice cream produced by Blue Bell Creameries.
Above all else, we need to acknowledge the tragic aftermath. Our hearts go out to the friends and family members of the victims – the 10 people who were hospitalized and the three who died.
Our mission in the face of such tragedies is to work to keep them from happening again, first by investigating the cause. If products are found to be contaminated with Listeria monocytogenes or other pathogens, we work with companies to recall anything that has the potential to cause illness. The FDA joins with other federal agencies, states, and industry, while also communicating directly with consumers — all in an effort to ensure that more people don’t get sick or worse.
But more needs to be done, and more is being done. Congress passed the
FDA Food Safety Modernization Act (FSMA) in December 2010 because of outbreaks like this, because of a widespread concern among legislators, consumers and industry about foodborne illnesses that kill thousands each year.
| By MARY CLARE JALONICK