Thursday, May 21, 2015

The Blue Bell Situation and the Impact of FSMA

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  In the FDA's 2008 draft guidance document,  Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods; Draft Guidance, recommendations for environmental and product sampling are made.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
Blue Bell and the Very Real Impact of the Food Safety Modernization Act
Posted on May 20, 2015 by FDA Voice

By: 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.

Ultimately, the only way we will achieve the goals that we are focused on—the goals that consumers expect us to achieve, and that industry wants us to reach—is if we have a system in which industry is systematically, every day, putting in place the measures that we know are effective in preventing contamination. And it’s not only a domestic issue; it’s an import issue. We’ve got to build prevention into the food safety system globally.

There’s no magic wand here. This is the most sweeping regulatory overhaul in the agency’s history and we’ve got to work systematically to put the right regulations in place. In the four years since FSMA became the law, we have been actively establishing the regulations that we will be issuing in final form beginning later this year.

For example, the preventive controls for human food rule, if finalized as proposed, would require that companies like Blue Bell have a written food safety plan, based on an analysis of likely hazards, and companies would have to show us that plan during inspections. Listeria monocytogenes is a classic example of a hazard that a company should be controlling. Under the proposed standards, companies would be required to have the right controls in place to minimize hazards and would have to verify that their controls are working.
We have in FSMA not only new, enforceable standards, but much stronger inspection and enforcement tools to make sure the standards are being met, such as access to company records and mandatory recalls –authorities we didn’t have before. Most companies want to do the right thing; many are doing it now. Through this law we want to promote strong food safety cultures and create real accountability throughout the industry.

We see broad support for implementing FSMA throughout our stakeholder community and among many people we talk to in Congress. President Obama’s 2016 request for $109.5 million in new budget authority to implement FSMA is crucial. If we receive that funding, we can move forward to implement this new, modern system in an effective and timely way. If we do not get the funding, we will lose momentum, and implementation will be badly disrupted.

No law can guarantee zero risk, from contaminated ice cream or any other food that has come in contact with a dangerous bacteria or other harmful substance. But FSMA is about providing assurances that the food system is doing everything it can to prevent problems and to provide food in grocery stores and restaurants that is as safe as it possibly can be.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

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