February 23, 2017

FDA Issues Draft Guidance for Control of Listeria in RTE Foods

The FDA is distributing a draft guidance, for comment purposes only, on the control of Listeria monocytogenes in ready to eat (RTE) foods. The guidance is for industry.

Listeria Monocytogenes Bacteria

All comments should be submitted electronically or written by July 17, 2017. The document is intended to help manufactures comply with current good manufacturing practices and risk-based preventive controls for human food. The final rule is the product of outreach by the FDA to industry, consumer groups, academia, and other stakeholders. The rule was first proposed in January 2013.

There is zero tolerance for Listeria monocytogenes in ready to eat foods. This bacteria causes serious illness and death. It grows at refrigerator temperatures, and freezing does not kill it. Heating to 160°F is the only way to destroy this pathogen.

There have been several outbreaks and many recalls in the past few years of ready to eat products for possible Listeria contamination. They include the deadly Dole salad Listeria outbreak in 2015, which sickened 33 people in Canada and the United States. Other outbreaks included the outbreak linked to Roos cheese in 2014 that sickened eight people; the Karoun Dairies outbreak that sickened 30 people and killed 3; and the deadly Listeria outbreak linked to recalled Blue Bell ice cream.

Facilities covered under this guidance must establish and implement a food safety system that begins with hazard identification and establishes preventive controls and oversight and management of those controls. The procedures must be monitored, and corrective actions must be taken to correct a minor, isolated problem before it becomes a big problem. Verification must be done to make sure that those preventive controls and implemented and are effective.

And the manufacturing facility must have a risk-based supply chain program for raw materials and other ingredients that have been identified as a hazard. Facilities that control hazards using preventive controls don’t need to have this program, or if the hazard will be controlled by a customer or other processor.

Very small businesses must comply by this rule three years from January 1, 2016. Businesses subject to the Pasteurized Milk Ordinance also have three years. Small businesses have two years, and all other businesses have one year to comply.

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