FDA Rule May Require Food Manufacturers To Have Contamination Prevention Plan

Following a number of major food poisoning outbreaks in recent years, which have sickened or killed large numbers of Americans, the FDA has proposed new industry rules that would require producers to have an established contamination plan.

In an FDA Voice blog post released on May 20, the agency highlighted the recent Blue Bell ice cream Listeria outbreak, indicating that proposed rules may have prevented the multi-state outbreak that has claimed at least three lives.

The rules were initially proposed as modifications to food safety rules via the Food Safety Modernization Act (FSMA), introduced in 2010. FSMA adds preventive controls for the safety of human food, including requiring manufacturers to have a written safety plan in place in case of outbreaks.

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The proposed rules add safety measures to the production of human food, while attempting to be more flexible and less burdensome in certain areas of the requirements. However, the proposal involves wider regulations in areas of the industry which are currently unregulated.

The rules call for requiring food producers to conduct product testing for contamination, environmental monitoring to prevent contamination and supplier controls.

Food manufacturers would be required to have a written safety plan in place in case of outbreaks, based on an analysis of current hazards at that facility, and companies would be required to show the plan during FDA inspections. Currently there are no federal requirements calling for food producers to have a written plan.

Farms that pack or hold food from other farms are not subject to the preventive controls and no longer need to register as a food facility. Yet, farms doing additional food processing would be subject to preventive controls.

Food manufactures with less than $1 million in sales would be exempt from the proposed requirements.

Recent Food Poisoning Outbreaks Raise Concerns

The regulations come on the heels of a string of large food poisoning outbreaks, most of which could have easily been prevented.

The Listeria contamination at Blue Bell was traced back to the Oklahoma facility that has had signs of problems as far back as 2010. During the company’s own testing of nonfood contact areas of the facility Listeria was found in 2013. However, the ice cream was not recalled and no alarms were sounded until consumers began to fall ill earlier this year and, in some cases, die.

Inspections later revealed 26 violations involving lax sanitary practices. These findings lead investigators to believe if stricter plans were in place, this outbreak may have been prevented.

Another major food outbreak in 2011 had agency officials worried about food safety when cantaloupes grown by a Colorado company became tainted with Listeria. The outbreak infected nearly 150 people and causing 33 deaths.

More recently a Salmonella contaminated chicken hatchery in 2014 sickened 250 people in 32 states. The hatchery sells birds to many different retailers in different states and allows visitors to the facility to pet the livestock.

FDA officials say the food safety rules will be finalized by August 30; however the proposed regulations require further funding to be fully implemented. The agency is pushing for funding to ensure the rules can be operational. President Barack Obama recently asked Congress for $109 million to help the FDA implement the food safety law.


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