Intentional Food Poisoning Targeted By New FDA Food Safety Rule

Federal health officials have finalized a new rule that will require food manufacturers to design defense programs to protect against intentional food poisoning outbreaks, which could cause wide spread harm in the United States. 

The FDA announced the finalized the Intentional Adulteration rule on May 26, requiring both foreign and domestic food facilities that manufacture, process, pack or hold food to create and maintain food defense strategies that assess the company’s vulnerability to deliberate food adulterations with the intent to cause public harm.

Although the FDA considers the likelihood of a deliberate act to cause harm to the public minimal, it is a precaution that the agency believes will strengthen the food supply market and close a vulnerability gap. The rule is the first of its kind to be issued under the FDA’s Food Safety Modernization Act (FSMA), which was enacted to create guidelines for the industry to prevent potential problems before they occur.

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Though no examples of past occurrences were cited in the press release, the FDA stats that intentional food poisonings designed to cause large-scale harm to the public could take many forms, including acts of disgruntled employees, consumers, competitors, and economically motivated reasons.

The Intentional Adulteration rule will require all foreign and domestic FDA-registered food facilities to abide by the rule to continue operating under their current conditions. The rule mandates that the facilities identify vulnerabilities in which they could be subject to intentional food adulteration.

Once these potential situations are recognized, the companies are to implement and maintain mitigation strategies to address the vulnerabilities, establish a food defense monitoring procedure and corrective actions, verify that the system is working, and ensure that personnel assigned to their specified areas receive appropriate training. Thorough record-keeping of the procedures will be required and will be subject to review upon the agency’s request.

The FDA announced it will be specifically monitoring, and may offer its own series or mitigation strategies for facilities involved in bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling, or the mixing of or any similar products and activities. The agency designated these types of facilities to be the most prone to and intentional adulteration.

The agency indicates that the rule will require partnership, education, and training and companies will be encouraged to share mitigation strategies to strengthen the new implementation. Federal agencies will be offering valuable tools such as guidance, training courses and technical assistance to make compliance easier on facilities.

The regulation will go into effect in 60 days and food manufacturers will be required to conform to the rule within three to five years, depending on the size of the business. Larger and high risk companies will be encouraged to conform as quickly as possible whereas smaller non-high risk facilities will be given more time to abide.


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