FDA issues food adulteration regulation

The Food and Drug Administration has finalised a rule intended to prevent intentional adulteration of the US food supply.

Under the new rule all food facilities - both domestic and overseas - are required to complete and maintain a documented plan that assesses potential vulnerabilities to deliberate contamination "where the intent is to cause wide-scale public health harm."

The intention is to adopt a risk-assessment approach to protect the US food supply against intentional contamination due to sabotage, terrorism, counterfeiting, or other illegal, intentionally harmful means, according to the agency.

The rule applies to food companies and facilities but food carriers are outside the scope of the requirements.

The latest rule is the seventh to be finalised under the auspices of the Food Safety Modernization Act (FSMA) and according to the FDA's Stephen Ostroff "will work in concert with other components of FSMA by preventing food safety problems before they occur."

Facilities now have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, says the FDA.

They must also ensure that personnel assigned to these areas receive appropriate training and maintain certain records.

There is a three- to five-year deadline for compliance with the rule - depending on the size of the business - which some observers have suggested is generous given the potential for public harm from this type of activity.

The final rule on intentional adulteration "will further strengthen the safety of an increasingly global and complex food supply," said Ostroff, incoming deputy commissioner for foods and veterinary medicine at the agency.

The previous rules covered preventive controls for human and animal food, produce safety, a foreign supplier verification programme, third-party certification, and sanitary transportation.

The FDA has established an Intentional Adulteration subcommittee under the existing Food Safety Preventive Controls Alliance, a public-private alliance of industry, academic and government stakeholders, to help industry prepare for compliance. It will develop food defense training resources for both industry and regulators.

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