FSMA Final Rule for Mitigation Strategies to Protect Food against Intentional Adulteration!!
The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Rather than targeting specific foods or hazards, this rule requires risk-reducing strategies for processes in certain registered food facilities. This regulation implements three provisions of the FD&C Act, as amended by FSMA, that relate to the intentional adulteration of food.
FDA has adopted an approach similar to Hazard Analysis Critical Control Point (HACCP) system to identify, evaluate and control the food safety hazard. The facilities covered under this rule must prepare and implement a “Food Defense Plan”. The plan should be reanalyzed every 3 years and should identify the various vulnerabilities and actionable process steps, risk analysis or mitigation strategies and procedure for food defense monitoring, corrective action and verification. Facilities must ensure that personnel assigned to the vulnerable areas receive appropriate training; facilities must maintain records for food defense monitoring, corrective actions, and verification activities.
Depending on the size of your business based on the sales in the preceding 3 years, the compliance dates for the rule varies as below
- Very Small Business- Average sales (including subsidiary and affiliates) less than $10 million have to comply within 5 years from date of final publication
- Small Business – Less than 500 employee have to comply within 4 years from date of final publication
- Other Business – In 3 years from date of final publication
A guidance document will be published to provide assistance to the industry. An online tool has already been setup for voluntary food defense program and a database is also available for strategies that can applied at various steps in food operation. An Intentional Adulteration Subcommittee with the Food Safety Preventive Controls Alliance has been established to develop food defense training resources for industry and regulators alike.
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