Food Defense Plan

"Each facility covered by this rule would be required to prepare and implement a written food defense plan, which would include the following:

Actionable process steps: Identify any actionable process steps, using one of two procedures. The FDA analyzed data from vulnerability assessments conducted using the CARVER + Shock methodology and identified four key activity types. The FDA has determined that the presence of one or more of these key activity types at a process step indicates a significant vulnerability to intentional adulteration aimed at large-scale public harm. Facilities may identify actionable process steps using the FDA-identified key activity types or conduct their own facility-specific vulnerability assessments.

Focused mitigation strategies: Identify and implement focused mitigation strategies at each actionable process step to provide assurances that the significant vulnerability at each step will be significantly minimized or prevented and that food manufactured, processed, packed, or held by the facility will not be adulterated. 

Monitoring: Establish and implement procedures, including the frequency with which they are to be performed, for monitoring the focused mitigation strategies.

Corrective actions: Using corrective actions if focused mitigation strategies are not properly implemented. 

Verification:  Verification activities would ensure that monitoring is being conducted and appropriate decisions about corrective actions are being made. It would also help ensure that the focused mitigation strategies are consistently implemented and are effectively and significantly minimizing or preventing any significant vulnerabilities. In addition, the rule includes requirements for periodic reanalysis of the food defense plan every three years or under certain conditions.

Training: Personnel and supervisors assigned to the actionable process steps would be trained in food defense awareness and in their responsibilities for implementing focused mitigation strategies.

Recordkeeping: Establish and maintain certain records, including the written food defense plan; records documenting monitoring, verification activities and corrective actions, and documentation related to training of personnel." – FDA

Is the Food Safety Modernization Act requiring it?

"The FDA Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011, to better protect human and animal health by helping to ensure the safety and security of the food and feed supply. FSMA embraces preventing food safety problems as the foundation of a modern food safety system and recognizes the need for a global approach to food and feed safety. The FDA has proposed five additional rules that are foundational to this preventive approach encompassed by FSMA. In addition to the rule on intentional adulteration, the FDA has proposed preventive controls for human food and separately for animal food; standards for produce safety. FDA has also proposed two rules related to imports: the Foreign Supplier Verification Program for importers, which requires importers to take steps to help ensure that imported human and animal food are as safe as that which is produced domestically, as well as a program for the accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce.

Acts of intentional adulteration may take several forms, including those where the intention is to cause large-scale public health harm; acts of disgruntled employees, consumers, or competitors; and economically motivated adulteration. Acts of disgruntled employees, consumers, or competitors are generally directed at attacking the reputation of the company and not at causing public health harm. The primary purpose of economically motivated adulteration is to obtain economic gain, and not to impact public health, although public health harm may occur.

Intentional adulteration of the food supply with intent to cause public health harm is unlikely to occur. However, intentional adulteration could have catastrophic results including human illness and death, loss of public confidence in the safety of food, and significant adverse economic impacts, including trade disruption, all of which can lead to widespread public fear. Efforts to protect against intentional adulteration require a shift in perspective from what is taken for traditional food safety. The FDA proposes an approach that targets certain processes within a facility that are most likely to be vulnerable, rather than targeting specific foods or hazards. The Agency recognizes the inherent challenges faced when creating practical and reasonable regulations to address this kind of intentional adulteration and seeks public input to help refine the approach and scope of the rule."- FDA

FDA's Food Defense Program & FSMA

What is a Food Defense Program? (As stated directly from the FDA website)

"FDA’s proposed rule on food defense would require domestic and foreign facilities to address vulnerable processes in their operations to prevent acts on the food supply intended to cause large-scale public harm. The proposed rule, which is required by the FDA Food Safety Modernization Act, would require the largest food businesses to have a written food defense plan that addresses significant vulnerabilities in a food operation.

The FDA is proposing that the requirements was effective 60 days after the final rule was published in the Federal Register. Recognizing that small and very small businesses may need more time to comply with the requirements, the FDA is proposing tiered compliance dates based on facility size. The proposed rule was published on December 24, 2013. 

Highlights of the Proposed Rule

The subject of this proposed rule is to protect food from intentional adulteration when the intent is to cause large-scale public harm. The FDA has identified four key activities within the food system that are most vulnerable to such forms of adulteration. They include:

bulk liquid receiving and loading;

liquid storage and handling;

secondary ingredient handling (the step where ingredients other than the primary ingredient of the food are handled before being combined with the primary ingredient); and

mixing and similar activities.

Facilities would be required to review their production system to determine if they have any of these activity types or complete their own vulnerability assessment. Once that is completed, they would need to identify actionable process steps, which are points, steps, or procedures in a food process that will require focused mitigation strategies to reduce the risk of intentional adulteration. Facilities are also required to complete a written food defense plan. Once in place, this proposed rule would establish measures that a food facility would be required to implement to protect against the intentional adulteration of food.

Compliance Dates:

Very Small Businesses—a business that has less than $10,000,000 in total annual sales of food would have to comply within three years after the publication of the final rule.

Small Businesses—a business employing fewer than 500 persons would have to comply two years after the publication of the final rule.

Other Businesses—a business that is not small or very small and does not qualify for exemptions would have to comply one year after the publication of the final rule." -FDA



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