December 28, 2013


FSMA Proposed Rule to Protect Intentional Adulteration of Food
FDA’s proposed rule, published on December 24, 2013, 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, mandated by the FDA Food Safety Modernization Act (FSMA), would require the largest food businesses to have a written food defense plan that addresses significant vulnerabilities in a food operation. Comments are invited by March 31, 2014.


The FDA is proposing that requirements be effective 60 days after the final rule is 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 FDA will hold a public meeting on February 20, 2014, to explain the proposal and provide additional opportunity for input. 

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 modern food and feed supply and recognizes the need for global approach food and feed safety as well. 

Acts of intentional adulteration may take several forms, such as the intentional large-scale public health harm; acts of disgruntled employees, consumers, or competitors; and economically motivated adulteration. 

While intentional adulteration of the food supply is unlikely to occur; however, it 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; FDA proposes targeting vulnerable processes rather than targeting specific foods or hazards.

With some exceptions, this proposed rule would apply to both domestic and foreign facilities that manufacture, process, pack, or hold food and are required to register as a food facility. This rule would not apply to farms or other food facilities not required to register.

The FDA has identified four key activities within the food system that are most vulnerable. 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)
  • Mixing and similar activities.
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
  • Focused mitigation strategies
  • Monitoring
  • Corrective actions
  • Verification
  • Training
  • Recordkeeping
The cost of the proposed rule to both domestic and foreign firms (annualized over 10 years at a 7 percent discount rate) is between $260 million and $470 million. The first-year cost is between $520 million and $860 million. The expected benefit of preventing a catastrophic terrorist attack on the US food supply is about $130 billion, such that the benefits of this rule outweigh the costs to Americans if the rule has a 1 in 730 or better annual chance of preventing such an attack.