FDA Proposes New Rule to Prevent Intentional Food Contamination

How the FDA Proposes the U.S. Protects Itself From Intentional Food Adulteration

Worker carrying crate of tomatoes in food processing plant
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In late December 2013, the U.S. Food and Drug Administration (FDA) proposed another rule in accordance with the 2011 Food Safety Modernization Act (FSMA) this time geared toward preventing intentional contamination of our food supply. This was the sixth rule proposed under FSMA, all of which have the common goal of ensuring the safety and security of our nation’s food and feed supply. The proposed rule is known as "Focused Mitigation Strategies to Protect Food Against Intentional Adulteration."

The New FSMA Rule

The FDA proposed its Focused Mitigation Strategies to Protect Food Against Intentional Adulteration rule as a response to calls for regulation that is aimed at mitigating intentional food adulteration. The rule requires the largest domestic and international food companies to take precautionary measures to prevent their facilities from intentional attempts to contaminate the food supply to cause public harm. FDA and FSMA will require these companies to create a written food defense plan addressing significant vulnerabilities in their food-related operations.

Instead of focusing on specific foods or hazards, this rule takes an approach targeting certain processes within a facility that are most likely to be vulnerable to adulteration. While the FDA believes intentional adulteration of the food supply to cause public harm is unlikely to occur, due to potential catastrophic results ranging from public health to adverse economic effects, the matter is not taken lightly.

Locating The Problem, Implementing The Plan

The FDA identified four specific areas where food adulteration is most likely to occur, which include:

  • Bulk liquid receiving and loading
  • Liquid storage and handling
  • Secondary ingredient handling (where ingredients other than the primary are handled prior to being combined with the primary ingredient itself)
  • Mixing and similar activities

Under the new FSMA rule, facilities having any of the aforementioned four areas will be required to complete their own vulnerability assessment. FSMA then requires the facility to identify procedures in the process in need of mitigation strategies and create a written food defense plan. Once in place, this rule holds the food facility responsible for implementation of their mitigation strategies to reduce risk of intentional adulteration.

What Food Defense Plans Will Look Like

FDA is requiring food defense plans to include seven steps to obtain the goals of this new rule:

  1. Actionable Process Steps: Facilities are required to identify any processing steps that will require attention and action. After analyzing data from vulnerability assessments using its CARVER+Shock methodology, the FDA recognized those four key activity types of concern. The FDA has determined that a facility with any of these activities presents an opportunity for intentional adulteration and must be handled accordingly.
  1. Focused Mitigation Strategies: At each identified processing step, mitigation strategies must be implemented to provide assurances of minimal chance of adulteration for food manufactured, processed, packed, or handled by the facility.
  2. Monitoring: Establish and implement procedures, including the frequency with which they are to be performed, for monitoring the focused mitigation strategies.
  3. Corrective Actions: The food defense plan should include possible corrective actions if focused mitigation strategies are not properly implemented.
  4. Verification: Verification activities would ensure monitoring is being conducted and appropriate decisions about corrective actions are being made. This will also help ensure mitigation strategies are consistently implemented, effective, and significantly minimizing or preventing vulnerabilities. Note: This rule also includes required reanalysis of a facility’s food defense plan ever three years or under specific conditions.
  5. 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.
  6. Recordkeeping: Of course, the rule will also require the establishing and maintenance of certain records, the written food defense plan, records documenting monitoring, verification activities and corrective actions, and documentation related to training of personnel.

Accommodating Companies of Different Sizes

The FDA proposed that the new rule requirements be implemented within 60 days after the final rule is published, but has recognized that smaller businesses may need additional time to comply. In response, the new rule proposed the following tier-based compliance dates have been provided based on company size:

  • Very Small Businesses: Defined as businesses with less than $10 million in total annual sales of food. Businesses that fall into this category would have three years from final publication of the rule to comply.
  • Small Businesses: Defined as businesses employing fewer than 500 employees. Businesses that are classified as small businesses under this definition would have to comply with the new rules within two years of the publication date.
  • Other Businesses: Businesses that are not classified as small or very small and do not qualify for exemptions (of which the FDA provided for many) must comply one year after the publication of the final rule.

Estimated Economic Impact of the New FSMA Rule

The expected benefit of preventing a catastrophic terrorist attack on the U.S. food supply is about $130 billion, which means 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. Of course, the primary benefit to rules aimed at preventing possible wide-spread intentional food adulteration is mitigating the health crisis and possible tragedy.

What's Next for the Proposed Rule

As with every other rule proposed under FSMA, the Focused Mitigation Strategies to Protect Food Against Intentional Adulteration rule was open for comments. The FDA also held a public meeting in February 2014 to explain the proposal and provide opportunity for additional input. The comment period on the proposed rule has ended, but the rule has yet to be finalized.


U.S. Food and Drug Administration. FSMA Proposed Rule for Focused Mitigation Strategies to Protect Food Against Intentional Adulteration. August, 2014.

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