Recognizing the vulnerability of the food supply to intentional adulteration, Congress has determined that rules be established to prevent it from happening. Under the rule for mitigation strategies to protect against intentional adulteration, food companies are required to establish a food defense plan similar to the HACCP approach. The defense plan must include the following key areas:

  1. Identify Actionable Process Steps
  2. Mitigation Strategies
  3. Procedures for Monitoring
  4. Procedures for Corrective Actions
  5. Procedures for Verification
  6. Training
  7. Record Keeping

Identify Actionable Process Steps: This involves conducting a vulnerability assessment for each step in the process to determine likelihood and severity of contamination due to intentional adulteration. The following considerations must be made:

  1. Severity and scale of the potential impact on public health. Severity is assessed based on: the volume of the product; number of servings; how fast the food moves through the distribution system; the food hazard of concern and its threat; and the possible number of illnesses and deaths from the injury
  2. The degree of physical access to the product. Here you must consider the presence of gates, railing, doors, lids, seals and shields
  3. The ability to successfully contaminate the food

Steps that are found to be likely places where intentional contamination is reasonably likely to occur without control are called “actionable process steps”. They are analogous to CCPs in HACCP. Areas that have been found to be most vulnerable for intentional contamination are:

  1. Bulk liquid receiving and loading
  2. Liquid storage and handling
  3. Secondary ingredient handling (i.e. handling of ingredients other than the main ingredients)
  4. Mixing and similar activities

Mitigation Strategies: Steps taken to prevent intentional adulteration at each actionable process step. Mitigation strategies may include:

  1. Background checks on workers
  2. Reducing access to sensitive areas e.g. fencing, guards, rails, sign-in procedures, swipe cards, assigning keys, tamper-proof seals on trucks
  3. Vigilance by supervisors, and use of surveillance cameras

Procedures for Monitoring: Checking the plan to make sure mitigation steps are taken at actionable process steps.

Procedures for Corrective Actions: The appropriate response to take if mitigation strategies are not followed properly.

Procedures for Verification: Checking that monitoring and corrective actions are followed according to plan. The plan must be reassessed every three years or as needed to ensure that it is effective.

Training and Record Keeping: Personnel must receive training in food defense. Appropriate records of monitoring, corrective action and verification must be kept.


  1. A very small business (averaging less than $10 million per year (average of last 3 years in sales plus market value of food processed, packed or held without sale)
  2. Facilities that just hold food i.e. food warehouses, except facilities holding food stored in liquid tanks
  3. Facilities that pack/repack, or label/relabel foods, where the package directly contacting the food remains intact
  4. Farms
  5. Facilities that manufacture, process, pack or hold food for animals
  6. Facilities that produce alcoholic beverages
  7. On-farm manufacturing, processing, packing or holding by a small or very small business, in the case that food is considered low-risk
Courtney Simons
Courtney Simons is a food science professor. He holds a BS degree in food science and a Ph.D. in cereal science from North Dakota State University.
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