Preparing For FDA Rule on Protecting Food Chain

Preparing For FDA Rule on Protecting Food Chain

Ever heard of food terrorism? It’s a term used to describe the poisoning of a nation’s food supply, and it became a greater point of focus for the Food and Drug Administration (FDA) after the Sept. 11 terrorist attacks.

A Homeland Security report concluded that if terrorists were to contaminate American livestock with foot-and-mouth disease, the impact on the U.S. economy would exceed $50 billion. And that hypothetical situation isn’t so far-fetched. A 2002 raid on an al-Qaeda warehouse found documents detailing plans to attack U.S. agriculture.

The FDA’s proposed rule on food defense, officially titled Focused Mitigation Strategies to Protect Food Against Intentional Adulteration, focuses on reducing the chance of food terrorism acts that could cause massive public harm and economic disruption.

The proposed intentional food adulteration rule would affect most food facilities. A key point to note is that the rule uses a Hazard Analysis Critical Control Point (HACCP) framework, but with a different approach and different terminology. The HACCP framework reflects the FDA’s desire for consistency between Section 103 of the Food Safety Modernization Act (FASMA), which addresses preventive controls, and Section 106, which concentrates on intentional adulteration.

Under the proposed rule, applicable facilities will be responsible for preparing a food defense plan that includes actionable process steps; focused mitigation strategies; and procedures for monitoring, corrective actions and verification.

Food Defense Plan

Actionable Process Steps

Creating a food defense plan starts with a vulnerability assessment. The vulnerability assessment will lead you to identify actionable process steps. Actionable process steps can be compared to HACCP’s Critical Control Points (CCPs) – they are a step or procedure in a food process at which food defense measures can be applied to reduce vulnerabilities.

Significant vulnerabilities are areas where there is potential for serious adverse health consequences due to certain food procedures and the accessibility to those process points. In the first phase of developing a food defense plan, facilities determine the steps in their process where significant vulnerabilities are present, which is similar to conducting a hazard analysis.

The proposed rule offers two options for performing vulnerability assessments in order to identify actionable process steps. First, it can review its processes to determine whether it has any of the four key activity types identified by the FDA, which comprise of bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling, and mixing or similar activities. The facility would then pinpoint actionable process steps for each key activity conducted.

The second option offers more flexibility. With this second option, a facility would conduct its own vulnerability assessment. The assessment would need to be performed by a qualified individual, who would be in charge of evaluating each food process system with the intention of detecting significant vulnerabilities, if any. The evaluation should include specific elements noted in the preamble provided by the FDA. For every significant vulnerability detected, the facility needs to choose actionable process steps. For both options, facilities must include a justification for their conclusions in their written food defense plan.

Focused Mitigation Strategies

After a facility has identified their actionable steps, the next stage is to determine their focused mitigation strategies, if any. Comparable to HACCP’s preventive control measures, mitigation strategies are methods meant to minimize significant vulnerabilities identified as actionable process steps.

A focused mitigation strategy is required for each identified actionable process step, tailored and customized to that facility and specific operation. Focused mitigation strategies are required regardless of whether or not a facility uses broad mitigation strategies applying to an entire facility, such as perimeter fencing or security cameras.

Examples of focused mitigation strategies laid out in the FDA’s food safety preamble include controlling access, ensuring adequate lighting, using automated equipment, and inspecting equipment prior to use.

Monitoring, Corrective Actions and Verification

As the final step in its food defense plan, a facility must have written monitoring and corrective action procedures. It must also be able to verify that monitoring is being conducted, appropriate decisions about corrective actions are being made, and focused mitigation strategies are consistently employed. Reanalysis is required at least once every three years, or when investigating specific causes.


Encompassing both domestic and foreign facilities, the proposed food adulteration rule applies to almost all food facilities that are registered with the FDA unless they are covered by a specific exemption. Notably, it includes many facilities that are exempt from FSMA preventive control requirements, such as juice, seafood and dietary supplements.

The rule does not, however, include restaurants, retailers, food contact substance manufacturers, animal feed, or farms (expect dairy farms). Some other notable proposed exemptions to the rule are packing, re-packing and labeling activities; all food storage activities except liquid storage; activities subject to federal produce safety rules; and certain alcoholic beverage facilities.

Once the final rule is published, large business must be compliant within one year, small businesses with less than 500 employees must be compliant within two years, and very small businesses with less than $10 million in annual sales must be compliant within three years of publication of the rule.

Training & Recordkeeping

Employees who are assigned to actionable process steps must receive appropriate training in food defense awareness and their respective responsibilities. It’s important that all training is documented in records.

Food defense plan records need to be detailed and accurate, and created concurrently with performance of the activity documented. Specifically, records should include the name and location of the facility, the date and time of the activity documented, a signature of the person performing the activity, and the product name and code when applicable.

A HACCP-based approach will help facilities implement food defense plans to not only reduce the risk of intentional food adulteration, but also keep consumers safe and healthy, protect employees, protect your brand, and help you achieve regulatory compliance.

Learn more about workplace safety training.

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