Food Defense

Definition

As defined by the US Food and Drug Administration, the efforts to prevent intentional food contamination by biological, physical, chemical, or radiological hazards that are not reasonably likely to occur in the food supply.

Applicable Code Requirements

  • 2.7.1.1
  • 2.7.1.2
  • 2.7.1.3
  • 2.7.1.4

Review Glossary Terms

  • Food Defense

Implementation & Audit Guidance

What does it mean?

Section 2.7 is about site security, including food defense. The supplier must document and implement a plan to assure the security of the site and the product from intentional damage or adulteration from sabotage or terrorist-like incident.

Why is it in the Code & why is it important?

The site must prepare, implement, and maintain a food defense protocol that is based off a food defense threat assessment and outlines the methods, responsibilities, and criteria for preventing food adulteration caused by deliberate acts of sabotage. This plan must be challenged and reviewed, at minimum, on an annual basis. The supplier must designate a member of senior management who has responsibility for food defense. This responsible individual must assure that there are procedures in place for recording and controlling access to areas of the site by employees, contractors, and visitors.

The food defense plan shall be tested or challenged to ensure the food defense strategies are effective, appropriate, and documented. The test of the food defense plan can be based off a description of a fictious scenario.

The protocol must identify how the supplier limits access to designated areas of the operation to only appropriately authorized employees. The supplier must implement steps to protect sensitive processing points from intentional contamination. The protocol should explain how the company ensures the secure storage and transportation of raw materials, packaging, equipment, hazardous chemicals and finished product.

The protocol must define how restricted, controlled or areas are to be addressed. The supplier is free to develop adequate measures to address specific areas to ensure control through a wide variety of solutions.

RIO Road to Audits (Records, Interviews, and Observations)

Records

The following are examples of records and/or documents to assist in the implementation and review of this topic:

  • The food defense plan including the food defense team, threat assessment, preventive strategies, contacts, and action plan.
  • Results from the annual review of the food defense plan.
  • Results from the annual test, or challenge, to the food defense plan.
  • Sign in sheets, identification tags or other means of how visitors and employees are monitored.
  • Corrective actions to any breaches to the plan.

Interviews

The following are examples of people to interview to assist in the implementation and review of this topic:

  • Senior site management responsible for food defense.
  • Site employees.

The following are examples of questions to ask to assist in the implementation and review of this topic:

  • What are the identified threats in the food defense plan?
  • How is the staff trained to ensure that these threats are controlled?
  • When and what was the last test or challenge to the system?
  • How often does the food defense team consider or assess any new threats?

Observations

The following are examples of observations to assist in the implementation and review of this topic:

  • Access points to secured/ restricted areas for controlled ingredients, sensitive processing points, hazardous chemicals, etc. is restricted.
  • Entry and controlled access points such as guard shacks, reception, production areas, physical security of the site including windows, doors, etc.
  • Tamper proof or tamper evident packaging.
  • Secure storage and transportation of ingredients, packaging, equipment not in use and storage and transportation of finished product.

Additional References

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Updated Date: 2022/10/01

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