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Smart Food Safe participating in SQF Unites 2025, from March 2nd - 5th, 2025 at the Hyatt Regency, Orlando, Florida. Meet us at Booth #16 .

Smart Food Safe participating in SQF Unites 2025, from March 2nd - 5th, 2025 at the Hyatt Regency, Orlando, Florida. Meet us at Booth #16 .

Smart Food Safe participating in SQF Unites 2025, from March 2nd - 5th, 2025 at the Hyatt Regency, Orlando, Florida. Meet us at Booth #16 .
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Food Safety Management

Setting up a Food Defense Plan: Focusing on Key Food Defense Regulatory Requirements

Setting up a Food Defense Plan: Focusing on Key Food Defense Regulatory Requirements

Arundhathy Shabu

May 10, 2024

Food Safety Management

Setting up a Food Defense Plan: Focusing on Key Food Defense Regulatory Requirements

Arundhathy Shabu

MAY 10, 2024

Setting up a Food Defense Plan: Focusing on Key Food Defense Regulatory Requirements

Food Safety Management

Arundhathy Shabu

.

May 10, 2024

A highly disturbing incident back in October 2022 depicted a factory worker “knowingly and maliciously” contaminated food destined for Nando’s by putting plastic bags, rubber gloves, and metal rings while working at a Worcestershire food manufacturer. 

This is a classic example of intentional food adulteration with an ideologically driven motive of harming, that happened in the contemporary scenario of food production and processing. It ushers the importance of establishing a powerful food defense system in any food business enterprise.

History of Food Defense 

The genesis of modern food defense concerns in the United States can be traced back to the aftermath of the tragic terrorist attack on September 11, 2001. This pivotal event underscored the vulnerability of food supply chains to deliberate acts of sabotage and terrorism. In response, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, commonly known as the Bioterrorism Act, was swiftly enacted. 

This landmark legislation empowered the Food and Drug Administration (FDA), in collaboration with U.S. Customs and Border Protection (CBP), with enhanced authority to safeguard the nation’s food supply against malevolent acts and emerging threats. Among its provisions was the mandate to fortify food safety measures and strengthen defense mechanisms.

In alignment with this directive, various institutions emerged across the United States dedicated to shielding agricultural and industrial systems from potential terrorist incursions. Notable among these is the Food Protection and Defense Institute, established in July 2004 under the auspices of the University of Minnesota. It was conceived with a mission to fortify food safety systems through rigorous research and educational initiatives.

A milestone in the evolution of food defense occurred in anticipation of the 2012 Olympics in London. Prior to the global event, stringent measures were enacted necessitating all food suppliers to implement comprehensive risk-based analysis and prevention plans. These measures aimed to preempt deliberate contamination and mitigate the looming specter of terrorism.

Over time, the conceptualization of food defense has undergone refinement, resulting in clearer and more concise definitions that resonate across diverse food institutions. This evolution reflects a concerted effort to adapt to emerging threats and uphold the integrity of today’s global food systems.

Significant Definitions of Food Defense

  • In 2014, the British Institute for Standardization (BSI) released a “Guide to protecting and defending food and drink from deliberate attack.” This guide outlines food defense as a set of measures and protocols aimed at ensuring the safety of food and beverages, along with their supply chains, against deliberate and ideologically motivated attacks that could result in contamination or supply disruptions.
  • Shortly after, the PAS 96:2017 states that food defense represents adopted procedures to ensure food and beverage security, as well as their supply chain from malicious and ideologically driven attacks that lead to contamination or disruption of supply
  • According to USDA FSIS, food defense is the protection of food products from contamination or adulteration intended to cause public health harm or economic disruption.
  • The GFSI definition of food defense is the process of ensuring the security of food and drink from all forms of intentional malicious attack including ideologically motivated attacks leading to contamination
  • FDA’s FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration demonstrates food defense as the effort to protect food from intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply.

Developing a Functional Food Defense Plan

An establishment can employ a functional food defense plan as a crucial measure to prevent, safeguard against, lessen the impact of, address, and recuperate from any deliberate contamination event. The main goal of a food defense plan is to lower the opportunities as much as possible for such contamination to take place through:

Step 1: Develop your food defense plan
The plan must be formally documented and signed, outlining mitigation strategies and protective measures. Conducting vulnerability assessments aids in identifying areas requiring mitigation strategies.

Step 2: Implement mitigation strategies and protective measures

Mitigation strategies and protective measures identified in the plan should be put into action to safeguard facilities, personnel, and operations.

Step 3: Test the mitigation strategies and protective measures

Regular testing of the food defense plan, preferably annually, is essential. Testing can involve verifying the functionality of implemented measures, such as locks and cameras.

Step 4: Review and maintain

Regular review and maintenance are crucial to keep the food defense plan current and effective. Annual reviews are recommended, with adjustments made as necessary based on routine monitoring, exercises, real-world incidents, or other changes.

However, implementing a food defense plan is equally paramount as adhering to food defense regulatory requirements, amplifying the importance of following standardized protocols consistently across the food sector. Compliance not only promotes a culture of safety and vigilance within food establishments but also fosters resilience against potential threats, ultimately upholding the fundamental right to access safe and secure food.

Comparison of Different Regulatory Body Requirements for Food Defense

Food Defense Guidelines Based on IFS Food Version 8 (Active from 01.01.2024)

4.21.1

  • The responsibility for the food defense plan shall be defined. Those responsible person(s) shall have the appropriate specific knowledge.
  •  

4.21.2

  • A food defense procedure and plan shall be documented, implemented, and maintained to identify potential threats and define food defense measures. This shall include at a minimum:
  • legal requirements identification of critical areas and/or practices and policy of access by employees visitors and contractors
  • how to manage external inspections and regulatory visits
  • The food defense plan shall be reviewed at least annually and updated when appropriate.

4.21.3

  • The food defense plan shall be tested for effectiveness and reviewed at least once within a 12- month period or whenever significant changes occur.
  •  

IFS V7

  • The food defense plan shall be tested for effectiveness and reviewed at least once within a 12- month period or whenever significant changes occur.
  •  

Food Safety Management Software

Boost your food business’s hygiene standards with Smart Food Safe’s tech-driven solutions—streamline 4C processes to yield optimal results, and ensure compliance effortlessly.

Food Safety Management Software

Boost your food business’s hygiene standards with Smart Food Safe’s tech-driven solutions—streamline 4C processes to yield optimal results, and ensure compliance effortlessly.

Food Defense Guidelines Based on FSSC 22000 Version 6 (Active from 01.04.2024)

2.5.3 Food Defense/FSSC 22000 Additional Requirements

2.5.3.1 Threat Assessment

  • The organization shall have a documented procedure in place to: Conduct a threat assessment to identify and assess potential threats; Develop and implement mitigation measures for significant threats.
  •  

2.5.3.2
Plan

  • The organization shall have a documented food defense plan specifying the mitigation measures covering the processes and products within the FSMS scope of the organization.
  • The food defense plan shall be supported by the organization's FSMS.
  • The plan shall comply with applicable legislation and be kept up-to-date.

18.1 Food Defense PRPs

  • Food defence, biovigilance, and bioterrorism 150/TS 220001
  • Each establishment shall assess the hazard to products posed by potential acts of sabotage, vandalism, or terrorism and shall put in place proportional protective measures.

18.2 Access Controls

  • Potentially sensitive areas within the establishment shall be identified, mapped, and subjected to access control.
  • Where feasible, access should be physically restricted by the use of locks, electronic card keys, or alternative systems.

Food Defense Guidelines Based on BRC Issue 9 (Active from 01.02.2024)

4.2 Site Security and Food Defence

4.2.1 Documented Assessment of Security

  • The company shall undertake a documented risk assessment (threat assessment) of the potential risks to products from any deliberate attempt to inflict contamination or damage. This threat assessment shall include both internal and external threats.
  • The output from this assessment shall be a documented threat assessment plan. This plan shall be kept under review to reflect changing circumstances and market intelligence. It shall be formally reviewed at least annually and whenever.

4.2.2 Additional Controls to Mitigate Risks

  • Where raw materials or products are identified as being at particular risk, the threat assessment plan shall include controls to mitigate these risks. Where prevention is not sufficient or possible, systems shall be in place to identify any tampering.
  • These controls shall be monitored, the results documented, and the controls reviewed at least annually.

4.2.3 Authorised Access

  • Areas where a significant risk is identified shall be defined, monitored, and controlled. These shall include external storage and intake points for products and raw materials (including packaging).
  • Policies and systems shall be in place to ensure that only authorized personnel have access to production and storage areas, and that access to the site by employees, contractors, and visitors is controlled. A visitor recording system shall be in place.
  • Staff shall be trained in site security procedures and food defense.

4.2.4 Registration of Food Production Sites

  • Where required by legislation, the site shall maintain appropriate registrations with the relevant authorities.

Food Defense Guidelines Based on SQF Code Edition 9 (Active from 24.05.2021)

2.7 Food Defense and Food Fraud/ 2.7.1 Food Defense Plan

2.7.1.1 Requirement

  • A food defense threat assessment shall be conducted to identify potential threats that can be caused by a deliberate act of sabotage or terrorist-like incident.

2.7.1.2 Requirement

  • A food defense plan shall be documented, implemented, and maintained based on the threat assessment (refer to 2.7.1.1). The food defense plan shall meet legislative requirements as applicable and shall include at a minimum:
  • The methods, responsibility, and criteria for preventing food adulteration caused by a deliberate act of sabotage or terrorist-like incident
  • The name of the senior site management person responsible for food defense
  • The methods implemented to ensure only authorized personnel have access to production equipment and vehicles, manufacturing, and storage areas through designated access points
  • The methods implemented to protect sensitive processing points from intentional adulteration

2.7.1.3 Requirement

  • Instruction shall be provided to all relevant staff on the effective implementation of the food defense plan (refer to 2.9.2.1).

2.7.1.4 Requirement

  • The food defense threat assessment and prevention plan shall be reviewed and tested at least annually or when the threat level, as defined in the threat assessment, changes. Records of reviews and tests of the food defense plan shall be maintained

Food Defense Guidelines Based on Global G.A.P Version 6 (Active from 01.01.2024)

AF10 Food Defense

AF 10.1 Requirement

  • Potential intentional threats to food safety in all phases of the operation shall be identified and assessed.
  • Food defense risk identification shall ensure that all input is from safe and secured sources. Information on all employees and subcontractors shall be available.
  • Procedures for corrective action shall be in place in case of intentional threat.

Empower Your Food Defense Compliance with Smart Food Safe’s Smart Docs

In the perpetually transforming scene of food defense compliance, staying ahead requires more than just diligence—it demands innovation. Smart Food Safe’s Smart Doc enables food businesses to fortify their food defense strategies, mitigate risks, and uphold the highest standards of safety and security. With Smart Doc, you can navigate the complexities of food defense compliance with confidence, knowing that your documents are not just managed, but mastered.

Food Safety Management Software

Fortify your food establishment’s food defense compliance by adhering to key regulatory requirements with Smart Docs.

A highly disturbing incident back in October 2022 depicted a factory worker “knowingly and maliciously” contaminated food destined for Nando’s by putting plastic bags, rubber gloves, and metal rings while working at a Worcestershire food manufacturer. 

This is a classic example of intentional food adulteration with an ideologically driven motive of harming, that happened in the contemporary scenario of food production and processing. It ushers the importance of establishing a powerful food defense system in any food business enterprise.

History of Food Defense 

The genesis of modern food defense concerns in the United States can be traced back to the aftermath of the tragic terrorist attack on September 11, 2001. This pivotal event underscored the vulnerability of food supply chains to deliberate acts of sabotage and terrorism. In response, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, commonly known as the Bioterrorism Act, was swiftly enacted. 

This landmark legislation empowered the Food and Drug Administration (FDA), in collaboration with U.S. Customs and Border Protection (CBP), with enhanced authority to safeguard the nation’s food supply against malevolent acts and emerging threats. Among its provisions was the mandate to fortify food safety measures and strengthen defense mechanisms.

In alignment with this directive, various institutions emerged across the United States dedicated to shielding agricultural and industrial systems from potential terrorist incursions. Notable among these is the Food Protection and Defense Institute, established in July 2004 under the auspices of the University of Minnesota. It was conceived with a mission to fortify food safety systems through rigorous research and educational initiatives.

A milestone in the evolution of food defense occurred in anticipation of the 2012 Olympics in London. Prior to the global event, stringent measures were enacted necessitating all food suppliers to implement comprehensive risk-based analysis and prevention plans. These measures aimed to preempt deliberate contamination and mitigate the looming specter of terrorism.

Over time, the conceptualization of food defense has undergone refinement, resulting in clearer and more concise definitions that resonate across diverse food institutions. This evolution reflects a concerted effort to adapt to emerging threats and uphold the integrity of today’s global food systems.

Significant Definitions of Food Defense

  • In 2014, the British Institute for Standardization (BSI) released a “Guide to protecting and defending food and drink from deliberate attack.” This guide outlines food defense as a set of measures and protocols aimed at ensuring the safety of food and beverages, along with their supply chains, against deliberate and ideologically motivated attacks that could result in contamination or supply disruptions.
  • Shortly after, the PAS 96:2017 states that food defense represents adopted procedures to ensure food and beverage security, as well as their supply chain from malicious and ideologically driven attacks that lead to contamination or disruption of supply
  • According to USDA FSIS, food defense is the protection of food products from contamination or adulteration intended to cause public health harm or economic disruption.
  • The GFSI definition of food defense is the process of ensuring the security of food and drink from all forms of intentional malicious attack including ideologically motivated attacks leading to contamination
  • FDA’s FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration demonstrates food defense as the effort to protect food from intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply.

Developing a Functional Food Defense Plan

An establishment can employ a functional food defense plan as a crucial measure to prevent, safeguard against, lessen the impact of, address, and recuperate from any deliberate contamination event. The main goal of a food defense plan is to lower the opportunities as much as possible for such contamination to take place through:

  • Identifying Vulnerabilities
  • Implementing Controls
  • Training and Awareness
  • Emergency Response

As per USDA FSIS, setting up a functional food defense plan involves:
Step 1: Develop your food defense plan

The plan must be formally documented and signed, outlining mitigation strategies and protective measures. Conducting vulnerability assessments aids in identifying areas requiring mitigation strategies.

Step 2: Implement mitigation strategies and protective measures

Mitigation strategies and protective measures identified in the plan should be put into action to safeguard facilities, personnel, and operations.

Step 3: Test the mitigation strategies and protective measures

Regular testing of the food defense plan, preferably annually, is essential. Testing can involve verifying the functionality of implemented measures, such as locks and cameras.

Step 4: Review and maintain

Regular review and maintenance are crucial to keep the food defense plan current and effective. Annual reviews are recommended, with adjustments made as necessary based on routine monitoring, exercises, real-world incidents, or other changes.

However, implementing a food defense plan is equally paramount as adhering to food defense regulatory requirements, amplifying the importance of following standardized protocols consistently across the food sector. Compliance not only promotes a culture of safety and vigilance within food establishments but also fosters resilience against potential threats, ultimately upholding the fundamental right to access safe and secure food.

Comparison of Different Regulatory Body Requirements for Food Defense

Food Defense Guidelines Based on IFS Food Version 8 (Active from 01.01.2024)

4.21.1

  • The responsibility for the food defense plan shall be defined. Those responsible person(s) shall have the appropriate specific knowledge.
  •  

4.21.2

  • A food defense procedure and plan shall be documented, implemented, and maintained to identify potential threats and define food defense measures. This shall include at a minimum:
  • legal requirements identification of critical areas and/or practices and policy of access by employees visitors and contractors
  • how to manage external inspections and regulatory visits
  • The food defense plan shall be reviewed at least annually and updated when appropriate.

4.21.3

  • The food defense plan shall be tested for effectiveness and reviewed at least once within a 12- month period or whenever significant changes occur.
  •  

IFS V7

  • The food defense plan shall be tested for effectiveness and reviewed at least once within a 12- month period or whenever significant changes occur.
  •  

Food Safety Management Software

Boost your food business’s hygiene standards with Smart Food Safe’s tech-driven solutions—streamline 4C processes to yield optimal results, and ensure compliance effortlessly.

Food Safety Management Software

Boost your food business’s hygiene standards with Smart Food Safe’s tech-driven solutions—streamline 4C processes to yield optimal results, and ensure compliance effortlessly.

Food Defense Guidelines Based on FSSC 22000 Version 6 (Active from 01.04.2024)

2.5.3 Food Defense/FSSC 22000 Additional Requirements

2.5.3.1 Threat Assessment

  • The organization shall have a documented procedure in place to: Conduct a threat assessment to identify and assess potential threats; Develop and implement mitigation measures for significant threats.
  •  

2.5.3.2
Plan

  • The organization shall have a documented food defense plan specifying the mitigation measures covering the processes and products within the FSMS scope of the organization.
  • The food defense plan shall be supported by the organization's FSMS.
  • The plan shall comply with applicable legislation and be kept up-to-date.

18.1 Food Defense PRPs

  • Food defence, biovigilance, and bioterrorism 150/TS 220001
  • Each establishment shall assess the hazard to products posed by potential acts of sabotage, vandalism, or terrorism and shall put in place proportional protective measures.

18.2 Access Controls

  • Potentially sensitive areas within the establishment shall be identified, mapped, and subjected to access control.
  • Where feasible, access should be physically restricted by the use of locks, electronic card keys, or alternative systems.

Food Defense Guidelines Based on BRC Issue 9 (Active from 01.02.2024)

4.2 Site Security and Food Defence

4.2.1 Documented Assessment of Security

  • The company shall undertake a documented risk assessment (threat assessment) of the potential risks to products from any deliberate attempt to inflict contamination or damage. This threat assessment shall include both internal and external threats.
  • The output from this assessment shall be a documented threat assessment plan. This plan shall be kept under review to reflect changing circumstances and market intelligence. It shall be formally reviewed at least annually and whenever.

4.2.2 Additional Controls to Mitigate Risks

  • Where raw materials or products are identified as being at particular risk, the threat assessment plan shall include controls to mitigate these risks. Where prevention is not sufficient or possible, systems shall be in place to identify any tampering.
  • These controls shall be monitored, the results documented, and the controls reviewed at least annually.

4.2.3 Authorised Access

  • Areas where a significant risk is identified shall be defined, monitored, and controlled. These shall include external storage and intake points for products and raw materials (including packaging).
  • Policies and systems shall be in place to ensure that only authorized personnel have access to production and storage areas, and that access to the site by employees, contractors, and visitors is controlled. A visitor recording system shall be in place.
  • Staff shall be trained in site security procedures and food defense.

4.2.4 Registration of Food Production Sites

  • Where required by legislation, the site shall maintain appropriate registrations with the relevant authorities.

Food Defense Guidelines Based on SQF Code Edition 9 (Active from 24.05.2021)

2.7 Food Defense and Food Fraud/ 2.7.1 Food Defense Plan

2.7.1.1 Requirement

  • A food defense threat assessment shall be conducted to identify potential threats that can be caused by a deliberate act of sabotage or terrorist-like incident.

2.7.1.2 Requirement

  • A food defense plan shall be documented, implemented, and maintained based on the threat assessment (refer to 2.7.1.1). The food defense plan shall meet legislative requirements as applicable and shall include at a minimum:
  • The methods, responsibility, and criteria for preventing food adulteration caused by a deliberate act of sabotage or terrorist-like incident
  • The name of the senior site management person responsible for food defense
  • The methods implemented to ensure only authorized personnel have access to production equipment and vehicles, manufacturing, and storage areas through designated access points
  • The methods implemented to protect sensitive processing points from intentional adulteration

2.7.1.3 Requirement

  • Instruction shall be provided to all relevant staff on the effective implementation of the food defense plan (refer to 2.9.2.1).

2.7.1.4 Requirement

  • The food defense threat assessment and prevention plan shall be reviewed and tested at least annually or when the threat level, as defined in the threat assessment, changes. Records of reviews and tests of the food defense plan shall be maintained

Food Defense Guidelines Based on Global G.A.P Version 6 (Active from 01.01.2024)

AF10 Food Defense

AF 10.1 Requirement

  • Potential intentional threats to food safety in all phases of the operation shall be identified and assessed.
  • Food defense risk identification shall ensure that all input is from safe and secured sources. Information on all employees and subcontractors shall be available.
  • Procedures for corrective action shall be in place in case of intentional threat.

Empower Your Food Defense Compliance with Smart Food Safe’s Smart Docs

In the perpetually transforming scene of food defense compliance, staying ahead requires more than just diligence—it demands innovation. Smart Food Safe’s Smart Doc enables food businesses to fortify their food defense strategies, mitigate risks, and uphold the highest standards of safety and security. With Smart Doc, you can navigate the complexities of food defense compliance with confidence, knowing that your documents are not just managed, but mastered.

Food Safety Management Software

Fortify your food establishment’s food defense compliance by adhering to key regulatory requirements with Smart Docs.

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