Food Defense & Intentional Adulteration

Food Defense & Intentional Adulteration

Food defense is the effort to protect food from acts of intentional adulteration—any act where there is an intent to cause wide-scale public health harm, including acts of terrorism. In May 2016, FDA issued its final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) as part of its focus on preventive strategies to ensure food safety.

This rule requires covered facilities to assess their vulnerabilities and then prepare and implement food defense plans. Just as important, FDA is conducting routine inspections to verify compliance with the IA rule.

Food Defense Plan

Kestrel Tellevate includes food defense in virtually all our program development activities. We work with companies to understand their risks and vulnerabilities and to develop compliant food defense plans that mitigate risks and comply with the IA rule. We incorporate the following four major elements into our plans.

Step 1. Vulnerability Assessment

KTL conducts a vulnerability assessment of weaknesses and critical control points to identify where someone could attempt product adulteration. We assess risks throughout the supply chain, including to the origin of raw materials, and identify those areas in the process that pose the greatest IA risks. The focus must be both inside and outside of company walls and extend to the source of materials and services within the supply chain for producers and distributors of food to the public.

Our assessment involves evaluating each step in the facility’s process for the following:

  • Potential severity and scale of the impact on the public: How much, how fast?
  • Physical access to the product: Who has access to critical control points and food material risk areas? Are their physical barriers and/or security implemented?
  • Ability to successfully alter/contaminate the product: How is the product packaged and stored?

Step 2. Mitigation/Preventive Strategies

We work with facility staff to develop appropriate mitigation strategies at each step in the process to address vulnerabilities identified in the assessment. These strategies may include broader efforts, such as general building security improvements, or more focused strategies that are customized to the facility’s specific process/procedure.

Step 3. Mitigation System

We help develop and implement a Food Safety Management System (FSMS) that ensures mitigation strategies are being implemented across the organization and that aligns with any food safety certification program (e.g., BRC, SQF, IFS, FSSC 22000).

Our mitigation systems focus on incorporating:

  • Monitoring mitigation strategies, including developing appropriate procedures and establishing monitoring frequency
  • Corrective action response if mitigation strategies are not properly implemented
  • Verification activities that ensure monitoring is being conducted and, if not, corrective actions are being fulfilled

We can also set up alerts of IA to the appropriate individuals, according to the documented food safety and defense program. Response time is critical. Every passing minute is a minute when more health risks could develop, leading to a greater chance of negative impacts on public safety and the related businesses.

Step 4. Recordkeeping and Training

Appropriate records must be maintained for food defense monitoring, corrective actions, and verification. We build this into the FSMS to ensure compliance with these requirements. In addition, our team can provide training for key personnel to ensure they understand IA, food defense systems, mitigation strategies, and their roles and responsibilities.

Mock Exercise Scenarios

When conducting an assessment of food defense, IA, and generally accepted industry vulnerability, threats, and controls, KTL can also complete a mock exercise scenario. This allows companies to:

  1. Assess their food defense and IA programs under FSMA;
  2. Test to confirm their program’s integrity, as documented and implemented; and
  3. Conduct vulnerability scenarios to verify, validate, and make improvements.

We address the following areas in the assessment, strategies, and plan information:

  • Facility
  • Materials
  • Packaging
  • Processing
  • Key activities
  • Storage
  • Transportation and distribution
  • Management and personnel

This activity provides the information needed to develop and implement an effective and compliant food defense and IA program under FSMA. Additionally, it can provide verification of the site’s programs, corrective actions to be implemented, and the necessary records of compliance.


Auditing operational and regulatory compliance helps to ensure and maintain best food defense practices and provide documentation of compliance to regulators. FSMA promotes the safety of the U.S. food supply by focusing on prevention, rather than reactive response. Prevention is only as effective as the actual compliance processes put in place. We can provide regular and random auditing to document evidence confirming that the appropriate preventive measures are taken and effective.