The US FDA recently published the draft of its new Guideline for Industry on Mitigation Strategies to Protect Food Against Intentional Adulteration. The document explains to business operators in the food supply chain how to perform vulnerability assessment for the products they produce or trade. This includes establishing a food defense team at each operation site. The team’s goal is to evaluate the different processes, e.g. production process, storage, handing incoming raw materials etc. and determine vulnerabilities at each critical point. The team needs to also identify training needs of staff.
The key elements listed in the assessment process include:
- Assemble a Food Defense Team
- Describe the product under evaluation
- Develop a process flow diagram
- Describe the process steps
An example is given for the production process of peanut butter, identifying the vulnerabilities at each step.
At the end of the assessment of each ingredient, a mitigation strategy needs to be developed. Such strategies could include the use of tamper evident seal-tapes, restriction of access to certain areas of production and storage and securing loading/unloading hoses.
The difficulty for most food business operators will be the assessment of the vast number of ingredients they source, often from several suppliers per ingredient. Here, it makes sense to focus efforts and optimize resources by prioritizing the most vulnerable ingredients.
The draft Guidance is open for comments until December 17, 2018 at the Government site.
