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FSMA Chat: Key Takeaways from FDA’s First Intentional Adulteration Draft Guidance for Industry
FSMA Chat: Key Takeaways from FDA’s First Intentional Adulteration Draft Guidance for Industry

Last week the FDA released the first of 3 planned draft guidance documents to help facilities prepare for compliance to the 21 CFR 121 Mitigation Strategies to Protect Food Against Intentional Adulteration rule. The first compliance deadline for the final rule is July 26, 2019. This regulation outlines the required actions FDA-registered facilities must take to prevent intentional adulteration of the food supply. The draft guidance was provided to explain FDA's current thinking on the topic. It is currently in draft form for facilities to read and respond with comments. 

AIB’s food defense expert, Earl Arnold, reviewed the draft guidance document this week and put together a summary of key takeaways you should be aware of.

Defining Requirements

The guidance document adds definitions that were not previously included in the regulation, including CARVER+Shock, facility-wide security measures, food defense qualified individual, etc. In addition to the new definition, the document includes exemptions and examples of each to clarify the regulation. Food defense plan requirements are detailed and include a statement on adding additional information such as security plans, flow charts, and emergency contacts.

The Plan and Assessment

A facility can choose any format to complete the FDP as long as the requirements of the rule are met.

When conducting the vulnerability assessment, only process steps should be include, not operational items such as mail handling or HR procedures. Related products that are produced on similar equipment can be grouped together.

FDA recommends 4 preliminary steps:

  1. Assemble food defense team - While not required, the draft guidance document recommends forming a food defense team if possible. At a minimum, the facility should have a food defense qualified individual. This role, including assigned responsibilities, is explained in more detail in this document.
  2. Describe the product – Include the full name(s) of the finished product and any other information that may be helpful to those conducting or reviewing the vulnerability assessment
  3. Develop flow diagram
  4. Describe the process - An example of a process step description is included in this guide. If a step matches more than one key activity type (KAT) then all KATs should be included in the description.

Key Activity Types

Key Activity Types (KATs) are explained in more detail. The FDA explains why using KATs is an acceptable method of conducting a vulnerability assessment. Additional explanations about how KATs are vulnerable and what is not included as a KAT is provided in the document. Footnotes are acceptable to describe why or why not a step is actionable.

Totes and or drums are included in bulk liquid storage once the seal is removed. Secondary ingredient handling also includes once the container has been breached and resealed.

The FDA states that there may be a potential for a facility to not identify any actionable process steps. If this is the case a facility is still required to state why each step is not.

An example of a vulnerability assessment using peanut butter for KATs is provided in the document.

Mitigation Strategies

When developing mitigation strategies, the FDA suggests focusing on accessibility and/or the ability to contaminate. The FDA Food Defense Mitigation Strategies database is mentioned as a potential resource. Examples and scenarios of mitigation strategies are included in the document.

Personnel-based mitigation strategies are specific actions conducted by personnel to significantly minimize or prevent significant vulnerabilities at actionable process steps. However, caution should be used if vetting personnel as background checks might not capture recent issues.

Operations-based mitigation strategies are specific operational actions to significantly minimize or prevent significant vulnerabilities at actionable process steps. For example, changing procedures such as not staging ingredients overnight.

Technology-assisted mitigation strategies generally rely on the implementation of a physical access barrier or the implementation of tamper-evident seals or other detection mechanisms that would prevent access to someone intending to adulterate the food without leaving detectable evidence. 

Facility-wide security measures are generally not targeted to particular processing steps but are rather practices that address the security of the facility as a whole.

Getting On Board

The food industry certainly faces some obstacles and threats in protecting against intentional adulteration. It may be difficult to convince upper management that the threat is real. However, a food defense plan is something every plant that produces, packs, or holds food products must develop and maintain for preventive measures to comply with FDA requirements. If your customers require a GFSI certification audit or a GMP inspection you will have specific requirements for food defense.

Want to take your intentional adulteration action plan to the next level?
  • Step 1 - Complete the free FSPCA Food Defense Awareness for the IA Rule course. This 30-minute awareness course is an excellent introduction to the FSMA rule: Mitigation Strategies to Protect Food Against Intentional Adulteration.
  • Step 2 - Take your knowledge to the next level and become a certified Food Defense Coordinator with practical training from AIB International. Our Food Defense Coordinator training is offered online or as a public or private seminar. Challenge how you would handle intentional adulteration in your food plant with the help of our case-study-based course.
  • Step 3 - Test your readiness with a vulnerability assessment! Our skilled experts will identify potential gaps in your current food defense plan focusing on current best practices and requirements linked to your facility, programs, and operational procedures. You’ll get a full report that outlines the top 10 identified vulnerabilities at your facility, along with a list of specific, actionable recommendations for improvement.







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