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Module 4: Using the Key A ctivity Type Method Page VAR(p) of VAR(np)

Conduct Key Activity Mapping to Identify APSs (continued) 4i) @

• Explain why each process step is or is not an APS:
• For each process step that aligns with a KAT, the written explanation could
simply state , "Th is step aligns with the KAT _ _ _ _ (e.g. , 'Th is step aligns
with the KAT mixing and similar activities')."
• For each process step that doesn 't align with a KAT, the written explanation
cou ld simply state, "Th is step does not align with a KAT. "

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Almond Cranberry Pressed Energy Bar Example Video

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Module 4: Using the Key A ctivity Type Method Page 53 of 55

Module 4 Summary 4i) @)

Congratulations! You have now completed Module 4.
Let's review what you have learned before you move on to the knowledge checks .

In th is module, you learned to :

1. Conduct key activity mapping.
2. Identify actionable process steps using the key activity type method.
3. Explain your decisions.

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Course Summary 4i) @)

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This concludes the instructional portion of this training course. Lets summarize what
you've learned today:
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• The KAT method is an acceptable method of conducting your fac ility's VA.
• The KAT method simplifies the VA process and is less intensive with respect to time,
resources , and technical expertise.
• The fou r KATs and their characteristics .
• The recommended preliminary steps that will help make your VA using the KAT
method streamlined and efficient.
• How to identify APSs by recognizing which process steps in your food operation align
with the KATS .
• How to explain your decisions of what is and what is not an APS in the context of the
KAT method .
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Key Activity Types Introduction Course Description Transcript

This training course is targeted towards food professionals using FDA's Key Activity Type , or KAT, method to
conduct their facility's vulnerability assessment, or VA. The VA is a required part of the facility's food defense
plan mandated under FDA's Mitigation Strategies to Protect Food Against Intentional Adulteration , or IA rule. By
successfully completing this course , the learner will have satisfied the training requirement to conduct the
vulnerability assessment using the KAT method .

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Key Activity Types Introduction Disclaimer Transcript

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Please note that this course satisfies the training requirement to conduct a vulnerability assessment using the
KAT method ONLY. Any deviation from the KAT method described in this course will necessitate that the
individual take a vulnerability assessment training recognized as adequate by the FDA, or be otherwise qualified
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through job experience to conduct a vulnerability assessment using another vulnerability assessment
methodology. See the Resources tab for information about other available trainings .

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Key Activity Types Introduction Course Modules Transcript

This course is divided into four modules , which will cover: an overview of food defense and the Intentional
Adulteration rule , an introduction to using the key activity type method as a way to conduct your vulnerability
assessment, getting prepared to use the key activity type method , and finally , putting the key activity type
method into practice .

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Key Activity Types Course Objectives Transcript

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After completing this course , you will be able to:

1. Explain the importance of food defense .
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2. Understand the basic requ irements of FDA's intentional adulteration rule .

3. Identify why using the key activity type method is an appropriate method of conducting a vulnerability
assessment.
4. Describe each of the key activity types .
5. Perform preparatory steps to use the key activity type method for conducting a vulnerabil ity assessment.
6. Conduct a vulnerability assessment us ing key activity types.

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Module 1: Food Defense Overview and Introduction to the Intentional Adulteration Final Rule

Module 1 - Welcome and Introduction Transcript

Welcome to Module 1: Food Defense Overview and Introduction to the Intentional Adulteration Final Rule

After completing this module, you will be able to:

1. Explain food defense.
2. Explain the general requirements of the Intentional Adulteration rule.
3. Describe the contents of a food defense plan .
4. Explain the vulne rability assessment requirements .
5. Define sign ificant vulnerabilities .
6. Define actionable process steps .

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7. Explain the training and qualifications requ ired to conduct vulnerability assessments.

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Module 1: Food Defense Overview and Introduction to the Intentional Adulteration Final Rule

What is Intentional Adulteration? Transcript

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Intentional adulteration is the deliberate contamination of food with a biological, chemical , radiolog ical , or
phys ical agent by an individual or group of individuals with the intent to cause wide scale public health harm . It is
a crim inal act that can have devastating results. Therefore, Congress mandated that FDA publish regulations
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setting forth requirements to protect the public from intentional adulteration of food . FDA has issued a final
regulation , Mitigation Strategies to Protect Food Against Intentional Adulteration (21 CFR Part 121), which
requ ires covered facilities to identify and protect the ir most vulnerable points aga inst intentional adulteration . To
keep things simple , this will be referred to as the IA rule.

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Module 1: Food Defense Overview and Introduction to the Intentional Adulteration Final Rule

What is Food Defense? Transcript

Food defense is the effort to protect food from intentional acts of adulteration intended to cause wide scale
public health harm. These efforts include measures taken to reduce or el iminate the possibility that an intentional
adulteration event would occu r. There are many measures that can be implemented fo r food defense purposes
but one of the most important is a food defense plan . The IA rule requires cove red fac ilities to develop and
implement a food defense plan that identifies and implements add itional food defense measures at the most
vulnerable po ints with in thei r fac ilities . We'll talk more about the requirements of the IA rule in later slides .

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Module 1: Food Defense Overview and Introduction to the Intentional Adulteration Final Rule

Why is Food Defense Important? Transcript

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Intentional adulteration of the food supply can result in wide scale public health harm including severe illness and
death . In add ition to illnesses and deaths , potential impacts include public loss of confidence in the food supply,
damage to a company's reputation , and job losses , among others . Malicious individuals , includ ing terrorists , may
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see th is as an opportunity to harm the public and furthe r their cause. Ha rd as it is to imag ine , intentional
adulteration has already occu rred . In December 2013, there were at least 2,843 mild foodborne illnesses
reported and 6.4 million packages of various frozen foods recalled because a contract employee at a food
fac ility intentionally adulterated several frozen foods with a pesticide. Th is example illustrates why food defense
plans are so important-they aim to prevent these potentially devastating events .

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Module 1: Food Defense Overview and Introduction to the Intentional Adulteration Final Rule

General Requirements of the IA Rule Transcript

The IA rule aims to prevent or significantly minimize intentional acts of food adulteration , including acts of terrorism ,
intended to cause wide scale public health harm . This is accompl ished by requiring that covered facilities develop and
implement a food defense plan that includes a vulnerability assessment to identify actionable process steps , or APSs ,
identification and implementation of mitigation strategies at those actionable process steps , and mitigation strategy
management components (food defense monitoring , food defense corrective actions , and food defense verification).
Reanalysis of the food defense plan is also required under certain cond itions . The IA rule also has records and training
requirements .

This training focuses on the first food defense plan component-a vulnerability assessment to identify actionable process
steps . Spec ifically , it covers one possible approach to conducting a vulnerability assessment: the key activity type method .

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Module 1: Food Defense Overview and Introduction to the Intentional Adulteration Final Rule

For more information on the IA Rule Requirements Transcript

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For more detailed information about the rule and its requirements , please vis it the following resources: The IA
rule link will take you to the full text of the regulation , and the FDA IA rule Fact Sheet provides a brief summary of
the rule's provisions , coverage , and exemptions.
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Additionally, the Food Safety Preventive Controls Alliance has developed an online course that provides on
overview of the IA rule requirements.

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