Key Activity-Type

DISCLAIMER
The information provided by the Food Safety Preventive Controls Alliance (FSPCA) is
for training purposes only. The FSPCA is not your attorney and cannot provide you with
legal advice. The FSPCA curriculum is intended as a training tool to assist companies
in complying with the FDA Food Safety Modernization Act (FSMA) intentional adultera-
tion regulation; however, following this curriculum does not ensure compliance with the
law or FDA’s regulations. For advice regarding the legal compliance with FSMA, please
consult your legal counsel.
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The information provided by the FSPCA will vary in applicability to each food manu-
facturer. It is not possible for the FSPCA training curriculum to address every situation.
Companies should implement practices and programs that are appropriate to their
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individual operations. FSPCA materials do not outline the only approach to developing
and implementing a Food Defense Plan. Companies can follow any approach that
satisfies the requirements of the applicable statutes and regulations related to FSMA.
The information provided by FSPCA does not create binding obligations for the Food
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and Drug Administration or industry.
FSPCA does not guarantee the accuracy, adequacy, completeness or availability of any
information provided in its curriculum and is not responsible for any errors or omissions
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or for any results obtained from the use of such information. FSPCA gives no express
or implied warranties, including but not limited to, any warranties of merchantability or
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fitness for a particular purpose or use. In no event shall FSPCA be liable for any indirect,
special or consequential damages in connection with any use of this training curriculum.
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Course Description 4i) @)

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This training course is targeted towards food professionals using FDA's Key Activity Type
(KAT) method to conduct their faci lity's vulnerability assessment (VA). The VA is a required
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part of the facil ity's food defense plan mandated under FDA's Mitigation Strategies to Protect
Food Against Intentional Adu lteration (IA) rule. By successfu lly completing this course , the
learner will have satisfied the training requirement to conduct a VA using the KAT method .
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Key Activity Type Sans Test Page 1

Disclaimer 4i) @)
Please note that th is cou rse satisfies the training requ irement to conduct a VA using the KAT
method ONLY. Any deviation from the KAT method descri bed in this cou rse will necessitate
that the individual take a vu lnerability assessment training recog nized as adequate by the
FDA, or be otherwise qualified through job experience to conduct a VA using another VA
methodology. See the Resources tab for information about other available trainings.
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Course Modules 4i) @)

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This course is divided into four modules:

• Module 1: Food Defense Overview and Introd uction to the Intentional Adu lteration
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Final Ru le
• Module 2: Introduction to the Key Activity Type Vu lnerability Assessment Method
• Module 3: Prepari ng to Use the Key Activity Type Method
• Module 4: Using the Key Activity Type Method
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Course Objectives 4i) @)

After completing this course, you will be able to:
1. Explain the importance of food defense.
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 vu lnerability assessment.
4. Describe each of the key activity types .
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5. Perform preparatory steps to use the key activity type method for conducting a
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vulnerability assessment.
6. Conduct a vu lnerability assessment using key activity types .
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Module 1: Food Defense Overview

and Introduction to the Intentional
Adulteration Final Rule
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Module 1: Food Defense Overview and Introduction to the Intentional Adulteration Final Rule Page VAR(p) of VAR(np)
Objectives 4i) @)
Welcome to Module 1: Food Defense Overview and Introduction to the Intentional Adu lteration
Final Ru le
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.
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4. Explain the vulnerability assessment requirements.
5. Define significant vu lnerabilities.
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6. Define actionable process steps .
7. Explain the training and qualifications required to conduct vu lnerability
assessments.
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What is Intentional Adulteration? 4i) @

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• Intentional adu lteration is the deliberate contamination of food with a biological,

chemical , rad iological, or physical agent by an individual or group of individuals with
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the intent to cause wide scale public health harm.
• FDA issued a final regu lation , Mitigation Strategies to Protect Food Against
Intentional Adulteration (21 CFR Part 121 ), which requires covered fac ilities to
identify and protect their most vu lnerable points again st intentional adulteration .
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What is Food Defense? 4i) @)

• Food defense is the effort to protect food from intentional acts of adu lteration
intended to cause wide scale public health harm .
• These efforts include measu res taken to significantly minimize or prevent an
intentional adulteration event.
• The IA rule requ ires covered facilities to develop and implement a food defense plan .
Th is is a fundamenta l step towards an effective food defense program.
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Why is Food Defense Important? 4i) @

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• Intentional adu lteration of the food supply can resu lt in wide scale public health harm
including severe illness and death.
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• Other potential impacts can include public loss of confidence in the food supply,
damage to a company's reputation , and job losses.
• Malicious individuals, including terrorists, may see th is as an opportun ity to harm the
public and further their cause.
• The primary pu rpose of the food defense plan is to prevent intentional adu lteration .
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Module 1: Food Defense Overview and Introduction to the Intentional Adulteration Final Rule Page VAR(p) ofVAR(np)
General Requirements of the IA Rule 4i) @

• Food defense plan , which includes:
Definitions: • Vu lnerability assessment to identify
During this course , actionable process steps (APSs) .
you will see certain • Identification and implementation of mitigation strategies.
words underlined in
• Mitigation strategies management components:
balded blue . Cl ick on
these words to read • Food defense monitoring
their definitions. • Food defense corrective actions
• Food defense verification
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• Reanalysis:
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• Reanalysis is required at certain times and under certain
cond itions.
• Training
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• Records
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For More Information on the IA Rule Requirements 4i) @

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Add itional Resou rces :

IA Rule Fact Sheet
• IA rule
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• Click here to learn

more about the IA • FDA IA rule Fact Sheet
rule . • IA Ru le Overview Requ irements On line Cou rse
FDA FOOD SAFETY

MODERNIZATION ACT
KEY REQUIREMENTS:
FSMA Final Rule for Mitigation Strategies to Protect Food
Against Intentional Adulterati on
The FOA Food Safety Modem,zabon Act IFSMAI final KEY PROVISIONS
rule 1-s aimed at preventing In tentiona l adulteration
from acu, intind'ed to CiU$9 w,de•$-Cili harm 10 public While thls1s the f.rst time th.tt companaes are ~u1red
health. 1nclud1ng acts of terrorism 1arget1ng the food 10 create a food defense plan, lhe FDA hH 1akenan
supply. Such acts, wtule not likely to occur. could cause ,approach Sim.liar lo Hazard Anal:;s1s Critical Control
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Requirements of the VA 4i) @)

• A VA is a systematic assessment of points, steps , or procedures to identify and rank
vulnerabilities to intentional adu lteration .
• The goal of the VA is to:
• Distinguish vu lnerabilities from significant vulnerabilities .
• Identify APSs .
• Each fac ility must conduct a VA for each type of food produced.
• Similar products and processes may be grouped together and assessed as one.
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Requirements of the VA (continued) 4i) @

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• VAs must consider, for each point, step , or procedure , the fo llowing three elements, at a
minimum:
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• The potential public health impact if a contaminant were successfully added to the
product at that step.
• The degree of physical access to the product.
• The abi lity of an attacker to successfu lly contaminate the product.
• These will be referred to as "the three fundamenta l elements" or "the three
elements."
• The KAT method is considered an appropriate method to conduct a VA. This will be
described in detail in upcoming modules.
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• When conducting a vulnerability assessment, the IA rule
req uires the consideration of an inside attacker.
• An inside attacker shou ld be assu med to have:
• Leg itimate access to the fac ility (e.g. , an employee ,
contractor, driver, authorized visitor, etc.).
• A basic understand ing of fac ility operations and the food
prod uct(s) under production.
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• The ability to acq uire and deploy a contaminant that is highly
lethal, capable of withstand ing the food production process ,
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and undetectable via simple observation if added to food .
• The intent to cause wide scale pu blic health harm.
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• Regardless of the outcome, the VA must be written and must include an explanation as to why
each point, step, or procedu re either was or was not identified as an APS.
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J. \Vorksheet 1-C: Vul.nern biJity Assessment A nalysis u_mmnry
PROD CT(S): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
FACILITY , AME: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
A DDRESS : _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
SIG NE D DATE: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
( 1) (2) (3) (-1) (5) (6)

# P,i>cess Step Process Des~ri plion Vulnera billt)' Ex planation Actlom1ble Process
Assessment Method Step
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Significant Vulnerabilities and APSs 4i) @

• A significant vulnerability is a vulnerability in a food process that, if exploited , cou ld be
expected to cause wide scale public health harm.
• APSs are points, steps , or procedures in a food process where a significant vu lnerability
exists .
• A point, step, or procedu re refers to any activity related to manufacturi ng , processing ,
packing, or holding of a food product.
• Another way to th in k about APSs is that once a fac ility conducts a VA these are the steps
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that are identified as most vulnerable to intentional adu lteration .
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Mitigation Strategies 4i) @)

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• Mitigation strateg ies must be identified and implemented at APSs .

• Mitigation strateg ies are measu res that are designed to reduce or eliminate significant
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vulnerabilities at APSs.
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Training and Qualifications Required for the VA 4i) @

• Individuals conducting the VA must:
For More
Information
• be a qualified individual (QI) , and
• For information on • successfu lly complete VA training received under a standardized
"Vulnerability
Assessment" curri culum recogn ized as adequate by FDA or be otherwise
training , click on the
"Resources" tab
qualified through job experience.
above • As noted earlier, th is training will ONLY qualify you to conduct a VA
using the KAT method .
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Module 1 Summary 4i) @)

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Congratulations! You have now completed Module 1.

Let's review what you have learned before you move on to the knowledge checks .
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In th is module , you learned to :

2. Explain the general requirements of the Intentional Adu lteration rule.
3. Describe the contents of the food defense plan .
4. Explain the vulnerability assessment requ irements.
5. Define significant vu lnerabilities.
6. Define actionable process steps.
7. Explain the training/qualifications required to conduct vulnerability assessments.
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Page 21 of 55
Module 2: Introduction to the

Key Activity Type Vulnerability
Assessment Method
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Module 2: Introduction to the Key Activity Type Vulnerability Assessment Method Page VAR(p) of VAR(np)
Objectives 4i) @)
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Welcome to Module 2: "Introduction to the Key Activity Type Vulnerability

Assessment Method"
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1. Summarize the origins of the key activity types .
2. Recogn ize why using key activity types is an appropriate method to conduct a
3. Describe bulk liquid receiving and load ing.
4. Describe liquid storage and hand ling.
5. Describe secondary ingredient handling .
6. Describe mixing and similar activities .
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Module 2: Introduction to the Key Activity Type Vulnerability Assessment Method Page VAR(p) ofVAR(np)
KAT Method Background 4i) @)

• Since 2004, FDA has conducted VAs and identified mitigation strategies to protect
the food system from acts of intentional adu lteration under the authority and
direction of Homeland Security Presidential Directive-9 (HSPD-9).
• FDA has conducted numerous food defense VAs on a wide variety of foods and
processes with industry, academia , and other government partners.
• Th is VA research forms the foundation of FDA's food defense program and informed
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the development of the IA ru le.
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• Over the cou rse of FDA conducting VAs , trends of vu lnerable points were identified ,
which led to the identification of the KATs.
Sources: Homeland Security Presidential Directive-9 (HSPD-9), issued Jan 2004; VA public summary documents.
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KAT Method Background (continued) 4i) @

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In response to the passage of the Food Safety Modernization Act (FSMA) , FDA
analyzed the VA data and found :
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• Certain general activities that frequently occu r in food processing operations

consistently ranked as the most vulnerable, regard less of the commod ity being
assessed. These became the KATs.
• A particular food is generally not more inherently vu lnerable than other foods to
intentional adu lteration.
• The main drivers of vu lnerability are the processing steps and procedures that
are used as food is moved from farm to table.
Sources: Food Safety Modernization Act (FSMA), issued Jan 20 11 ; VA public summary documents.
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KAT Method Background (continued) 4i) @

• From the resu lts of the analysis , FDA concluded that four groups of processing
steps consistently scored highly in the VAs .
• These fou r groups of processing steps were identified as the KATs .
• At the conclusion of th is analysis, FDA produced a detailed report on the
development of the Key Activity Types . You can access a link to th is report in
Resources above.
Bulk Liquid Receiving Liquid Storage Secondary Mixing and
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and Loading and Handling Ingredient Handling Similar Activities
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Why KAT is an Appropriate Method 4i) @)

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• FDA's VAs in cluded the consideration of the

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th ree requ ired elements and the possibility of

an inside attacker as an underlying
consideration in the evaluation of all th ree
elements.
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Why KAT Is an Appropriate Method (continued) 4i) @)
• Using KATs are an efficient, science-based approach that companies may

use to identify APSs.
Completed by. FDA in .collaboration _VJith iindusby_, . To be completed by covered facilities

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vulnerability
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assessments Conduct Identify
Identified
vulnerability actionable
Key Activity
assessments process
Types (KATS)
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Three using KATs steps
elements
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Bulk Liquid Receiving and Loading 4i) @

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• Bulk liquid receiving refers to the inbound movement of liquid

ingredients into a fac ility for its use in the food production
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process.
• Bu lk liquid loading refers to the outbound sh ipping of liquid
intermediate or fin ished liquid product from a fac ility onto a
transport vehicle for further processing or use.
• Bulk liquid receiving and loading leads to a high probability of
ingredient mixing and thus an even dispersal of a potential
contaminant throughout the liquid.
• These steps include large volumes of liquid and frequent worker access to the liquid and/or
handling equipment such as hoses.
• Activities that do not fall under this KAT include the receiving or loading of sealed jugs,
drums, jars , and totes .
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Liquid Storage and Handling 4i) @

• Liquid storage and handling refers to a step when a bulk or non-
bulk liquid is contained in storage tanks or silos or in holding,
surge, metering, or other types of intermediate processing tanks.
• Liquid storage refers to any storage silo or tank where liquid
product may be stored prior to introduction into the product stream
or prior to loading for outbound shipping .
• Bulk or non-bulk tanks can be used to store liquid ingredients,
hold liquid product for sample testing and other quality control
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activity, or to control flow rates of liquid ingredients or product
through the production system.
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• Handling tanks also include tanks or totes where the tamper-evident seals are opened and the
container itself is used for holding.
• At these steps, there is a high probability of mixing due to agitation which would likely cause even
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dispersion of a contaminant and likely application to a large amount of servings.
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Secondary Ingredient Handling 4i) @

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• Includes any point, step, or procedure where

dry or liquid secondary ingredients (e.g. ,
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inclusions, minor ingredients, processing aids,

and food add itives , etc.) are manipulated by
human contact prior to or during add ition to the
product stream:
• Staging
• Preparation
• Addition
• Rework
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Secondary Ingredient Handling (continued) 4i) @

• Includes the storage of partially used , open containers of secondary ingredients where
the tamper-evident packaging has been breached.
• Does not include computer metering or automatic weighing , sizing , batch ing , or
measuring so long as the process does not requ ire the active involvement of a person.
• These activities are generally open , accessible points at which a contaminant may be
added , then distributed into a larger volume of the main product flow.
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Mixing and Similar Activities 4i) @

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A point, step , or procedure where the primary purpose or result is:

• mixing (i.e., to blend a powder, dough , or liquid ingredient
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together).
• homogenizing (i.e., to reduce the particle size of an ingredient
and disperse it throughout a liquid).
• grinding (i.e. , to reduce the particle size of a solid ingredient or
mass to a smaller granularity).
• coating (i. e. , to layer a powder or liquid onto the surface of a
product, such as a batter, bread ing , glazing , or flavoring).
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Mixing and Similar Activities (continued) 4i) @

• Frequently includes use of equipment such as mixers, homogenizers , blenders , cascade-
style breaders and other cascade-style applicators where unused coating is continuously
recycled and reappl ied , mills, grinders, and pulverizers .
• Successfu lly added contaminants at th is step would generally be even ly dispersed
throughout product.
• Accessibility through access ports , lids, in-feed conveyors, flumes etc.
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In th is module, you learned to :

1. Summarize the origins of the key activity type.
2. Recognize why using key activity type is an appropriate method to conduct a
vu lnerability assessment.
3. Describe bulk liquid receiving and loading .
4. Describe liquid storage and handling .
5. Describe secondary ingredient handling .
6. Describe mixing and similar activities .
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Module 3: Preparing to Use the Key

Activity Type Method
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Module 3: Preparing to Use the Key A ctivity Type Method Page VAR(p) of VAR(np)
Objectives 4i) @)
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Welcome to Module 3: "Preparing to Use the Key Activity Type Method"

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1. Assembling a food defense team.
2. Describi ng the product under evaluation.
3. Developing a process flow diagram.
4. Describi ng the process steps under evaluation.
5. Grouping similar products.
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Introduction to Preliminary Steps 4i) @

• Preliminary steps will help you prepare , organize , and conduct your VA using the
KATs in an efficient way. They are:
• Assembling your food defense team
• Describing the product under evaluation
• Developing a process flow diagram
• Describing the process steps under evaluation
• Grouping similar products
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• These preliminary steps are not required by the IA rule , but you may find them
helpful.
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• Facilities may find that they have already completed some or all of these preliminary
steps for other purposes, wh ich may be leveraged to maximize efficiency and reduce
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duplicate efforts .
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Assemble the Food Defense Team 4i) @

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• Your food defense team may include your Ql(s) and people with expertise in day-to-
day operations of your fac ility.
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• Facilities have the flexibility to determine the composition/size of the food defense
team .
• At a minimum, you must have a QI.
• Having a multi-disciplinary food defense team is recommended , but not required.
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Menu Resources Help Exi t
Module 3: Preparing to Use the Key A ctivity Type Method Page VAR(p) ofVAR(np)
Describe Product Under Evaluation 4i) @
• A product descri ption helps team members Product Name(s) Almond, Cranbeny Energy Bar
Product Description, including This product is a ready to eal energy bar packed in a pouch
understand characteri stics of the prod uct Important Food Safety

Characteristics
for on--the-go eating. The low water activity makes the product
shelf stable. Processing Involves dry mixing and forming with
no process lethality slep.
that may impact food defense , for example, Water activity s0.65
Ingredients Corn syrup, blanched/slivered almonds, crisped rice, dried
whether or not it has tamper-evident seals. cranberries, canola oil, pan release agen1 (soy lecithin).
vitamin and mineral ore-blend
Packaging Used Melalized polyethylene fi lm, indWidual retail package with
• See the sample Almond , Cran berry label
Intended Use Ready-to-ea! bars
Energy Bar Prod uct Descri ption on the General consumption
Intended Consumers
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right-hand side of the screen. Shelf Life One year
• Feel free to use any product Labeling Instructions None
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descri ptions you already have. Storage and Distribution Ambient, nol to exceed 90"F
FDA (2017). Food safety: Ifs especially important for at-risk groups. Retrieved from
https1/www.fda.gov/food/foodbomeillness contaminants/peoplealrisk/ucm352830.htm
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Sources:
Food Safety Preventive Controls Alliance (FSPCA), Product Description for illustratrve purposes only.
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Produce a Process Flow Diagram 4i) @

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Sample Food Processing Flow Diagram

for Ground Black Pepper • You may use an existing flow diag ram.
Receiving Packaging
Receiving Shelf Stable • List or draw a diag ram of each point, step , or
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Ingredients
procedure.
Ingredient Storage Packaging Storage
• This shou ld cover all process steps in the food
Cleaning
operation that the fac ility perform s from receipt of
Pathogen Destruction
ingred ients through loadout of fi nished product.
Grinding • Processes and proced ures that are not part of the
Metal Detection
food operation do not need to be in cluded in the
flow diag ram (e.g., utilities) .
Packaging
Source: Food Safety Preventive Controls Allian ce (FSPCA), Food Processing Flow
Storage
Diagram for illustrative purposes only.
Shipping
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Describe Process Steps Under Evaluation 4i) @

~ - - -E_x_a_m_p_le_o_f_a_P_r_o c_e_s_s _o_e_sc_r_ip_ti_o_n_ _ _ _~ • Include a description of what each
Proc••• Oucrtptlon - Plain. ChHs• and ChHs• Biscuit Om•l•t
Receiving Ingredients and Packaging: process step entails to explain what
Ingredients and raw malenals are purchased from repu1able suppliers that comply with
inlemabOnally recognized food safety and quahty sys1ems For each ingredien the same brand
1s used conststently lo minnnze varialion. Ingredients are slo,ed acco,ding lo manufacturers'
happens at each of the process steps
recommendabOnS when specified
Receiving packaging. Corrugated shippers, paperboard ltays and plastic wrap are listed in the process flow diag ram.
received ,n bul Speafications require food grade material fo, 1rays and plasllc wrap
thal ,s compabble with frozen s1orage of food products. uibeled cartons are reviewed for
conformance with producl allergen requiremenlS and ingred,enlS
• The process step descri ption can serve to
• Receiving shelf st.Ible Ingredients
o Salt Received In 10-pound bags from our d,slribulo,_Specificalions require food
inform whether or not the process step
grade salt
o Pan release o,t The pan release od conla,ns soybean 011, soy leathm and natural
flavo, 11 is received from our dislributo, in 10-gallon jugs.
aligns with a KAT.
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Source: Food Safety Preventive Controls Alliance (FSPCA), Partial Process Description or Narrative
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for illustrative purposes only.
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• VAs of like prod ucts can be grouped into

similar processes .
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• Identify any diffe rences between

grouped prod ucts .
• Examples :
• Different flavo red fruit juices using the
same processing line.
• Cereals of diffe rent flavo rs using very
similar processes .
• Yog urts with different inclusions (e.g. ,
strawberries , blueberries) .
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In th is module, you learned certain steps that can help you prepare to use the KAT
method , including:
1. Assembling a food defense team.
2. Describing the product under evaluation.
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3. Developing a process flow diagram .
4. Describing the process steps under evaluation.
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5. Grouping similar products.
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Module 4: Using the Key Activity

Type Method
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Objectives 4i) @)
Welcome to Module 4: "Using the Key Activity Type Method"

1. Conduct key activity mapping.
2. Identify actionable process steps using the KAT method .
3. Explain you r decisions .
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• Review KAT descri ptions .

• Map process steps to KATs :
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• For each process step , determine if it is a KAT.

• Process steps that align with KATs are APSs .
• Process steps that do not align with KATs are not APSs .
• Any deviation from th is method will requ ire the individual conducting or overseeing
the VA receive training in conducting the VA using an evaluation of the th ree
elements , or be otherwise qualified through job experience.
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• 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

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

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 .
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7. Explain the training and qualifications requ ired to conduct vulnerability assessments.
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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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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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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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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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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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Requirements of the VA Transcript
When conducting a vulnerability assessment, facilities are systematically assess ing each step of their food
processing operations to identify and rank vulnerabilities to intentional adulteration .
Recognizing that all points , steps, or procedures have some level of vulnerability, the goal of a vulnerability
assessment is to identify those points , steps, or procedures that have what the IA rule terms "sign ificant
vulnerabilities" or those points which are most vulnerable to an intentional adulteration attack. These points are
called actionable process steps . More details on actionable process steps will be covered later in this module.
You must conduct a vulnerability assessment for each type of food produced . However, like products and
processes may be grouped together and assessed as a single group. For example, if a facility manufactures
yogurt with different fruit flavor add-ins and the processing steps for these lines are the same , the fac ility may
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group these food products into one food type (e .g. , "yogurt with fruit add-ins") for the vulnerability assessment
and consider them together.
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Requirements of the VA (continued) Transcript

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This requirement provides significant flexibility. FDA is not specifying a particular methodology for conducting
vulnerability assessments . Facilities may choose the vulnerability assessment method of their liking . However, it
must consider, for each point, step, or procedure , at a minimum: the potential public health impact if a
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contaminant were added to the product at that step; the degree of phys ical access to the product; and the ability
of an attacker to successfully contaminate the product.
One appropriate approach of conducting a vulnerability assessment is using the FDA-identified Key Activity Type
method , which takes into account these three elements and is the focus of this training . This method will be
detailed in subsequent modules.

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The IA rule requires a cons ideration of an inside attacker when conducting a vulnerability assessment.
An inside attacker is someone who has legitimate access to the fac ility, is knowledgeable about the facility's
operations and procedures , and can potentially introduce a contaminant.
Based on years of collaboration with the law enforcement and the intelligence community, it is widely recognized
that an inside attacker poses the highest risk for intentional adulteration of food and represents a worst-case
scenario. The vulnerability assessment must be conducted based on the assumption that an inside attacker is
poss ible .
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Regardless of the outcome , the vulnerability assessment must be written and must include an explanation as to
why each point, step, or procedure either was or was not identified as an actionable process step. These written
documents must be part of the food defense plan . Here is an example form that can be used to document the
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vulnerability assessment. Using this specific form is not a requirement; it simply illustrates one poss ible method
of documenting the vulnerability assessment in the food defense plan .

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Significant Vulnerabilities and APSs Transcript
Let's continue on and talk in more detail about two concepts we introduced earlier that make up the outcome of
your vulnerability assessment: the identification of significant vulnerabilities and actionable process steps .
FDA uses the term sign ificant vulnerability to describe a vulnerability in a food process that is highly susceptible
to intentional adulteration and one that, if exploited , could be expected to cause wide scale public health harm.
Those points, steps , or procedures in a food process where a significant vulnerability exists are called
actionable process steps . Another way to think about actionable process steps is that once a facility conducts a
vulnerability assessment, these are the steps that are identified as most vulnerable to intentional adulteration.
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Mitigation Strategies Transcript

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Mitigation strategies must be applied and are essential to significantly minimize or prevent the significant
vulnerability at actionable process steps . The IA rule defines mitigation strategies as "Risk-based , reasonably
appropriate measures that a person knowledgeable about food defense would employ to sign ificantly min imize or
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prevent significant vulnerabilities identified at actionable process steps , and that are cons istent with the current
scientific understanding of food defense at the time of the analysis ."

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Training/Qualifications Required for the VA Transcript
The individual conducting a facility's vulnerability assessment must be a qual ified ind ividual , or QI, and
successfully complete VA training under a standardized curriculum recognized as adequate by FDA or be
otherwise qualified through job experience . In order to be cons idered qualified , this person must have the
education , training , or experience , or a combination thereof, to conduct a vulnerability assessment. It is
important to note that this person could be , but does not have to be , an employee of the fac ility. Outside
expertise may be sought.
As mentioned earlier, this training will qualify an individual to conduct a vulnerability assessment using the key
activity type method ONLY. A separate training is required for those seeking to be qualified to conduct a
vulnerabil ity assessment using other methods .
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Summary Transcript
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Congratulations on completing module one . Let's review what you have learned before you move on to the
knowledge checks .
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In this module you learned to:

1. Expla in food defense.
2. Expla in the general requirements of the Intentional Adulteration rule .
3. Describe the contents of the food defense plan .
4. Expla in the vulnerability assessment requ irements .
5. Define sig nificant vulnerabilities .
7. Expla in the training and qualifications required to conduct vulnerability assessments .

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Module 2: Introduction lo the Key Activity Types Vulnerability Assessment Method
Welcome and Introduction Transcript
Welcome to Module 2: "Introduction to the Key Activity Type Vulnerability Assessment Method"
Afte r completing th is module, you will be able to:

1. Summarize the origins of the key activity types ;
2. Recogn ize why using key activity types is appropri ate method to conduct a vulnerabil ity assessment;
3. Describe bulk liquid rece iving and loading ;
4. Describe liquid storage and handling ;
5. Desc ri be seconda ry ing red ient handli ng ; and
6. Desc ri be mixing and similar activities.
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Module 2: Introduction lo the Key Activity Types Vulnerability Assessment Method
KAT Method Background Transcript

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Let's start he re with a qu ick discussion of how the key activity type method was developed .
As directed by Homeland Security Presidential Directive-9, FDA has , since 2004, conducted numerous
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vulnerabil ity assessments covering a wide array of food manufactu ring settings in collaboration with industry,
academia, and othe r government partners. These activities have fo rmed the foundation of FDA's food defense
program, informed the development of the IA rule , and resulted in the identification of trends with regards to
vulnerabil ities with in the food system wh ich led to the development of the key activity type method .

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Module 2: Introduction to the Key Activity Types Vulnerability Assessment Method
Module 2 - KAT Method Background (continued) Transcript
In response to the passage of the Food Safety Modernization Act, or FSMA, FDA further analyzed the
vulnerabil ity assessment data and found a few key results. Certain general categories of food processing steps
or procedures (i. e., the key activity types) consistently ranked high in terms of vulnerability, regardless of the
commodity in question . It turned out that particular foods were not inhe rently more vulnerable to intentional
adulteration compared to other foods . Rather, the main drivers of vulnerability to intentional adulteration caused
by acts intended to cause wide scale publ ic health ha rm are the process ing steps and procedures that are used
as food is moved from farm to table.
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Module 2 - KAT Method Background (continued) Transcript

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From the data , FDA and its partners concluded that four groups of processing steps cons istently scored high in
the vulnerabil ity assessments-these four groups became the key activity types.
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They are:
• Bulk Liquid Rece iving and Loading;
• Liquid Storage and Handling;
• Secondary Ing red ient Handling , and ;
• Mixing and Similar Activities.

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Module 2 - Why K.ATs Are an Appropriate Method Transcript
Because the FDA's vulnerability assessments included cons ideration of the three elements (the potential public
health impact if a contam inant were successfully added to the product; the degree of physical access to the
product; and the ability of an attacker to successfully contaminate the product), with the possibility of an inside
attacker as an underlying assumption , as is required in the IA rule , the key activity types already have these
factors "built in." This is why the key activity types are considered an appropriate method for conducting a
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Why Using KATs Is an Appropriate Method Transcript

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The vulnerability assessment requirement under the IA ru le was written with a level of flexibility that allows firms
to dec ide which vulnerability assessment method is best for them. Conducting a vulnerability assessment us ing
an evaluation of the three elements , of which there are a number of appropriate methodologies , is one option.
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Another appropriate approach is using the key activity type method. If the facility uses the key activity
type method to conduct a vulnerability assessment it is not required to separately consider the three elements
and the inside attacker as FDA already did that work in identifying the key activity types. However, the fac ility
may choose to do so, provided such work is conducted by a qualified individual. Remember that this course
does not address conducting a vulnerability assessment by a method that is not the key activity types .
The key activity type approach enables facilities to identify actionable process steps in an efficient way that is
consistent with current food defense scientific understanding and that may be less resource intensive than a
full vulnerability assessment evaluating the three elements individ ually.
Now let's move on to a more detailed discussion of the four key activity types .

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Bulk Liquid Receiving and Loading Transcript
Bulk liquid receiving refers to a point, step, or procedure that involves the inbound movement of liquid ingredients into a
facility for its use in the food production process . This includes opening the inbound transport vehicle , opening any
venting hatches or other access points, attaching pumping equipment or hoses, and unloading the bulk liquid .
Bulk liquid loading refers to the outbound shipping of liquid intermediate or finished liquid product from a facility onto a
transport vehicle for further processing or use. This includes opening the outbound transport vehicle , attaching any
pumping equipment or hoses , and opening any facility venting hatches.
Examples of products that may be received or loaded in bulk include juices, high fructose corn syru p and other
sweeteners, milk, animal fats , syrups , and vegetable oils.
These processing steps are key activity types because there is a high probability of a contaminant, if intentionally
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added , to be mixed within the liquid due to significant sloshing , movement, or turbulence associated with the receiving
or loading activity. These activities involve a large volume of liquid that , if contaminated , could cause wide scale public
health harm. In addition, the need for worker activity associated with these processing steps provides access to
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hoses, the transport vessel, and potentially the product as it is being received or loaded .
Activities that do not fall under this key activity type include the receiving or loading of sealed jugs , drums , jars , and
totes . The receiving or loading of these sealed containers are not included in this key activity type regardless of the
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Liquid Storage and Handling Transcript

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Liquid storage and handling refers to a point, step, or procedu re in which a bulk or non-bulk liquid is contained
in storage tanks or silos or in holding , surge , metering , or other types of intermediate processing tanks. Liquid
storage refers to any storage silo or tank where liquid product may be stored prior to introduction into the
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product stream or prior to loading for outbound shipping . Bulk or non-bulk tanks can be used to store liqu id
ingredients (e.g., fats , oi ls, vitamin mixes , and sweeteners), hold liquid product for sample testing and other
quality control activity, or to control flow rates of liqu id ingredients or product through the production system .
Handling tanks also include tanks or totes where the tamper-evident seals are opened and the container itself is
used for holding, such as when a drum is opened and a pump is attached directly onto the drum to meter an
ingredient into the product line .
These are considered key activity types because if a contaminant were successfully introduced , there is a high
probability of the contaminant mixing within the liqu id. This could be due to the ag itation commonly used to
prevent separation within the liquid medium, the mixing or ag itation caused as liquid enters or exits the tanks , or
the likelihood that liqu id ingredients will be metered or applied to a large amount of servings . Access necessary
for the introduction of a contaminant is generally available through hatches , sample ports, or containe r lids .

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Secondary Ingredient Handling Transcript
Secondary ingredient handling refers to a point, step, or procedure in wh ich staging , preparation , add ition , or
rework occurs and ingredients (either dry or liquid) are manipulated by human contact prior to or during addition
to the product stream. Inclus ions , minor ingredients , process ing aids , and food additives are all examples of
secondary ingredients .
Specifically, "staging" refers to the process of opening the tamper-evident packaging of a secondary ingredient
and moving the ingredient to the production area in advance of being added into the primary product
stream. "Preparation" refers to any act of measuring , weighing , premixing , or otherwise manipulating the
ingred ient prior to addition to the product stream. "Add ition" refers to any act of phys ically adding ingredient
directly into the product stream or into surge or meter hoppers in order to deliver the ingred ient into the product
stream . "Rework" refers to clean , unadulterated food that has been removed from processing for reasons other
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than insanita ry conditions or that has been successfully recond itioned by reprocess ing and that is su itable for
use as food .
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Secondary Ingredient Handling (continued) Transcript

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This key activity type also includes the storage of partially used , open containers of secondary ingredients
where the tamper-evident packag ing has been breached .
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Computer metering or automatic weigh ing , sizing , batching, or measuring is not included in th is activity so long
as the process does not require the active involvement of a person .
Staging , preparation , addition, and rework involving secondary ingredients are key activity types because a
contaminant added to a relatively small volume of product would likely be distributed into a larger volume of food
within the ma in product flow. These activities are generally open and accessible and that accessibil ity is an
inherent component of the activity.
Also , mixing frequently occurs immed iately afte r ingredients are staged , prepared and/or added to the product
stream . Whereas mixing would homogeneously distribute an agent in a batch , the activities of ingredient
stag ing/preparation/addition provide a point of access to introduce the agent into the product stream .

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Mixing and Similar Activities Transcript
Mixing and sim ilar activities refers to a point, step, or procedure where the primary purpose or result is :
• mixing , i.e. , to blend a powder, dough , or liquid ingredient together;
• homogenizing , i.e., to reduce the particle size of an ingredient and disperse it throughout a liquid ;
• grinding , i.e. , to reduce the particle size of a solid ingredient or mass to a smaller granularity, and;
• coating , i.e ., to layer a powder or liquid onto the surface of a product, such as a batter, breading , glazing or
flavoring .
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Mixing and Similar Activities (continued) Transcript

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Examples of equ ipment assoc iated with these activities include: mixers , homogenizers , blenders , cascade-style
breaders, mills , grinders , and pulverizers .
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These are key activity types because a potential contaminant successfully added at one of these steps would
generally be readily dispersed throughout the product. Further, access is generally available through access
ports or lids .

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Summary Transcript
Congratulations on completing module two. Let's review what you have learned before moving on to the
knowledge checks .
In this module you learned to :

1. Summarize the origins of the key activity types.
2. Recognize why using key activity types is an appropriate method to conduct a vulnerability assessment.
3. Describe bulk liquid receiving and loading.
4. Describe liquid storage and handling.
5. Describe secondary ingredient handling.
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6. Describe mixing and similar activities.
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Module 3: Preparing to Use the Key Activity Types Method

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Welcome to Module 3: "Preparing to Use the Key Activity Type Method ."
After completing this module, you will understand certain activities that can help you prepare to use the key
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activity type method , such as:

1. Assembl ing a food defense team ;
2. Describing the product under evaluation ;
3. Developing a process flow diagram;
4. Describing the process steps under evaluation , and ;
5. Grouping similar products .

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Introduction to Preliminary Steps Transcript
Introduction to Preliminary Steps
Preliminary steps will help you prepare , organize, and conduct your vulnerability assessment using the key
activity types in an efficient way. They are :
• Assembling your food defense team ;
• Describing the product under evaluation ;
• Producing a process flow diagram ;
• Describing the process steps under evaluation , and ;
• Grouping similar products .
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These steps are not required by the IA rule but you may find them helpful.
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Facilities may find that they have already completed some or all of these preliminary steps for other purposes .
For example , you may have process flow diagrams and process descriptions prepared for food safety activities .
You may leverage these and all relevant resources already available to you to maximize efficiency and reduce
duplicate efforts .
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Assemble the Food Defense Team Transcript

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The first prelim inary step that is recommended is assembling the food defense team. Th is group of individuals
and their expertise related to the facility's practices, processes, and products will impact the quality and
completeness of your vulnerability assessment. It is therefore recommended that facilities gather a food defense
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team comprised of personnel with a diverse range of expertise in the day-to-day operations of the
facility. Facilities have the flexibility to determine the composition and size of the food defense team that best
fits their needs and circumstances, but at least one member of the group must be a qual ified individual. Multiple
team members may not be necessary for some facilities , especially considering the streamlined nature of the
key activity type method .
Having a diverse range of skills and expertise represented on the food defense team can help ensure a
complete understanding of, and thorough approach to, the vulnerability assessment process. It may be helpful to
include individuals from management, production , qual ity assurance or quality control , security, sanitation ,
maintenance, laboratories , human resources , purchasing , and other relevant departments , but again , this not
required.

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Describe Product Under Evaluation Transcript
The next recommended prelimina ry step is describing the product under evaluation . Product descriptions will help
food defense team members understand the characteristics of the product that may impact food defense , for
example , whether or not it has tamper-evident seals . The description should 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.
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Produce a Process Flow Diagram Transcript

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The next recommended prelimina ry step is producing a process flow diagram . The purpose of a process flow
diagram is to provide a clear outline of the steps involved in the processing of your food product and its
assoc iated ingred ients as they "flow" from receipt to distribution . Th is will provide an organ izing foundation on
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wh ich your vulnerability assessment using the key activ ity types is based .
Existing flow diagrams , for example those used for food safety purposes , may be used .
Processes and procedures that are not part of the food operation (e.g., utilities) do not need to be included in
the flow diagram .

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Describe Process Steps Under Evaluation Transcript
Next, it is recommended that the activity at each process step be described . The purpose of a process
description is to explain what happens at each of the process steps listed in the process flow diagram. It is
helpful to include a description of what each process step entails so that when you are conducting the
vulnerability assessment you have the background information you would need to assist you in determining
whether or not it aligns with a key activity type.
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Grouping Similar Products and Processes Transcript

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Let's conclude the discuss ion of preliminary steps with grouping similar products or very similar processes . As
with the vulnerability assessment discussion earl ier, similar food products may be grouped together and
assessed as one grouping when conducting a vulnerability assessment us ing the key activity types. However,
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any product or process-specific differences must be carefully delineated and noted in the vulnerability
assessment, and the facility must clearly identify the specific products included in each vulnerability
assessment. This grouping of sim ilar products may help streamline the analys is when facilities are
manufacturing sim ilar products us ing either the same equ ipment or very similar processes.

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Summary Transcript
Congratulations on completing module three . Let's review what you have learned before you move on to the
knowledge checks .
In this module, you learned certain steps that can help you prepare to use the key activity type method ,
including :
1. Assembl ing a food defense team ;
2. Describing the product under evaluation ;
3. Developing a process flow diagram ;
4. Describing the process steps under evaluation , and ;
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5. Grouping similar products .
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Module 4: Using the Key Activity Types Method

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Welcome to Module 4: "Us ing the Key Activity Type Method"

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1. Conduct key activity type mapping ;

2. Identify actionable process steps using the key activity type method , and ;
3. Expla in your decisions .

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Module 4: Using the Key A ctivity Types Method
Conduct Key Activity Mapping to Identify APSs Transcript
Now that you have completed the preliminary steps, you have the resources and preparation needed to move forward
with conducting your vulnerability assessment using the key activity type method . As you proceed , it may be helpful to
review the four key activity type descriptions so that they are fresh in your mind .
To conduct a vulnerability assessment using the key activity type method, you will assess each point, step, or
procedure to determine whether those activities fit within one or more of the key activity types. Process steps that fit
within one or more of the key activity types are actionable process steps. Process steps that do not fit within any of
the key activity types are not actionable process steps. For example , a step where multiple ingredients are
combined and mixed would fit within the "Mixing and Similar Activities" key activity type. This process step would then
be identified as an actionable process step. In contrast, the storage of dry ingredients that are sealed with tamper-
evident packaging in a storage room would not fit within any of the key activity types , and therefore would not be an
actionable process step.
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It should be noted again that any deviation from this key activity type method , for example choosing to further evaluate
the points, steps, or procedures identified as key activity types to determine whether or not they are actionable
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process steps using the three elements , what the FDA calls the hybrid approach , will require the individual conducting
or overseeing the vulnerability assessment to receive training in conducting vulnerability assessments using the three
elements , or be otherwise qualified through job experience.
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Conduct Key Activity Mapping to Identify APSs (continued) Transcript

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While identifying actionable process steps using any vulnerability assessment method , including the key acti v ity
type method , written explanations are required as to why each point, step, or procedure was or was not
identified as an actionable process step. Explanations can be straightforward and simple . For example , if a
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process ing step fits w ithin the Mixing and Similar Activities key activity type , then you should identify that
process step as an actionable process step and write an explanation as to why, which could s imply be: "This
point, step, or procedure fits within the key activity type- Mixing and Similar Activities ."
Conversely, for each process step that doesn 't align with a key activ ity type , the written explanation could
s imply state , "This step does not align w ith a key activity type ."
If a process step aligns with more than one key activity type , the facility could identify them both or the primary
one . The result is the same . However, identifying all applicable key acti v ity types in the explanation is
recommended because determining the specific key activity types may assist with the identifying the mitigation
strategies best su ited for that actionable process step.

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KAT Mapping Exercise #1 Instructions
In the following exercises , you will see excerpts from some sample flow diagrams. They have been simplified for
training purposes . Your task is to click on each process step and read the accompanying description ,
then decide whether or not that process step aligns with one of the four KATs : bulk liquid receiving and loading ;
liquid storage and handling ; secondary ingredient handling ; mixing and sim ilar activities . Select "Yes" or "No" to
respond to the question : Does this process step al ign with a KAT?
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KAT Mapping Exercise #2 Instructions

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As noted in KAT Mapping Exercise 1, your task is to click on each process step and read the accompanying
description , then decide whether or not that process step aligns with one of the four KATs : bulk liquid receiving
and loading ; liqu id storage and handling ; secondary ingredient handl ing ; mixing and similar activities. Select
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"Yes" or "No" to respond to the question : Does this process step align with a KAT?

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Summary Transcript
Congratulations on completing module four. Let's review what you have learned before you move on to the
knowledge checks .
In this module you learned to :

1. Conduct key activity type mapping ;
2. Identify actionable process steps using the key activity type method , and ;
3. Expla in your decisions.
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Key Activity Types Course Summary Transcript

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This concludes the instructional portion of this training course . Before finishing up with a short assessment, lets
summarize what you've learned today:
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• The key activity type method is an acceptable method of conducting your facility's vulnerability assessment
• The key activity type method simplifies the vulnerability assessment process and is less intensive with respect to
time , resources , and technical expertise
• How to describe the four key activity types
• The recommended preliminary steps that will help make your vulnerability assessment using the key activity
type method streamlined and efficient
• How to identify actionable process steps by recognizing which process steps in your food operation align with the
key activity types
• How to explain your decisions of what is and what is not an actionable process step in the context of the key
activity type method

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Resources Resources Help Exit

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• Analysis of Resu lts fo r FDA Food Defense Vu lnerability Assessments and

Identification of Activity Types
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• FDA Fact Sheet for the IA Ru le
• FDA Techn ical Assistance Network (TAN)
• FSPCA Intentional Adu lteration Training and Materials
• IA Rule
• IA Rule Overview Course: (In order to access the IA Rule Overview course.
You will need to log out first and then click the link on the FSPCA webpage.)
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If you are experiencing technical difficulties , please contact us at

LMSAdmin @ifpti. org, or call (269)488-3258.
IFPTl's regu lar business hours are:

Monday - Friday 8am to 5pm EST*
*Holidays may affect these hours
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