Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  
Mitigation Strategies to Protect Food 
Against Intentional Adulteration: 
Guidance for Industry  
 
Revised Draft Guidance 
This guidance is being distributed for comment purposes only. 
 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to 
ensure that FDA considers your comment on this draft guidance before we begin work on the 
final version of the guidance, submit either electronic or written comments on the draft 
guidance within 120 days of publication in the Federal Register of the notice announcing the 
availability of the draft guidance.  Submit electronic comments to 
https://www.regulations.gov.  Submit written comments to the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852.  All comments should be identified with the docket number FDA-2018-D-1398 listed 
in the notice of availability that publishes in the Federal Register.  
 
For questions regarding this draft document contact the Center for Food Safety and Applied 
Nutrition (CFSAN) at 240-402-3712. 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
 
March 2019 
    Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
 
Table of Contents 
I.  Introduction............................................................................................................................ 7 
II.  Purpose of this Guidance.................................................................................................. 9 
III.  Glossary of Terms Used in This Guidance ................................................................... 10 
A.  Definitions Established in 21 CFR 121 .......................................................................... 10 
B.  Other Terms Used in this Guidance ............................................................................... 12 
C.  Table of Abbreviations Used in This Guidance ............................................................. 15 
IV.  Exemptions ...................................................................................................................... 16 
A.  Very Small Business ...................................................................................................... 16 
B.  Holding of Food ............................................................................................................. 16 
C.  Packing and Labeling ..................................................................................................... 16 
D.  Farm Activities Covered by Standards for Produce Safety ........................................... 16 
E.  Alcoholic Beverages ....................................................................................................... 16 
F.  Animal Food ................................................................................................................... 17 
G.  Low-Risk Activities at Farm Mixed-Type Facilities ..................................................... 17 
Chapter 1: The Food Defense Plan ........................................................................................... 18 
A.  What is a Food Defense Plan? ....................................................................................... 18 
B.  Individuals to Assist with Developing Your Facilitys Food Defense Plan ................... 19 
C.  Formatting a Food Defense Plan .................................................................................... 20 
D.  Determining When to Make Changes to a Food Defense Plan ...................................... 20 
E.  Maintaining a Food Defense Plan .................................................................................. 21 
Chapter 2:  Vulnerability Assessment to Identify Significant Vulnerabilities and Actionable 
Process Steps................................................................................................................................ 22 
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A.  What is a Vulnerability Assessment? ............................................................................. 22 
B.  Recommended Activities Prior to Conducting a Vulnerability Assessment .................. 23 
C.  Key Activity Types as an Appropriate Method for Conducting a Vulnerability 
Assessment to Identify Significant Vulnerabilities and Actionable Process Steps ............... 25 
D.  Key Activity Type Descriptions ..................................................................................... 26 
E.  Identifying Actionable Process Steps Using the Key Activity Types Method ............... 28 
F.  Evaluating the Three Fundamental Elements [New March 2019] ................................. 36 
1.  Considerations in Evaluating the Three Fundamental Elements ............................... 37 
2.  Potential Public Health Impact (Element 1) ............................................................... 40 
3.  Degree of Physical Access to the Product (Element 2) .............................................. 52 
4.  Ability of Attacker to Successfully Contaminate the Product (Element 3) ............... 54 
G.  Identifying Significant Vulnerabilities and Actionable Process Steps Using the 
Three Fundamental Elements [New March 2019] ................................................................. 58 
1.  Using the Scores from the Three Fundamental Elements to Identify 
Significant Vulnerabilities and Actionable Process Steps ................................................ 59 
2.  Written Explanation for Identification of Actionable Process Steps ......................... 64 
H.  Identifying Actionable Process Steps Using the Hybrid Approach: Combining the 
Key Activity Types and the Three Fundamental Elements [New March 2019] ................... 65 
Chapter 3: Mitigation Strategies for Actionable Process Steps .............................................. 67 
A.  Mitigation Strategies Requirement ................................................................................ 67 
B.  Identifying Mitigation Strategies .................................................................................... 68 
1.  Minimizing the Accessibility of the Product to an Inside Attacker ........................... 69 
2.  Reducing the Ability of an Inside Attacker to Contaminate the Product ................... 73 
C.  Using Multiple Mitigation Strategies ............................................................................. 75 
D.  Facility-wide Security Measures and Their Role in a Facilitys Food Defense 
System.................................................................................................................................... 76 
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E.  The Role of Existing Measures ...................................................................................... 77 
F.  Accompanying Explanation for Mitigation Strategies in the Food Defense Plan .......... 79 
G.  Mitigation Strategy Example Scenarios ......................................................................... 80 
1.  Scenario 1 ................................................................................................................... 80 
2.  Scenario 2 ................................................................................................................... 81 
3.  Scenario 3 ................................................................................................................... 81 
4.  Scenario 4 ................................................................................................................... 82 
Chapter 4: Mitigation Strategies Management Components: Food Defense Monitoring ... 89 
A.  Overview of Food Defense Monitoring ......................................................................... 89 
B.  How Food Defense Monitoring Differs from Food Safety Monitoring ......................... 89 
C.  What to Monitor ............................................................................................................. 90 
D.  How to Monitor .............................................................................................................. 91 
1.  How Often to Monitor (Frequency of Monitoring) .................................................... 91 
2.  Who Performs the Monitoring ................................................................................... 93 
E.  Food Defense Monitoring Records................................................................................. 93 
F.  Exception Records .......................................................................................................... 94 
Chapter 5: Mitigation Strategies Management Components: Food Defense Corrective 
Actions (coming soon) ............................................................................................................... 103 
Chapter 6: Mitigation Strategies Management Components: Food Defense Verification 
(coming soon) ............................................................................................................................. 104 
Chapter 7: Reanalysis (coming soon) ...................................................................................... 105 
Chapter 8:  Education, Training, or Experience [New March 2019] ................................... 106 
A.  Individuals Who Perform Activities Required by Subpart C ....................................... 106 
B.  Individuals Assigned to an Actionable Process Step ................................................... 107 
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C.  Individuals Doing or Overseeing Four Specified Activities (Food Defense 
Qualified Individuals) .......................................................................................................... 107 
D.  Supervisors ................................................................................................................... 108 
E.  Training Frequency ....................................................................................................... 109 
F.  Training Records ........................................................................................................... 109 
Chapter 9: Records (coming soon) .......................................................................................... 111 
Appendix 1: Food Defense Plan Worksheets.......................................................................... 112 
A.  Introduction .................................................................................................................. 112 
B.  Food Defense Plan Cover Sheet ................................................................................... 112 
1.  How to Fill in Worksheet 1-A: Food Defense Plan Cover Sheet............................. 112 
2.  Worksheet 1-A:  Food Defense Plan Cover Sheet ................................................... 113 
C.  Food Defense Plan Product Description ...................................................................... 114 
1.  How to Fill in Worksheet 1-B: Food Defense Plan Product Description ................ 114 
2.  Worksheet 1-B: Food Defense Plan Product Description ........................................ 115 
D.  Food Defense Plan Vulnerability Assessment [Updated March 2019] ....................... 116 
1.  How to Fill in Worksheet 1C: Vulnerability Assessment Analysis Summary ...... 116 
2.  Worksheet 1-C: Vulnerability Assessment Analysis Summary ............................... 118 
3.  How to Fill in Worksheet 1-D: Calculating Volume of Food at Risk...................... 119 
4.  Worksheet 1-D: Calculating Volume of Food at Risk ............................................. 121 
5.  How to Fill in Worksheet 1-E: Calculating Potential Public Health Impact 
using a Representative Contaminant ............................................................................... 122 
6.  Worksheet 1-E: Calculating Potential Public Health Impact Using a 
Representative Contaminant ........................................................................................... 124 
7.  How to Fill in Worksheet 1-F: Identifying Significant Vulnerabilities and 
Actionable Process Steps using the Three Fundamental Elements ................................ 127 
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8.  Worksheet 1-F: Identifying Actionable Process Steps Using the Three 
Fundamental Elements .................................................................................................... 129 
E.  Food Defense Plan Mitigation Strategies ..................................................................... 130 
1.  How to Fill in Worksheet 1-H: Mitigation Strategies .............................................. 130 
2.  Worksheet 1-H: Mitigation Strategies...................................................................... 131 
F.  Food Defense Plan Mitigation Strategies Management Components .......................... 132 
1.  How to Fill in Worksheet 1-I: Mitigation Strategies Management 
Components .................................................................................................................... 132 
2.  Worksheet 1-I: Mitigation Strategies Management Components ............................ 134 
Appendix 2: Mitigation Strategies in the Food Defense Mitigation Strategies Database 
(coming soon) ............................................................................................................................. 135 
Appendix 3: Calculating Small Business and Very Small Business Sizes (coming soon) ... 136 
Appendix 4: Vulnerability Assessment Examples [New March 2019] ................................. 137 
A.  Example of a Vulnerability Assessment Using the Three Fundamental Elements ...... 137 
Figure 2b-1. Three Fundamental Elements VA Example  Breaded Morsel 
Process Flow Diagram .................................................................................................... 138 
Figure 2b-2. Three Fundamental Elements VA Example - Worksheet 1-F  
Breaded Morsels ............................................................................................................. 139 
Figure 2b-3. Three Fundamental Elements VA Example  Process Steps Rank 
Ordered by Sum Score  Breaded Morsels ..................................................................... 150 
B.  Example of a Vulnerability Assessment Using the Hybrid Approach ......................... 152 
Figure 2c-1. Hybrid Approach VA Example- Cold Pressed Almond Cranberry 
Energy Bar Process Flow Diagram* ............................................................................... 153 
Figure 2c-2. Hybrid Approach VA Example- Worksheet 1-F- Cold Pressed 
Almond Cranberry Energy Bar ....................................................................................... 154 
References .................................................................................................................................. 158 
 
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Mitigation Strategies to Protect Food 
Against Intentional Adulteration: 
1
Guidance for Industry   
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration (FDA or we) on this topic.  It does not establish any rights for any person and is 
not binding on FDA or the public.  You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.  To discuss an alternative approach, 
contact the FDA staff responsible for this guidance as listed on the title page.  
I.  Introduction  
The FDA Food Safety Modernization Act (FSMA) added to the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) several new sections that reference intentional adulteration.  For 
example, section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional adulteration in the 
context of facilities that manufacture, process, pack, or hold food, and that are required to 
register under section 415 (21 U.S.C. 350d).  Section 420 of the FD&C Act (21 U.S.C. 350i) 
addresses intentional adulteration in the context of high-risk foods and exempts farms except for 
farms that produce milk.2   
We implemented these intentional adulteration provisions through a rule entitled Mitigation 
Strategies to Protect Food Against Intentional Adulteration (IA rule).  We published the final 
rule in the Federal Register of May 27, 2016.  (81 FR 34166).  The rule, which includes the 
requirements for food defense measures against intentional adulteration, and related 
requirements, can be found in 21 CFR part 121, as shown in Table 1.  
                                                 
1 This guidance has been prepared by the Office of Analytics and Outreach, Food Defense and Emergency 
Coordination Staff, in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.   
2 The IA rule did not include any requirements for farms that produce milk.  As such, farms that produce milk are 
not covered under this draft guidance.  
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Table 1. Subparts Established in 21 CFR Part 121 
Subpart  Title 
A  General Provisions 
B  Reserved 
C  Food Defense Measures 
D  Requirements Applying to Records That Must Be Established and Maintained 
E  Compliance 
 
As shown in Table 2 below, the amount of time we are allowing you to comply with the IA rule 
depends on your particular business. 
Table 2.  Compliance Dates for IA Rule Based on Size of Business 
Size of Business  Compliance Date 
Very small   July 26, 2021 
Small   July 27, 2020 
Other businesses that do not qualify  July 26, 2019 
for exemptions 
 
The IA rule applies to the owner, operator, or agent in charge of a domestic or foreign food 
facility that manufactures/processes, packs, or holds food for consumption in the United States 
and is required to register under section 415 of the FD&C Act, unless one of the exemptions 
provided in 21 CFR 121.5 applies.  (21 CFR 121.1).  (See Section IV below for a list of the 
exemptions).   
Acts of intentional adulteration may take several forms: acts intended to cause wide scale public 
health harm, such as acts of terrorism focused on the food supply; acts of disgruntled employees, 
consumers, or competitors; and economically motivated adulteration (EMA).  Acts intended to 
cause wide scale public health harm are associated with intent to cause significant human 
morbidity and mortality.  (Ref. 1, Ref. 2).  The other forms are typically not intended to cause 
wide scale public health harm, although some public health harm may occur because of the 
adulteration.  For example, acts of disgruntled employees, consumers, and competitors are 
generally intended to attack the reputation of a company, and EMA is intended to obtain 
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economic gain.  In the spectrum of risk associated with intentional adulteration of food, attacks 
intended to cause wide scale public health harm to humans are ranked as the highest risk.  
Therefore, the IA rule is focused on addressing those acts and not acts of disgruntled employees, 
consumers, or competitors, or acts of EMA.3  
This document is directed to those persons who are subject to the Intentional Adulteration (IA) 
requirements of 21 CFR part 121 (you).  Identifying significant vulnerabilities at your facility 
and implementing mitigation strategies and mitigation strategy management components enables 
you to apply a proactive and systematic approach to your food defense program to protect your 
food from intentional adulteration intended to cause wide scale public health harm.   
II.  Purpose of this Guidance  
The purpose of this guidance is to help you develop and implement a food defense plan (FDP) in 
accordance with the IA rules requirements.  Specifically, this document provides guidance on: 
  Understanding the components of an FDP and the importance of each component; 
  Understanding how to conduct a vulnerability assessment to identify significant 
vulnerabilities and actionable process steps; 
  Understanding how to identify and implement mitigation strategies for the actionable 
process steps associated with a facilitys processes;  
  Understanding how to identify and apply the mitigation strategies management 
components (i.e., food defense monitoring, food defense corrective actions, and food 
defense verification);  
  Understanding the reanalysis requirements associated with the FDP; 
  Understanding the education, training, and/or experience required for individuals who 
perform certain activities; and 
  Understanding the recordkeeping requirements associated with the FDP and 
implementation of the FDP. 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required.  
                                                 
3 As we noted in the final rule, the protections required by the rule will help minimize the likelihood of success of a 
disgruntled employee, consumer, or competitor who attempts an act of intentional adulteration at an actionable 
process stepeven if that act is not intended to cause wide scale public health harm.  (81 FR at 34183). 
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III.  Glossary of Terms Used in This Guidance 
A. Definitions Established in 21 CFR 121 
Actionable process step means a point, step, or procedure in a food process where a significant 
vulnerability exists and at which mitigation strategies can be applied and are essential to 
significantly minimize or prevent the significant vulnerability.  
Adequate means that which is needed to accomplish the intended purpose in keeping with good 
public health practices. 
Affiliate means any facility that controls, is controlled by, or is under common control with 
another facility. 
Calendar day means every day as shown on the calendar. 
Contaminant means, for purposes of this part, any biological, chemical, physical, or 
radiological agent that may be added to food to intentionally cause illness, injury, or death.   
Facility means a domestic facility or a foreign facility that is required to register under section 
415 of the FD&C Act, in accordance with the requirements of 21 CFR part 1, subpart H. 
Food defense means the effort to protect food from intentional acts of adulteration where there is 
an intent to cause wide scale public health harm. 
Food defense monitoring means to conduct a planned sequence of observations or 
measurements to assess whether mitigation strategies are operating as intended.   
Food defense verification means the application of methods, procedures, and other evaluations, 
in addition to food defense monitoring, to determine whether a mitigation strategy or 
combination of mitigation strategies is or has been operating as intended according to the food 
defense plan. 
Full-time equivalent employee is a term used to represent the number of employees of a 
business entity for the purpose of determining whether the business qualifies as a small business.  
The number of full-time equivalent employees is determined by dividing the total number of 
hours of salary or wages paid directly to employees of the business entity and of all of its 
affiliates and subsidiaries by the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 
52 weeks).  If the result is not a whole number, round down to the next lowest whole number. 
Holding means storage of food and also includes activities performed incidental to storage of 
food (e.g., activities performed for the safe or effective storage of that food, such as fumigating 
food during storage, and drying/dehydrating raw agricultural commodities when the 
drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or 
alfalfa)).  Holding also includes activities performed as a practical necessity for the distribution 
of that food (such as blending of the same raw agricultural commodity and breaking down 
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pallets), but does not include activities that transform a raw agricultural commodity into a 
processed food as defined in section 201(gg) of the FD&C Act.  Holding facilities could include 
warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.   
Manufacturing/processing means making food from one or more ingredients, or synthesizing, 
preparing, treating, modifying or manipulating food, including food crops or ingredients.  
Examples of manufacturing/processing activities include:  Baking, boiling, bottling, canning, 
cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a 
distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, 
eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, 
labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, 
peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing.  For farms 
and farm mixed-type facilities, manufacturing/processing does not include activities that are part 
of harvesting, packing, or holding.  
Mitigation strategies mean those risk-based, reasonably appropriate measures that a person 
knowledgeable about food defense would employ to significantly minimize or prevent 
significant vulnerabilities identified at actionable process steps, and that are consistent with the 
current scientific understanding of food defense at the time of the analysis. 
Mixed-type facility means an establishment that engages in both activities that are exempt from 
registration under section 415 of the FD&C Act and activities that require the establishment to be 
registered.  An example of such a facility is a farm mixed-type facility, which is an 
establishment that is a farm, but also conducts activities outside the farm definition that require 
the establishment to be registered. 
Packing means placing food into a container other than packaging the food and also includes re-
packing and activities performed incidental to packing or re-packing a food (e.g., activities 
performed for the safe or effective packing or re-packing of that food (such as sorting, culling, 
grading, and weighing or conveying incidental to packing or re-packing)), but does not include 
activities that transform a raw agricultural commodity into a processed food as defined in section 
201(gg) of the FD&C Act.  
Qualified individual means a person who has the education, training, or experience (or a 
combination thereof) necessary to perform an activity required under 21 CFR subpart C, as 
appropriate to the individuals assigned duties.  A qualified individual may be, but is not required 
to be, an employee of the establishment.  
Significant vulnerability means a vulnerability that, if exploited, could reasonably be expected 
to cause wide scale public health harm.  A significant vulnerability is identified by a 
vulnerability assessment conducted by a qualified individual, that includes consideration of the 
following: (1) Potential public health impact (e.g., severity and scale) if a contaminant were 
added, (2) degree of physical access to the product, and (3) ability of an attacker to successfully 
contaminate the product.  The assessment must consider the possibility of an inside attacker. 
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Significantly minimize means to reduce to an acceptable level, including to eliminate. 
Small business means, for purposes of this part, a business (including any subsidiaries and 
affiliates) employing fewer than 500 full-time equivalent employees. 
Subsidiary means any company which is owned or controlled directly or indirectly by another 
company.  
Very small business means, for purposes of this part, a business (including any subsidiaries and 
affiliates) averaging less than $10,000,000, adjusted for inflation, per year, during the 3-year 
period preceding the applicable calendar year in sales of human food plus the market value of 
human food manufactured, processed, packed, or held without sale (e.g., held for a fee). 
Vulnerability means the susceptibility of a point, step, or procedure in a facilitys food process 
to intentional adulteration.  
You means, for purposes of this part, the owner, operator, or agent in charge of a facility.  
B. Other Terms Used in this Guidance 
CARVER + Shock: An adapted military targeting tool that assesses vulnerabilities of the food 
and agriculture sector.  CARVER is an acronym for six attributes used to evaluate the 
attractiveness of a target for attack: Criticality, Accessibility, Recuperability, Vulnerability, 
Effect, and Recognizability.   
Facility-wide security measures: general, non-targeted, protective measures that are 
implemented at the facility-wide level to protect personnel, property, or product.  Such measures 
may include physical security, personnel security, securing hazardous materials, management 
practices, and crisis management planning.  A facility-wide security measure could be identified 
as a mitigation strategy if it specifically addresses a significant vulnerability at an actionable 
process step. 
Farm means:   
(1) Primary production farm. A primary production farm is an operation under one management 
in one general (but not necessarily contiguous) physical location devoted to the growing of 
crops, the harvesting of crops, the raising of animals (including seafood), or any combination of 
these activities. The term farm includes operations that, in addition to these activities:  
(i)  Pack or hold raw agricultural commodities;  
(ii)  Pack or hold processed food, provided that all processed food used in such activities 
is either consumed on that farm or another farm under the same management, or is 
processed food identified in paragraph (1)(iii)(B)(1) of this definition; and  
(iii)  Manufacture/process food, provided that:  
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(A) All food used in such activities is consumed on that farm or another farm under 
the same management; or  
(B) Any manufacturing/processing of food that is not consumed on that farm or 
another farm under the same management consists only of:  
(1) Drying/dehydrating raw agricultural commodities to create a distinct 
commodity (such as drying/dehydrating grapes to produce raisins), and packaging 
and labeling such commodities, without additional manufacturing/processing (an 
example of additional manufacturing/processing is slicing);  
(2) Treatment to manipulate the ripening of raw agricultural commodities (such as 
by treating produce with ethylene gas), and packaging and labeling treated raw 
agricultural commodities, without additional manufacturing/processing; and  
(3) Packaging and labeling raw agricultural commodities, when these activities do 
not involve additional manufacturing/processing (an example of additional 
manufacturing/processing is irradiation); or  
(2) Secondary activities farm. A secondary activities farm is an operation, not located on a 
primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or 
holding of raw agricultural commodities, provided that the primary production farm(s) that 
grows, harvests, and/or raises the majority of the raw agricultural commodities harvested, 
packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in 
the secondary activities farm. A secondary activities farm may also conduct those additional 
activities allowed on a primary production farm as described in paragraph (1)(ii) and (iii) of this 
definition.  (See 21 CFR 1.227). 
Food means food as defined in section 201(f) of the FD&C Act and includes raw materials and 
ingredients.  Food is defined in section 201(f) as (1) articles used for food or drink for man or 
other animals, (2) chewing gum, and (3) articles used for components of any such article and 
includes raw materials and ingredients. 
Food defense plan: A set of written documents that is based upon food defense principles and 
incorporates a vulnerability assessment, includes mitigation strategies, and delineates food 
defense monitoring, corrective action, and verification procedures to be followed.  (21 CFR 
121.126). 
Food defense qualified individual: An individual who meets the requirements in 21 CFR 
121.4(c)(1) and (2) to do or oversee the activities listed in 21 CFR 121.4(c)(3). 
Food defense system: The result of the implementation of the Food Defense Plan. 
Fundamental elements: The three elements that must be evaluated for each point, step, or 
procedure in a facilitys food process when conducting a vulnerability assessment.  (21 CFR 
121.130(a)).  These elements are (1) The potential public health impact (e.g., severity and scale) 
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if a contaminant were added; (2) The degree of physical access to the product; and (3) The 
ability of an attacker to successfully contaminate the product.  (21 CFR 121.130(a)).  
HACCP (Hazard Analysis and Critical Control Point): A system that identifies, evaluates, 
and controls hazards that are significant for food safety. 
Intentional adulteration: The deliberate contamination of food with a biological, chemical, 
radiological, or physical agent by an individual or group of individuals with the intent to cause 
wide scale public health harm.   
Key Activity Types (KAT): The four activity types identified by FDA through an analysis of 
the results of over 50 vulnerability assessments as the activities consistently ranked as the most 
vulnerable, regardless of the food commodity assessed.   The KATs reflect significant 
vulnerabilities to intentional adulteration caused by acts intended to cause wide scale public 
health harm.  The four KATs are: bulk liquid receiving and loading, liquid storage and handling, 
secondary ingredient handling, and mixing and similar activities. 
Preventive Controls for Human Food Rule (PCHF): Refers to the preventive controls 
requirements of 21 CFR part 117 (primarily located in subparts C & G).    
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C. Table of Abbreviations Used in This Guidance 
Abbreviation  What It Means 
FD&C Act  Federal Food, Drug, and Cosmetic Act 
CCTV*  Closed-circuit television 
CFR   Code of Federal Regulations  
EMA  Economically motivated adulteration 
FDA  U.S. Food and Drug Administration 
FDP  Food defense plan 
FDPB  Food Defense Plan Builder  
FSPCA  Food Safety Preventive Controls Alliance  
FSMA  FDA Food Safety Modernization Act 
FSP  Food Safety Plan, as required under the PCHF rule 
HACCP  Hazard Analysis and Critical Control Point 
HEPA  High-Efficiency Particulate Air 
HFCS*  High fructose corn syrup 
IA  Intentional Adulteration 
IA rule  Mitigation Strategies to Protect Food Against Intentional 
Adulteration (21 CFR part 121) 
KAT  Key Activity Types 
LD*  Lethal Dose 
FDMSD  Food Defense Mitigation Strategies Database 
PCHF   Preventive Controls for Human Food 
VA  Vulnerability Assessment (as required in 21 CFR 121.130) 
  *[Updated March 2019] 
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IV.  Exemptions 
The owner, operator, or agent in charge of a facility that manufactures, processes, packs, or holds 
food for consumption in the United States and is required to register under section 415 of the 
FD&C Act (21 U.S.C. 350d) is subject to the requirements of the IA rule, with some exemptions, 
as provided in 21 CFR 121.5.  (21 CFR 121.1).  Some regulatory exemptions apply to entire 
facilities and others apply to particular activities or food.  If a facility satisfies the requirements 
for an exemption under 21 CFR 121.5, then it receives the exemption; no application is 
necessary but some documentation may be required. 
A. Very Small Business  
The only IA rule requirement for a very small business (defined in 21 CFR 121.3) is that it must, 
upon request, provide for official review documentation sufficient to show that the facility meets 
the criteria for the exemption; such documentation must be retained for 2 years.  (21 CFR 
121.5(a)).  The IA rules requirements otherwise do not apply to a very small business.   
B. Holding of Food  
The IA rule requirements do not apply to the holding of food, except the holding of food in 
liquid storage tanks.  (21 CFR 121.5(b)).  Examples of holding of food that are not covered by 
the IA rule include the storage of whole grains, shell eggs, fruits and vegetables, and packaged 
foods (including packaged orange juice).  Examples of holding food that are covered by the IA 
rule include the storage of liquid milk, juice, or syrup in storage tanks.   
C. Packing and Labeling  
The IA rule requirements do not apply to the packing, re-packing, labeling, or re-labeling of food 
where the container that directly contacts the food remains intact.  (21 CFR 121.5(c)).  Packing 
means placing food into a container other than packaging the food and also includes re-packing 
and activities performed incidental to packing or re-packing a food (e.g., activities performed for 
the safe or effective packing or re-packing of that food (such as sorting, culling, grading, and 
weighing or conveying incidental to packing or re-packing)), but does not include activities that 
transform a raw agricultural commodity into a processed food as defined in section 201(gg) of 
the FD&C Act.  (21 CFR 121.3).  An example of packing is placing a variety of individually 
wrapped bite-sized candies into a larger variety pack.   
D. Farm Activities Covered by Standards for Produce Safety 
The IA rule requirements do not apply to activities of a farm that are subject to section 419 of the 
FD&C Act (Standards for Produce Safety).  (21 CFR 121.5(d)).  The definition of farm is 
found at 21 CFR 1.227 and in Section IV.A. of this chapter. 
E. Alcoholic Beverages 
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The IA rule requirements do not apply with respect to alcoholic beverages at a facility that meets 
the following two conditions: 
  Under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) or chapter 51 of 
subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5001 et seq.) the facility is 
required to obtain a permit from, register with, or obtain approval of a notice or 
application from the Secretary of the Treasury as a condition of doing business in the 
United States, or is a foreign facility of a type that would require such a permit, 
registration, or approval if it were a domestic facility; and  
  Under section 415 of the FD&C Act the facility is required to register as a facility 
because it is engaged in manufacturing, processing, packing, or holding one or more 
alcoholic beverages.  (21 CFR 121.5(e)(1)).  
Additionally, this exemption applies to food at these facilities that is not an alcoholic beverage, if 
such food is in prepackaged form that prevents any direct human contact with the food and 
constitutes not more than 5 percent of the overall sales of the facility, as determined by the 
Secretary of the Treasury.  (21 CFR 121.5(e)(2)). 
F. Animal Food  
The IA rule requirements do not apply to the manufacturing, processing, packing, or holding of 
food for animals other than man.  (21 CFR 121.5(f)).  If a facility manufactures, processes, 
packs, or holds food for both humans and animals, only the activities related to human food are 
covered by the rule. 
G. Low-Risk Activities at Farm Mixed-Type Facilities  
The IA rule requirements do not apply to on-farm manufacturing, processing, packing, or 
holding of the following foods on a farm mixed-type facility, when conducted by a small or very 
small business if such activities are the only activities conducted by the business subject to 
section 418 of the FD&C Act:   
  Eggs (in-shell, other than raw agricultural commodities, e.g., pasteurized eggs in shell); 
and 
  Game meats (whole or cut, not ground or shredded, without secondary ingredients).  (21 
CFR 121.5(g)).   
(See the Final Evaluation of Food Manufactured, Processed, Packed, or Held (Outside the Farm 
Definition) in a Facility Co-Located on a Farm for Risk of Intentional Adulteration at 
https://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM50278
3.pdf). 
   
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Chapter 1: 
The Food Defense Plan 
This chapter is intended to help you understand what a food defense plan (FDP) is, the required 
components of a FDP, and the individuals needed and useful for developing or overseeing the 
development of the FDP.  If the IA rule applies to you, you must prepare, or have prepared, and 
implement a written food defense plan.  (21 CFR 121.126(a)).   
A. What is a Food Defense Plan?  
An FDP is a set of written documents that is based upon food defense principles and incorporates 
a vulnerability assessment, includes mitigation strategies, and delineates food defense 
monitoring, corrective action, and verification procedures to be followed (21 CFR 121.126(b)).  
A written FDP is essential for you to significantly minimize or prevent significant vulnerabilities 
related to intentional adulteration of food.  Documentation and implementation of the plan are 
necessary so that both your facility and FDA can ensure that significant vulnerabilities are 
properly addressed.   
Below are the required FDP components in more detail: 
  Vulnerability assessment to identify significant vulnerabilities and actionable process 
steps, including an explanation of why each point, step, or procedure was or was not 
identified as an actionable process step (See 21 CFR 121.130); 
  Mitigation strategies for each actionable process step and written explanations of how 
each mitigation strategy sufficiently minimizes or prevents the significant vulnerability 
associated with the actionable process step (See 21 CFR 121.135);   
  Food defense monitoring procedures for the implementation of the mitigation strategies, 
as appropriate to the nature of the mitigation strategy and its role in the facilitys food 
defense system (See 21 CFR 121.140); 
  Food defense corrective action procedures that must be taken if mitigation strategies are 
not properly implemented, as appropriate to the nature of the actionable process step and 
the nature of the mitigation strategy (See 21 CFR 121.145); and 
  Food defense verification procedures for verification activities, as appropriate to the 
nature of the mitigation strategy and its role in the facilitys food defense system (See 21 
CFR 121.150).    
Although the IA rule specifies the required contents of the FDP as described above, you can also 
use the FDP as a resource to capture additional food defense-related information.  For example, 
you could include information such as process flow diagrams; general site security procedures or 
policies; emergency contact information for suppliers, customers, and government agencies; a 
crisis management plan; a risk communications plan; a supplier audits plan; and a recall plan.    
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B. Individuals to Assist with Developing Your Facilitys Food Defense Plan   
In developing your FDP, you will need the assistance of individuals with knowledge and 
expertise of your facilitys operations as well as general food defense principles.   
1.  Food Defense Qualified Individuals 
The IA rule requires special qualifications for individuals who do or oversee the following 
activities, which require the most food defense expertise: 
  preparation of the FDP;  
  conduct of a vulnerability assessment;  
  identification and explanation of mitigation strategies; and  
  performance of the reanalysis.  (21 CFR 121.4(c)(3)). 
Such an individual must meet the following requirements:  
1)  Education, training, or experience (or a combination thereof) necessary to properly 
perform the activities; and 
2)  Successful completion of training for the specific function that is at least equivalent to 
that received under a standardized curriculum recognized as adequate by FDA or be 
otherwise qualified through job experience to conduct the activities.  Job experience may 
qualify an individual to perform these functions if such experience has provided an 
individual with knowledge at least equivalent to that provided through a standardized 
curriculum recognized as adequate by FDA (e.g., the curriculum used in the Food Safety 
Preventive Controls Alliance (FSPCA) training).  (21 CFR 121.4(c)(1) and (2)).  
The individual you enlist to perform the specified activities does not have to be an employee of 
your facility, but it may be beneficial for you to have at least one food defense qualified 
individual on staff to provide expertise and insight if there are questions about the food defense 
plan or if the plan needs to be updated.  If you do not have such an individual on your staff, you 
can enlist one from outside your facility to perform the specified activities.  See Chapter 8 of this 
guidance for more information on education, training, or experience.   
2.  Food Defense Team  
For some facilities, such as small companies, the responsibility for writing the FDP may fall to a 
single individual.  For facilities that have sufficient resources, although it is not required, we 
recommend that you put together a team to help develop your FDP, including one or more food 
defense qualified individuals.  Food defense team members should be knowledgeable about 
general food defense principles and concepts, and the team should include members who are 
directly involved with food processes and daily operations at your facility.  Team members could 
include personnel from security, maintenance, food production (including equipment experts), 
sanitation, food safety quality assurance or quality control, engineering, purchasing, human 
resources, or laboratory.  Additionally, colleges and universities, cooperative extensions, 
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consulting groups, and trade associations are potential sources of assistance in developing an 
FDP.   
In addition to developing the FDP, the food defense team can also provide oversight or guidance 
on the implementation of the plan in the daily operations of the facility.  This includes ensuring 
that appropriate people are trained to handle their FDP-related duties. 
C. Formatting a Food Defense Plan  
There is no standardized or required format for an FDP.  If your FDP includes all the 
components required by the IA rule, you have the flexibility to use whatever format works best 
for your facility and organize the content of the FDP in any way you would like.  Appendix 1 of 
this guidance includes sample FDP worksheets for particular components of an FDP.  The format 
used in the included worksheets is just one possibility; you may format your FDP differently.  In 
addition, FDAs software tool, the Food Defense Plan Builder (FDPB), may help you with 
compiling and organizing the content of your FDP.  FDA intends to update the FDPB to align 
with the IA rule and guidance.   
Your FDP could consist of multiple documents, some of which you developed specifically for 
the IA rule and others that may already exist for other purposes.  Although you must sign and 
date the FDP, the information required in an FDP does not need to be kept in one set of records.  
(21 CFR 121.310).  One approach for organizing the FDP to allow for signing and dating is to 
collect and maintain all the required documents in a single location (e.g., a binder or folder) with 
a cover page containing the required signature and the date on which the cover page was signed. 
Another approach is for you to sign and date a list of the relevant documents (e.g., a Table of 
Contents) that make up the FDP.   
Some facilities may have already independently developed and implemented food defense plans 
that can be modified to fit the requirements of the IA rule.  You may use existing records for 
your required FDP if the records satisfy all the requirements of the IA rule.  If existing records 
contain only some of the required information, you may keep any additional required 
information either separately or combined with the existing records.  (21 CFR 121.330).  
D. Determining When to Make Changes to a Food Defense Plan 
The FDP is a dynamic document that reflects your current vulnerability assessment, actionable 
process steps, mitigation strategies, and applicable management component procedures.  The 
FDP as a whole must be reanalyzed at least every 3 years.  (21 CFR 121.157(a)).  The following 
circumstances also necessitate reanalysis: whenever a significant change to activities  creates a 
reasonable potential for a new vulnerability or a significant increase in an existing vulnerability; 
whenever you become aware of new information about potential vulnerabilities associated with 
the food operation or your facility; whenever you find that a mitigation strategy or the food 
defense plan as a whole is not properly implemented; and whenever FDA requires reanalysis to 
respond to new vulnerabilities, credible threats to the food supply, and developments in scientific 
understanding.  (21 CFR 121.157(b)).  For reanalysis conducted in response to such 
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circumstances, you may limit the reanalysis to the affected portions of your FDP.  (See 21 CFR 
121.157(b)). 
E. Maintaining a Food Defense Plan  
The FDP is a record that is subject to the records requirements of the IA rule.  (21 CFR 
121.126(c)).  You must sign and date the FDP upon initial completion and upon any 
modification.  (21 CFR 121.310).  The FDP must be retained at the facility for at least 2 years 
after its use is discontinued.  (21 CFR 121.315(b)).  The FDP must remain onsite.  (21 CFR 
121.315(c)).  Electronic records are considered to be onsite if they are accessible from an onsite 
location.  (21 CFR 121.315(c)). 
As FDPs may contain information that present sensitivities not likely to be present in food safety 
plans, such as a facilitys food defense vulnerabilities, we encourage facilities to adequately 
protect food defense plans and associated information and records. 
   
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Chapter 2:  
Vulnerability Assessment to Identify Significant Vulnerabilities and 
Actionable Process Steps  
[New March 2019 - This chapter provides guidance to help you understand how to conduct a 
vulnerability assessment (VA) to identify significant vulnerabilities and actionable process steps.  
In a VA, you identify and evaluate points, steps, and procedures in your 
manufacturing/processing operation where an act of intentional adulteration could occur; and, 
through that evaluation, identify mitigation strategies to significantly minimize or prevent any 
significant vulnerability associated with that point, step, or procedure (i.e., actionable process 
step).  The VA requirement is flexible.  There are many possible approaches to conducting a 
vulnerability assessment.  You may choose an approach based on considerations such as the time 
and resources available and the level of specificity desired.  You have the flexibility to choose 
any VA approach, as long as your VA contains each required component (21 CFR 121.130).   
In sections A and B of this chapter, we describe a VA, the general requirements of a VA, and 
recommended activities prior to conducting a VA. In sections C, D, and E, we describe a simple, 
less resource-intensive approach using KATs to identify significant vulnerabilities at actionable 
process steps.  In Sections F and G, we describe how to conduct a VA using the three 
fundamental elements to identify significant vulnerabilities at actionable process steps.  Finally, 
in section H, we describe how to conduct a VA using the hybrid approach (i.e., a combination of 
the KATs and the three fundamental elements).   
In Appendix 4 of this guidance, there are two examples of vulnerability assessments  one 
conducted by evaluating the three fundamental elements, and another conducted using the hybrid 
approach.]  
A. What is a Vulnerability Assessment? 
The VA is an essential component of your overall food defense plan (21 CFR 121.126(b)(1)).  
The VA provides a mechanism for you to identify, prioritize, and focus resources on preventing 
or significantly minimizing significant vulnerabilities at specific points, steps, or procedures.  
Your VA should reflect detailed knowledge of the points, steps, or procedures associated with 
your facility, relevant scientific expertise, and judgment.  It is critical to carefully conduct a VA 
because it identifies those points, steps, or procedures within your facility where significant 
vulnerabilities exist.  Furthermore, many of the other major parts of your FDP (e.g., mitigation 
strategies and mitigation strategy management components) are dependent upon your VA.    
You must conduct or have conducted a vulnerability assessment for each type of food 
manufactured, processed, packed, or held at your facility using appropriate methods to evaluate 
each point, step, or procedure in your food operation to identify significant vulnerabilities and 
actionable process steps.  (21 CFR 121.130(a)).  A significant vulnerability means a vulnerability 
that, if exploited, could reasonably be expected to cause wide scale public health harm.  (21 CFR 
121.3).  Although the IA rule does not specify a particular method that you must use to conduct 
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your VA, the following elements must be considered during your evaluation of each point, step, 
or procedure: 
1.  The potential public health impact (e.g., severity and scale) if a contaminant were added 
(21 CFR 121.130(a)(1)); 
2.  The degree of physical access to the product (21 CFR 121.130(a)(2)); and 
3.  The ability of an attacker to successfully contaminate the product (21 CFR 
121.130(a)(3)). 
When you are evaluating each of these three elements, you also must consider the possibility of 
an inside attacker.  (21 CFR 121.130(b)).  See section F.1.a. of this chapter for more information 
on the inside attacker.   
1.  The Scope of Points, Steps, and Procedures for Consideration in a Vulnerability 
Assessment 
Your VA must evaluate each point, step, or procedure in your food operation to identify 
significant vulnerabilities and actionable process steps.  (21 CFR 121.130(a)). Your VA should 
include only those points, steps, and procedures that are related to manufacturing, processing, 
packing, or holding of the food product.  The phrase point, step, or procedure has a similar 
meaning as it does in the context of HACCP plans and PCHF food safety plans.  These points, 
steps, and procedures include receiving and storage steps for each raw material or other 
ingredient, preparation, manufacturing, processing, packaging, storage, and load out of the 
product.  You do not need to evaluate points, steps, and procedures that are not part of your food 
operation.  For example, you would not consider mail handling procedures, human resources 
procedures, utilities and processing aids that do not come into contact with or that are not 
incorporated into the food, facility emergency evacuation procedures, and other business 
processes.   
2.  Grouping of Similar Food Products  
Some facilities manufacture similar products using either the same equipment or very similar 
processes.  In such instances, the facility could group these products or food types into one or 
more processes and conduct VAs on these groupings.  For example, if a facility manufactures 
yogurt with different flavor add-ins, such as strawberry, raspberry, and blueberry and the 
processing steps for these lines are the same, the facility may group these food products into one 
food type (e.g., yogurt with fruit add-ins) for the VA and consider them together.  
B. Recommended Activities Prior to Conducting a Vulnerability 
Assessment  
We recommend that you take certain preliminary steps to help you prepare, organize, and 
conduct your VA efficiently.   
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You may find that you have already completed these preliminary steps for other purposes; we 
recommend that you leverage whatever relevant existing resources and documents are available 
to you to improve efficiency and eliminate duplicative efforts.  For example, you may have 
already developed a process flow diagram and process descriptions for your food production 
process.   
Box 2a-1. Preliminary Steps 
1.  Assemble a Food Defense Team 
2.  Describe the product under evaluation 
3.  Develop a process flow diagram  
4.  Describe the process steps 
 
1.  Assemble a Food Defense Team 
Your written VA is part of your FDP (21 CFR 121.126(b)(1)), which must be prepared, or its 
preparation overseen, by one or more specially qualified individuals (21 CFR 121.4(c)(3)(i)).  
The individuals conducting the VA and their expertise related to your facility practices, food 
manufacturing processes, and food product(s) under evaluation will impact the quality and 
completeness of your VA.  We therefore recommend that you assemble a food defense team of 
individuals with expertise in the day-to-day operations of your facility to conduct your VA.  The 
food defense team could include, as appropriate, personnel from your facilitys quality assurance 
or quality control, laboratories, management, security, sanitation, maintenance, and other 
relevant departments.  Having people on the food defense team from different functions within 
the facility can help provide a complete understanding of the VA process.  If necessary or 
desired, you can supplement the expertise of the food defense team with technical experts from 
other off-site functions within the firm, such as research and development, technical applications 
groups, and quality management, as well as outside experts from universities, cooperative 
extension services, trade associations, private consulting firms, or other sources.  
2.  Describe the Product Under Evaluation 
Including a description of the food product(s) under evaluation for the VA is critical for you and 
others (i.e., colleagues, corporate office, auditors, investigators) to know what food(s) are 
included in the VA.  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 VA.  
3.  Develop a Process Flow Diagram  
We recommend that a facility develop a list or draw a process flow diagram of each point, step, 
or procedure in the process under evaluation.  A process flow diagram can provide a clear, 
simple description of the steps involved in the processing of your food product and its associated 
ingredients as they flow from receipt to product load out.  Note that process flow diagrams 
developed for other purposes, such as food safety, can also be used for VA purposes.  
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4.  Describe the Process Steps 
A detailed process description explains what happens at each of the process steps listed in the 
process flow diagram.  We have found through experience that a short description of what each 
process step entails can provide background information for a VA to assist in determining 
whether there is a significant vulnerability.  This information, such as whether a food is handled 
manually, whether the processing equipment is in a high-traffic area, and whether rework is 
incorporated into product, can contribute to the accuracy of a VA.  Additionally, information 
about the process step can assist in identifying and implementing mitigation strategies, as well as 
preparing the explanation for why mitigation strategies significantly minimize or prevent a 
significant vulnerability.  For example, for a raw juice surge tank step, it would be helpful to 
include information in the description such as: A surge tank is used to control flow rates into the 
pasteurizer.  The surge tank has a maximum capacity of 200 gallons, but typical volumes of juice 
in the surge tank range from 130-150 gallons.  Resident time of juice in the surge tank is 
approximately 8-10 minutes.  The surge tank is generally not accessed during operations, but a 
lid does provide potential access at the top of the surge tank.  The surge tank is cleaned during 
each weekly cleaning cycle.  Including information about how accessible the food is in the tank, 
cleaning frequencies, and volume of juice in the tank can assist during the VA.  This information 
would also be helpful when identifying mitigation strategies.  If access via the lid is the main 
reason the facility determined the tank is an actionable process step with a significant 
vulnerability, then the facility may identify and implement a mitigation strategy that significantly 
minimizes this access.   
C. Key Activity Types as an Appropriate Method for Conducting a 
Vulnerability Assessment to Identify Significant Vulnerabilities and 
Actionable Process Steps  
FDA developed the KAT method based on our analysis of the results of over 50 vulnerability 
assessments that we conducted in partnership with other government agencies and the food 
industry that reflect the activities and associated vulnerabilities present in a wide array of food 
manufacturing settings.  (Ref. 3).  In conducting the VAs, FDA used an assessment methodology 
that included characteristics (e.g., lethal dose) of an unnamed, representative contaminant that is 
highly lethal and heat stable.  This analysis resulted in two important findings: (1) Criticality, 
Accessibility, and Vulnerability were the three CARVER + Shock elements identified as the 
most important to consider when conducting facility-specific VAs, and (2) four general activity 
types (i.e., the key activity types), consisting of points, steps, or procedures consistently ranked 
as the most vulnerable, regardless of the food commodity assessed, and reflect significant 
vulnerabilities to intentional adulteration caused by acts intended to cause wide scale public 
health harm.  
The KAT method is an appropriate method for conducting a VA because it reflects consideration 
of the three required elements and the inside attacker (21 CFR 121.130).  Further, using the KAT 
method to identify actionable process steps is likely to require fewer resources (e.g., time, 
research, and technical analysis) than applying the three required elements to each point, step, or 
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procedure.  See Section E. of this chapter for an explanation of how a facility can use the KAT 
method to identify actionable process steps.      
D. Key Activity Type Descriptions 
The four KATs are: bulk liquid receiving and loading, liquid storage and handling, secondary 
ingredient handling, and mixing and similar activities.  Each are described below.  
1.  Bulk Liquid Receiving and Loading 
Bulk liquid receiving and loading includes a point, step, or procedure where the primary purpose 
or result is:  
  Bulk liquid receiving at the facility from an inbound conveyance (the inbound movement 
of liquid product into a facility for its use in the food production process).  This activity 
includes opening the inbound transport vehicle, the opening of venting hatches or other 
access points, attaching any pumping equipment or hoses, and unloading of the bulk 
liquid; or 
  Bulk liquid loading into an outbound conveyance (the outbound movement of liquid 
product from a facility for further processing or use).  This activity includes opening the 
outbound transport vehicle, attaching any pumping equipment or hoses, and opening any 
venting hatches at the facility.   
These are key activities because there is a high probability of a contaminant, if intentionally 
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 hoses, the transport 
vessel, and potentially the product as it is being received or loaded.   
Activities that do not fall under this KAT include the receiving or loading of sealed jugs, drums, 
jars, and totes because the liquid is not using the vehicle as the bulk container.  The receiving or 
loading of these sealed containers are not included in this KAT regardless of the total volume of 
liquid received or loaded.  
2.  Liquid Storage and Handling  
Liquid storage and handling includes a point, step, or procedure where the primary purpose or 
result is:  
  Storage or holding of liquids (bulk or non-bulk) either in storage tanks or in other tanks at 
the facility.  This includes bulk or non-bulk liquids in storage silos.  The KAT also 
includes the use of totes or other liquid storage containers where the tamper-evident seals 
are opened and the container itself is used for storage and where the container is not 
resealed in a tamper-evident fashion.  Tanks can be used to store liquid ingredients (e.g., 
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fats, oils, vitamin mixes, and sweeteners), hold liquid product for sample testing and 
other quality control activities, or to store liquid food for other processing purposes; or 
  Handling, metering, surge, or other types of intermediate processing tanks used to control 
flow rates of liquid 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 as a handling tank (e.g., when a drum is opened and a pump is attached 
directly onto the drum to meter an ingredient into the product line).   
These are key activity types because if a contaminant were successfully introduced, there is a 
high probability of a contaminant mixing within the liquid due to the agitation commonly used to 
prevent separation within the liquid medium, the mixing or agitation caused as liquid enters or 
exits the tanks, or the likelihood that liquid 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 the container lid. 
3.  Secondary Ingredient Handling 
Secondary ingredient handling includes any point, step, or procedure where dry or liquid 
secondary ingredients (e.g., inclusions, minor ingredients, processing aids, and food additives) 
are manipulated by human contact prior to or during addition to the product stream.  
Secondary ingredient handling includes a point, step, or procedure where the primary purpose or 
result is:  
  Staging of secondary ingredients, i.e., 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 of secondary ingredients, i.e., the process of measuring, weighing, premixing, 
or otherwise manipulating the ingredient prior to addition to the product stream; 
  Addition of secondary ingredients, i.e., the process of physically adding ingredient 
directly into the product stream or into surge or meter hoppers to deliver the ingredient 
into the product stream; or 
  Rework product, i.e., removing clean, unadulterated food from processing for reasons 
other than insanitary conditions or that has been successfully reconditioned by 
reprocessing and that is suitable for use as food.   
This KAT also includes the storage of partially used, open containers of secondary ingredients 
where the tamper-evident packaging has been breached.  
These are key activities because a contaminant can be intentionally introduced into a relatively 
small amount of ingredient or rework and, if it is, it is likely that the contaminant will be 
distributed into a larger volume of food within the main product flow.  Handling of secondary 
ingredients is generally open and accessible and that accessibility is an inherent component of 
the activity.  Thus, these key activities provide a potential point of access where a contaminant 
could be introduced into the product stream.   
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4.  Mixing and Similar Activities 
Mixing and similar activities includes 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); or 
  Coating (i.e., to layer a powder or liquid onto the surface of a product, such as a batter, 
breading, glazing, or flavoring).  
Equipment associated with these activities include: mixers, blenders, homogenizers, cascade-
style breaders, mills, grinders, and other similar equipment. 
Process steps that are not specifically designed to evenly mix product may still be included in the 
KAT of mixing and similar activities because mixing is a result of the process conducted.  For 
example, a roaster with a primary purpose of evenly roasting beans or nuts that uses paddles or 
other agitation mechanisms to achieve an even roast may effectively mix a contaminant into the 
food during the roasting process. 
Mixing and similar activities are a key activity type because a potential contaminant successfully 
added at one of these steps would generally be readily dispersed throughout the product because 
of the nature of the activity (i.e., mixing, homogenizing, grinding, or coating).   
E. Identifying Actionable Process Steps Using the Key Activity Types 
Method 
To conduct a VA using the KAT method, you should assess each point, step, or procedure to 
determine whether the activities at the point, step, or procedure fit within one or more of the 
KATs.  Process steps that fit within one or more of the KATs are actionable process steps.  
Process steps that do not fit within any of the KATs are not actionable process steps and do not 
require mitigation strategies.  For example, a process step where multiple ingredients are 
combined into one large bowl and mixed would fit within the activities in the Mixing and 
Similar Activities KAT.  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 refrigerated storage room would not fit within any of the KATs, and therefore would not be an 
actionable process step.  Figure 2a-2 is an example of a completed VA Analysis Summary 
worksheet showing how to use the KAT method to conduct a VA.   
Your VA must include a written explanation as to why each point, step, or procedure was or was 
not identified as an actionable process step.  (21 CFR 121.130(c)).  For example, if a processing 
step fits within the Mixing and Similar Activities KAT, then you should identify that process 
step as an actionable process step and write an explanation as to why.  This written explanation 
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may be: This point, step, or procedure fits within the KAT- Mixing and Similar Activities.  
Abbreviations or footnotes may be used for written explanations, when appropriate.  For 
example, if multiple processing steps do not fit within any of the KATs, then you may use a 
footnote where the written explanation This point, step, or procedure does not fit within any of 
the KATs is stated once, and a number, letter, or symbol is used in its place.  Alternatively, if 
multiple processing steps do not fit within any of the KATs, then you may choose to write out all 
of those steps, and state, with one sentence, that none of the listed steps fit within any of the 
KATs.   
There may be instances where a process step fits within more than one KAT.  In this case, you 
should include each applicable KAT in your explanation.  Doing so would be helpful for the 
identification and implementation of mitigation strategies because the activity type may inform 
the mitigation strategies that will minimize or prevent significant vulnerabilities at the actionable 
process step. Including each applicable KAT also would be helpful when conducting a VA as 
part of a reanalysis of the food defense plan because if there are changes to the process step, such 
as a major equipment change, you can quickly determine whether the changes would affect 
whether the step fits within the KATs identified in the previous VA. 
If a processing step does not align with any of the KATs, then that step is not an actionable 
process step and your written explanation may be: This point, step, or procedure does not align 
with any of the KATs. 
There may be instances when facilities determine that their food production does not involve any 
of the KATs.  In this situation, there would be no actionable process steps identified and no 
mitigation strategies or management components included in the FDP.  However, the facility is 
still required to document its finding that none of the KATs apply to its food processes and 
include a written explanation of the conclusion.  (21 CFR 121.130(c)).  The documentation must 
be a part of the written FDP (121.126(b)(1)), and the facility must conduct a reanalysis when 
required by 21 CFR 121.157.   
Figure 2a-1 is a sample process flow diagram for smooth peanut butter and Figure 2a-2 is an 
example of a completed VA Analysis Summary worksheet showing how to use the KAT method 
to conduct a VA.   
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Figure 2a-1.  Smooth Peanut Butter Process Flow Diagram4
4 Courtesy of the Food Safety Preventive Controls Alliance. Used with permission. 
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Figure 2a-2.  Worksheet 1-C: Vulnerability Assessment Analysis Summary Smooth Peanut Butter 
PRODUCT(S):  Smooth Peanut Butter  
FACILITY NAME:  PB #12345 
ADDRESS: 123 Main Street, Anytown, USA 
SIGNED DATE:  February 28, 2018 
(1)  (2)  (3)  (4)  (5)  (6) 
#  Process Step   Process Description  Vulnerability  Explanation  Actionable 
Assessment Method    Process Step 
1  Receiving  Corrugated shippers, shrink  Key Activity Types  This point, step, or procedure  No 
packaging  film, plastic containers,  does not fit within any of the 
material   plastic lids, and labels are  KATs. 
  received individually cased.  
Supplier specifications 
  require food grade material 
for packaging material that is 
 
compatible with ambient 
storage of food products. 
2  Receiving  Sugar and salt are received in  Key Activity Types  This point, step, or procedure  No 
shelf stable  50 lb. tote bags.  does not fit within any of the 
ingredients  Hydrogenated vegetable oil  KATs. 
(sugar,  (rapeseed and refined soy) is 
vegetable oil,  received in 5-gallon plastic 
salt)  pails that are sealed with 
  tamper-evident packaging.  
 
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(1)  (2)  (3)  (4)  (5)  (6) 
#  Process Step   Process Description  Vulnerability  Explanation  Actionable 
Assessment Method    Process Step 
3  Raw peanut  Shelled peanuts are received  Key Activity Type  This point, step, or procedure  No 
receiving  on trucks from several sheller  does not fit within any of the 
domestic locations in 2000 lb.  KATs. 
super sacks.  
 
4  Packaging  Corrugate, shrink film, plastic  Key Activity Type  This point, step, or procedure  No 
storage  containers, plastic lids, and  does not fit within any of the 
labels are stored in a dry  KATs. 
storage area and segregated 
from raw food material. 
Packaging is used on a first-
in-first-out basis. 
5  Non-peanut  Sugar, hydrogenated  Key Activity Type  This point, step, or procedure  Yes 
ingredient  vegetable oil, and salt are  fits within the KAT- Secondary 
storage  received and stored at  Ingredient Handling since 
ambient conditions in an area  partially used ingredient 
separate from raw peanuts.   containers are open containers 
Ingredients are stored in  that are accessible. 
tamper-evident sealed 
containers. These materials 
are used on a first-in-first-out 
basis.  Open containers of 
partially used ingredients 
may be put back into storage 
for later use.   
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(1)  (2)  (3)  (4)  (5)  (6) 
#  Process Step   Process Description  Vulnerability  Explanation  Actionable 
Assessment Method    Process Step 
6  Raw peanut  Raw peanuts are stored in a  Key Activity Type  This point, step, or procedure  No 
storage  segregated area at ambient  does not fit within any of the 
temperature and <70%  KATs. 
relative humidity.  Raw 
peanuts are used on a first-in-
first-out basis. 
7  Raw peanut  Prior to roasting, shelled raw  Key Activity Type  This point, step, or procedure  No 
cleaning  peanuts are visually inspected  does not fit within any of the 
and passed over a vibratory  KATs. 
conveyor to remove residual 
foreign material, including 
sticks, rocks, or metal pieces.  
A high-efficiency particulate 
air (HEPA) filtered air stream 
is used to remove light 
extraneous material such as 
shell fragments. 
8  Roasting  Raw peanuts are conveyed  Key Activity Type  This point, step, or procedure  No 
through a roaster in a  does not fit within any of the 
continuous process that  KATs. 
applies forced heated air 
uniformly from above and 
below the peanut bed at a 
uniform bed depth.  No 
mixing occurs during the 
roasting process.  The roaster 
is not accessible. 
 
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(1)  (2)  (3)  (4)  (5)  (6) 
#  Process Step   Process Description  Vulnerability  Explanation  Actionable 
Assessment Method    Process Step 
9  Cooling  Roasted peanuts are cooled  Key Activity Type  This point, step, or procedure  No 
on the conveyor under  does not fit within any of the 
ambient conditions prior to  KATs. 
grinding. 
10   Grinding  Peanuts are conveyed across  Key Activity Type  This point, step, or procedure  Yes 
a magnet to a grinder where  fits within the KAT- Mixing and 
the peanuts are coarse ground  Similar Activities. 
to a paste consistency. 
11  Mixing all  The peanut paste is pump- Key Activity Type  This point, step, or procedure  Yes 
ingredients   conveyed to a mixer to which  fits within the KAT- Mixing and 
sugar, salt, and oil are added.   Similar Activities. 
The batch is mixed until 
ingredients are adequately 
dispersed. 
12  Cleaning jars   Inverted jars are blown with  Key Activity Type  This point, step, or procedure  No 
HEPA-filtered, de-ionized air  does not fit within any of the 
to remove foreign material  KATs. 
prior to filling. 
13  Fill, weigh,  Peanut butter is dispensed  Key Activity Type  This point, step, or procedure  No 
seal  into cleaned jars to the  does not fit within any of the 
appropriate fill weight.  KATs. 
Nitrogen is injected into the 
headspace after filling; thin 
foil induction seal 
(compatible with metal 
detection) and the 
plastic caps are applied.  
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(1)  (2)  (3)  (4)  (5)  (6) 
#  Process Step   Process Description  Vulnerability  Explanation  Actionable 
Assessment Method    Process Step 
14  Label, code  Immediately after the  Key Activity Type  This point, step, or procedure  No 
capping, the lot identifier  does not fit within any of the 
code is printed on each jar  KATs. 
and labels are applied.  
Labels are checked prior to 
adding to the labeler to 
ensure the correct label is 
used.  The label contains an 
allergen declaration statement 
that this product contains 
peanuts. 
15  Metal  The product is passed  Key Activity Type  This point, step, or procedure  No 
detection  through a metal detector.   does not fit within any of the 
KATs. 
16  Casing  Jars are placed by hand into  Key Activity Type  This point, step, or procedure  No 
corrugate cases, with 12 jars  does not fit within any of the 
per case.  Cases are sealed  KATs. 
and coded with lot 
information. 
17   Dry storage  Finished product is stored in  Key Activity Type  This point, step, or procedure  No 
ambient warehouses until  does not fit within any of the 
distributed.  KATs.  
18   Shipping  Finished product is shipped  Key Activity Type  This point, step, or procedure  No 
in ambient trucks to  does not fit within any of the 
customers.  KATs. 
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F. Evaluating the Three Fundamental Elements [New March 2019] 
The IA rule requires that your vulnerability assessment include consideration of the following 
three fundamental elements at each point, step, or procedure you evaluate (21 CFR 121.130(a)):  
Element 1: Potential public health impact (e.g., severity and scale) if a contaminant were 
added;  
Element 2: Degree of physical access to the product; and  
Element 3: Ability of an attacker to successfully contaminate the product.   
All points, steps, and procedures have some degree of vulnerability.  Evaluating the degree of 
vulnerability within each of the three fundamental elements, along with the consideration of an 
inside attacker, provides you a way to identify significant vulnerabilities.  If the point, step, or 
procedure under evaluation has significant vulnerabilities, it is an actionable process step.  In the 
following text, we outline some possible approaches for evaluating the three fundamental 
elements and determining the degree of vulnerability associated with each element.  Note that if 
you are using KATs to conduct a VA, you do not need to separately consider the three 
fundamental elements because they are already incorporated into the KAT approach.   
The three fundamental elements approach allows you to consider detailed, facility-specific 
aspects of each point, step, or procedure in your VA.  In Sections F and G of this chapter, we 
describe the following components of a vulnerability assessment conducted using this approach:  
  Two important, overarching factors to consider while you are evaluating each 
fundamental element (i.e., the inside attacker and inherent characteristics);  
  Element 1 characteristics, three ways you may choose to estimate Element 1 (i.e., 
volume of food at risk, representative contaminant approach, and contaminant-
specific approach), additional factors you may choose to include in your estimate, and 
how to use this information to assign a score for this element; 
  Element 2 characteristics and how to use this information to assign a score for this 
element 
  Element 3 characteristics, additional factors you may choose to include in your 
evaluation if you use the contaminant-based approaches in Element 1, and how to use this 
information to assign a score for this element; 
  Summing the individual element scores you assign, ranking the summed scores, and 
identifying which steps are actionable process steps that have significant vulnerabilities; 
and    
  Writing the explanation for why you determined each step is, or is not, an actionable 
process step. 
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Appendix 4 of this guidance includes an example of a vulnerability assessment conducted by 
evaluating the three fundamental elements.   
Diagram 2a-1 provides a visual representation of how the three fundamental elements can be 
used to identify significant vulnerabilities and actionable process steps.  
  
 
1.  Considerations in Evaluating the Three Fundamental Elements 
a.   Inside Attacker 
When you evaluate each of the fundamental elements, you must consider the possibility of an 
inside attacker.  (21 CFR 121.130(b)).  This requirement is a critical component of a VA because 
it incorporates the highest risk related to intentional adulteration and subsequent public health 
harm.  Therefore, your analysis should include a realistic consideration of the susceptibility of 
the process step to adulteration by someone with legitimate access to the facility.  Failing to 
consider the possibility of an inside attacker likely would lead to artificially low scores for each 
of the fundamental elements and adversely affect identification of significant vulnerabilities.    
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i.  Background 
The most effective means of protecting food from intentional adulteration intended to cause wide 
scale public health harm is to protect significantly vulnerable points, steps, or procedures in a 
food operation from an inside attacker.  Law enforcement statements describe the insider threat 
as one posed by an individual who exploits his/her position, credentials, or employment to 
achieve trusted access to the means, processes, equipment, material, location, facility, and/or 
target necessary to carry out a terrorist action. (References 4-5).  Recent reports have 
highlighted the risk from an inside attacker (References 4-7).    
Current information related to intentional adulteration of food further emphasizes the importance 
of addressing the possibility of an inside attacker.  Threats to the food supply from intentional 
adulteration by an inside attacker have increased since the publication of the IA final rule in 
2016.  Published reporting indicates terrorist groups have called on followers to intentionally 
adulterate food in different settings (References 8-9).  Additionally, terrorist groups have 
experimented with food contaminants on prisoners to gauge the effects of various poisons 
(Reference 9).  Recent reporting describes a foiled terror plot in the United Kingdom involving 
an employee at a food manufacturing plant who was interested in intentionally adulterating food 
and was investigating lethal substances to contaminate supermarket-ready foods (Reference 10).  
See also discussion of an intentional adulteration incident in Japan in the final rule at 81 FR 
34166, 34172 (May 27, 2016).   
ii.  How to Consider an Inside Attacker 
When you are conducting your vulnerability assessment, you should assume that an inside 
attacker has: 
  Legitimate access to the facility (e.g., an employee, contractor, driver, authorized visitor); 
  A basic understanding of the facilitys operations and the food product(s) under 
production;  
  The ability to acquire and deploy a contaminant that is highly lethal, capable of 
withstanding the food production process, and undetectable via simple observation if 
added to food; and  
  The intent to cause wide scale public health harm. 
You should also consider the number and nature of individuals with legitimate access to the 
facility (e.g., permanent workers, temporary and seasonal workers, vendors, contractors, visitors, 
drivers, maintenance personnel, and customers), the ability of these individuals to move freely 
throughout the facility, and the personnel in the area around the point, step, or procedure (e.g., 
multiple workers in a well trafficked area or a single worker in an isolated area).  When 
considering how an insider may be able to attack a process step, key parts of the analysis include 
the possibility that the process step employee is an inside attacker; factors related to workers, or 
a single worker, who have responsibilities associated with the process step (i.e., are stationed at 
the process step as a part of their job function); other people who have legitimate access to the 
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facility who may have access to the area surrounding the process step; and whether there are any 
circumstances where an inside attacker could feasibly enter the area to adulterate the food 
without the process step employee(s) knowing.  If a process step is generally accessible to any 
person working or traversing through the area, you should consider all such individuals and 
evaluate the degree of vulnerability of the process step should one of these persons attempt to 
intentionally adulterate the food.  For example, you should consider drivers and pest control 
contractors with legitimate access at a receiving bay as potential attackers.   
Recognizing the potential for an inside attacker importantly informs the decision-making for the 
evaluation of each of the three fundamental elements of a VA.  The level of access an inside 
attacker may have is variable.  Some points, steps, or procedures are completely open, while 
others, due to inherent characteristics, may be completely inaccessible to an insider (see Section 
2.F.b for more information on inherent characteristics).  Similarly, the ability of an inside 
attacker to successfully contaminate the food is variable.  For some points, steps, or procedures, 
an inside attacker may have a relatively high level of ability to contaminate the product, while 
inherent characteristics of other points, steps, or procedures may result in a relatively low ability 
of an inside attacker to contaminate the product.  The scoring tables for Elements 2 and 3 are 
specifically designed to facilitate the identification of differing degrees of accessibility to and 
ability to contaminate a point, step, or procedure, respectively.   
b.  Inherent Characteristics  
Inherent characteristics are conditions, activities, practices, or characteristics that are integral to 
the operation of a point, step, or procedure; the point, step, or procedure could not properly 
operate without these inherent characteristics in place.  Furthermore, inherent characteristics are 
not easily changed or altered.  Properly evaluating inherent characteristics of a process step, and 
distinguishing these characteristics from those that are not inherent4, is critical to accurately 
conducting an adequate VA.  The following are examples of inherent characteristics: 
 
  Design of the food production area 
  e.g., the layout of permanent equipment  
o
  e.g., general level of visibility of activity in the area 
o
  Type and nature of equipment  
  e.g., a process step that is entirely enclosed and inaccessible during operation, 
o
such as piping, pasteurization, retorting, or a similarly enclosed process step such 
that accessing the food anywhere at this step would interrupt the process operation 
  e.g., a process step that is pressurized so that access would result in noticeable 
o
ejection of the food or cause bodily harm to anyone accessing the food at this 
process step 
  Nature of the food being processed (e.g., whether the food is solid or liquid) 
                                                 
4 In most instances, non-inherent characteristics include existing measures.  See Chapter 3.E of this guidance for 
more information about existing measures.   
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  Nature of the processing 
  e.g., a process step where the food is moving at such a rate that adding enough 
o
contaminant to cause wide scale public health harm is highly unlikely or 
impossible (such as a belt, flume, bucket lift, vacuum, or pneumatic conveyor 
where product is moving at a high rate) 
  e.g., a process step where a contaminant, if added at the step under evaluation, 
o
will not be incorporated into the food due to minimal to no mixing or agitation 
  Presence of employees in the immediate area  
  e.g., a process step that can function only when there are multiple employees 
o
working and constantly observing the step, such as where workers are lined up 
and manually working assembly line style and are constantly observing each 
other 
  e.g., a step requiring two workers to each perform an action for it to properly 
o
function, and if one worker is absent then the line would stop 
  A process step where standard operating procedures would prevent or remove a 
contaminant added to the process step when not in use, such as flushing equipment or 
running a discard batch prior to the introduction of production batches   
  Practices that are fundamental to a safe working environment such that a deviation of the 
safety practice would immediately result in a response by equipment (e.g., a safety 
mechanism would alarm or shut the equipment down if it is improperly accessed)    
 
Non-inherent characteristics are unnecessary for a process step to function.  Process steps will 
continue to function if non-inherent measures are improperly implemented (e.g., a worker 
neglects to verify a seal on a bulk tanker truck but still unloads the liquid food).  Note that non-
inherent characteristics may include practices to ensure their implementation (e.g., review of 
shipping documentation and verifying the presence of seals on transport conveyances), or they 
may not (e.g., requiring shipping documentation but accepting receipt of ingredients without 
verifying shipping documentation).  The following are examples of measures that are not 
inherent characteristics: 
  positioning a person of specific seniority or experience at a particular process step to 
protect food against intentional adulteration  
  preventing delivery drivers from entering unauthorized areas in the facility 
  requiring workers in specific areas or with specific responsibilities to wear specially 
colored uniforms or caps 
  requiring seals on incoming bulk liquid tanker trucks   
 
 
2.  Potential Public Health Impact (Element 1)  
The IA rule does not require you to use a specific method to estimate potential public health 
impact, but the estimate should include potential acute illnesses, deaths, or both (or proxies such 
as servings at risk), caused by the addition of a contaminant at each point, step, or procedure.  
We provide Table 1 as an optional tool to assist you in estimating potential public health impact.    
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Table 1. Potential Public Health Impact 1 
Description   Score 
Potential public health impact over 10,000 (acute illnesses, deaths, or  10 
both), or over 10,000 servings at risk  
Potential public health impact between 1,001  10,000 (acute illnesses,  8 
deaths, or both), or 1,001  10,000 servings at risk  
Potential public health impact between 100 and 1,000 (acute illnesses,  5  
deaths, or both), or 100  1,000 servings at risk  
Potential public health impact between 1 - 99 (acute illnesses, deaths, or  3  
both), or between 1  99 servings at risk  
No potential public health impact (i.e., no illnesses or deaths) or no  1  
servings at risk 
1 The range between scores of 5 and 8 is larger than the ranges between other scores to 
facilitate the separation between points, steps, or procedures that are significantly vulnerable 
compared to those that are not.  This scoring scheme also is used in Table 2 and Table 3.     
How to Use Table 1 to Estimate Potential Public Health Impact 
The information included in Table 1 is explained below, along with recommendations on how to 
use this information to estimate the potential public health impact if a contaminant were added to 
food at a particular point, step, or procedure.  
Description: Quantifies the potential public health impact related to the corresponding 
score.  The descriptions provide information that will assist you in differentiating the 
potential extent of acute public health impact if a contaminant were added at the relevant 
point, step, or procedure.  See Section 2.F.2.a for several alternative approaches you 
could use to determine this quantity.   
Score: The potential public health impact score to be assigned for each relevant point, 
step, or procedure based on the corresponding potential public health impact 
Description.   
a.  Approaches to Evaluating Potential Public Health Impact  
This subsection provides some possible approaches to evaluating the potential public health 
impact that include: (i) estimating the volume of food at risk; (ii) using a representative 
contaminant; and (iii) using specific contaminants.  The severity and scale of the public health 
impact are incorporated into each approach in different ways.  The volume of food at risk 
approach considers each serving at risk to be a potential acute illness or death.  The 
representative contaminant approach considers only potential deaths.  The contaminant-
specific approach also estimates the scale of potential public health impact based on potential 
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deaths, but includes flexibility to consider acute morbidity as well.  Each of these approaches 
provides a way for you to estimate potential public health impacts that fall within the 
Description column that relates to the Score column in Table 1.    
i.  Calculating Volume of Food at Risk 
This approach estimates the potential public health impact without the need to examine specific 
contaminants and their characteristics (e.g., consideration of lethal dose and quantity needed) by 
calculating the number of servings at risk.  Calculating potential servings at risk in a batch-type 
process is typically straight-forward.  For example, a facility estimating the potential public 
health impact of the intentional adulteration of its primary ingredient storage tank would 
consider the volume of food in the tank and the servings generated from this volume.  If the 
facility has a 50,000 gallon primary ingredient liquid storage tank that would generate 800,000 
one cup servings (50,000 gallons*16 cups/gallon), the facility would consider all 800,000 
servings as being at risk.     
Facilities also can use a time-factored analysis to consider the volume of food at risk.  For 
example, a facility that has a bin of premixed seasoning blend staged for use for one days 
production could consider the days production as the volume of food at risk  and thus the 
servings generated from that volume would represent the potential public health impact if the bin 
of premixed seasoning were intentionally adulterated.  For a continuous flow process, a facility 
would determine the flow rate of food through the process step and evaluate the potential time 
available to an attacker to introduce a contaminant without being discovered.  The facility would 
then extrapolate the potential volume of food impacted within the time available to an attacker, 
and then calculate the total number of servings generated from that volume of food.   
For example, at an open and accessible point of constant flow processing of a granular product, a 
facility could assess facility operations and personnel movement to determine that a person 
would have no more than 2 minutes to stand at the access point and introduce a contaminant to 
the food as it passes by the point of access.  The facility determines that the flow rate of food is 
1,000 pounds per minute and calculates that 2,000 pounds of product is at risk (1,000 lbs. per 
minute * 2 minutes).  Based on a serving size of 4 ounces for this product, the facility determines 
that 8,000 servings (2000 lbs. = 32,000 oz. and 32,000 oz. / 4 oz. serving size = 8,000 servings) 
are at risk to an act of intentional adulteration at this step.  Note that it is important to make sure 
your calculations consider any changes in units, as this will affect your public health impact 
estimates (e.g., 1 gallon = 128 fl. oz., 1 lb. = 16 oz., 1 g = .001 kg). 
You can use Worksheet 1-D to organize your calculation of volume of food at risk.  Regardless 
of whether you use Worksheet 1-D, we recommend that you include such information in your 
VA documentation if you use the volume of food at risk method to estimate potential public 
health impact.   
How to Fill in Worksheet 1-D: Calculating Volume of Food at Risk  
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The information included in Worksheet 1-D is explained below, along with recommendations on 
how to use this information to estimate the volume of food at risk if a contaminant were added to 
food at a particular point, step, or procedure.     
A.  Process Step: Provide the name of each of the process steps from the process flow 
diagram or other source.   
B.  Batch Size: Provide an estimate of the amount of product held or processed at the 
process step.  The batch size is usually the volume of the process steps operation 
(e.g., the volume of food in a mixer or tank, or the amount of product in a constant 
flow process).  For constant flow process steps, batch size is the amount of product 
you determine an attacker could contaminate, given the time the attacker would have 
to add a contaminant to a constant flow process and the flow rates of product at that 
step.   
C.  Amount of Product (Ingredient) in Final Serving:  Provide the amount of the 
product being processed at the step under evaluation in the final consumable serving.  
For process steps that involve single ingredient products or that occur after all 
ingredients are added to the product line, this is likely the same as the serving size.  
For process steps that involve an ingredient, the amount of the ingredient in the final 
serving would not be the same as the serving itself.  For example, the amount of 
concentrated fruit juice in a final serving of 8 ounces of fruit juice might be 0.8 
ounces.   
The column is used to calculate the number of finished servings an ingredient may 
affect if that ingredient were intentionally adulterated.  You should consult your 
finished product formulations to determine the amount of product (ingredient) in final 
servings.   
D.  Servings per Batch: Divide the value in Column B by the value in Column C.  This 
number is the estimate of the volume of food at risk.   
E.  Score from Table 1: Provide the number from the Score column in Table 1 
associated with the servings per batch from Column D in this worksheet.  For example, if 
Column D in this worksheet shows 3,000 servings per batch, then you would determine 
that it corresponds to a score of 8 in Table 1.  The score from Column E of this worksheet 
goes into Column 4 (Element 1) in Worksheet 1-F.    
F.  Notes: Provide any information that would assist review of this VA, such as how 
batch size was calculated. 
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Worksheet 1-D: Calculating Volume of Food at Risk 
A  B  C  D  E  F 
Process  Batch  Amount of  Servings per  Score from  Notes 
Step  Size  Product  Batch  Table 1 
(Ingredient) in   
Final Serving  B  C 
 
           
           
 
Contaminant-Based Approaches 
Rather than estimating volume of food at risk, you may wish to estimate potential public health 
impact using a contaminant-based approach, which would give you the information on deaths or 
deaths and acute illnesses for use in Table 1.  A contaminant is any biological, chemical, 
physical, or radiological agent that may be added to food to intentionally cause illness, injury, or 
death.  (21 CFR 121.3).  Food safety and food defense approaches consider contaminants 
differently.  For food safety purposes, contaminants are often considered based on their historical 
association with a commodity and outbreaks of foodborne illness; whereas food defense 
considers intelligent adversaries who may attempt to contaminate food with a wide range of 
potential contaminants.   
ii.  Using a Representative Contaminant 
We have found that focusing on individual contaminants is generally not effective or efficient in 
evaluating the potential public health impact from the addition of a contaminant to food because 
there are many potential contaminants that could be used in such an attack.  Therefore, FDA used 
the best available data to create a representative contaminant.  The characteristics of the 
representative contaminant do not reflect a single, actual contaminant; they are based on an 
amalgam of characteristics from actual contaminants.  The representative contaminant reflects 
contaminants whose acquisition is possible, and in some cases, readily so.  The representative 
contaminant incorporates characteristics that would allow the attacker to achieve the goal of 
causing wide scale public health harm (i.e., the mortality rate and amount of contaminant needed 
per serving of a highly lethal contaminant that would survive the food production process and 
would be undetectable via simple observation if added to the food).   
In our experience conducting VAs, we have used a representative contaminant approach to 
estimate potential public health impact for each process step under evaluation.  We have found 
that using a representative contaminant significantly decreases the time, resources, and expertise 
needed to estimate potential public health impact as compared to performing contaminant-
specific analyses.  When compared to approaches that do not include the consideration of a 
contaminant (e.g. volume of food at risk), this approach allows for a higher degree of specificity 
for a potential public health impact estimate because contaminant characteristics, such as a lethal 
dose (LD) value and associated mortality rate, are included in this approach.  Toxic dose 
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information is commonly reported as LD50 (i.e., the amount of contaminant sufficient to kill 
50% of a population).  Using the LD50 is one way to measure the acute poisoning potential 
(acute toxicity) of a contaminant.  
 
In addition to providing more specificity for consideration of Element 1, the calculation of the 
amount of contaminant needed (Column J in Worksheet 1-E) facilitates considering this factor as 
part of your analysis of Element 3 (the ability of an attacker to successfully contaminate the 
product).  See Section 2.F.4 Amount of Contaminant Needed for more information related to 
this consideration.     
If you choose to use a representative contaminant, we recommend that you use representative 
contaminant values used in this guidance because they reflect the best available data.5  
Additionally, associating agent-specific information, such as mortality rate and public health 
estimates of an intentional adulteration event, with a specific agent can generate results that are 
particularly important to protect from disclosure because of their usefulness to a potential 
attacker.  While estimates derived from the representative contaminant approach should be 
protected from disclosure, these estimates may be of relatively less value to a potential attacker 
because these estimates are not associated with a specific contaminant.   
You can use Worksheet 1-E to organize your potential public health impact estimate using a 
representative contaminant.  Regardless of whether you use Worksheet 1-E, we recommend that 
you include such information in your VA documentation if you use this method to estimate 
potential public health impact.   
How to Fill in Worksheet 1-E: Calculating Potential Public Health Impact using a 
Representative Contaminant  
The information included in Worksheet 1-E is explained below, along with recommendations on 
how to use this information to calculate potential public health impact using a representative 
contaminant if a contaminant were added to food at a particular point, step, or procedure.  For 
Columns A  D, please see descriptions provided in How to Fill in Worksheet 1-D: Calculating 
Volume of Food.  
E.  Mortality Rate of Representative Contaminant: We use an LD50 value to calculate 
the dose needed per serving (See Column I); therefore, the mortality rate value is 50%.  
The representative contaminant approach relies on this value to estimate potential public 
health impact.   
                                                 
5 As new, pertinent information becomes available, FDA will reevaluate the representative contaminant values to 
determine whether revisions should be made to the values.  As appropriate, FDA may require facilities to conduct a 
reanalysis of their food defense plans to respond to new vulnerabilities, credible threats to the food supply, or new 
developments in scientific understanding.  (21 CFR 121.157(b)(4)). In this circumstance, FDA would communicate 
that a reanalysis is required and would provide the associated industry or industries with information needed to 
conduct the reanalysis. 
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F.  Number of Potential Deaths: Multiply the value of Column D by the value of 
Column E (D x E). 
G.  Score from Table 1: Provide the number from the Score column in Table 1.  
Determine into which Description from Table 1 the number of potential deaths from 
Column F in this worksheet fits and then find the corresponding Score in Table 1.  For 
example, if Column F in this worksheet shows 3,000 potential deaths, then you would 
determine it fits into the Table 1 Description of Potential public health impact 
between 1,001  10,000 (acute illness or deaths), or 1,001  10,000 servings at risk 
which corresponds to a score of 8.  The score from column G of this worksheet goes into 
Column 4 (Element 1) in Worksheet 1-F.   
H.  Notes:  Provide any information that would assist during review of this VA. 
I.  Representative Contaminant Dose Needed per Serving: We use the value of 40 
milligrams per serving.  We derived this dose value, in consultation with our interagency 
governmental partners, from the LD50 data of a compilation of potential contaminants 
that are applicable to food.  LD50 is typically expressed in dose per kg body weight.  We 
converted this into a dose per serving value based on a typical adult body weight of 85 
kg.6 
J.  Amount of Representative Contaminant Needed per Batch: Multiply the value in 
Column D by the value in Column I (D x I).  This will provide the total amount of 
contaminant the attacker needs to intentionally adulterate the food at this process step to 
achieve wide scale public health harm.  This estimate informs the amount of the 
contaminant the attacker needs to carry out the attack, which is a component of Element 
3. 
 
                                                 
6 When conducting its vulnerability assessments, FDA has historically used 85 kg as a representative adult body 
weight to calculate potential LD50 dose amounts of contaminants.  This value represents an amalgamation of 
anthropometric data from the National Health Examination Survey published periodically by Centers for Disease 
Control and Prevention (CDC).(Ref. 11) 
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 Worksheet 1-E: Calculating Potential Public Health Impact using a Representative Contaminant  
 
Element 1 Calculations using Representative Contaminant  Element 3 Calculations 
A  B  C  D  E  F  G  H  I  J 
Process  Batch Size  Amount of  Servings  Mortality Rate  Number of  Score  Notes  Representative  Amount of 
Step  Product  per Batch  of Contaminant  Potential  from  Contaminant Dose  Representative 
(Ingredient) in  B  C  (FDA provided  Deaths   Table 1  Needed per Serving  Contaminant 
Final Serving  value = 50%)  D x E  (FDA provided value  Needed per Batch 
= 40 milligrams)  D x I 
                   
                   
 
 
 
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iii.  Performing a Contaminant-Specific Analysis  
Although you have the flexibility to evaluate potential public health impact using specific 
contaminants of concern, it is difficult and resource-intensive to consider the multiple 
combinations of potential contaminants at each point in a food operation.  Moreover, in many 
cases, the limited information publicly available to support contaminant-specific analyses makes 
this type of analysis particularly challenging.  Additionally, individual facilities may find it 
difficult to remain up-to-date on the threat landscape regarding contaminants, which may change 
quite rapidly.  For these reasons, we encourage you to carefully weigh the advantages and 
disadvantages before undertaking contaminant-specific analyses to perform your VA and 
encourage you to first explore using Key Activity Types to perform your VA or use one of the 
other methods we describe for evaluating potential public health impact (i.e., volume of food at 
risk and representative contaminant), which do not require an in-depth knowledge of a wide 
array of potential contaminants. 
If you choose to perform a contaminant-specific analysis, you should estimate potential public 
health impact using many contaminants from different classes of contaminants.  You will need to 
research numerous contaminants to identify those that are relevant to the food being produced in 
the facility and to estimate the potential public health impact of an intentional adulteration event.  
In rare circumstances, you might identify certain food products that may only be vulnerable to 
certain types of contaminants because of the use of certain process steps; volumes of food being 
manufactured, processed, or held; the nature of the food itself (e.g., water activity, pH); or other 
factors.  In this situation, your VA should include an explanation of why you limited your 
consideration of contaminants.   
Your analysis should include contaminants that survive the food production process, are 
undetectable via simple observation, and are similar in lethality to the representative 
contaminant.  Incorporating these characteristics provides for an adequately robust vulnerability 
assessment because there are numerous lethal contaminants that exhibit these characteristics, and 
such contaminants could be selected by an attacker for intentional adulteration with the goal of 
causing wide scale public health harm.  Conducting a VA using only contaminants that are 
neutralized by a process step (e.g., neutralized by heat or pressure) or are easily detectable by 
simple observation would omit potential contaminants that would survive that step and/or would 
not be readily detectible.  Similarly, conducting a VA using only contaminants that are less lethal 
than the representative contaminant would omit potential contaminants that are highly lethal and 
available.  If your VA fails to incorporate an adequate range of contaminants, it is likely to 
significantly underestimate potential public health impact.  If you choose to use the contaminant-
specific approach, we recommend focusing on potential acute public health impact because this 
is the type of harm most associated with the goals of an attacker intending to cause wide scale 
public health harm.  We provide further detail below regarding the types of contaminants 
facilities should assess when using a contaminant-specific analysis.   
Types of Contaminants 
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A contaminant-specific approach should consider biological, chemical, radiological, and physical 
contaminants.  We do not provide a list of specific contaminants you should consider because of 
their large number and constant evolution.  There may be a scarcity of data related to lethality, 
toxicity, infectivity, and organoleptic properties for uncommon and exotic contaminants.  As 
such, we expect that many facilities will not be able to use this method because of insufficient 
information to make contaminant-specific estimates for all relevant contaminants.  
 
Biological Contaminants 
Potential biological contaminants include microbiological hazards such as parasites, 
environmental pathogens, and other pathogens.  Bacterial pathogens can be classified based on 
whether they form spores (sporeformers) or exist as vegetative cells and do not form spores 
(non-sporeformers).  Spores are not hazardous if they remain in the spore state.  Spores are 
very resistant to heat, chemicals, and other treatments that would normally kill vegetative cells of 
both sporeformers and non-sporeformers.  When spores survive a processing step designed to kill 
vegetative bacteria, they may become a hazard in the food if they are exposed to conditions that 
allow germination and growth as vegetative cells.   
Chemical Contaminants 
Potential chemical contaminants include pesticide and drug residues, heavy metals, 
environmental contaminants, histamine due to decomposition, chemicals used to clean 
manufacturing equipment, natural toxins (e.g., mycotoxins), and synthetically derived 
compounds.  Chemical contaminants have the potential to be heat resistant and soluble in water 
or fats.  Chemical contaminants can be in powdered or liquid form, and they can be colorless, 
odorless, and tasteless.   
Radiological Contaminants 
Consuming food contaminated with radionuclides will increase the amount of radioactivity a 
person is exposed to, which could have adverse health effects that depend on the radionuclide 
and the amount of radiation to which a person is exposed.  Radiological hazards can be in solid, 
powdered, or liquid form.   
Physical Contaminants 
Physical contaminants are broadly classified as hard/sharp physical contaminants or choking 
contaminants.  Physical contaminants from either category can injure consumers.  These injuries 
may include dental damage, laceration of the mouth or throat, laceration or perforation of the 
intestine, or choking, and may even lead to death.  Physical contaminants cover a broad range of 
contaminants, such as glass, metal, plastic, wood, and stone.  Because it would be difficult to use 
a physical contaminant to cause wide scale public health harm, this type of contaminant is 
unlikely to create a significant vulnerability for most facilities. 
We are providing Worksheet 1-E as an example of how to organize your potential public health 
impact estimate using a contaminant-specific analysis.  If you choose this type of analysis and 
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use Worksheet 1-E, you will need to replace the FDA-provided values in Columns E and I with 
contaminant values from your own research.  Regardless of whether you use Worksheet 1-E, we 
recommend that you include such information in your VA documentation if you use a 
contaminant-specific analysis to estimate potential public health impact.  
How to Fill in Worksheet 1-E: Calculating Potential Public Health Impact using a 
Contaminant-Specific Analysis  
Calculating potential public health impact using specific contaminants is essentially the same as 
using the representative contaminant approach already discussed.  The calculation should be 
repeated for each contaminant considered.  The contaminant with the largest estimated public 
health impact should be used to identify the appropriate score from Table 1, as this is the 
estimate that adequately captures the full extent of the potential public health impact.  To use 
Worksheet 1-E in considering individual contaminants, you should use values you have 
determined are appropriate to the analysis.  At a minimum you will need to update the following 
Columns from Worksheet 1-E: 
E.  Mortality Rate of Contaminant: Provide the mortality rate for the specific contaminant.  
If an LD50 value is used to calculate the dose per serving, 50% should be placed in this 
Mortality Rate column.  The mortality rate should be from the same source (e.g., scientific 
literature) used for the contaminant dose needed per serving calculation.    
H.  Notes: Provide any information that would assist during review of this VA, such as the 
source of information for the contaminant under evaluation, including characteristics and 
toxicity information.  
I.  Contaminant Dose Needed Per Serving: Provide an estimated contaminant dose per 
serving derived from oral toxic dose information found in scientific literature.  The value is 
typically reported as the dosage per kilogram of bodyweight, which is then converted to a 
dose per serving.  For example, if a substance has a reported LD50 of 1 mg/kg and you 
assume a typical adult male weighs 85 kg, then the LD dose is 85 kg * 1 mg/kg = 85 
mg/serving.  Only oral routes of exposure should be considered.   
Estimating Morbidity for the Contaminant-Specific Analysis 
If you perform a contaminant-specific analysis, you could choose to include estimates of acute 
morbidity (i.e., acute illnesses) and mortality in your Element 1 evaluation.  Columns E, I, and J 
in Worksheet 1-E could be used for morbidity by replacing the mortality-specific information 
with morbidity-specific information.  Morbidity and mortality estimates should then be added 
together, and this sum entered into Column F.  The score in Column G will be based on the 
summed estimate from Column F.  
b. Additional Considerations for Evaluating Potential Public Health Impact  
Although not required, you have the flexibility to consider additional factors (i.e., factors not 
included in the worksheets) in your evaluation of potential public health impact.  Such factors 
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include end use of the food and consumer packaging.  The food system is complex, and this 
complexity can make incorporation of such factors into the estimate of the potential public health 
impact challenging.  Therefore, we recommend that you only consider other factors if you have 
enough information to adequately incorporate them into your analysis. 
i.  End Use of the Food  
If you have information to support this consideration, you may consider the end use of a food 
product being manufactured, processed, packed, or held at your facility.  Considering end use is 
most useful for facilities manufacturing/processing, packing, or holding ingredients used in other 
products because it may be difficult to determine a serving size for an ingredient without doing 
so (see juice example in explanation of Column C in Worksheet 1-D). We recommend that you 
determine the amount of the ingredient used in the end product based on the most common use 
of your ingredient.  The most common use may be different for the same product made by two 
different facilities.  For example, consider two facilities that manufacture high fructose corn 
syrup (HFCS).  Facility A primarily sells its HFCS to a manufacturer for use in soft drinks.  
Facility B primarily sells its HFCS to a bakery for use in cookies and cakes.  Given the different 
uses of HFCS by these facilities different customers, the amount of HFCS in the final product 
(soft drinks and baked goods respectively) would be different.  Each facility should evaluate the 
potential public health impact of its HFCS operation based on the most common use of its 
products.  As another example, if a facility sells HFCS to both soft drink manufacturers and 
bakeries, the facility should evaluate the potential public health impact of its HFCS operation 
based on which customer receives the most HFCS, by volume.  If a facility does not know the 
final use of its product, it could assume the most likely use based on industry-wide usage.   
ii.  Consumer Packaging 
Food is commonly packaged in units that include many servings, and a facility may choose to 
consider how its food is packaged in its analysis of potential public health impact.  For example, 
a manufacturer of breakfast cereal may package its product in boxes that contain multiple 
servings.  The manufacturer could consider this in its evaluation of potential public health impact 
by converting the number of servings at risk into the number of consumer packages for those 
servings.  Next, the manufacturer would multiply the number of packages by the average number 
of consumers per package.  Considering consumption in this way may reduce the number of 
potential exposures to contaminated product because a single packaged product typically is 
consumed by fewer consumers than the number of servings it contains.   
For example, consider a facility that manufactures breakfast cereal.  At the cooking step the 
facility toasts 1,000 pounds of cereal at a time (batch size).  A typical serving size is one ounce, 
so this 1,000 pounds of cereal would generate 16,000 servings (1,000 lbs. x 16 oz./lb.).  
However, the 16,000 one-ounce servings will be packaged into 24-ounce boxes, yielding 666 
boxes (16,000 / 24 = 666.67).  Based on market research or other information, the manufacturer 
determines that, on average, a household of 3 persons will consume its breakfast cereal from a 
single box.  With this information, the manufacturer concludes that the potential public health 
impact from its cooking step is 1998 potential exposures (666 boxes x 3 consumers/box = 1,998).  
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Facilities that use multiple package sizes may wish to evaluate a selection of packages (such as 
the smallest, a medium size, and largest units), or identify the most common package size to 
inform their analysis. 
Note that the calculation is based on how the food is purchased by consumers.  If a food is 
packaged in individual sizes, then packed in cases for distribution, and then unpacked and sold in 
individual packages, the total number of servings should be divided by the number of servings in 
a consumer package, not the servings in a case.   
3.  Degree of Physical Access to the Product (Element 2) 
In this element, you consider an inside attackers level of accessibility to the product at each 
point, step, or procedure.  You may find the accessibility of the product to intentional 
adulteration to be the most straightforward element to evaluate, and we therefore suggest you 
consider starting your evaluation with this element.  As discussed in Section 2.F.1.a, you should 
consider the accessibility of the product to an insider.  Further, as discussed in Section 2.F.1.b, 
when evaluating accessibility, you should consider the presence of inherent characteristics that 
may increase or decrease accessibility.   
The IA rule does not require you to use a specific method to evaluate the degree of physical 
access to the product.  We provide Table 2 as an optional tool to assist you in estimating the 
degree of physical access to the product for each point, step, or procedure under evaluation. 
Table 2. Degree of Physical Access to the Product 
Description1  Score 
Easily Accessible.    10 
  Inside attacker has access to the product (e.g., attacker can physically 
touch the product).   
  There are no inherent characteristics that would make access to the 
product difficult (e.g., enclosed systems, pressurized equipment, railings, 
equipment safety features, or shields).   
  Product is open and unsecured by packaging, equipment, or other 
physical access barriers. 
  Product is handled, staged, or moved in an easily accessible manner.  
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Accessible.    8 
  There are limited inherent characteristics that would make access to the 
product difficult (e.g., enclosed systems, pressurized equipment, railings, 
equipment safety features, or shields).   
  Product is in equipment that can be accessed without tools or specialized 
supplies.   
  Access to the food is not difficult (e.g., there are minimal physical space 
constraints that limit access to food) but may require opening equipment, 
access points, or non-tamper-evident packaging. 
Partially Accessible.    5  
  Inside attacker has partial access to the product.   
  There are some inherent characteristics that would make access to the 
product somewhat difficult (e.g., enclosed systems, pressurized 
equipment, railings, equipment safety features, or shields).  
Hardly Accessible.    3  
  There are significant inherent characteristics that would make access to 
the product very difficult (e.g., enclosed systems, pressurized equipment, 
railings, equipment safety features, or shields).   
  Product is in equipment that make access difficult without tools or 
specialized supplies.   
  Physical space constraints limit access to food being processed or stored. 
Not Accessible.    1  
  Inside attacker has no access to the product (e.g., attacker cannot 
physically touch the product).   
  There are significant inherent characteristics that would make access to 
the product impossible (e.g., enclosed systems, pressurized equipment, 
railings, equipment safety features, or shields). 
  Product is enclosed and secured by packaging, equipment, or other 
physical access barriers. 
  Product is handled, staged, or moved in an inaccessible manner (e.g., 
bucket conveyors being moved via elevated track, an elevated ingredient 
surge tank with no means of access). 
1 Descriptions are meant to be illustrative of the conditions that may be present at a process step 
that can indicate the nature of the vulnerability.  Every condition need not be present to warrant 
the corresponding score. 
How to Use Table 2 to Evaluate the Degree of Physical Access to the Product 
The information included in Table 2 is explained below, along with recommendations on how to 
use this information to evaluate the degree of physical access to the product. 
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Description: The level of access around or near each point, step, or procedure under 
evaluation.   
Score: The degree of physical access score to be used for each point, step, or procedure 
under evaluation.  After determining the most appropriate description of the level of 
access at each point, step, or procedure, as provided in the Description column, assign 
the appropriate score and record that score in Worksheet 1-F, Column (5) Element 2. 
4.  Ability of Attacker to Successfully Contaminate the Product (Element 3) 
In this element, you consider how easy or difficult it is for an attacker, who has obtained access 
to the product (which is assessed in Element 2), to introduce a contaminant, and remain 
undetected, to achieve the attackers goal of causing wide scale public health harm.  As 
discussed in Section 2.F.1.a, you should consider the possibility of an inside attacker when 
evaluating this element.  Further, as discussed in Section 2.F.1.b, when evaluating this element, 
you should consider the presence of inherent characteristics that may increase or decrease the 
ability of an attacker to successfully contaminate the product.  Some considerations for Element 
3 are only applicable if you are doing a contaminant-based analysis (i.e., either a representative 
contaminant or contaminant-specific analysis) for Element 1.  These considerations are 
addressed separately after Table 3.   
The IA rule does not require you to use a specific method to evaluate Element 3.  We provide 
Table 3 as an optional tool to assist you in evaluating the ability of an attacker to successfully 
contaminate the product at each point, step, or procedure under evaluation. 
Table 3. The Ability of an Attacker to Successfully Contaminate the Product 
Description1  Score  
Highest Ease of Successful Contamination.   10 
  The process step is in an isolated area, or obscured from view, enabling an 
inside attacker to work unobserved with little or no time limitations. 
  It is easy to successfully add sufficient volume of contaminant to the food. 
  Inherent characteristics of the point, step, or procedure (e.g., uniform 
mixing) would evenly distribute the contaminant into the food.  
  It is highly unlikely the inside attacker would be detected adding a 
contaminant to the food; an attacker would need to act with little to no 
stealth to introduce the contaminant. 
  There are no, or few, workers in the area, and it is highly unlikely that they 
would notice a contamination attempt by an inside attacker.  
  There is a low likelihood of the contaminant being removed (e.g., by 
washing, screening, vibration), diluted, or neutralized at this or later points, 
steps, or procedures in the process. 
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Moderately High Ease of Successful Contamination.   8 
  The process step is seldom observed, enabling an inside attacker to work 
unobserved with minor time limitations.  
  It would be relatively easy for an inside attacker to successfully add a 
contaminant in sufficient volume.   
  It is unlikely the inside attacker would be detected adding a contaminant to 
the food; an inside attacker would need to act with minimal stealth to 
introduce the contaminant.  
  There are few workers in the area, and it is unlikely that they would notice a 
contamination attempt by an inside attacker.   
  Mixing, or agitation, is present but the contaminant may not be evenly 
distributed throughout the food because of inherent characteristics of the 
point, step, or procedure. 
  There is a moderately low likelihood of the contaminant being removed 
(e.g., by washing, screening, vibration), diluted, or neutralized at this or 
later points, steps, or procedures in the process. 
Moderate Ease of Successful Contamination.   5 
  The process step is observed about half of the time, or semi-obscured from 
view; an inside attacker would be under time limitations.  
  It would be somewhat difficult for an inside attacker to successfully add a 
contaminant in sufficient volume without being detected.  
  An inside attacker only would be able to add a reasonably small volume of 
contaminant (e.g., what can be carried in a pocket) without being detected.   
  It is moderately likely the inside attacker would be detected adding a 
contaminant to the food; an inside attacker would need to act with some 
degree of stealth, irregular, or suspicious activity to introduce the 
contaminant.  
  There is no intended mixing or agitation of the product, but processing 
conditions may distribute the contaminant into the surrounding food 
because of inherent characteristics of the point, step, or procedure. 
  There is a moderate likelihood of the contaminant being removed (e.g., by 
washing, screening, vibration), diluted, or neutralized at this or later points 
in the process.   
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Moderately Low Ease of Successful Contamination.   3 
  The process step is observed more than half of the time; an inside attacker 
would be under relatively strict time limitations.  
  It would be difficult for an inside attacker to successfully add a contaminant 
in sufficient volume without being detected.   
  It is highly likely the inside attacker would be detected adding a 
contaminant to the food; an inside attacker would have to conduct 
suspicious or irregular activities to contaminate the product.   
  There are some, or many, workers in the area, and it is highly likely that 
they would notice a contamination attempt by an inside attacker.   
  Mixing or agitation is not present, and the contaminant would not be 
effectively distributed into surrounding food because of inherent 
characteristics of the point, step, or procedure.  
  There is a high chance that the contaminant would be removed (e.g., by 
washing, screening, vibration), diluted, or neutralized at this or later points 
in the process.   
Lowest Ease of Successful Contamination.   1 
  The process step is under constant observation, or the view of the step is 
unobscured, preventing an inside attacker from adding a contaminant 
without being detected.  
  It is extremely likely the inside attacker would be detected adding a 
contaminant to the food due to the need to conduct highly irregular or 
suspicious activities to contaminate the food; successful introduction of a 
contaminant at the point, step, or procedure is extremely difficult or 
impossible.  
  There are numerous workers in the immediate area that would notice a 
contamination attempt by an inside attacker.   
  An inside attacker would need to add a large volume of contaminant without 
being detected.   
  The contaminant likely would be removed (e.g., by washing, screening, 
vibration), diluted, or neutralized at this or later points in the process.   
  Other inherent characteristics of the point, step, or procedure (e.g., multiple 
workers are required to be present for the step to function; positive airflow 
would prevent introduction of a contaminant; product is moving at a high 
rate of speed; introduction of a contaminant would result in human injury 
such as burns, cuts, or lacerations) significantly reduce the ability of an 
inside attacker to contaminate the product. 
1 Descriptions are meant to be illustrative of the conditions that may be present at a process step 
that can indicate the nature of the vulnerability.  Every condition need not be present to warrant 
the corresponding score. 
 
 
 
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How to Use Table 3 to Evaluate the Ability of an Attacker to Successfully Contaminate the 
Product 
The information included in Table 3 is explained below, along with recommendations on how to 
use this information to evaluate the ability of an attacker to contaminate the product. 
Description: Characteristics of the relevant point, step, or procedure that can assist you 
in differentiating the level of ability of an attacker to contaminate the product at each 
point, step, or procedure under evaluation.  Some characteristics (e.g., amount of 
contaminant needed, concentration, dilution, removal) are only applicable if you are 
using a contaminant-based approach to estimate potential public health impact for 
Element 1. 
 
Score: The score associated with the ability of an attacker to contaminate the product at 
each point, step, or procedure under evaluation.  After determining the most appropriate 
description of the degree of difficulty for an attacker to contaminate the product at each 
point, step, or procedure, as provided in the Description column, assign the appropriate 
score and record that score in Worksheet 1-F, Column (6) Element 3. 
 
Considerations Applicable to Element 3 if You Perform a Contaminant-Based Analysis  
Amount of Contaminant Needed 
If you have determined the amount of contaminant needed as part of a contaminant-based 
approach to evaluating Element 1 (Column J in Worksheet 1-E), you can use this information as 
part of your consideration of the difficulty of an attacker introducing that volume of the 
contaminant to the point, step, or procedure under evaluation.  For example, a few ounces of 
contaminant, which could easily fit in a pocket, would be less difficult to introduce than 5 
gallons of contaminant, which would be difficult to conceal.  There are no definitive criteria 
regarding the volume of contaminant that would be considered large enough to impact the ability 
of an attacker to successfully contaminate the product.  Each food processing facility is unique 
but knowing your facilitys practices should help you determine whether the amount of 
contaminant could realistically be concealed, moved, and introduced into the product without 
being detected.   
Even if an attacker could bring enough contaminant into the area without detection, some 
process steps may make it very difficult to introduce sufficient volume of the contaminant to 
cause wide scale public health harm.  For example, a narrow aperture sample port on an 
otherwise enclosed tank might make it difficult to introduce a large amount of contaminant into 
the tank in the time available for an attacker.  Similarly, a rapidly moving conveyor where an 
attacker would need to stand at the point of introduction for an extended period while constantly 
adding the contaminant over food as it passes might make it difficult to contaminate many 
servings.   
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Concentration or Dilution of a Contaminant 
The volume of a contaminant that needs to be added at the current step under evaluation to cause 
wide scale public health harm may be affected by processing activities that concentrate or dilute 
the contaminant at downstream points, steps, or procedures.  For example, food paste at a 
holding step may be followed by a process step where the volume of liquid is reduced.  The 
subsequent process step that removes liquid may increase the concentration of a contaminant and 
thereby decrease the amount of contaminant needed to cause wide scale public health harm.  By 
decreasing the amount of contaminant needed, the downstream process step may increase the 
score you assign to Element 3 at earlier steps.  Conversely, a downstream process step that 
increases the amount of contaminant needed (e.g., adds a significant amount of liquid), may 
decrease the score you assign to Element 3 at earlier steps.     
Removal of a Contaminant 
Steps that are intended to remove contaminants, such as screening or washing processes, may 
reduce the ability of an attacker to successfully contaminate a product.  Washing, screening, 
distillation, and other methods intended to remove natural contaminants may also remove 
intentionally introduced contaminants.  Further, if a contaminant added to the product would be 
discarded as waste (e.g., a contaminant applied to the exterior of a product that will be peeled), 
this would significantly reduce the ability of an attacker to successfully contaminate the product 
and lead to a lower score for Element 3.  The evaluation as to whether a process step would 
remove a contaminant should consider the removal of all contaminants.  Processes that are 
designed only to remove common food safety hazards or detritus may not remove the types of 
contaminants that an attacker may select.   
Neutralization of Contaminant 
Although facilities could exclude some specific contaminants from consideration for specific 
process steps based on neutralization, in almost every instance other contaminants will not be 
neutralized during those processing steps.  For example, there are many chemical contaminants 
that would not be neutralized by a thermal processing step designed to kill spore forming 
bacteria.  Furthermore, even if a particular contaminant can be neutralized at one process step, an 
attacker could potentially contaminate the food after the neutralization step.  Therefore, you 
should evaluate subsequent process steps to determine the ability of an attacker to successfully 
introduce a contaminant at those points.  We expect the consideration of contaminant 
neutralization to be uncommon, given the numerous contaminants that could potentially be used 
and the level of knowledge needed to determine whether each contaminant can be neutralized for 
each of a facilitys process steps.   
G. Identifying Significant Vulnerabilities and Actionable Process Steps 
Using the Three Fundamental Elements [New March 2019] 
If a step has a significant vulnerability, all three elements will have some elevated presencei.e., 
there will be some level of public health impact, there will be some level of access to the 
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product, and the attacker will have some ability to contaminate the product.  A high score for one 
element does not automatically result in identification of a significant vulnerability at an 
actionable process step.  For example, a process step could have an estimated potential public 
health impact of over 100,000 illnesses or deaths, but either be inaccessible or have the highest 
difficulty of successful contamination.  Such a step would not be an actionable process step, 
regardless of the potential number of illnesses or deaths caused if a contaminant were added at 
this point, because the vulnerability of the step could not be exploited (e.g., the process step is 
completely inaccessible).  In contrast, a different process step with a much lower potential public 
health impact could be an actionable process step based on the other two elements.  For example, 
a process step with a potential public health impact between 100 - 1000 servings at risk that is 
accessible to an inside attacker and has a moderate ease of attack may be an actionable process 
step.  Because each of the three elements are important to evaluating vulnerability, identification 
of significant vulnerabilities and actionable process steps is not based on a single element, no 
matter how high the score.    
1.  Using the Scores from the Three Fundamental Elements to Identify Significant 
Vulnerabilities and Actionable Process Steps  
Generally, you will assign scores for each of the process steps and add them to calculate a total 
score for each step.  However, if one of the elements is assigned a score of 1, then the step does 
not have a significant vulnerability and is not an actionable process stepregardless of the 
scores of the other two elements.  Therefore, you do not need to calculate a total score for that 
process step.  For example, if there is some level of public health impact (i.e., the Element 1 
score >1), and the step is accessible (i.e., the Element 2 score > 1), but the attacker has no ability 
to contaminate the product (i.e., the Element 3 score =1), then the step would not be an 
actionable process step because the inability of the attacker to contaminate the product prevents 
it from being significantly vulnerable (See Appendix 4, Figure 2b-2, process step 1 for more 
details regarding a similar scenario).   
Once you have calculated scores for the points, steps, and procedures where each of the three 
elements scored greater than 1, rank order the process steps by the sum value from highest to 
lowest.  There is typically a group of process steps that have higher total scores, with other 
process steps differentiated from this grouping by a noticeable separation in sum score (See 
Appendix 4, Figure 2b-3 for an example of score grouping and separation).  You should consider 
steps in this highest grouping of sum scores as significantly vulnerable and identify these process 
steps as actionable process steps.  In our experience, including in the identification of the KATs7, 
this grouping of the highest scoring process steps includes approximately the top 20-25% of the 
scores for the rank ordered process steps, but this distribution is not universal  especially in 
facilities with a small number of points, steps, or procedures.   
                                                 
7 In the analysis that identified the Key Activity Types, we observed that, at approximately the top 25% of process 
step sum scores in a given VA, a noticeable separation in scoring occurred among all points, steps, or procedures.   
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Vulnerability assessments using the three fundamental elements are specific to a facility and its 
policies and processes.  The combination of individual element scores that together sum to create 
a single score may reflect a wide variety of circumstances.  As a result, it is not appropriate to 
specify a universally-applied sum score at which all greater sum scores are always actionable 
process steps and all lesser sum scores are never actionable process steps.  Therefore, we have 
not specified such a value as a single threshold for the identification of actionable process steps.  
However, it is possible to provide upper and lower thresholds for vulnerability.  We expect 
significant vulnerabilities will exist when each of the elements are highly scored, i.e., when a 
process step sum score is greater than or equal to 26 (26).  Similarly, we expect that significant 
vulnerabilities will not exist when each of the elements score low, i.e., when a process step sum 
score is less than or equal to 13 (13).   
When a process step sum score is within 14-25, whether significant vulnerabilities are present 
depends on the nature of the vulnerability at the process step under evaluation and the 
contribution of each of the three elements in each case.  Within this range of sum scores (14-25), 
the nature and degree of each of the three elements is such that a process step at one facility with 
a sum score within this range might have a significant vulnerability while a step at another 
facility with the same score does not have a significant vulnerability.  Significant vulnerabilities 
are more likely to exist at the upper range of sum scores in this range, but there is no specific 
number within this grouping that indicates that a significant vulnerability is present in all cases.   
For example, a process step at one facility has a sum score of 18 (Element 1 = 8, Element 2 = 5, 
Element 3 = 5).  Given the potential for a large public health impact, this facility may identify 
this step as an actionable process step because of the moderately high presence of Elements 2 
and 3.  Another process step in this facility also has a sum score of 18 (Element 1 = 5, Element 2 
= 10, Element 3 = 3).  In this case, the facility may consider that while Element 1 is scored a 5, 
the actual calculated public health impact is at the bottom of the scale for the 5 score.  Further, 
the facility may consider that while this process step is easily accessible, there is only a 
moderately low ease of a successful contamination at this step because the inherent 
characteristics of the process step would make the introduction of a sufficient volume of 
contaminant difficult.  The facility may also consider that there is no mixing at the step and that 
there is a high likelihood that an attack would be detected because of the high number of workers 
in the area observing the process step.  Considering the nature of each element, and their 
combined contributions to the overall vulnerability of the step, the facility might conclude that 
this process step is not significantly vulnerable and thus, not an actionable process step.   
In a different facility, a process step has a sum score of 21 (Element 1 = 3, Element 2 = 10, 
Element 3 = 8).  At this step, a limited number of open cans of a liquid food that are gathered and 
lined up prior to capping pose a highly accessible target (Element 2 = 10) and the ease of 
successful contamination is moderately high (Element 3 = 8).  However, the facility calculates 
that only a small public health impact would result because of the small amount of food available 
for attack (Element 1 = 3).  Despite a sum score of 21, the facility determines this step is not an 
actionable process step because, even if successfully adulterated, wide scale public health harm 
would not be the result.  The facility may identify another process step with a similar sum score 
elsewhere in the facility.  The facility may determine that this other process step is an actionable 
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process step because the food is partially accessible (Element 2 = 5), successfully contaminating 
the food would be relatively easy (Element 3 = 8), and there would be a large public health 
impact at this step (Element 1 = 8).   
You can use Worksheet 1-F to organize the three fundamental elements of the vulnerability 
assessment.  Regardless of whether you use Worksheet 1-F, we recommend that you include 
similar information in your VA documentation.   
How to Fill in Worksheet 1-F: Identifying Significant Vulnerabilities and Actionable Process 
Steps using the Three Fundamental Elements 
The information included in Worksheet 1-F is explained below, along with recommendations on 
how to use this information to determine actionable process steps using the three fundamental 
elements.       
(1) Number (#):  Provide a number for each process step evaluated, e.g., process steps 
from a process flow diagram.   
(2) Process Step: Provide the name of each of the process steps. 
(3) Process Step Description: Explain what happens at the process step under 
evaluation.    
(4) Element 1: Score and Rationale: Provide the score that corresponds to the potential 
public health impact if a contaminant were added at the relevant process step.  Also 
include an explanation or notes on why you chose this score for the process step.  See 
Section F.2 of this chapter for possible methods to estimate the public health impact 
and how to score this element using Table 1. 
(5) Element 2: Score and Rationale: Provide the score that corresponds to the degree of 
physical access to the product at the relevant process step.  Also include an 
explanation or notes on why you chose this score for the process step.  See Section 
F.3 of this chapter for a possible method to estimate the degree of physical access to 
the product and how to score this element using Table 2.    
(6) Element 3: Score and Rationale: Provide the score that corresponds to the ability of 
an attacker to successfully contaminate the product at the relevant process step.  Also 
include an explanation or notes on why you chose this score for the process step.  See 
Section F.4 of this chapter for a possible method to estimate the ability of an attacker 
to successfully contaminate the product and how to score this element using Table 3.   
(7) Sum: Calculate the sum of the scores entered in Columns 4 - 6.   
(8) Explanation: Explain why you determined that the point, step, or procedure is or is 
not an actionable process step, based on the evaluation of the three fundamental 
elements and the rationale as to the element scores.    
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(9) Actionable Process Step: Indicate Yes or No regarding whether the process step 
is an actionable process step.  If you organize your vulnerability assessment by using 
Worksheet 1-C, you would have the same response for this column and Column 6 of 
that worksheet because both columns indicate whether a step is an actionable process 
step.  
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Worksheet 1-F: Identifying Actionable Process Steps Using the Three Fundamental Elements 
PRODUCT(S): ____________________________________________________________________________________ 
FACILITY NAME: ________________________________________________________________________________ 
ADDRESS: _______________________________________________________________________________________ 
DATE SIGNED:___________________________________________________________________________________ 
 
(1)  (2)  (3)  (4)  (5)  (6)  (7)  (8)  (9) 
#  Process  Process Step  Element 1:  Element 2:  Element 3:  Sum  Explanation  Actionable 
Step   Description   Score and  Score and  Score and    Process Step 
Rationale  Rationale  Rationale 
 
                 
                 
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2.  Written Explanation for Identification of Actionable Process Steps  
Your vulnerability assessment must include a written explanation as to why each point, step, or 
procedure either was or was not identified as an actionable process step.  (21 CFR 121.130(c)).  
Because the three fundamental elements must be considered in the vulnerability assessment, we 
expect most explanations to include information about these elements.  Depending on the amount 
of information a facility incorporates into its analysis for each point, step, or procedure, the 
complexity of the explanation can vary from simple to more detailed.  A more complex 
vulnerability assessment would, in many, but not all, instances, be accompanied by a more 
detailed explanation.  On the other hand, a vulnerability assessment based on the KAT method 
(see Section 2.E) would not need explanation beyond addressing whether the step fits within one 
of the four KAT descriptions.   
You have flexibility in how you write the VA explanations.  As seen in Appendix 4, Figure 2b-2, 
process step 1, Columns 4 - 6 include rationale about the bulk dry ingredient receiving steps 
vulnerability based on each of the three elements.  These rationales include specifics about the 
large public health impact if a contaminant were added at this receiving step, how the bulk dry 
ingredient receiving is accessible, and the very low likelihood that an inside attacker could 
contaminate the product at this step due to the infeasibility of introducing a very large amount of 
contaminant at this step.  The final explanation in Column 8 states, No significant vulnerability 
is present because Element 3 = 1.  In this example, the information supporting the explanation is 
found in the columns for each of the elements (Columns 4 - 6).  In process step 2 of Appendix 4, 
Figure 2b-2, there is scoring rationale in each of Columns 4 - 6, but the explanation column, 
Column 8, includes more detail stating, This step is significantly vulnerable.  If successfully 
contaminated, it is anticipated that the result would be a very large public health impact.  An 
intentional contamination by an insider at this step would not be prevented by any inherent 
characteristics of this step.  Observation of this process is low since the design of the receiving 
bay presents visual obstructions.  This summary explanation emphasizes the high scores for 
each of the elements.  
Your required explanation as to whether a process step is significantly vulnerable requires the 
most detail for process steps that score within the range of 14  25 because such process steps 
may or may not be actionable process steps, depending on the particular circumstances.  For 
scores that are less than or equal to 13 or greater than or equal to 26, the required explanation 
may be less detailed, such as No significant vulnerability is present because score is less than 
14 or This step is significantly vulnerable because score is greater than 25. 
Written explanations can include abbreviations or footnotes when appropriate.  If you rely on the 
same reason for determining that multiple processing steps are not actionable process steps, then 
you could state the written explanation once, and subsequently use a number, letter, or symbol in 
its place from then on.  For example, process steps 23-27 of Appendix 4, Figure 2b-2 describe a 
food being packaged into consumer-ready packages.  The steps following packaging may not be 
actionable process steps because the individual packages are enclosed and not easily accessible 
to an inside attacker.  An attacker would have to contaminate the tamper-evident package one 
package at a time, making it very difficult to contaminant enough food to cause wide scale public 
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health harm.  After writing the explanation for why the food at this step has very low physical 
accessibility, you could use a footnote for the additional steps where this explanation is also 
applicable. 
Note that the explanation accompanying the decision as to whether a point, step, or procedure is 
an actionable process step can inform the selection of mitigation strategies.  For example, if the 
explanation for identifying the primary ingredient storage tank as an actionable process step is 
that an unsecured access hatch with unrestricted access created a significant vulnerability, this 
suggests that an appropriate mitigation strategy is likely to address the accessibility of the hatch.   
There may be instances when a facility determines that it does not have any actionable process 
steps.  The facility is still required to document its finding that none of the points, steps, or 
procedures in their facility are actionable process steps and include a written explanation of the 
conclusion.  (21 CFR 121.130(c)).  The documentation must be a part of the written FDP (21 
CFR 121.126(b)(1)), and the facility must conduct a reanalysis when required by 21 CFR 
121.157.   
H. Identifying Actionable Process Steps Using the Hybrid Approach: 
Combining the Key Activity Types and the Three Fundamental 
Elements [New March 2019] 
In addition to conducting a VA using the KATs (See Section 2.E) or the three fundamental 
elements (See Sections 2.F and 2.G), a facility may use a hybrid approach.  The hybrid approach 
allows you to use the strengths of both the KAT and three elements methods.  In the hybrid 
approach, a facility first assesses each point, step, or procedure to identify steps that fit within 
any of the four key activity types.  Then, rather than concluding the VA with those steps 
identified as the actionable process steps, the facility uses the three elements to conduct a more 
in-depth evaluation of some of the steps.  A facility may choose to conduct a more in-depth 
evaluation of those process steps that, while fitting within the KATs, may have factors present at 
the step (e.g., inherent characteristics) that would further inform the analysis as to whether a 
significant vulnerability exists.  The hybrid approach combines the speed of KATs with the in-
depth analysis of the three fundamental elements.  Using the hybrid approach, a facility can 
conduct its vulnerability assessment faster than if evaluating the three fundamental elements at 
all of its steps and may possibly identify fewer actionable process steps than if using the KAT 
method alone.   
Appendix 4 of this guidance includes an example that illustrates use of the hybrid approach by a 
manufacturer of fictional almond cranberry energy bars at a fictional facility.  In this example, 
the facility begins its vulnerability assessment by using KATs to quickly identify its steps at 
highest risk.  The facility identifies five of its fifteen steps as fitting within KATs (See Figure 2c-
2, steps 3-7).  The facility determines that steps 4 and 5 fit within the KATs of Mixing and 
Similar Activities and Liquid Storage and Handling but identifies factors present at these 
steps that warrant further analysis using the three elements.   
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The facility determines that an inherent characteristic of step 4, Mix and Warm Syrup, is that it 
is completely enclosed.  The facility determines that this factor will further inform the analysis of 
this step, so the facility uses the three elements.  The facility assigns Element 2 a score of 1.  The 
facility then determines that because this mixer is not accessible, there is no significant 
vulnerability, and it is not an actionable process step.   
The facility determines that step 5, Cool Syrup, has factors that will further inform whether 
there is a significant vulnerability and considers the three elements.  Element 1 is scored as 5 
because the potential number of deaths, if a contaminant were added at this point, is estimated to 
be 900.  Element 2 is scored as 3 (Hardly Accessible) because there is limited physical access 
to the cooling tank.  Element 3 is scored as 3 based on a moderately low ease of attack because it 
would be difficult for an attacker to bring enough of a representative contaminant into the area 
and have sufficient time to get the contaminant into the tank.  Based on a total score of 11, the 
facility concludes that the cooling step does not have a significant vulnerability and is not an 
actionable process step.   
In addition, the facility identifies steps 3, 6, and 7 as actionable process steps using the KAT 
method because they fit within the KATs of Liquid Storage and Handling and Secondary 
Ingredient Handling, and Mixing and Similar Activities, respectively.  The facility does not 
further evaluate these steps using the three elements because it determines no additional factors 
are present that would inform the analysis of the existence of a significant vulnerability.  
   
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Chapter 3: 
Mitigation Strategies for Actionable Process Steps 
This chapter provides guidance to help you identify and implement mitigation strategies for the 
actionable process steps identified during your vulnerability assessment (VA).  It includes an 
overview of common mitigation strategies that you could use to significantly minimize or 
prevent intentional adulteration at actionable process steps.  This chapter also provides 
information on how to consider existing measures when identifying mitigation strategies, 
selecting mitigation strategies to address specific aspects of an actionable process steps 
vulnerability, and the contribution of facility-wide security measures in a facilitys food defense 
system.   
In this chapter, we provide recommendations for the types of mitigation strategies you can 
implement and what you should consider when choosing mitigation strategies, but you have the 
flexibility to identify and implement mitigation strategies from among all procedures, practices, 
and processes available to you that would provide assurances that you are significantly 
minimizing or preventing the significant vulnerabilities. 
A. Mitigation Strategies Requirement 
Mitigation strategies are those risk-based, reasonably appropriate measures that a person 
knowledgeable about food defense would employ to significantly minimize or prevent 
significant vulnerabilities identified at actionable process steps, and that are consistent with the 
current scientific understanding of food defense at the time of the analysis.  (21 CFR 121.3).   
The nature of mitigation strategies is different from the nature of preventive controls put in place 
for food safety purposes.  Mitigation strategies are intended to minimize or prevent intentional 
adulteration while preventive controls are intended to minimize or prevent the occurrence of an 
unintentionally introduced food safety hazard.  Further, mitigation strategies are typically 
implemented to reduce physical access to a point, step, or procedure, or reduce the opportunity 
for an attacker to successfully contaminate the food, and do not lend themselves to scientific 
validation in most instances.  In contrast, preventive controls are more likely to be process-
oriented and lend themselves to scientific validation. Mitigation strategies are practices or 
conditions that are not inherent to the operation of a process step.  That is, the process step could 
still function if the mitigation strategy was not applied.  The inherent characteristics of a process 
step should be evaluated during a VA.  See Chapter 2, Section F.1.b. for more information on 
inherent characteristics.       
You must identify and implement mitigation strategies at each actionable process step to provide 
assurances that the significant vulnerability at each step will be significantly minimized or 
prevented and the food manufactured, processed, packed, or held by your facility will not be 
adulterated under section 402 of the FD&C Act.  For each mitigation strategy implemented at 
each actionable process step, you must include a written explanation of how the mitigation 
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strategy sufficiently minimizes or prevents the significant vulnerability associated with the 
actionable process step.  (21 CFR 121.135(a)).  Abbreviations or footnotes may be used for 
written explanations, when appropriate.  For example, if locks are used as mitigation strategies at 
multiple actionable process steps, and the written explanations for how the locks significantly 
minimize or prevent the significant vulnerabilities at each of these steps is the same (e.g., the 
lock prevents an inside attacker from accessing the food at this point, step, or procedure), then 
you may choose to use a footnote or abbreviation when this explanation appropriately applies to 
each mitigation strategy.  Additionally, the information in the explanation can assist you in 
identifying the most appropriate mitigation strategies management components.  (See Chapter 4 
of this guidance for food defense monitoring.  We intend to publish additional chapters at a later 
date addressing food defense corrective actions and food defense verification).  
After you have conducted a VA and identified any actionable process steps, the next step is to 
choose mitigation strategies for the actionable process steps.  Mitigation strategies are:  
  Customized to the process step at which they are applied;  
  Tailored to existing facility practices and procedures; and 
  Directed toward the actionable process steps vulnerability, including vulnerability to an 
inside attacker.  
Consistent with the requirements, you have the flexibility to choose which mitigation strategies 
are appropriate for your facilitys particular vulnerabilities.  You must prepare written 
explanations that describe how the strategies sufficiently minimize or prevent each significant 
vulnerability.  (21 CFR 121.135(a)).  These explanations will help you to verify the proper 
implementation of mitigation strategies.  (21 CFR 121.150(a)(3)).  It is important to note that 
mitigation strategies that increase food safety risks or negatively impact worker safety should not 
be implemented.  Due to the degree of flexibility you have in choosing mitigation strategies 
appropriate for your facility, we expect facilities will be able to identify strategies that do not 
negatively impact food safety or worker safety.   
B. Identifying Mitigation Strategies 
As discussed in Chapter 2 of this guidance, there are three elements of a VA: (1) public health 
impact; (2) physical access; and (3) likelihood of successful attackwhich, when taken together 
along with considering the possibility of an inside attacker, characterize a process steps degree 
of vulnerability to intentional adulteration.  You must evaluate each of these elements (21 CFR 
121.130(a)), and, in doing so, you should consider and understand how each element contributes 
to the overall vulnerability of each process step.  This analysis should help you identify the 
mitigation strategies that your facility should implement to significantly minimize significant 
vulnerabilities at actionable process steps.  When identifying and implementing mitigation 
strategies, the consideration of these three elements will help to form the written explanations for 
your mitigation strategies, as required by 21 CFR 121.135(b).   
Because of efficiencies and economies of scale from processing large batches of products in a 
single step, we generally expect that you would not implement mitigation strategies to reduce the 
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volume of food being processed and thus would not identify strategies designed to address 
element 1 (public health impact) of the elements of the VA.  It is likely that you will generally 
design your mitigation strategies to address element 2 (degree of physical access) or element 3 
(likelihood of successful attack).  Accordingly, in most circumstances, you should design your 
mitigation strategies to either:  
1)  minimize the accessibility of the product to an inside attacker (e.g., physically reducing 
access to the product, such as by locking storage tanks); or  
2)  reduce the opportunity for an inside attacker to contaminate the product (e.g., increasing 
observation of the area through supervision or use of the buddy system);  
or a combination of both.   
As discussed in Chapter 2 of this guidance, we consider use of FDAs Key Activity Types to be 
an appropriate method for conducting a facility VA because we included the three elements and 
the consideration of an inside attacker in our analysis that identified the Key Activity Types.  So, 
while a Key Activity Type-based VA may not include detailed evaluation of each of the three 
elements specifically for each process step, when you consider mitigation strategies for 
actionable process steps identified using Key Activity Types, you should still focus your 
consideration on minimizing an inside attackers accessibility to the product and reducing the 
opportunity for an inside attacker to contaminate the product. 
Mitigation strategies found within FDAs Food Defense Mitigation Strategies Database 
(FDMSD) are generally designed to address one or both elements (degree of physical access and 
an attackers ability to contaminate the food).  We derived the content of the FDMSD from our 
experience conducting VAs with industry, and it can serve as a resource for facilities to identify 
mitigation strategies.  We expect that the strategies in the database will provide general ideas of 
mitigation strategies that facilities can then tailor to the specific characteristics of their actionable 
process steps.  The explanation of how the mitigation strategy sufficiently minimizes or prevents 
the significant vulnerability associated with the actionable process step would, generally, address 
the mitigation strategys impact on element 2 or element 3, or both.  See Section F. of this 
chapter for additional information about the required explanations.  
Finally, you have the flexibility to implement whichever mitigation strategy, or strategies, is 
most appropriate for your facility. We expect that facilities will implement the most cost 
effective mitigation strategy that addresses their significant vulnerabilities, (with some instances, 
such as the use of existing measures, resulting in minor to no implementation costs), and not 
implement strategies that would be prohibitively expensive when other, cheaper strategies would 
suffice. 
1.  Minimizing the Accessibility of the Product to an Inside Attacker 
Mitigation strategies designed to reduce an inside attackers access to a product can take many 
specific forms, but all such strategies perform the same essential function  reducing or 
eliminating physical access to the product at the actionable process step.  Access-based 
mitigation strategies can be physical in nature, such as using locking hatches, or they can be 
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personnel-management or operations-based strategies that prevent an attacker from accessing a 
sensitive area or piece of equipment, or contacting the food.   
a.  Personnel and Operations-Based Mitigation Strategies 
Personnel-based mitigation strategies are specific actions conducted by personnel to significantly 
minimize or prevent significant vulnerabilities at actionable process steps.  The actions should 
not be inherent characteristics of the process step, which are considered during the VA8.  Once 
an actionable process step is identified, personnel-based mitigation strategies should be designed 
and applied to mitigate a significant vulnerability present at the actionable process step through 
consistent and proper implementation of a specific practice that reduces the vulnerability of the 
step.   
Personnel-based mitigation strategies that can reduce accessibility involve establishing who is 
authorized to be present at an actionable process step and prohibiting individuals from being 
there if not required by work function.  You can establish who should be authorized to be in a 
particular area based on an evaluation of the actionable process step, the specific job function 
requiring human presence, and the quantity and skill level of workers needed to perform the 
function.  You should also evaluate the skill set of the workers in this area, their seniority, level 
of responsibility, and other factors that may contribute to their trustworthiness for working in a 
sensitive area of the facility.  For example, you may authorize senior or long-term employees, or 
those who have otherwise established elevated trust by management to work at a particular 
actionable process step, as a mitigation strategy.   For personnel-based mitigation strategies, 
authorized employees would be responsible for excluding unauthorized persons from the area. 
One way employee vetting can serve as a mitigation strategy that is directed towards an 
actionable process step is to apply the vetting process in a progressive nature such that 
employees working in less vulnerable areas receive a less intrusive level of vetting than workers 
at actionable process steps.  For example, a facility may determine that workers responsible for 
unloading dry ingredients in sealed, tamper-evident packaging need only a basic level of vetting, 
such as a reference check conducted as a standard part of pre-employment screening.  This 
facility also identifies an actionable process step at its secondary ingredient premixing station.  
As one of its mitigation strategies for this step, the facility requires that workers at this step 
undergo a more robust vetting process that includes a criminal background check and credit 
check.  Due to the vulnerability associated with the actionable process step, the facility has 
                                                 
8 Inherent characteristics are conditions, activities, practices, or characteristics that are integral to the 
operation of a process point, step, or procedure.  These characteristics, such as integrated equipment 
safety features that stop operation of the processing line to prevent bodily harm when equipment is 
accessed, or a processing step that is pressurized to an extent that makes access to the food and 
introducing a contaminant improbable, should be considered when conducting the vulnerability 
assessment. See Chapter 2, Section F.1.b. for more information on inherent characteristics.   
 
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determined that workers in this area require elevated levels of vetting, which would work in 
concert with a second mitigation strategy to clearly identify the authorized individuals (such as 
by color-coded hats) and restricts access to the area to only those authorized individuals. 
A facility can also establish standards for workers that are assigned to actionable process steps 
that are more stringent than the standards that may be required for workers in less vulnerable 
areas.  For example, a facility that conducts criminal background and credit checks on all 
employees may allow a worker with minor infractions in their past to work at a process step of 
relatively low vulnerability, but for workers assigned to actionable process steps, the facility 
requires these workers to have a clear background check with no infractions and not have any 
other history of behavior that may show potential for poor decision making, being extorted or 
coerced, or other concerning behavior (e.g., excessive debt, substance abuse). 
You can use several methods to vet employees, for example: performing criminal background 
checks, reference checks with previous employers, and credit checks; however, we caution 
against using cursory background checks as the sole determination for establishing who is 
authorized access to a particular actionable process step because information obtained through a 
background check may be outdated or missing more recent key information that could be 
valuable in assessing the potential for an insider threat. 
Typically, mitigation strategies that restrict access to, and prohibit unauthorized individuals 
from, entering an area would be designed around an existing, facility-wide security measure of 
positively identifying people in the facility and employing some practice to easily identify 
workers who are authorized to work in the particular area.  For example, a facility may have an 
actionable process step with a mitigation strategy designed to restrict access to only those 
employees whose job function is to oversee the actionable process step.  The facility identifies 
these individuals by issuing them distinct (e.g., specially colored) uniforms enabling 
management and other staff to easily determine whether they are authorized to be in the area.  If 
an unauthorized person enters the area, they would be immediately identifiable due to the lack of 
distinct uniform, and should be removed from the area.  Implementation of the access restriction 
is paramount to these types of mitigation strategies, and you should take steps to ensure that 
authorized individuals and management know how to respond to the presence of an unauthorized 
person in a particular area.   
Unlike technology-assisted mitigation strategies (such as locks and seals) that physically restrict 
access (further discussed in Section B.1.b. of this chapter), worker attentiveness and action may 
be the only access barrier to an actionable process step covered by a personnel-based mitigation 
strategy.  When you rely on workers to implement a mitigation strategy that restricts access to 
only employees authorized to be in the area, proper training of employees on the consistent and 
proper implementation of this mitigation strategy is critical.  See Chapter 8 for more information 
on training for workers and supervisors working at actionable process steps.   
Operations-based mitigation strategies are specific operational actions to significantly minimize 
or prevent significant vulnerabilities at actionable process steps.  These actions should not be 
inherent characteristics of the process step.  For example, a facility may have a process step 
where ingredients are staged, in an accessible manner, overnight.  This procedure may be 
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identified as an actionable process step because a facility determines that any time these 
containers are accessible, there is a potential opportunity for an attacker to introduce a 
contaminant into the ingredient or rework material.  The mitigation strategy the facility 
implements reduces the staging time (i.e., ingredients are not staged overnight) in order to reduce 
access to staged ingredients and limit the opportunity for intentional adulteration.  This minor 
operational change significantly reduces the significant vulnerability associated with staging of 
ingredients over extended timeframes.  This mitigation strategy can be implemented with little to 
no cost incurred by the facility. Reducing the time ingredients and rework materials are staged in 
unsecured containers reduces the time ingredients are potentially accessible for an attacker to 
adulterate the ingredient or rework material.   
Another operations-based mitigation strategy to reduce access is to relocate the staging or short-
term storage of partially-used, open ingredient containers to a secure, limited-access part of the 
facility.  Moving the location where this activity is conducted to an area that already has 
restricted access significantly reduces the accessibility of an attacker to the open containers.  
b.  Technology-Assisted Mitigation Strategies 
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.  The most illustrative and intuitive example of a technology-assisted mitigation 
strategy that reduces access is that of a lock on a hatch, inspection port, lid, or other access point.   
Additional examples of technology-assisted mitigation strategies to reduce access to the food 
include: 
  Using tamper-evident tape or seals to reseal ingredient storage containers when tamper-
evident packaging has been opened (e.g., for staging, handling, or ingredient sampling); 
  Restricting access to the area around an actionable process step with locking gates, doors, 
or other barriers where only authorized persons can open the barrier by using specially-
issued keys or other authority-based access mechanisms such as radio-frequency 
identification cards or swipe cards;  
  Securing loading/unloading hoses in locking cabinets or by securing the hose opening 
with tamper-evident caps or seals; 
  Blocking access pathways by implementing barriers to reduce access to food and 
equipment; 
  Employing seals on a shipping conveyance to reduce the likelihood that the shipping 
conveyance is accessed during transport; 
  Using automated and enclosed equipment, such as automated computer-weighing, 
measuring, and addition equipment, to reduce human contact with secondary ingredients 
or rework; 
  Using enclosed tanks and transfer systems to move materials to reduce the potential for 
an attacker to access the product. 
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2.  Reducing the Ability of an Inside Attacker to Contaminate the Product 
In addition to reducing access to actionable process steps, you can also significantly minimize or 
prevent significant vulnerabilities by using mitigation strategies that reduce or eliminate the 
ability of an inside attacker to introduce a contaminant into the product to achieve wide scale 
public health harm.  These types of mitigation strategies may be appropriate in situations where 
reducing access to the food is not feasible, would be cost prohibitive, or poses challenges to the 
operations of the facility.  Reducing the ability of an inside attacker to contaminate the food such 
that the outcome of the contamination may result in wide scale public health harm can include 
several types of measures.  Facilities should consider the environment surrounding the actionable 
process step, equipment used, the number and nature (e.g., seniority, education, training, 
experience, status (i.e., temporary, seasonal, permanent)) of employees in the area, and other 
factors that may inform the identification of mitigation strategies that would significantly reduce 
the ability of an inside attacker to successfully contaminate food. 
Mitigation strategies of this type can include increased observation of an actionable process step 
so that an inside attackers actions would be readily evident and, thus, prevented or interdicted.  
They can also include, for example, strategies that make the carry and introduction of a 
contaminant extremely challenging or impossible, or strategies that would require the inside 
attacker to undertake implausible or impossible actions to carry out the attack.  Like mitigation 
strategies that reduce access, mitigation strategies that reduce the ability of an inside attacker to 
introduce a contaminant into the product also can generally be broken down into those strategies 
that focus on managing personnel behavior or process operations and those that are technology 
assisted.   
a.  Personnel and Operations-Based Mitigation Strategies 
Personnel-based mitigation strategies that reduce the ability of an inside attacker to adulterate a 
product typically include strategies that increase observation of a significantly vulnerable area 
such that an attackers actions would be easily detected.  Generally, increased observation is 
facilitated by adequate lighting, clear sight lines, and/or eliminating visual obstructions.  We do 
not expect that most facilities will reengineer processing lines or undertake other major structural 
changes to facilitate clear lines of sight or eliminate visual obstructions.  We expect that more 
commonly facilities may choose to move easily movable objects that are blocking lines of sight.   
One personnel-based mitigation strategy is to use peer monitoring at an actionable process step 
by requiring at least two staff members to be in the area at any given time during operations.  
This can reduce the opportunity for an attacker to discreetly introduce a contaminant into the 
food.  In addition to increasing visibility and observation of an attackers actions once they have 
accessed the actionable process step, peer monitoring can make it more difficult for an attacker 
to bring the contaminant into the area.  Peer monitoring need not require hiring additional 
personnel.  It may be feasible to incorporate peer monitoring into the existing job functions of 
workers in the area.  Peer monitoring is one of many possible strategies.  Other strategies that 
can reduce an attackers ability to successfully adulterate the food include: 
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  Increasing the supervision of highly vulnerable activities, such as bulk liquid receiving or 
loading; 
  Moving highly vulnerable activities to easily observable areas; 
  Requiring workers at actionable process steps to wear uniforms or clothing without 
pockets or other means of concealing items; 
  Implementing procedures where workers are required to check in with a supervisor or 
security personnel before entering highly vulnerable areas to ensure workers are not 
carrying in a potential contaminant; 
  Altering existing operations, such as visual inspection procedures, to ensure that a 
contaminant has not been introduced into a tank, mixer, or other piece of equipment prior 
to the introduction of food; 
  Using cleaned-in-place equipment or flushing equipment, or running a discard batch prior 
to resuming production after equipment has been idle and accessible to eject an 
intentionally introduced contaminant from the system and prevent it from adulterating the 
food; 
  Requiring driver check-in and identification to confirm driver identity matches shipping 
documentation; and 
  Accepting only previously scheduled shipments from known suppliers. 
b.  Technology-Assisted Mitigation Strategies 
Technology-assisted mitigation strategies that reduce the ability of an inside attacker to introduce 
a contaminant to the product typically include measures that would detect an attackers actions, 
alert management of a problem, and thereby prevent an attackers actions from resulting in 
public health harm, or would neutralize the threat if an act of intentional adulteration occurred.  
Technology-assisted mitigation strategies that reduce the ability of an inside attacker to 
contaminate a product may include strategies that alert management when a person accesses an 
actionable process step or unusual activity occurs.  Alerts, notifications, alarms, and other similar 
measures can make a suspicious action noticeable, thereby enabling workers or supervisors in the 
area to investigate the action and disrupt an attempted intentional contamination of the food.  For 
example, an alarm could notify personnel in a control room that a mixing tank, which is typically 
not opened during operation, has been accessed.  Similarly, motion detection equipment could 
notify supervisors or security personnel when a person enters a secure area around an actionable 
process step.  You could also use sensors and other similar technologies to detect whether there 
is a difference in the volume, mass, or density of ingredients that are added to a product to ensure 
that no additional material is added and that an ingredient is not replaced, in part, by a 
contaminant. 
You may also use technology-assisted mitigation strategies to enhance human supervision or 
observation of actionable process steps.  For example, using closed-circuit television (CCTV) 
systems or other monitoring devices can support observation of highly vulnerable areas and 
actionable process steps.  The mitigation strategy in this case is the act of observation and CCTV 
or other technologies can be used to facilitate the increased observation. Additionally, a CCTV 
system may support this mitigation strategy even without constant observation or an employee 
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tasked solely with observing the CCTV feed.  For example, workers might monitor several 
processing activities from a control room, including an actionable process step through a CCTV 
monitor.  The facilitys evaluation of that mitigation strategy could conclude that the CCTV 
monitor elevates observation of the actionable process step to the point that the significant 
vulnerabilities associated with the actionable process step have been significantly minimized 
because one or more workers in the control room would notice the actions of an attacker while 
routinely, but not constantly, watching the CCTV monitor as part of their duties. 
C. Using Multiple Mitigation Strategies  
In some cases, one mitigation strategy significantly minimizes or prevents the significant 
vulnerability at an actionable process step.  In other cases, a facility may choose to use more than 
one strategy to minimize or prevent the significant vulnerability. When appropriate, a facility 
may use a single mitigation strategy to significantly reduce vulnerabilities, but facilities may 
want to consider layering mitigation strategies together to achieve protection rather than focusing 
only on single mitigation strategies to protect actionable process steps.  In some instances, using 
two or more relatively inexpensive mitigation strategies at an actionable process step may be as 
effective at significantly reducing a vulnerability as a more expensive single mitigation strategy, 
while being more cost effective. 
In some cases, a facility may employ multiple mitigation strategies together to achieve sufficient 
protection of an actionable process step.  For example, a facility may restrict access to an 
actionable process step, such as a mixing tank, by issuing specially colored helmets only to those 
employees working at the actionable process step and train those employees, or security 
personnel, to identify authorized workers and to limit unauthorized workers from accessing the 
mixing tank.  While in many facilities, colored helmets for authorized employees would be a 
sufficient mitigation strategy for a mixing tank, in this example, the facility concludes that, due 
to the number and variety of workers who are required in the area as part of their job function, 
restricting access to the area by requiring employees to wear specially colored helmets 
contributes to reducing the significant vulnerability but does not sufficiently reduce access to the 
area around the mixing tank to significantly minimize the significant vulnerability.  The facility 
determines an additional mitigation strategy is needed.  The facility secures the access hatch to 
the equipment and uses an alarm system to alert when the hatch is opened.  The facility 
determines that these two strategies work synergistically to significantly minimize the significant 
vulnerability at the mixing tank.      
Another example of using multiple mitigation strategies involves bulk liquid receiving 
operations.  Here, a facility concludes that solely using shipping seals on the transport vehicle 
does not ensure the actionable process step is adequately protected from an act of intentional 
adulteration, but it does contribute to the minimization of the significant vulnerability; it also 
determines that it needs to increase observation of the unloading process itself to ensure that a 
contaminant is not introduced into the food while the conveyance is open for unloading.  This 
example illustrates that more than one characteristic of the process (e.g., both the potential 
accessibility of the product and the ability of an attacker to adulterate the product) may 
contribute to an actionable process steps vulnerability and further that addressing multiple 
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drivers of vulnerability may require more than one mitigation strategy.  In other cases, a single 
mitigation strategy may address both drivers of vulnerability.   
The number of mitigation strategy(ies) needed is dependent on the specific conditions around a 
given actionable process step. For example, a facility using the same liquid storage tank 
configuration, but in two different locations in the facility, may find it needs a different number 
and/or type of mitigation strategy(ies) at each location, based on the nature of the environment 
surrounding each respective tank, such as number of employees routinely working in the area, or 
number of times during a shift the storage tank is accessed.  It is up to the facility to evaluate the 
process step and identify and implement the most appropriate mitigation strategy(ies) necessary 
to address the significant vulnerability(ies) present at the actionable process step. 
Using another example, a facility protects its secondary ingredient preparation area that is 
identified as an actionable process step by implementing a mitigation strategy of conducting 
premixing and measuring of secondary ingredients behind a locked gate.  The facility determines 
that this mitigation strategy contributes to reducing the significant vulnerability at this actionable 
process step, but does not sufficiently reduce the access to the area around the secondary 
ingredient preparation area to significantly minimize the significant vulnerability here.  The 
facility determines an additional strategy is necessary at this step because of the number of 
people who require access to the area and have keys to the gate.  The facility determines that it is 
important to be able to observe who is accessing the secondary ingredient preparation area.  
Therefore, the facility uses an existing measure (for more details about the role of existing 
measures, see Section E. of this chapter), that redirects a security camera, which is already 
installed and primarily used for worker safety purposes, to observe the area when the gate is 
opened, with the camera feeding to a manned control room where personnel, who are already 
monitoring multiple camera feeds, can observe whoever enters the secondary ingredient prep 
area.  In this case, the facility employs an access restriction mitigation strategy (the locking gate) 
and an additional mitigation strategy (supported by the camera, which is an existing measure) to 
increase observation of the actionable process step. The facility determines that these two 
strategies work synergistically to significantly minimize the significant vulnerability at the 
secondary ingredient preparation area.      
D. Facility-wide Security Measures and Their Role in a Facilitys Food 
Defense System 
Facilities may have implemented general, non-targeted practices to protect personnel, property, 
or product.  We refer to these practices as facility-wide security measures.  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 (e.g., a perimeter fence and locking exterior doors, 
securing hazardous materials) or are practices internal to the facility but that are conducted 
broadly throughout the facility (e.g., requiring employees, visitors, contractors and other persons 
in the facility to wear ID badges).  Importantly, facility-wide security measures do not require a 
VA to inform their identification and implementation.  Mitigation strategies are identified and 
implemented based on a vulnerability assessment that considers an inside attacker, and are 
specially tailored to significantly reduce or prevent the significant vulnerabilities associated with 
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actionable process steps.  There are cases when a facility-wide security measure could be 
identified as a mitigation strategy if it specifically addresses a significant vulnerability at an 
actionable process step.  In other cases, facility-wide security measures, such as a fence or 
locking exterior doors, would not provide appropriate protection at actionable process steps, 
particularly from an attacker who has achieved legitimate access to the facility and has a basic 
understanding of facility operations and the food product(s) under production.  Facilities may 
choose to implement facility-wide security measures to protect against outside attackers, but 
such measures are not required by the rule.  There are also cases when mitigation strategies and 
facility-wide security measures can complement each other and support the facilitys overall 
food defense system.  Further, some mitigation strategies may leverage an existing facility-wide 
security measure as part of its implementation.   
For example, a facility that uses identification badges to identify employees could use the pre-
existing badging process to implement a strategy to restrict access at an actionable process step 
to only those authorized individuals who work in the area.  The badging process is a facility-
wide security measure upon which the facility builds a mitigation strategythe restriction of non-
authorized persons from a specific area associated with an actionable process step and the 
monitoring or enforcement of the restriction by authorized workers and supervisors.  The facility 
may elect to issue specially colored badges to authorized people, or use some other method of 
delineating authorization on the ID badges, which could serve to further facilitate access 
restriction to the actionable process step. 
E. The Role of Existing Measures 
For reasons other than food defense (e.g., quality control, worker safety), you may already have 
certain measures in place at a particular process step that also could serve as mitigation 
strategies.  Generally, such measures are not, by nature, inherent characteristics of the process 
steps operation and the VA should not consider these practices when identifying whether the 
process step is an actionable process step.  Rather, you should evaluate these measures when 
determining whether these practices could serve as a mitigation strategy in their current or 
altered form and whether you need an additional mitigation strategy to augment the existing 
practice.  Examples of existing measures that may serve as mitigation strategies include: 
  A process step where a worker is a senior employee or an employee who has 
undergone additional vetting to establish increased trustworthiness.  For example, the 
more trusted employee may be posted there because the step is sensitive due to 
ingredient cost, or as a preferred position for senior employees due to working 
conditions.  In this case, the process step would be able to operate without a more 
trusted employee working there (i.e., it is not inherent to the process step), and the 
facility has implemented the practice of positioning more trusted employees in this 
area for a business purpose.  If the presence of the senior employee is relied upon by 
the facility as the protective measure to minimize an otherwise significant 
vulnerability at the process step, then the presence of this senior employee is a 
mitigation strategy. 
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  A process step where you require a buddy system for worker safety.  For example, 
your cold storage facility uses buddy systems to prevent workplace injury when 
working in an area.  This practice could be identified by the facility as a food defense 
mitigation strategy if the area was identified as an actionable process step.  If the 
actionable process step is dependent upon the buddy system as the protective 
measure, then it should be identified as a mitigation strategy because there would be 
an unmitigated significant vulnerability without the buddy system procedure. 
  A process step such as bulk liquid receiving where procedures to confirm the veracity 
of the shipment, identity of the driver, and the integrity of seals already exist and are 
applied for quality or product integrity reasons but also protect against intentional 
adulteration of the load during transport. 
Your facility may already have multiple policies or procedures in place that you can use as 
mitigation strategies or modify to serve as mitigation strategies to provide protection against acts 
of intentional adulteration.  When identifying mitigation strategies, we suggest you first consider 
these existing policies and procedures, because they have the benefit of already being familiar to 
employees and could reduce costs if fewer new mitigation strategies need to be implemented.  
For example, when the liquid food storage tank with an inward opening hatch in Scenario 3 (see 
Table 3-3) is full, the pressure of the liquid prevents the hatch from being opened, rendering the 
interior of the tank inaccessible.  However, when the tank is empty, the hatch may be opened 
and, therefore, an attacker could add a contaminant.  It may be part of normal facility practice for 
a supervisor to conduct a visual check of the storage tank after a cleaning cycle to ensure proper 
cleaning.  The facility may elect to implement a food defense mitigation strategy by altering its 
visual check procedure so that the supervisor conducts the visual check immediately prior to 
food being added to the storage tank instead of after the cleaning, thereby inspecting the tank 
after it has been empty and accessible for an extended period.  Alternatively, the facility could 
elect to secure the tanks hatch with a tamper-evident seal or tape after a visual inspection.  
Either of these slight modifications to an existing facility practice could be implemented to 
protect the actionable process step from an attacker. 
In some instances, you may be able to use existing measures or facility-wide security measures 
to serve as mitigation strategies; in other cases, existing measures or facility-wide security 
measures may need modification in order for them to be used as mitigation strategies.  For 
example, a facility might already have a standard operating procedure to prohibit personal items, 
such as backpacks, in food production areas.  In its VA, the facility identifies the process step of 
flavor addition as an actionable process step because this step aligns with the Key Activity Types 
of secondary ingredient handling and mixing and similar activities. When evaluating potential 
mitigation strategies, the facility also concludes that the existing practice of prohibiting personal 
items from food production areas contributes to the reduction of a significant vulnerability 
associated with an actionable process step, such as a secondary ingredient preparation area, by 
reducing the ability of an inside attacker to carry enough volume of a contaminant into the area 
to adulterate the food.  With this rationale, this facility-wide prohibition against personal 
materials in food production areas can be used as a mitigation strategy for the actionable process 
step.  The facility then would evaluate if any additional mitigation strategies are needed to 
significantly reduce any additional components of the significant vulnerability associated with 
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this actionable process step.  Since the prohibition against personal materials in the secondary 
ingredient preparation area is a mitigation strategy, it must have associated management 
components to ensure its proper implementation, considering the nature of the mitigation 
strategy and its role in the food defense system.  Additionally, management components for this 
mitigation strategy are required only for the implementation of the strategy at the secondary 
ingredient preparation area and not more broadly throughout the facility.  This ensures that 
resources are used in a targeted manner, and not diluted to multiple areas of the facility that are 
not the most vulnerable.   
If the facility determines through the course of the VA that an existing measure  that is not an 
inherent characteristic of a process step  is specifically important to the reduction of a 
significant vulnerability (e.g., because a significant vulnerability would exist at the process step 
absent the consistent implementation of the existing measure), the facility should identify that 
measure as a mitigation strategy and manage it accordingly with applicable mitigation strategy 
management components.   
Actionable process steps identified through a VA do not cease to become actionable process 
steps just because they are protected with mitigation strategies.  Actionable process steps are 
process steps that a facility identifies as significantly vulnerable and requiring protection; the 
facility makes this determination before implementing mitigation strategies.  Facilities still need 
to identify as actionable process steps in the food defense plan those process steps that are 
protected by mitigation strategies.   
For example, a facility identifies a liquid ingredient storage tank as an actionable process step.  
The VA identifies the tank as significantly vulnerable due to the accessibility to a hatch at the top 
of the tank via a ladder and gangway and the tanks location in a relatively isolated part of the 
facility, where it is rarely observed and not easily viewable.  A contaminant added into the tank 
would be evenly applied to many consumer servings of the final product.  The facility decides to 
mitigate the significant vulnerability associated with this actionable process step by installing a 
ladder cage secured with a lock to prevent access to the hatch at the top of the tank.  If the 
mitigation strategy is not properly applied, the significant vulnerability of the tank would remain.  
If the existing mitigation strategy is properly implemented (i.e., the ladder cage remains locked 
when not in use), the facility would conclude that it is significantly minimizing the significant 
vulnerability at the actionable process step.  The facility would not need to implement additional 
or alternative mitigation strategies unless it determined  via the mitigation strategy management 
components  that the previously identified strategy is not adequate when properly implemented.   
F. Accompanying Explanation for Mitigation Strategies in the Food 
Defense Plan 
Your food defense plan must identify your mitigation strategies, and each mitigation strategy 
must include an explanation of how the facility expects the mitigation strategy(ies) to 
significantly minimize or prevent the significant vulnerabilities associated with the actionable 
process step.  (21 CFR 121.135(a)).  In identifying and implementing mitigation strategies, you 
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will need to explain how each mitigation strategy will protect the respective actionable process 
step.   
We expect the mitigation strategy explanations to be relatively brief and straightforward. For 
example, for a mitigation strategy that consists of a lock to protect access to a storage tank, your 
explanation may be simply that the lock prevents unauthorized access to the food in the tank, 
thereby minimizing the significant vulnerability of the storage tank.   
An actionable process step where several mitigation strategies have been identified may require a 
slightly lengthier explanation.  For example, if your facility restricts access around a mixing tank 
only to those employees required by job function to be in the area and implements an alarm tone 
on the mixing tank hatch to notify personnel that someone has accessed the tank, that 
combination of mitigation strategies would require more explanation than the lock on the storage 
tank, though it still need not be lengthy.  You could explain that restricting the area only to those 
workers required to be there reduces the number of potential individuals who could reasonably 
intentionally adulterate the food at this step.  You could further explain that the alarm tone on the 
mixing tank lid provides additional protection to the actionable process step by alerting other 
personnel that someone is accessing the mixing tank, thereby elevating awareness and 
observation of the mixing tank; both mitigation strategies, used together, minimize the 
significant vulnerability associated with the mixing tank. 
Mitigation strategy explanations have the benefit of clarifying the facilitys thinking and 
supporting the consistent implementation of the mitigation strategy(ies), especially if there is 
staff turnover or changes in responsibility.  The written explanations help ensure that the 
rationale for the identification and implementation of each mitigation strategy is clear to persons 
responsible for its implementation as well as the monitoring of the mitigation strategy, correcting 
any deviations of its intended operation, and verifying its proper implementation.  Further, the 
explanation for how the mitigation strategies minimize the significant vulnerability will also be 
highly beneficial in supporting your choice of mitigation strategies, if needed, during an 
inspection or audit.   
G.  Mitigation Strategy Example Scenarios 
1.  Scenario 1 
A facility identified the primary ingredient storage tank as an actionable process step because of 
the public health impact that would occur if the tank were contaminated, the presence of physical 
access via a hatch, and the likelihood that an inside attacker could contaminate the food in the 
tank without being detected or the contamination being discovered.  The VA identified that the 
unsecured access hatch at the top of the tank provided unrestricted access to the ingredient in the 
tank and would enable an attacker to intentionally contaminate the food.  The facility, in 
considering mitigation strategies, concludes that there is no legitimate need to open the hatch 
when liquid food is in the tank and that locking the hatch would be a simple, cost effective way 
of significantly reducing accessibility to the ingredient in the tank and would significantly 
minimize or prevent the significant vulnerability identified in the vulnerability assessment.  The 
facility specifies that the security office will hold the keys to the lock and will allow access to the 
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keys only for those persons with a legitimate need based on their job duties and approval from 
the facility security manager or food defense coordinator. 
The facilitys food defense plan should identify the lock on the hatch as the mitigation strategy 
and explain that the lock on the hatch renders the food in the tank inaccessible to an attacker, 
including an inside attacker, thereby significantly reducing the vulnerability present at this 
actionable process step. 
2.  Scenario 2 
A facilitys VA identified the receiving of bulk liquid ingredients as an actionable process step.  
The facility recognizes that there are several factors in this process that are relevant to the food 
defense vulnerability of receiving bulk liquid ingredients.  The facility identifies a multi-strategy 
approach to mitigate the significant vulnerabilities associated with the receipt of bulk liquids. 
The facility concludes that its existing measure of using seals on inbound shipping conveyances 
significantly reduces vulnerability of the food during transport and that this measure is a 
mitigation strategy.  The facility documents this existing measure in its food defense plan as a 
mitigation strategy that significantly minimizes or prevents significant vulnerabilities associated 
with receiving bulk liquid ingredients.  
The facility determined that transfer hoses used to unload the liquid food from the conveyance 
and pump it to a storage tank in the facility provided an access point for an attacker to introduce 
a contaminant.  During operations, the facility is constantly receiving liquid ingredients and 
hoses are in near constant use.  Outside of operating hours, however, the hoses are open and 
accessible.  The facility implemented a mitigation strategy for the hoses after daily operations: 
the hose ends must be capped and the cap must be taped with tamper-evident tape, which would 
prevent an inside attacker from accessing the hose openings when not in use and introducing a 
contaminant. 
The facility also identified other aspects of the receiving process as significant vulnerabilities; 
namely, the opening of venting and sampling hatches on the transport conveyance.  To address 
this, the facility implements slight changes to its unloading procedures.  The facility implements 
a mitigation strategy of increasing observation of unloading operations by having the worker 
responsible for reviewing shipping documentation witness the opening of the transport 
conveyance and the attachment of transfer hoses and pumping equipment.  This increases the 
level of observation of the activity in the receiving bay, thereby significantly reducing the ability 
of an attacker to bring a contaminant into the area and introducing it to the food during the 
opening of venting or sampling hatches on the tanker truck without being detected. 
The facility documents each mitigation strategy in its food defense plan and provides an 
explanation for how the strategies reduce different aspects of the significant vulnerability of the 
bulk liquid receiving process that was identified in the VA. 
3.  Scenario 3 
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A facility identified the liquid food storage tank as an actionable process step.  The tank is 
accessible with an inward opening hatch.  When the tank is full, the pressure of the liquid 
ingredient inside prevents the hatch from being opened, rendering the tank inaccessible.  
However, a significant vulnerability exists when the tank is emptya person could open the hatch 
and add a contaminant.  Normal facility practice is for a supervisor to conduct a visual check of 
storage tanks after a cleaning cycle to ensure the cleaning has been conducted as intended.  The 
tank is then accessible and empty for an extended period.  The facility considers potential 
mitigation strategies and rather than installing a lock or other access control or seal on the hatch, 
the facility elects to implement a modification to its existing visual check procedure so that the 
visual check by the supervisor is conducted immediately prior to food being added to the storage 
tank.  The open hatch provides clear visibility of the interior of the tank, allowing the supervisor 
to inspect the condition of the tank walls and floor to ensure that there is no residue in the tank 
that may indicate the introduction of a contaminant.  To facilitate a thorough inspection, the 
quality control manager will use high intensity flashlights as well as ultraviolet lights to detect 
any potential contamination.  The mitigation strategy is that personnel observe the tank after it 
has been cleaned and sat empty and accessible for an extended period, but immediately prior to 
the introduction of food into the tank to ensure that a contaminant has not been added to the 
empty tank.  This mitigation strategy, the facility explains, would significantly reduce or 
eliminate the vulnerability associated with an attacker, including an inside attacker, introducing a 
contaminant to the empty tank while it is open and accessible after the cleaning cycle. 
The facility would document this mitigation strategy in its food defense plan along with the 
associated explanation. 
4.  Scenario 4 
A facility identifies a process step where a breading coating is applied to food as an actionable 
process step.  The facility concludes in its vulnerability assessment that the hopper that feeds the 
breader at this step allows both significant physical access to the product as well as a sufficient 
likelihood that an inside attacker could contaminate the food without detection.  To mitigate an 
attackers physical access to the product, the facility implements a mitigation strategy that 
restricts access only to specific employees who directly work at or supervise the breading 
process step.  The facility issues those employees special red caps and identifies their job 
function on their employee identification badges.  This allows their fellow authorized workers, 
supervisors, management, and security personnel to easily determine whether persons in the area 
surrounding the breader are authorized.  As part of the mitigation strategy, the facility requires 
workers who are permitted access to the breading area to be with the company for at least 4 
years, have no disciplinary or job performance issues during that time, and be approved by 
company human resources and security offices.  The mitigation strategy requires that authorized 
workers immediately escort any unauthorized person out of the area, and notify security 
personnel or management of the intrusion.  As part of their training on proper implementation of 
the mitigation strategy, workers are specifically trained on how to address the access restriction.  
Any person who requires access to the area and is not previously cleared (e.g., contractors) 
would be escorted and observed by an authorized employee or other authorized personnel. 
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The facility details this mitigation strategy in its food defense plan and provides rationale in its 
explanation that this mitigation strategy significantly reduces the ability of an inside attacker to 
enter the area to contaminate the food.  The facility also explains that the additional vetting of 
employees authorized to be in the area around the breader appropriately considers the actions of 
an inside attacker by ensuring that workers in this highly vulnerable area have consistently 
demonstrated their responsibility and trustworthiness.  Also, the facility explains that the 
mitigation strategy that authorized workers escort from the area anyone who is not cleared also 
significantly reduces the ability of an inside attacker to approach the breader and introduce a 
contaminant without being detected and interdicted.   
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Table 3-1. Scenario 1.  
Worksheet 1-H:  Mitigation Strategies  
PRODUCT(S): FOOD XYZ 
FACILITY NAME: Anytown #12345 
ADDRESS: 1245 Washington Street, Anytown, USA  
SIGNED DATE: March 7, 2018 
 
(2)  
(3) 
(1)  Actionable  (4) 
Mitigation 
#  Process  Explanation 
Strategy 
Step 
  Liquid  Use a lock to  The lock on the hatch renders the food in the tank 
ingredient  secure access  inaccessible to an attacker, including an inside attacker, 
storage tank  hatch on  thereby significantly reducing the vulnerability present 
ingredient  at this actionable process step.  
storage tank.  
Keys to the 
lock are held 
in the security 
office and can 
only be 
retrieved with 
good reason 
and approval 
from the 
facility 
security 
manager or 
food defense 
coordinator. 
 
   
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Table 3-2. Scenario 2. 
Worksheet 1-H:  Mitigation Strategies 
PRODUCT(S): FOOD XYZ 
FACILITY NAME: Anytown #12345 
ADDRESS: 1245 Washington Street, Anytown, USA  
SIGNED DATE: March 7, 2018 
(2)   (4) 
(3) 
(1)  Actionable  Explanation 
Mitigation 
#  Process   
Strategy 
Step 
  Bulk liquid  Use tamper- Using numbered wire or plastic seals to secure hatches, 
receiving  evident seals  ports, and other access points to the transport 
on inbound  conveyance significantly reduces the ability of an 
shipping  attacker to successfully contaminate the product 
conveyances.  without being detected. Tamper-evident seals will 
Match the  indicate if the product has been interfered with during 
numbers on the  transport.   
seals with the 
numbers   
provided on 
the shipping 
documentation 
from the 
supplier.  If the 
seals do not 
match, the load 
will be rejected 
to prevent 
potentially 
adulterated 
ingredient 
from entering 
the facility. 
  Bulk liquid  Use tamper- Using tamper-evident tape to seal the hose caps when 
receiving  evident tape on  not in use limits the ability of an attacker to 
hose ends after  successfully contaminate the product without being 
capping.  detected.  
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(2)   (4) 
(3) 
(1)  Actionable  Explanation 
Mitigation 
#  Process   
Strategy 
Step 
  Bulk liquid  Use authorized  Having the employee responsible for reviewing 
receiving  personnel for  shipping documentation visually observe the opening 
visual  of venting and sampling hatches as well as the hooking 
observation of  up of hoses and pumping equipment significantly 
the unloading  reduces the ability of an attacker to introduce a 
bay during the  contaminant either to the conveyance via the venting or 
opening of the  sampling hatches, or into the hoses prior to unloading 
conveyance  without being detected. 
and the 
attachment of 
hoses and 
pumping 
equipment. 
   
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Table 3-3. Scenario 3. 
Worksheet 1-H:  Mitigation Strategies  
PRODUCT(S): FOOD XYZ  
FACILITY NAME: Anytown #12345 
ADDRESS: 1245 Washington Street, Anytown, USA  
SIGNED DATE: March 7, 2018 
(2)  
(1)  Actionable  (3)  (4) 
#  Process  Mitigation Strategy  Explanation 
Step 
  Liquid food  Inspect liquid food storage tank  The use of both high intensity 
storage tank  prior to use.  Immediately prior  flashlights and ultraviolet lights will 
to reintroducing food, the tank  enable the quality control manager to 
will be visually inspected by the  make a thorough inspection of the 
quality control manager using  tank to ensure no contamination 
high intensity flashlights and  occurred.  The hatch is wide enough 
ultraviolet lights to ensure that  to provide a clear view of both the 
no contaminant has been added  walls and floor of the tank, enabling 
to the tank while it was open  inspection of all surfaces of the tank 
and accessible after cleaning.  interior. 
 
 
 
   
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Table 3-4. Scenario 4. 
Worksheet 1-H:  Mitigation Strategies  
PRODUCT(S): FOOD XYZ 
FACILITY NAME: Anytown #12345 
ADDRESS: 1245 Washington Street, Anytown, USA  
SIGNED DATE: March 7, 2018 
(2)  
(1)  Actionable  (3)  (4) 
#  Process  Mitigation Strategy  Explanation 
Step 
  Breader  Restrict access to breader  This mitigation strategy significantly 
to authorized personnel.   reduces the ability of an attacker to enter the 
The facility issues these  area to contaminate the food.  Restricting 
employees special red  this area to only Food Safety Technician 
caps and identifies their  Level 3 workers significantly reduces the 
job function on their  number of people who are authorized to be 
employee identification  in the area and significantly minimizes the 
badges.  Workers  vulnerability posed by an attacker, including 
authorized to work at the  an inside attacker.  Food Safety Technician 
breader will have attained  Level 3 workers in good standing and with 
at least the position of  more than 4 years of employment have 
Food Safety Technician  demonstrated their level of responsibility 
Level 3 with at least 4  and trustworthiness to work in this highly 
years of employment and  vulnerable area and to restrict access to the 
be in good standing with  area.  
human resources with no 
pending or previous   
disciplinary actions.  
Employees working at the 
breader will immediately 
escort out of the area 
anyone not authorized to 
be in the area surrounding 
the breader. 
 
   
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Chapter 4: 
Mitigation Strategies Management Components: Food Defense Monitoring 
This chapter provides an overview of the food defense monitoring mitigation strategy 
management component, and is intended to help you understand the requirements for food 
defense monitoring as a part of your FDP.  Food defense monitoring is conducted to assess 
whether mitigation strategies are operating as intended (21 CFR 121.3) and with adequate 
frequency to provide assurances strategies are consistently performed (21 CFR 121.140(b)). 
Food defense monitoring is one of three mitigation strategies management components.  The 
other two are food defense corrective actions and food defense verification.  You must apply 
appropriate mitigation strategies management components by considering the nature of the 
mitigation strategy and its role in the facilitys food defense system to ensure the proper 
implementation of the mitigation strategy.  (21 CFR 121.138).  (See Chapter 3 of this guidance 
for information on identifying and implementing mitigation strategies).   You have the flexibility 
to identify and implement food defense monitoring procedures that are appropriate for your 
facility.  Note that if, through your vulnerability assessment, you appropriately determine that 
your facility has no actionable process steps, then you would not need to establish mitigation 
strategies or associated mitigation strategies management components.   
A. Overview of Food Defense Monitoring 
The purpose of food defense monitoring is to conduct a planned sequence of observations or 
measurements to assess whether mitigation strategies are operating as intended.  You must 
establish and implement written procedures, including the frequency with which they are to be 
performed, for food defense monitoring of the mitigation strategies.  (21 CFR 121.140).  In an 
FDP, each mitigation strategy is monitored as appropriate to the nature of the mitigation strategy 
and its role in the facilitys food defense system.  As discussed in Chapter 3 of this guidance, 
most mitigation strategies are implemented to reduce access to the product at a particular point, 
reduce the ability of an attacker to contaminate the food at that point, or reduce both access to the 
product and ability of an attacker to contaminate the product.  Monitoring procedures should be 
appropriate to assess whether the mitigation strategy is operating as intended, as detailed in the 
mitigation strategys accompanying explanation.  Monitoring must be documented in records and 
is subject to food defense verification (21 CFR 121.140(c)).    
Your food defense monitoring procedures should answer four questions: (1) What will be 
monitored? (2) How will monitoring be done? (3) How often will monitoring be done 
(frequency)? and (4) Who will do the monitoring?  Facilities have significant flexibility in how 
to accomplish each of these aspects of monitoring.   
The tables at the end of this chapter provide examples of food defense monitoring procedures for 
the scenarios listed in Chapter 3 of this guidance. 
 
B. How Food Defense Monitoring Differs from Food Safety Monitoring 
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Some aspects of food defense monitoring are similar to the food safety monitoring requirement 
in the PCHF rule.  For example, each preventive control is monitored as appropriate to the nature 
of the preventive control and its role in the facilitys food safety system in a food safety plan 
(FSP).  However, some aspects of food defense monitoring are different than food safety 
monitoring, primarily because of the different nature of mitigation strategies and preventive 
controls.  Food safety monitoring is more likely than food defense monitoring to document that 
the minimum or maximum values for a parameter have been met, and food safety monitoring 
frequently is continuous.  Food defense monitoring, in comparison, observes whether the 
mitigation strategy is operating as intended and often occurs less frequently, and is therefore less 
resource intensive.  For example, in Scenario 1 (first described in Chapter 3), the employee 
assigned to ingredient storage observes whether the lock is in place and locked at the beginning 
and end of the tanks 48-hour cleaning cycle.  
C. What to Monitor 
What you monitor should be directly related to the implementation and nature of the mitigation 
strategy.  You have the flexibility to determine what to monitor, how often the monitoring will 
occur, and who will monitor the mitigation strategy, as long as your monitoring procedures allow 
you to assess whether the mitigation strategies are operating as intended.  In Scenario 1, the 
facility has identified a liquid ingredient storage tank as an actionable process step, and identified 
the mitigation strategy of using a lock to secure the access hatch.  In this scenario, the facility 
would monitor whether the storage tank is locked.  In Scenario 2, the facility has identified bulk 
liquid receiving as an actionable process step, and one of the mitigation strategies is to use 
tamper-evident tape on pump hose ends after a cap is placed on the end; the facility would 
monitor whether the tamper-evident seal is in place on the ends.  In Scenario 3, the facility has 
identified the liquid food storage tank as an actionable process step; the mitigation strategy 
chosen is to inspect the liquid food storage tank prior to use.  For this strategy, the facility would 
monitor the inside of the liquid food storage tank. 
Additionally, there may be instances when food defense monitoring coincides with activities 
already being conducted for either food safety purposes or as part of pre-existing operational 
procedures.  In Scenario 3, the QA technician may be inspecting the food storage tank for food 
safety purposes (i.e., cleaning) as well as mitigation strategy implementation and monitoring.  In 
a different example, a facility identifies bulk liquid receiving as an actionable process step, and 
implements a mitigation strategy to use only known shippers.  The monitoring procedure for this 
strategy is that a technician assesses the delivery paperwork to determine whether the stated 
shipment and shipper information matches that of the scheduled delivery to ensure the mitigation 
strategy of using known shippers is operating as intended.  The technician then documents that 
the paperwork has been checked by recording the date and time that the documentation was 
checked, and initials the document.  This documentation check may already be occurring in your 
facility each time you receive bulk liquids to ensure the receipt of the appropriate type and 
amount of ingredient from the shipper.  Existing quality and food safety activities may also 
function as food defense monitoring procedures.  In the FDP, the facility should indicate that the 
food defense monitoring procedure will be the same as the existing food safety monitoring 
procedure for this mitigation strategy.   
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D. How to Monitor 
Once you determine what to monitor, you have flexibility regarding how you monitor the 
mitigation strategy.  In some cases, it may be necessary to develop a new procedure to 
adequately monitor a mitigation strategy.  In many instances, facilities may elect to have an 
employee observe whether the mitigation strategy is operating as intended; however, facilities 
have the flexibility to monitor mitigation strategies in other ways, such as electronic monitoring 
of an access control device (e.g., automated monitoring of electronic locks on a door or gate that 
prevents access to an actionable process step).  When considering monitoring procedures for 
mitigation strategies, it is important to consider what existing practices, procedures, and 
conditions are in place around the actionable process step and to consider the nature of the 
mitigation strategy and its implementation.   
Facilities also have the flexibility to consider the existing presence of employees and supervisors, 
and how monitoring of a mitigation strategy could be incorporated into normal operations or job 
duties.  In some circumstances, food defense monitoring may be incorporated into other security, 
maintenance, quality, or worker safety procedures performed at the facilitywhich decreases 
additional human or other resources the facility uses to monitor some mitigation strategies.  For 
example, it may be most efficient to task an employee who frequently traverses the area to 
monitor the implementation of that mitigation strategy as part of their normal duties.  
Furthermore, there may be some cases when monitoring of the mitigation strategy may occur 
concurrently with the implementation of the mitigation strategy itself.  For example, in Scenario 
3, the mitigation strategy is to visually inspect the tank immediately prior to the introduction of 
food.  In this case, the QA manager is implementing the mitigation strategy and is also 
monitoring its implementation by completing monitoring documentation.  The documentation is 
being completed, for food safety purposes, using the Storage tank cleaning sign off form. 
Because this food safety record is fulfilling food defense monitoring record requirements as well, 
the facility may decide to use it as the food defense monitoring record (See Table 4-7).  In 
Scenario 4, the authorized workers are implementing the mitigation strategy to restrict access to 
the area around the breader to only authorized personnel wearing special red caps and 
identification badges listing their job function.  Concurrently, these employees also are 
constantly monitoring the implementation of the mitigation strategy by observing whether other 
people in the area are wearing the cap and the badge; if an unauthorized person is identified in 
the restricted area, employees implementing this strategy escort the person out of the area, and 
notify security personnel of the deviation from the strategy. Security personnel then document 
deviations to the strategy by using exception records (See Section F. of this chapter).  In other 
cases, you may choose to periodically monitor a mitigation strategy to ensure it is operating as 
intended.  For example, the lock on the tank in Scenario 1 is periodically monitored (e.g., at the 
beginning and end of the tanks 48-hour cleaning cycle) at a frequency sufficient to provide 
assurances that it is in place and reducing access to the tank.   
Regardless of how a mitigation strategy is monitored, monitoring activities must be documented 
(21 CFR 121.140(c)).   
1.  How Often to Monitor (Frequency of Monitoring) 
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The frequency of monitoring depends on the nature of the mitigation strategy and the facilitys 
food defense system.  You have the flexibility to determine the frequency of monitoring needed 
so long as the frequency is adequate to provide assurances that the mitigation strategies are 
consistently performed.  (21 CFR 121.140(b)).   
For food defense, many mitigation strategies may be monitored less frequently than preventive 
controls for food safety, which are often monitored continuously.  In large part, preventive 
controls for food safety are monitored continuously because they relate to physical or chemical 
parameters of the process, such as the temperature of a pasteurizer.  These types of controls lend 
themselves to continuous monitoring and necessitate that level of monitoring to ensure that the 
process is under control.  On the other hand, most mitigation strategies for food defense are put 
in place to reduce accessibility to the food at a particular step or reduce the ability of an attacker 
to contaminate the food at that step.  In Scenario 1, the mitigation strategy of using a lock to 
secure the access hatch on the ingredient storage tank would not require continuous monitoring.  
Part of this mitigation strategy is to keep keys to the lock in a security office, and restrict access 
to the keys to predesignated times when the keys would be needed to access the food in the tank.  
The employee assigned to ingredient storage would observe whether the lock is in place and 
locked at the beginning and end of the tanks 48-hour cleaning cycle.  This frequency will help 
the manager ensure that the lock stayed locked during the food processing because it would not 
be possible to check out the key during an unapproved time. In another example, a facility uses 
an existing camera to facilitate the implementation of a mitigation strategy that increases 
observation of a liquid storage tank the facility identified as an actionable process step.  The 
facility determines that the camera feed can be monitored, by an employee already monitoring 
other feeds, periodically throughout his shift.   
Non-continuous monitoring is appropriate in many other circumstances as well.  For example, a 
facility identifies bulk liquid receiving as an actionable process step, and implements a 
mitigation strategy of restricting drivers to a lounge area.  The facility determines this strategy 
should be monitored periodically, but at least once a week.  This monitoring activity can be done 
any time there is a driver in the facility, but the monitoring procedure requires that it be done at 
least once per week.  A monitoring procedure occurring on a periodic basis but at irregular 
intervals can be beneficial for the facility in two ways: 1) it is more difficult for an inside 
attacker to anticipate, and 2) it requires less human and other resources than more frequent 
monitoring.   
For mitigation strategies that are monitored concurrently with the mitigation strategys 
implementation, the monitoring frequency would depend on the mitigation strategy frequency.  
For example, consider the mitigation strategy in Scenario 2, use of tamper-evident seals on 
transport conveyances.  The monitoring procedure would be to check the seals for integrity or 
indications of tampering and match seal or documentation numbers upon arrival of the load, 
before hooking up the hose for each delivery.  This monitoring frequency is dictated by the 
frequency of inbound shipments  which may vary depending on seasonality, the nature of the 
ingredient, and other factors not associated with the mitigation strategy itself.  In this case, the 
FDP would provide that this monitoring procedure would occur concurrently with receiving. 
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2.  Who Performs the Monitoring 
You have the flexibility to decide who will monitor your mitigation strategies.  You should 
specify in the written procedures the position of the employee who will do the monitoring and 
describe how they are to perform the monitoring procedure.  The employees duties should 
include notifying management and following the food defense corrective actions procedures as 
specified in the food defense plan when observations or measurements indicate mitigation 
strategies are not operating as intended.  
When a person is assigned to perform monitoring, that person must have the education, training, 
or experience (or a combination thereof) necessary to perform the individuals assigned duties.  
(21 CFR 121.4(b)(1)).  You have flexibility to assign monitoring responsibilities consistent with 
this requirement.  Such individuals who perform these duties may include, among others: 
  Line personnel; 
  Equipment operators; 
  Supervisors; 
  Maintenance personnel; or 
  QA personnel. 
You may choose to assign monitoring duties to personnel who actively and constantly watch the 
product or equipment as a part of their regular jobs, such as line personnel and equipment 
operators.  In addition, including production workers in food defense activities can help build a 
broad base of understanding and commitment to food defense. 
In the liquid storage tank lock example in Scenario 3, the person doing the monitoring may be 
the line operator (e.g., kettle cook, baker), quality control personnel, or any other person who 
understands the nature of the mitigation strategy and has the required training to properly 
implement the strategy. 
See Tables 4-5 through 4-8 for examples of some of the other individuals who you may choose 
to monitor the mitigation strategies and record their findings.   
E. Food Defense Monitoring Records 
In addition to documenting the monitoring procedures in the FDP (21 CFR 121.126(b)(3)), you 
must document the monitoring of mitigation strategies in records that are subject to verification 
and records review (21 CFR 121.140(c)(1)).  All food defense monitoring information must be 
recorded at the time the observation is made.  (21 CFR 121.305(d)).  Accurate recordkeeping 
provides documentation that mitigation strategies are operating as intended.  Each monitoring 
record should capture the observations or actual values for the mitigation strategy, along with the 
time (if appropriate) and date that the observation was made, and the signature or initials of the 
person who made the observation.  (21 CFR 121.305).  
Using Scenario 1, one example of what to document in records of monitoring activities is a 
determination of whether the lock is in place and locked.  The monitoring record could be 
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written in a log entitled liquid storage tank observations record and include the date, time, and 
a written yes or no to indicate whether the lock was locked.  If you are using the mitigation 
strategies management components table (Worksheet 1-I in Appendix 1 to this guidance), the 
name of the monitoring record should also be documented under the Food Defense Record 
column in the table.  For example, in Scenario 1, in the Food Defense Record column, you 
would write Liquid storage tank observations record (See Table 4-5).  
F. Exception Records 
In some cases, you can document monitoring of a mitigation strategy with a record of when the 
mitigation strategy is not functioning, or operating, as intended.  In this case, the monitoring 
record generated would be an exception record demonstrating a deviation (compared to 
affirmative records, which demonstrate that the mitigation strategy is functioning as intended).  
Exception records demonstrating the mitigation strategy is not functioning as intended are 
adequate in some, but not all, circumstances.  (21 CFR 121.140(c)(2)).  
In a food safety context, exception records are used when an automated monitoring system 
detects a deviation from food safety parameter limits.  For example, under the PCHF rule, 
records of refrigeration temperature during storage of food that requires time/temperature control 
to significantly minimize or prevent the growth of, or toxin production by, pathogens may be 
affirmative records demonstrating temperature is controlled or exception records, via an 
automated system constantly monitoring the temperature, demonstrating loss of temperature 
control. (See 21 CFR 117.145(c)(2)). 
Some mitigation strategies may lend themselves to constant monitoring, and exception records to 
document monitoring may be appropriate.  This can be through an automated system that is put 
in place to monitor whether the mitigation strategy is operating as intended.  For example, a 
mitigation strategy may be to restrict access using a locking gate that is opened only by a 
specially coded access card.  If the gate is left ajar for any period beyond the time it takes to 
enter and re-secure the gate, an automated monitoring system alarm indicates that the gate is not 
secured.  Whenever the system alarms, an automatically generated exception record documents 
the instance where the mitigation strategy was not operating as intended.   
In addition to technology-based mitigation strategies, there also may be personnel-based 
mitigation strategies that lend themselves to constant monitoring.  Mitigation strategies that are 
personnel-based and restrict unauthorized access to designated areas rely on personnel to ensure 
the mitigation strategy is operating as intended.  The mitigation strategies may rely on these 
personnel to constantly monitor an area.  In the example in Scenario 4, the employees working in 
the restricted access area surrounding the breader both implement the mitigation strategy of 
preventing unauthorized persons from entering the area and constantly monitor the 
implementation of the mitigation strategy (with the monitoring being incorporated into the 
employees current responsibilities).  In this case, it may be appropriate to generate an exception 
record when an unauthorized person is discovered in the area, rather than proactively generating 
monitoring records, on a predetermined frequency that indicate whether unauthorized individuals 
have entered the area.  In this case, the presence of an unauthorized person in the area would be 
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documented by security personnel after they were notified by the employees implementing this 
strategy, as a deviation from the mitigation strategy.   
In another example, a facility identifies a liquid ingredient holding tank as an actionable process 
step.  The facility uses an existing measure, prohibiting personal items from the food production 
area (which includes the area around the liquid ingredient holding tank), as a mitigation strategy 
to significantly minimize the significant vulnerability associated with the tank by reducing the 
ability of an inside attacker to carry enough volume of a contaminant into the area to adulterate 
the food.  There are personnel working in the area around the tank (although their presence is not 
an inherent characteristic of the step (i.e., the tank can operate without their presence)), and their 
current responsibilities are modified to include monitoring the area for personal items.  In this 
case, it may be appropriate to generate an exception record when an unauthorized personal item 
is discovered in the area, rather than proactively generating monitoring records, on a 
predetermined frequency that indicate whether personal items are in the area.  In this case, the 
presence of a personal item in the area would be documented by a supervisor after she was 
notified by the employees implementing this strategy, as a deviation from the mitigation strategy.   
There are instances where exception records are not appropriate to monitor the operating of a 
mitigation strategy.  Generally, situations where a mitigation strategy is implemented to maintain 
a static situation that is not under constant monitoring do not lend themselves to a monitoring 
procedure that uses an exception record approach.  For example, a lock on a hatch of a storage 
tank typically requires a monitoring procedure that generates an affirmative record as to the 
mitigation strategys functioning.  Because this mitigation strategy is not under constant 
monitoring by an automated system or a personnel-based monitoring procedure, it would be 
difficult, or impossible, to conclude that the mitigation strategy is operating as intended based 
only on exception records.  This mitigation strategy should have an accompanying monitoring 
procedure that, at an appropriate frequency, includes an observational determination whether the 
lock is securing the hatch.  A record must be generated to document this monitoring activity 
(121.140(c)(1)).  A record documenting the date and time the lock was observed and whether the 
mitigation strategy was operating as intended will enable the facility to determine whether the 
strategy was properly implemented, and that monitoring was properly conducted during food 
defense verification procedures.    
 
 
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Table 4-5. Scenario 1. 
Worksheet 1-I: Mitigation Strategies Management Components 
PRODUCT(S): FOOD XYZ 
FACILITY NAME: Anytown #12345 
ADDRESS: 1245 Washington Street, Anytown, USA  
SIGNED DATE: March 7, 2018 
(4)  (5)  (6)  (7)  
(2)   Food Defense  Food Defense  Food Defense  Food Defense 
(1)  (3) 
Actionable Process  Monitoring  Corrective Action  Verification  Records 
#  Mitigation Strategy 
Step  Procedure and  Procedures  Procedures 
Frequency 
  Liquid ingredient  Use a lock to secure  Employee assigned  Guidance  Guidance  Liquid storage tank 
storage tank  access hatch on  to ingredient storage  forthcoming  forthcoming  observations record 
ingredient storage  observes whether the 
tank.  Keys to the  lock is in place and   
lock are held in the  locked at the 
security office and  beginning and end of 
can only be retrieved  the tanks 48-hour 
with good reason  cleaning cycle. 
and approval from 
the facility security 
manager or food 
defense coordinator. 
 
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Table 4-6. Scenario 2. 
Worksheet 1-I: Mitigation Strategies Management Components 
PRODUCT(S): FOOD XYZ 
FACILITY NAME: Anytown #12345 
ADDRESS: 1245 Washington Street, Anytown, USA  
SIGNED DATE: March 7, 2018 
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(4)  (5)  (6)  (7)  
(2)   Food Defense  Food Defense  Food Defense  Food Defense 
(1)  (3) 
Actionable Process  Monitoring  Corrective Action  Verification  Records 
#  Mitigation Strategy 
Step  Procedure and  Procedures  Procedures 
Frequency 
  Bulk liquid receiving  Use tamper-evident  Technician assesses  Guidance  Guidance  Receiving/delivery 
seals on inbound  whether the seal is  forthcoming  forthcoming  paperwork that 
shipping  intact and matches  includes additional 
conveyances.  Match  seal or  information to 
the numbers on the  documentation  indicate monitoring 
seals with the  numbers upon  was completed 
numbers provided on  arrival of the load, 
the shipping  before hooking up   
documentation from  the hose for each 
the supplier.  If the  delivery.   
seals do not match, 
the load will be 
rejected to prevent 
potentially 
adulterated 
ingredient from 
entering the facility. 
  Bulk liquid receiving  Use tamper-evident  After daily  Guidance  Guidance  Food defense 
tape on hose ends  operations, supply  forthcoming  forthcoming  monitoring log 
after capping.  chain supervisor 
confirms that the   
hose cap is on and 
taped. 
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  Bulk liquid receiving  Use authorized  On a periodic basis  Guidance  Guidance  Food defense 
personnel for visual  (but at least twice  forthcoming  forthcoming  monitoring log 
observation of the  weekly), a manager 
unloading bay  observes whether   
during the opening  personnel are 
of the conveyance  visually observing 
and the attachment  the unloading bay 
of hoses and  during the opening 
pumping equipment.  of the conveyance 
and the attachment 
of hoses and 
pumping equipment. 
 
   
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Table 4-7. Scenario 3. 
Worksheet 1-I: Mitigation Strategies Management Components 
PRODUCT(S): FOOD XYZ 
FACILITY NAME: Anytown #12345 
ADDRESS: 1245 Washington Street, Anytown, USA  
SIGNED DATE: March 7, 2018 
(4)  (5)  (6)  (7)  
(2)   Food Defense  Food Defense  Food Defense  Food Defense 
(1)  (3) 
Actionable Process  Monitoring  Corrective Action  Verification  Records 
#  Mitigation Strategy 
Step  Procedure and  Procedures  Procedures 
Frequency 
  Liquid food storage  Inspect liquid food  QA technician signs  Guidance  Guidance  Storage tank 
tank  storage tank prior to  and dates log  forthcoming  forthcoming  cleaning signoff 
use.  Immediately  immediately prior to  form kept with 
prior to  the liquid food being  records for 
reintroducing food,  added to the tank  Preventive Controls 
the tank will be  after the monthly  for Human Food 
visually inspected by  cleaning cycle.  requirements 
the quality control 
manager using high   
intensity flashlights 
and ultraviolet lights 
to ensure that no 
contaminant has 
been added to the 
tank while it was 
open and accessible 
after cleaning. 
   
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Table 4-8. Scenario 4. 
 Worksheet 1-I: Mitigation Strategies Management Components 
PRODUCT(S): FOOD XYZ 
FACILITY NAME: Anytown #12345 
ADDRESS: 1245 Washington Street, Anytown, USA  
SIGNED DATE: March 7, 2018 
(4)  (5)  (6)  (7)  
(2)   Food Defense  Food Defense  Food Defense  Food Defense 
(1)  (3) 
Actionable Process  Monitoring  Corrective Action  Verification  Records 
#  Mitigation Strategy 
Step  Procedure and  Procedures  Procedures 
Frequency 
  Breader  Restrict access to  Employees assigned  Guidance  Guidance  Food defense 
breader to authorized  to the breader  forthcoming  forthcoming  monitoring log 
personnel.  The  constantly monitor 
facility issues these  the area and ensure   
employees special  that only authorized 
red caps and  employees (i.e., 
identifies their job  those wearing 
function on their  special badges and 
employee  red caps) are in the 
identification  area.  The employees 
badges.  Workers  in the breader area 
authorized to work at  will notify security 
the breader will have  personnel if an 
attained at least the  unauthorized person 
position of Food  is in the restricted 
Safety Technician  area.  The security 
Level 3 with at  personnel will use 
least 4 years of  exception records to 
employment and be  record when a 
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(4)  (5)  (6)  (7)  
(2)   Food Defense  Food Defense  Food Defense  Food Defense 
(1)  (3) 
Actionable Process  Monitoring  Corrective Action  Verification  Records 
#  Mitigation Strategy 
Step  Procedure and  Procedures  Procedures 
Frequency 
in good standing  deviation from the 
with human  strategy is observed.   
resources with no 
pending or previous 
disciplinary actions.  
Employees working 
at the breader will 
immediately escort 
out of the area 
anyone not 
authorized to be in 
the area surrounding 
the breader. 
 
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Chapter 5: Mitigation Strategies Management Components: Food Defense 
Corrective Actions (coming soon) 
   
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Chapter 6: Mitigation Strategies Management Components: Food Defense 
Verification (coming soon) 
   
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Chapter 7: Reanalysis (coming soon) 
   
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Chapter 8:  
Education, Training, or Experience [New March 2019] 
The guidance provided in this chapter is intended to help you understand the education, training, 
and experience required for individuals who perform certain activities under the IA rule.  
Requirements for education, training, and experience are applicable to the following personnel: 
 
  Individuals who perform activities required under subpart C (Food Defense Measures); 
  Individuals assigned to actionable process steps; 
  Individuals performing or overseeing four specific activities (food defense qualified 
individuals); and  
  Supervisors.   
 
Although the requirements vary depending on the nature and significance of the food defense 
activity, many activities require that the person performing the activity be a qualified 
individual.  A qualified individual is a person who has the education, training, or experience 
(or a combination of these) necessary to perform an activity required under subpart C, as it 
relates to their assigned duties.  (21 CFR 121.3).  Education and training can include in-house 
instruction and instruction by outside entities, such as educational institutions, associations, and 
consultants.  Experience can include both job-related and non-job-related experience relevant to 
the individuals assigned duties.  For example, you may determine that the experience an 
individual gained writing corrective action records for another program, such as HACCP, 
coupled with training on the IA rules requirements for food defense corrective action records, is 
sufficient to enable the individual to adequately document food defense corrective actions 
records.  Alternatively, you may determine that the individual needs some additional training to 
supplement that experience because that individual is unaware of the IA rule requirements for 
food defense corrective action records.   
A qualified individual may be, but is not required to be, an employee of your facility. (21 CFR 
121.3).  To identify individuals with the necessary background to perform a particular activity, 
you should assess the activity to which you intend to assign the individual in relation to an 
individuals current level of education, training, and experience.  You should ensure that each 
individual has the necessary education, training, and experience, or combination of these, to 
properly perform the relevant activity.  Some individuals may require additional education, 
training, or experience to be qualified to perform an activity.  For example, an individual who 
has been operating a mixer in your facility prior to the implementation of a food defense plan 
would not need additional training or education on proper operation of the mixer but may require 
additional training regarding the new mitigation strategy that requires the lid of the mixer to be 
locked while the mixer is in operation because this mitigation strategy is a new requirement 
based on the food defense plan 
A. Individuals Who Perform Activities Required by Subpart C   
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An individual who performs any of the activities required under subpart C of the rule must 
satisfy the requirements to be considered a qualified individual.  As discussed above, a 
qualified individual is a person who has the education, training, or experience (or a 
combination of these) necessary to perform an activity required under subpart C, as it relates to 
their assigned duties.  For example, food defense monitoring is required by subpart C. (21 CFR 
121.140).  Therefore, an individual doing food defense monitoring must be a qualified 
individual.  We expect that many individuals doing food defense monitoring will be qualified 
through in-house training, on-the-job training, or have experience in food safety monitoring that 
can be coupled with in-house or on-the-job training for food defense monitoring.   
B. Individuals Assigned to an Actionable Process Step  
Similar to an individual who performs activities required by subpart C, an individual assigned to 
an actionable process step must be a qualified individual.  (21 CFR 121.4(b)(1)).  In addition, 
an individual assigned to an actionable process step must receive training in food defense 
awareness.  (21 CFR 121.4(b)(2)).  Food defense awareness training should describe food 
defense and explain why it is important.  Food defense awareness training should also provide 
information about what to do if an employee notices any suspicious individuals or activities.  
Food defense awareness training can take place at any location and in any format.  Facilities can 
do their own training or rely on training offered through other sources.  One option is to use the 
online course FSPCA Food Defense Awareness for the IA Rule that was collaboratively 
developed by FDA and the Food Safety Preventive Controls Alliance (FSPCA).  This training 
was designed specifically to satisfy the requirement in 21 CFR 121.4(b) and can be accessed at 
the FSPCA website. 
The diligence of employees to recognize and report suspicious activities is an important factor in 
ensuring the protection of food from intentional adulteration.  Although not all employees are 
required to have food defense awareness training, you should consider increasing general 
awareness of food defense throughout your facility.  For example, you might incorporate food 
defense awareness training into routine facility communications, such as brochures, staff 
meetings, or payroll stuffers.  You should encourage all employees to report unusual or 
suspicious individuals or activities to management.   
C. Individuals Doing or Overseeing Four Specified Activities (Food 
Defense Qualified Individuals) 
As discussed in Chapter 1, Section B.1, the preparation of the FDP, conduct of a vulnerability 
assessment, identification and explanation of the mitigation strategies, and reanalysis of the FDP 
must be performed or overseen by a food defense qualified individual.  A food defense 
qualified individual must be a qualified individual as defined in 21 CFR 121.3 and have 
successfully completed training that is considered to be at least equivalent to that received under 
a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job 
experience to perform those activities.  (21 CFR 121.4(c)).   
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The FSPCA, in collaboration with FDA, is developing and delivering standardized curriculum 
training on: the preparation of the FDP; the conduct of a vulnerability assessment, including use 
of the Key Activity Types method; the identification and explanation of the mitigation strategies; 
and reanalysis.  Information about the curriculum is located on the FSPCA website.  Note that 
your training options for the specific activities described in 21 CFR 121.4(c)(3), are not limited 
to the curriculum from FSPCA.  Any training that is at least equivalent to the standardized 
curriculum is acceptable. (21 CFR 121.4(c)(2)).    
We recognize that many individuals have experience in food defense.  It is possible to satisfy the 
training requirement to perform or oversee the four specified activities based on job experience 
that has provided an individual with knowledge at least equivalent to that provided through the 
standardized curriculum.  (21 CFR 121.4(c)(2)).  For example, if an individual has been working 
on food defense initiatives, including performing vulnerability assessments, in a facility for many 
years, that experience may render them qualified to conduct a vulnerability assessment if the 
previously conducted vulnerability assessments included all components required in the IA rule.  
Similarly, job experience identifying mitigation strategies and writing or conducting a reanalysis 
of an FDP could qualify an individual to perform those activities without training equivalent to 
the standardized curriculum.   
You have flexibility to determine how many and which people will be food defense qualified 
individuals at your facility.  For example, a facility may have two people with the training 
required to perform each of the four activities specified at 21 CFR 121.4(c)(3)).  These two 
individuals could together perform each activity or divide responsibility for them.  Another 
facility may have one person trained to prepare the FDP and perform the reanalysis, and a 
different individual trained to perform the vulnerability assessment and the identification and 
explanation of mitigation strategies.  A third facility may train four people, one person for each 
of the four activities.  A fourth facility may choose to have one person trained to perform all four 
activities.  A fifth may choose to hire consultants to perform some, or all, of these activities 
because the rule does not require that employees of the facility perform the activities.     
We are not establishing minimum standards for competency and do not intend routinely to 
directly assess the qualifications of persons who function as the food defense qualified 
individual, whether by their training or by their job experience.  Instead, we intend to focus our 
inspections on the adequacy of the food defense plan.  As necessary and appropriate, we will 
consider whether deficiencies we identify in the food defense plan suggest that the food defense 
qualified individual may not have adequate training or experience to carry out the assigned 
functions. 
 
D. Supervisors 
A supervisor assigned to an actionable process step must meet the requirements to be a qualified 
individual and must have food defense awareness training, similar to a non-supervisor assigned 
to such a step.  (21 CFR 121.4(b)).  In addition, responsibility for ensuring compliance by 
individuals with the requirements of part 121 must be clearly assigned to supervisory personnel 
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with a combination of education, training, and experience necessary to supervise the activities.  
(21 CFR 121.4(d)).  You may find that you will need multiple individuals to be responsible for 
ensuring compliance with the IA rule but, in some cases, one individual may be able to perform 
all the necessary duties to ensure compliance.  You should assess the education, training, and 
experience of your supervisory personnel to determine the provisions of the IA rule for which 
they are qualified to ensure compliance.  For example, a supervisor with education and 
experience in developing food defense plans may be the best person to supervise this activity.  In 
another example, you may identify a supervisor who has been overseeing monitoring for food 
safety purposes, and this experience would be useful for supervising food defense monitoring 
activities for the food defense plan. 
Supervisory personnel who are assigned to ensure compliance by individuals with the 
requirements of this subpart should be able to effectively assess whether individuals are 
conducting activities in a manner that complies with the IA rule.  You should ensure that your 
supervisory personnel are aware of their role in recognizing and ensuring compliance with the 
requirements of the IA rule.  You should also charge your supervisory personnel with 
recognizing when individual deviations are recurring, or are widespread among personnel, as 
either of these occurrences indicate a need to reassess the qualifications of the responsible 
individuals.  
E. Training Frequency 
Any individual performing activities that require education, training, or experience should have 
completed that education, training, or experience prior to undertaking the relevant activities.  The 
IA rule does not include specific retraining frequency requirements; however, in most cases, 
individuals conducting activities with associated requirements for education, training, and 
experience should repeat training periodically and as necessary to ensure that they are qualified 
to perform their duties.  For example, employees and supervisors may need retraining if their 
responsibilities under subpart C change because of changes to the food defense plan from a 
production change resulting in a modified or new mitigation strategy.  Another circumstance that 
may require retraining is if an individual performing an activity under subpart C is not 
performing the activity correctly.  Also, a corrective action may result in a need for retraining or 
additional training.  For example, if food defense monitoring indicates that certain mitigation 
strategies are not operating as intended, a component of the corrective action may be to retrain 
the individuals assigned to implement the mitigation strategy.  Forthcoming guidance will 
include more information about corrective actions.     
F. Training Records 
Required training must be documented in records and must include the date of training, the type 
of training, and the persons trained.  (21 CFR 121.4(e)).  There are many acceptable ways of 
documenting training, such as using a sign-in sheet provided for a group training or retaining a 
certificate of completion provided to each attendee at the end of a training.  Training records 
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must be established and maintained in accordance with the records requirements.  (21 CFR 
121.4(e)).  
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Chapter 9: Records (coming soon) 
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Appendix 1: Food Defense Plan Worksheets 
A. Introduction  
This appendix includes sample worksheets FDA developed to help facilities develop a written 
food defense plan (FDP).  There is no standardized or required format for a FDP.  Using these 
worksheets is voluntary, and using a different format for your FDP is acceptable if it includes the 
required components.  (21 CFR 121.126, 121.305, and 121.310.)  If facilities choose to use 
worksheets, abbreviations or footnotes may be used when appropriate.    
 
B. Food Defense Plan Cover Sheet 
Your facilitys FDP contains sensitive information about its vulnerabilities and mitigation 
strategies.  We recommend that you store the FDP in a secure location (either electronic or 
physical) and restrict access to the FDP.  Access to the FDP should be granted only on a need-to-
know basis; not all employees at the facility or company may need to have access to the whole 
FDP.  In some cases, you may want to provide access only to parts of the FDP.  
We also recommend that you include a cover sheet on the FDP that clearly notes that the 
information it contains is sensitive and should be protected from unauthorized access or 
disclosure.  Such a cover sheet can remind those who have access to the FDP of the need to take 
appropriate measures to protect the FDP when it is in their possession.  
1.  How to Fill in Worksheet 1-A: Food Defense Plan Cover Sheet 
The information included in Worksheet 1-A are listed and explained below.   
  Product Name(s): Provide the full name of the finished product(s). 
  Facility Name: Include the facility name. 
  Company Name: Include the company name.  
  Facility Identifier/Address: Provide a facility identifier and/or the address of the 
facility.  
  Facility Contact Information: Provide the name and contact information for someone at 
the facility who is in charge of or who can answer questions about the FDP. 
  Signature: Include the signature of the owner, operator, or agent in charge of the facility.  
  Date Signed: Provide the date that the FDP was signed. 
   
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2.  Worksheet 1-A:  Food Defense Plan Cover Sheet 
 
 
 
The information contained in the Food Defense Plan is sensitive and should be protected 
from unauthorized access or disclosure. 
 
 
 
FOOD DEFENSE PLAN 
 
PRODUCT NAME(S):__________________________________________________________ 
FACILITY NAME:____________________________________________________________ 
COMPANY NAME:____________________________________________________________ 
FACILITY IDENTIFIER/ADDRESS:_____________________________________________ 
FACILITY CONTACT INFORMATION:_________________________________________ 
SIGNATURE:_________________________________________________________________ 
DATE SIGNED:_______________________________________________________________ 
   
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C. Food Defense Plan Product Description 
Including information about the food product in your FDP helps you and others (i.e., colleagues, 
corporate officials, auditors, and investigators) know what food is included in the FDP and any 
relevant characteristics that may help better understand the FDP.  
In Chapter 2 of this guidance, we recommend that you take certain preliminary steps before 
conducting your VA.  One of these preliminary steps is to describe the product under evaluation.  
Worksheet 1-B: Food Defense Plan Product Description is similar to the FSPCA food safety plan 
form for Product Description, Distribution, Consumers, and Intended Use.  If you have already 
completed the FSPCA form for your FSP for the same food products, you may save time and 
resources by copying over the information from that worksheet to use for your FDP.    
Some of the information in the product description may not be important or necessary to inform 
your VA if you use the KAT method. This worksheet is voluntary, and you have the flexibility to 
use as much or as little of the worksheet as you choose. 
1.  How to Fill in Worksheet 1-B: Food Defense Plan Product Description  
The information included in Worksheet 1-B are listed and explained below.  Regardless of 
whether you use Worksheet 1-B, you may find that having such information is helpful in any 
product description that you develop.  
  Product Name(s): Provide the full name of the finished product.  
  Company Name, Facility Name, Address:  Include the company and facility names, 
and addresses.  
  Product Description: Describe the food productwhat it is and include descriptors such 
as packaging type.  
  Ingredients: List the ingredients used to make the food product.   
  Intended Use: Describe the intended use of the food product, e.g., for retail, foodservice, 
or further processing. 
  Intended Consumers: Describe the intended end consumer, if known, of your product.  
Usually this would be the general public; however, some food product is intended 
specifically for specific populations such as those in hospitals, infants, or the elderly.  
  Storage and Distribution: Describe the nature of how the food is stored and distributed 
into the marketplace (e.g., speed of distribution from processor to consumer; local, 
regional, national, or global distribution patterns).  
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2.  Worksheet 1-B: Food Defense Plan Product Description 
PRODUCT NAME(S):_________________________________________________________  
COMPANY NAME: __________________________________________________________ 
FACILITY NAME: ___________________________________________________________  
ADDRESS: __________________________________________________________________ 
 
Product Name(s)   
Product Description   
 
 
Ingredients   
 
Intended Use    
 
 
Intended Consumers   
 
Storage and   
Distribution 
 
 
 
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D. Food Defense Plan Vulnerability Assessment [Updated March 2019]9 
In Chapter 2 of this guidance, we provide guidance on how to conduct a vulnerability assessment 
[to identify significant vulnerabilities and actionable process steps by using Key Activity Types, 
by evaluating the three fundamental elements, or a hybrid of both (See Chapter 2, Sections 2.E, 
2.F- G, and 2.H, respectively).]  The VA must be written (21 CFR 121.126(b)(1)), and 
Worksheet 1-C can assist you in conducting and documenting your VA.  Even if you do not use 
Worksheet 1-C, we recommend that you include similar information in your VA documentation. 
1.  How to Fill in Worksheet 1C: Vulnerability Assessment Analysis Summary 
Once you have assembled the Food Defense Team and started gathering the information you will 
use in your VA, we recommend that you create a document that you will use to organize the 
vulnerability assessment results.  Below is a description of each of the columns in the VA 
analysis summary worksheet and how you should fill them out to document your VA.  In 
Chapter 2.E of this guidance, we provide an example of a completed VA analysis summary 
worksheet for a VA using the KAT method.   
(1) Number (#):  Number each process step from your process flow diagram.  
(2) Process Step: List the name of each of the process steps.  We recommend that you 
draw out a process flow diagram or use an existing process flow diagram as a 
preliminary step.  If you already have this process flow diagram completed, simply 
list the names of the process steps in each row of this column.  
(3) Process Description: Describe the process step.  We have found it helpful to include 
a short description of what each process step involves so that when you are 
conducting the VA you have the background information you would need to justify 
whether it presents a significant vulnerability.  Additionally, if mitigation strategies 
are required at this process step, information about the process step can assist with 
identifying and implementing the mitigation strategies.   
(4) Vulnerability Assessment Method: Note the methodology that was used to conduct 
the VA.  For example, if you used FDAs Key Activity Type methodology as 
described in Chapter 2.E of this guidance, then you will write Key Activity Types 
in this column.  [If you used the three fundamental elements or the hybrid approach, 
as described in Chapter 2.F-G and H, respectively, of this guidance, then you will 
write Three Fundamental Elements or Hybrid Approach in this column.] 
(5) Explanation: Include the reasons that led to the conclusions of your VA (i.e., the 
reasons for the Yes/No conclusions listed in column (6) for each process step).  Your 
                                                 
9 Revisions were made to the text in the introduction and D.1 sections, and denoted by [...].  
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VA must include an explanation as to why the process step was or was not identified 
as an actionable process step.  (21 CFR 121.130(c)).  Explaining your reasons for a 
No conclusion can be just as important as explaining your reasons for a Yes 
conclusion.  Including more details in this column will help you during your own 
review of your FDP and during review of your FDP by others  e.g., if an inspector or 
auditor questions why a process step was not identified as an actionable process step.  
Having the appropriate amount of detail for the explanations in this column will also 
help you during a reanalysis of your FDP.    
(6) Actionable Process Step: Record the conclusions of your vulnerability assessment 
for the process step as Yes if that process step has a significant vulnerability and is 
an actionable process step, or No if that process step is not an actionable process 
step.  
 
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2.  Worksheet 1-C: Vulnerability Assessment Analysis Summary 
PRODUCT(S): ____________________________________________________________________________________ 
FACILITY NAME: ________________________________________________________________________________ 
ADDRESS: _______________________________________________________________________________________ 
SIGNED DATE:___________________________________________________________________________________ 
(1)  (2)  (3)  (4)  (5)  (6) 
#  Process Step   Process Description  Vulnerability  Explanation  Actionable Process 
Assessment Method    Step 
           
 
           
 
 
 
 
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[New March 2019] 
In Chapter 2.F.2.a.i, we provide guidance on how to calculate volume of food at risk to inform 
your public health impact estimate if you conduct a VA using the three fundamental elements to 
identify significant vulnerabilities and actionable process steps.  The VA must be written (21 
CFR 121.126(b)(1)), and Worksheet 1-D can assist you in conducting and documenting your 
VA.  You can use Worksheet 1-D to organize your calculation of volume of food at risk.  
Regardless of whether you use Worksheet 1-D, we recommend that you include such 
information in your VA documentation if you use the volume of food at risk method to estimate 
potential public health impact.   
3.  How to Fill in Worksheet 1-D: Calculating Volume of Food at Risk 
The information included in Worksheet 1-D is explained below, along with recommendations on 
how to use this information to estimate the volume of food at risk if a contaminant were added to 
food at a particular point, step, or procedure.     
A.  Process Step: Provide the name of each of the process steps from the process flow 
diagram or other source.   
B.  Batch Size: Provide an estimate of the amount of product held or processed at the 
process step.  The batch size is usually the volume of the process steps operation 
(e.g., the volume of food in a mixer or tank, or the amount of product in a constant 
flow process).  For constant flow process steps, batch size is the amount of product 
you determine an attacker could contaminate, given the time the attacker would have 
to add a contaminant to a constant flow process and the flow rates of product at that 
step.   
C.  Amount of Product (Ingredient) in Final Serving:  Provide the amount of the 
product being processed at the step under evaluation in the final consumable serving.  
For process steps that involve single ingredient products or that occur after all 
ingredients are added to the product line, this is likely the same as the serving size.  
For process steps that involve an ingredient, the amount of the ingredient in the final 
serving would not be the same as the serving itself.  For example, the amount of 
concentrated fruit juice in a final serving of 8 ounces of fruit juice might be 0.8 
ounces.   
The column is used to calculate the number of finished servings an ingredient may 
affect if that ingredient were intentionally adulterated.  You should consult your 
finished product formulations to determine the amount of product (ingredient) in final 
servings.   
D.  Servings per Batch: Divide the value in Column B by the value in Column C.  This 
number is the estimate of the volume of food at risk.   
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E.  Score from Table 1: Provide the number from the Score column in Table 1(See 
Chapter 2, Section F.2 of this guidance) associated with the servings per batch from 
Column D in this worksheet.  For example, if Column D in this worksheet shows 3,000 
servings per batch, then you would determine that it corresponds to a score of 8 in Table 
1.  The score from Column E of this worksheet goes into Column 4 (Element 1) in 
Worksheet 1-F.    
F.  Notes: Provide any information that would assist review of this VA, such as how 
batch size was calculated. 
 
   
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4.  Worksheet 1-D: Calculating Volume of Food at Risk 
A  B  C  D  E  F 
Process  Batch  Amount of  Servings per  Score from  Notes 
Step  Size  Product  Batch  Table 1 
(Ingredient) in   
Final Serving  B  C 
 
           
           
   
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In Chapter 2.F.2.a.ii, we provide guidance on how to calculate potential public health impact 
using a representative contaminant, if you conduct a VA using the three fundamental elements to 
identify significant vulnerabilities and actionable process steps.  The VA must be written (21 
CFR 121.126(b)(1)), and Worksheet 1-E can assist you in conducting and documenting your VA.  
You can use Worksheet 1-E to organize your calculation of public health impact using a 
representative contaminant.  Regardless of whether you use Worksheet 1-E, we recommend that 
you include such information in your VA documentation if you use the representative 
contaminant method to estimate potential public health impact.   
5.  How to Fill in Worksheet 1-E: Calculating Potential Public Health Impact using 
a Representative Contaminant  
You can use Worksheet 1-E to organize your potential public health impact estimate using a 
representative contaminant.  Regardless of whether you use Worksheet 1-E, we recommend that 
you include such information in your VA documentation if you use this method to estimate 
potential public health impact.   
The information included in Worksheet 1-E is explained below, along with recommendations on 
how to use this information to calculate potential public health impact using a representative 
contaminant if a contaminant were added to food at a particular point, step, or procedure.  For 
Columns A  D, please see descriptions provided in How to Fill in Worksheet 1-D: Calculating 
Volume of Food at Risk.  
E.  Mortality Rate of Representative Contaminant: We use an LD50 value to calculate 
the dose needed per serving (See Column I); therefore, the mortality rate value is 50%.  
The representative contaminant approach relies on this value to estimate potential public 
health impact.   
F.  Number of Potential Deaths: Multiply the value of Column D by the value of 
Column E (D x E). 
G.  Score from Table 1: Provide the number from the Score column in Table 1 (See 
Chapter 2, Section F.2 of this guidance).  Determine into which Description from Table 
1 the number of potential deaths from Column F in this worksheet fits and then find the 
corresponding Score in Table 1.  For example, if Column F in this worksheet shows 
3,000 potential deaths, then you would determine it fits into the Table 1 Description of 
Potential public health impact between 1,001  10,000 (acute illness or deaths), or 1,001 
 10,000 servings at risk which corresponds to a score of 8.  The score from column G 
of this worksheet goes into Column 4 (Element 1) in Worksheet 1-F.   
H.  Notes:  Provide any information that would assist during review of this VA. 
I.  Representative Contaminant Dose Needed per Serving: We use the value of 40 
milligrams per serving.  We derived this dose value, in consultation with our interagency 
governmental partners, from the LD50 data of a compilation of potential contaminants 
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that are applicable to food.  LD50 is typically expressed in dose per kg body weight.  We 
converted this into a dose per serving value based on a typical adult body weight of 85 
kg.  
J.  Amount of Representative Contaminant Needed per Batch: Multiply the value in 
Column D by the value in Column I (D x I).  This will provide the total amount of 
contaminant the attacker needs to intentionally adulterate the food at this process step to 
achieve wide scale public health harm.  This estimate informs the amount of the 
contaminant the attacker needs to carry out the attack, which is a component of Element 
3. 
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6.  Worksheet 1-E: Calculating Potential Public Health Impact Using a Representative Contaminant  
 
Element 1 Calculations using Representative Contaminant  Element 3 Calculations 
A  B  C  D  E  F  G  H  I  J 
Process  Batch Size  Amount of  Servings  Mortality Rate  Number of  Score  Notes  Representative  Amount of 
Step  Product  per Batch  of Contaminant  Potential  from  Contaminant Dose  Representative 
(Ingredient) in  B  C  (FDA provided  Deaths   Table 1  Needed per Serving  Contaminant 
Final Serving  value = 50%)  D x E  (FDA provided value  Needed per Batch 
= 40 milligrams)  D x I 
                   
                   
 
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In Chapter 2.F.2.a.iii, we provide guidance on how to calculate potential public health impact 
using a contaminant-specific analysis, if you conduct a VA using the three fundamental elements 
to identify significant vulnerabilities and actionable process steps.  The VA must be written (21 
CFR 121.126(b)(1)), and Worksheet 1-E can assist you in conducting and documenting your VA.  
You can use Worksheet 1-E to organize your calculation of public health impact using a 
contaminant-specific analysis.  Regardless of whether you use Worksheet 1-E, we recommend 
that you include such information in your VA documentation if you use the contaminant-specific 
analysis method to estimate potential public health impact.   
 
How to Fill in Worksheet 1-E: Calculating Potential Public Health Impact using a 
Contaminant-Specific Analysis  
Calculating potential public health impact using specific contaminants is essentially the same as 
using the representative contaminant approach.  The calculation should be repeated for each 
contaminant considered.  The contaminant with the largest estimated public health impact should 
be used to identify the appropriate score from Table 1 in Chapter 2 of this guidance, as this is the 
estimate that adequately captures the full extent of the potential public health impact.  To use 
Worksheet 1-E in considering individual contaminants, you should use values you have 
determined are appropriate to the analysis.  At a minimum you will need to update the following 
Columns from Worksheet 1-E: 
E.  Mortality Rate of Contaminant: Provide the mortality rate for the specific contaminant.  
If an LD50 value is used to calculate the dose per serving, 50% should be placed in this 
Mortality Rate column.  The mortality rate should be from the same source (e.g., scientific 
literature) used for the contaminant dose needed per serving calculation.    
H.  Notes: Provide any information that would assist during review of this VA, such as the 
source of information for the contaminant under evaluation, including characteristics and 
toxicity information.  
I.  Contaminant Dose Needed Per Serving: Provide an estimated contaminant dose per 
serving derived from oral toxic dose information found in scientific literature.  The value is 
typically reported as the dosage per kilogram of bodyweight, which is then converted to a 
dose per serving.  For example, if a substance has a reported LD50 of 1 mg/kg and you 
assume a typical adult male weighs 85 kg, then the LD dose is 85 kg * 1 mg/kg = 85 
mg/serving.  Only oral routes of exposure should be considered.   
Estimating Morbidity for the Contaminant-Specific Analysis 
If you perform a contaminant-specific analysis, you could choose to include estimates of acute 
morbidity (i.e., acute illnesses) and mortality in your Element 1 evaluation.  Columns E, I, and J 
in Worksheet 1-E could be used for morbidity by replacing the mortality-specific information 
with morbidity-specific information.  Morbidity and mortality estimates should then be added 
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together, and this sum entered into Column F.  The score in Column G will be based on the 
summed estimate from Column F.  
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In Chapter 2, Sections F and G of this guidance, we provide guidance on how to conduct a 
vulnerability assessment using the three fundamental elements to identify significant 
vulnerabilities and actionable process steps.  The VA must be written (21 CFR 121.126(b)(1)), 
and Worksheet 1-F can assist you in organizing information related to the three fundamental 
elements.  Regardless of whether you use Worksheet 1-F, we recommend that you include 
similar information in your VA documentation.   
7.  How to Fill in Worksheet 1-F: Identifying Significant Vulnerabilities and 
Actionable Process Steps using the Three Fundamental Elements  
The information included in Worksheet 1-F is explained below, along with recommendations on 
how to use this information to determine actionable process steps using the three fundamental 
elements.       
(1) Number (#):  Provide a number for each process step evaluated, e.g., process steps 
from a process flow diagram.   
(2) Process Step: Provide the name of each of the process steps. 
(3) Process Step Description: Explain what happens at the process step under 
evaluation.    
(4) Element 1: Score and Rationale: Provide the score that corresponds to the potential 
public health impact if a contaminant were added at the relevant process step.  Also 
include an explanation or notes on why you chose this score for the process step.  See 
Chapter 2, Section F.2 for possible methods to estimate the public health impact and 
how to score this element using Table 1. 
(5) Element 2: Score and Rationale: Provide the score that corresponds to the degree of 
physical access to the product at the relevant process step.  Also include an 
explanation or notes on why you chose this score for the process step.  See Chapter 2, 
Section F.3 for a possible method to estimate the degree of physical access to the 
product and how to score this element using Table 2.    
(6) Element 3: Score and Rationale: Provide the score that corresponds to the ability of 
an attacker to successfully contaminate the product at the relevant process step.  Also 
include an explanation or notes on why you chose this score for the process step.  See 
Chapter 2, Section F.4 for a possible method to estimate the ability of an attacker to 
successfully contaminate the product and how to score this element using Table 3.   
(7) Sum: Calculate the sum of the scores entered in Columns 4 - 6.   
(8) Explanation: Explain why you determined that the point, step, or procedure is or is 
not an actionable process step, based on the evaluation of the three fundamental 
elements and the rationale as to the element scores.    
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(9) Actionable Process Step: Indicate Yes or No regarding whether the process step 
is an actionable process step.  If you organize your vulnerability assessment by using 
Worksheet 1-C, you would have the same response for this column and Column 6 of 
that worksheet because both columns indicate whether a step is an actionable process 
step.  
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8.  Worksheet 1-F: Identifying Actionable Process Steps Using the Three Fundamental Elements 
PRODUCT(S): ____________________________________________________________________________________ 
FACILITY NAME: ________________________________________________________________________________ 
ADDRESS: _______________________________________________________________________________________ 
DATE SIGNED:___________________________________________________________________________________ 
 
 
(1)  (2)  (3)  (4)  (5)  (6)  (7)  (8)  (9) 
#  Process  Process Step  Element 1:  Element 2:  Element 3:  Sum  Explanation  Actionable 
Step   Description   Score and  Score and  Score and    Process 
Rationale  Rationale  Rationale  Step 
 
                 
                 
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E. Food Defense Plan Mitigation Strategies 
Chapter 3 of this guidance provides detailed guidance on identifying and implementing 
mitigation strategies for the actionable process steps identified during the vulnerability 
assessment.  The IA rule requires that mitigation strategies and their accompanying explanations 
be written (21 CFR 121.135(b)), and Worksheet 1-H can assist you in creating that 
documentation.  Regardless of whether you use Worksheet 1-H, we recommend that you include 
similar information in your mitigation strategies documentation in the FDP. 
1.  How to Fill in Worksheet 1-H: Mitigation Strategies  
Below is a description of each of the columns in this worksheet and how you should fill them out 
to document your mitigation strategies and explanations.  
(1) Number (#):  Include the numbers for the process steps identified as actionable process 
steps during the vulnerability assessment.  If you used Worksheet 1-C to document the 
vulnerability assessment, you should only carry over to this worksheet those process 
steps that have a Yes in column (6) Actionable Process Step.  Note that this column 
may not include every consecutive number (e.g., 1 through 20) used in Worksheet 1-C 
unless every process step has been identified as an actionable process step.  If you 
identify and implement more than one mitigation strategy for an actionable process step, 
we recommend that you use a numbering system such as 1a, 1b, 1c to denote this, with 
the first mitigation strategy for process step 1 being 1a, the second mitigation strategy 
being 1b, and so on.  This will make it easier to connect the mitigation strategies with the 
appropriate process steps as you work through the other worksheets within this appendix, 
and it will help you keep track of the management components for each mitigation 
strategy.   
(2) Actionable Process Step:  Insert the process step names that correspond to the process 
step numbers in column (1) identified as actionable process steps during the vulnerability 
assessment.  If you used Worksheet 1-C to document the vulnerability assessment, you 
can copy over the process steps from column (2) of Worksheet 1-C.   
(3) Mitigation Strategy: Include the mitigation strategy identified for implementation at the 
applicable actionable process step.   
(4) Explanation: Provide the explanation(s) for how the mitigation strategy sufficiently 
minimizes or prevents the significant vulnerability associated with the actionable process 
step.  See Chapter 3 of this guidance for detailed guidance on how to write this 
explanation.  
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2.  Worksheet 1-H: Mitigation Strategies 
PRODUCT(S): ____________________________________________________________________________________ 
FACILITY NAME: ________________________________________________________________________________ 
ADDRESS: _______________________________________________________________________________________ 
SIGNED DATE:___________________________________________________________________________________ 
(1)  (2)   (3)  (4) 
#  Actionable Process Step   Mitigation Strategy   Explanation 
       
 
       
 
       
 
 
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F. Food Defense Plan Mitigation Strategies Management Components 
As appropriate to ensure the proper implementation of the mitigation strategies, taking into 
account the nature of each mitigation strategy and its role in the facilitys food defense system, 
you must have mitigation strategy management components (i.e., written procedures for food 
defense monitoring, food defense corrective actions, and food defense verification) for each 
mitigation strategy (21 CFR 121.138).  Worksheet 1-I will assist you in documenting your 
mitigation strategy management components.  Regardless of whether you use Worksheet 1-I, we 
recommend that you include such information in your food defense monitoring, food defense 
corrective actions, and food defense verification procedures documentation in your FDP.  
Chapter 4 of this guidance includes guidance on food defense monitoring.  Guidance related to 
food defense corrective actions and food defense verification is forthcoming.  
1.  How to Fill in Worksheet 1-I: Mitigation Strategies Management Components  
Below is a description of each of the columns in this worksheet and how you should fill them out 
to document your mitigation strategies management components procedures.  
(1) Number (#):  Include the process step numbers for the process steps identified as 
actionable process steps during the vulnerability assessment.  If you used Worksheet 
1-H to document the mitigation strategies, you should carry over the process step 
numbers from column (1) of that worksheet.    
(2) Actionable Process Step:  Insert the process step names that correspond to the 
process step numbers in column (1).  If you used Worksheet 1-H to document the 
mitigation strategies, you should copy over the process steps from column (2) of that 
worksheet.   
(3) Mitigation Strategy: Include the mitigation strategy identified for each of the 
actionable process steps.  If you used Worksheet 1-H to document the mitigation 
strategies, you can copy over the mitigation strategies from column (3) of that 
worksheet.  
(4) Food Defense Monitoring Procedure and Frequency: Provide the food defense 
monitoring procedures for each mitigation strategy as well as the frequency with 
which the procedure will be performed.  See Chapter 4 of this guidance for detailed 
guidance on food defense monitoring procedures.    
(5) Food Defense Corrective Action Procedures: Provide the food defense corrective 
action procedures for each mitigation strategy.   
(6) Food Defense Verification Procedures: Provide the food defense verification 
procedures for each mitigation strategy.   
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(7) Records: List the names of the records that will document the implementation of the 
mitigation strategies management components (e.g., cleaning/sanitizing records, 
monitoring records, security patrol records, corrective action records, verification 
records).
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2.  Worksheet 1-I: Mitigation Strategies Management Components 
PRODUCT(S): ____________________________________________________________________________________ 
FACILITY NAME: ________________________________________________________________________________ 
ADDRESS: _______________________________________________________________________________________ 
SIGNED DATE:___________________________________________________________________________________ 
(4)  (5)  (6)  (7)  
(2)  
(1)  (3)  Monitoring  Corrective Action  Verification  Records 
Actionable Process 
#  Mitigation Strategy   Procedure and  Procedures  Procedures 
Step  
Frequency 
             
 
             
 
 
 
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Appendix 2: Mitigation Strategies in the Food Defense Mitigation 
Strategies Database (coming soon) 
   
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Appendix 3: Calculating Small Business and Very Small Business Sizes 
(coming soon) 
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Appendix 4: Vulnerability Assessment Examples [New March 2019] 
A. Example of a Vulnerability Assessment Using the Three Fundamental 
Elements  
Figure 2b-1 is a sample process flow diagram for a fictional breaded morsel product.  Figure 2b-
2 is an example of a VA conducted using the fictional breaded morsel product at a fictional 
facility.  Figure 2b-3 is an example of rank ordering process steps after each element is scored 
and those scores are summed.  Figure 2b-2 illustrates scoring of the fundamental elements using 
Tables 1-3 in Chapter 2 of this guidance, and demonstrates the flexibility and range of 
information you can include.  For instance, you may choose to include detailed information in 
your element score and rationale boxes (i.e., Columns 4-6), and only summarize this in the 
explanation box (Column 8), or you could provide more information in the score and rationale 
boxes and just reference those in the explanation box.  Figure 2b-2 also illustrates a variety of 
approaches such as footnotes, referencing other worksheets you may have used, referencing 
previous scoring of identical process steps, and consolidating into a single scoring evaluation 
different processes that are conducted by integrated equipment (e.g., cutting and forming in this 
example); you may find these strategies helpful in reducing the time needed to conduct your VA. 
 
You are not required to use the worksheet in Figure 2b-2 or the rank ordering in Figure 2b-3 to 
organize your VA.  How you capture and organize your VA information is up to you; however, 
your food defense plan must include information required by 21 CFR 121.130.  
   
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Figure 2b-1. Three Fundamental Elements VA Example  Breaded Morsel Process Flow 
Diagram  
1 Bulk Dry Ingredient  2 3 Packaged Ingredient 
Bulk Liquid Receiving
Receiving Receiving
4 5 6 7
Bulk Dry Storage Bulk Liquid Storage Dry Storage Refrigerated Storage
8 10 9 Minor Ingredient 
Water Mixer
Preparation
11
Belt Conveying
12
Rolling
13
Cutting
14
Forming
16 15
Vitamin Application Vitamin Tank
17
Breading
18
Cooking
19
Cooling
20
Bucket Conveying
21
Weighing
22
Packaging
23
Metal Detection
24
Casing
25
Palletizing
26 27
Finished Product Storage Outbound Loading
 
 
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Figure 2b-2. Three Fundamental Elements VA Example - Worksheet 1-F  Breaded Morsels 
 
(1)  (2)  (3)  (4)  (5)  (6)  (7)  (8)  (9) 
#  Process  Process Step  Element 1:  Element 2:  Element 3:  Sum  Explanation1  Actionable 
Step   Description  Score and Rationale  Score and Rationale  Score and Rationale    Process 
  Step 
1  Bulk Dry  Trucks arrive, enter a  Score = 10  Score = 8  Score = 1  N/A3  No significant  No 
  Ingredient  receiving bay, and dump bulk  vulnerability is present 
Receiving  dry ingredients into a  One truck typically  This area is accessible from  The amount of a representative  because Element 3 = 1.   
collector where an auger  contains 50,000 lbs. of  outside the facility when the  contaminant was determined 
  conveyor moves the  bulk dry ingredient. Each  receiving bay doors are  using Worksheet 1-E.2  It is not 
ingredients into the storage  serving of the finished  open. Additionally, there is  feasible to introduce the amount 
  silo.   product includes 4 oz. of  easy access to the collector  of agent required to contaminate 
the ingredient. Using  when the ingredients are  the entire batch undetected. The 
Usually one employee  FDAs representative  being unloaded.   auger conveyor does not mix the 
performs unloading activity.  contaminant approach, this  ingredient. Any contaminant 
The entire receiving process  will result in  would be conveyed as a 
takes approximately fifteen  approximately 200,000  concentrated slug and would not 
minutes. Facility procedures  servings. Successful  be distributed throughout the 
allow truck drivers to remain  contamination at this  product.   
in the area, but not to  process step would result 
participate in unloading  in 100,000 deaths.2 
activity. 
2  Bulk Liquid  Bulk liquid is received at the  Score = 10  Score = 8  Score = 8  26  This step is  Yes 
Receiving4  receiving bay in tanker trucks.  significantly 
Upon receipt, venting hatches  Contamination at this  Vent and sampling hatches  When multiple trucks are in the  vulnerable.  If 
at the top of the vehicle are  process step could result in  are opened before unloading    receiving bay (which is not  successfully 
opened and hoses are attached  80,000 deaths.  See  Hoses are accessible when  uncommon), it is difficult for  contaminated, it is 
to the back of the vehicle.  Worksheet 1-E for  not in use.  Open hatches  other workers in the area to  anticipated that the 
Facility procedures allow  calculations.2  provide a means of access to  observe opening of vent hatches  result would be a very 
truck drivers to remain in the  the food.  This area is  and hooking-up of hoses.  A  large public health 
area but not to participate in  accessible by anyone already  contaminant added to either the  impact. An intentional 
unloading activity. The entire  in the facility.  vent or the hose itself would  contamination by an 
receiving process takes  mix with the food during  insider at this step 
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approximately thirty minutes.  unloading and pumping to the  would not be prevented 
One truck typically contains  storage tank.  by any inherent 
5,000 gallons of liquid  characteristics of this 
ingredient.  step.  Observation of 
this process is low 
since the design of the 
receiving bay presents 
5
visual obstructions.  
3  Packaged  Packages of secondary  Score = 5  Score = 3  Score = 3  11  No significant  No 
Ingredient  ingredients such as seasoning  vulnerability is present 
Receiving  (salt, spices), dehydrated  Bags of seasoning were  Product here is wrapped in  Pallets are moving quickly via  because score < 14.  
minced onions and garlic, and  used as the representative  multiple layers of packaging  forklift to storage and under   
premixed breading are  product for this step6.   or wrapping and generally  constant observation of the 
received via truck in 50 lb.  Due to the movement of  not accessible (i.e., hardly  forklift operator, but a pallet 
bags on shrink-wrapped  the pallets, as described in  accessible).  Only if shrink- may sometimes be left in the 
pallets.  Product is moved  the Element 3 rationale for  wrap has a gap in its  receiving area for a short time if 
directly to storage via forklift.  this step, it was  coverage would potential  quality testing is performed.  An 
determined that only 1 bag  access exist for an inside  attacker would have to conduct 
could potentially be  attacker to try and rip or  irregular/suspicious activities to 
available for  puncture a bag.    contaminate a bag on a pallet 
contamination (such as if  that is being held in the 
there was a gap in the  Even if there was a gap in  receiving area.  Surrounding 
shrink-wrap).  A single 50  the wrapping, an inside  workers would make it highly 
lb. bag will generate 800  attacker would need  likely that an inside attacker 
finished product servings  specialized tools to access  attempting to introduce a 
(1 oz.  of  the food (knives, syringes, or  contaminant into a bag would be 
seasoning/serving). This  other way to penetrate the  detected, even if the attacker 
will result in 400 potential  packages).   were the quality control 
2 manager taking samples.  It 
deaths.  
  would be difficult to introduce a 
contaminant into the small tear 
in the bag used for QC testing 
without significantly deviating 
from the established normal 
sampling process and engaging 
in suspicious behavior.  
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4  Bulk Dry  Bulk dry ingredient is stored  Not assessed because  Score = 10  Score = 1  N/A  No significant  No 
Storage  in large silos and then  Element 3 score = 17  vulnerability is present 
pneumatically conveyed to  Access to the silo is easily  It would be extremely difficult,  because Element 3 = 1. 
the mixer.  achieved from an attached  if not impossible, to carry 
ladder on the side that is  enough contaminant up the silo 
accessible from the exterior  ladder to introduce into the 
of the building. A  food.2  No mixing occurs at this 
maintenance hatch is at the  step.  A contaminant added to 
top of the silo.    the silo would proceed through 
the system as a concentrated 
lump but would not be spread 
across a large number of 
servings. 
5  Bulk Liquid  Bulk liquid is stored in two  Score = 10  Score = 8  Score = 8  26  This step is  Yes 
Storage  10,000 gallon tanks.  These  significantly vulnerable 
two tanks are assessed as one  Bulk storage tanks hold  An unsecured hatch at the  It would be possible for an  because the score > 25.  
step because they are of the  enough liquid ingredient  top of the tank provides  attacker to bring enough 
same equipment design, and  to generate a public health  access to the food in the  contaminant into the area to 
are located together in an  impact of well over 10,000  tank.  An attacker would  introduce it into the tank 
isolated part of the facility.   deaths if successfully  need to climb a ladder to  without being detected.2  Tanks 
Liquid ingredient is typically  contaminated.2  reach the hatch at the top of  are agitated so if a contaminant 
held for up to 48 hours prior  the tank.  was added to the empty tank, it 
to processing.  Tanks are    would be mixed into the food 
agitated to prevent separation  when food is reintroduced. 
of the liquid ingredient. 
6 & 7  Dry Storage  These process steps are being  Score = 5  Score = 3  Score = 3  11  While the public health  No 
assessed together since the  impact is 
Refrigerated  conditions are essentially  We believe that because of  Bags of ingredients are still  It would be difficult for an  approximately 600 
Storage  identical.  The only difference  the way the bags are  sealed and any attempt to  inside attacker to introduce  potential deaths, there 
is that the refrigerated storage  stored in the shelves, an  access would likely leave  enough contaminant into a bag  is a moderately low 
room is chilled to 41 degrees.  attacker would only  indications of tampering.   in a way that would not be  ease of attack at this 
realistically be able to  When stored on the shelves,  readily identified as  step.  Sealed bags also 
Pallets from dry and  contaminate the food in  it is difficult to physically  suspicious.2  The attacker  present significant 
refrigerated receiving are  the 3 bags on the top row  access the bags because the  would have to remove some  access limitations to 
moved into their respective  of an unwrapped pallet.   pallets are shrink-wrapped.   ingredient from the bag to  any attacker trying to 
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storage rooms.  Pallets may  Three bags would generate  There may be cases where a  introduce sufficient volumes of  introduce a 
be broken down, but bags are  approximately 600  single pallet has been stored  contaminant.  There is a high  contaminant.9 
not opened in the storage  potential deaths.2  on the floor.  An attacker  chance any attempt to introduce 
rooms.  Partially used bags  could potentially access the  a contaminant to the bags would 
are not returned into storage.  top 3 bags on the pallet, but  be detected.  This is not scored 
this would likely result in  as a 1 because we consider that 
  evidence of tampering.  the inside attacker could 
successfully introduce a 
contaminant if given enough 
time. 
8  Water  Municipal water is pumped  Not assessed because  Score = 1  Not assessed because Element 2  N/A  See Element 2  No 
directly into the mixer.  The  Element 2 score = 1.  score = 1.  rationale.  
facility does not hold or treat  The water system is fully 
water on-site.  enclosed and pressurized 
(inherent characteristics).  
Therefore, this step is not 
accessible.   
9  Minor  Dry ingredients (e.g. spices,  Score = 8  Score = 10  Score = 8  26  The public health  Yes 
Ingredient  salt, onions, garlic) are  impact is high.  Open 
Preparation  prepared by hand in advance  Ingredients are measured  Minor ingredients are easily  Ingredient prep technicians are  and accessible 
of their introduction to the  and prepped for inclusion  accessible because they are  some of the most senior  ingredients are 
mixer. The preparation area is  into the mixer so at any  staged in open bins with no  members of the staff and  available to an inside 
in a separate room, but not  one time, at least 1 mixers  inherent characteristics to  extremely unlikely to act as an  attacker.  No inherent 
secured and easily accessible  worth of minor ingredients  limit access.     attacker  but unless they are  characteristics limit 
to many employees, including  will be measured and  actively prepping the  access, and ingredients 
those who are not responsible  staged-- but it is common  ingredients, the ingredient prep  are unobserved for 
for ingredient preparation.  for 3-4 mixers worth to  technicians are typically not in  extended times.5 
Tamper-evident bags are  be staged.  Four mixer  the prep room.  It would be 
opened and ingredients are  batches were used as a  relatively easy for an insider to 
weighed, measured, and  potential target for  add a sufficient volume of 
staged for addition to the  adulteration to estimate  contaminant to the staged bins.2  
primary product stream at the  the public health impact.   The attacker would have to act 
mixer. The staged ingredients  A mixers worth of minor  with minimal stealth to select a 
can sit out for up to two hours  ingredients would  time when an ingredient prep 
before use. These activities  potentially yield 1,600 
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are performed by the  deaths and four mixers  technician was not in the room 
ingredient prep technician.  worth would result in  to introduce a contaminant. 
There are approximately 4-5  6,400 deaths.2 
ingredient prep technicians  Staged minor ingredients may 
who perform this function  sit for extended times while 
during their respective shifts.   awaiting inclusion to the mixer. 
10  Mixer  Measured minor ingredients  Score = 8  Score = 8  Score = 8  24  The public health  Yes 
are taken from the ingredient  impact is 1,600 deaths.  
preparation room and added  2,000 lbs. of dough is  The mixer has an unsecured  It would be relatively easy for  Mixer provides 
by hand to the mixer. Bulk  mixed at a time.  A  lid and the mixer operator  an inside attacker to introduce a  elevated levels of 
liquid ingredients are pumped  finished 12 oz. serving of  periodically opens the lid to  sufficient volume of  access.  An insider 
directly from the bulk liquid  morsels has 10 oz. of  check on the status of  contaminant to the product  would be able to 
storage tank and computer- dough.  3,200 finished  mixing.  The mixer is on the  during mixing either during the  introduce a 
metered into the mixer. Bulk  product servings are  primary production floor and  introduction of minor  contaminant, but it 
dry ingredients are  present in the mixer per  anyone in the facility can  ingredients or during the mixing  would require a 
automatically fed from the  batch.  This would result  enter the area.  stage.2  The mixer operator is  moderate degree of 
dry storage silo into the  in potentially 1,600  not constantly in the area, and  stealth to do so.  The 
mixer, also via computerized  deaths.2  there are times when the mixer  ingredients are mixed 
metering. The mixer  area is not under observation.  at this step so the entire 
combines ingredients with  batch would be evenly 
water into a uniform mixture.  contaminated. 
Batch size of the mixer is 
2,000 lbs. Mixing takes 
approximately 30-45 minutes.  
11  Belt Conveying  Product is pumped from the  Score = 5  Score = 8  Score = 3  16  Despite an elevated  No 
mixer onto a flat belt  degree of access at the 
conveyor where it is  Given our Element 3  Rollers are open and  No mixing occurs at this step  conveyors, high levels 
conveyed to the rollers for  estimation that an inside  accessible to any person  and the application of a  of observation in the 
flattening.  The line speed of  attacker could stand at this  within the facility.  The  sufficient volume of  surrounding area mean 
the belt conveyor is 100 lbs.  step for three minutes, this  railing provides a minor  contaminant would have to  that an inside attacker 
per minute.  The distance of  period would place 300  amount of separation  occur over an extended period  would need to act with 
the belt conveyor is  lbs. of food at risk, which  between the conveyor and  to contaminant many servings.2   great stealth to add a 
approximately 50 feet, but it  would generate 480  worker movement paths.  An  Multiple workers in the area can  contaminant at this 
is in a highly visible location  finished servings.  This  inside attacker would have to  observe the equipment, making  step.  Any contaminant 
in an area with many  would result in the  enter the area beyond the  it difficult for an inside attacker  would be limited to the 
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employees with a high degree  potential to generate 240  railing or reach over the  to contaminate the food without  surface of the mixture 
of observation of the  deaths.2   railing to introduce a  being detected.  We estimate  and not be incorporated 
surrounding area. A railing is  contaminant.  that an inside attacker would  into the product.  
present to prevent personnel  only be able to stand at the  Mixing does not occur 
from accidentally bumping  conveyor and add a contaminant  at this step or 
into the conveyor.  for three minutes without being  subsequent steps. 
detected.  Additionally, an 
inside attacker reaching over or 
entering the area beyond the 
railing would be noticeable and 
suspicious. 
12  Rolling  Product is pumped from the  Score = 5  Score = 5  Score = 3  13  Inherent characteristics  No 
mixer onto flat belts and  of the roller limits 
conveyed to a series of rollers  Line speed is the same as  Rollers themselves provide  Similar to belt conveying, no  physical access to the 
to flatten the mixture prior to  process step #11.  Element  only limited space to add a  mixing occurs at this step, and  product, and it would 
cutting and forming. The line  3 considerations are the  contaminant, but the food is  any contaminant would have to  be difficult for an 
speed of the belts is  same and we conclude that  more accessible while on the  be applied to the food over an  attacker to successfully 
approximately 100 lbs./min.  an act of intentional  conveyor before entering the  extended period to contaminant  contaminate the food at 
of product.  adulteration would be  roller.  However, worker  many servings.  Multiple  this step and achieve 
limited to 300 lbs. of food,  safety railings surrounding  workers in the area can observe  wide scale public 
which has the potential to  the roller prevent people  the equipment, making it  health harm.9 
cause 240 deaths.  from inadvertently getting  difficult for an inside attacker to 
too close to the equipment  contaminate the food without 
and possibly getting clothing  being detected.  We estimate 
caught in the rollers.   that an inside attacker would 
Anyone attempting to access  only be able to stand at the 
the food here would have to  rollers for three minutes and 
cross over the railing.    introduce a contaminant without 
being detected.   
13 &  Cutting  The product continues into  Score = 5  Score = 3  Score = 3  11  No significant  No 
14  cutting and forming after  vulnerability is present 
Forming  flattening.  Cutting blades   Given our Element 3  The physical space to  It is unlikely an inside attacker  because score < 14. 
slice the ribbon of product  estimation that an inside  introduce a contaminant is  would be able to contaminate 
into small squares that are  attacker would only be  very constrained and access  the food via the side opening of 
then moved to the former,  able to introduce a  is only possible along the  the machine.  While the food is 
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which molds the cut squares  contaminant by attempting  side of the machine where  visible from the side opening, it 
into spheres.  Line speed is  to propel it onto the food  food is visible to workers  is at a distance from the side of 
the same as the roller (100  from the side of the  viewing the status of cutting  the machine such that an inside 
lbs./min.).  This is an  machine, we estimate that  and forming.  There are  attacker could only contaminate 
integrated piece of equipment,  only a few servings would  panels that can be removed  the food by propelling a 
so both processes are  be impacted due to the  during cleaning but access is  contaminant into the immediate 
evaluated as one.  movement of product and  prevented by worker safety  area where cutting and forming 
the likelihood that only the  mechanisms that are inherent  occurs.  We consider this is an 
food closest to the edge of  to the equipment.  An alarm  unlikely strategy to intentionally 
the machine would be  will sound and shut down  adulterate the food. An attempt 
potentially exposed to the  the machine if the safety  likely would be detected given 
contaminant.  This would  panels are removed during  how suspicious this activity is.  
result in few deaths.2  operations to access the  For these reasons, there is doubt 
food.  as to the feasibility of successful 
contaminant introduction at this 
step. 
15  Vitamin Tank  5 Gallon jugs of vitamin  Score = 8  Score = 8  Score = 8  24  Large public health  Yes 
mixture are manually added  impact is possible and 
to the vitamin tank.  The tank  At an application rate of  Tank is accessible. The top  There are periods when this  vitamin tank is 
has a lid that is accessible to  0.25 fl. oz. vitamin  hatch is not secured. The  process step is unobserved and  accessible.  There are 
fill the tank.  The tank has a  mixture per serving of  gangway is not locked or  an inside attacker would be able  frequent periods where 
capacity of 25 gallons.  The  morsels, 25 gallons of  otherwise access-restricted;  to climb the gangway stairs  an inside attacker could 
tank lid at the top is  vitamin mix would  however, introducing a  without being detected.  It does  act without being 
unsecured and is used to add  contaminate 12,800  contaminant would require  not take much time to open the  observed or detected. 
more vitamin mixture. The  servings.  This would  releasing the lid clasp and  lid, and it would be relatively 
vitamin tank is adjacent to  potentially result in 6,400  opening the lid to access the  easy to transport and introduce a 
and elevated above the  deaths if an intentional  vitamin mixture.  sufficient volume of agent.  The 
forming machine, and  adulteration were  tank is not agitated, but adding 
workers access it via an  successfully attempted at  more vitamin mix would serve 
elevated gangway to fill the  this step.2  to distribute the contaminant 
tank.  within the mixture. 
16   Vitamin  The vitamin mixture is  Not assessed because  Score = 1  Not assessed because Element 2  N/A  No significant  No 
Application  pumped directly to applicator  Element 2 score = 1.   score = 1.  vulnerability is present 
nozzles within the breading  System is pressurized and  because Element 2 = 1. 
enclosed (inherent 
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equipment.  The system is  characteristics).  There is no 
pressurized and enclosed.  means of access without 
completely disassembling 
the equipment. 
17  Breading8  After application of the  Score = 8  Score = 10  Score = 8  26  See each element  Yes 
vitamin mixture, which also  rationale.5 
serves as a medium for  500 lbs. of breading (ten  Breader is easily accessible  The openness of the hopper 
breading adhesion, the dough  50 lb. bags) are loaded  through the hopper where  would enable an inside attacker 
spheres are conveyed through  into the hopper and will  bags of breading are added  to easily add sufficient volumes 
a breader where they pass  coat many mixer batches  to the system.  The hopper is  of contaminant into the hopper.  
through a curtain of breading,  of morsels.  If  uncovered and accessible  During the process of breading a 
are rotated, and pass through  contaminated, this would  from floor level.  There are  contaminant would be mixed 
another curtain of breading to  result in a potential public  no inherent characteristics of  across several batches of 
achieve complete coverage.   health impact of 4,000  this process step that would  product as the breading is 
Unadhered breading is  deaths via 8,000 servings.2  limit the ability of an insider  recycled for continuous use. An 
recycled in a continuous  to contaminate the breading.    inside attacker would have to 
process.  Bags of premixed  use a minor degree of stealth to 
breading are brought from dry  add a sufficient amount of 
storage, opened, and added to  contaminant without detection.  
the breaders hopper.    The hopper is partially obscured 
by the breader, thus creating an 
impediment to clear 
observation. 
18  Cooking  Once breaded, dough spheres  Not assessed because  Score = 1  Score = 1  N/A  No significant  No 
are conveyed through a  scores for Elements 2 and  vulnerability is present 
cooker where they are baked  3 = 1.   Due to inherent  Serious injury would result if  because Elements 2 
at 425F for 20 minutes.    characteristics, there is no  any attempt to adulterate the  and 3 = 1. 
access at this step.  Cooker is  food at this point were 
enclosed for worker safety  attempted. 
reasons.  Therefore, due to 
inherent characteristics, 
there is no access at this 
step.   
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19  Cooling  After cooking, the product is  Score = 3  Score = 3  Score = 3  9  Relatively low public  No 
immediately conveyed  health impact.  Step is 
through a cooling tunnel to  Product flow rate is 100  There is a space between the  There is no mixing of the  hardly accessible.  Low 
reduce its temperature to  lbs./min.  However, given  cooker and the cooler where  product.  An inside attacker  ease of attack.  
approximately 40F. The  the time estimation in  access to the conveyed  would have to stand at the  Minimal timeframes 
cooling tunnel is enclosed  Element 3, 75 lbs. of food  product is possible, but  intake or discharge of the  for contaminant 
with only access points at its  would be impacted by an  physical space limitations  cooling tunnel for an extended  introduction and 
immediate entrance and exit.  intentional adulteration at  would make introduction of  period while applying the  surrounding workers 
Product flows through the  the cooler.  Therefore, 60  a contaminant difficult.   contaminant to the product,  prevent an inside 
cooling tunnel at  deaths are possible if  Removing the access panel  which would arouse suspicion.   attacker from working 
approximately 100 lbs./min.   product is contaminated at  to access the food within the  We estimate that an individual  unobserved for enough 
this step.2     cooling tunnel would require  would be able to stand at the  time to contaminate 
specialized tools and time to  entrance/exit of the cooling  any significant amount 
work.  tunnel for less than a minute  of product.9 
without being detected.   
20  Bucket  This is included as a process  Score = 3  Score = 3  Score = 3  9  No significant  No 
conveying  step in this assessment  vulnerability is present 
because it is not assessed as  Due to general levels of  Access is only possible  Timeframes are very short to  because score < 14. 
part of another process steps  observation and time  immediately after the cooler,  contaminate the product while 
evaluation.  Bucket conveyers  constraints noted in  but buckets fill quickly and  each bucket fills as product is 
take discharge morsels from  Element 3 of this step, we  then elevate product away  discharged from the cooler.  
the cooler on an elevated  determine it is potentially  from an inside attacker.   Once filled, buckets move very 
track from the primary  feasible to contaminate 5  Accessing the buckets could  quickly on an elevated track.  
production room to the  buckets loaded with  very easily cause bodily  Mixing does not occur. 
packaging room.  Buckets  morsels after they exit the  harm as they move rapidly, 
move quickly and carry  cooler. This would result  and guard rails are present to 
approximately 15 lbs. of  in potentially 75 lbs. or  prevent accidental contact 
product.  approximately 100  with the buckets. Once 
servings at risk.  This  filled, buckets are 
would lead to 50 potential  inaccessible as they are 
deaths if contaminated.2  moving rapidly on an 
elevated track. 
21  Weighing  Bucket conveyers deposit the  Score = 5  Score = 8  Score = 5  18  Even though there is an  No 
product into a hopper above a  elevated degree of 
carousel-style weighing  access, and, once 
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machine where morsels are  The carousel may have, at  The hopper is elevated above  The volume of contaminant  accessed, it would be 
funneled into weigh scales in  any given time,  the carousel and is not  needed is minimal and would be  easy to introduce a 
preparation for packaging.   approximately 50 lbs. of  accessible without bringing a  easily concealed.2 However,  contaminant to the 
This process is conducted in  product that would yield  ladder up the stairs and onto  mixing is not present at this step  food, this process step 
an elevated area above the  about 200 servings that are  the gangway.  However, the  and any contamination would be  would not generate 
packaging equipment, and  at risk.  This would cause  food in the carousel is  concentrated in only a limited  wide scale public 
access to the process step is  100 potential deaths.2   accessible and open as it is  number of packages.    health harm if 
possible via stairs and a  This is the very bottom of  being funneled to the weigh  intentionally 
gangway.  the public health impact  scales.  adulterated.  The small 
range for score 5.  volume of food 
available coupled with 
the lack of mixing 
across many packages 
result in this step not 
being an actionable 
process step. 
22  Packaging  Once weighed, morsels are  Score = 3  Score = 3  Score = 3  9  Access is difficult.  An  No 
dropped into an automated  attack at this step 
packaging machine where  At this point, only  Access is difficult but  As mentioned in Element 1,  would adulterate 
individual 24 oz. consumer  individual packages are at  possible at the point where  only individual packages are at  individual packages, 
packages (2 servings per  risk of adulteration by an  morsels drop from the weigh  risk.  There is no mixing.  After  and not result in wide 
package) are filled.   inside attacker.  At most,  scales into the packaging  a short time, the inside  scale public health 
Packaging consists of filling a  an inside attacker  machine.  An inside attacker  attackers actions would be  harm.9 
plastic pouch with product  accessing the intake of the  would need to bring a stool  detected because reaching up 
and vacuum sealing the  packager could  or ladder to reach the intake.  into the intake as food is falling 
pouch.  The pouch is then  contaminate only 5  into the packager is a safety 
moved automatically into a  packages, resulting in  hazard. 
box that is labeled and then  potentially 3 deaths. 
sealed. 
23,  Metal  Sealed boxes pass under a  Not assessed because  Score = 1   Not assessed because Element 2  N/A  No significant  No 
24,  Detection,  metal detector, and are  Element 2 score = 1.   score = 1.  vulnerability is present 
25,  Casing,  automatically placed in cases  Product is in multiple layers  because Element 2 = 1. 
26,  Palletizing,  of 48 boxes.  Cases are then  of tamper-evident packaging  These process steps are 
27   Finished  sealed for distribution.  Cases  that eliminates access to the  being grouped together 
  Product  are then loaded by hand onto  food by an inside attacker.  because the product is 
Storage,  a pallet which is moved via  in the same 
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Outbound  hand truck to an automated  inaccessible state due 
Loading10  palletizing machine.  Fully  to multiple layers of 
packaged and palletized  packaging.   
finished product is stored for 
up to three days in a storage 
room and then forklift loaded 
on to outbound trucks. 
 
                                                 
1 If the rationale for your determination of the individual element scores explains in sufficient detail why a process step is or is not an actionable process step, you do not need to include an explanation in this column. 
2 These estimates were generated by completing Worksheet 1-E, described in Chapter 2, Section F.2.a.ii, with the information included in this example.  The calculations generating these results are not included in 
this guidance.  Worksheet 1E can also generate estimates for the total amount of contaminant needed, which can inform the evaluation of Element 3. 
3 Process steps that receive a score of 1 for any of the three fundamental elements should not go through the summation process since the facility has concluded that one of the three elements is not present at that step.  
4 This process step is discussed in Chapter 3, Scenario 2 of this guidance.  
5 This text provides an example for how you could summarize your analysis of the scoring of the three fundamental elements; however, it is not required that you do so in this manner.  Alternatively, you could state 
This step is significantly vulnerable because the score > 25. See Chapter 2, Section G.1 for more information on identifying actionable process steps and Section G.2 for more information on written explanations. 
6 Similar food products can be grouped when conducting VAs.  For more information, see Chapter 2, Section A.2 of this guidance.  
7 Because Element 3 was scored as 1, there is no need to continue to evaluate public health impact because if any of the elements score as 1, then there is no significant vulnerability present.  Process step1 in this 
example has scores for all three elements, and this process step has scores for two elements, for explanatory purposes only.   
8 This process step is discussed in Chapter 3, Scenario 4 in this guidance. 
9 This text provides an example for how you could summarize your analysis of the scoring of the three fundamental elements; however, it is not required that you do so in this manner.  Alternatively, you could state 
This step is not significantly vulnerable because the score < 14. See Chapter 2, Section G.1 for more information on identifying actionable process steps and Section G.2 for more information on written 
explanations. 
10 In this example, process steps 23-27 have the same scores and rationale for why these points, steps, or procedures are not actionable process steps.  You have the flexibility to combine these steps into one row if 
you so choose.   
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Figure 2b-3. Three Fundamental Elements VA Example  Process Steps Rank Ordered by Sum Score  Breaded Morsels 
Rank-ordering process steps by the sum score can assist you in quickly identifying process steps with significant vulnerabilities.  Once 
the scores for the three fundamental elements have been assigned, these scores are added together to give an overall value (i.e., sum) 
for each point, step, or procedure.  Once the facility sums the scores for all of the points, steps, or procedures evaluated in the 
vulnerability assessment (except for those steps where one or more elements scored a 1), the facility orders the process steps from 
highest to lowest sum values.  The facility should identify steps with sum scores >25 as actionable process steps, and steps with sum 
scores <14 not as actionable process steps.  For steps with scores in the range of 14  25, significant vulnerabilities may or may not be 
present depending on the nature of the vulnerability at the process step under evaluation and the contribution of each of the three 
elements in each case.  The following Figure rank orders the sum scores, and associated information for the process steps of those 
scores, from Figure 2b-2, Columns 1, 2, and 4-8.   
(1)  (2)  (4)  (5)  (6)  (7)  (8) 
#  Process Step   Element 1 Score   Element 2 Score   Element 3 Score   Sum  Actionable 
    Process Step 
2  Bulk Liquid Receiving  10  8  8  26  Yes 
5  Bulk Liquid Storage  10  8  8  26  Yes 
9  Minor Ingredient Preparation  8  10  8  26  Yes 
17  Breading  8  10  8  26  Yes 
10  Mixer  8  8  8  24  Yes 
15  Vitamin Tank  8  8  8  24  Yes 
21  Weighing  5  8  5  18  No 
11  Belt Conveying  5  8  3  16  No 
12  Rolling  5  5  3  13  No 
3  Packaged Ingredient Receiving  5  3  3  11  No 
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6  Dry Storage  5  3  3  11  No 
7  Refrigerated Storage  5  3  3  11  No 
13  Cutting  5  3  3  11  No 
14  Forming  5  3  3  11  No 
19  Cooling  3  3  3  9  No 
20  Bucket Conveying  3  3  3  9  No 
22  Packaging  3  3  3  9  No 
1  Bulk Dry Ingredient Receiving  10  8  1  N/A*  No 
4  Bulk Dry Storage  Not assessed  10  1  N/A  No 
8  Water  Not assessed  1  Not assessed  N/A  No 
16  Vitamin Application  Not assessed  1  Not assessed  N/A  No 
18  Cooking  Not assessed  1  1  N/A  No 
23  Metal Detection  Not assessed  1  Not assessed  N/A  No 
24  Casing  Not assessed  1  Not assessed  N/A  No 
25  Palletizing  Not assessed  1  Not assessed  N/A  No 
26  Finished Product Storage  Not assessed  1  Not assessed  N/A  No 
27  Outbound Loading  Not assessed  1  Not assessed  N/A  No 
 
                                                 
* Process steps with a score of one for any of the three fundamental elements are not actionable process steps. 
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B. Example of a Vulnerability Assessment Using the Hybrid Approach 
Figure 2c-1 is a sample process flow diagram for a fictional cold pressed almond cranberry 
energy bar.  Figure 2c-2 is an example of a VA conducted using the fictional cold pressed 
almond cranberry energy bar at a fictional facility.  Figure 2c-2 is an example of how Worksheet 
1-F can be modified to document a vulnerability assessment using the hybrid approach.  In 
Section 2.G.1, we provided a description for how to use this worksheet, and much of that 
description is applicable when documenting a VA using the hybrid approach.  When using 
Worksheet 1-F for documenting the hybrid approach, you should complete Columns 4 - 7 for 
steps where the three fundamental elements analysis is used in combination with the KAT 
analysis; you do not need to complete these columns when the KAT analysis is the only one used 
for a step.      
   
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Figure 2c-1. Hybrid Approach VA Example- Cold Pressed Almond Cranberry Energy Bar 
Process Flow Diagram* 
1
Receive ingredients
2
Store ingredients
4 3
Mix and warm syrup (canola oil, 
Measure ingredients
corn syrup)
6 Mix dry ingredients (almonds, 
crisped rice, dried cranberries, 
vitamin/mineral pre-blend)
5 7
Cool syrup Blend ingredients
8 9
Spray pans Form/press
10
Set
11
Cut
12
Metal detection
13
Wrap, case
14
Store
15
Ship
 
*Courtesy of the Food Safety Preventive Controls Alliance. Used with permission. 
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Figure 2c-2. Hybrid Approach VA Example- Worksheet 1-F- Cold Pressed Almond Cranberry Energy Bar  
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar 
FACILITY NAME:  EB #12345 
ADDRESS: 12345 Main Street, Anywhere, USA  
SIGNED DATE:  May 17, 2018 
 
(1)  (2)  (3)  (4)  (5)  (6)  (7)  (8)  (9) 
#  Process Step  Process Step Description  Element 1:  Element 2:  Element 3:  Sum  Explanation  Actionable 
Score and  Score and  Score and    Process Step 
Rationale  Rationale  Rationale 
1  Receive  Corn syrup  Received in 5 gal. tamper- NA  NA  NA  NA  Does not fit within  No 
  Ingredients  evident sealed plastic containers  any of the KATs. 
Canola oil  Received in 5 gal. tamper-
evident sealed plastic containers 
Almonds, blanched and slivered  Received 
in 20 lb. bags  
Crisped rice  Received in 22 lb. bag-in-box  
Dried cranberries  Received in 25 lb. cases  
Powdered vitamin/ mineral pre-blend  
Vitamins (A, B-mix, C, E) and minerals (Ca, 
Mg, K, Zn) received in 1 lb. plastic sealed 
bags, with 10 bags in a box  
Pan release agent  contains soy lecithin  
received in spray cans 
2  Store  All ingredients are stored in the dry storage  NA  NA  NA  NA  Does not fit within  No 
Ingredients  room (temperature kept below 75F) in the  any of the KATs. 
ingredient area, arranged by ingredient code 
number. All containers are sealed to avoid 
cross-contact and cross-contamination during 
storage.  
3  Measure  Liquid ingredients are measured and staged in  NA  NA  NA  NA  Fits within the KATs-  Yes 
Ingredients  a dedicated room. Ingredients are measured  Liquid Storage and 
and weighed before being staged in dedicated  Handling, and 
containers. When needed, liquid ingredients  Secondary Ingredient 
Handling. 
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are directly pumped from the containers into 
the mixer.  
4  Mix and  The corn syrup and canola oil mixture is  Not assessed  Score = 1  Not assessed  N/A  While this step fits  No 
Warm  pumped from the ingredient measuring room  because  Because of  because  within the KAT 
Syrup  to the main production floor and into an  Element 2  inherent  Element 2  Mixing and Similar 
enclosed jacketed mixer and warmed to 195 -  score = 1.  characteristics,  score = 1.  Activities, no 
205F, and blended for 20 minutes to ensure  there is no  significant 
even distribution.   access at this  vulnerability is 
step. The  present because this 
mixer is  step has no means of 
enclosed for  physical access. 
worker safety 
reasons, and 
accessing the 
tank would 
require special 
tools and 
disassembling 
equipment. 
5  Cool Syrup  The syrup is pumped into a cooling tank and  Score = 5  Score = 3  Score = 3  11  While this step fits  No 
cooled to 120-130F. The cooling tank is  Using a  Because of  Using a  within the KAT 
enclosed except for a hatch that can only be  representative  inherent  representative  Liquid Storage and 
opened when product in not in the tank.   contaminant,  characteristics,  contaminant, it  Handling, no 
the cooling  there is limited  would be  significant 
tank holds  access at this  difficult to  vulnerability is 
enough liquid  step. The  bring enough  present because score 
ingredient to  cooling tank is  contaminant  < 14. 
generate a  enclosed and  into the area 
potential  access is only  and have 
public health  possible when  sufficient time 
impact of 900  product is not  to get the 
deaths.*    in the tank. 
                                                 
* These estimates were generated by completing Worksheet 1-E, described in Chapter 2, Section F.2.a.ii, with the information included in this example.  The 
calculations generating these results are not included in this guidance.   
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contaminant 
into the tank.  
6  Mix Dry  Dry ingredients, including almonds, crisped  NA  NA  NA  NA  Fits within the KAT-  Yes 
Ingredients   rice, dried cranberries, and the  Mixing and Similar 
vitamin/mineral pre-blend, are added to a  Activities. 
mixer and blended for 30 minutes to ensure 
even distribution. 
7  Blend All  Mixed dry ingredients are gradually added to  NA  NA  NA  NA  Fits within the KAT-  Yes 
Ingredients  the syrup mixer.  Mixing and Similar 
Activities. 
8  Spray Pans  Pans that have been cleaned and dried are  NA  NA  NA  NA  Does not fit within  No 
sprayed by hand with a processing aid  any of the KATs. 
containing soy lecithin. 
9  Form/Press  The blended mass is dispensed onto pans. The  NA  NA  NA  NA  Does not fit within  No 
mixture is formed and pressed with rollers to  any of the KATs. 
ensure consistent spreading and density. 
10  Set  Pans are placed in cooling racks and moved to  NA  NA  NA  NA  Does not fit within  No 
setting area where they are cooled to ambient  any of the KATs. 
temperature--around 70F. 
11  Cut  Sheets are cut mechanically in two successive  NA  NA  NA  NA  Does not fit within  No 
cutting operations, vertically and horizontally  any of the KATs. 
(rotary blade, reciprocal blade). 
12  Metal  Cut bars are passed through a calibrated metal  NA  NA  NA  NA  Does not fit within  No 
Detection  detector on the conveyor. Bars that are kicked  any of the KATs. 
off during this operation are passed through a 
more sensitive metal detector. Rejected bars 
are inspected and sent to waste.  
13  Wrap, Case  Trays containing cut bars are flipped onto  NA  NA  NA  NA  Does not fit within  No 
wrappers and bars are individually heat sealed  any of the KATs. 
and cut. Lot information is printed onto each 
sealed package. Bars are transferred by hand 
into cases, with 24 bars/case. Product and lot 
information is printed on each case. Cases are 
transferred by hand to pallets, which are 
sealed in plastic. 
14  Store  Pallets are transferred by fork lift to the  NA  NA  NA  NA  Does not fit within  No 
warehouse where they are stored under  any of the KATs. 
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ambient condition at < 70% RH until 
shipping. 
15  Ship  Wrapped pallets are loaded into trucks via  NA  NA  NA  NA  Does not fit within  No 
forklift for outbound distribution.  any of the KATs. 
NA = Not applicable.   
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References  
We have placed the following references on display at the Dockets Management Staff, Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may see them at 
that location between 9 a.m. and 4 p.m., Monday through Friday.  As of April 9, 2018, FDA had 
verified the Web site address for the references it makes available as hyperlinks from the Internet 
copy of this guidance, but FDA is not responsible for any subsequent changes to Non-FDA Web 
site references after April 9, 2018.  
 
1.  Norton, R.A., "Food Defense in the Age of Domestic Terrorism."  Food Safety Magazine 
(https://www.foodsafetymagazine.com/enewsletter/food-defense-in-the-age-of-domestic-
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  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
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