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Mitigation Strategies to Protect Food 
Against Intentional Adulteration: 
Guidance for Industry  
 
Supplemental Draft Guidance 
 
The additional chapters and appendices of this guidance are being distributed for comment 
purposes only.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that FDA considers your comment on this draft guidance before we begin work on the final 
version of the guidance, submit either electronic or written comments on the draft guidance 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of the draft guidance.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 
 
February 2020 
 
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Table of Contents 
 
Chapter 5: Mitigation Strategies Management Components: Food Defense Corrective Actions ....... 5 
A.  Overview of Food Defense Corrective Actions ................................................................................ 5 
B.  How Food Defense Corrective Actions Differ from Food Safety Corrective Actions ..................... 5 
C.  Food Defense Corrective Action Procedures .................................................................................... 6 
D.  Circumstances When an Improperly Implemented Mitigation Strategy May Be the Result of a 
Potential Intentional Adulteration Event - Using Corrective Actions and Awareness Training ............... 8 
E.  Food Defense Corrective Actions Records ....................................................................................... 8 
Chapter 6:  Mitigation Strategies Management Components: Food Defense Verification ................ 15 
A.  Overview of Food Defense Verification ......................................................................................... 15 
B.  How Verification of Mitigation Strategies Differs from Verification of Preventive Controls ....... 16 
C.  Food Defense Verification Activities.............................................................................................. 16 
1.  Verification that Food Defense Monitoring is Being Conducted ............................................... 16 
2.  Verification that Appropriate Decisions About Food Defense Corrective Actions are Being 
Made ................................................................................................................................................... 17 
3.  Verification that Mitigation Strategies are Properly Implemented and are Significantly 
Minimizing or Preventing the Significant Vulnerabilities .................................................................. 18 
4.  Verification of Reanalysis ........................................................................................................... 23 
D.  Documentation of Food Defense Verification Activities ................................................................ 23 
E.  Scenarios ......................................................................................................................................... 24 
Chapter 7: Reanalysis ............................................................................................................................... 31 
A.  Overview of Reanalysis .................................................................................................................. 31 
B.  Circumstances Requiring a Reanalysis ........................................................................................... 32 
1.  Every Three Years ...................................................................................................................... 32 
2.  Significant Changes in Activities ................................................................................................ 32 
3.  New Information about Potential Vulnerabilities ....................................................................... 33 
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4.  Improper Implementation ........................................................................................................... 34 
5.  Reanalysis Required by FDA ...................................................................................................... 35 
C.  Voluntary Reanalysis ...................................................................................................................... 35 
D.  Conducting a Reanalysis ................................................................................................................. 35 
E.  Timeframe for Completing a Reanalysis ........................................................................................ 36 
F.  Documenting the Reanalysis ........................................................................................................... 37 
Chapter 9: Records ................................................................................................................................... 38 
A.  Required Records ............................................................................................................................ 38 
B.  Generally Applicable Requirements ............................................................................................... 38 
1.  Records Format ........................................................................................................................... 38 
2.  Accurate, Indelible, and Legible ................................................................................................. 39 
3.  Created when Activity is Performed ........................................................................................... 39 
4.  As Detailed as Necessary ............................................................................................................ 40 
5.  Information Adequate to Identify the Facility ............................................................................ 40 
6.  Date and Time ............................................................................................................................. 40 
7.  Signature or Initials of the Individual Performing the Activity Recorded .................................. 41 
8.  Identity of Product and Lot Code ................................................................................................ 41 
C.  Additional Requirements for Food Defense Monitoring ................................................................ 41 
D.  Additional Requirements for the Food Defense Plan ..................................................................... 42 
E.  Record Retention Requirements ..................................................................................................... 42 
F.  Offsite Storage of Records .............................................................................................................. 42 
G.  Existing Records ............................................................................................................................. 43 
H.  Protecting Records .......................................................................................................................... 44 
Appendix 2: Mitigation Strategies in the Food Defense Mitigation Strategies Database ................... 45 
Appendix Organization ........................................................................................................................... 45 
Table 1. Points, Steps, or Procedures by Category/Subcategory ............................................................ 46 
Table 2.  Mitigation Strategies and Associated Categories ..................................................................... 49 
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Appendix 3: Determination of Status as a Very Small Businesses or Small Businesses Under Part 
121: Mitigation Strategies to Protect Food Against Intentional Adulteration .................................... 55 
I.  Very Small Business Under the IA Rule ........................................................................................ 55 
A. Definition of Very Small Business Under Part 121 ........................................................................... 55 
B. Calculations to Determine Status as a Very Small Business Under Part 121 .................................... 57 
C. Examples of Calculations to Determine Market Value of Food Held Without Sale Under Part 121 61 
II.  Small Business Under the IA Rule ................................................................................................. 63 
 
 
   
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Chapter 5: 
Mitigation Strategies Management Components: Food Defense Corrective 
Actions 
This chapter provides an overview of the food defense corrective actions mitigation strategy 
management component and is intended to help you understand the requirements for food 
defense corrective actions as a part of your FDP.  Food defense corrective actions is one of three 
mitigation strategies management components.  The other two are food defense monitoring (See 
Chapter 4) and food defense verification (See Chapter 6).  You must apply mitigation strategies 
management components as appropriate to ensure the proper implementation of the mitigation 
strategies, taking into account the nature of the mitigation strategy and its role in the facilitys 
food defense system. (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 corrective actions 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, including corrective actions. 
A. Overview of Food Defense Corrective Actions  
You must establish and implement written food defense corrective actions procedures that must 
be taken if mitigation strategies are not properly implemented (121.145(a)(1)).  The food defense 
corrective actions procedures must describe the corrective actions steps you would take to ensure 
that appropriate action is taken to identify and correct a problem that has occurred with 
implementation of a mitigation strategy (21 CFR 121.145(a)(2)(i)) and, when necessary, to 
reduce the likelihood that the problem will recur (21 CFR 121.145(a)(2)(ii)).  Corrective actions 
must be appropriate to the nature of the actionable process step and the nature of the mitigation 
strategy (21 CFR 121.145(a)).  As discussed in Chapter 3, mitigation strategies are usually 
implemented to reduce access to the product at a particular point, to reduce the ability of an 
attacker to contaminate the product at that point, or both.  Food defense corrective actions are 
intended to address situations where those strategies are not properly implemented.  Food 
defense corrective actions must be documented in records and are subject to food defense 
verification.  (21 CFR 121.145(b)).  
 
The tables at the end of this chapter (Tables 5.9  5.12) provide examples of food defense 
corrective actions procedures for the scenarios listed in Chapters 3 and 4 of this guidance.   
B. How Food Defense Corrective Actions Differ from Food Safety 
Corrective Actions  
Some aspects of food defense corrective actions are similar to the food safety corrective actions 
in the PCHF rule.  For example, corrective actions procedures for food safety require that you 
take steps to ensure that appropriate action is taken to identify and correct a problem that has 
occurred with implementation of a preventive control (as with a mitigation strategy for food 
defense) and appropriate action is taken, when necessary, to reduce the likelihood that the 
problem will recur.  (21 CFR 117.150(a)(2)(i) and (ii)).  However, because of the different nature 
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of intentional adulteration, your corrective actions procedures do not need to ensure that all 
affected food is evaluated for safety and that all affected food is prevented from entering into 
commerce if it cannot be ensured that the affected food is not adulterated or misbranded. (21 
CFR 117.150(a)(2)(iii) and (iv)).  Specifically, intentional adulteration of food requires not just 
the opportunity for a contamination event (i.e., failure to properly implement a mitigation 
strategy), but also someone with intent to cause harm (i.e., an inside attacker) attacking the food 
at the point where the mitigation strategy was not properly implemented at the time it was not 
properly implemented.   
C. Food Defense Corrective Actions Procedures 
You must establish and implement written food defense corrective actions procedures that must 
be taken if mitigation strategies are not properly implemented. (21 CFR 121.145(a)(1)).  You 
have the flexibility to identify and implement the procedures that are appropriate for your facility 
as long as they accomplish the following goals, as appropriate to the nature of the actionable 
process step and the nature of the mitigation strategy:  
 
1.  Ensure that appropriate action is taken to identify and correct the problem that has 
occurred with the implementation of a mitigation strategy (21 CFR 121.145(a)(2)(i)); and  
2.  Ensure that the appropriate action is taken, when necessary, to reduce the likelihood that 
the problem will recur.  (21 CFR 121.145(a)(2)(ii)).  
 
Corrective actions are taken after food defense monitoring or verification determines that a 
mitigation strategy is not operating as intended.  Through food defense monitoring, you may 
determine that a mitigation strategy is not operating as intended and immediately ensure 
appropriate action is taken to identify and correct a problem that has occurred with the 
implementation of a mitigation strategy.  For example, monitoring may provide direct evidence 
of the problem (e.g., an employee conducting monitoring observes another employee not locking 
a gate after accessing a piece of equipment and implemented the corrective actions procedures to 
address the problem).  Through food defense verification, you also may determine that a 
mitigation strategy is not operating as intended.  This determination is likely to occur longer after 
the failure than a determination made via monitoring.  In both cases, identifying the cause of the 
problem may be useful in determining how to prevent recurrence.   
Food defense corrective actions must be written.  (21 CFR 121.145(a)(1)).  Written 
predetermined corrective actions in your FDP provide a how to guide that describes the steps 
to take when a mitigation strategy is not properly implemented and enables you to act quickly 
and appropriately.  Written food defense corrective actions procedures do not need to address 
every possible way a mitigation strategy may be improperly implemented but should address 
circumstances where improper implementation is most likely to occur.  We expect most 
corrective actions procedures will be simple and easy to undertake.   
 
For example, the mitigation strategy in Scenario 1 is to use a lock to secure the access hatch on 
an ingredient 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 
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coordinator.  The facility concludes that the circumstances where improper implementation of 
this mitigation strategy will most likely occur is when the lock is not locked.  If the lock is not 
properly engaged, a simple corrective actions procedure is to lock the lock.  If it is determined 
that the employee assigned to implement the strategy did not properly engage the lock, a simple 
corrective actions procedure is to retrain the employee on the proper implementation of the 
strategy.  Retraining reduces the likelihood of recurrence of the problem.  If the lock is broken, a 
simple corrective actions procedure is to replace the lock.  This action corrects the problem with 
implementation of the mitigation strategy and also reduces the likelihood of recurrence because 
an operational lock is more likely to be used.  These corrective actions would be documented in 
the food defense corrective actions log as required by 21 CFR 121.145(b) (see Table 5-9).   
 
In Scenario 3, the mitigation strategy is to inspect a liquid food storage tank prior to use.  
Immediately before reintroducing food, the quality control manager visually inspects the tank 
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.  The facility concludes that the 
circumstances where improper implementation of this mitigation strategy will most likely occur 
are when (1) the flashlights or ultraviolet lights malfunction, and (2) the quality control manager 
fails to inspect the tank prior to reintroduction of the food.  For the first circumstance, the quality 
control manager identifies the problem (malfunctioning lights), corrects it (replaces the lights), 
and documents the actions in the food defense corrective actions log.  (21 CFR 121.145(b)).  For 
the second circumstance (failure to inspect the tank), an employee conducting monitoring 
identifies the problem (the tank was not inspected) and ensures it is corrected (the tank is 
inspected).  The corrective actions procedure also includes retraining the quality control manager 
on the proper implementation of the mitigation strategy to reduce the likelihood that the manager 
will fail to inspect the tank in the future.  Inspecting the tank and retraining would be 
documented in the food defense corrective actions log (see Table 5-11).   
 
In Scenario 4, the mitigation strategy is to restrict access to the breader area to authorized 
personnel with specifically issued identification.  The facility issues these employees special red 
caps and identifies their job functions on their employee identification badges.  As part of their 
training in the proper implementation of the mitigation strategy, employees working at the 
breader are instructed to immediately escort any unauthorized individuals out of the area and 
notify security personnel or management of the intrusion.  The facility concludes that the 
circumstances where improper implementation of this mitigation strategy will most likely occur 
are when (1) an employee fails to immediately escort any unauthorized individuals out of the 
restricted area, and (2) an authorized worker forgets his red cap or badge.   
 
A simple corrective actions procedure for the first circumstance is to identify the unauthorized 
person and the employee who failed to escort the unauthorized person out of the area.  To correct 
the problem, the unauthorized person is escorted out of the area, and the employee who failed to 
escort the person out of the area is immediately retrained on the proper implementation of the 
mitigation strategy.  Retraining the employee also reduces the likelihood that the problem will 
recur.  A simple corrective actions procedure for the second circumstance (authorized worker 
forgets cap or badge) is to give the authorized worker a replacement cap or badge for that day.  
These corrective actions would be documented in records in the food defense corrective actions 
log (see Table 5-12).   
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D. Circumstances When an Improperly Implemented Mitigation Strategy 
May Be the Result of a Potential Intentional Adulteration Event - Using 
Corrective Actions and Awareness Training 
Intentional adulteration of food requires more than an opportunity for a contamination event (i.e., 
failure to properly implement a mitigation strategy).  It also requires a person with intent to cause 
harm (i.e., an inside attacker) attacking the food at the point where the mitigation strategy was 
not properly implemented at the time it was not properly implemented.  Therefore, in most cases, 
the failure to properly implement a mitigation strategy would not be expected to result in an IA 
event.  
 
However, some circumstances can raise significant enough concern that others should be 
notified.  For example, in Scenario 4, if an unknown and suspicious person entered the restricted 
area of the actionable process step, the corrective actions include escorting the unauthorized 
person out of the area.  However, if there is a question as to whether the food at that step was 
contaminated by the unauthorized person, this incident should be immediately reported to facility 
management, security personnel, or other individuals designated by facility management.  The 
need for such reporting is typically addressed in food defense awareness training.   
In addition, there may be times when a mitigation strategy is not operating as intended and a root 
cause cannot be determined.  This may lead the facility to suspect that an IA event or attempt 
may have occurred.  In this situation, it is our expectation that an employee or supervisor at that 
actionable process step would report the incident as taught in food defense awareness 
training.  For example, in Scenario 2, if the tamper-evident tape on the hose capping indicates 
someone accessed the hose caps in an unauthorized manner, and no one in the receiving bay has 
knowledge of this activity, employees should report the incident to facility management, security 
personnel, or other individuals designated by facility management.  In a similar set of 
circumstances, in Scenario 1, if the lock is cut but maintenance personnel have no knowledge of 
this activity, employees should report the incident (see Chapter 8.C for more information on 
awareness training and reporting suspicious events).   
E. Food Defense Corrective Actions Records 
You must document the corrective actions you take. (21 CFR 121.145(b)).  Records of corrective 
actions are necessary to determine whether corrective actions are being taken as specified in the 
FDP.  Corrective actions records help to inform food defense verification activities, including 
identifying recurring problems with mitigation strategies, ensuring proper implementation of 
mitigation strategies, and determining whether a mitigation strategy needs to be reanalyzed.   
 
All food defense corrective actions taken must be recorded at the time the activity is conducted. 
(21 CFR 121.305(d)).  Each corrective actions record should be as detailed as necessary to 
provide a history of work performed, capture the time (if appropriate) and date that the activity 
was conducted, and include the signature or initials of the person who performed the activity. (21 
CFR 121.305). 
 
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Food defense corrective actions records must include a description of the steps taken to identify 
and correct the problem with implementation of the mitigation strategy. (21 CFR 121.145(b)).  
For example, corrective actions records should document how you identified what went wrong 
with a mitigation strategy and then document the action(s) you took to resolve the problem.  If it 
is necessary to take corrective actions to reduce the likelihood that the problem will recur, 
corrective actions records must also document these activities.  (21 CFR 121.145(b)). 
 
For example, in Scenario 1, the mitigation strategy is to use a lock to secure the access hatch on 
an ingredient storage tank.  You find that the lock is not locked and follow your corrective 
actions procedure to secure the lock and retrain the responsible employee on lock use.  To 
document the corrective actions taken, you could write in a food defense corrective actions log 
that the lock was relocked, date/time, name of the employees that were retrained, date of the 
retraining, and name of the trainer.   
 
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Table 5-9. Scenario 1. 
Worksheet 1-I: Mitigation Strategy Management Components 
 
(4)  (5)  (6)  (7)  
(2)   Food Defense  Food Defense  Food Defense  Food Defense 
(1)  (3) 
Actionable  Monitoring  Corrective Actions  Verification  Records 
#  Mitigation Strategy 
Process Step  Procedure and  Procedures  Procedures 
Frequency 
  Liquid  Use a lock to secure  Employee assigned to  If lock is not locked,  See Chapter 6,  Liquid storage tank 
ingredient  access hatch on ingredient  ingredient storage  properly engage  Table 6.13.   observations record 
storage tank  storage tank.  Keys to the  observes whether the  lock, and retrain 
Food defense 
lock are held in the  lock is in place and  employee on proper 
corrective actions 
security office and can  locked at the beginning  lock use. 
log 
only be retrieved with  and end of the tanks 
If lock is broken, 
good reason and approval  48-hour cleaning cycle. 
 
replace lock. 
from the facility security 
manager or food defense 
 
coordinator. 
 
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Table 5-10. Scenario 2. 
Worksheet 1-I: Mitigation Strategy Management Components  
(5)  (6)  (7) 
(4) 
(2)  Food Defense  Food Defense  Food Defense 
(1)  (3)  Food Defense 
Actionable  Corrective Actions  Verification  Records 
#  Mitigation Strategy  Monitoring Procedure 
Process Step  Procedures  Procedures 
and Frequency 
  Bulk liquid  Use tamper-evident seals on  Technician assesses  If seals do not match,  See Chapter 6,  Receiving/delivery 
receiving  inbound shipping conveyances.  whether the seal is intact  are broken, or are  Table 6.14.  paperwork that 
Match the numbers on the seals  and matches seal or  missing, the load will be  includes additional 
with the numbers provided on  documentation numbers  rejected.   information to indicate 
the shipping documentation  upon arrival of the load  monitoring was 
from the supplier.  If the seals  before hooking up the  completed 
do not match, the load will be  hose for each delivery.   
rejected to prevent potentially  Food defense 
adulterated ingredient from  corrective actions log 
entering the facility. 
  Bulk liquid  Use tamper-evident tape on  After daily operations,  If caps are broken,  See Chapter 6,  Food defense 
receiving  hose ends after capping.  supply chain supervisor  replace caps. Clean and  Table 6.14.  monitoring log 
confirms that the hose 
flush hose.   
caps are on and taped.  Food defense 
corrective actions log 
If tape is ripped, reapply 
 
tape. Clean and flush   
  hose.  
  Retrain employee on 
capping and tape use. 
 
 
 
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(5)  (6)  (7) 
(4) 
(2)  Food Defense  Food Defense  Food Defense 
(1)  (3)  Food Defense 
Actionable  Corrective Actions  Verification  Records 
#  Mitigation Strategy  Monitoring Procedure 
Process Step  Procedures  Procedures 
and Frequency 
  Bulk liquid  Use authorized personnel for  On a periodic basis, (but  Retrain employee on  See Chapter 6,  Food defense 
receiving  visual observation of the  at least twice weekly), a  observation of the bay.  Table 6.14.  monitoring log 
unloading bay during the  manager observes 
opening of the conveyance and  whether personnel are    Food defense 
the attachment of hoses and  visually observing the  corrective actions log 
pumping equipment.  unloading bay during the 
 
opening of the 
conveyance and the 
attachment of hoses and 
pumping equipment. 
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Table 5-11. Scenario 3. 
Worksheet 1-I: Mitigation Strategy Management Components  
(4)  (5)  (6)  (7)  
(2)   Food Defense  Food Defense Corrective  Food Defense  Food Defense 
(1)  (3) 
Actionable  Monitoring  Actions Procedures  Verification  Records 
#  Mitigation Strategy 
Process Step  Procedure and  Procedures 
Frequency 
  Liquid food  Inspect liquid food storage  QA technician signs  If flashlights or ultraviolet  See Chapter 6,  Storage tank cleaning 
storage tank  tank prior to use. Immediately  and dates log  lights are malfunctioning or  Table 6.15.  sign off form kept with 
prior to reintroducing food,  immediately prior to  broken, repair or replace  records for Preventive 
the tank is visually inspected  the liquid food being  them.  Controls for Human 
by the quality control  added to the tank after  Food corrective 
manager using high intensity  the monthly cleaning  If tank is not inspected,  actions log 
flashlights and ultraviolet  cycle.  technician directs quality 
lights to ensure that no  control manager to inspect   
contaminant has been added  tank.  Retrain quality 
to the tank while it was open  control manager on 
and accessible after cleaning.  procedures for inspecting 
the storage tank prior to use 
  to determine whether a 
contaminant was added. 
 
 
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Table 5-12. Scenario 4. 
Worksheet 1-I: Mitigation Strategy Management Components  
(4)  (5)  (6)  (7) 
(2) 
(1)  (3) 
Food Defense  Food Defense  Food Defense  Food Defense 
Actionable 
#  Mitigation Strategy  Monitoring Procedure  Corrective Actions  Verification  Records 
Process Step 
and Frequency  Procedures  Procedures 
  Breader  Restrict access to breader to  Employees assigned to the  Escort unauthorized  See Chapter  Food defense 
authorized personnel.  The facility  breader constantly  personnel from  6, Table 6.16.  monitoring log 
issues these employees special red  monitor the area and 
restricted area.   
caps and identifies their job  ensure that only  Food defense 
function on their employee  authorized employees  corrective actions log 
Immediately retrain 
identification badges.  Workers  (i.e., those wearing special 
employees on   
authorized to work at the breader  badges and red caps) are 
identifying 
will have attained at least the  in the area.  The 
authorized personnel 
position of Food Safety  employees in the breader 
Technician Level 3 with at least 4  area will notify security  and escorting 
years of employment and be in  personnel if an  unauthorized 
good standing with human  unauthorized person is in  personnel out of the 
resources with no pending or  the restricted area. The 
area. 
previous disciplinary actions.   security personnel will 
Employees working at the breader  use exception records to  If red cap or 
will immediately escort out of the  record when a deviation 
identification badge 
area anyone not authorized to be in  from the strategy is  is missing, provide 
the area surrounding the breader.  observed.    worker with 
replacement cap or 
badge for that day. 
 
   
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Chapter 6:  
Mitigation Strategies Management Components: Food Defense Verification 
This chapter provides an overview of the food defense verification mitigation strategy 
management component and is intended to help you understand the requirements for food 
defense verification as a part of your FDP.  Food defense verification is one of three mitigation 
strategies management components.  The other two are food defense monitoring (see Chapter 4) 
and food defense corrective actions (see Chapter 5).  Mitigation strategies management 
components 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.  (21 CFR 
121.138).  (See Chapter 3 for information on identifying and implementing mitigation 
strategies).  You have the flexibility to identify and implement food defense verification 
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 Verification  
Food defense verification is 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.  
(21 CFR 121.3).  Food defense verification activities must be documented (21 CFR 121.150(c)) 
and must include, as appropriate to the nature of the mitigation strategy and its role in the 
facilitys food defense system: 
  Verification that food defense monitoring is being conducted (21 CFR 121.150(a)(1));  
  Verification that appropriate decisions about food defense corrective actions are being 
made (21 CFR 121.150(a)(2)); 
  Verification that mitigation strategies are properly implemented and are significantly 
minimizing or preventing the significant vulnerabilities.  To do so, you must conduct 
activities that include the following, as appropriate to the facility, the food, and the nature 
of the mitigation strategy and its role in the facilitys food defense system: 
  review of the food defense monitoring and food defense corrective actions records 
o
to ensure that the records are complete, the activities reflected in the records 
occurred in accordance with the FDP, the mitigation strategies are properly 
implemented, and appropriate decisions were made about food defense corrective 
actions (21 CFR 121.150(a)(3)(i)), and 
  other activities appropriate for verification of proper implementation of mitigation 
o
strategies (21 CFR 121.150(a)(3)(ii)) (requires written procedures); and  
  Verification of reanalysis (21 CFR 121.150(a)(4)).   
 
Written verification procedures are required for [o]ther activities appropriate for verification of 
proper implementation of mitigation strategies.  (21 CFR 121.150(a)(3)(ii) and (b)).  If you 
conduct verification by reviewing food defense monitoring and corrective actions records, 
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although not required, we recommend that you include these activities and their frequency in 
your FDP to help ensure that the verification activities are conducted.   
B. How Verification of Mitigation Strategies Differs from Verification of 
Preventive Controls 
Preventive controls are often process-based, and therefore require verification activities such as 
validation, calibration, product testing, and environmental monitoring (see 21 CFR 117.155 and 
117.165).  In contrast, mitigation strategies are implemented to either restrict access to a product 
or reduce the ability of an attacker to contaminate a product and therefore do not require the 
same verification activities.  Consequently, the food defense verification requirements are more 
flexible and less resource intensive than those needed for preventive controls.  Discussion of 
other differences between food defense verification and food safety verification are included in 
the specific sections below.  
C. Food Defense Verification Activities 
Food defense verification activities must include, as appropriate to the nature of the mitigation 
strategy and its role in the facilitys food defense system,  
(1)  verification that food defense monitoring is being conductedas required by 21 
CFR 121.138 (and in accordance with 21 CFR 121.140) (21 CFR 121.150(a)(1)); 
 
(2)  verification that appropriate decisions about food defense corrective actions are 
being made as required by 21 CFR 121.138 (and in accordance with 21 CFR 
121.145) (21 CFR 121.150(a)(2));  
(3)  verification that mitigation strategies are properly implemented and are 
significantly minimizing or preventing the significant vulnerabilities (21 CFR 
121.150(a)(3)); and  
(4)  verification of reanalysis in accordance with 21 CFR 121.157 (21 CFR 
121.150(a)(4)).   
 
Many of the examples of food defense verification activities in this chapter involve records 
review because we expect this activity will be the most common method used to conduct 
verification activities; however, records review is not always required for verification.  You have 
flexibility to use activities other than records review when appropriate, and some of the examples 
in this chapter demonstrate that flexibility.  For example, in Scenario 3 an employee verifies 
monitoring by observing whether another employee assigned to monitoring is doing so as 
required by the facilitys monitoring procedure.   
 
The following sections describe each of these verification activities in more detail, provide 
examples, and highlight areas of flexibility.   
1.  Verification that Food Defense Monitoring is Being Conducted 
You must verify that food defense monitoring is being conducted. (21 CFR 121.150(a)(1)).  You 
have flexibility to determine how you verify food defense monitoring is being conducted, how 
frequently you do so, and who conducts this activity.  One way to verify that food defense 
monitoring is being conducted is to review food defense monitoring records.  If you choose to 
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review monitoring records and do so consistent with the requirements in 21 CFR 
121.150(a)(3)(i), then you are not required to conduct additional monitoring verification 
activities under 21 CFR 121.150(a)(3)(i).  
 
Scenario 2 includes an example of reviewing records to verify monitoring.  In this scenario, a 
mitigation strategy is to visually observe the unloading bay during the opening of the conveyance 
and the attachment of hoses and pumping equipment.  The monitoring procedure consists of a 
manager observing (at least twice weekly) the unloading bay during the opening of the 
conveyance and the attachment of hoses and pumping equipment.  To verify that monitoring is 
being conducted, a senior manager reviews the monitoring logs weekly.   
Verification of monitoring does not always require review of monitoring records.  For example, 
an activity to verify monitoring that does not involve records review is for an employee to 
perform a similar, but independent, monitoring activity (e.g., the monitoring procedure is to 
ensure a gate is locked every Monday and Friday; the verification procedure is for a different 
employee to ensure the gate is locked on Wednesdays).  Another example of an activity to verify 
monitoring that does not involve records review is for a different employee to periodically 
observe the employee conducting the food defense monitoring activity.  In Scenario 3, the 
quality control manager inspects the food storage tank to ensure that a contaminant has not been 
added.  The food defense monitoring procedure is that the QA technician signs and dates a log 
immediately prior to the liquid food being added to the tank after the monthly cleaning cycle 
indicating whether the inspection has occurred.  As part of verification for food safety, a senior 
manager visually observes, quarterly, whether the QA technician is performing monitoring 
activities, and documents the observation in the verification log.  In this scenario, the technician 
was already monitoring the tank for food safety purposes (i.e., to determine whether the tank had 
been cleaned), and the senior manager was verifying that activity.  This scenario provides an 
example where food safety activities can be leveraged to comply with the food defense 
verification requirement.   
 
Another appropriate verification method that does not include review of records is described in 
Chapter 4.F of this guidance.  A mitigation strategy restricts access to an area using a locking 
gate that is opened with a specially coded access card.  If the gate is left ajar beyond a specified 
time period, an automated monitoring system alarm indicates that the gate is not secured and 
generates an exception record that documents the instance where the mitigation strategy was not 
operating as intended.  To verify monitoring, the facility periodically checks whether the 
restricted access system is working properly (and therefore that monitoring is being conducted 
automatically) by leaving the door unlocked, and checking whether the alarm is activated.   
2.  Verification that Appropriate Decisions About Food Defense Corrective Actions are 
Being Made 
You must verify that appropriate decisions about food defense corrective actions are being made. 
(21 CFR 121.150(a)(2)).  You have flexibility to determine how you verify that appropriate 
decisions about food defense corrective actions are being made, how frequently you do so, and 
who conducts this activity.  One way to verify that appropriate decisions about food defense 
corrective actions are being made is to review food defense corrective actions records.  If you 
choose to review corrective actions records and do so consistent with the requirements in 21 
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CFR 121.150(a)(3)(i), then you are not required to conduct additional corrective actions 
verification activities under 21 CFR 121.150(a)(3)(i). 
Scenario 2 includes an example of reviewing records to verify corrective actions.  In this 
scenario, a mitigation strategy is to have authorized personnel visually observe the unloading bay 
during the opening of the conveyance and the attachment of hoses and pumping equipment.  The 
corrective action is to retrain an employee who is not observing the unloading bay.  To verify 
that the appropriate corrective action is being taken, a senior manager reviews the corrective 
actions logs weekly.   
Verification of food defense corrective actions does not always require review of corrective 
actions records.  An activity to verify that appropriate decisions are being made about corrective 
actions that does not involve records review is for an employee to observe the corrective actions 
being taken by another employee (e.g., when a broken lock is found, a senior manager visually 
observes replacement of the lock).  Similarly, in Scenario 4, the manager visually observes 
whether corrective actions are being taken (e.g., the manager observes whether unauthorized 
personnel are escorted out of the restricted area and whether employees are being immediately 
retrained).  
3.  Verification that Mitigation Strategies are Properly Implemented and are 
Significantly Minimizing or Preventing the Significant Vulnerabilities 
You must verify that mitigation strategies are properly implemented and are significantly 
minimizing or preventing the significant vulnerabilities.  (21 CFR 121.150(a)(3)).  To do so, you 
must review food defense monitoring and food defense corrective actions records and conduct 
other activities as appropriate to the facility, the food, and the nature of the mitigation strategy 
and its role in the facilitys food defense system.  The purpose of the records review is to ensure 
that the records are complete, activities reflected in the records occurred in accordance with the 
FDP, mitigation strategies are properly implemented, and appropriate decisions were made about 
food defense corrective actions (21 CFR 121.150(a)(3)).   
a.  Review of Food Defense Monitoring and Corrective Actions Records Within 
Appropriate Timeframes  
If you conduct verification by reviewing monitoring and corrective actions records, you must 
review the records within appropriate timeframes.  (21 CFR 121.150(a)(3)(i)).  In Chapter 4.D.1 
of this guidance, we discuss how to consider the nature of the mitigation strategy and its role in 
the facilitys food defense system in determining the frequency of food defense monitoring.  
Because of their nature, most food defense mitigation strategies may be monitored less 
frequently than preventive controls for food safety, which are often monitored continuously.  
Similarly, food defense verification may occur less frequently.  
Determining an appropriate timeframe to verify the records for monitoring should take into 
account the frequency of the monitoring activity, which reflects the nature of the mitigation 
strategy.  Generally, the more frequently that monitoring occurs, the shorter the appropriate 
timeframe for records review is likely to be.  In most cases there will be more than one 
appropriate timeframe possible for records review.  For example, in Scenario 1, an employee 
assigned to ingredient storage monitors whether a lock is in place and locked at the beginning 
and end of a tanks 48-hour cleaning cycle.  The facility determines that a QA technician will 
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review monitoring and corrective actions records once per week.  The facility could have 
decided to review the records less frequently, e.g., every two weeks.  In addition, more frequent 
records review is always an option.  For example, the facility could have chosen to review 
monitoring and corrective actions records every other day to minimize the potential time 
between the occurrence of an implementation problem and the discovery and correction of the 
problem.  
b.  Ensuring that Food Defense Monitoring and Corrective Actions Records are 
Complete 
If you conduct verification by reviewing monitoring and corrective actions records, you must 
review the records to ensure that they are complete (i.e., that they contain the required 
information).  (21 CFR 121.150(a)(3)(i)).   
In Scenario 1, a monitoring procedure is for an employee assigned to ingredient storage to 
observe whether a lock is in place and locked at the beginning and end of a tanks 48-hour 
cleaning cycle.  The monitoring is documented in a log entitled liquid storage tank observations 
record and includes the date, time, and a written yes or no to indicate whether the lock was 
locked.  The food defense corrective actions are to properly engage the lock if it is unlocked and 
retrain the employee and to replace a broken lock.  The food defense corrective actions are 
documented in the food defense corrective actions log, which includes a description of the 
actions taken (e.g., the lock was relocked and an employee was retrained), the date and time the 
lock was relocked, the name of the employee who was retrained, the date of the retraining, and 
the name of the trainer.  To ensure the records are complete, the following questions are 
considered: 
  Are the records accurate, indelible, and legible, as required by 21 CFR 121.305(c)? 
  Were the records created when the activities were performed, as required by 21 CFR 
121.305(d)?  For activities described in Scenario 1, did the employee create the 
monitoring record when she observed whether the lock was locked at the beginning and 
end of the tanks cleaning cycle?  If corrective actions were required, were the corrective 
actions records created when the lock was properly engaged or replaced, and when the 
employee was retrained? 
  Do the records contain the necessary details to provide the history of the work performed, 
as required by 21 CFR 121.305(e)?  For activities described in Scenario 1, do the 
corrective actions records include details needed to determine if the lock was properly 
engaged or replaced, when the employee was retrained, who the employee was, and who 
retrained the employee?  Additionally, does the monitoring record contain the actual 
values and observations obtained during monitoringin this example, a yes or no 
indicating whether the lock was locked, as required by 21 CFR 121.305(b)? 
  Do the records include the signature or initials of the individuals performing the 
activities, as required by 21 CFR 121.305(f)(3)?  Do the records include the dates and, 
when appropriate, times the activities were documented, as required by 21 CFR 
121.305(f)(2)?  In this example, the monitoring procedure occurs at a set time, so the 
record should include the time the activity was documented.   
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c.  Ensuring that Activities Reflected in Food Defense Monitoring and Corrective 
Actions Records Occurred in Accordance with the Food Defense Plan  
If you conduct verification by reviewing monitoring and corrective actions records, you must 
ensure that the activities reflected in the records occurred in accordance with the food defense 
plan.  (21 CFR 121.150(a)(3)(i)).  This verification can be done by comparing the written 
procedures for food defense monitoring and corrective actions in the FDP with the records 
documenting these activities.   
 
In Scenario 2, a mitigation strategy is the use of tamper-evident tape on hose ends after capping.  
The monitoring procedure is for the supply chain supervisor to observe whether the hose caps are 
on and taped after daily operations.  As part of verification, a supervisor conducts a weekly 
review of the information in the monitoring log to ensure that the facility followed its monitoring 
procedure.  If the monitoring log indicates that the supply chain supervisor observed each day 
whether the hose caps were on and taped at the end of operations (i.e., the supply chain 
supervisor marked yes or no on the monitoring record and initialed and dated the monitoring 
record), the supervisor would conclude that the monitoring activities occurred in accordance with 
the FDP.   
The corrective actions for this mitigation strategy include replacing broken caps, reapplying 
ripped tape, cleaning and flushing the hoses, and retraining the employee on capping and tape 
use.  As part of verification, a supervisor conducts a weekly review of the information in the 
corrective actions log to ensure the that the facility followed its corrective actions procedure.  If 
the corrective actions log indicates that, when the mitigation strategy was not properly 
implemented, appropriate corrective actions were taken (e.g., broken tape was reapplied, the 
hoses were cleaned and flushed, and the employee was retrained), the supervisor would conclude 
that the corrective actions occurred in accordance with the FDP.   
Another mitigation strategy in Scenario 2 is to use tamper-evident seals on inbound shipping 
conveyances.  The monitoring procedure is for a technician, upon arrival of the load and before 
hooking up the hose for each delivery, to observe whether the seal is intact and matches 
documentation numbers.  As part of verification, a supervisor conducts a monthly review of the 
monitoring records (the receiving/delivery paperwork) to ensure that the facility followed its 
monitoring procedure.  If the monitoring records indicate that, for each load, the technician 
checked upon arrival whether the seal was intact and matched documentation numbers, the 
supervisor would conclude that the monitoring activities occurred in accordance with the FDP.       
The corrective action for this mitigation strategy is to reject the load.  As part of verification, a 
supervisor conducts a monthly review of the information in the corrective actions log to ensure 
that the facility followed its corrective action procedure.  If the corrective actions log indicates 
that whenever a seal was not intact or did not match documentation numbers upon arrival, the 
load was rejected, the supervisor would conclude that the corrective action occurred in 
accordance with the FDP.    
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d.  Review of Food Defense Monitoring and Food Defense Corrective Actions Records 
to Ensure that Mitigation Strategies are Properly Implemented  
If you conduct verification by reviewing monitoring and corrective actions records, you must 
review the records to ensure that mitigation strategies are properly implemented. (21 CFR 
121.150(a)(3)(i)).  This review may overlap records review for other purposes (e.g., to ensure 
that activities occurred in accordance with the FDP) and may occur simultaneously with review 
for other purposes or sequentially with such review.  Below we provide an example of sequential 
review. 
First, a facility could review the monitoring and corrective actions logs for completeness (e.g., is 
the monitoring log legible?  Do the entries indicate whether and when monitoring was 
performed?  Were the entries made at the time of monitoring?).  In Scenario 2, for the bulk liquid 
receiving actionable process step, the facility would review the food defense monitoring log to 
check whether it contains, among other things, entries made after daily operations indicating 
whether the hose caps were on and taped, and review the corrective actions log to determine 
whether, among other things, the corrective actions were documented when they occurred.     
Next, the facility could determine whether monitoring was conducted and corrective actions 
were taken as required by the FDP.  For example, did the supply chain supervisor conduct 
monitoring at the required frequency?  Did the supervisor observe whether the hose caps were on 
and taped?  Does the corrective actions log indicate that broken caps were replaced, ripped tape 
was reapplied, the hoses were cleaned and flushed, and that employees were retrained?  
Next, as part of ensuring that mitigation strategies are properly implemented, the facility could 
consider the results of the monitoring, i.e., what did the monitoring show regarding whether the 
mitigation strategy was properly implemented?  This might be as simple as a yes or no in the 
monitoring log for a particular date and time referring to whether the hoses were capped and 
taped.  If a monitoring log indicates that the mitigation strategy was properly implemented on a 
specific occasion, no further records review regarding that monitoring result would be taken.  If 
the monitoring log indicates that a mitigation strategy was not properly implemented (e.g., the 
hose caps were not taped), then the corrective actions log could be reviewed for that date to see 
whether appropriate corrective actions were taken (see next section for further discussion of 
review of corrective actions).   
e.  Review of Food Defense Monitoring and Food Defense Corrective Actions Records 
to Ensure Appropriate Decisions were Made About Food Defense Corrective 
Actions 
If you conduct verification by reviewing monitoring and corrective actions records, you must 
review the records to ensure that appropriate decisions about food defense corrective actions 
were made. (21 CFR 121.150(a)(3)(i)).  If a monitoring record indicated a mitigation strategy 
was not properly implemented, a corrective actions record should indicate that corrective actions 
were taken.  In reviewing the corrective actions records, you would determine whether 
appropriate action was taken to identify and correct an implementation problem and whether 
appropriate action was taken, if necessary, to reduce the likelihood that the problem will recur.  
For example, in Scenario 1, if a monitoring record indicates that the access hatch on the tank was 
not locked, a corrective actions record should reflect that the lock on the access hatch was 
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locked, and the responsible employee was retrained.  If the corrective actions records reflect a 
sustained pattern of implementation failures (i.e., the lock on the hatch being left unlocked) after 
corrective actions were taken, you should consider whether the appropriate corrective actions 
were taken to reduce the likelihood of recurrence and consider whether a different mitigation 
strategy is needed.  See Chapter 7.B.4 of this guidance for more information on when to conduct 
a reanalysis.   
f.  Other Activities Appropriate for Verification of Proper Implementation of 
Mitigation Strategies 
Section 121.150(a)(3)(ii) provides for [o]ther activities appropriate for verification of proper 
implementation of mitigation strategies.  We explained in the final rule that we made this 
addition to allow for increased flexibility in verifying mitigation strategies are properly 
implemented beyond what is included in  121.150(a)(3)(i) [review of monitoring and corrective 
action records]. 81 Fed. Reg. 34166 at 34205 (May 27, 2016).  As explained below, you have 
the flexibility to conduct other activities appropriate for verification of proper implementation of 
mitigation strategies instead of the records review specified in 21 CFR 121.150(a)(3)(i).  If you 
conduct other verification activities, you must have written procedures for them, including the 
frequency for which they are to be performed, in your FDP. (21 CFR 121.150(b)).  
Scenario 4 contains an example of a verification activity that can substitute for records review 
under 21 CFR 121.150(a)(3)(i).  In Scenario 4, the mitigation strategy provides that authorized 
employees in the breader area are to wear special red caps and identification badges that identify 
their job functions.  Employees working at the breader are to immediately escort unauthorized 
individuals (i.e., individuals not wearing the cap and badge) out of the restricted area.  To verify 
implementation of the mitigation strategy, the facility conducts a penetration audit once per 
month, which consists of sending an employee who is not wearing the cap or badge into the area 
and observing whether the authorized employees identify and escort the unauthorized individual 
out of the restricted area.  If they do so, the manager would conclude the strategy is properly 
implemented.  If this verification activity is used, records review is not required under 21 CFR 
121.150(a)(3)(i). 
In addition, it is possible for an [o]ther activit[y] appropriate for verification of proper 
implementation of mitigation strategies to satisfy some or all of the verification requirements in 
21 CFR 121.150(a)(1) and (2).  Those provisions require verification of monitoring and 
corrective actions but do not require that it be achieved via records review.  To the extent a 
verification activity, such as a penetration audit, is able to verify that food defense monitoring is 
being conducted as required or that appropriate decisions about corrective actions are being 
made, no additional verification is required by 21 CFR 121.150(a)(1) and (2).  The penetration 
audit described above is able to verify whether monitoring is occurring (i.e., the manager can 
observe if the employees are monitoring the area) as required by 21 CFR 121.150(a)(1).  The 
audit also is able to verify whether appropriate decisions are made about corrective actions 
procedures (i.e., the manager can observe if the employees escort unauthorized employees out of 
the area, if employees are immediately retrained on escorting employees out of the area, and if 
caps or badges are given to authorized employees) as required by 121.150(a)(2).  Note that 
because the penetration audit is not specified in 21 CFR 121.150(a)(3)(i), the procedure and its 
frequency must be written.  (21 CFR 121.150(b)). 
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4.  Verification of Reanalysis 
You must verify that reanalysis of your FDP occurred when required by 21 CFR 121.157.  (21 
CFR 121.150(a)(4)).  Verifying reanalysis is done by reviewing documentation of the basis for a 
conclusion that no revisions were needed or reviewing the revised FDP to ensure that reanalysis 
was conducted on the applicable portion(s) of the FDP.  In Chapter 7.B.3 of this guidance, we 
provide an example involving reanalysis triggered by new information about potential 
vulnerabilities associated with a food operation (such as information from an equipment 
manufacturer that a newly identified equipment design flaw allows the integrated safety features 
to be easily disabled, providing access to the food).  To verify reanalysis, the facility would 
consider whether a reanalysis of the relevant part of the vulnerability assessment was conducted 
to determine whether a significant vulnerability is present at this process step and, if so, what 
mitigation strategies and management components are necessary.  (21 CFR 121.157(b)(2)).   
 
In another example, a company installs an electronic badging/access system intended to give 
different levels of access to different categories of people inside the companys facilities (e.g., 
visitors are limited to the front lobby, contractors are given temporary access to designated areas, 
and the most trusted employees are assigned to restricted areas immediately surrounding 
actionable process steps).  After the company becomes aware of new information about potential 
vulnerabilities (i.e., that the system will not be able to distinguish between contractors and the 
most trusted employees), a reanalysis of any mitigation strategies relying on the badging system 
to significantly minimize or prevent access to actionable process steps was required by 21 CFR 
121.157(b)(2).  During her verification of reanalysis, a headquarters official determines that no 
modifications were made to the FDP after the facility learned the new information about the 
system, and the facility did not document a determination that no changes were needed.  The 
headquarters official therefore concludes that a reanalysis was required but did not occur and 
arranges for a reanalysis to be conducted.    
D. Documentation of Food Defense Verification Activities 
You must document your food defense verification activities in records. (21 CFR 121.150(c)).  
Accurate recordkeeping provides documentation that verification activities are being conducted 
as required and as specified in the FDP.  We discuss records requirements in detail in Chapter 9 
of the guidance.  
 
For example, in Scenario 2, a supervisor determines whether the hoses were monitored as 
required by the FDP and records this determination in a verification record that is signed and 
dated.  The time period covered by the verification of monitoring should be indicated in the 
record.  The supervisor also determines whether corrective actions were implemented as required 
by the FDP, including whether appropriate decisions were made, and records this determination 
in a signed and dated verification record.  The supervisor also would record a determination that 
corrective actions should have been taken but were not and indicate the relevant date.  For 
example, on May 2, monitoring records show that the hoses were not capped and corrective 
actions do not indicate that any corrective actions were taken.  The corrective actions procedures 
were not followed.  
 
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E. Scenarios 
Tables 6.13  6.16 below provide examples of food defense verification procedures for the 
scenarios listed in Chapters 3-5 of this guidance.  Because in many cases food defense 
verification activities will be similar across mitigation strategies, you may choose to use short 
phrases, abbreviations, or footnotes to minimize repetition of text.   
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Table 6-13. Scenario 1. 
Worksheet 1-I: Mitigation Strategies Management Components 
 
(4)  (5)     
(1)  (2)  Food Defense  Food Defense  (6)  (7) 
(3) 
Actionable Process  Monitoring  Corrective Actions  Food Defense Verification  Food Defense 
Mitigation Strategy 
#  Step  Procedure and  Procedures  Procedures  Records 
Frequency 
  Liquid ingredient  Use a lock to secure  Employee assigned to  If lock is not locked,  QA technician reviews tank  Liquid storage 
storage tank  access hatch on  ingredient storage  properly engage lock,  observation records to  tank observations 
and retrain employee 
ingredient storage tank.  observes whether the  verify monitoring (weekly),  record 
on proper lock use. 
Keys to the lock are held  lock is in place and  and reviews correction 
Corrective actions 
in the security office and  locked at the  If lock is broken,  action log (weekly) 
log 
can only be retrieved  beginning and end of  replace lock. 
Review records to verify 
with good reason and  the tanks 48-hour 
Food defense 
  reanalysis every 3 years 
approval from the  cleaning cycle. 
verification log 
and when required by 21 
facility security manager 
CFR 121.157(b) 
or food defense   
coordinator. 
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Table 6-14. Scenario 2. 
Worksheet 1-I: Mitigation Strategies Management Components 
 
(4)  (5)     
(1)  (2)  Food Defense  Food Defense  (6)  (7) 
(3) 
Actionable Process  Food Defense  Food Defense 
Monitoring  Corrective Actions 
Mitigation Strategy 
#  Step  Verification Procedures  Records 
Procedure and  Procedures 
Frequency 
  Bulk liquid receiving  Use tamper-evident seals  Technician assesses  If seals do not match,  Supervisor reviews  Receiving/delivery 
on inbound shipping  whether the seal is  are broken, or are  receiving/delivery  paperwork that 
conveyances.  Match the  intact and matches  missing, the load will  paperwork, and reviews  includes additional 
numbers on the seals  seal or documentation  be rejected.  corrective actions log  information to 
with the numbers  numbers upon arrival  (monthly)   indicate 
provided on shipping  of the load, before  monitoring was 
Review records to verify 
documentation from the  hooking up the hose  completed 
reanalysis every 3 years 
supplier.  If the seals do  for each delivery.   
and when required by 21  Food defense 
not match, the load will 
CFR 121.157(b)  corrective actions 
be rejected to prevent 
log 
potentially adulterated 
ingredient from entering 
Food defense 
the facility. 
verification log 
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(4)  (5)     
(1)  (2)  Food Defense  Food Defense  (6)  (7) 
(3) 
Actionable Process  Food Defense  Food Defense 
Monitoring  Corrective Actions 
Mitigation Strategy 
#  Step  Verification Procedures  Records 
Procedure and  Procedures 
Frequency 
  Bulk liquid receiving  Use tamper-evident tape  After daily operations,  If caps are broken,  Supervisor reviews  Food defense 
on hose ends after  supply chain  replace caps. Clean and  monitoring and corrective  monitoring log 
capping.  supervisor confirms  flush hose.    actions logs (weekly)  
Food defense 
that the hose caps are 
If tape is ripped,  Review records to verify  corrective actions 
on and taped. 
reapply tape. Clean and  reanalysis every 3 years  log 
flush hose.   and when required by 21 
Food defense 
CFR 121.157(b) 
Retrain employee on  verification log 
capping and tape use. 
  Bulk liquid receiving  Use authorized personnel  On a periodic basis,  Retrain employee on  Senior manager reviews  Food defense 
for visual observation of  (but at least twice  observation of the bay.  monitoring and corrective  monitoring log 
the unloading bay during  weekly), a manager  actions logs (weekly)  
Food defense 
the opening of the  observes whether 
Review records to verify  corrective actions 
conveyance and the  personnel are visually 
reanalysis every 3 years  log 
attachment of hoses and  observing the 
and when required by 21 
pumping equipment.  unloading bay during 
Food defense 
CFR 121.157(b) 
the opening of the 
verification log 
conveyance and the 
attachment of hoses 
and pumping 
equipment. 
   
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Table 6-15. Scenario 3. 
Worksheet 1-I: Mitigation Strategies Management Components 
 
(4)  (5)  (6)  (7)  
(2)   Food Defense  Food Defense  Food Defense  Food Defense 
(1)  (3) 
Actionable Process  Monitoring  Corrective Actions  Verification Procedures  Records 
#  Mitigation Strategy 
Step  Procedure and  Procedures 
Frequency 
  Liquid food storage  Inspect liquid food  QA technician signs  If flashlights or  Senior manager observes  Storage tank 
tank  storage tank prior to use.  and dates log  ultraviolet lights are  QA technician performing  cleaning sign off 
malfunctioning or 
Immediately prior to  immediately prior to  monitoring activities  form kept with 
broken, repair or 
reintroducing food, the  the liquid food being  (quarterly) and reviews  records for 
replace them. 
tank will be visually  added to the tank after  corrective actions log  Preventive 
inspected by the quality  the monthly cleaning  If tank is not inspected,  (quarterly)   Controls for 
control manager using  cycle.  technician directs    Human Food  
high intensity flashlights  quality control 
Review records to verify 
Food safety 
and ultraviolet lights to  manager to inspect 
reanalysis every 3 years 
corrective actions 
ensure that no  tank.  Retrain quality 
and when required by 21 
log 
contaminant has been  control manager on 
CFR 121.157(b) 
added to the tank while it  procedures for 
Food safety 
was open and accessible  inspecting the storage 
verification log 
after cleaning.  tank prior to use in 
order to determine 
whether a contaminant 
was added. 
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Table 6-16. Scenario 4. 
Worksheet 1-I: Mitigation Strategies Management Components 
 
 
 
 
 
 
 
 
 
Table 6.16 appears on the next page 
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(1)  (2)  (4)  (5)  (6)  (7) 
(3) 
Actionable  Food Defense  Food Defense  Food Defense Verification  Food Defense 
Mitigation Strategy 
#  Process Step  Monitoring Procedure  Corrective Actions  Procedures  Records 
and Frequency  Procedures 
  Breader  Restrict access to breader  Employees assigned to  Escort unauthorized  Once per month, and on an  Food defense 
to authorized personnel.  the breader constantly  personnel from  unannounced, irregular basis, a manager  monitoring/ 
Issue these employees  monitor the area and  restricted area.    conducts a penetration audit, which  exception records 
special red caps and  ensure that only  consists of sending an employee, who is  log 
Immediately retrain 
identify their job function  authorized employees  not wearing the cap or badge, into the 
employees on  Food defense 
on their employee  (i.e., those wearing  area and observing whether the 
identifying authorized  corrective actions 
identification badges.  special badges and red  authorized employees adhere to 
personnel and  log 
Authorize only workers to  caps) are in the area.   mitigation strategy implementation 
escorting 
work at the breader who  The employees in the  responsibilities.  The audit verifies food 
Food defense 
unauthorized 
have attained at least the  breader area notify  defense monitoring is being conducted 
verification log 
personnel out of the 
position of Food Safety  security personnel if an  because it provides the manager the 
area. 
Technician Level 3 with  unauthorized person is in  opportunity to observe whether the   
at least 4 years of  the restricted area.  The  employees are implementing the 
If red cap or 
employment and are in  security personnel use  monitoring procedure.  The audit verifies   
identification badge 
good standing with  exception records to  whether appropriate decisions about 
is missing, provide 
human resources with no  record when a deviation  corrective actions were made because the 
worker with 
pending or previous  from the strategy is  manager can observe whether the 
replacement cap or 
disciplinary actions.   observed.    unauthorized personnel are escorted 
badge for that day. 
Employees working at the  from the area, and whether immediately 
breader immediately  retraining of employees occurred.  The 
escort out of the area  manager can also observe whether the 
anyone not authorized to  red cap or identification badge was 
be in the area surrounding  provided for the day.  
the breader. 
Review records to verify reanalysis 
every 3 years and when required by 21 
CFR 121.157(b) 
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Chapter 7: 
Reanalysis 
This chapter describes food defense plan (FDP) reanalysis activities and is intended to help you 
understand when to conduct a reanalysis of your FDP, how to conduct the reanalysis, and what 
aspects of the reanalysis you should document.   
A. Overview of Reanalysis 
The purpose of the reanalysis is to determine whether your FDP continues to be current and 
accurately reflects your significant vulnerabilities and to determine whether your mitigation 
strategies and mitigation strategy management components remain appropriate for your facility.     
You must conduct a reanalysis of your FDP as a whole at least once every 3 years.  (21 CFR 
121.157(a)).  You also must conduct a reanalysis of the FDP as a whole, or the applicable portion 
of the FDP, whenever:  
(1) A significant change made in the activities conducted at your facility creates a 
reasonable potential for a new vulnerability or a significant increase in a previously 
identified vulnerability (21 CFR 121.157(b)(1));  
(2) You become aware of new information about potential vulnerabilities associated with 
the food operation or facility (21 CFR 121.157(b)(2));  
(3) You find that a mitigation strategy, a combination of mitigation strategies, or the FDP 
as a whole is not properly implemented (21 CFR 121.157(b)(3)); and  
(4) FDA requires reanalysis to respond to new vulnerabilities, credible threats to the food 
supply, and developments in scientific understanding including, as appropriate, results 
from the Department of Homeland Security biological, chemical, radiological, or other 
terrorism risk assessment (21 CFR 121.157(b)(4)).   
The results of your reanalysis will vary depending on each situation and may not always lead to 
changes to your FDP.  If your reanalysis concludes that a significant change in the activities 
conducted at your facility has created a reasonable potential for a new vulnerability or a 
significant increase in a previously identified vulnerability, then you must revise your written 
FDP or document the basis for the conclusion that no revision is needed.  (21 CFR 121.157(d)).  
For example, if your reanalysis concludes that implementation of additional mitigation strategies 
is needed, you would need to revise your FDP to include the new strategies and associated 
management components.  
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B. Circumstances Requiring a Reanalysis 
The FDP is a dynamic document that includes your current vulnerability assessment, mitigation 
strategies, mitigation strategy management components, and other documents.  It is important 
that you update your FDP so that it remains current and relevant.  The FDP as a whole must be 
reanalyzed at least once every 3 years.  (21 CFR 121.157(a)).  In addition, several situations may 
trigger a reanalysis of your entire FDP or portions of the plan, which we refer to as a situational 
reanalysis.   
1.  Every Three Years 
You must reanalyze your entire FDP at least once every 3 years. (21 CFR 121.157(a)).  For 
example, if your FDP was last fully reanalyzed on July 1, 2019, you must fully reanalyze it again 
by July 1, 2022.  However, if you reanalyze the entire plan before three years have elapsed for 
example, you perform a reanalysis of the whole FDP two years later (on March 3, 2021)  then 
the three years begins again starting with the date that the entire plan was reanalyzed (March 3, 
2021), and you would have until March 3, 2024 to perform the next full reanalysis under this 
requirement.  Note that a reanalysis that does not include the entire FDP does not restart the 
three-year time period. Further, when the full reanalysis is conducted, it must include those parts 
that were previously reanalyzed during a partial reanalysis. (21 CFR 121.157(a)). 
2.  Significant Changes in Activities   
The first trigger for a situational reanalysis is a significant change in the activities conducted at 
your facility that creates a reasonable potential for a new vulnerability or a significant increase in 
a previously identified vulnerability.  (21 CFR 121.157(b)(1)).  A reasonable potential for a new 
vulnerability could arise, for example, from installation of new equipment that includes an access 
hatch not present on the previous equipment.  Because the access hatch provides a greater degree 
of physical access to the product, it could increase the score you assign to Element 2 (degree of 
physical access to the product).  A reasonable potential for a significant increase in a previously 
identified vulnerability could arise, for example, from new equipment with increased capacity.  
The increased capacity could increase the score you assign to Element 1 (potential public health 
impact) because a greater number of servings could now be adulterated, leading to more 
potential illnesses and deaths.  In your situational reanalysis you should reanalyze the applicable 
sections of your FDP (at a minimum, the step where it occurs) to see what, if any, effect the 
change has on your current vulnerabilities, mitigation strategies, and mitigation strategy 
management components.  (21 CFR 121.157(b)(1)).  Your reanalysis will help you determine 
whether you need to make changes to your existing FDP. 
Whether a change creates a reasonable potential for a new vulnerability or a significant 
increase in a previously identified vulnerability depends on the circumstances.  For example, if 
you replace a piece of aging equipment with a newer version of the same equipment (i.e., same 
design, features, and specifications), this will most likely have little to no effect on the evaluation 
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of the three fundamental elements and, in most cases, would not constitute a reasonable potential 
for a new vulnerability or a significant increase in a previously identified vulnerability at this 
point, step, or procedure.  On the other hand, if you replace a piece of equipment with a newer 
model that has a different design, different features, or larger capacity, your original evaluation 
of the three fundamental elements is likely outdated.  The significant changes in this equipment 
create a reasonable potential for a new vulnerability or a significant increase in a previously 
identified vulnerability.  This equipment change should trigger a reanalysis of at least the portion 
of the FDP that addresses the vulnerability at this point, step, or procedure to determine whether 
the change has created a new vulnerability or an increase in an existing vulnerability, and 
whether any changes in mitigation strategies are necessary.   
In some circumstances, a permanent equipment change may alter inherent characteristics of a 
processing step to such a degree that a reanalysis of the vulnerability of this step would 
determine that a significant vulnerability no longer exists.  Once the permanent equipment 
change has occurred, you may choose to reanalyze the FDP so that new inherent characteristics 
associated with the process step are considered in determining whether a significant vulnerability 
exists.  If the reanalysis determines that the permanent equipment change results in no significant 
vulnerability now being present at this step, the process step is no longer an actionable process 
step and does not require mitigation strategies.  (See Chapter 2.F for detailed discussion on 
inherent characteristics).  The facility would update the FDP to reflect these changes.   
For example, based on its VA, a facility determines that a liquid holding tank with a hatch at the 
top is an actionable process step because the hatch is accessible via a ladder that is affixed to the 
side of the tank.  A lock is chosen as the mitigation strategy to reduce access to the hatch.  
Subsequently, the facility notices that the hatch is rarely opened and concludes that the ladder on 
the side of the tank is not necessary.  The facility then permanently removes the ladder from the 
tank, which eliminates access to the hatch and changes the inherent characteristics of the tank.  In 
the reanalysis, because physical access (Element 2) to the hatch has been eliminated, the facility 
assigns Element 2 a score of 1.  Based on this reanalysis of the holding tank, the facility 
concludes the holding tank is not an actionable process step and no mitigation strategies are 
needed. 
3.  New Information about Potential Vulnerabilities 
The second trigger for a situational reanalysis is when you become aware of new information 
about potential vulnerabilities associated with your food operation or facility.  (21 CFR 
121.157(b)(2)).  New information about potential vulnerabilities could come from many possible 
sources (e.g., media, the food industry, equipment manufacturers), and may provide information 
related to reanalysis activities for the entire FDP or specific portions of it.  For example, your 
processing line may include a piece of equipment with integrated safety features that you 
considered as inherent characteristics in your VA.  Based in part on the integrated safety 
features, you determine that this process step was not significantly vulnerable and therefore is 
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not an actionable process step.  After conducting your VA, you receive a letter from the 
equipment manufacturer informing you that a newly identified design flaw allows the integrated 
safety features to be easily disabled, providing access to the food.  This new information about a 
potential vulnerability of this equipment requires that you conduct a reanalysis of the relevant 
part of your vulnerability assessment to determine whether a new significant vulnerability is 
present at this process step and whether associated mitigation strategies and management 
components are necessary.  (21 CFR 121.157(b)(2)). 
4.  Improper Implementation  
The third trigger for a situational reanalysis is when you find that a mitigation strategy, a 
combination of mitigation strategies, or the FDP as a whole is not properly implemented.  (21 
CFR 121.157(b)(3)).    
For example, an FDP provides that a mitigation strategy for a bulk liquid storage tank is to use a 
lock to secure the access hatch when unattended or not in use.   
A verification review of food defense monitoring and corrective actions records shows that the 
lock was not consistently being placed on the access hatch to the storage tank (i.e., the hatch on 
the tank was left unlocked on multiple days).  The improper implementation of the mitigation 
strategy triggers a reanalysis.  As a result, the facility might determine that a new mitigation 
strategy is needed (e.g., restrict access to the storage tank to authorized personnel).  Note that if a 
mitigation strategy is changed, mitigation strategy management components (i.e., food defense 
monitoring, corrective actions, and verification) must be reanalyzed because they are dependent 
on the nature of the mitigation strategy.   
You are also required to conduct a reanalysis when the FDP as a whole is not properly 
implemented.  For example, a facility identifies background checks as a mitigation strategy to be 
used in combination with other mitigation strategies for all actionable process steps within the 
facility.  The monitoring procedure is to assess whether the checks were completed prior to 
assigning the employee to an actionable process step.  The corrective actions procedure is to 
conduct the check prior to assigning the employee to an actionable process step if the check has 
not yet been conducted and to reassign an employee who has been assigned to an actionable 
process step without a background check.  A manager discovers that there are no monitoring or 
corrective actions records for the background checks and determines the background check 
program was never implemented.  Further, the manager determines it is no longer feasible to 
implement the program.  In this example, the entire FDP must be reanalyzed because the 
mitigation strategies at each actionable process step were determined to be adequate based on the 
inclusion of background checks which were not conducted.  Without the implementation of 
background checks, the mitigation strategies may not be adequately minimizing or preventing 
the significant vulnerabilities at each actionable process step.   
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5.  Reanalysis Required by FDA 
The final trigger for a situational reanalysis is whenever FDA requires a reanalysis to respond to 
new vulnerabilities, credible threats to the food supply, or new developments in scientific 
understanding.  (21 CFR 121.157(b)(4)).  These new developments could include results from 
the U.S. Department of Homeland Security biological, chemical, radiological or other terrorism 
risk assessments.    
C. Voluntary Reanalysis 
A voluntary reanalysis can occur at any time.  For example, after you have conducted a VA and 
during your consideration of mitigation strategies for an actionable process step, you conclude 
that making a permanent change to the equipment at the process step is the most appropriate and 
cost-effective way to significantly minimize the significant vulnerability at the step.  After the 
permanent equipment change has been made, you can choose to immediately conduct a 
reanalysis of that process step, which may result in a determination that you no longer have a 
significant vulnerability at that process step.     
D. Conducting a Reanalysis 
Once you have determined the need to conduct a reanalysis, you should determine how much of 
the FDP should be reanalyzed.  
Verifying that the FDP is still applicable and relevant and making any necessary changes is the 
focus of reanalysis.  Depending on the reason for the reanalysis, reanalysis activities may 
include: 
  Confirming the accuracy of the product description and flow diagram; 
  Checking for new guidance or information related to vulnerabilities;  
  Ensuring that any changes at the facility are assessed to determine whether there is a 
change in the vulnerabilities; 
  Ensuring that mitigation strategies are operating as intended;  
  Ensuring that mitigation strategies are monitored as specified by the FDP; 
  Ensuring that appropriate corrective actions have been taken and verification activities 
have been completed; 
  Ensuring that records are completed accurately and at the appropriate time intervals. 
 
Determining How Much of the Plan Needs Reanalysis  
A situational reanalysis may include all or part of the FDP, depending on the circumstances.  
Once you have determined that a certain circumstance triggers a reanalysis, you should decide 
whether you need to reanalyze the entire FDP or whether only a part of the FDP is implicated.    
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If you have not reanalyzed your plan for three years, you must reanalyze the entire plan.  Many 
other situations will require that you reanalyze only part of your FDP.  For example, your facility 
adds an entirely new stand-alone production line for a new type of product, and this line has no 
effect on any of the other activities at your facility.  This would trigger a reanalysis because there 
is a potential that this change may create a new vulnerability. (21 CFR 121.157(b)(1)).  Your 
reanalysis should include a VA for this new product and each point, step, or procedure associated 
with it.  (21 CFR 121.130(a)).  Your reanalysis would not need to include parts of the FDP not 
associated with the new production line.  
In another situation, your facility replaces a grinder with a new one with different attributes and 
access controls that trigger a reanalysis because there is a reasonable potential that this change 
may create a new vulnerability or a significant increase in a previously identified vulnerability. 
(21 CFR 121.157(b)(1)).  Your VA was conducted using the Key Activity Types method (see 
Chapter 2.E).  This grinding step aligned with the Mixing and Similar Activities KAT and was 
identified as an actionable process step.  The new grinder would still align with this KAT, but 
you should reanalyze the mitigation strategies previously chosen to determine whether these 
strategies provide assurances that the significant vulnerability at the grinding step will be 
significantly minimized or prevented.  If changes are made to the mitigation strategies, the 
mitigation strategies management components must also be updated. 
E. Timeframe for Completing a Reanalysis 
You must complete a reanalysis of your FDP as a whole within 3 years from the date of your 
previous complete reanalysis. (21 CFR 121.157(a)).  See Section B.1 of this chapter for more 
information on the 3-year reanalysis timeframe.   
To ensure adequate protection of the food at your facility, we recommend that you perform a 
situational reanalysis and make any necessary changes as quickly as possible after you determine 
that a situational reanalysis is needed.  You must complete your reanalysis and implement any 
necessary additional mitigation strategies before changes in activities become operative and, 
when necessary, within 90 calendar days after production.  A time period exceeding 90 days 
after production of the applicable food first begins is permissible if the time period is reasonable 
and a written justification is prepared.  (21 CFR 121.157(c)).  What constitutes a reasonable 
timeframe beyond the 90 day requirement will depend on the relevant circumstances, which you 
should describe in your justification.   
For anticipated changes in your facility (e.g., installation of new equipment, modifications to a 
production line, or adding a new product), you should conduct your reanalysis in advance of 
production, once you have all relevant information to inform the reanalysis.  For example, if you 
are planning on upgrading processing equipment due to advances in technology and the age and 
wear of your existing equipment, you should conduct the reanalysis and implement mitigation 
strategies before the changes you make are operational.  In contrast, if a sudden equipment 
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failure causes you to upgrade processing equipment, you may need additional time to perform a 
reanalysis and implement mitigation strategies.  If necessary, you would have 90 days after 
production with the new equipment begins and a longer time period if reasonable and you 
prepare a written justification.  (21 CFR 121.157(c)(3)).   
F. Documenting the Reanalysis 
If you revise the FDP as a result of a reanalysis, the results of the reanalysis will be reflected in 
your newly signed and dated FDP.  If you conduct a reanalysis and determine that no revisions 
are needed, you must document the basis for this conclusion (i.e., an explanation for why there 
were no changes needed). (21 CFR 121.157(d)).  
 
   
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Chapter 9: 
Records 
This chapter provides guidance on the general recordkeeping requirements that apply to all 
required records, including identifying the records you are required to keep and their format, 
location, and length of required retention.  This chapter also provides recommendations on how 
you can protect your records from unauthorized release and describes FDAs protection of your 
records in our possession.    
A. Required Records 
You are required to make and keep records related to the following:  
  Food defense plan, including vulnerability assessment, mitigation strategies, food defense 
monitoring procedures, food defense corrective actions procedures, and food defense 
verification procedures (21 CFR 121.126(b) and (c)); 
  Documentation of food defense monitoring of mitigation strategies (21 CFR 121.140(c)); 
  Documentation of food defense corrective actions taken (21 CFR 121.145(b)); 
  Documentation of food defense verification activities (21 CFR 121.150(c));  
  Documentation of food defense plan reanalysis (21 CFR 121.157(d)); and 
  Records documenting required training (21 CFR 121.4(e)). 
For detailed guidance on the specific records required, see Chapters 1-8 regarding the food 
defense plan, vulnerability assessment, mitigation strategies, mitigation strategy management 
components, reanalysis, and training.  
B. Generally Applicable Requirements 
You should evaluate which records are required and that are applicable to your facility, and 
develop an approach to complete and maintain the required records.  You must incorporate all of 
the general requirements of 21 CFR 121.305 into each record, as applicable.  (21 CFR 
121.301(a)).  You should ensure that any personnel tasked with developing, creating, 
completing, or reviewing records are aware of the applicable requirements.   
1.  Records Format 
You have the flexibility to maintain your records in multiple formats: original records, true 
copies, or electronic records.  (21 CFR 121.305(a)).  True copies include photocopies, pictures, 
scanned copies, microfilm, microfiche, or any other accurate reproduction of the original record.  
True copies of records should be of sufficient quality to reveal whether the original record was 
changed in a manner that obscured an original entry (e.g., through the use of liquid correction 
fluid).   
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As long as they meet the requirements of 21 CFR 121.305, many types of records are acceptable, 
including original handwritten logs, forms with handwritten entries, and true copies of invoices 
or shipping documentation.  Paper and electronic records can co-exist as long as they both meet 
the records requirements.  Electronic records are subject to the same requirements as paper 
records.   
2.  Accurate, Indelible, and Legible 
Your required records must be accurate, legible, and indelible.  (21 CFR 121.305(c)).  Legibility 
is particularly important for any record involving handwritten entries.  For example, if the only 
person who can interpret the handwriting on a record is the individual who created the 
handwritten part of the record, then you should not consider this record legible.  Indelibility 
markings that cannot be erased or removedis important to ensure that the original content has 
not been altered; therefore, records should not be erasable.  If changes are necessary, your 
personnel should correct the original marking in a way that allows both the original content and 
the updated content to be read; in other words, removing, erasing, or marking over the original 
content in a way that prevents reading is not appropriate.  For example, if an employee writes an 
incorrect time of 12:45 PM in permanent ink, the employee can correct the error by drawing a 
single line through the 12:45 PM, adding the accurate value of 1:45 PM, and writing their 
initials nearby. 
3.  Created when Activity is Performed 
Your required records must be created concurrently with performance of the activity 
documented.  (21 CFR 121.305(d)).  This requirement is intended to ensure that the accuracy of 
recorded information is not impacted because of lapses in memory.  If an individual does not 
immediately document the information related to a record, they may create an inaccurate record 
because they have forgotten the exact activity performed or confused information among 
multiple activities.   
For example, in Scenario 2, a mitigation strategy is to use tamper-evident seals on inbound 
shipping conveyances and match the numbers on the seals with the numbers provided on the 
shipping documentation from the supplier.  The food defense monitoring procedure states: 
Technician assesses whether the seal is intact and matches seal or documentation numbers upon 
arrival of the load, before hooking up the hose for each delivery.  The technician who conducts 
the monitoring should immediately write down whether the seal is intact, whether the seal and 
documentation numbers match, the date and time, and any other relevant information for that 
activity to ensure accuracy of the record. This is an example of using concurrently created 
affirmative records for food defense monitoring; exception records must also be created 
concurrently.  (21 CFR 121.305(d)).   
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4.  As Detailed as Necessary 
Your required records must be as detailed as necessary to provide history of the work performed.  
(21 CFR 121.305(e)).  For example, a facility implements a mitigation strategy of only accepting 
scheduled deliveries from known and secure shippers.  The monitoring record likely should 
include details about the shipment, including the date and time that it arrives, the name and 
drivers license number of the driver, what is delivered in the shipment, and any other details that 
might be helpful for implementing corrective actions procedures and conducting verification.  In 
a scheduled delivery, an employee who is monitoring this step may simply be checking that all 
of this information matches that provided in the scheduled shipment paperwork and indicating 
this with a checkmark, the employees signature, and the date and time.  However, there may be 
an unscheduled shipment that comes in from a known and secure shipper.  In this example, the 
employee would record the additional details described above.   
5.  Information Adequate to Identify the Facility 
Your required records must include information adequate to identify your facility.  (21 CFR 
121.305(f)(1)).  This may include, for example, the facility name, location or address, or facility 
identifying numbers.  We do not specify which identifier must be on the record, only that some 
identifier is included.  If you keep your records offsite or electronically, having facility-
identifying information on records is especially important so that one facilitys records can be 
easily distinguished from those of another facility kept at the same location.   
6.  Date and Time 
You must record the date and, when it is appropriate, the time of the activity documented.  (21 
CFR 121.305(f)(2)).  There may be instances where documenting the time of an activity is not 
necessary.  For mitigation strategies that are not time-dependent, facilities are likely not required 
to document the time the activity was performed.  Food defense monitoring records are an 
example of when documenting the time of the activity may be appropriate.   
 
For example, in Scenario 3, a quality control manager visually inspects the liquid food storage 
tank immediately before reintroducing food to ensure that no contaminant has been added to the 
tank while it was open and accessible after cleaning.  When monitoring this mitigation strategy, 
the QA technician documents on the storage tank cleaning sign-off form, the date and time that 
the tank was inspected before the food was added to the tank.  (See Table 4-7 in Chapter 4).  The 
liquid storage tank is cleaned on a time-dependent schedule (e.g., every 48 hours), so 
documenting the date and time of this activity is critical for food defense monitoring to assess 
whether the mitigation strategy is operating as intended.   
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7.  Signature or Initials of the Individual Performing the Activity Recorded 
Each required record must include the signature or initials of the person who performed the 
activity recorded.  (21 CFR 121.305(f)(3)).  This ensures that you can identify the individual who 
performed the activity recorded and that the activity is not recorded as completed based on the 
assumption that someone else performed the activity.  While this provision allows for the use of 
initials instead of a signature, there may be circumstances in which initials alone may be 
confusing.  For example, if you have multiple employees with the same initials (e.g., John Dab, 
Jane Dell, and Jennifer Doe), your policies or procedures may direct those employees to sign 
their full name or provide some additional identifier (e.g., JD1 or J. Dab or JWD) instead 
of using only their first and last initials.  Such policies or procedures could help to provide clarity 
if you, a supervisor, or another responsible party need to quickly determine who performed a 
particular activity. 
8.  Identity of Product and Lot Code 
Where appropriate, your records must include the identity of the product and the lot code, if any.  
(21 CFR 121.305(f)(4)).  The identity of the product and the lot code in your records may be 
helpful for linking a record to a specific product and, when applicable, the lot code would enable 
you to isolate a product if necessary. 
C. Additional Requirements for Food Defense Monitoring 
In addition to the requirements described in Section B above, your food defense monitoring 
records must contain the actual values and observations obtained during the monitoring.  (21 
CFR 121.305(b)).  Vague or generalized notations provide minimal information and make it 
difficult for reviewers to verify compliance, note potential trends, or identify deviations.   
You have the flexibility to tailor the amount of detail recorded based on the nature of the record.  
However, you should ensure that your monitoring records include actual observations with 
sufficient detail to allow accurate assessment of the performance of your mitigation strategies.  
These records will assist you in determining the extent to which, and identifying when and how, 
a mitigation strategy was not properly implemented, and whether the mitigation strategy is 
appropriate to the actionable process step.  For example, you identify a mixer as an actionable 
process step.  The mitigation strategy you implement is to use a lock to secure the access hatch 
on the mixer.  During monitoring, an employee could record yes or no in response to 
whether the lock was locked.  If the lock was unlocked, a facility may choose to document 
additional observations.  For example, the record may state: the lock was on the access hatch 
with the key in the keyhole, but the lock was not engaged or the lock was removed from the 
access hatch and placed on a surface adjacent to the mixer.   
As another example, one of the mitigation strategies implemented at an actionable process step at 
an unloading bay where bulk liquids are received is to maximize visibility through use of 
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adequate lighting in the truck unloading bay.  Personnel performing food defense monitoring of 
the adequate lighting at a truck unloading bay could record yes or no in response to one or 
more items in either a narrative or checklist format.  The employee may also choose to record the 
actual observations that provide sufficient detail to assess the extent to which the strategy was 
not operating as intended.  If the employee sees that half of the lights in bay number 5 are not 
illuminated, then he would document this in the record.  This information would be helpful to 
facility management to first identify the source of the problem (i.e., why the lights were not 
illuminated) and then to determine whether the mitigation strategy is properly implemented and 
appropriate to the actionable process step in question.  In this case, the employee performing 
monitoring may also document that he observed that the switches controlling the relevant light 
fixtures had been turned off.   
D. Additional Requirements for the Food Defense Plan 
The FDP is a record and must comply with all of the generally applicable records requirements.  
(21 CFR 121.126(c)).  In addition, the owner, operator, or agent in charge of the facility must 
sign and date the FDP upon completion and upon any modification.  (21 CFR 121.310).  For 
example, if you conduct a reanalysis, and it results in changes in the FDP, the owner, operator, or 
agent in charge of the facility must sign and date the new FDP.  (21 CFR 121.310(b)).  
E. Record Retention Requirements  
You are required to retain records for at least 2 years after they were prepared.  (21 CFR 
121.315(a)(1)).  You must retain a food defense plan for 2 years after you have stopped using it.  
(21 CFR 121.315(b)).  
Records must be retained at the facility for as long as necessary to support the facilitys very 
small business (VSB) status for the applicable calendar year. (21 CFR 121.315(a)(2)).  FDA 
considers this to be 2 years from the applicable calendar year (21 CFR 121.5(a)).  For example, if 
the applicable calendar year is 2023, FDA would expect that the required records from the 
previous 3 years (2020-2022) would be kept at the facility until 2025 (i.e., 2 years after the 
applicable calendar year).   
F. Offsite Storage of Records  
You have the flexibility to store your records in a way that allows you to easily access them as 
necessary and to organize them consistent with your operating procedures.  You should evaluate 
how frequently you need to access your records and how you use them at your facility, and then 
develop a record management strategy that best fits your needs.   
You can store required records, except for the FDP, either at your facility (i.e., onsite) or 
offsite (i.e., away from your facility), as long as you can retrieve and provide them onsite within 
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24 hours of an FDA request for official review.  (21 CFR 121.315(c)).  For example, if you have 
multiple facilities at different locations, you may choose to keep relevant records at each site or 
consolidate all records from each site at a single location.  Alternatively, you may store certain 
records for each site at that site while storing other records at a central office.  As another 
example, your facility may generate some daily records that you need to easily access for a 
period of time, such as one month.  After that time, you may choose to transfer the records for 
long-term storage to a central storage location that is not part of your facility.   
Note that the FDP must remain onsite.  (21 CFR 121.315(c)).  Electronic records, including the 
FDP, are considered onsite if they are accessible from an onsite location.  (21 CFR 121.315(c)).  
If your facility is closed for a prolonged period, you may transfer the FDP to some other 
reasonably accessible location but you must be able to retrieve it and make it available within 24 
hours of an FDA request.  (21 CFR 121.315(d)). 
G. Existing Records 
You may use existing records kept for other purposes (e.g., records that you have already 
developed and maintain during your normal course of business, including for compliance with 
other Federal, state, or local regulations, or for any other reason) to meet the requirements of the 
IA rule, if those records contain all of the required information and satisfy all of the requirements 
of the IA rule.  (21 CFR 121.330(a)).  You may supplement existing records as necessary to 
include all of the required information.  In addition, you do not need to keep all of the 
information required by this rule in only one set of records, nor do you need to duplicate already 
existing records.  
If existing records contain only some of the required information, you may keep any additional 
information this rule requires either separately or in combination with the existing records (21 
CFR 121.330(b)).  For example, if your facility had already conducted a VA prior to the 
publication of the IA rule and you have records that document the public health impact 
determinations for each of the points, steps, and procedures on all your food processing lines, 
you may use those records as a part of your VA records, assuming that those public health 
impact determinations are calculated correctly and still relevant.  If so, you could use the existing 
records to comply with the VA component required under 21 CFR 121.130(a)(1).  In some 
instances, you may also use existing food safety records for IA rule compliance.  For example, 
you may have records that document that a liquid food storage tank has been cleaned for food 
safety and sanitation purposes prior to use for food processing.  As seen in Scenario 3, a 
mitigation strategy at this same step is to inspect the liquid food storage tank prior to use to 
ensure no contaminant has been added after cleaning and prior to the introduction of food.  If the 
tank is checked prior to use for food safety reasons, you can use the same monitoring records for 
both food safety and for food defense.  If you choose to use existing food safety records for some 
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or all of your required records, you should indicate the use of existing records in the appropriate 
section of the FDP.  (See Table 4-7 in Chapter 4). 
In some cases, there may be several ways (i.e., using several different types of existing records) 
for you to document compliance with a specific requirement of the IA rule.  For example, to 
document your status as a VSB, you may find that your existing invoices, tax records, and other 
financial records each provide the necessary information to meet the requirement; therefore, you 
would only need to provide one of these types of records to satisfy the requirement for 
documentation, as long as it includes all of the necessary information.   
H. Protecting Records  
FDPs, as well as many other required records, contain information about your facilitys potential 
vulnerabilities and may contain other sensitive information related to food defense.  As such, it is 
important for you to protect your facilitys FDP and any accompanying records from improper or 
unauthorized disclosure.   
1.  Protection of Records in FDAs Possession 
You must have all required records, including your FDP, available for official review and 
copying upon oral or written request of an authorized official.  (21 CFR 121.320).  FDA will 
copy or collect records when, for example, FDA investigators need assistance reviewing a 
certain record from other FDA subject matter experts.  Records that FDA obtains to determine 
compliance with this rule will be protected from public disclosure to the extent allowable under 
21 CFR part 20 and other applicable statutory and regulatory provisions.  (See 21 CFR 121.325).    
FDPs generally will include information that meets the definition of trade secret in 21 CFR 
20.61(a).  FDAs general policies, procedures, and practices relating to the protection of 
information received from third parties also apply to information we receive pursuant to this rule.   
2.  Protection of Records at the Facility   
Because of the sensitive nature of some food defense information, we recommend that you limit 
access to your facilitys FDP and associated records to only those trusted individuals who have a 
need to see or access the records to perform an assigned duty at the facility.  Examples of 
limiting access may include: keeping hard copies of records in a secure location (e.g., locked 
drawer) when not in use; maintaining electronic records on updated operating systems with 
current antivirus software and establishing password protection; and ensuring that access is 
controlled when employees change duties or cease employment with your facility.  
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Appendix 2: Mitigation Strategies in the Food Defense Mitigation Strategies 
Database  
FDAs online Food Defense Mitigation Strategies Database (FDMSD) contains a collection of 
potential mitigation strategies that could be implemented to significantly minimize or prevent 
significant vulnerabilities at actionable process steps.  This collection of strategies was 
developed in collaboration with other government partners and food industry representatives 
who participated in the vulnerability assessments that FDA conducted.  The FDMSD is intended 
as a starting point for facilities to consider when identifying potential mitigation strategies.  
Facilities can customize and tailor strategies listed in the FDMSD to apply to their specific 
circumstances.  Use of the FDMSD is voluntary.  Chapter 3 of this guidance includes details 
about the requirements for mitigation strategies and information to help you identify and 
implement mitigation strategies for the actionable process steps identified during your 
vulnerability assessment.   
The FDMSD includes mitigation strategies for some common points, steps, and procedures that 
are often found at facilities covered under the IA rule.   
The FDMSD is not an exhaustive list of potential mitigation strategies or associated points, steps, 
or procedures; facilities have the flexibility to identify and implement mitigation strategies that 
are not contained in the FDMSD.  Although in some instances, a single strategy may be 
sufficient to significantly minimize or prevent significant vulnerabilities, some strategies in the 
FDMSD may not be suitable alone and may need to be complemented with additional 
strategy(ies) to sufficiently reduce significant vulnerabilities at an actionable process step. The 
content in this appendix is the same on the FDMSD.  The FDMSD can be accessed at 
https://www.fda.gov/food/food-defense-tools-educational-materials/mitigation-strategies-
database. 
Appendix Organization 
The mitigation strategies within the FDMSD are organized by category, subcategory (if 
applicable), and points, steps, or procedures.  In this Appendix, we list the categories and 
subcategories (if applicable), and the points, steps, and procedures under each 
category/subcategory.  We also provide a table (Table 2) that includes the mitigation strategies 
and the associated categories under which they appear in the FDMSD.  The mitigation strategies 
are listed in the left column, and the categories are listed across the top row.  An X indicates 
that the mitigation strategy is associated with a point, step, or procedure in that category. 
The categories are: 
  Conveyance 
  Material Handling 
  Packaging 
  Processing 
  Storage 
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  Transportation/Distribution  
  Key Activity Types (KAT) 
 
Some categories include subcategories.  For example, under the Processing category there are 
several subcategories (e.g., Chilling/Cooling, Cooking/Heating, and Cutting/Grinding).  Table 1 
includes the points, steps, and procedures organized by categories and subcategories (if 
applicable).  There are no points, steps, or procedures under the Key Activity Types (KAT) 
category.  See Chapter 2.D for descriptions of each of the KATs and the general activities that 
fall under each KAT.  
Table 1. Points, Steps, or Procedures by Category/Subcategory 
Below is the list of the categories and subcategories (if applicable), and the points, steps, and 
procedures under each category/subcategory. 
Category  Subcategory  Points, Steps, or Procedures 
Conveyance   None  Bin Dumping; Blower; Conveyor Belt; Conveyor, 
Bucket; Conveyor, Pneumatic; Direct Line; Flume; 
Forklift; Hose; In-Feed Conveyor; Pump; Tote, 
Conveyance; Valve; Valve Matrix 
Material Handling  None  Ingredient Addition; Ingredient Preparation; 
Measuring; Premixing; Processing Aids; Reject 
Materials; Reworked Product; Staging, Dry 
Ingredients; Staging, Liquid Ingredients; Weighing 
Packaging  Packaging Materials  Bags; Bottles; Boxes; Cans; Drums; Paper; Plastic 
Container; Plastic Wrap; Pouches; Super Sack 
Packaging  Packaging Processes  Aseptic Packager; Bottle Hopper; Bottler, Capper; 
Caser; Hand/Manual Packer, Labeler; Modified 
Atmospheric Packaging; Packer, Packager; 
Palletizer, Sacker; Scanner; Sealer; Seamer; Shrink 
Bander; Shrink Wrapper; Vacuum Sealer 
Processing  Chilling/Cooling  Blast Freezer; Chiller/Cooler; Cold Press; Cooling 
Tunnel; Freezer; Hydro-Cooler; Spray Cooler 
Processing  Cooking/Heating  Blancher; Boiler; Broiler; Browner; Cooker; 
Evaporator; Fryer; Heat Exchanger; Heater; Hot 
Press; Incinerator; Microwave; Oven/Baking; 
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Pasteurizer; Pre-Heater; Proofer; Renderer; Retort; 
Roaster; Rotary Cooker; Scalder; Screw Cooker; 
Singer; Smoker; Sterilizer; Thermal Processor 
Processing  Cutting/Grinding  Chopper; Corer; Cracker/Breaker; Crusher; Cutter; 
Dicer; Disintegrator; Flaker; Grinder; Husker; Mill; 
Peeler/Parer; Pulper; Pulverizer; Shredder; Splitter; 
Trimmer 
Processing  Drying  Air Dryer; Drum Dryer; Dryer; Freeze Dryer; 
Osmotic Dryer; Spin Dryer; Spray Dryer 
Processing  Filling  Drum Filler; Filler; Load Out Spout; Tank Truck 
Filler 
Processing  Meat Processing  Butcher; Eviscerater; Scraper; Slaughter; Stuffer 
Processing  Mixing  Blender; Homogenizer; In-Line Mixer; 
Liquefier/Emulsifier; Mixer 
Processing  Other Processing  Batterer; Bottle Cleaner/Soaker; Breader; Briner; 
Coater; Concentrator; Condenser; Disinfecting 
Equipment; Dry Ice Blaster; Enzyme Treatment; 
Finisher; Fluidized Bed; Formulator; Fruit 
Processing; Glazer; Hopper; Hopper, Meter; Hopper, 
Surge; Husker; Inversion Equipment; Ion 
Exchanger; Magnet; Metal Detector; Pitter/Destoner; 
Rinsing Equipment; Sheller; Stemmer; Tempering; 
Vacuum Pump; Washer; Waxer 
Processing  Processing Tanks  Auger Tank, Balance Tank, Batch Tank, Blend 
Tank, Cooling Tank, Culturing Tank, Make-up 
Tank, Mixing Tank, Neutralization/Buffer Tank, 
Reaction Tank, Standardization Tank; Vacuum 
Tank, Wetting Tank 
Processing  Separation/Extraction  Centrifuge; Clarifier; Decanter; Distiller; Drainer; 
Entolator; Extractor; Filter; Freeze Concentrator; 
Grader, Size; Gravity Separator; Osmotic Filter; 
Screen; Separator; Sifter; Skimmer; Solvent 
Extractor; Sorter 
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Processing  Sizing/Shaping  Former; Granulator; Press; Roller; Standardizer 
Storage  None  Bin/Tub; Bulk Storage; Drum Storage; Dry Storage; 
Dump Pit; Equipment Storage; Holding Tank; 
Ingredient Storage; Liquid Storage; Metering Tank; 
Product Storage; Refrigerated/Frozen Storage; Silo 
Storage, Liquid; Storage Tank, Dry/Solid; Silo 
Storage, Solid; Storage Tank, Liquid; Storage Tank, 
Refrigerated; Surge Hopper; Surge Tank; Thaw 
Room; Tote, Storage; Warehouse; Warehouse, 
Refrigerated/Frozen 
Transportation/  None  Distribution/Transport; Hopper Truck; LTL (Less-
than Truckload); Liquid Loading; Liquid Receiving; 
Distribution 
Loading Materials at Multiple Stops; Railcar; 
Receiving; Refrigerated Transport; Shipping; Tanker 
Truck; Vehicle Storage; Transportainer; Truck; 
Vehicle Cleaning; Vehicle Loading; Stock Truck; 
Vehicle Maintenance; Vehicle Unloading 
Key Activity Types  Bulk Liquid Receiving  None 
and Loading 
Key Activity Types  Liquid Handling and  None 
Storage 
Key Activity Types  Mixing and Similar  None 
Activities 
Key Activity Types  Secondary Ingredient  None 
Handling 
 
     
       
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Table 2.  Mitigation Strategies and Associated Categories 
 
#  Mitigation Strategies   Conveyance Material  Handling  Packaging  Processing  Storage ransportation/ Distribution Key Activity  Types (KATs)
T
1  Clean / sanitize equipment and components periodically  X  X  X  X  X  X  X 
(e.g., immediately prior to use, after maintenance) 
2  Clean / sanitize locations immediately around the step  X  X  X  X  X  X  X 
periodically (e.g., immediately prior to use, after 
maintenance, when security devices are breached) 
         
3  Conduct periodic checks of both vehicle and products  X  X 
prior to loading/unloading for suspect items (e.g., seals 
not present or intact; product and packaging integrity 
compromised; abandoned, removed, or returned items; 
lacks proper identification; lacks proper documentation) 
4  Conduct periodic checks of package integrity (e.g.,  X  X  X  X  X  X  X 
upon receipt and prior to use), including for products, 
ingredients, and processing aids 
         
5  Keep one authorized operator with transportation  X  X 
vehicle at all times (e.g., use relay operators, relief 
driver, team driving) 
6  Maximize visibility of operations, equipment, and  X  X  X  X  X  X  X 
locations (e.g., install mirrors, light adequately, keep 
area clear of visual obstructions) 
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#  Mitigation Strategies   Conveyance Material  Handling  Packaging  Processing  Storage ransportation/ Distribution Key Activity  Types (KATs)
T
         
7  Require driver check-ins  X  X 
         
8  Restrict access of drivers to specified locations  X  X 
9  Restrict access to equipment and controls to authorized  X  X  X  X  X  X  X 
personnel  
10  Restrict access to ingredients, products, and/or cargo to  X  X  X  X  X  X  X 
authorized personnel  
11  Restrict access immediately around the step to  X  X  X  X  X  X  X 
authorized personnel  
12  Restrict access to openings or access points (e.g., to  X  X  X  X  X  X  X 
bins, tanks, vats, ports/valves, inspection points, system 
openings) to authorized personnel 
     
13  Restrict access to supplies (e.g., containers/tanks/sacks,  X  X  X  X 
packaging, coverings, trays, pads, wrappings, uniforms, 
gloves) to authorized personnel  
       
14  Restrict access to transport operations to authorized  X  X  X 
personnel  
15  Restrict operations to authorized personnel   X  X  X  X  X  X  X 
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#  Mitigation Strategies   Conveyance Material  Handling  Packaging  Processing  Storage ransportation/ Distribution Key Activity  Types (KATs)
T
       
16  Schedule deliveries (e.g., schedule departure/arrival  X  X  X 
time, confirm driver identity, confirm on-time delivery, 
and report schedule deviation) 
         
17  Use a dedicated trip plan that schedules stops at well-lit  X  X 
and public locations, prohibits unscheduled/unattended 
stops, and requires reporting of unscheduled stops 
   
18  Store equipment and components (e.g., bins, scoops,  X  X  X  X  X 
measuring cups) in a secured location 
   
19  Store ingredients and products in a secured location  X  X  X  X  X 
20  Use an alarm system to alert access breaches to  X  X  X  X  X  X  X 
location, equipment, controls, and coverings for 
openings or access points (e.g., contact, motion, 
infrared) 
21  Use an alarm system to detect suspect events (e.g.,  X  X  X  X  X  X  X 
motion detection in restricted area where personnel 
should not be present) 
22  Use automated equipment (e.g., for dispensing,  X  X  X  X  X  X  X 
injection, incorporating, packing) to restrict access to 
product 
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#  Mitigation Strategies   Conveyance Material  Handling  Packaging  Processing  Storage ransportation/ Distribution Key Activity  Types (KATs)
T
23  Use Clean in Place (CIP) equipment and prescribed CIP  X  X  X  X  X  X  X 
procedures (e.g., pre-rinse, wash, post-rinse, drain, and 
sanitize) 
24  Use coverings to secure openings, access points and  X  X  X  X  X  X  X 
open systems/operations (e.g., shrouds, covers, lids, 
panels, seals) to restrict access to product 
25  Use electronic access control system to restrict access to  X  X  X  X  X  X  X 
location and/or controls (e.g., cipher lock, swipe cards, 
biometric devices, RFID) 
         
26  Use GPS/RFID (Radio Frequency Identification) or  X  X 
similar security measures to track transport vehicles 
27  Use locks to secure location, equipment, and controls  X  X  X  X  X  X  X 
when not in use or unattended (e.g., use tamper-proof 
containers, locks) 
28  Use one-way valves, sample ports to restrict access to  X  X  X  X  X  X  X 
product 
29  Use peer monitoring (e.g., buddy system) during  X  X  X  X  X  X  X 
operations  
           
30  Use peer monitoring (e.g., buddy system) to supervise  X 
deliveries 
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#  Mitigation Strategies   Conveyance Material  Handling  Packaging  Processing  Storage ransportation/ Distribution Key Activity  Types (KATs)
T
31  Use personnel (e.g., guards, supervisors, trusted  X  X  X  X  X  X  X 
employees) for visual observation  
32  Use personnel identification (e.g., color coded uniforms,  X  X  X  X  X  X  X 
badges) to clearly identify authorized personnel around 
restricted locations, equipment, controls, and operations 
33  Use physical barriers to restrict access to location,  X  X  X  X  X  X  X 
operations, and equipment (e.g., locate in secure room, 
enclose with a fence, cage, gate, ladder locks, or panel) 
         
34  Use packaged, pre-measured portions for food additives  X   
and ingredients to minimize access to these materials 
while weighing/measuring 
       
35  Use tamper-evident packaging (e.g., self-voiding tape,  X  X  X 
shrink wrapped pallets) 
36  Use surveillance equipment (e.g., cameras) to increase  X  X  X  X  X  X  X 
observation   
37  Use tamper-evident devices (e.g., seals, covers, locks)  X  X  X  X  X  X  X 
to secure openings, access points, equipment and 
components 
38  Use tamper-evident devices (e.g., seals, covers, locks)  X  X  X  X  X  X  X 
to secure packaging and storage containers 
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#  Mitigation Strategies   Conveyance Material  Handling  Packaging  Processing  Storage ransportation/ Distribution Key Activity  Types (KATs)
T
         
39  Use tamper-evident devices (e.g., seals, covers, locks)  X  X 
to secure transport operations or vehicles 
40  Visually inspect equipment, equipment components,  X  X  X  X  X  X  X 
and supplies prior to use  
41  Prohibit personal items from production, storage or  X  X  X  X  X  X  X 
other restricted areas 
42  Accept goods and packages that includes proper            X  X 
documentation review, screening procedures and chain-
of-custody 
 
  
   
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Appendix 3: Determination of Status as a Very Small Businesses or Small 
Businesses Under Part 121: Mitigation Strategies to Protect Food Against 
Intentional Adulteration  
The IA rule includes an exemption for very small businesses.  Small businesses are subject to the 
full requirements of the IA rule but are given additional time to comply.  Both very small 
business and small business are defined in the rule (see 21 CFR 121.3).  Section I of this 
appendix explains how to determine whether you are a very small business, and Section II of this 
appendix explains where to find guidance regarding determining the number of employees for 
purposes of the small business definition.  
The process to determine whether your facility is a very small business for the purposes of Part 
121 is the same as for determining whether a facility is a very small business for purposes of 
Parts 117 and 507 (Preventive Controls rules).  We have addressed the latter in previous 
guidance.  See Determination of Status as a Qualified Facility Under Part 117: Current Good 
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food 
and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Food for Animals, which can be found at: 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-
determination-status-qualified-facility.  Because the dollar threshold for being a very small 
business in Part 121 is higher than for Parts 117 and 507, in this guidance we use higher dollar 
amounts in example calculations.  In addition, we have made editorial changes and shortened the 
length of this guidance as compared to the guidance for the Preventive Controls rules.  
I.  Very Small Business Under the IA Rule 
The IA requirements do not apply to a very small business, except that a very small business 
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)).   
A. Definition of Very Small Business Under Part 121 
1.  How does part 121 define very small business?  
Very small business means, for purposes of the IA rule, 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).  See the 
definition of very small business in 21 CFR 121.3.    
2.  How does part 121 define affiliate? 
Part 121 defines affiliate as any facility that controls, is controlled by, or is under common 
control with another facility. See the definition of affiliate in 21 CFR 121.3. 
3.  How does part 121 define subsidiary? 
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Part 121 defines a subsidiary as any company which is owned or controlled directly or indirectly 
by another company. See the definition of subsidiary in 21 CFR 121.3. 
4.  Who determines whether my business meets the definition of a very small 
business under part 121?  
You are responsible for determining whether your business meets the definition of a very small 
business under part 121, subject to verification by FDA.  Although we do not intend to review 
financial records supporting your status as a very small business during routine inspections, you 
must, upon request, provide for official review of documentation sufficient to show that the 
facility meets this exemption (21 CFR 121.5(a)). 
5.  Can a facility that is a subsidiary meet the definition of very small business 
under part 121 even if its parent company is not a very small business?  
Yes. It is possible for a facility that is a subsidiary to be a very small business even if its parent 
company is not a very small business because not all human food sold or manufactured, 
processed, packed, or held without sale by the parent company is counted in a subsidiary 
facilitys calculation of whether it is a very small business.  Specifically, a subsidiary facility 
only includes operations of the parent company in the calculation if the parent company is an 
affiliate of the subsidiary facility. 
 
Figure 1  
 
COMPANY P 
 
 
Facility B  Farm C 
 
$6 M  $5 M 
 
 
 
 
Company S is a 
  subsidiary of Company P 
 
COMPANY S 
 
  Facility A 
$3 M 
 
 
 
In the example in Figure 1, a subsidiary (Company S) consists of Facility A with $3 million in 
annual human food sales.  The subsidiarys parent Company P includes Facility B, a 
manufacturer/processor with $6 million in annual human food sales, and Farm C with $5 million 
in annual human food sales.  Facility A would include Facility Bs sales in its calculation 
because Facility B is an affiliate of Facility A.  Facility A would not include Farm Cs sales in its 
calculation because Farm C is not an affiliate or a subsidiary.  Therefore, Facility A would 
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determine that it has $9 million ($6 million + $3 million) in annual human food sales for its 
business.  If the average over three years was less than $10 million adjusted for inflation for the 
most recent of the three years, then Facility A would be a very small business.  
 
Facility Bs calculation to determine whether it is a very small business would be different. 
Facility B would include its own sales ($6 million) plus Farm Cs sales ($5 million) because 
Farm C is part of the same company (Company P).  Note that a subsidiary is not considered to be 
part of the same company as its parent company for this calculation.  Facility B would also 
include Facility As sales ($3 million) because Facility A is a subsidiary of the parent Company 
P that includes Facility B. Therefore, Facility B would determine that it has $14 million in annual 
human food sales for its business.  (Note, in this example none of the entities have human food 
manufactured, processed, packed, or held without sale that must be included in the calculation).  
 
6.  What does food manufactured, processed, packed, or held without sale mean 
in the definition of very small business in part 121?  
Food manufactured, processed, packed, or held without sale means any food for human 
consumption that you manufacture, process, pack or hold at your facility and do not offer for 
sale.  This does not include food that you will sell at a later date.  Examples of food 
manufactured, processed, packed, or held without sale include food held for a fee (e.g., by a 
warehouse), food processed for a fee (e.g., by a contract processor (such as a facility that 
irradiates spices)), and food packaged for a fee (e.g., by a contract packager). 
B. Calculations to Determine Status as a Very Small Business Under Part 
121 
1.  Which products do I include in, and which products do I exclude from, the 
calculation of annual sales plus market value to determine my status as a very small 
business under part 121?  
Include all human food, including food manufactured, processed, packed, or held by all 
subsidiaries and affiliates, regardless of whether the human food is subject to part 121.  For 
example, you would include fruits and vegetables on a produce farm that is exempt from the rule 
under 21 CFR 121.5(d).  Likewise, you would include human food subject to the jurisdiction of 
the U.S. Department of Agriculture (e.g., meat products for human consumption).  You do not 
need to include the value of food that you have processed but not yet sold.  Do not include 
animal food or other items not intended for human consumption. 
 
2.  Do I include human food sold in countries other than the United States in the 
calculation of total sales?  
Yes.  Include sales of all human food in the calculation of total sales, regardless of where the 
food is sold.  For example, if you are a domestic facility and you export some of your food to 
other countries, you would include sales of food for export in your calculation of total annual 
sales.  If you are a foreign facility, you would include sales of human food in all countries, 
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including sales in your own country, sales in the United States, and sales in other countries.  See 
Question I.B.8 on what currency conversion rates to use for a foreign facility. 
 
3.  How do I determine whether my average annual sales plus market value of human 
food manufactured, processed, packed, or held without sale is under the inflation-
adjusted cut-off?  
We have outlined what we believe to be the simplest method below.  You are free to choose a 
different method (e.g., deflating average annual sales to 2011-dollars).  
  
One method of determining whether your annual sales plus market value of human food 
manufactured, processed, packed, or held without sale is below the inflation-adjusted threshold 
for a very small business is to:  
 
  Determine which three years to include in the average;  
  Determine annual sales and market value of food manufactured, processed, packed, or 
held without sale for each of the three years;  
  Calculate the average for the three years; and  
  Determine whether your three-year average is less than $10,000,000 adjusted for 
inflation by comparing your average to the three-year average value posted on FDAs 
website at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-
inflation-adjusted-cut-offs.  
 
4.  How do I determine which three years to include for determining the inflation-
adjusted average annual sales plus market value of human food?  
The definition of a very small business (21 CFR 121.3) specifies that the average is based on the 
three-year period preceding the applicable calendar year.  The applicable calendar year is the 
current year.  If the current year is 2019, the three preceding calendar years would be 2016, 
2017, and 2018.  
 
See question I.B.5 if you dont have three years of financial records to use for your calculations. 
 
5.  How do I determine average annual sales plus market value of human food if I dont 
have three years of financial documentation to use for my calculations?  
Note that if you have been operating for three years prior to the IA rule applying to you, it is 
likely that you have financial records kept for other purposes (e.g., accounting, taxes, calculating 
size under Part 117).  If you have just begun operations, we recommend you project average 
annual sales plus market value of human food for your first three years of operation.  After you 
have been operating for one or more years, you could make the calculation based on the records 
you have (i.e., for one or two preceding calendar years).   
 
6.  How do I determine annual sales of human food?  
Determine your annual sales using resources such as:  
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  Tax Forms, e.g. Gross Receipts or Sales (Line 1a) from Internal Revenue Service (IRS) Form 
1120;  
  Accounting documents, e.g., Total Sales or Revenues from an Income Statement; or  
  Invoices and bills of lading.  
 
You should not adjust the total sales for the year to include the cost of the sales  for example, 
you should not adjust total sales for the cost of labor.  
 
Table 1 provides an example of determining annual sales for Business L for the years 2016-2018 
based on tax documents.  Business L does not process, pack, or hold human food without sale, 
and, thus, does not calculate market value.  Business L consists of a facility (Facility L) that does 
not have any subsidiaries or affiliates.  
 
Table 1: Determining Annual Sales of Human Food for Business L for the Years 2016-2018  
 
Source  2016  2017  2018 
Facility L: Gross Sales of  $8,000,000   $8,005,000   $9,000,000  
Human Food (Item 1a, 
IRS Form 1120)  
Facility L: Market Value  Not Applicable*   Not Applicable*  Not Applicable* 
of Human Food 
Manufactured, Processed, 
Packed, or Held Without 
Sale  
Total Non-Inflation  $8,000,000   $8,005,000   $9,000,000  
Adjusted Annual Sales + 
Market Value of Human 
Food Manufactured, 
Processed, Packed, or 
Held Without Sale  
*There is no entry for market value of human food manufactured, processed, packed, or held 
without sale because Facility L does not manufacture, process, pack, or hold human food without 
sale.  
 
Table 2 below provides a more complex example of determining annual sales for Business M for 
the years 2016-2018 based on tax documents.  Business M consists of Facility M and one 
affiliate (Affiliate M1), which produced and sold human and animal food.  Neither Facility M 
nor Affiliate M1 manufactures, processes, packs, or holds human food without sale and, thus, 
neither Facility M nor Affiliate M1 calculates market value. 
Table 2. Determining Annual Sales of Human Food for Business M (Facility M and its 
Affiliate) for the Years 2016-2018 
Source   2016  2017  2018  
Facility M: Gross Sales of  $8,000,000  $8,005,000  $9,000,000 
Human Food (Derived 
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from Item 1a, IRS Form 
1120)  
Facility M: Market Value  Not Applicable*    Not Applicable*  Not Applicable* 
of Human Food 
Manufactured, Processed, 
Packed, or Held Without 
Sale  
Affiliate M1: Gross Sales  $1,900,000   $2,000,000   $2,000,000  
of Human Food (Item 1a, 
IRS Form 1120)  
Affiliate M1: Market  Not Applicable*  Not Applicable*  Not Applicable* 
Value of Human Food 
Manufactured, Processed, 
Packed, or Held Without 
Sale  
Affiliate M1: Gross Sales  $500,000**  $550,000**  $600,000** 
of Animal Food (Derived 
from Item 1A, IRS Form 
1120)  
Total Non-Inflation  $9,900,000   $10,005,000   $11,000,000  
Adjusted Annual Sales + 
Market Value of Human 
Food Manufactured, 
Processed, Packed, or 
Held Without Sale  
*There is no entry for market value of human food manufactured, processed, packed, or held 
without sale because neither Facility M nor Affiliate M1 manufactures, processes, packs, or 
holds human food without sale. 
**Gross sales of animal food is not included in the calculation because the total annual sales 
includes only human food.  
7.  How do I determine the market value of human food manufactured, processed, 
packed, or held without sale?  
Use the value of the food, not the fee for the service (e.g., for holding, processing, or packing), to 
calculate the market value of food that you manufacture, process, pack or hold without sale. We 
recommend you determine the market value of human food manufactured, processed, packed, or 
held without sale by considering factors such as:  
 
  The market value of incoming food obtained from the customer for whom the food is 
being manufactured, processed, packed, or held;  
  The amount of insurance that a warehouse holds for its products;  
  The value obtained by multiplying market price by volume of food manufactured, 
processed, packed, or held; or  
  Assets on a balance sheet.  
 
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See Section I.C of this appendix for examples of how to determine market value for human food 
manufactured, processed, packed, or held without sale.  The examples describe the calculation 
for a cold storage warehouse that holds human food.  In one example (Question I.C.1), the 
warehouse calculates market value using the value of an insurance policy.  In a second example 
(Question I.C.2), the same warehouse calculates market value using the market value of 
incoming food using information or accounting documents from the customer.  In these 
examples, the warehouse reaches the same conclusion regardless of the method used to do the 
calculation. 
8.  What conversion rate should a foreign facility use when converting annual sales 
plus market value of human food to U.S. dollars?  
A foreign facility should use the exchange rate in effect as of the ending date of the period during 
which it collected the reported receipts or sales.  For example, for sales during 2019 a foreign 
facility would use the conversion rate in effect on December 31, 2019.  
9.  What documentation must I keep to demonstrate my facilitys status as a very 
small business under part 121?  
The IA rule requires that you keep documentation sufficient to show that your facility qualifies 
as a very small business, but does not otherwise specify the types of documentation that you 
must keep.  (see 21 CFR 121.5(a)).  You should keep the documentation that you use to 
determine your annual sales and the market value of human food manufactured, processed, 
packed, or held without sale.  You also should keep documentation of the actual calculations that 
you make.  You must, upon request, provide for official review documentation sufficient to show 
that your facility meets the exemption.  (21 CFR 121.5(a)).  
You must retain for two years the documentation that you rely on (e.g., tax and/or insurance 
documents) to show that your facility meets the very small business exemption.  (21 CFR 
121.5(a)).  Generally, these records will cover the three years preceding the applicable calendar 
year.  You would keep these records for two years from the time when you rely on them to 
establish your very small business status (the applicable calendar year).  You would keep these 
records at your facility as long as necessary so that you have them until two years after the 
applicable calendar year (21 CFR 121.315(a)(2)).  For example, if the applicable calendar year is 
2021 and a facility calculates its average annual sales by using financial records from 2020, 
2019, and 2018, then the facility would keep records that it relies on from those years until 2023 
(two years from 2021).    
C. Examples of Calculations to Determine Market Value of Food Held 
Without Sale Under Part 121  
1.   How can I calculate market value of human food held without sale in my warehouse 
using the values in my insurance policy for the warehouse?  
In this example, Warehouse N is a cold storage warehouse.  Its inventory turns over 
approximately every two months.  It has an insurance policy that covers the market value of food 
stored at any given time.  Because the inventory turns over approximately every two months, 
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Warehouse N could multiply the value of the insurance policy times six to arrive at an 
approximate value of the food stored for the entire year.  
 
See Table 3 for an example of how Warehouse N could do its calculation of market value on an 
annual basis for the years 2016, 2017, and 2018.  Warehouse N can then determine whether the 
three year average is less than $10,000,000 adjusted for inflation by comparing its three-year 
average market value to the inflation-adjusted value for the most recent year included in the 
average posted on FDAs website at https://www.fda.gov/food/food-safety-modernization-act-
fsma/fsma-inflation-adjusted-cut-offs.  
 
Table 3. Calculation of Market Value of Human Food Held Without Sale by Warehouse N 
Using the Value of an Insurance Policy 
Item  2016  2017  2018 
Value of Insurance Policy   $2,000,000   $2,255,000   $2,500,000  
Number of times inventory  6   6   6  
turns over during the year  
Total Market Value of  ($2,000,000)(6) =  ($2,225,000)(6) =  ($2,500,000)(6) = 
human food manufactured,  $12,000,000   $13,530,000   $15,000,000  
processed, packed, or held 
without sale  
 
Warehouse N does not meet the definition of a very small business because the three-year 
average value of $13,510,000 is greater than $11,011,028 (inflation adjusted value of 
$10,000,000 in 2018).  
 
Because an insurance policy may cover a slightly higher value than is in the warehouse at any 
given time, Warehouse N may decide to calculate the market value using information or 
accounting documents from their customer to determine the actual value of product received 
each year.  See Question I.C.2 for an example of how one could calculate the market value using 
information or accounting documents from the customer. 
 
2.  How can I calculate the market value of human food held without sale as a contract 
processor using information or accounting documents from the customer? 
In this example, Contract Processor O uses information on the value of the food received from 
the customer to determine the total market value of all food held without sale for each year.  
Using this method, Contract Processor O would add up the value of food for each shipment 
received throughout the year.  Contract Processor O can then compare its three-year average 
market value to the inflation-adjusted value for the most recent year included in the average 
posted on FDAs website at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-
inflation-adjusted-cut-offs.  
 
 
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Table 4. Calculation of Market Value of Human Food Held Without Sale by Contract 
Processor O Using Information from the Customer to Determine the Value of Human Food 
for Each Shipment  
Item  2016  2017  2018 
Total Market Value  $8,700,000   $10,300,000   $10,400,000  
of human food 
manufactured, 
processed, packed, 
or held without sale  
 
Three-year average = ($8,700,000 + $10,300,000 + $10,400,000)   3 = $9,800,000.    
Contract Processor O does meet the definition of a very small business because the three-year 
average value of $9,800,000 is less than $11,011,028 (inflation adjusted value of $10,000,000 in 
2018). 
II. Small Business Under the IA Rule 
Small businesses are subject to the full requirements of the IA rule but are given additional time 
to comply.  The definition of a small business is a business (including any subsidiaries and 
affiliates) employing fewer than 500 full-time equivalent employees (21 CFR 121.3).  Because 
the definition for small business and how to determine whether your business is a small business 
for the purposes of the IA rule in Part 121 is the same as for Parts 117 and 507 (Preventive 
Controls Rules), rather than repeating the comprehensive guidance on this same topic for 
Preventive Controls Rules, we refer you to the final guidance entitled, Determining the Number 
of Employees for Purposes of the Small Business Definition in Parts 117 and 507 (Preventive 
Controls Rules): Guidance for Industry, which can be found at: https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/guidance-industry-determining-number-employees-
purposes-small-business-definition-parts-117-and-507.  Specifically, we refer you to Sections 
III.A. and III.B. of that guidance.  
 
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