1. Actionable Process Steps and Focused Mitigation Strategies

2. Actionable Process Steps
Defined as:
“a point, step, or procedure in a food process at which food defense measures can be applied and are essential to prevent or eliminate a significant vulnerability or reduce such vulnerability to an acceptable level.”

3. History of FDA Vulnerability Assessments

4. Using Vulnerability Assessments to Identify Key Activity Types
Distill individual processing steps down to the basic activity being conducted
Standardize diverse processing steps for analysis
Use information gathered in vulnerability assessments to target mitigation strategies to most vulnerable areas

5. Using Vulnerability Assessments to Identify Key Activity Types
Results of this analysis show:
Certain processing steps repeatedly ranked high across vulnerability assessments, regardless of food
Focus on the activity being conducted at high ranking processing steps
Common vulnerabilities can be organized into broad activity groups = key activity types

6. Proposed Requirements
Covered facilities will be required to prepare and implement a written food defense plan, which would include the following:
Actionable process steps– this step identifies actionable process steps by using one of the two options. If a facility chooses Option 1, the facility must assess whether it has one ore more of the following FDA-identified key activity types:
Bulk liquid receiving and loading
Liquid storage and handling
Secondary ingredient handling
Mixing and similar activities
If a facility chooses Option 2, the facility must perform a vulnerability assessment using appropriate methods and qualified individuals to identify and prioritize points in the food operation that are vulnerable to intentional adulteration
Focused mitigation strategies would be identified and implemented at each actionable process step in order to significantly minimize or prevent the significant vulnerability and ensure food is not adulterated
Monitoring procedures would provide assurance that focused mitigation strategies are consistently performed and records to document the monitoring would be required
Corrective actions would be used if focused mitigation strategies are not properly implemented
Verification would ensure that monitoring is being conducted, appropriate decisions about corrective actions are being made, and focused mitigation strategies are consistently implemented and are effective
Recordkeeping is also required
The proposed rule requires food defense awareness and specific mitigation strategy training of employees and supervisors working at actionable process steps
The proposed rule also requires certain records to be prepared and maintained

7. Key Activity Type I: Bulk Liquid Receiving and Loading
Likelihood of uniform mixing (sloshing and turbulence)
High volume of food is at risk
Activity where an “outsider” could gain access (e.g. truck driver)

8. Key Activity Type II: Liquid Storage and Handling
Likelihood of uniform mixing
Tanks are frequently agitated
High volume of food is at risk
Especially in bulk storage or ingredient metered tanks
Frequently located in isolated areas, increasing the likelihood an attacker could gain access without being observed

9. Key Activity Type III: Secondary Ingredient Handling
Likelihood of uniform mixing
ingredient handling is likely immediately prior to a mixing step
High volume of food is at risk
Ingredients are open and accessible

10. Key Activity Type IV: Mixing and Similar Activities
Likelihood of uniform mixing
High volume of food is at risk
Food is typically accessible
Extended mixing times may present opportunity for the attacker to “choose the best moment” to introduce a contaminant

11. Sample Processes not Considered Key Activity Types
Conveyer belts, augers, flumes, etc.
Bulk storage of dry ingredients
Finished ingredient storage (containerized)
Packaging
Baking, frying, pasteurization, etc.
Dry ingredient receiving/loading
Frozen storage
breader, mill, grinder, pulverizer, etc.

12. Perform a Facility-Specific Vulnerability Assessment
Perform a vulnerability assessment using appropriate methods and qualified individual(s)
Identify and prioritize points in food operation that are vulnerable to intentional adulteration
Identify actionable process steps for significant vulnerabilities

13. Elements of a Facility-Specific Vulnerability Assessment
Evaluate agents of concern
Assemble vulnerability assessment team
Develop process flow diagram

14. Elements of a Facility-Specific Vulnerability Assessment cont.
Identify significant vulnerabilities, consider:
Public health impact
Downstream processing
Physical access to product
Ability of aggressor to contaminate product
Volume of product impacted
Identify actionable process steps

15. Actionable Process Steps
Requirements:
Identified using key activity types, or
Identified by vulnerability assessment
Identification and assessment must be written

16. Proposed Requirements
1. Actionable Process Steps
2. Focused Mitigation Strategies
Identify and implement focused mitigation strategies at actionable process steps
Option 1
Assess whether your facility has one or more of these FDA-identified key activity types*:
Bulk liquid receiving and loading
Liquid storage and handling
Secondary ingredient handling
Mixing and similar activities
3. Monitoring
Establish and implement procedures for monitoring focused mitigation strategies
Identify actionable process steps for each applicable key activity type
4. Corrective Actions
Establish and implement procedures for corrective actions if focused mitigation strategies are not properly implemented
Option 2
Perform a vulnerability assessment using appropriate methods and qualified individual(s)
Covered facilities will be required to prepare and implement a written food defense plan, which would include the following:
Actionable process steps– this step identifies actionable process steps by using one of the two options. If a facility chooses Option 1, the facility must assess whether it has one ore more of the following FDA-identified key activity types:
Bulk liquid receiving and loading
Liquid storage and handling
Secondary ingredient handling
Mixing and similar activities
If a facility chooses Option 2, the facility must perform a vulnerability assessment using appropriate methods and qualified individuals to identify and prioritize points in the food operation that are vulnerable to intentional adulteration
Focused mitigation strategies would be identified and implemented at each actionable process step in order to significantly minimize or prevent the significant vulnerability and ensure food is not adulterated
Monitoring procedures would provide assurance that focused mitigation strategies are consistently performed and records to document the monitoring would be required
Corrective actions would be used if focused mitigation strategies are not properly implemented
Verification would ensure that monitoring is being conducted, appropriate decisions about corrective actions are being made, and focused mitigation strategies are consistently implemented and are effective
Recordkeeping is also required
The proposed rule requires food defense awareness and specific mitigation strategy training of employees and supervisors working at actionable process steps
The proposed rule also requires certain records to be prepared and maintained
5. Verification
Verify that monitoring is conducted
Verify that appropriate decisions about corrective actions are made
Verify that focused mitigation strategies are consistently implemented and are effective
Conduct reanalysis of the food defense plan, as appropriate
Identify and prioritize points in food operation that are vulnerable to intentional adulteration
Identify actionable process steps for significant vulnerabilities
*FDA identified these key activity types using findings of vulnerability assessments of over 50 food products and processes.  These activity types commonly rank high in vulnerability based on various factors, including the ability to physically access the food or process and the potential to adulterate a sufficient quantity of product in order to cause massive public health harm. 

17. Focused Mitigation Strategies
Defined as:
“those risk-based, reasonably appropriate measures that a person knowledgeable about food defense would employ to significantly minimize or prevent significant vulnerabilities identified at actionable process steps, and that are consistent with the current scientific understanding of food defense at the time of the analysis”

18. Focused Mitigation Strategies
Applied in response to an identified significant vulnerability
Customized to the actionable processing step
Tailored to the facility
Depend on an evaluation of vulnerabilities

19. Types of Mitigation Strategies
FDA categorizes mitigation strategies into two buckets:
Broad mitigation strategies: general facility-level measures not necessarily specific to the product or process, for example:
Exterior fencing, periodic employee drug testing, visitor sign-in procedures, cyber-security, contractor or supplier audits

20. Types of Mitigation Strategies cont.
Focused mitigation strategies:
Specific and customized to the actionable processing step where they are applied.
More effective at countering an attacker who has legitimate access to the facility

21. Mitigation Strategies
Broad
Facility or company level measures
Broadly applied
Almost universally applicable
Not required, though still recommended
Focused
Specific measures applied at an actionable process step
Tailored to address an identified significant vulnerability
Required under Proposed §121

22. Focused Mitigation Strategies
FDA giving facilities flexibility to determine appropriate focused mitigation strategies
Preamble to Proposed §121 provides:
Examples of focused mitigation strategies for reference and context for each key activity type
A series of hypothetical scenarios to illustrate the decision-making process of identifying and determining appropriate focused mitigation strategies

23. Focused Mitigation Strategies
Designed to minimize chances of intentional adulteration at the specific process step by:
Minimizing the accessibility of an attacker to the product
Reducing the opportunity for the attacker to successfully contaminate the product
Or both

24. Focused Mitigation Strategies Examples
Control access to the actionable processing step and related equipment
Limit staff access, lock access hatches, physical barriers
Ensure the area is free of unrelated materials
Prohibit and monitor employees for personal items in work areas
These examples can be found in Preamble to Proposed §121.

25. Focused Mitigation Strategies Examples cont.
Maximize visibility around actionable process step
Improve lighting or install cameras intended to prevent an attacker from adding a contaminant
Peer-monitoring or “buddy system” procedures
Prevents an attacker from operating in isolation
These examples can be found in Preamble to Proposed §121.

26. Focused Mitigation Strategies Examples cont.
Make engineering enhancements to equipment
Install lids or other barriers to prevent introduction of a contaminant
Reduce time products and ingredients are accessible
Reduce the opportunity for an attacker to introduce a contaminant

27. Focused Mitigation Strategies Examples cont.
Conduct inspections of equipment immediately prior to use
Inspections increase chances of detecting a contaminant in tanks, hoses, and other equipment
Use automated, self-contained, enclosed equipment
Prevents introduction of a contaminant into the system

28. Focused Mitigation Strategies
Facilities will need to evaluate their situation to understand why and how their actionable process steps are significantly vulnerable
May be different in every facility

29. Focused Mitigation Strategies
Facilities would then need to identify and implement the appropriate focused mitigation strategies to reduce the significant vulnerabilities
Document this decision and provide justification for how the strategy significantly reduces or eliminates the risk of intentional adulteration at the actionable process step

30. Focused Mitigation Strategies
Focused mitigation strategies must be:
Documented in the food defense plan with justification
Monitored for consistent application, with corrective actions as necessary
Monitoring procedures must be documented
Verified to confirm they are implemented as planned through a review of records and periodic re-analysis of the food defense plan

31. Focused Mitigation Strategies
When identifying and implementing focused mitigation strategies, consider:
Do you already have a procedure in place that protects this process step?
Modify or improve an existing practice?
FDA tools and guidance to assist in identifying suitable and appropriate focused mitigation strategies: