1. Establish Critical Limits
Chapter 7
Establish Critical Limits

2. Objective In this module, you will learn:
How to define critical limits
How to set critical limits for a CCP
How to find sources of critical limit information
How to determine the relationship between critical limits and operating limits

3. Principle 3
Establish critical limits

4. Critical Limit
A maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food-safety hazard

5. Examples of Critical Limits
Hazard CCP Critical Limit
bacterial pasteurizer ≥161oF for ≥15
pathogens seconds
(biological) for elimination of
pathogens from milk

6. Examples of Critical Limits
Hazard CCP Critical Limit
bacterial drying drying schedule:
pathogens oven oven temperature: 200oF
(biological) drying time: 120 min.
air flow rate: 2 ft3/min.
product thickness: 0.5 inches
(to achieve aw 0.85 to control
pathogens in dried foods)

7. Examples of Critical Limits
Hazard CCP Critical Limit
bacterial acidification Batch schedule:
pathogens product weight: 100 lbs.
(biological) soak time: 8 hours
acetic acid concentration: 3.5% volume: 50 gallons
(to achieve maximum pH of to control Clostridium botulinum in pickled foods)

8. Sources of Information on Critical Limits
General Source Examples
scientific publications journal articles, food science texts, microbiology texts
regulatory guidelines state and local guidelines, tolerances and action levels; USDA guidelines, tolerances and action levels; FDA guidelines, tolerances and action levels

9. Sources of Information on Critical Limits
General Source Examples
FDA FDA Fish and Fisheries Products Hazards and Controls Guidance Manual (referenced in Chapter 13)

10. Sources of Information on Critical Limits
General Source Examples
experts NACMCF (National Advisory Committee on Microbiological Criteria for Foods), thermal process authorities; consultants, food scientists/ microbiologists, equipment manufacturers, sanitarians, university extension, trade associations
experimental studies In-house experiments; contract labs

11. Options for Controlling Hazards
Often a variety of options exist for controlling a particular hazard
The selection of the best control option and critical limit is often driven by practicality and experience

12. (Not typically the best option)
Monitoring for Pathogens at a Cook Step Option No. 1: Monitoring for Pathogens
Hazard
presence of pathogens (microbiological)
CCP
fryer
Critical Limit
no pathogens detected
(Not typically the best option)

13. Monitoring for Pathogens at a Cook Step Option No
Monitoring for Pathogens at a Cook Step Option No. 2: Monitoring Internal Temperature
Hazard
presence of pathogens (microbiological)
CCP
fryer
Critical Limit
minimum internal temperature of 150oF for 1 minute

14. Monitoring for Pathogens at a Cook Step Option No
Monitoring for Pathogens at a Cook Step Option No. 3: Monitoring Factors That Affect Internal Temp.
Hazard
presence of pathogens (microbiological)
CCP
fryer
Critical Limits
minimum fryer oil temperature of 350oF
maximum patty thickness of 1/4 inch
minimum cook time in the oil of 1 minute

15. Operating Limits
Criteria that are more stringent than critical limits and that are used by an operator to reduce the risk of a deviation
Operating limits may be selected for various reasons:
For quality reasons
To avoid exceeding a critical limit
To account for normal variability

16. Process Adjustment
An action taken by the firm to bring the process back within operating limits

17. Operating Limit/Process Adjustment Example
Cooker Temperature
Operating Limit
Process Adjustment Needed
Degrees F
Corrective Action
Required
Critical Limit
Lot 1

18. Operating Limit/Process Adjustment Example
Cooker Temperature
Operating Limit
Process Adjustment Needed
Degrees F
Corrective Action
Required
Critical Limit
Lot 1
Lot 2
Lot 3
Lot 4
Lot 5

19. Establishment of Critical Limits
Critical Control Point Critical Limits
CCP Cooker Cook at 212oF for 3 minutes
CCP - Weigh/Pack/Label All product containing sulfiting agent must declare presence

20. HACCP Plan Form: Critical Limits1.
CCP 2.
Hazard 3.
Critical
Limits 4. 5. 6. 7. 8.
Corrective
Action(s) 9.
Verification
10.
Records
What How Frequency Who
Monitoring

21. HACCP Plan Form: Cooked Shrimp
Page 80