1. THE CONCEPTS of PERFORMANCE STANDARDS, CUMULATIVE STEPS AND VALIDATION STUDIES Dr. John Kvenberg, Acting Director, Office of Field Programs July 15, 1999

2. Performance Standards — Background A control measure must prevent, eliminate or reduce a hazard to acceptable levels A performance standard sets the criteria for “acceptable reduction” Applied to individual control measures or to a series of control measures

3. Performance Standards Performance standards define level of acceptable hazard reduction Have created need for scientific studies Issues in designing validation studies: –Laboratory studies vs In-plant validation –Pathogens vs surrogates –Other study design considerations (e.g. individual control vs entire process evaluation)

4. Performance Standard for Juice — Warning Statement Rule Fresh juice industry: –No control measures to prevent a pathogen hazard from occurring – raw agricultural product –No control measures to eliminate a pathogen – no kill step Have to reduce hazards to an acceptable level

5. What is a 5 Log Reduction Performance Standard? Reduction in number of microorganisms by a factor of 100,000 fold (from 100,000 to 1 organism) Reduction of risk to less than 1 in 100,000

6. Advantages of a Performance Standard Gives industry flexibility -- use different control measures Shift away from a “command and control” approach Disadvantage -- validation more complicated: –individual controls only partially effective –can use different combinations of controls

7. How Does a Manufacturer Achieve 5 Log Reduction? Use of control measures shown to be effective Use of a single control measures alone or in combination with other measures Combination results in a cumulative reduction

8. Which Control Measures are Effective? Sources of Information: –Scientific literature –Federal and state agencies –Industry associations –Data generated at the facility or by a consultant FDA Technical Workshop proceedings for citrus processing

9. Which Control Measures Can Be Counted as Cumulative? A measure that has been shown to be effective A measure that the processor can verify has been effectively applied to every lot

10. How Effective are Control Measures? Effectiveness of Citrus Fruit Industry Control Measures (APPROXIMATE REDUCTIONS): –Culling -- 0.6 to 1.0 log reduction –Cleaning, washing, brushing, and sanitizing -- 2.5 log reduction –Hot waxing -- 1.0 log reduction –Hot dip or steam tunnel -- 5+ log reduction –Pinpoint juice extraction -- 1.2 to 1.9 log reduction

11. Validation Study Design Study design not specified by FDA Options include: –In-plant studies using surrogate microorganisms –Pilot plant studies –Laboratory studies using pathogens Laboratory studies need in-plant confirmation that controls are applied

12. Validating 5 Log Reduction Processors may contract with a private laboratory: –use laboratory to test a simulated process using a know pathogen or pertinent microorganism –conduct tests on a simulated process using surrogates Processors may conduct their own studies: –conduct studies in-plant using a surrogate microorganism

13. What are Pertinent Microorganisms? Most resistant illness-causing microbe Ability to survive the specific treatment being tested Examples include: –E. coli O157:H7 –Salmonella sp. –Listeria monocytogenes

14. What are Surrogate Microorganisms? Any non-pathogenic microbe that is acid- resistant and heat-resistant Has other relevant characteristics Should have GRAS status Examples include: –food grade lactic acid bacteria –Klebsiella pneumoniae which is naturally occurring

15. Validation Studies Assess whether the hazard analysis and controls are working: –all hazards have been identified, and –the control measures being used are effective.

16. Microbial Testing and the Initial Validation Purpose of Validation: –Demonstrate that control measures selected as critical are effective –Demonstrate that proper control limits are applied –Confirm that CCP’s are sufficient to control identified hazards and reduce the microbial levels appropriately

17. Verification Audits Purpose is to assess whether preventive measures have been applied as designed Audits based upon control records

18. FDA’s Role in Validation Studies Provides for self-validation by processor FDA’s role is auditing validation studies FDA needs baseline data on effectiveness of various control measures and critical limits Requires shift from regulatory samples to research

19. Validation Studies Types of Validation Activities: –Review documents and scientific literature –Challenge studies –Product testing

20. Using Validating Data Processors may rely upon scientific studies and validations conducted by others including: –ingredient suppliers –equipment and chemical providers –academia and government agencies Processors may rely upon ‘standard’ controls that utilize equivalent procedures and limits

21. Microbial Testing and Verification Microbial testing not currently required but encouraged by FDA Microbial testing can help: –keep management informed on safety issues –evaluate sanitation & cleaning –evaluate incoming ingredients –provide data for annual validations –provide data for customer reviews Microbial testing not required but