the concepts of performance standards, cumulative steps and validation studies dr. john kvenberg,...
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THE CONCEPTS of THE CONCEPTS of PERFORMANCE STANDARDS, PERFORMANCE STANDARDS,
CUMULATIVE STEPS AND CUMULATIVE STEPS AND VALIDATION STUDIESVALIDATION STUDIES
Dr. John Kvenberg,
Acting Director, Office of Field Programs
July 15, 1999
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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
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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)
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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Validation Studies
• Assess whether the hazard analysis and controls are working:
– all hazards have been identified, and
– the control measures being used are effective.
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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
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Verification Audits
• Purpose is to assess whether preventive measures have been applied as designed
• Audits based upon control records
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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
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Validation Studies
• Types of Validation Activities:– Review documents and scientific literature– Challenge studies– Product testing
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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
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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