Under the Foreign Supplier Verification Program (FSVP), foreign food manufacturers exporting to the U.S. must demonstrate that food hazards are controlled. By controlled, we mean that potential hazards are eliminated, prevented, or reduced to an acceptable level. Among these controls, process controls are the foundation of consistent and verifiable safety. In this short blog post, we will review one aspect of process controls, critical parameters.
Understanding Critical Parameters
A critical parameter is a measurable condition that must be maintained within a specific range to control an identified hazard. These parameters are determined through scientific validation and are monitored regularly to confirm that a process remains under control.
Common parameters include:
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Temperature
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Time
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pH (acidity)
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Water activity (aw)
Each parameter defines the conditions necessary to prevent, eliminate, or reduce that hazard to an acceptable level.
An Example: Pasteurizing Milk
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Hazard Controlled: Pathogenic microorganisms (Salmonella, E. Coli).
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Critical Parameters:
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Temperature: Must reach validated lethality conditions
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Time: Duration must be long enough to achieve the necessary microbial reduction.
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Milk should be heated to 72°C for 15 seconds for milk pasteurization. This pasteurization process kills harmful bacteria like E. coli and Salmonella, reducing the risk of foodborne illness. However, milk can also be heated at 63°C for 30 seconds.
- If the fat content of the milk is 10 percent or more, or if it contains added sweeteners, the heat should be increased by 3°C.
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These levels are particular for milk and, as you can see, must be adjusted depending on the fat content ect. Food safety specialists must look at each product and implement customized critical control points to prevent, eliminate, or reduce the risk of hazards to an acceptable level.
How an FSVP Agent can help?
Under 21 CFR 1.506(e), importers must maintain documentation demonstrating that foreign suppliers are implementing adequate preventive controls. This includes:
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Validation studies supporting critical limits.
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Monitoring and verification records.
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Records of corrective actions for deviations.
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Supplier verification activities such as audits, sampling, or review of safety records.
During an FSVP inspection, an FSVP agent at Ken Lehat & Associates can review these records to confirm that process controls are properly validated and consistently implemented. They can ensure that US standards are maintained, ensuring uninterrupted access to the U.S. market.
By establishing, validating, and monitoring critical parameters within their process controls, foreign suppliers can demonstrate that they produce food under the same rigorous standards required in the United States.