We are pleased that Dr. Michael Fisher has joined the FTCLDF website as a regular contributor. Dr. Fisher is a retired United States Department of Agriculture (USDA) Food Safety and Inspection Services (FSIS) veterinarian, bringing decades of experience enforcing FSIS regulations during the slaughter and processing of animals for which the USDA provides inspection services. Dr. Fisher is thrilled to bring you his expertise and guidance to help you navigate regulatory compliance. His goal is for small, USDA-inspected meat processors to succeed and to understand how to best maintain compliance and reduce regulatory issues.
Hazard Analysis and Critical Control Point Definitions
Hazard Analysis and Critical Control Point (HACCP) 9 Code of Federal Regulations (CFR) 417.1 definitions are 9 CFR Part 417 language. In other words, they have regulatory meaning only within the context of 9 CFR 417. Apply these definitions improperly and you create a false HACCP requirement and noncompliance. Food Safety and Inspection Services (FSIS) in-plant personnel (IPP) inspectors often do exactly that; attach HACCP meaning to these and similar terms in non-HACCP context. Failure to recognize misapplication of these definitions can have you chasing your tail attempting to fix a problem that cannot be fixed because it does not exist.
A HACCP corrective action is a procedure to be followed when a deviation from a critical limit occurs, and for no other reason. Because the term corrective action appears throughout 9 CFR to describe an action taken to correct a regulatory noncompliance, FSIS IPP often wrongly apply the HACCP corrective action performance standard to non-HACCP noncompliance.
A critical control point is a “point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels.” There are many control points in a production process. Not all are critical control points. A critical control point only exists in the presence of a food safety hazard reasonably likely to occur. A point, step, or procedure that prevents, eliminates, or reduces to acceptable levels a non-food safety hazard is a control point; not a critical control point. A point step, or procedure that constrains, but does not prevent, eliminate, or reduce to acceptable levels a food safety hazard is a control point; not a critical control point. Only a point, step, or procedure that prevents, eliminates, or reduces to acceptable levels a food safety hazard reasonably likely to occur is a critical control point.
A critical limit is the maximum or minimum value to which a physical, biological, or chemical food safety hazard reasonably likely to occur must be controlled at a critical control point. A critical limit only exists at a critical control point. A value is one or more numerical measurements that is quantifiable using a process monitoring instrument. There are many quantifiable values in a production process. Only those controlled at a critical control point are critical limits.
A food safety hazard is any biological, chemical, or physical property that may cause a food to be unsafe for human consumption. The food safety hazard is a property of an article, not the article itself. All food safety hazards are adulterants. Not all adulterants are food safety hazards. Adulterants that are a poisonous or deleterious substance injurious to health, or a pesticide chemical, food additive, or color additive unsafe within the meaning of the Food Drug and Cosmetic Act, are a food safety hazard. All other adulterants are not food safety hazards.
A HACCP System is the HACCP plan in operation, including the written HACCP plan itself. A HACCP system is not a food safety system. A food safety system is an FSIS concept that incorporates all actions taken to prepare not adulterated product.
A HACCP Hazard is a food safety hazard. Because the term hazard appears throughout 9 CFR to describe an adulterant, FSIS IPP often wrongly view non-food safety hazard adulterants as food safety hazards.
A preventive measure is a physical, chemical, or other means that can be used to control an identified food safety hazard. A preventive measure only exists at a critical control point and is the control that prevents, eliminates, or reduces to acceptable level a food safety hazard reasonably likely to occur. There are many measures taken in a production process to prevent adulteration that are not preventive measures. A physical, chemical, or other means that does not prevent, eliminate, reduce to acceptable level a food safety hazard reasonably likely to occur is not a preventive measure. It is a form of control, but not a critical control. Because FSIS places such emphasis on prevention of adulteration, FSIS IPP often wrongly view any prevention as a HACCP preventive measure.
A HACCP process-monitoring instrument is “an instrument or device used to indicate conditions during processing at a critical control point.” A process-monitoring instrument only exists at a critical control point. Any device used to monitor a quantifiable value which 9 CFR 417.2(c)(3) requires to be listed as a critical limit that must be met at a critical control point is a HACCP process-monitoring instrument. Many instruments are used to monitor a process, but not all are HACCP process-monitoring instruments. Instruments used to monitor process parameters other than a critical limit are not a HACCP process-monitoring instrument.
A responsible establishment official is the individual with overall authority on-site or a higher-level official of the establishment. A responsible establishment official only exists within the context of the 9 CFR 417.5(c) pre-shipment review. Per FSIS Office of Policy and Program Development via personal communication (askFSIS Reference Number 200816-000007), the establishment designates the responsible establishment official. The responsible establishment official need not be named on Form 5200-2 – Application for Federal Inspection, or in the Public Health Information System Plant Profile. The establishment can change the designation at will and is not required to formally identify the responsible establishment official to FSIS.
We will revisit these terms as we work through the 9 CFR 417 requirements. Next month we tackle the hazard analysis.
As always, if you have a question, please use the Contact Us link and ask.
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Services provided by FTCLDF go beyond legal representation for members in court cases.
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