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.
The Hazard Analysis
Conducting a hazard analysis is like a physician diagnosing a patient. Every patient has a different medical history (i.e. foundation). A physician considers the patient’s medical history, but the physician’s focus is on the condition causing the patient’s illness. Every establishment process rests upon different prerequisite programs (i.e. foundation) such as training, pest control, and sanitation; however, the focus of the hazard analysis are adulterants that render product injurious to health or unsafe; not adulterants that render product unfit, damaged or inferior, and not the prerequisite programs upon which the process rests.
Beware of anyone who offers to provide you with a hazard analysis that does not consider your process and the prerequisite programs upon which the process rests. You can copy a hazard analysis from a website or another establishment, but you risk creating a design flaw in your hazard analysis that eventually results in noncompliance.
A prescribed, one-size-fits-all methodology to the conduct of a hazard analysis does not exist. Each establishment exercises autonomy in how they conduct their hazard analysis, provided the finished product achieves the 9 CFR 417.2(a)(1) performance standard for a hazard analysis.
The 9 CFR 417.2(a)(1) reads:
“Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. The hazard analysis shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls.”
Food Safety Hazards
First, a hazard analysis must determine the food safety hazards reasonably likely to occur in the production process before, during, and after entry of the food safety hazards into the establishment. This is the hard part.
- What does “determine the food safety hazards” mean? It means you must establish exactly, as a result of research or calculation, which of the properties in the production process are food safety hazards and be able to give a reason why the property is a food safety hazard.
- What does “reasonably likely to occur” mean? The 9 CFR 417.2(a)(1) answers the question, but what does “historically occurred” and “reasonable possibility” mean? “Historically occurred” means there is a record that the establishment produced a product bearing an adulterant that rendered the product injurious to health or unsafe (i.e. food safety hazard) that entered commerce. “Reasonable possibility” means that, based on some intelligible fact, an adulterant that renders the product injurious to health or unsafe (i.e. food safety hazard) may happen.
- What does “in the production process” mean? It means the combination of operations used by the establishment to prepare product. Product is any carcass, meat, meat by-product, meat food product, or poultry product capable of use as human food. Operations not involving product are not “in the production process.”
The most common problems occurring during this first step involve a determination that a non-food safety hazard is a food safety hazard and inclusion of operations not involving product in the hazard analysis.
Second, a hazard analysis must identify the preventive measures the establishment can apply to control the food safety hazards determined to be reasonably likely to occur in the production process. This part is easy.
- What does “identify” mean? It means name the means to control the food safety hazards determined to be reasonably likely to occur at the step in the process where the method is applied.
Over the years, FSIS has come to view the hazard analysis as requiring consideration of everything that possibly impacts the production process. The FSIS Meat and Poultry Hazards and Controls Guide “represents FSIS’s current thinking” (i.e. what FSIS wants) on what is/is not determined to be a “food safety hazard,” “reasonably likely to occur,” “in the production process,” and a “means to control.” The Meat and Poultry Hazards and Controls Guide includes everything that possibly impacts the production process, which far exceeds the 9 CFR 417.2(a)(1) performance standard.
FSIS Directive 5000.6 Performance of the Hazard Analysis Verification Task instructs inspection program personnel on how to evaluate a hazard analysis and implies that 9 CFR 417.2(a)(1) noncompliance might exist if the hazard analysis is inconsistent with the Meat and Poultry Hazards and Controls Guide. There is the rub. The FSIS Meat and Poultry Hazards and Controls Guide is not the 9 CFR 417.2(a)(1) performance standard, but inspection program personnel often apply it as if it were, and issue Noncompliance Records accordingly.
A hazard analysis answers two questions. What food safety hazards are reasonably likely to occur in the production process and what preventive measures control the hazards? That is conducting in hazard analysis in a nutshell. But it is never that simple.
Next month we will discuss 9 CFR 417.2(a)(2), the flow chart, and the intended use or consumers of the finished product. In the upcoming months we will then examine basic hazard analysis requirements for the different process categories.
As always, if you have a question, please use the Contact Us link and ask.
Did you miss Dr. Fisher’s previous posts?
YOUR FUND AT WORK
Services provided by FTCLDF go beyond legal representation for members in court cases.
Educational and policy work also provide an avenue for FTCLDF to build grassroots activism to create the most favorable regulatory climate possible. In addition to advising on bill language, FTCLDF supports favorable legislation via action alerts and social media outreach.