What Is a Foreseeable Hazard?

With an emphasis on prevention, the Food Safety Modernization Act (FSMA) directs manufacturers and suppliers along the food chain to identify “foreseeable hazards” in their operations as they prepare mandatory food safety plans. But nowhere is that term defined. So what is a foreseeable hazard?

The answer is, there is no clear answer. Dictionaries aren’t much help because they repeat the word in their definition. Yet there is some agreement around the notion that something is foreseeable when it is predictable and will probably last a long time.

food-processing.ashxSuch vagueness is often a problem with new regulations (which are the end result of years of revisions, give-and-take, and compromises between regulators and the industries to be covered), but in the case of the new food safety law, a foreseeable hazard sounds like, walks like and talks like what you would uncover as a problem in analyzing your production operations. Such problems – hazards – must be identified in advance of production and preventative controls put in place to eliminate the problem, a process, by the way, that must be undertaken every three years.

In the Federal Register, the FDA says this: “A facility subject to the (FSMA) rule must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed . . .”

A Maryland-based consulting company, FDAImports, established a website, harpc.com on perhaps the key provision of the new food safety law, Hazard Analysis and Risk-Based Preventive Controls, or HARPC. But even this website skirts around foreseeable hazards, although noting in clear language that (quoting):

“HARPC requires virtually every food manufacturer, packer, bottler and storage facility to identify food safety and adulteration risks associated with their foods and processes, to implement controls to minimize the risks, to verify that the controls are working, and to design and implement corrective actions to address any deviations from the controls that might arise. 

So what we are left with is a kind of working definition that directs the food industry to uncover and deal with areas in their production facility that will, or might, pose food safety risks, and take steps to eliminate them. They might be places where water is sprayed on raw food, or a hard-to-reach nook in a piece of machinery where listeria could grow. It could be a non-food grade lubricant on bread pans, or a production worker with hepatitis.

Whatever the precise definition, FSMA is going to require a great deal of new work and oversight by companies regulated by the FDA. Undoubtedly, the major food manufacturers and processors will have the budgets and people to insure compliance. The smaller companies, however, may be hard-pressed to manage the new regulations. Budgets will have to be created and people assigned to food safety management. Training will become essential to help workers and managers identify potential risks in the production process, so that a comprehensive food safety plan (another FSMA requirement) can be drafted and implemented.

Clearly, there will be growing pains associated with FSMA’s rollout. Defining terms, always a challenge, will most likely be settled through a combination of administrative decision-making, compliance challenges, and even legal action.

For now, though, anyone responsible for food safety ought to become very familiar with the term “foreseeable hazard.” It very well could be something that may end up helping save lives.

 

 

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