What Food Safety Hazards Were Emphasized or Added under the Preventive Controls Rule?

Continuing with our FSMA tip of the week series, this week’s tip is about some of the hazards that need to be carefully considered when undertaking the hazard analysis under the Preventive Controls Rule.

The rule defines a Hazard to mean “any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury”. Let us look at each hazard category and see which hazards are emphasized and why.


Well known food borne pathogens were included such as pathogenic bacteria and viruses. However, the rule emphasized parasites due to their association with poor sanitation in many countries from which we import food products. Parasite transmission can be prevented with proper personal hygiene, proper disposal of human feces and manure used to fertilize crops in addition to the quality of the water coming in contact with food. Methods to eliminate parasites include freezing and cooking. Thus, if you source your raw materials or finished products from a foreign supplier, pay close attention to the potential for parasitic contamination.


Natural toxins, pesticides, drug residues, decomposition, allergens, unapproved additives, and radiological were highlighted.

Most of these chemical hazards are well understood. So, let us briefly review three of them. Decomposition was emphasized because some foods can decompose and produce a chemical toxin due to bacterial growth. Again, if your product or incoming ingredients can be subject to such decomposition and consequences, it would important to pay closer attention and implement the appropriate Preventive Controls to prevent decomposition.

Allergens, while well known, were highlighted because they are the number one reason for product recalls in the US. Unless you do not have allergens in your food plant or only one, an allergen Preventive Controls will be part of your Food Safety Plan.

Radiological hazards are very rarely encountered in foods. This hazard was included due to potential sources such as contaminated ground, water or air. The contamination can be natural and present in the soil or water, which can then be incorporated into the food product during the growing period or manufacturing process. The other potential source of contamination is related to radiation leaks from nuclear facilities. In the event of such an accident, the food plant needs to activate a crisis management response per their location to the accident site or in relationship to the sourcing of your raw materials or ingredients if that accident were to occur.


The rule did not mention any new physical hazard nor emphasize any of the known ones. This should not surprise us. The food industry has done a great job of reducing such hazards to where they represent less than 1% of today’s recalls.

Economically Motivated Adulteration (EMA)

While not unknown or uncommon, the inclusion of economically motivated adulteration was due to incidents of adulteration that led to food safety concerns. Examples include the disastrous addition of melamine into milk products to enhance the apparent protein content in China, the use of dyes containing lead to improve the color of spices and olives, and the addition of milled peanut husk to cumin to increase volume and weight.

The best way to prevent being subject of such fraudulent and potentially lethal adulterations is to 1) review past cases and see if your product, raw material or ingredient has been subject to such intentional adulteration in the past, and 2) to keep your ears and eyes open for any sign or change that such adulteration may be taking place or might take place if certain production and market conditions change that might encourage such fraudulent behavior. In other words, a supply-chain control depending on if historical adulteration has taken place in certain geographic regions or could take place under certain market conditions.

Next week, we will look into Economically Motivated Adulteration. Again, we will explore practical understanding and applications.

1 Comment
Print Friendly and PDF