Are you confident in your FSMA preventive controls for hazards from food fraud? Here’s a quick reminder about economically motivated adulteration hazards.
Hazards are chemical, physical and biological agents that may be present in food and that are capable of causing harm to consumers of the food. (Find the official FDA definition here)
FSMA (The food safety modernization act of USA) requires that preventive controls are implemented by food manufactures to prevent hazards to human health. The relevant regulation is called the preventive controls rule.
The preventive controls must be described by the food manufacturer in a food safety plan.
The US Food and Drug Administration (FDA) is responsible for enforcement of the rules.
The Preventive controls rules requires food manufacturers to identify and control hazards that could arise from:
- natural occurrences (for example, some raw meat products naturally contain certain human pathogens);
- unintentional contamination (for example food may be accidentally contaminated with a pesticide during a pest control treatment), and
- economically motivated adulteration (EMA).
A separate part of the FSMA rules also requires food manufactures to create and implement systems to prevent adulteration of food that is perpetrated for the purposes of causing large-scale harm to consumers. The FDA calls this type of adulteration Intentional Adulteration (IA). The Intentional Adulteration rule, which addresses the risks from deliberate attempts to create large-scale harm, relates to issues of food defense rather than food fraud and is not related to economically motivated hazards. Click here to learn more about food defense.
HAZARDS from economically motivated adulteration (EMA)
Economically motivated adulteration (EMA) is a subset of food fraud. Food fraud includes many types of deception carried out for the purposes of economic gain. It includes activities such as mislabeling (for example making false claims about the geographical origin of a food product) and other fraudulent activities that do not involve adulteration of food. Economically motivated adulteration is a type of food fraud in which a person has added a substance to food to enhance its apparent value or profitability. Often the added substance will boost the apparent quality or appearance of the food, other times the substance will be a diluent, which dilutes or replaces the genuine material with a cheaper material, thereby increasing the profitability of the resulting mix.
According to food safety laws, food manufacturers must know about hazards that may be in their products and must create and implement systems that will prevent, minimize or eliminate those hazards. The systems must be documented in a food safety plan.
How to identify hazards from economically motivated adulteration (EMA):
- For each raw material used in a food manufacturing process, investigate whether economically motivated adulteration is likely to occur within the supply chain; that is, could there be adulterants present in the raw material when it is purchased? Learn how to investigate susceptibility to food fraud here.
- For each raw material and each finished product, investigate whether economically motivated adulteration could occur when the product is within the manufacturing facility. This is sometimes known as ‘insider activity’.
- After you have understood whether adulteration is likely to occur for each food type, make a list of adulterants that could be added to each of the susceptible food types. Historical records of past incidences of food fraud provide the best indication of the types of adulterants that can be expected in different foods and ingredients. This page has a list of databases you can use to find historical records. .
- For each possible adulterant, make a note of whether it could be hazardous to human health if present in the food. As an example, olive oil is commonly adulterated with (non-olive) vegetable oils. That type of adulteration is unlikely to be hazardous and as such it would not require a preventive control. Document your decisions and justifications for such.
- Within the food safety plan, add the economically motivated hazards you have identified to the preventive controls systems. Implement effective controls to prevent or control each hazard. Supplier approvals programs are commonly used for control of economically motivated hazards in incoming raw materials.
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