Updated 31st December, 2022
Are you confident in your FSMA preventive controls for hazards from food fraud?
This post is for you if your company manufactures food in the USA or exports food to the USA.
Food companies in the USA must comply with food safety regulations that require them to identify and address hazards from economically motivated adulteration (EMA), a type of food fraud.
In this post you can learn what EMA is and how to identify food safety hazards from EMA. You can also discover what type of preventive controls are best for EMA hazards.
EMA is short for economically motivated adulteration which is a type of food fraud. Other types of food fraud include counterfeiting, making false claims (for example, fake ‘organic’ food) and species substitution (for example, selling cheap white fish labelled as snapper).
“Economically motivated adulteration (EMA) occurs when someone intentionally leaves out, takes out, or substitutes a valuable ingredient or part of a food. EMA also occurs when someone adds a substance to a food to make it appear better or of greater value.” (US FDA)
FSMA denotes the Food Safety Modernization Act (USA). is a set of rules for food manufacturers. Under the rules, food manufacturers must assess food safety hazards and implement preventive controls. The US Food and Drug Administration (FDA) is responsible for the enforcement of the rules. If your company is outside the USA but exports to the USA, you must also comply with the FSMA rules.
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)
Preventive controls are procedures and systems that are designed to ensure that food safety hazards are prevented or minimized to an acceptable level.
Rules for food fraud (USA)
FSMA requires that preventive controls are implemented by food manufacturers to prevent hazards to human health. The relevant regulation is called the FSMA Final Rule for Preventive Controls for Human Food, and is commonly known as the Preventive Controls Rule.
The Preventive Controls Rule 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).
After food manufacturers have identified the hazards, they must minimize or prevent the hazards by creating and implementing preventive controls in their food manufacturing operations. These are procedures and systems that are documented and that include monitoring, corrective actions systems and verification activities. The preventive controls form part of the food manufacturer’s food safety plan.
Learn more about the preventive controls rule on the FDA’s preventive controls guidance webpage.
A separate part of the FSMA rules also requires food manufacturers to create and implement systems to prevent intentional, malicious adulteration. The FDA calls this type of adulteration Intentional Adulteration (IA). It is different from economically motivated adulteration. Intentional adulteration prevention is also known as food defense. Click here to learn more about food defense.
Examples of 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 the 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.
Food businesses are required by law to 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.
Economically motivated food fraud (EMA) happens when food fraud perpetrators add materials to increase the apparent value of the food or to extend its shelf life in an undeclared or unlawful manner. Materials that are added to make food or ingredients seem bigger, or heavier include water and other liquids, or fillers and bulking agents, such as starches, husks or sawdust. Adulterants that are added to make food look better include unauthorised colorants, glosses and glazes. Adulterants that extend shelf life include non-approved preservatives.
The food safety risks from such adulterations include acute or chronic chemical poisoning, allergenic reactions, and microbial illnesses from pathogens introduced during the adulteration processes.
Example: Unauthorized color in turmeric
A significant proportion of powdered turmeric traded worldwide contains unsafe levels of lead. Researchers in Bangladesh have confirmed that the lead is added to the spice in the form of toxic lead chromate which has an intense yellow-gold color, the color favoured by turmeric traders and buyers as an indicator of freshness and quality. Curry powder, cumin and cinnamon have also been affected. A survey of more than 1496 samples of 50 spices from 41 countries found that 50% of the spice samples had detectable lead, and more than 30% had lead concentrations greater than 2 ppm, a level that is 200 times higher than the recommended maximum lead content of candy in the USA. Lead is a potent neurotoxin that damages organs including the brain.
Example: Undeclared peanuts in chopped hazelnuts
Peanuts are cheaper than most other nuts which makes them an attractive ‘filler’ or bulking agent in chopped nuts, powdered nuts and nut pastes. When a food fraud perpetrator adds peanuts to a tree nut product, they gain more profit than if they sold a pure paste or powder. In Germany in 2017, authorities found bulk quantities of chopped hazelnuts adulterated with 8% chopped peanuts. The chopped hazelnuts were sold as ‘pure’ hazelnuts and did not declare any peanut ingredients on the label. Because peanuts are a regulated human food allergen, their presence in the hazelnut product presented a serious food safety hazard.
How to identify hazards from economically motivated adulteration (EMA)
Follow the five steps below to identify hazards from EMA food fraud for your food manufacturing preventive controls plan.
- For each raw material that your company purchases to use in the food manufacturing process, investigate whether economically motivated adulteration is likely to occur within the supply chain. Ask yourself: could adulterants be 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 your company makes, also investigate whether economically motivated adulteration could occur inside your manufacturing facility or storage areas. This is sometimes known as ‘insider activity’.
- After you have understood whether adulteration is likely to occur for each raw material, make a list of adulterants that could be added to each of the susceptible foods. 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 under the FSMA rules*. Document your decisions and justifications for such.
- Add the economically motivated hazards you have identified to your company’s food safety plan. Implement preventive controls for each hazard. Supplier approvals programs are commonly used for control of economically motivated hazards in incoming raw materials.
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*Even if not strictly required under FSMA rules, it is always a good idea to prevent any type of food fraud from affecting your products. This will protect your company and brand as well as your consumers’ health.