The proposed FSMA rule for Focused Mitigation Strategies to Protect Food Against Intentional Adulteration establishes new requirements for the protection of food products against intentional contamination, including economically motivated adulteration (EMA) or food fraud. It’s estimated that EMA costs the global food industry $10-15 billion every year.
FDA’s definition of EMA is the “fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production (i.e., for economic gain).” The European Union defines food fraud as the deliberate and intentional substitution, addition, tampering, or misrepresentation of food, food ingredients, or food packaging; or false or misleading statements made about a product for economic gain.
EMA is not a new thing; it was prevalent during the Middle Ages. Because of this, trade guilds were set up to establish standards and maintain quality. In the 19th century, food manufacturers would add water to milk, then add flour or chalk to make it appear normal. Old produce would be colored with copper to brighten its appearance; and twigs and leaves added to coffee or tea. For the last 15 years, EMA issues have included adding melamine to dairy products and pet food, selling horse meat as beef products, and adding excessive cellulose to parmesan cheese.
EMA RISK IN YOUR FACILITY. There are several areas that need to be evaluated to determine if EMA is a potential hazard in your facility: ingredients, supply-chain traceability, supplier specifications, certificate of analysis (COA), and analytical testing.
To determine how vulnerable an ingredient is to EMA, you need to determine risk. Although there are many ways to do so, the most popular method is operational risk management (ORM). ORM cross references the probability that EMA of an ingredient will occur vs. how severe the action would be if an EMA event took place. As depicted in the chart above, there are five ratings for probability: frequent, likely, occasional, seldom, and unlikely; and four ratings for severity: catastrophic, critical, moderate, and negligible.
To show this, let’s run through an example of the questions you would ask for cumin powder:
- Is it an ingredient that has had an EMA issue? For this scenario, we will answer yes. To determine this, you could go to www.foodfraud.org to search for the ingredient for which you are determining risk.
- Is the supply chain complicated? For this scenario, we will answer yes.
- Does our supplier have food safety and food defense programs in place? For this scenario, it does and this has been verified by a third-party audit.
- Have we created detailed specifications for this ingredient to include testing for known EMA additives? Or have we requested the supplier to do this and provide a COA? For this scenario we have specifications, but testing for known EMA additives have not been included.
Looking at all these, the following questions illustrate how to assign risk for this ingredient:
- Is it possible for someone to conduct an EMA action on this ingredient? Yes.
- How likely is it to occur? I would rate this as an occasional frequency due to the past historical data and complicated supply chain of this ingredient.
- If an EMA incident did occur, how severely would this action affect our facility? Looking at past incidents, an allergen was added to this ingredient. For those with allergies, this could be a catastrophic event and could lead to death of individuals who ingest this ingredient without the knowledge of an allergen additive.
When we cross reference this on our chart we see a risk level of extremely high. So extremely high would be our risk level without any additional mitigation strategies.
REDUCING RISK. We can reduce this risk level by implementing some additional requirements or controls into our programs. Following are some possible suggestions (which may or may not work for your facility).
- During the ingredient review process, if an ingredient is found to have had historical EMA activity, try to determine if a substitute ingredient that has not had EMA activity will work.
- If the supply chain for an ingredient is long, complicated, and not easily traceable, consider finding suppliers who will use the most direct route from the farm.
- If this is not possible, ask the supplier to provide traceability documents showing the route that the ingredients took to arrive at your facility.
- If determined that the ingredient has had an EMA incident in the past, determine if there are tests that can be added to your quality program to ensure these items are not tainted. For example, testing cumin for peanut allergens.
Additionally, you should know all specifications of all the types of ingredients you purchase and use in manufacturing your products. The importance of reviewing all ingredients is to determine if they have been adulterated for economic gain in the past.
This task is not as difficult as it sounds, as there are two great resources available. The U.S. Pharmacopeia Convention developed www.foodfraud.org, which enables you to search ingredients and see historical adulteration data. It displays the types of adulterants that were used for that ingredient. Another resource is http://tiny.cc/IncidentsDatabase which gives access to industry specialists, researchers, and education materials related to EMA.
The most common foods or ingredients to have had EMA issues, as listed in Economically motivated adulteration: implications for food protection and alternate approaches to detection by Karen Everstien, are:
- Fish (usually replacing high-dollar species with less expensive species).
- Dairy products (e.g, melamine).
- Fruit juices (substituting fruit juices with less expensive ones or rotten fruit juices).
- Oils and fats (cutting high-quality oils with used oil).
- Honey (labeled organic but including antibiotics).
- Spices (adding allergens, twigs, or dirt).
Once you have reviewed historical data for potential EMA activities, you need to review the complete supply chain for those ingredients. This task can be quite difficult to accomplish due to globalization and the complexity of today’s food industry. To asses this, you need to look at the complete trail of your ingredient from the farm to the various manufacturers and distributors.
Let’s look at an example of how complex the supply chain can be: In 2005, more than 600 food products were recalled because Sudan 1 (a Class 3 carcinogen) was added to chili powder. The chili powder was then used to make Worcestershire sauce, which was then used in hundreds of different products.
This case was difficult to trace because the contaminated chili powder was sold numerous times to multiple suppliers and brokers over several years before it was finally used. A total of 300 companies were involved in the tracing of this recall. Having a complex supply chain can increase the potential of EMA.
Other factors are market trends and agricultural news about your ingredient. A hypothetical example could be:I read in an agricultural report that tea will have a bad yield this year. As expected, the price increased because of demand. This led to individuals intentionally adulterating tea for economic gain – adding other ground organic material and charging full price.
EVALUATING SUPPLIERS. How you evaluate and review suppliers is another consideration in the assessment process for the potential of EMA activity. Things to consider in the evaluation process:
- How do you determine the effectiveness of your supplier’s food safety and food defense programs? You can either require the supplier to have qualified third-party audits or conduct audits of suppliers by trained in-house personnel. Additionally, you should evaluate the performance history of your suppliers annually.
- Have you had to refuse a shipment?
- Have there been quality issues or customer complaints relating to the ingredients from this supplier? This information should be assessed to determine if vulnerabilities exist.
- What type of quality tests are required in your ingredient specifications?
- Have you identified quality parameters and asked your supplier to prove and provide this on COAs? A potential source of information is the U.S. Pharmacopeia Food Chemicals Codex, which has monographs of more than 1,000 food ingredients that contain potential quality tests that can be performed on that ingredient. This source is not all inclusive, but can be a great starting point on determining the types of testing available for ingredients.
- Who will perform the quality tests? If you require your supplier to periodically perform these tests, you should verify and validate that the tests are accurate by sampling product and performing the tests yourself on a defined frequency.
Protecting your company against food fraud is not as difficult as it may seem. It doesn’t take detective skills or an undercover agent. You simply need to have a plan in place and follow and adjust it where necessary: Identify your risk level. Determine vulnerabilities and potential EMA activity. Find weaknesses and threats in the supply chain and mitigate those risks. Determine the extent of your suppliers’ food safety and food defense programs. Decide the type of testing parameters you’ll set.
These strategies will help you reduce the risk level of a potential economically motivated adulteration of your ingredients.The author is subject matter expert, food defense, AIB International.