Customized Chemical Risk Assessment

Image of a field being mechanically sprayed with pesticide.

Customized Chemical Risk Assessment

A CORE PRINCIPLE of the clean label movements is that consumers expect transparency in the foods they eat. This translates to expectations that the food will be safe in all aspects.

While food safety plans have always focused on microbial contaminants, the Food Safety Modernization Act identifies chemical hazards, including heavy metals and pesticides, as factors that now must be considered by food producers. As explained in her presentation, “Chemical Risk Assessment: A Tool for Determining Customized Contaminant Programs,” prepared for the 2020 Clean Label Conference, speaker Grace Bandong, MSc, Global Scientific Strategy Leader, Contaminants, Eurofins Food Integrity and Innovations, explained that chemicals in foods are clearly a problem.

According to the USDA Pesticide Database, 52% of food commodity samples contained a pesticide residue, with more than one pesticide identified in 32% of samples. The FDA is continuously issuing Import Alerts for pesticide and heavy metal violations. A recent Consumer Reports study even found heavy metals in many baby foods.

In her role as Global Scientific Strategy Leader for Contaminants, Bandong hears several questions over and over: What chemicals should I test for? How do I test? How often do I test? To answer these questions, Eurofins developed a tool to help food companies, even those with limited budgets.

To control a chemical risk, you must identify, control and manage the hazard. The chemical risk-assessment process described by Bandong uses a phased approach. (See chart “Chemical Risk Assessment.”)

Chart presented by Grace Bandong at 2020 Clean Label Conference on the Chemical Risk Assessment 3-phase Process.

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The first phase of chemical risk assessment includes identifying and characterizing hazards and exposures to those hazards. The data you must collect and review includes an ingredient list, along with a categorization and specification for each ingredient. Purchasing information, including supplier and audit records, are also required, as are the product formula and marketing information.

Identification of risk factors, starting with inherent risk factors, occurs next. To assess inherent risk factors, you need to know the incidence history and evaluate growing, harvesting, storage, processing and distribution practices for each ingredient. Is there potential for economic adulteration? The FDA’s annual Pesticide Database Program Reports or FDA’s Import Alerts are possible sources for this information, as are USP’s Economic Adulteration Database and intra-company databases.

This information is then used to answer three questions: What is the likelihood of occurrence? What is the likelihood that the hazard will be removed by processing? Are multiple hazards present? Depending on the answers to these questions, an ingredient is given an inherent risk value of 1 (low) to 3 (high) risk.

Other characteristics of the ingredient that contribute to risk are similarly scored:
• Volume driver: The more of an ingredient you purchase, the greater the risk.
• Percent of formula: As the percentage of an ingredient within the formulation increases, so does risk.
• Supplier history: Do you trust them; do you audit them; are they compliant?
• Targeted market: Products marketed to infants, immunocompromised individuals or children are given higher scores.
• Source geography is also a consideration (evaluated on a scale of 1 to 5).
The scores for each risk factor are then multiplied together to calculate an overall risk classification for the ingredient.

Each company can then assign an overall risk classification for a range of scores. For example, if the ingredient score is greater than 100, that ingredient might be considered high risk; ingredients with scores less than 50 might be considered low risk. The testing program for each ingredient can then be tailored to these scores and your budget. An unlimited budget may permit frequent testing for even low-risk ingredients.

If the budget is more limited, you can allocate more testing to the higher risk ingredients and test lower risk products less frequently. For example, fruits may be at risk for pesticides, so you will screen them four-six times per year. Medium-risk ingredients might be tested twice a year, while low-risk ingredients might only be tested every other year. A chemical risk assessment allows one to assign a risk value (high, medium or low) to every ingredient in a product. With risk values determined, more funds can be directed towards high-risk ingredients—so you can achieve excellent control and under-standing of the materials; avoid surprises; and reduce customer exposure to contaminants, such as pesticides and heavy metals.

“Chemical Risk Assessment: A Tool for Determining Customized Contaminant Programs,” Grace Bandong, MSc, Global Scientific Strategy Leader, Contaminants, Eurofins Food Integrity and Innovations,