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TAG April 26, 2018 0 Comments

Certain metals, such as such as arsenic, lead, cadmium, and mercury, are elements of the Earth’s environment and are, thus, naturally present in some foods. But natural is not always a good thing. In fact, the detection and reduction of these natural elements is a direction in which FDA is moving more aggressively lately – increasing its monitoring and limiting of their levels in foods. Just this month, FDA issued a statement and “Conversation with Conrad Choiniere” on its activity in this area, including that of its recently established Toxic Elements Working Group; its finalizing of draft guidance that sets an action level for the presence of inorganic arsenic in infant rice cereals and apple juice; its reevaluation of allowed lead levels in food to coincide with CDC’s lowering of acceptable blood levels; and its general commitment to “taking a more strategic, global approach – looking at all the metals across all foods rather than one contaminant, one food at a time.” The heavy metals, which occur naturally and as pollutants in air, water, and soil enter the food supply when plants take them up as they grow. But at high levels, they can be toxic, and can be especially harmful to children’s neurological development. The top four metals, with brief overviews of their presence in food, are: Cadium is deposited on the ground by rain or simply falling out of the air. It then moves easily through soil layers and is taken up by plants such as leafy vegetables, root crops, cereals and grains. (ATSDR) Arsenic is an element in the Earth’s crust. Because it is present in water, air, and soil, it is absorbed by some food crops and cannot be completely eliminated. Rice has been shown to have higher levels of inorganic arsenic than other foods. (FDA) Lead in soil can be deposited on or absorbed by plants and cannot always be completely removed by washing or other steps in food processing. (FDA) Organic mercury compounds are formed when mercury combines with carbon. Microscopic organisms in water and soil can convert elemental and inorganic mercury into an organic mercury compound, methylmercury, which accumulates in the food chain, particularly fish and seafood. (CDC) FDA’s monitoring of the metals is not new, but with scientific advances enabling increased detection and data, the agency is expanding its efforts to identify ways by which the levels can be reduced in foods. So, in 2017, FDA established the Toxic Elements Working Group in 2017. Led by Choiniere, CFSAN’s Office of Analytics and Outreach director, the workgroup is looking at the presence of metals in all products CFSAN regulates and identifying the areas where the FDA can have the greatest impact on reducing exposures. As Choiniere explained, “There isn’t one single source we can point to that results in exposure to these metals. Even though the levels of a metal in any particular food is low, our overall exposure adds up because many of the foods we eat contain them in small amounts.” What does this mean to you? If you produce or use as an ingredient a food that is susceptible to these natural metals, especially at high levels, you will likely be subject to tighter detection and control efforts in the near future. The workgroup is studying data that FDA has collected for decades on contaminants and nutrients in foods; sampling hundreds of retail foods from across the country that it sees as representative of the American diet; and using data from other studies to understand consumer consumption of the foods – who and how much. The data is then compiled to determine how much of a contaminant may be getting into any person’s diet on an annual basis. From all this, it is applying a risk-based approach to prioritize its efforts for the greatest impact. That is, a primary focus is being put on whether and how levels can be reduced in foods with the highest risk – those identified as potentially having relatively high levels of a heavy metal. This includes questions such as: Can the metal level be reduced by changing how the food is grown or manufactured? Should FDA inform consumers about what they can do to protect themselves? What remedies can the offer to the industry? One of those remedies is its finalization of draft guidance that sets an action level for the presence of inorganic arsenic in infant rice cereals and apple juice. A second will likely focus on lead levels in foods, as CDC’s lowering of the acceptable level of lead in blood has led FDA to begin reevaluating the specific lead levels that it has set for a variety of foods. And even while we await guidance, FDA has made a point to state that although it has set specific levels for the metals in a variety of foods, “the FDA has—and uses—the authority to take action on a case-by-case basis where a particular food is found through routine or targeted testing to be adulterated.” So, what does it mean to you? It means that you should start taking a deeper look, now, to determine what heavy metals are or may be in the foods you produce and ingredients you use. I also would urge all food producers to review the draft guidance when it becomes available – whether you produce a related food or not, as this first guidance is likely to set the tone for all heavy metals. And, with FDA stating that it plans to seek stakeholder input – make your voice heard whenever FDA provides the opportunity. As a final thought, I want to make it clear that while much of the current and past focus for food safety has been on microbiological risks, there is a definite move at FDA toward increased focus on chemical risks with a particular focus on heavy metals. The challenge is that much of this relates to supply chain control and lack of visibility into the supply chain. So we suggest taking a good look at the heavy metal risks in the ingredients and products you are currently using that are supplied by others to at least assess your degree of exposure. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance.


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