WASHINGTON – A March 27 letter from 13 food industry groups, including the American Bakers Association and the North American Millers’ Association, seeks more details about how the US Food and Drug Administration, in draft guidance, established action levels for lead in baby food.
The draft guidance, which was published Jan. 25 in the Federal Register, sets levels for lead in processed food intended for babies and young children by food category. The levels are 10 parts per billion for fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings and single-ingredient meats; 20 ppb for root vegetables (single ingredient); and 20 ppb for dry cereals.
The industry groups agreed with the FDA that a level of zero for heavy metals in food is not practicable or achievable, and it may have an unintended consequence of limiting or eliminating certain nutrient-dense foods from the market.
The industry groups also agreed with the FDA that separate levels are warranted for different types of products due to variations in lead levels. However, because of the “relatively small” sample sizes for certain product categories, the industry groups want to hear how the FDA determined that sample sizes for the categories were sufficiently large enough to account for the variability of lead in the products. The items may have been produced with different ingredients from varying growing regions, according to the letter. Explaining how various processing methods were considered was another request.
“Significant data gaps exist with regards to geographic concentrations of lead in growing environments, the extent of lead uptake in a given crop if present in the soil, and science-based mitigation measures to either prevent uptake or reduce levels in the ingredients and final processed products,” the letter said. “For this reason, we request supporting information for the identified food products in scope of this guidance, and their related ingredients, on how these action levels may best be achieved. Mitigation measures should consider supply chain realities and challenges, recognizing that growing regions for certain ingredients are limited, and that simply changing growing regions is not feasible for all implicated raw agricultural commodities.”
Besides the ABA and NAMA, other industry groups signing the letter were the American Frozen Food Institute, the American Spice Trade Association, the Consumer Brands Association, the Corn Refiners Association, FMI — The Food Industry Association, the International Food Additives Council, the International Fresh Produce Association, the National Confectioners Association, the National Seasoning Manufacturers Association, the USA Rice Federation and the Western Growers Association.
Lead is especially harmful to vulnerable populations, including infants, young children, women who are pregnant and their fetuses, and those with chronic health conditions, according to the FDA. Lead exposure may harm children’s health and development, specifically the brain and nervous system.
The FDA originally gave March 27 as a deadline to submit comments on the draft guidance, but the deadline was extended by 30 days.