The U.S. Food and Drug Administration (FDA) announced a new action plan, Closer to Zero, that sets forth its approach to reducing exposure to toxic elements in foods commonly eaten by babies and young children to the lowest possible levels.
Although FDA’s testing shows that children are not at an immediate health risk from exposure to toxic elements at the levels found in commonly consumed foods, it is starting the plan’s work immediately, with both short- and long-term goals for achieving continued improvements in reducing levels of toxic elements in these foods over time.
FDA’s goal is to reduce the levels of arsenic, lead, cadmium, and mercury in these foods to the greatest extent possible. Its plan outlines a multi-phase, science-based, iterative approach to achieving its goal of getting levels of toxic elements in foods closer to zero over time.
Closer to Zero includes researching and evaluating changes in dietary exposures to toxic elements, setting action levels (recommended limits of toxic elements in foods that can be achieved by industry and progressively lowered as appropriate), encouraging adoption of best practices by industry, and monitoring progress.
The action plan will occur in three phases. As part of the first phase, FDA will immediately begin its work setting action levels using a four-pronged approach:
- Evaluate the scientific basis for action levels. The cycle of continual improvement starts with FDA evaluating existing data from routine testing of the food supply, research and data on chemical analytical methods, toxicological assays, exposure and risk assessments, and other relevant scientific information. Through a process that may include advisory committees, public workshops, and consultation with scientific experts, federal agency partners, and other stakeholders, the agency will establish interim reference levels (IRLs) for certain toxic elements as appropriate. An IRL is a measure of exposure from food that the FDA may use to determine if the amount of exposure to an individual element across foods could result in a specific health impact.
- Propose action levels. The IRLs may be among the key factors that inform the development of FDA’s proposed action levels for certain toxic elements in categories of baby foods (e.g., cereals, infant formula, pureed fruits and vegetables, etc.) and other foods commonly eaten by babies and young children.
- Consult with stakeholders on proposed action levels, including the achievability and feasibility of action levels. For each toxic element—every identified category of food—FDA will gather data and other information through a process of consultation that could include workshops, scientific meetings, and collaboration with federal partners to assess, among other things, the achievability and feasibility of the proposed action levels and the timeframes for reaching them.
- Finalize action levels. FDA will use the information gathered from stakeholders, updated scientific research, and routine monitoring data to make any needed adjustments and finalize action levels.
Through this plan, FDA will take measures to ensure that limiting exposure to toxic elements in foods does not have unintended consequences—like limiting access to foods that have significant nutritional benefits—by making them unavailable or unaffordable for many families, or unintentionally increasing the presence of one toxic element when foods are reformulated to reduce the presence of another.
In addition, FDA's goal of moving closer to zero reflects the reality that fruits, vegetables, and grains take up toxic elements in the environment as they grow. With a cycle of continual improvement and collaboration, FDA aims to push the levels of toxic elements in these foods closer and closer to zero over time.
