The action plan will occur in three phases. As part of the first phase, FDA will immediately begin work setting action levels using a four-pronged approach:
- Evaluate the scientific basis for action levels. The cycle of continual improvement starts with the 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 the 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 — for every identified category of food — the 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. The FDA will use the information gathered from stakeholders, updated scientific research and routine monitoring data to make any needed adjustments and finalize action levels.
Once the FDA has published final action levels, the agency will establish a timeframe for assessing industry's progress toward meeting the action levels and recommence the cycle to determine if the scientific data support efforts to further adjust the action levels downward.
The action plan will start with prioritizing FDA's work on those elements for which it has the most data and information — arsenic and lead — while research continues on other elements, progressing through each element over time across various categories of foods consumed by babies and young children. During the plan's first year (phase one), FDA will be proposing action levels for lead in categories of foods consumed by babies and young children, consulting with and gathering data from stakeholders and federal partners on issues such as the feasibility of meeting action levels for lead, and sharing resources with industry on best practices for reducing or preventing lead contamination. FDA will also complete updated sampling assignments, testing toxic element levels in baby foods and evaluating the science related to arsenic exposure from foods beyond infant rice cereal. Phases two, three and beyond are outlined in the plan.
Through this plan, FDA will also 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 do take up toxic elements in the environment as they grow. With a cycle of continual improvement and collaboration, FDA aim's to push the levels of toxic elements in these foods closer and closer to zero over time.
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