The U.S. Food and Drug Administration (FDA or the agency) recognizes that exposure to toxic elements including arsenic, lead, cadmium, and mercury from foods depends on the levels of the elements in the food and the amount consumed. The levels of the toxic elements in foods also depends on many factors. Thus, the FDA acknowledges that reducing levels of toxic elements in foods is complicated and multifaceted, as well as that it is “crucial that measures taken to limit toxic elements in foods do not have unintended consequences – like eliminating from the marketplace foods that have significant nutritional benefits or reducing the presence of one toxic element while increasing another.”
Closer to Zero outlines a science-based approach to incremental improvements over time, and focuses on evaluating the science, drafting proposed action levels, consulting with stakeholders, and finalizing action levels for the four toxins identified.2 This update provides a summary of the FDA’s plans.
Four stages of the FDA’s approach
The FDA’s goal is to reduce the levels of lead, arsenic, cadmium, and mercury to the greatest extent possible without jeopardizing access to nutritionally beneficial food at reasonable prices. Closer to Zero outlines a multi-phase, science-based, iterative approach to achieving this goal of getting levels of toxic elements in foods closer to zero over time.
The action plan will follow four stages:
- Evaluate the scientific basis for action levels. The FDA will evaluate existing information and 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.
The FDA will engage in a process involving stakeholders, advisory committees, public workshops, and/or consultation with scientific experts, federal agency partners, and other stakeholders to 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 proposed action levels for certain toxic elements in categories of baby foods (e.g., cereals, infant formula, pureed fruits and vegetables) 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 in every identified food category, the FDA will gather data and other information through a process of consultation which could include workshops, scientific meetings, and collaboration with federal partners to assess 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 of data to make any needed adjustments and finalize action levels.
Once final action levels are published, 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.
Phases for the FDA’s planned actions
Closer to Zero outlines a three phase approach to evaluate and propose action levels for each chemical, starting with lead, then arsenic, and then cadmium and mercury. The agency is operating in this order based on currently available data.
Phase 1: April 2021 – April 2022
- Lead: The FDA will propose action levels in certain foods eaten by babies and young children, considering the IRLs for dietary lead the FDA has published and other data.3 The FDA will also consult with stakeholders to assess the feasibility of achieving those levels, among other things.
- Arsenic: The FDA will gather data through a consultative process to work toward establishing an IRL.
- All toxins: The FDA will (1) provide resources to industry on best practices for reducing or preventing lead contamination and (2) complete a sampling assignment for baby foods.
Phase 2: April 2022 – April 2024
- Lead: The FDA will finalize action levels for lead in categories of foods consumed by babies and young children.
- Arsenic: The FDA will (1) propose action levels in certain foods eaten by babies and young children and (2) consult with stakeholders to assess the feasibility of achieving those levels, among other things.
- Cadmium and Mercury: The FDA will gather data through a consultative process to work toward establishing an IRL.
- All toxins: The FDA will:
- Issue a guidance chapter on chemical hazards in the Draft Guidance for Industry on Hazard Analysis and Risk-Based Preventive Controls for Human Food.
- Publish results from the sampling assignment for baby foods.
- Publish Total Diet Study results (to occur biennially).
- Publish exposure assessments for children to toxic elements (to occur biennially).
Phase 3: April 2024 – beyond
- Lead: The FDA will review new scientific data, assess progress on reducing lead in foods consumed by babies and young children, and determine the feasibility of attaining even lower levels.
- Arsenic: The FDA will finalize action levels for arsenic in categories of foods consumed by babies and young children.
- Cadmium and Mercury: The FDA will (1) propose action levels in certain foods eaten by babies and young children and (2) consult with stakeholders to assess the feasibility of achieving those levels, among other things.
- All toxins: The FDA will:
- Complete additional baby food sampling assignments.
- Publish the results from sampling assignment for baby foods.
- Publish Total Diet Study results (to occur biennially).
- Publish exposure assessments for children to toxic elements (to occur biennially).
Additional work
The FDA also plans to continue its ongoing research and collaborations and its work to set action levels in juices, including:
- Finalizing action levels for arsenic in apple juice and issuing draft action levels for lead in other juices.
- Continuing development and validation of analytical methods.
- Continuing toxicological research on impacts of toxic elements on development in children.
- Developing new dose-response models to consider the probability of other adverse health effects in different sub-populations, including infants and young children.
- Collaborating with the U.S. Department of Agriculture on research on agronomic techniques that may mitigate uptake of toxic elements in agricultural commodities.
- Collaborating with the National Institutes of Health and U.S. Centers for Disease Control and Prevention to better understand impacts of toxic elements on development and the role of nutrition for mitigating those impacts.
- Evaluating potential impact of new technologies, interventions, or mitigation controls to reduce exposure and resulting risk to consumer health.
- Reevaluating risk assessments based on declining levels of toxic elements in foods.
We will continue to monitor the Closer to Zero initiative and the FDA’s activity related to chemical hazards. Please contact us if you have any questions.
References
1 FDA Closer to Zero: Action Plan for Baby Foods (8 April 2021), https://www.fda.gov/food/metals-and-your-food/closer-zero-action-plan-baby-foods; see also FDA Constituent Update FDA Shares Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies and Young Children (8 March 2021), https://www.fda.gov/food/cfsan-constituent-updates/fda-shares-action-plan-reducing-exposure-toxic-elements-foods-babies-and-young-children.
2 See FDA Statement from Acting Commissioner of Food and Drugs, Janet Woodcock, MD, Director of the Center for Food Safety and Applied Nutrition, Susan T Mayne, PhD: FDA Releases Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies, Young Children (8 April 2021), https://www.fda.gov/news-events/press-announcements/fda-releases-action-plan-reducing-exposure-toxic-elements-foods-babies-young-children.
3 The U.S. Centers for Disease Control and Prevention (CDC) has identified a blood reference level of five micrograms of lead per deciliter of whole blood (ug/dL) as the level at which they recommend clinical monitoring of lead exposure in children. Using the CDC’s level as a biomarker, in 2018 the FDA calculated a maximum daily intake for lead from food (the IRL). The IRL is the calculated amount of dietary lead intake that would be required to reach the CDC’s blood reference level, including a 10x safety factor. The calculated IRLs are three micrograms (µg) per day for children and 12.5 µg per day for adults.
Authored by Maile Hermida and Christine (Chris) Forgues.
