About | Approach | Action Items & Proposed Timeline | Public Meetings, Workshops, and Webinars | Ongoing Work | Announcements
About Closer to Zero
Why are arsenic, lead, cadmium, and mercury found in some foods?
These contaminants are present in the environment due to natural geological occurrences and human activities. The levels of these substances in the air, water, and soil used for agriculture and food processing can vary based on geographical location and proximity to pollution sources, both past and present.
The concentration of arsenic, lead, cadmium, or mercury in specific foods is determined by their environmental presence and the degree to which plants or animals absorb them from their surroundings.
The primary objective of the FDA is to minimize dietary exposure to these contaminants as much as possible while ensuring that nutritious food options remain accessible. The agency has made significant strides in reducing environmental contaminant exposure through food, and Closer to Zero is designed to build upon this progress. We prioritize foods commonly consumed by infants and young children because their bodies are more susceptible to the adverse effects of these contaminants due to their smaller size and metabolic processes. Our efforts within Closer to Zero are focused on:
Research and Analysis:
- Developing advanced testing methodologies to detect trace levels of contaminants in food.
- Conducting comprehensive surveys of foods popular among infants and young children to assess the variability in arsenic, lead, cadmium, and mercury concentrations.
- Collaborating with federal partners to devise strategies for lowering contaminant levels in food products.
- Analyzing consumption patterns across diverse populations.
- Measuring dietary exposure to these contaminants.
- Establishing reference levels for these contaminants to identify levels of concern.
- Investigating the protective role of nutrients against the health impacts associated with contaminant exposure.
Regulation:
- Establishing action levels for contaminants in food.
- Intensifying targeted compliance and enforcement measures.
- Continuously monitoring contaminant levels to inform potential adjustments to proposed action levels.
Consultation:
- Encouraging the food industry to adopt best practices in agriculture and processing to reduce environmental contaminants in agricultural commodities and food products.
Lowering contaminant levels in food is a complex and multifaceted challenge. It is essential to ensure that measures implemented to reduce arsenic, lead, cadmium, and mercury in foods do not inadvertently lead to negative consequences. These could include removing nutritionally important foods from the market or reducing one contaminant while increasing another.
The FDA is dedicated to a science-based, transparent, and inclusive approach. This includes actively engaging with stakeholders and publicly sharing data and information. We will regularly update our action items and timelines as new data, information, and resources become available.
For further details, including links to FDA guidelines and data tables, please visit the FDA’s webpages dedicated to lead, arsenic, mercury, cadmium, and testing results.
Understanding the FDA’s Approach
Closer to Zero employs a science-driven, iterative process aimed at achieving continuous improvements over time in reducing contaminant levels in food.
What are action levels in food safety?
Action levels are regulatory benchmarks used by the FDA to reduce chemical contaminants in food when complete elimination is not currently feasible.
An action level indicates a contaminant concentration at which a food may be considered adulterated, according to section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act. It’s important to note that action levels do not represent a safe or permissible level of contamination.
The FDA uses action levels, in conjunction with other scientific evidence and factors, to determine whether to take regulatory action in specific situations.
The Four Stages of the FDA’s Approach:
1. Evaluate the scientific basis for action levels. The continuous improvement cycle begins with the FDA assessing existing data from routine food supply testing, chemical analysis methods, toxicology studies, exposure and risk assessments, and other relevant scientific information. Through stakeholder engagement, advisory committees, public workshops, and consultations with scientific experts, federal agency partners, and other stakeholders, the agency will establish Interim Reference Levels (IRLs) as needed. An IRL is a measure of contaminant exposure from food that the FDA uses to evaluate if the total exposure across different foods could lead to specific health impacts.
2. Propose action levels. IRLs are key factors in developing the FDA’s proposed action levels for arsenic, lead, cadmium, and mercury in various baby food categories (e.g., cereals, pureed fruits and vegetables) and other foods commonly consumed by babies and young children. Once action levels are identified, the FDA submits draft guidance to other federal agencies, including The White House, for review.
3. Consult with stakeholders on proposed action levels, including their achievability. For each contaminant in every identified food category, the FDA gathers data and feedback through consultations, including workshops, scientific meetings, and collaborations with federal partners. This process assesses the feasibility and achievability of the proposed action levels and the timelines for reaching them.
4. Finalize action levels. The FDA uses the information collected from stakeholders, updated scientific research, and ongoing monitoring data to make necessary adjustments and finalize the action levels.
The FDA’s Approach in Action
After publishing final action levels, the FDA will set a timeframe to evaluate the food industry’s progress in meeting these levels. The cycle then restarts to determine if scientific data supports further adjustments to the action levels. The availability of data and the need for additional research differ for arsenic, lead, cadmium, and mercury. Currently available data allows us to begin by proposing action levels for lead while continuing to assess data for arsenic, cadmium, and mercury. We will then proceed through the cycle for each element as we gather more data and information across various food categories consumed by babies and young children.
As action levels are finalized, the continuous improvement cycle will continue. We will address arsenic, lead, cadmium, and mercury to assess whether downward adjustments to IRLs are needed, propose new action levels as appropriate, consult with stakeholders on feasibility and achievability, and adjust and finalize action levels as necessary.
While action levels are valuable for reducing contaminants in foods, the agency can take enforcement action against unsafe food products even without established action levels. Food manufacturers and processors are legally responsible for implementing preventive controls to minimize or prevent chemical hazards, including lead, arsenic, cadmium, and mercury. If the FDA determines that a contaminant level makes food unsafe, we will take action. This may involve working with manufacturers to resolve the issue and preventing the product from entering or remaining in the U.S. market.
Planned Action Items
Action Levels
| Contaminant/Commodity | Current Phase | Evaluate the Science Gather data and collaborate with federal partners. | Propose Draft Action Levels Propose action levels for specific contaminants in foods or food groups in draft guidance to industry and open for public comment. | Consult with Stakeholders Engage with stakeholders to assess feasibility and best practices, among other things. | Finalize Action Levels Review new scientific data, assess progress on reducing environmental contaminants, and feasibility of attaining lower levels. |
|---|---|---|---|---|---|
| Lead in Juices | Consult | February 2020: Interim Reference Level for lead identified | April 2022: Issued draft guidance | *June 2022: Stakeholder webinar | Target: 2025 |
| Lead in Foods Intended for Babies and Young Children | Finalize | August 2022: Interim Reference Level for lead updated | January 2023: Issued draft guidance | *March 2023: Stakeholder webinar | January 2025: Issued final guidance |
| Arsenic in Foods Intended for Babies and Young Children | Propose | 2022-2023: Evaluated, with federal partners, the science for arsenic and other work related to establishing interim reference levels | 2025: Develop action levels and issue draft guidance | * | Target: Issue final guidance one year after issuing draft guidance |
| Cadmium in Foods Intended for Babies and Young Children | Propose | 2022-2023: Evaluated the foundational science for cadmium and established interim reference levels | 2025: Develop action levels and issue draft guidance | * | Target: Issue final guidance one year after issuing draft guidance |
| Mercury in Foods Intended for Babies and Young Children | Evaluate | 2022-2023: The FDA and federal partners sponsored a study on the role of seafood consumption in child growth and development NASEM public meetings: January, February, April 2023 and March 2024 March 2024: NASEM pre-publication version of report on the role of seafood in child growth and development, including mercury | Mercury is unique as bioaccumulation in seafood is the primary dietary source. To date, the FDA and EPA have issued Advice About Eating Fish to consumers to encourage choices lowest in mercury. | * | The FDA and EPA are reviewing the NASEM report, current data, and existing and emerging methodologies to determine if updates to the Advice About Eating Fish are warranted. The FDA will consider whether additional regulatory action would be beneficial. |
*130 stakeholder engagements since 2021. Stakeholder engagements often focus on multiple contaminants/commodities and/or the overall Closer to Zero initiative.
Research, Monitoring, and Compliance
Public Meetings, Workshops, and Webinars*
| Events | Related Links |
|---|---|
| The Role of Seafood Consumption in Child Growth and Development Public Webinar, March 26, 2024 | Event Page |
| NIH Workshop on Multigenerational Nutrition Influences on Health and Disease, July 12-13, 2023 | Event Page Recording Day 1 Recording Day 2 |
| Stakeholder Webinar on Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry March 2, 2023 | Event Page and Recording |
| Partnership for Food Safety Education 2023 Consumer Food Safety Education Conference, Pre-conference Workshop: FDA’s Closer to Zero Action Plan – What’s the Food Safety Message? March 1, 2023 | Event Page |
| The Role of Seafood Consumption in Child Growth and Development (Meeting #2), February 23, 2023 | Recording |
| NIH-FDA Joint Scientific Workshop “Bridging the Biological and Communication Sciences on Nutrients and Environmental Contaminants in Foods to Support Child Development” February 9-10, 2023 | Event Page Recording Day 1 Recording Day 2 |
| National Academies of Sciences, Engineering, and Medicine Committee Review of The Role of Seafood in Child Growth and Development Information Gathering Session, January 19, 2023 | Recording |
| Science Board to the Food and Drug Administration Advisory Committee – Cadmium, December 8, 2022 | Event Page and Recording |
| FDA Stakeholder Webinar on the Draft Guidance for Industry on Action Levels for Lead in Juice, June 14, 2022 | Event Page and Recording |
| JIFSAN-CFS3 Advisory Council Virtual Annual Symposium: Understanding of the Impact of Arsenic, Cadmium, and Lead Across the Food Supply, May 25-26, 2022 | Event Page Recording link |
| USDA-FDA Joint Public Meeting – Closer to Zero: Impacts of Toxic Element Exposure and Nutrition in the Food System, April 27, 2022 | USDA Closer to Zero Page |
| USDA NIFA Workshop on Toxic Elements in Food: Identification of Critical Knowledge Gaps to Ensure a Safe Food Supply, April 4-5, 2022 | Workshop report |
| FDA Grand Rounds on Closer to Zero, December 9, 2021 | Event Page and Recording |
| FDA-Society of Toxicology Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety – Arsenic and Children’s Health, December 1, 2021 | Event page |
| FDA Public Meeting: Closer to Zero Action Plan: Impacts of Toxic Element Exposure and Nutrition at Different Crucial Developmental Stages, on Closer to Zero, November 18, 2021 | Event page and Recording |
*Includes public events hosted, co-hosted, and/or funded/sponsored by the FDA.
Ongoing Work to Support Closer to Zero
To further the Closer to Zero goals and build upon the significant progress already made in reducing contaminants in the food supply, our ongoing efforts include:
- Developing and refining analytical methods for contaminant detection.
- Continuing toxicological research on the developmental impacts of arsenic, lead, and cadmium in children.
- Creating advanced dose-response models to assess the likelihood of various adverse health effects in different populations, especially infants and young children.
- Collaborating with the U.S. Department of Agriculture on research into agricultural techniques that can reduce the uptake of these contaminants in crops.
- Partnering with the National Institutes of Health and the Centers for Disease Control and Prevention to enhance our understanding of the developmental impacts of these contaminants and the role of nutrition in mitigating these impacts.
- Assessing the potential of new technologies, interventions, and mitigation strategies to decrease exposure and associated health risks for consumers.
- Re-evaluating risk assessments based on the decreasing levels of toxic elements in foods.
The FDA’s regulatory actions, combined with research and collaborations across industry, advocacy groups, policymakers, academia, and consumers, will lead to significant and lasting reductions in exposure to arsenic, lead, mercury, and cadmium for both children and the general population, resulting in a major positive public health impact.
For access to FDA’s published research, please visit the Monitoring and Testing sections on the FDA websites dedicated to Lead, Arsenic, Cadmium, and Mercury.
