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                Environmental Contaminants in Food

Environmental Contaminants in Food

                        Arsenic in Food
          Lead in Food and Foodwares
          Mercury in Food
          Cadmium in Food and Foodwares
          Closer to Zero: Reducing Childhood Exposure to Contaminants from Foods
          Perchlorate
          Radionuclides in Domestic and Imported Foods
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          Dioxins & PCBs
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          Testing Results for Arsenic, Lead, Cadmium and Mercury Home
          Food
          Chemical Contaminants & Pesticides
          Environmental Contaminants in Food
          Closer to Zero: Reducing Childhood Exposure to Contaminants from FoodsEnvironmental Contaminants in Food Closer to Zero: Reducing Childhood Exposure to Contaminants from Foods
  
  	
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    PrintCloser to Zero - Reducing Children's Exposure to Metals from Food
About | Approach | Action Items & Proposed Timeline Public Meetings, Workshops, and Webinars | On-Going Work | Announcements

About Closer to Zero

***Why are arsenic, lead, cadmium, and mercury in some foods?***

These contaminants may occur in the environment naturally (as elements in the earth’s crust) and from human activities. Levels in the air, water, and soil used to grow crops, process foods, and raise animals can vary depending on natural geographical differences and proximity to past or current pollution.

The amount of arsenic, lead, cadmium, or mercury in certain foods depends on the amount in the environment and how much the plant or animal ‘takes up’ from the environment.

The FDA’s goal is to reduce dietary exposure to contaminants to as low as possible, while maintaining access to nutritious foods. The agency’s work to date has resulted in significant progress in reducing exposure to environmental contaminants from foods and *Closer to Zero* builds on this progress. We have prioritized foods commonly eaten by babies and young children because their smaller body sizes and metabolism make them more vulnerable to the harmful effects of these contaminants. To meet the goals of *Closer to Zero*, we have focused our efforts on:

**Research and Analysis:**

developing new and improved testing methods to measure lower levels of contaminants in food;
	conducting surveys on foods commonly eaten by infants and young children to understand variability in concentrations of arsenic, lead, cadmium, and mercury in these foods;
	working with federal partners to identify strategies to reduce contaminant levels in food products;
	evaluating consumption patterns for different populations;
	measuring dietary exposures to these contaminants;
	identifying reference levels for these contaminants to determine levels of concern; and
	understanding how nutrients can help protect against the health effects associated with contaminants.**Regulation:**

establishing action levels;
	increasing targeted compliance and enforcement activities; and
	monitoring levels over time to determine potential adjustments to proposed action levels.**Consultation:**

encouraging adoption of agricultural and processing best practices by industry to lower levels of environmental contaminants in agricultural commodities and products.Reducing levels of contaminants in foods is complicated and multifaceted. It is crucial to ensure that measures taken to limit arsenic, lead, cadmium, and mercury in foods do not have unintended consequences—like eliminating from the marketplace foods that have significant nutritional benefits or reducing the presence of one element while increasing another.

The FDA is committed to a science-driven, transparent, and inclusive process that will include active stakeholder engagement and public sharing of data and information. We will update our action items and timelines as new data, information, and resources become available.

More information, including links to FDA guidance and data tables, can be found on FDA’s lead, arsenic, mercury, cadmium, and testing results webpages.

Understanding the FDA’s Approach

Cycle of Continual Improvement: Decreasing Exposure to Toxic Elements from Foods for Babies and Young Children
Closer to Zero uses a science-based, iterative approach for achieving continual improvements over time.

***What are action levels?***

Action levels are one regulatory tool the FDA uses to help lower levels of chemical contaminants in foods when a certain level of a contaminant is unavoidable.

Action levels are a level of contamination at which a food may be regarded as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act. Action levels do not establish a permissible level of contamination.

The FDA considers action levels, in addition to other factors and scientific evidence, when considering whether to bring enforcement action in a particular case.

The Four Stages of the FDA’s 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 engagement with stakeholders, advisory committees, public workshops, and consultation with scientific experts, federal agency partners and other stakeholders, the agency will establish interim reference levels (IRLs) as appropriate. An IRL is a measure of exposure to a contaminant from food that the FDA may use to determine if the amount of exposure to the contaminant 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 arsenic, lead, cadmium, and mercury in categories of baby foods (e.g., cereals, pureed fruits and vegetables) and other foods commonly eaten by babies and young children. After the FDA identifies action levels, the agency submits our draft guidance on action levels for review by other federal agencies, including The White House.

**Consult with stakeholders on proposed action levels, including the achievability of action levels.** For each individual element in every identified category of food, 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, 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 of data to make any needed adjustments and finalize action levels.

The FDA's Approach in Action

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 resume the cycle to determine if the scientific data support efforts to further adjust the action levels.
The availability of data and additional research needs for arsenic, lead, cadmium, and mercury are different. Therefore, because of currently available data, we will start with proposing action levels for lead while we evaluate data for arsenic, cadmium, and mercury. We will then progress through the cycle for each element as we gather more data and information across various categories of food eaten by babies and young children.

As action levels are finalized, we will continue the cycle of continual improvement, addressing arsenic, lead, cadmium, and mercury to evaluate whether downward adjustments of interim reference levels should be made; proposing new action levels, as appropriate; consulting with stakeholders on feasibility, achievability, and other issues; and adjusting (as needed) and finalizing action levels.

While action levels are a useful tool to drive down levels of contaminants in foods, the agency does not need an action level for a contaminant to take enforcement action on a food product that violates safety laws. By law food manufacturers and processors have a responsibility to implement preventive controls as needed to significantly minimize or prevent exposure to chemical hazards—including lead, arsenic, cadmium, and mercury. If the agency finds that the level of a contaminant in a food causes the food to be unsafe, we take action, which may include working with the manufacturer to resolve the issue and taking steps to prevent the product from entering, or remaining in, the U.S. market.

Planned Action Items

Action Levels

Contaminant/Commodity
			Evaluate the
			Science

			FDA Blue Circle
Gather data and collaborate with federal partners.
			Propose Draft Action Levels

			FDA Red Circle
Propose action levels for specific contaminants for foods or food groups in draft guidance to industry and open for public comment.
			Consult with Stakeholders

			FDA Dark Blue Circle
Engage with stakeholders to assess, among other things, feasibility and best practices.
			Finalize Action
			Levels

			Green Circle
Review new scientific data, assess progress on reducing environmental contaminants in products and feasibility of attaining even lower levels.**Lead in Juices**
			February 2020: Interim Reference Level for lead identified
			April 2022: Issued draft guidance
			June 2022: Stakeholder webinar
			No update**Lead in Foods Intended for Babies and Young Children**
			August 2022: Interim Reference Level for lead updated
			April 2022: Developed action levels and submitted draft guidance for interagency review
			January 2023: Issued Draft Guidance
			March 2023: Stakeholder webinar
			No update**Arsenic in Foods Intended for Babies and Young Children**
			2022-2023: Continue evaluating, together with federal partners, the science for arsenic and other work related to establishing interim reference levels.
			2024: Develop action levels and submit draft guidance for interagency review
			No update
			No update**Cadmium in Foods Intended for Babies and Young Children**
			2022-2023: Continue evaluating the foundational science for cadmium to establish interim reference levels
			2024: Develop action levels and submit draft guidance for interagency review
			No update
			No update**Mercury in Foods Intended for Babies and Young Children**
			2022-2023: FDA and federal partner’s sponsor study on the role of seafood consumption in child growth and development
			January 2023: NASEM webcast
			No update
			No update

Research, Monitoring, and Compliance

Activities
			Status**Research: Cadmium - toxicology**
			2022: Completed systematic review of adverse health effects from oral cadmium exposure; review of adverse health effects of cadmium in infants and children, modeling of low bone mass and osteoporosis in US adults; and modeling of cadmium dose response.**Research: Lead - toxicology**
			2020: Identified Interim Reference Level for lead to calculate maximum daily intake from food.

			2022: Completed updating the Interim Reference Level for lead to align with CDC’s 2021 updated blood lead reference value (CDC’s BLRV of 3.5 μg/dL).**Research: Arsenic - toxicology**
			Ongoing: evaluating data and other information on the dose response of arsenic.**Research: Mercury – toxicology**
			2022-2023: Contracted NASEM for an independent consensus study on the role of seafood in child growth and developing, including mercury.**Research: Predictive toxicology**
			2022: Applying predictive toxicology to assess toxicity of arsenic, lead, cadmium, and mercury using predictive toxicology. FDA assessed developmental toxicity of arsenic and mercury in a non-vertebrate, alternative model using C. elegans and developmental toxicity and neurotoxicity of arsenic in a vertebrate alternative model using zebrafish.**Research: Methods development**
			Ongoing: Developing and validating analytical methods for toxic elements in foods.**Research, Monitoring, and Compliance: Testing foods commonly consumed by babies and young children, for arsenic, lead, cadmium and mercury.**
			2022: FDA Total Diet Study (TDS) FY2018-FY2020 Elements Report and Data

			2022: A survey of toxic elements in ready to eat baby foods in the US market 2021

			2022: Analytical Results for Lead in Juice -TEP FY2005-FY2018 - PDF, in XLSX

			2022: Analytical Results for Total Arsenic in Single-Strength Apple Juice-TEP (FY2013-FY2022)

			2022: Speciation Results from Arsenic Analysis in Single-Strength Apple Juice -TEP (FY2013-FY2022)**Issue guidance chapter on chemical hazards in the Draft Guidance for Industry on Hazard Analysis and Risk-Based Preventive Controls for Human Food**
			Target 2024**Research: Consumer studies to inform educational content for target audiences**
			Ongoing: In-depth interviews with health educators and additional focus groups with parents and caregivers are under development.

			Ongoing: Focus groups conducted with parents and caregivers.

			Ongoing: FDA and USDA collaboration to gather informational needs for consumer and health professional education.

Public Meetings, Workshops, and Webinars*

Events
			Related LinksAdvancing Health Professionals' Understanding of Heavy Metals in Food: What Can Be Done to Protect Public Health? December 14, 2023
			RecordingNIH Workshop on Multigenerational Nutrition Influences on Health and Disease, July 12-13, 2023
			Event Page

			Recording Day 1

			Recording Day 2Stakeholder Webinar on Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry March 2, 2023
			Event Page and RecordingPartnership 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 PageThe Role of Seafood Consumption in Child Growth and Development (Meeting #2), February 23, 2023
			RecordingNIH-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 2National Academies of Sciences, Engineering, and Medicine Committee Review of The Role of Seafood in Child Growth and Development Information Gathering Session, January 19, 2023
			RecordingScience Board to the Food and Drug Administration Advisory Committee – Cadmium, December 8, 2022
			Event Page and RecordingFDA Stakeholder Webinar on the Draft Guidance for Industry on Action Levels for Lead in Juice, June 14, 2022
			Event Page and RecordingJIFSAN-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 linkUSDA-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 PageUSDA NIFA Workshop on Toxic Elements in Food: Identification of Critical Knowledge Gaps to Ensure a Safe Food Supply, April 4-5, 2022
			Workshop reportFDA Grand Rounds on Closer to Zero, December 9, 2021
			Event Page and RecordingFDA-Society of Toxicology Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety - Arsenic and Children’s Health, December 1, 2021
			Event pageFDA 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 that are hosted, co-hosted, and/or funded/sponsored by FDA.

Ongoing Work to Support Closer to Zero

Trends in Exposure to Toxic Elements from Foods for Babies & Young Children
Trends in Exposure to Toxic Elements from Foods for Babies and Young Children (PDF: 1.7MB)

To help us reach the Closer to Zero goals and build on the significant progress that has already been made in reducing contaminants in the food supply, we will also continue:

Developing and validating analytical methods.
	Continuing toxicological research on impacts of arsenic, lead, cadmium, and 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 these elements in agricultural commodities
	Collaborating with the National Institutes of Health and the Centers for Disease Control and Prevention to better understand impacts of these 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.The FDA’s regulatory actions, along with research and collaboration with all of our stakeholders – industry, advocacy, policy makers, academia, and consumers – will result in significant reductions in exposures to arsenic, lead, mercury, and cadmium, among children and the general population and have lasting public health impact.

For FDA’s published research, please visit our FDA Monitoring and Testing sections on the Lead, Arsenic, Cadmium, and Mercury pages.

Announcements

FDA to Hold Webinar on the Draft Guidance for Industry on Action Levels for Lead in Food Intended for Babies and Young Children (January 26, 2023)
	FDA Issues Guidance for Industry on Action Levels for Lead in Baby Foods (January 24, 2023)
	Registration Open for Scientific Workshop Exploring Research on Nutrients and Environmental Contaminants in Foods and Child Development (January 12, 2023)
	Update on Study of the Role of Seafood Consumption in Child Growth and Development (January 12, 2023)
	FDA and Federal Partners Launch Study on the Role of Seafood Consumption in Child Growth and Development (October 11, 2022)
	FDA to Hold Webinar on the Draft Guidance for Industry on Action Levels for Lead in Juice (June 20, 2022)
	FDA Issues Draft Guidance to Industry on Action Levels for Lead in Juice (April 27, 2022)
	FDA Announces First Closer to Zero Action Plan Public Meeting (October 8, 2021)
	FDA Statement: FDA Releases Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies, Young Children (April 8, 2021)
	FDA Shares Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies and Young Children (April 8, 2021)
	FDA Letter to Industry on Chemical Hazards, including Toxic Elements, in Food and Update on FDA Efforts to Increase the Safety of Foods for Babies and Young Children (March 5, 2021)
	FDA Statement: FDA Announces New Actions Aimed at Further Reducing Toxic Elements in Food for Babies, Young Children (March 5, 2021)
	FDA Response to Questions About Levels of Toxic Elements in Baby Food, Following Congressional Report (February 16, 2021)

                                                                                  Content current as of:
      01/19/2024
              
              
Regulated Product(s)
		 Food & Beverages
			  			     			  						              
			
			
			
			
			
						  Baby Food ProductEnvironmental Contaminants in Food

          
                        Arsenic in Food
          Lead in Food and Foodwares
          Mercury in Food
          Cadmium in Food and Foodwares
          Closer to Zero: Reducing Childhood Exposure to Contaminants from Foods
          Perchlorate
          Radionuclides in Domestic and Imported Foods
          Benzene
          Dioxins & PCBs
          Per- and Polyfluoroalkyl Substances (PFAS)
          Testing Results for Arsenic, Lead, Cadmium and Mercury
 
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