Janet Woodcock, the acting Commissioner of Food and Drugs, and Susan T. Mayne, director of the Center for Food Safety and Applied Nutrition (CFSAN) Thursday announced Closer to Zero, a new action plan for reducing exposure to toxic elements in foods commonly eaten by babies and young children to the lowest possible levels.

Their comments associated with the announcement included the following:

“Although the FDA’s testing shows that children are not at an immediate health risk from exposure to toxic elements at the levels found in foods, we are 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.

“We recognize that Americans want zero toxic elements in the foods eaten by their babies and young children. In reality, because these elements occur in our air, water, and soil, there are limits to how low these levels can be. The FDA’s goal, therefore, is to reduce the levels of arsenic, lead, cadmium, and mercury in these foods to the greatest extent possible. We are also sensitive to the fact that requiring levels that are not currently feasible could result in significant reductions in the availability of nutritious, affordable foods that many families rely on for their children. Our plan, therefore, outlines a multi-phase, science-based, iterative approach to achieving our goal of getting levels of toxic elements in foods closer to zero over time.

“Closer to Zero includes research and evaluation of 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.

“Our action plan will occur in three phases. As part of the first phase, we’ll immediately begin our work setting action levels using a four-pronged approach:

1. evaluate the scientific basis for activity 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.
2. 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.
3. 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.
4. 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 the 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.

“Our action plan will start with prioritizing our work on those elements for which we have 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), we 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. We will also complete updated sampling assignments testing toxic element levels in baby foods and evaluate the science related to arsenic exposure from foods beyond infant rice cereal. Phases two, three, and beyond are outlined in our plan.

“Through this plan, we’ll 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, our 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, we aim to push the levels of toxic elements in these foods closer and closer to zero over time.

“While our testing of toxic elements in foods has shown there have already been significant reductions of toxic elements found in foods, the FDA is confident that our new plan will help further advance our work in this area. As part of our ongoing efforts to reduce exposure to toxic elements from foods, we’ll be continuing our research and collaborations on this topic, finalizing action levels for arsenic in apple juice and issuing draft action levels for lead in juices in the near future, evaluating the potential impact of new technologies, interventions, or mitigation controls to reduce exposure, and reevaluating risks based on declining levels of toxic elements in foods. We view this work and our Closer to Zero plan as part of a larger effort to improve maternal and infant nutrition and health. We plan to combine our efforts to reduce exposure to toxic elements in baby foods with other FDA initiatives to improve the health of mothers, infants, and children.

“Again, it’s important to note that the FDA’s testing shows that children are not at an immediate health risk from exposure to toxic elements at the levels found in foods. However, we know that additional progress can be made and are confident that a science-driven, transparent and inclusive process will help lead to even further reductions in exposure to these toxic elements. We look forward to providing additional updates on our plan as new data, information, progress updates, and additional material are made available.”

A decade of requests
Consumer Reports (CR) called the FDA plan “a positive development after years of inaction.” but said it’s unclear whether it will result in the kind of limits needed to protect children.”

CR has called on the FDA for more than a decade to establish strict limits given its own tests and research by others showing concerning levels of heavy metals in baby food that can pose serious health problems in children over time.

“Experts agree that there is no safe level of exposure to heavy metals, especially for children,” said Brian Ronholm, director of food policy at Consumer Reports.  “It is encouraging that the FDA is beginning to develop a plan to address these hazards, but it’s too early to know whether the agency is prepared to set the kind of strict limits necessary to keep children safe. Congress should not wait for the FDA to act, and should move forward with legislation to protect children from toxic heavy metals that are all too common in popular baby foods.”

Under the new action plan,  the FDA will evaluate the scientific basis for setting limits on heavy metals starting with arsenic and lead and propose limits based on that review.  The FDA will then conduct a similar review for cadmium and mercury and propose limits for both.

According to CR, exposure to even small amounts of heavy metals at an early age may increase the risk of several health problems, especially lower IQ and behavior problems, and has been linked to autism and attention deficit hyperactivity disorder. The FDA has a limit of 100 parts per billion (ppb) of inorganic arsenic in baby rice cereals, but not for other baby foods, nor any limits for other heavy metals in foods made for young children.

In 2018, Consumer Reports food safety team analyzed 50 nationally distributed packaged foods made for babies and toddlers, checking for cadmium, lead, mercury, and inorganic arsenic, the type most harmful to health.  CR’s tests found that about two-thirds (68 percent) had worrisome levels of at least one heavy metal. Fifteen of the foods would pose potential health risks to a child regularly eating just one serving or less per day. Snacks and products containing rice and/or sweet potatoes were particularly likely to have high levels of heavy metals.

CR supports the Baby Food Safety Act of 2021, introduced in March by Rep. Raja Krishnamoorthi, along with Sens. Amy Klobuchar and Tammy Duckworth, which requires the FDA to establish separate limits for baby cereal and all other baby foods for cadmium, inorganic arsenic, lead, and mercury.

The initial limits proposed in the bill are 15 ppb for inorganic arsenic in baby cereals and 10 ppb for other baby foods; 10 ppb for cadmium and lead in baby cereals, and 5 ppb for other baby foods; and 2 ppb of mercury for baby food and baby cereals. These levels would go into effect two years after the bill is signed into law.

The bill would require these levels to be lowered further within two years of the bill’s enactment, and lowered to “levels protective of infant and toddler neurological development, taking into account the most sensitive testing available” within three years.

Consumer Reports advises parents to talk to their pediatrician if they are concerned about potential exposure. Consuming these foods doesn’t guarantee that a child will develop health problems, but it may increase that risk. CR recommends a number of steps parents can take to reduce heavy metals exposure, including serving their children a broad array of healthful whole foods; limiting the intake of infant rice cereal and packaged snacks and being conscious of intake of fruit juices; and choosing rice that generally contains less inorganic arsenic.