What You should Know about the FDA's "Closer to Zero" Plan

By Katie Black

When it comes to certain chemicals, we know some have a maximum recommended level of exposure and as long as this is not exceeded, they don't seem to pose significant health risks—but for others, there is no safe amount of exposure. Heavy metals like lead, mercury, arsenic, and cadmium pose great health risks to all humans, but infants and their developing brains are more vulnerable to their effects. 

The U.S. Food and Drug Administration’s action plan, Closer to Zero, is trying to reduce the amount of these four toxic metals to the lowest possible in food for babies and young children. Before we break down the plan, you might be wondering,

How do heavy metals get into baby food in the first place? 

There are lots of factors. Some of these include but are not limited to:

  • Contamination in the air, soil or water where the crops are grown. 
  • Natural occurrences based on geographical location. 
  • Specific types of plants/crops which absorb them from their environment.
  • Agricultural or manufacturing processes. 

In order to limit exposure, the FDA laid out an overview of its Closer to Zero plan. (For the timeline outlined in Closer to Zero, see the images at the bottom of the page.)

Closer to Zero:

  1. The FDA will expand and evaluate its research on exposure from food. 
  2. It will set “action levels” (levels of toxicity which are high enough to possibly require action to lower) informed by stakeholders. Stakeholders are the relevant scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry. 
  3. It will encourage the industry to choose the best agricultural practices that reduce levels of toxic elements.
  4. It will increase targeted compliance (making sure the plan’s targets are being complied with) and policy enforcement.
  5. It will monitor progress over time. 

The FDA will approach Closer to Zero with a four part system that encourages ongoing improvement:

1. Evaluation of science behind action levels:

This includes looking at existing data, routine food tests, “chemical analytical methods, toxicological assays, exposure and risk assessments, and other relevant scientific information.” The process may include communications with advisory committees, public workshops, scientific experts, federal agency partners and other stakeholders. This will all be used to establish IRLs (interim reference levels). An IRL is a measure of exposure to a specific element across foods. It is used to determine whether the exposure may link to specific health impacts.

2. Proposition of Action Levels:

The IRLs will help determine what the FDA proposes the action levels should be for toxicity in baby and young child foods. 

3. Consultation with stakeholders on proposed action levels: 

Data and other scientific information will be gathered for each toxic element in the selected food categories in collaboration with stakeholders in order to determine action levels. Some considerations are how achievable or feasible the action levels will be, as well as determining the time frames of when they can be achieved. 

4. Finalization of action levels:

Using the gathered information from scientific research, stakeholders, and ongoing data monitoring, the action levels will be adjusted if needed and finalized. 

Currently, the FDA is focusing only on determining action levels for lead because there is a lack of research on arsenic, cadmium, and mercury. Using guidelines from the CDC, the FDA calculated an IRL for lead exposure at 2.2 micrograms a day for children and 8.8 micrograms a day for those who are at a childbearing age (in case of a pregnancy that goes unnoticed or to protect against exposure while breastfeeding). 

It might seem logical that the FDA simply ban foods found to have unacceptable levels of toxicity, but it isn't that simple. While getting rid of arsenic, lead, cadmium, and mercury is important, it is also important that nutritional foods are not removed. It is also crucial that in reducing one element, another does not increase. Determining action levels is complicated—but necessary. 

To learn more about how pollution can affect children, click here. If you are breastfeeding or may breastfeed in the future and are worried about heavy metals in your breast milk, we now offer testing for levels of lead, arsenic, cadmium, and mercury. 

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