Global Issues with Lead: US Food and Drug Administration Guidance

According to the WHO, lead exposure is estimated to be linked to approximately 1.5 million deaths annually primarily from cardiovascular disease and causes irreversible neurological and behavioral damage, particularly in children. Children tend to more easily absorb lead than adults, and this results in reduced IQ, learning difficulties and behavioral issues. Because lead can accumulate in the body over time, even low level, chronic exposure can be hazardous. 

Both the European Union and Unites States Food and Drug Administration (FDA) have set maximum levels of contamination of some foods. The FDA has focused on setting maximum levels for food consumed by infants and children. 

The United States Food Safety and Inspection Service (FSIS) has not set actionable levels for lead in foods they regulate. However, when levels of lead in food exceeds what might be considered naturally occurring, they have taken action to recall foods. 

In California, Proposition 65 requires warnings on food labels if the food is contaminated with lead or other heavy metal above what would otherwise be considered “normal”. 

FDA data indicates, for example, that according to their analysis at least 12% of single use root crops will exceed the maximum lead levels allowed in food for infants. This reality supports the need for companies to know more about the levels of lead in ingredients they purchase.  

Natural and Contamination-Based Lead Levels in Foods 

In the United States, the following are considered “normal” levels of lead in common food items: 

Analysis has shown that many plants will absorb lead from contaminated soils:

• High uptake: lettuce, spinach, carrot, endive, broccoli, beet leaves
• Moderate uptake: onion, mustard, potato, radish
• Low uptake: corn, cauliflower, asparagus, celery, and berries
• Very low uptake: beans, peas, melon, tomatoes, fruit 
   

Food companies need to know what are the naturally occurring levels of lead in foods they grow, harvest, and process.  

The regulation is based on the premise that a business should not have to provide a warning for a chemical that it did not put in the food. There are several caveats in the regulation that are intended to prevent it from being used inappropriately: 

• A chemical contaminant such as lead can be considered naturally occurring only to the extent that it was not avoidable through good agricultural and manufacturing practices, and that quality-control measures were used to reduce contaminant levels to the lowest level currently feasible.
• A Proposition 65 chemical absorbed from the soil must have been naturally present in the soil. A plant that took up lead from soil contaminated as a result of human activity would not meet the requirements of this regulation. 

Complying with US, EU, and California regulations pertaining to lead requires companies to document the typical levels of lead in the food ingredients they grow, harvest or process. Then they need to take steps to comply with regulations as well as take steps to reduce lead exposures as much as possible.  

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