FDA reduces maximum daily limit for lead in children’s food by half

Tom Neltner, J.D.is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

On September 27, 2018, the Food and Drug Administration (FDA) reduced the maximum allowed daily intake of lead for children from 6 to 3 micrograms per day (µg/day). It has also set a limit for adults of 12.5 µg/day, to protect against possible fetal exposure in women who are unaware they are pregnant and to reduce infant exposure during nursing. The agency now refers to these limits as the “Interim Reference Level” to match the Centers for Disease Control and Prevention’s (CDC) terminology for elevated blood lead levels that warrant action. FDA reports that the new level for children is the amount of lead in food expected to result in a blood lead level of 5 µg/deciliter, with a 10-fold safety factor to account for differences across the population.

This change is a major step in FDA’s new push to limit heavy metals in food to protect children’s neurological development. In April 2018, FDA explained that its Toxic Elements Working Group is “looking at all the [heavy] metals across all foods rather than one contaminant, one food at a time,” and that “even though the level of a metal in any particular food is low, our overall exposure adds up because many of the foods we eat contain them in small amounts.”

As the agency indicated earlier this year, the next step for the Working Group is to “begin reevaluating the specific lead levels that FDA has set for a variety of foods.”

To help understand the implications of this change, it is important to consider that in our June 2017 Lead in Food Report, we estimated that more than one million children aged 2 to 6 years exceeded the old daily intake level of 6 µg/day of lead. This estimate was based on an exposure model by the Environmental Protection Agency (EPA) using FDA’s Total Diet Study (TDS) data from 2007 to 2013.

Later in 2017, FDA provided us with more recent TDS data from 2014 to 2016 in response to our Freedom of Information Act request. We contracted with Abt Associates[i] to run the new data through the same EPA model to develop an updated food lead exposure assessment.

Table 1 below compares the new data to the older data.

Table 1. Estimated number of children 2 to 6 years old consuming more than FDA’s old and new maximum allowed daily intake of lead (excluding drinking water) based on the FDA’s Total Diet Study data.

Daily intake levelEstimated number of children over level (2007-2013 TDS Data*)Estimated number of children over level (2014-2016**)
> 6 µg/day in food~ 1 million~ 0.02 million
> 3 µg/day in food~ 10 million~ 1.2 million
* Based on Section 5.9 of EPA January 2017 report with 6 µg/day is comparable to 95th percentile and 3 µg/day is comparable to geometric mean.
** Based on an EDF-commissioned preliminary analysis by Abt Associates.

While it suggests a significant reduction in the amount of children’s lead exposure, direct comparisons are difficult because FDA used a new, more sensitive ICP-MS method and the dataset was smaller. Using the more recent data, it appears that approximately 1.2 million children aged 2 to 6 consume more than 3 µg/day of lead in food excluding drinking water – meaning they are above FDA’s updated daily intake level.

We applaud FDA’s decision to 1) update its 1993 limit for children’s exposure; 2) establish a limit for adults to protect fetuses and infants, and 3) link the limit for children to CDC’s reference level. This update is long overdue and signals an important step to reducing lead in food – especially children’s food. We look forward to seeing FDA develop limits for specific foods that would be used to set priorities, identify problems, and trigger recalls when levels are high.

[i] We can provide the preliminary analysis on request.

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