{"id":8226,"date":"2018-10-25T08:55:51","date_gmt":"2018-10-25T13:55:51","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=8226"},"modified":"2026-03-07T09:25:04","modified_gmt":"2026-03-07T14:25:04","slug":"fda-reduces-limit-lead-childrens-food","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2018\/10\/25\/fda-reduces-limit-lead-childrens-food\/","title":{"rendered":"FDA reduces maximum daily limit for lead in children\u2019s food by half"},"content":{"rendered":"<p><a href=\"https:\/\/www.edf.org\/people\/tom-neltner\"><em>Tom Neltner, J.D.<\/em><\/a><em>,\u00a0<\/em>is Chemicals Policy Director and\u00a0<em>Maricel Maffini, Ph.D.,<\/em>\u00a0Consultant<\/p>\n<p>On September 27, 2018, the Food and Drug Administration (FDA) <a href=\"https:\/\/www.fda.gov\/food\/foodborneillnesscontaminants\/metals\/ucm2006791.htm\">reduced the maximum allowed daily intake of lead<\/a> for children from 6 to 3 micrograms per day (\u00b5g\/day). It has also set a limit for adults of 12.5 \u00b5g\/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 \u201cInterim Reference Level\u201d to match the Centers for Disease Control and Prevention\u2019s (CDC) terminology for <a href=\"https:\/\/www.cdc.gov\/lead-prevention\/about\/index.html?CDC_AAref_Val=https:\/\/www.cdc.gov\/nceh\/lead\/data\/definitions.htm\">elevated blood lead levels<\/a> 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 \u00b5g\/deciliter, with a 10-fold safety factor to account for differences across the population.<\/p>\n<p>This change is a major step in <a href=\"https:\/\/blogs.edf.org\/health\/2018\/04\/25\/fda-new-push-heavy-metals-food\/\">FDA\u2019s new push to limit heavy metals in food<\/a> to protect children\u2019s neurological development. In April 2018, FDA explained that its <a href=\"https:\/\/www.fda.gov\/food\/foodborneillnesscontaminants\/metals\/ucm604173.htm\">Toxic Elements Working Group<\/a> is \u201clooking at all the [heavy] metals across all foods rather than one contaminant, one food at a time,\u201d and that \u201ceven 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.\u201d<\/p>\n<p>As the agency indicated earlier this year, the next step for the Working Group is to \u201cbegin reevaluating the specific lead levels that FDA has set for a variety of foods.\u201d<\/p>\n<p><!--more--><\/p>\n<p>To help understand the implications of this change, it is important to consider that in our <a href=\"https:\/\/www.edf.org\/health\/lead-food-hidden-health-threat\">June 2017 Lead in Food Report<\/a>, we estimated that more than one million children aged 2 to 6 years exceeded the old daily intake level of 6 \u00b5g\/day of lead. This estimate was based on an exposure <a href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2017-10\/documents\/lcr_peer_review_summary_report_final_10-25-17_508.pdf\">model by the Environmental Protection Agency (EPA)<\/a> using FDA\u2019s Total Diet Study (TDS) data from 2007 to 2013.<\/p>\n<p>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 <a href=\"https:\/\/www.abtassociates.com\/\">Abt Associates<\/a> to run the new data through the same EPA model to <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2019\/01\/Abt-Lead-in-Food-Exposure-Analysis-FDA-TDS-2014-2016-Xue-LOD-revised-1-7-19.pdf\">develop an updated food lead exposure assessment<\/a>.<\/p>\n<p>Table 1 below compares the new data to the older data.<\/p>\n<h2 id=\"tablepress-8-name\" class=\"tablepress-table-name tablepress-table-name-id-8\">Table 1. Estimated number of children 2 to 6 years old consuming more than FDA\u2019s old and new maximum allowed daily intake of lead (excluding drinking water) based on the FDA\u2019s Total Diet Study data.<\/h2>\n\n<table id=\"tablepress-8\" class=\"tablepress tablepress-id-8 tbody-has-connected-cells\" aria-labelledby=\"tablepress-8-name\">\n<thead>\n<tr class=\"row-1\">\n\t<th class=\"column-1\">Daily intake level<\/th><th class=\"column-2\">Estimated number of children over level (2007-2013 TDS Data*)<\/th><th class=\"column-3\">Estimated number of children over level (2014-2016**)<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-striping row-hover\">\n<tr class=\"row-2\">\n\t<td class=\"column-1\">> 6 \u00b5g\/day in food<\/td><td class=\"column-2\">~ 1 million<\/td><td class=\"column-3\">~ 0.02 million<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">> 3 \u00b5g\/day in food<\/td><td class=\"column-2\">~ 10 million<\/td><td class=\"column-3\">~ 1.2 million<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td colspan=\"3\" class=\"column-1\"><a href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2017-01\/documents\/report_proposed_modeling_approaches_for_a_health_based_benchmark_for_lead_in_drinking_water_final_0.pdf\">* Based on Section 5.9 of EPA January 2017 report with 6 \u00b5g\/day is comparable to 95th percentile and 3 \u00b5g\/day is comparable to geometric mean. <\/a><\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td colspan=\"3\" class=\"column-1\"><br \/>\n<a href=\"http:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2019\/01\/Abt-Lead-in-Food-Exposure-Analysis-FDA-TDS-2014-2016-Xue-LOD-revised-1-7-19.pdf\">** Based on an EDF-commissioned preliminary analysis by Abt Associates. <\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n<p>While it suggests a significant reduction in the amount of children\u2019s lead exposure, direct comparisons are difficult because FDA used a new, <a href=\"https:\/\/www.fda.gov\/food\/fda-total-diet-study-tds\/fda-total-diet-study-tds-results\" target=\"_blank\" rel=\"noopener\">more sensitive ICP-MS method<\/a> 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 \u00b5g\/day of lead in food excluding drinking water \u2013 meaning they are above FDA\u2019s updated daily intake level.<\/p>\n<p>We applaud FDA\u2019s decision to 1) update its 1993 limit for children\u2019s exposure; 2) establish a limit for adults to protect fetuses and infants, and 3) link the limit for children to CDC\u2019s reference level. This update is long overdue and signals an important step to reducing lead in food \u2013 especially children\u2019s 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.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On September 27, 2018, the FDA reduced the maximum allowed daily intake of lead for children from 6 to 3 micrograms per day (\u00b5g\/day).<\/p>\n","protected":false},"author":69548,"featured_media":7738,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[69,114082,44,5009,114106,39263,56096],"tags":[91633,107191,91644,106376],"coauthors":[114044],"class_list":["post-8226","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-fda","category-food","category-policy","category-health-science","category-lead","category-public-health","category-omboira","tag-fda","tag-heavy-metals-in-food","tag-lead-exposure","tag-lead-in-food"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8226","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/users\/69548"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/comments?post=8226"}],"version-history":[{"count":3,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8226\/revisions"}],"predecessor-version":[{"id":13584,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8226\/revisions\/13584"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media\/7738"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=8226"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=8226"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=8226"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=8226"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}