Monthly Archives: May 2019

Too much cadmium and lead in kids’ food according to estimates by FDA

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 7, 2019

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

The Food and Drug Administration (FDA) released a study in April estimating young children’s exposure to lead and cadmium from their diets and identifying food groups that are a significant source of these heavy metals. The study used data from the agency’s Total Diet Study (TDS) program for 2014 to 2016 and the Center for Disease Control and Prevention’s (CDC) What We Eat in America (WWEIA) Survey for 2009 to 2014.[1]

The study is a reminder of how pervasive heavy metals are in children’s diets and that, while the levels are relatively low, the cumulative exposure is significant. Based on FDA’s analysis (Table 1 below), we estimate that about 2.2 million children exceeded the agency’s maximum daily intake (MDI) for lead at a given time. The results for cadmium are new and worrisome, with estimated daily intake (EDI) levels that are 3 to 4 times greater than lead. And while FDA has not yet set an MDI limit for cadmium, the average young child exceeds most of the relevant daily exposure limits set by other agencies. Clearly, cadmium warrants greater attention, but note that the evidence of neurotoxicity is still emerging.

Table 1: Young children’s estimated dietary intake (EDI) of lead and cadmium based on FDA’s TDS results for years 2014 to 2016 (based on hybrid method)

Age GroupLead Mean EDI Lead 90th Percentile EDICadmium Mean EDICadmium 90th Percentile EDI
1-6 years1.8 µg/day2.9 µg/day6.8 µg/day11.0 µg/day
1-3 years1.7 µg/day2.6 µg/day5.8 µg/day9.7 µg/day
4-6 years2.0 µg/day3.1 µg/day7.8 µg/day12.1 µg/day
LimitsFDA’s MDI is 3.0No MDL set by FDA. Intake exceeded most limits set by other agencies

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Posted in FDA, Food, Lead / Tagged , , , , | Comments are closed

EDF tells EPA it must modify its proposed CBI Claim Review Rule to comply with recent D.C. Circuit decision

By Richard Denison / Published: May 3, 2019

Richard Denison, Ph.D., is a Lead Senior Scientist.

Yesterday Environmental Defense Fund (EDF) sent a letter to the Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention in follow-up to last month’s decision by the D.C. Circuit Court of Appeals in EDF’s challenge to EPA’s Inventory Notification Rule (EDF v. EPA, 17-1201).

The letter identifies “immediate, time-sensitive implications [of the decision] for EPA’s ongoing rulemaking for” EPA’s proposed Confidential Business Information (CBI) Claim Review Rule, which is currently undergoing public comment.  EDF noted that, in addition to addressing problems the Court identified in EPA’s regulations promulgated pursuant to its Inventory Notification Rule, EPA will need to modify the current proposed rule to ensure it is consistent with the Court’s Opinion, and accept comments on the modified proposal.

This is because the proposed rule explicitly references and applies regulatory provisions that the Court found were unlawful.  Specifically, the Court found that EPA’s CBI claim substantiation questions were flawed because they failed to inquire into “a chemical identity’s susceptibility to reverse engineering” and “effectively excised a statutorily required criterion from the substantiation process.”  Hence, to align the proposed rule with the Court’s ruling and the representations that EPA made to the Court in its briefing and at argument, EPA will need to revise the substantiation questions and the substantive standard that EPA plans to use when reviewing claims under the CBI Claim Review Rule.

EDFs letter also notes that the proposed rule allows persons to rely on the voluntary substantiations they submitted as part of the Inventory notification process.  But the Court’s Opinion establishes that these substantiations are inadequate because they fail to address a chemical’s susceptibility to reverse engineering, and EPA will need to modify the proposed rule to require companies to provide substantiations that address this statutory factor for confidentiality claims.

See EDF’s letter for more details.

Posted in Health policy, TSCA reform / Tagged , , | Comments are closed

Industry deletions in PV29 study summaries should raise alarm bells on both sides of the Atlantic

By Richard Denison / Published: May 2, 2019

Richard Denison, Ph.D., is a Lead Senior Scientist.

[pullquote]The intentional alteration of industry study summaries under REACH that I report here should raise major alarms on both sides of the Atlantic and illustrates why public access to full studies on chemicals to which we are or may be exposed must be paramount.[/pullquote]Well, I certainly wasn’t expecting to find this when I started working on EDF’s comments on supplemental materials the Environmental Protection Agency (EPA) recently made available on Pigment Violet 29 (PV29), the first of 10 chemicals undergoing risk evaluations under the amended Toxic Substances Control Act (TSCA).  What I discovered – almost by chance – strongly reinforces EDF’s and others’ view that the public’s ability to independently assess and trust EPA chemical assessments falls flat without access to full and unredacted copies of the health and safety information EPA cites in support of its risk evaluation.   Read More »

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