EDF Health

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

By / 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 / 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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Traffic pollution causes 1 in 5 new cases of kids’ asthma in major cities: How data can help

By Ananya Roy / Published: April 29, 2019

Dr. Ananya Roy is a Senior Health Scientist

[pullquote]

City leadership can ill afford to ignore this issue and must strive for opportunities to prevent new cases of asthma.

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A landmark new study shines a light on the massive impact of vehicular air pollution on the health of our children. The study estimates that nitrogen dioxide (NO2) – a key traffic air pollutant – leads to approximately 4 million new asthma cases in children across the globe, or 1 in 10 new cases.

To address this pervasive threat, leaders need local data to create targeted approaches and policies. That’s why Environmental Defense Fund (EDF) is leveraging sensor technology to develop novel methods to measure and map air pollution – including NO2 concentrations – block by block in cities across the world, from Oakland to Houston to London.

Cities bear the worst burden

The study, released this month in The Lancet Planetary Health, finds that children living in cities are most at risk of asthma due to NO2 pollution. A staggering 90% of all new cases due to traffic were in urban and adjoining suburban areas.

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D.C. Circuit Affirms Public’s Right to Know about Chemicals in Use under Reformed Law

By / Published: April 26, 2019

Court strongly rebukes Trump EPA’s unlawful attempts to scale back transparency requirements

(April 26, 2019 – Washington, D.C.) Today, the U.S. Court of Appeals for the D.C. Circuit delivered a strong rebuke to the Trump Environmental Protection Agency’s (EPA) implementation of the nation’s chemical safety law, protecting key aspects of the public’s right to know about the toxic chemicals in our homes, schools, and workplaces.

The Court agreed with EDF that EPA had failed to require companies to show that the identities of their chemicals cannot be reverse-engineered in order to claim them confidential under the Toxic Substances Control Act (TSCA).

The Court remanded the rule back to EPA to require that companies make this showing to claim confidentiality.  The Court also affirmed that other key TSCA requirements apply to confidentiality claims despite EPA’s failure to include them in its regulations.

“This decision is a significant win for public disclosure and a strong affirmation by the Court of the public’s right to know about the chemicals to which we all are or may be exposed. The Court ruled that EPA must require companies to provide real substantiation for their claims for confidentiality – and that EPA had failed to do so in the rule we challenged,” said Robert Stockman, Senior Attorney at Environmental Defense Fund.  “EPA will now have to require significantly more evidence from companies before they can conceal the identities of chemicals they make and sell.  As a result, fewer such claims will be allowed and workers, consumers and the public will gain access to more information about those chemicals.”

In the case, EDF v. EPA (D.C. Cir. 17-1201), EDF aimed to ensure that EPA upholds the requirements set forth in the reformed Toxic Substances Control Act (TSCA) to maximize transparency and public knowledge about which chemicals are currently in use by narrowing the grounds for asserting confidentiality claims and requiring more scrutiny of them.  The Court affirmed that these requirements apply despite EPA’s failure to incorporate them into its regulation.

“A key goal of the reformed chemical safety law is to make more information public about the chemicals we’re exposed to at home, in our workplaces and schools, and through our environment.” said Dr. Richard Denison, Lead Senior Scientist at Environmental Defense Fund. “While the Trump EPA has taken every opportunity to skirt its responsibility and conceal information that the public has a right to know, the Court’s decision today affirms that the law trumps those efforts.”

On some issues, the Court gave deference to EPA in interpreting the law as it did:  EPA’s decision to delay assigning “unique identifiers” to certain chemicals with confidential chemical identities; and its decision to exempt chemicals made only for export from the law’s Inventory notification requirement.  Finally, the Court unfortunately ruled that EPA could in its discretion allow any manufacturer or processor to make a claim for the confidentiality of a chemical, regardless of whether that company had previously made such a claim.  While EDF does not agree with the Court’s characterization of our position, the Court cited the Chevron standard that provides agencies with considerable deference.

For more background on the decision, see the bullets below.  For more information on this and other lawsuits challenging EPA’s implementation of TSCA, see: https://www.edf.org/health/tsca-case-resources. Read More »

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EDF asks judge to rule on legality of FDA rule allowing companies to secretly decide on chemicals in our food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 18, 2019

Tom Neltner, J.D., is Chemicals Policy Director

At the end of March, EDF, represented jointly by counsel from Earthjustice and the Center for Food Safety (CFS), asked a federal district court judge to decide as a matter of law that the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) regulation is unlawful. The GRAS Rule allows food manufacturers to make secret safety determinations for chemicals added to food without notifying FDA or the public and to use such chemicals. If the judge agrees to our request, this would vacate the rule. Two years ago, EDF and others challenged the legality of the GRAS Rule in the Federal District Court for the Southern District of New York. Last September, the court ruled that plaintiffs EDF and the CFS have standing, setting the stage for a decision on the merits of the case.

In the Motion for Summary Judgment, we identify the following four ways in which FDA violated the law in the GRAS Rule. FDA has until May 28 to respond to our motion.

  1. FDA unlawfully delegated to food manufacturers its authority to determine the safety of chemicals added to our food.

When Congress enacted the Federal Food Drug and Cosmetic Act (FFDCA) of 1938, it gave FDA the responsibility to ensure the nation’s food is safe and free from harmful substances. To implement this responsibility, it provided the agency broad authority to adopt necessary regulations.

Unfortunately, in the GRAS Rule, instead of fulfilling its responsibility to keep food safe, FDA formally and unlawfully outsourced its responsibility to the regulated entities themselves – namely, for-profit additive manufacturers – allowing them to decide for themselves, in secret, whether the chemical substances they have manufactured can be added to food. This unlawful delegation – made without express statutory authorization – makes it all but impossible for FDA to fulfill its obligations under the FFDCA.

As a result, the GRAS Rule impermissibly allows regulated, private companies with obvious conflicts of interest to self-certify the use of their chemical additives as GRAS without notifying FDA. This is not a case where FDA is seeking legitimate outside input to gather factual information or advice and make policy recommendations. Here, FDA retains no oversight over these secret GRAS determinations that directly affect the safety of our food and thus render it impossible for the agency to fulfill its statutory mandate to keep our food safe.

By delegating its authority in the GRAS Rule, the agency violated Constitutional principles, the FFDCA, and the Administrative Procedures Act (APA). The rule effectively insulates the agency from democratic accountability for food safety decisions and denies citizens their right to seek judicial review of decisions about the safety of substances that may be added to food.

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