EDF Health

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: October 25, 2018

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.”

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One click away: We discovered just how easy it still is to purchase deadly paint strippers

By Sam Lovell / Published: October 18, 2018

Sam Lovell, Project Specialist, and Andrew Reagan, Campaign Project Manager.

Methylene chloride is a deadly chemical used in common paint stripping products. It is known to have caused over 50 deaths from acute exposure – though many more likely have gone unreported. Health impacts from lower-level, chronic exposure to the chemical through use of these products, while much harder to measure, have no doubt occurred as well. Due to its health risks, the EPA proposed a rule to ban consumer and most commercial uses of the chemical in paint and coating removal products on January 12, 2017. Over a year and a half later, the ban on methylene chloride in paint strippers still has not been finalized.

As the current Administration continues to delay action on this critical ban, some companies have stepped up and committed to take paint strippers containing methylene chloride off their shelves. Unfortunately, this isn’t enough to protect all consumers or workers. We found out that it’s still shockingly easy to buy products containing the chemical from other companies – it’s a simple click away.

To figure out just how easy it is, we searched for “paint stripper” and “paint remover” on Amazon. On the first page of our search results were several products containing methylene chloride. (This information is not at all obvious to consumers – you need to read the fine print on the product description.)

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EPA Updates its 3Ts Guidance for Reducing Lead in Drinking Water

By Lindsay McCormick / Published: October 16, 2018

Lindsay McCormick, is a Project Manager. Tom Neltner, J.D., is the Chemicals Policy Director.

Earlier this month, EPA released its updated 3Ts for Reducing Lead in Drinking Water Toolkit, which provides guidance for schools and child care facilities seeking to ensure children are safe from lead in water.  The new 3Ts – an update to the agency’s 2006 guidance – is now a web-based toolkit that includes modules, customizable templates, and factsheets.

Overall, the new toolkit is an improvement.  While the protocol itself is largely the same, the new toolkit is more user friendly and written for the non-technical audience, making it more likely that school and child care staff will use it.  EPA has also reframed the toolkit from “Training, Testing, and Telling” to “Training, Testing, and Taking Action” – placing more emphasis on the critical step of addressing lead sources than the previous version.  “Telling” is now integrated throughout the entire toolkit to highlight the importance of communication at every step. The agency has also developed a helpful flushing best practices factsheet, which is a topic that often causes considerable confusion.

In EDF’s June 2018 report on our pilot of 11 child care facilities, “Tackling lead in water at child care facilities,” we recommended EPA update its 2006 guidance to address four key gaps.  The agency has made progress on the two most important of those but leaves the other two unresolved. The most important change to the guidance is that the agency has removed the 20 parts per billion (ppb) action level and instead recommends action whenever there are “elevated lead levels.” While EPA does not define an elevated lead level, a deep dive into the appendix suggests that levels over 5 ppb warrant follow-up. The updated guidance also puts a greater emphasis on the identification of lead service lines (LSLs) and includes LSL replacement as a permanent control measure, though not as an explicit recommendation. Further, the agency did not update the protocol to deal with challenges posed by aerator cleaning and hot water heaters.  Below we explore each of these issues in further detail. Read More »

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Have we learned anything in the last 4 decades when it comes to allowing chemicals like PCBs onto the market?

By / Published: September 28, 2018

Richard Denison, Ph.D., is a Lead Senior Scientist.  Stephanie Schwarz, J.D., is a Legal Fellow.

The Science section of today’s New York Times reports “Killer Whales Face Dire PCBs Threat” – more than four decades after Congress largely banned PCBs (polychlorinated biphenyls).

Concentrations of the chemicals in the blubber of orcas living in waters off the coasts of industrialized countries remain high, and new research indicates the contamination presents an existential threat to the survival of these populations.

Reading the article brought to mind concerns we have raised in recent comments to EPA on proposed rules it has issued for new chemicals under the Toxic Substances Control Act (TSCA).  Read More »

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The TSCA new chemicals mess: A problem of the chemical industry’s own making

By / Published: September 19, 2018

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

Nary a day goes by without a complaint being lodged by someone in the chemical industry, or in one of the myriad law firms that represent its interests in Washington, D.C., about the delays in EPA’s approval of new chemicals under the Toxic Substances Control Act (TSCA).

Here’s the irony:  Those delays and the general chaos in the TSCA new chemicals program are entirely of the industry’s own making.   Read More »

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Challenge to FDA’s GRAS rule moves forward after court rejects request for dismissal

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 14, 2018

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

In a critical ruling for food additive safety, a federal district court ruled on Wednesday that EDF, represented by Earthjustice, has standing in its legal challenge to the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) rule. This 2016 final rule allows food manufacturers to make secret GRAS safety determinations for chemicals added to food, without notifying FDA or the public, and to use the chemical in food without anyone else’s knowledge. The court was considering a motion to dismiss from FDA arguing that plaintiffs did not have standing to bring the case. The judge found EDF and the Center for Food Safety (CFS) “plausibly allege harm to their members” and therefore “satisfy the injury-in-fact requirement for standing.” Our legal challenge now moves to the substance of our concerns with the flaws in the agency’s GRAS Rule.

The court found that members of EDF and CFS showed a risk of harm consistent with the requirements of the law in alleging that FDA’s “GRAS Rule poses a credible threat to their members.” Specifically the court stated that:

  • Their members “have been and will be exposed to potentially dangerous substances that were introduced into the food supply without FDA oversight, public participation, or the opportunity for judicial review.”
  • They “explicitly identify multiple substances that manufacturers determined to be GRAS and used in food despite concerns raised by FDA about their safety, as well as additional undisputedly dangerous substances that Plaintiffs reasonably anticipate will be introduced into the food supply under the GRAS Rule.”
  • “[T]hese injuries are ongoing and imminent.

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