EDF Health

Lead in hair dye – one company considers it safe

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 4, 2019

Tom Neltner, J.D., Chemicals Policy Director

In October 2018, the Food and Drug Administration (FDA) banned the use of lead acetate in hair dyes in response to a March 2017 color additive petition from EDF and other health advocates. In December, we learned that Combe, Inc., the maker of the lead-acetate based hair dye Grecian Formula, objected to FDA’s decision, requested a formal evidentiary public hearing to review the decision, and claimed the use is safe. The objection puts the FDA’s decision on hold awaiting a process that may take years to resolve. Apparently, the company thinks it is safe for men to slather skin-soluble lead on their head every couple of days and to risk exposing their families to a heavy metal for which no safe level of exposure has been identified.

Combe’s action was somewhat surprising because the company told CBS News that it removed lead acetate from its Grecian Formula “quite a long time ago,” but was unable to provide an exact date. Presumably, someone in the know updated the product’s Wikipedia page, which says Grecian Formula does not contain lead acetate as of July 2018, although an earlier version of the page said April 2018.

Whatever the date it was reformulated, why would Combe block FDA’s decision when it has long sold a lead-free brand – Just For Men – and had already reportedly removed lead from Grecian Formula? From a market standpoint, objecting to FDA’s decision benefits Youthair, Combe’s main competitor, which continues to sell a leaded-version of progressive hair dye.

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Trump Administration’s lead action plan is a missed opportunity to protect kids from lead

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: December 20, 2018

Tom Neltner, J.D., Chemicals Policy Director

Yesterday, the President’s Task Force on Environmental Health Risks and Safety Risks to Children released its long-delayed Federal Action Plan to Reduce Childhood Lead Exposures and Associated Health Impacts (Lead Action Plan). A year ago the Task Force described this document as a federal lead strategy that would identify clear goals and objectives to “serve as a ‘roadmap’ for federal agencies on actions to take to reduce childhood lead exposure.” It requested feedback on the approach and received over 700 public comments.

The Trump Administration’s Lead Action Plan falls far short of what was promised. To understand what the Plan is and what it is not, we compared it to two earlier documents from the Task Force: 1) A federal lead strategy released in February 2000 by the Clinton Administration focused on reducing exposure to lead-based paint; and 2) An inventory of key federal programs released in November 2016 by the Obama Administration summarizing the activities of the 17 federal agencies and departments with responsibilities to protect children from lead.

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FDA-approved PFAS: A serious breakdown in assessing food additive safety

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 4, 2018

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

This blog is the fourth in a series describing information we discovered in reviewing thousands of pages from the Food and Drug Administration’s (FDA) response to our Freedom of Information Act (FOIA) of the agency’s approval of 31 Food Contact Substance Notifications (FCNs) from 2002 to 2016 submitted by six companies for 19 distinct chemical mixtures of per- and poly-fluorinated substances (PFAS).

In this blog, we identify one company’s serious breach of its obligation to provide FDA with all relevant toxicology data. While hindsight is 20/20, we have reason to believe that if FDA had had all relevant information, it would have demanded more studies potentially revealing risks that are only now coming to light with related chemicals. Though we have not completed a similar review for the other companies, we think this inadequate approach to chemical safety is not unique to a single company, and FDA should reassess all its reviews given what is now known about PFAS chemicals.

Safety assessment requirements for food additives – including food contact substances

When a company seeks FDA’s approval of food additives (including food contact substances), it is required to provide the agency with all relevant chemistry, toxicology and environmental data so it can conduct a safety assessment. While the agency typically conducts a literature search of its own and of public databases, the company that is claiming the chemical’s use is safe is obligated to include any data that is inconsistent with the company’s conclusion.

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Also posted in Drinking water, FDA, Food, Health policy, Regulation / Tagged , , , , , | Read 1 Response

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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