EDF Health

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

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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Posted in EPA, Health Policy, lead, Public Health, Regulation / Tagged , , | Read 2 Responses

California Water Board makes misleading claim that only four water systems have lead lines

Tom Neltner, J.D.Chemicals Policy Director

[Update 12/14/18: The California Water Boards added a webpage providing more background for customers on the inventory requirement, including the clarification that “user service line” does not include the service line on private property. This clarification was also added to the Status Map webpage.]

The California Water Board posted the results of its statewide inventory of lead service lines (LSLs) in community water systems (CWSs) yesterday. They also became the first in the nation to post the results in an interactive online map. We are pleased to see the state take this important step, but are disappointed that the press release it sent out to announce the map’s launch undermines its efforts with misleading and confusing statements.

The central problem is that the press release fails to be clear that the inventory does not cover the portion of the service line between the meter and the home or building.  As a result, a CWS that removed all of the lead pipes between the main under the street and the meter but left them on private property was listed as having no LSLs. A customer would justifiably – but mistakenly – assume that LSLs were not an issue in their community.

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Posted in Drinking Water, lead, States / Tagged , , , | Read 1 Response

Lead from a new “lead-free” brass faucet? More common than you’d hope

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

Until NSF/ANSI 61 standard is updated to reduce or eliminate lead leaching, users must extensively clean and flush new brass fixtures before use and make a short flush standard practice for older fixtures.

During this past year, we undertook a pilot project to tackle the problem of lead in drinking water at child care facilities. As part of the effort, we collected 250 mL samples (about 8 ounces of water) from every drinking water fixture, as recommended in the Environmental Protection Agency’s (EPA) 3Ts guidance for schools and child care facilities. We replaced 26 faucets that exceeded our action level with new brass faucets that were labeled “lead-free” and complied with NSF/ANSI 61 standard for drinking water system components.[1] To our surprise, when we sampled the faucets a few days after replacement, the lead levels were higher– between 9 and 10 ppb – on three of the new faucets.

The increase left us scratching our heads. Federal law allows a drinking water fixture to be labeled “lead-free” if the amount of lead in wetted surfaces[2] averages less than 0.25% (down from the 8% limit between 1986 and 2014). However, it isn’t clear how much this amount might contribute to levels of lead in water. To explore this issue, we contacted the supplier who said its product was certified under NSF/ANSI 61 and, therefore, not likely the source. The supplier suggested the source could be from existing upstream valves or from disturbing the plumbing. We could not rule these other possibilities out.

A study by Virginia Tech’s Jeff Parks on three models of new NSF/ANSI 61 certified brass faucets found similar results and concluded that even newly manufactured “lead-free” faucets may not meet the 1 ppb limit that the American Academy of Pediatrics (AAP) recommends for schools.

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

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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Posted in Drinking Water, EPA, FDA, Food, Health Policy, PFAS, Public Health, Regulation / Tagged , , , , | Read 1 Response

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

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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Posted in FDA, Food, Health Policy, Health Science, lead, Public Health, Regulation / Tagged , , | Comments are closed

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

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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Posted in FDA, Food, GRAS, Health Policy, Public Health / Tagged , , , , | Comments are closed