EDF Health

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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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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American Water demonstrates strong leadership on lead service line replacement

Tom Neltner, J.D.is Chemicals Policy Director

In a landmark decision on July 25, 2018, the Indiana Utility Regulatory Commission (IURC) approved American Water’s plan to fully replace the lead service lines (LSLs) in the communities served by its Indiana subsidiary over the next 10 to 24 years. This represents the replacement of about 50,000 LSLs across 27 community water systems (CWSs). As we highlighted in our blog on the company’s January 2018 proposal, the plan provides a framework that enables the cost of fully replacing LSLs, whether owned by the utility or by customers, to be shared by its 300,000 customers. As far as we know, this is the first comprehensive, voluntary LSL replacement program developed by an investor-owned utility in the country.

In its plan, American Water cited both long-term health and economic benefits that would be realized from avoiding partial replacements when rehabilitating water mains and laterals. The plan showed that having a single contractor handle the entire line reduces the overall cost by 25 t0 30%. It also avoids the likely increased risk of consumer’s exposure to lead when only part of the lead pipe is replaced.

IURC’s approval found the plan “to be reasonable and in the public interest.” Even though the customer will continue to own the service line, American Water will be allowed to add the cost to remove and replace the customer-owned portion to the value of the utility’s property. The increase would be considered an infrastructure improvement cost once the new service line is placed into service.

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Paint-lead hazard standard – A reconsideration

Tom Neltner, J.D.is Chemicals Policy Director

After 20 years working on lead poisoning prevention, it has become almost second nature for me to object when someone suggests that children eating paint chips is a significant route of exposure. All too often, the claim implies that the blame rests with parents who are not conscientious enough to clean or maintain their home or to properly care for their children. The implication is demeaning to the parents and distracts from the often – invisible lead dust hazards on floors that pose the greatest risk to children. So when I hear that idea, I quickly respond that dust is the key route of exposure.

However, a discussion with Hannah Chang at Earthjustice over my blog on the Environmental Protection Agency’s (EPA) July 2, 2018 proposed rule helped me realize that I was misguided with regards to defining the hazards of lead-based paints. She is the main attorney for the organizations that convinced a panel of judges in the Ninth Circuit Court of Appeals to order the EPA to update its lead-based paint hazard standard.

Hannah Chang told me I missed the most compelling point when I pointed out in my previous blog that “EPA did not appear to have considered HUD’s 2007 American Healthy Housing Survey, which should provide a solid basis for identifying the relationship between lead in paint and lead in dust.”  She was right; my logic was too focused on dust as the primary source of exposure. Here is my reasoning; it may be helpful to those planning to submit comments to EPA by the August 16 deadline on the proposed rule.

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