EDF Health

New EPA model enables comparison of various sources of childhood exposure to lead

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 14, 2017

Tom Neltner, J.D., is Chemicals Policy Director and Dr. Ananya Roy is Health Scientist

This week, Environmental Health Perspectives published an important article by scientists at the Environmental Protection Agency (EPA) that sheds important light on the various sources of children’s lead exposure. Led by Valerie Zaltarian, the article shares an innovative multimedia model to quantify and compare relative contributions of lead from air, soil/dust, water and food to children’s blood lead level. The model couples existing SHEDS and IEUBK models to predict blood lead levels using information on concentrations of lead in different sources, intake and gut absorption. The predicted blood lead levels compared well with observed levels in the National Health and Nutrition Evaluation Survey population. Given the variety of independent sources of lead exposure, the model provides a critical tool that public health professionals can use to set priorities and evaluate the impact of various potential standards for all children and not just those with the greatest exposure.

This peer-reviewed article builds on a draft report EPA released in January 2017 evaluating different approaches to setting a health-based benchmark for lead in drinking water. The report has provided a wealth of insight into a complicated topic. Earlier this year, we used it to show that formula-fed infants get most of their lead exposure from water and toddlers from food, while the main source of lead for the highest exposed children is soil and dust. In our February blog, we provided our assessment of a health-based benchmark for lead in drinking water and explained how public health professionals could use it to evaluate homes. The information was also critical to identifying lead in food as an overlooked, but meaningful, source of children’s exposure to lead.

The new article reaffirms the analysis in the January 2017 EPA report and highlights that evaluating source contribution to blood lead in isolation versus aggregating across all sources can lead to very different answers and priorities. A health-based benchmark for lead in drinking water could vary from 0 to 46 ppb depending on age and whether all other sources of lead are considered. For example, a health-based benchmark for infants (birth to six months old) would be 4 ppb or 13 ppb depending on whether or not you consider all sources of exposure.

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Posted in Drinking water, Emerging science, Food, Health policy, Lead / Tagged , , , , , , , , | Authors: / Comments are closed

FDA finds more perchlorate in more food, especially bologna, salami and rice cereal

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 9, 2017

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

Last month, the Food and Drug Administration’s (FDA) scientists published a study showing significant increases in perchlorate contamination in food sampled from 2008 and 2012 compared to levels sampled from 2003 to 2006. The amount of perchlorate infants and toddlers eat went up 34% and 23% respectively. Virtually all types of food had measurable levels of perchlorate, up from 74%. These increases are important because perchlorate threatens fetal and child brain development. As we noted last month, one in five pregnant women are already at great risk from any perchlorate exposure. The FDA study doesn’t explain the increase in perchlorate contamination. Yet, it’s important to note that there is one known factor that did change in this time period: FDA allowed perchlorate to be added to plastic packaging.

Reported perchlorate levels in food varied widely, suggesting that how the food was processed may have made a significant difference. The increase in three foods jumped out to me:

  • Bologna: At a shocking 1,557 micrograms of perchlorate per kilogram (µg/kg), this lunchmeat had by far the highest levels. Another sample had the fifth highest levels at 395 µg/kg. Yet a quarter of the other bologna samples had no measurable perchlorate. Previously, FDA reported levels below 10 µg/kg.
  • Salami: One sample had 686 µg/kg giving it a third ranking. Other samples showed much lower levels and six of the 20 had no detectable levels of perchlorate. Previously, FDA reported levels below 7 µg/kg.
  • Rice Cereal for Babies: Among baby foods, prepared dry rice cereal had the two highest levels with 173 and 98 µg/kg. Yet, 15 of the 20 samples had non-detectable levels of perchlorate. Previously, FDA reported levels less than 1 µg/kg.

The increases are disturbing in light of the threat posed by perchlorate to children’s brain development and the emerging science showing the risk at lower levels is greater than thought a decade ago. The risk is particularly significant for children in those families loyal to those brands with high levels. Unfortunately, FDA’s study does not identify the brand of food tested. Read More »

Posted in Emerging science, FDA, Food, Health policy, Perchlorate, Regulation / Tagged , , , , , , , | Comments are closed

Nanoparticles on the brain?

By John Balbus / Published: February 21, 2008

John Balbus, M.D., M.P.H., is Chief Health Scientist.

It’s been a worry for engineered nanoparticles. Now, a new study from the Harvard School of Public Health (Suglia et al., 2008) is the first to suggest that particulate air pollution not only damages the lungs and heart, but also may damage the developing brain.

Researchers measured cognitive function in over 200 children in Boston in relation to their residential exposure to traffic-related air pollution by measuring airborne carbon black particles. They found the IQ-lowering effect of higher exposure is comparable to a pregnant mother smoking 10 cigarettes a day or moderate lead exposure. Read More »

Posted in Emerging science, Health science, Nanotechnology / Tagged , | Read 3 Responses

Unleaded Juice: FDA needs to start with public health—not market impact

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 22, 2022

Tom Neltner, Senior Director, Safer Chemicals 

This is the fifth in our Unleaded Juice blog series exploring how the Food and Drug Administration (FDA) sets limits for toxic elements like lead, arsenic, and cadmium in food and its implications for the agency’s Closer To Zero program. 

FDA’s approach to setting draft action levels for lead in juice is based on two ill-conceived presumptions:

  • Action levels should not impact more than 5% of the market. Unfortunately, FDA does not appear to consider market trends or whether the products were made using best practices shown to reduce contamination.
  • Action levels should help ensure 90% of young children have a dietary intake of lead that is below FDA’s Interim Reference Level, the maximum daily intake from food. Unfortunately, this effectively ignores the top 10% or 2.4 million of the most-exposed young children.[1]

To its credit, the agency has shown it is willing to go beyond the 5% impact for three types of juices (grape at 12%, pomegranate at 6%, and prune at 6%),[2] and it has proposed the most protective lead-in-juice standards in the world. However, for a heavy metal like lead where relatively short-term exposures can result in long-term harm to young children’s developing brains, the current approach has serious weaknesses.

We think the agency should evaluate alternatives that impact more than 5% of the market and protect more than 90% of children. And when FDA evaluates impacts, it should assess the socioeconomic benefits of the alternatives. For substances like lead (and arsenic), these societal benefits can be quantified using established methods. In a previous blog, we showed that reducing young children’s overall dietary intake of lead by just 6% would yield $1 billion a year in benefits. The agency should compare these benefits to the investments that industry would need to make to achieve these action levels using best practices.

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Posted in FDA, Food, Lead, Unleaded Juice / Tagged , , , , , | Comments are closed

FDA reinstates ban on lead added to hair dyes

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: October 8, 2021

Tom Neltner, Chemicals Policy Director

On October 7, FDA announced that it is reinstating its ban on lead acetate as the active ingredient in hair dyes that hide grey hair when used regularly. In 1980, the agency approved the chemical for hair dyes. In response to a color additive petition from the Environmental Defense Fund and others, in October 2018, the agency revoked its approval. Combe Inc, the maker of Grecian Formula, objected and forced the FDA to suspend its decision. With this new action, the FDA reinstates its decision effective January 6, 2022 and gives companies one year to reformulate lead acetate out of their products.

Grecian Formula reportedly stopped using lead acetate shortly before the FDA acted in 2018. From our searches, Youthair is the remaining brand that uses the chemical.

We applaud the FDA’s affirmation of its 2018 decision where it determined these products are not safe. The agency soundly rejects Combe’s arguments that low levels of lead are safe and concludes that “we have determined that there is no known level of exposure to lead that does not produce adverse effects” in adults. These adverse effects include heart and kidney damage.

People should not be spreading lead on their head! It gets through the skin where it can hurt their body in myriad of ways. While we applaud the decision, we don’t see anything in the record that explains why FDA took almost three years to reaffirm the obvious and allow consumers to unknowingly continue using the unsafe product. Therefore, it is even harder to understand why FDA chose to give Youthair another year – until January 2023 – to remove the product from the shelves.

The FDA has known for more than forty years that the lead in these hair dyes is absorbed through the scalp, especially when used every day to hide grey hair, but previously thought there was a safe level. Other federal agencies acknowledged a decade ago there is no known safe amount of exposure to lead in adults or children. The FDA’s action in 2018, reaffirmed today, brings it in line with the scientific consensus.

Beyond lead acetate hair dyes, the FDA needs to do more to drive down consumer’s exposures from all sources of lead in food and cosmetics by tightening limits on this heavy metal in common ingredients. To protect kids and adults, it needs to translate its recognition that there is no known safe level of lead exposure by updating its outdated standards for food additives, bottled water, metal cans, and brass faucets as we demanded in a petition last year. The agency’s Closer to Zero Action Plan for children’s foods is critical but not sufficient to protect adults.

Posted in FDA / Comments are closed

FDA scientists push back on an industry-funded analysis about bioaccumulation and toxicity of short-chain PFAS

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 1, 2020

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

Note to readers: As we all grapple with the grave global health challenge from COVID19, we want to acknowledge the essential services that professionals at the Food and Drug Administration (FDA) and in the food production, processing and retail industries provide in continuing to deliver food. In the meantime, we are continuing to work towards improved health protections – including reducing chemicals in food. We’ll plan to keep sharing developments that may be useful to you. In the meantime, please stay safe and healthy.

Last year, we reported on a sophisticated analysis performed by FDA’s scientists showing that 5:3 acid, a breakdown product of a short-chain PFAS known as 6:2 fluorotelomer (6:2 FTOH) was slow to be eliminated by the body. The authors concluded that the metabolite was an important biomarker for assessment of long-term exposure to 6:2 FTOH and showed potential bioaccumulative (aka biopersistence[1]) properties. The chemical 6:2 FTOH is a common starting substance in the manufacture of many PFAS polymers, including those used to greaseproof paper and paperboard. As a result, it is a major impurity in, and degradation product of, these polymers.

We are now reporting on two recent publications by the same group of FDA scientists (Kabadi et al.[2] and Rice et al.)[3] in which they not only confirmed their initial findings but also produced new evidence on the behavior of short-chain PFAS when they enter the body. The new evidence highlights:

  • Bioaccumulation: 6:2 FTOH is transformed by the body into several metabolites; one of them, called 5:3 acid, bioaccumulates, and the bioaccumulation is greater with lower exposure to 6:2 FTOH.
  • Toxicity: The toxicity of 6:2 FTOH is concerning and its risk to human health may have been significantly underestimated previously. Data on perfluorohexanoic acid (PFHxA), the industry’s proposed reference chemical for the short-chain PFAS class are not appropriate for assessing the potential health effects of 6:2 FTOH.

The FDA’s scientists reached these important conclusions after reviewing “recently received additional data on 6:2 FTOH and 5:3 acid” and more than a dozen reports on oral toxicity studies that “had been conducted and submitted by industry in support for food contact uses” of short-chain PFAS in addition to a study by the National Toxicology Program. They also called out flaws in industry-funded analyses that reached different conclusions.

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Posted in FDA, Health policy, Industry influence, PFAS / Tagged , | Comments are closed