EDF Health

EDF and others take FDA to court to demand action on carcinogenic flavors petition

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 17, 2018

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

FDA’s priority must be resolving safety concerns with
existing chemicals over approval of new ones.

On May 2, EDF and other consumer health advocates filed a lawsuit to force the Food and Drug Administration (FDA) to make a final decision on our food additive petition, which asked the agency to reverse its approvals of seven carcinogenic synthetic flavors. Earthjustice is representing EDF in this petition for a writ of mandamus to the court of appeals. We did not take this action lightly. However, with the statutory deadline for a decision passing more than 20 months ago, we saw little chance that FDA would act without court oversight.

Our food additive petition narrowly focused on one specific issue where the law and science were clear, and laid out our review of both the scientific literature and the law concluding that the seven chemicals were no longer safe. FDA formally accepted the petition for filing – essentially confirming it was complete – which triggered a 180-day deadline under the statute to make a final decision. That deadline passed in August 2016 without a decision by FDA.

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EPA reaffirms Lead-Safe Renovation, Repair, and Painting Rule, citing 150% to 500% payback

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 10, 2018

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

In April 2018, the Environmental Protection Agency (EPA) completed a thorough review of its Lead-Safe Renovation, Repair, and Painting Rule (RRP) promulgated a decade ago. This rule requires contractors and landlords to use lead-safe work practices when more than minor amounts of lead-based paint in homes built before 1978 are disturbed. It also applies to pre-1978 child-occupied facilities. This review was conducted pursuant to Section 610 of the Regulatory Flexibility Act because of RRP’s significant impact on more than 300,000 small businesses that perform more than 4 million affected projects each year.

EPA concluded that RRP, including several post-2008 amendments, “should remain unchanged without any actions to amend or rescind it.” As part of the review, the agency updated its economic analysis and found that the estimated annual societal benefits, primarily in improved children’s IQ, of $1.5 to $5 billion exceeds the $1 billion in estimated annual compliance costs. Those estimates translate into an impressive annual payback of 150% to 500%. Keep in mind that these benefits do not include the lower risk of premature cardiovascular deaths attributed to adult lead exposure in a March 2018 report in Lancet.

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FDA details its new push on heavy metals in food

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

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

In May 2017, the US Food and Drug Administration (FDA) Center for Food Safety and Nutrition (CFSAN) announced it had “established a Toxic Elements Working Group whose mission in part is to develop a strategy for prioritizing and modernizing the Center’s activities with respect to food/toxic element combinations using a risk-based approach.” FDA set a goal of limiting lead “to the greatest extent feasible.”

In April 2018, FDA released an interview with the Working Group’s chair, Conrad Choiniere, providing an update on its activities. An overarching point expressed by Choiniere during the interview is that “these metals [lead, arsenic, cadmium and mercury] can have effects on children’s neurological development.” This affirmation of scientific evidence is a welcome sign from the agency. FDA’s key statements are:

  • Initial scope: Children’s exposure to “metals like lead, arsenic, cadmium, and mercury in foods, cosmetics, and dietary supplements.”
  • Approach: “Looking at all the metals across all foods rather than one contaminant, one food at a time.”
  • Initial findings: “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.”
  • Next steps:
    • “Finalizing the draft guidance that sets an action-level for the presence of inorganic arsenic in infant rice cereals and apple juice.”
    • “Begin reevaluating the specific lead levels that FDA has set for a variety of foods.”

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Heavy metals in food: Carrageenan as an example of the need to improve ingredient quality

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 6, 2018

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

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Arsenic, cadmium and lead levels in carrageenan varied widely but were within international standards. This is not reassuring since current specifications for the heavy metals are inadequate. Food manufacturers can and should set tighter limits to better protect their customers. Consumers, especially those buying from internet-only retailers, need to ask the ingredient supplier how much of the heavy metals is acceptable.

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In the fall of 2013, the Food and Drug Administration (FDA) bought 10 samples of carrageenan from 5 companies sold through internet-only retailers to test for three heavy metals – lead, arsenic (total and inorganic), and cadmium. The agency published the results on its combination metals testing webpage in September 2016.

Each of these metals are carcinogens. In addition, lead and inorganic arsenic are widely acknowledged as harming children’s brain development even at low levels of exposure. EDF found that more than one million children consume lead in amounts that exceeds the maximum exposure level set by FDA in 1993, a level that subsequent research shows is of great risk to children’s health. Further, recent research has strengthened evidence of the relationship between low levels of lead exposure in adults and cardiovascular deaths. In 2011, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) took the extraordinary step of withdrawing its previous tolerable intake level for lead because it could not determine a safe level of exposure for children.

In light of these risks, we must make every effort to reduce the levels of these heavy metals in food to the greatest extent possible – without undermining other food safety measures or compromising quality. A key step to success is examining the levels of heavy metals in all ingredients used to make a food since the risk is based on the cumulative exposure – even if the amounts in individual additives are small. With this in mind, we revisited FDA’s analysis of carrageenan.

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New Study Says Lead – Even at Low Levels – is Associated with Risk of Premature Death

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 15, 2018

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

This week, a team of researchers led by Dr. Bruce Lanphear published an important new study on the deadly impact of lead exposure for adults. The researchers examined data on more than 14,000 adults and found that an increase of 1 to 6.7 micrograms of lead per deciliter of blood (µg/dL) was significantly associated with an increase in mortality of 37% for all-causes, 70% for cardiovascular, and 108% for ischemic heart disease. The findings remained significant even after they considered and accounted for other factors that could have explained this effect.

This research fills a gap identified by the National Toxicology Program in 2011 in our understanding of the risk of lead exposure at low levels in adults. And it goes further by providing a quantitative relationship crucial to better evaluating the potential economic benefits of various policy options.

The study also had startling estimates about how many people are hurt by lead exposure. The authors estimated that over 400,000 Americans every year die from lead related illnesses – ten times higher than previous assessments. That’s on par with deaths from smoking cigarettes.

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A path to leadership: Food packaging product stewardship considerations released

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 13, 2018

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

Last week, we spent two days at a Chemical Watch food packaging conference with manufacturers and suppliers trying to better understand the process for bringing innovative products to market. They learned what the Food and Drug Administration (FDA) and other countries will demand and what challenges they need to anticipate. While regulatory aspects are complicated, the attendees often talked about the difficulties of navigating requirements from companies and reacting to consumer expectations about packaging chemicals.

These concerns were timely. On March 9, the Food Safety Alliance for Packaging (FSAP), a part of the Institute of Packaging Professionals, released “Food Packaging Product Stewardship Considerations,” a set of best practices. This marks the first public recognition by a sector of the packaging industry of the expectations and demands from food manufacturers, retailers, and consumers.

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