EDF Health

FDA says “Cookware that exhibits any level of leachable lead upon testing is prohibited.”

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 15, 2023

What’s New?

For the first time, FDA has provided guidance on how to evaluate whether metal cookware is prohibited due to lead leaching into food.

As part of an investigation to find the source of elevated blood lead levels in some refugee children, the Hazardous Waste Management Program in King County, Washington [1] encountered high lead levels in certain imported [2] aluminum cookware, including pressure cookers and pots & pans. The program attempted to bring this to FDA’s attention in late 2019, and submitted a formal product report to FDA in October 2021, after several attempts to contact an FDA representative directly.

In May 2022, the Program published a journal article about its findings; a year later, staff emailed FDA again seeking guidance. On June 1, 2023, FDA responded with a letter [PDF, 166KB] providing a method (see below) to evaluate lead in metal cookware. The agency also said:

  • “The marketing in interstate commerce, including importation, of cookware that exhibits any level of leachable lead upon testing is prohibited.”
  • “Neither lead nor lead-containing materials (e.g., metals, solder) are permitted under FDA regulations for use in contact with food.”
  • The Program should “feel free to share this letter or any of its contents with Amazon.com, Inc.,[3] and any other firms involved in the marketing or sale of cookware.”[4]

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Posted in FDA, Health hazards, Lead, Risk evaluation, Vulnerable populations / Tagged , , | Authors: / Comments are closed

New Approach Methodologies Should Adhere to TSCA Standards

By Susanne Brander, PhD, Senior Contributing Scientist / Published: August 15, 2023

What’s New?

EPA recently asked its Board of Scientific Counselors (BOSC), comprised of experts in the fields of toxicology and environmental chemistry, to make recommendations on implementing new approach methods (NAMs) for testing the safety of new chemicals.

NAMs encompass a wide array of new evaluation strategies, including testing cell lines or invertebrates (rather than mammals); using computational approaches; and estimating potential harms of new chemicals by looking at existing toxicity data on similar substances.

Why It Matters

EPA announced in 2019 that it would be redirecting resources towards developing NAMs to replace those studies. The looming concern is the possibility that NAMs may miss effects that whole animal mammalian testing accounts for and generate false negatives — potentially allowing toxic chemicals to appear in consumer products or end up in our environment.

This could happen because relying only on NAMs or using data from one chemical to predict how a new one might behave opens the door to missing negative effects. NAMs could also cause evaluators to miss opportunities to use the Toxic Substances Control Act (TSCA), the nation’s primary chemical safety law, to limit toxic chemical exposures. Read More »

Posted in Chemical regulation, Cumulative risk assessment, Emerging science, Emerging testing methods, Frontline communities, Health science, New approach methods (NAMs), Risk assessment, Risk evaluation, TSCA / Tagged , , | Authors: / Comments are closed

Fatally Flawed: EDF & partners call on EPA to revoke approval for new chemicals with shocking health risks

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: August 10, 2023

 

 

A sepia-toned image showing a factory with dark smoke billowing out of multiple smokestacks.

What Happened?

EDF and other environmental groups recently asked the Environmental Protection Agency (EPA) to withdraw the approval it issued for a group of new chemicals. This approval, also known as a consent order, allows Chevron to create fuels at its refinery in Pascagoula, Mississippi, by using oils produced through a process of superheating plastic waste to break it down (a process known as pyrolysis). The consent order also allows for the use of these fuels derived from waste plastic at more than 100 locations. ProPublica published an article on the issue on August 4, 2023.

Why It Matters

EPA is required by law to provide protections against unreasonable risks posed by new chemicals. But in the consent order EPA approved the production and use of these new chemicals despite significant health risks. One of the chemicals posed a 1 in 4 risk of developing cancer for people exposed to it. Another chemical carried risks of a 7 in 100 cancer risk from eating fish contaminated by it and a greater than 1.3 in 1 cancer risk from inhaling it.

When asked about the shockingly high cancer risks it estimated, EPA claimed its cancer risk assumptions were overly conservative but failed to provide any information about what it believes are the actual risks and pointed to undefined controls under other laws as controlling the risks.

Until now, the acceptable risk standard for cancer in the general population has been 1 in 1,000,000. The risk levels EPA identified are up to 1,000,000 times greater than that. Read More »

Posted in Adverse health effects, Chemical exposure, Chemical regulation, Frontline communities, Health hazards, Health policy, Industry influence, Risk assessment, Risk evaluation, TSCA, Vulnerable populations / Tagged , , , , | Authors: / Comments are closed

Lead Cables: 66,000 miles overhead or underwater

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: July 26, 2023
Abandoned telecom cable leaching lead into Idaho fishing waters.

Abandoned telecom cable leaching lead into Idaho fishing waters Photo: Monique Rydel-Fortner

What’s New?

A blockbuster Wall Street Journal (WSJ) investigation showed that lead-sheathed telecom cables are releasing toxic lead into water or surface soil. We are aware of more than 2,000 of these cables across the nation—and more than 300 of those pose a threat to community drinking water sources.

Recognizing the potential risks to public health, EDF, Clean Water Action, and Below the Blue asked EPA on July 17 to investigate potential harms and replace abandoned lead cables strung between telephone poles, as well as any that are accessible to children.

In response, AT&T reported that it has more than 66,000 miles of lead cables, most of which are the overhead type, with the balance running underwater. This is a stunning amount – enough to circle the earth 2.5 times!

Legislators are already demanding that telecom firms act, and EPA and the Department of Justice say they are reviewing the issue. In addition, New York Governor Kathy Hochul directed three key state agencies to investigate the risks. In response, the agencies sent letters to 246 telecom providers requesting their inventory of lead cables. I also appeared on CNBC’s Squawk Box to explain the situation, EDF’s role in the investigation, and the cables’ potential risks. Read More »

Posted in Contamination, Drinking water, Health hazards, Health policy, Regulation, Risk assessment, Risk evaluation / Tagged , , , , | Authors: / Comments are closed

Broken GRAS: FDA’s lack of post-market oversight continues to create health risks

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: July 11, 2023

Brown glass vial surrounded by pepper corns

What Happened?

In April, a company called Prime Research Reports issued a press release in which it claimed FDA had approved THP (tetrahydropiperine) as a Generally Recognized As Safe (GRAS) substance “for use in food products.” There is no record that FDA has either reviewed or approved THP for use in food.

The report describes Sabinsa as a manufacturer of THP and as “a major player” in that market.[1] The substance, commercially known as Cosmoperine, is derived from a highly purified extract from black pepper; the extract, which is more than 95% piperine, is also made by Sabinsa and is marketed as BioPerine. The company describes piperine as an alkaloid present in black and long pepper.

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Posted in Adverse health effects, Broken GRAS, FDA, Food, GRAS, Health hazards, Industry influence, Risk assessment, Risk evaluation / Tagged , , , , , , | Authors: , / Read 1 Response

Is it time to rethink “lead-safe” and “lead-free”?

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 30, 2023

By Tom Neltner, Senior Director, Safer Chemicals Initiative, Environmental Defense Fund and Charlotte Brody, National Director, Healthy Babies Bright Futures

Key Message

The scientific consensus is that there is no known safe level of lead exposure, and that no environment or home is truly free of lead.

With a few exceptions, we think it is time to retire the terms “lead-safe” and “lead-free” from our vocabulary. It sends conflicting messages to the public, consumers, and decision-makers. And it may undermine our efforts to reduce children’s exposure to lead from any source.

Rationale

Collectively, we have dedicated over a half-century to protecting children from lead. During that time, we and other advocates have used different terms to communicate our goals. Often, we drew our terms from the federal government. For example:

  • “Lead-free” has been used by Congress since 1986 to define drinking water pipes with no more than 80,000 parts per million (ppm) of lead. It kept the term in 2014 when it changed the level from 80,000 to 2,500 ppm. Similarly, FDA issued guidance in 2010 allowing a “lead-free” label on pottery if it meets the agency’s limits on lead.
  • “Lead-safe” is in the title for HUD’s 1999 rule to reduce lead-based paint exposure in federally assisted EPA also refers to “lead-safe work practices” in its 2008 renovation, repair and painting (RRP) rule for residential property. In addition, EPA created a “lead-safe” logo in 2010 for certified RRP firms. And HUD, EPA, and CPSC use the term in their pamphlet given to millions of families renting or buying homes built before 1978.

As a result, terms like “lead-safe” and “lead-free” have been commonly used to describe community-wide initiatives, label houses on maps, describe the state of a house after remediation, and much more.

What does lead-free mean? It depends on who you’re asking and what you’re asking about. A contractor may understand the term to mean that a house meets the EPA definition of not having a lead hazard, but does the average resident understand the term the same way? Is it accurate to describe a house as lead-free if there is still lead in the drinking water? Or in the spices in the cabinets?

Read More »

Posted in Contamination, FDA, Lead, Public health, Unleaded Juice / Tagged , , , , | Authors: / Read 2 Responses