Monthly Archives: August 2023

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]

Read More »

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