EDF Health

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

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

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

 

 

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

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

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

Petrochemical pollution doesn’t affect communities equally. Better regulations can help.

By Michelle Allen, Manager, Community Engagement

Recent high-profile chemical disasters in East Palestine, Ohio, and Deer Park, Texas, have highlighted the risks facing communities where the petrochemical industry operates, but not every spill or toxic pollution release makes headlines. By some counts, there is a chemical fire, explosion or release every other day in this country.

As countries around the world invest in strategies to reduce carbon pollution and rely less on fossil fuels, the oil and gas industry has turned to petrochemicals as an opportunity for growth. Petrochemicals are chemical derivatives refined from petroleum, and they’re found in products we use every day: from water bottles and plastic cases on our phones to paints, fertilizers and carpets.

But images of billowing black clouds of smoke hanging over homes, schools and parks in communities from Appalachia to the Gulf Coast are a reminder that our everyday products—many of which are for the sole purpose of convenience—are not without cost. And too often, these costs are borne by someone else.

Communities are exposed to health risks from petrochemical pollution

Exposure to petrochemical pollution—from acute events like these environmental disasters, but also from prolonged exposure to these air toxics, day in and day out—puts communities at risk. But communities don’t experience these risks equally. Black and brown communities and low-income areas bear the brunt of this unequal and unjust pollution. Children, pregnant people, seniors and people with existing medical conditions are especially at risk of developing a host of health issues from exposure to this toxic pollution, including cancer, respiratory illness, asthma and more.

Communities on the frontlines of petrochemical pollution have long expressed that they have the right to know what’s in the air they’re breathing so they can take action to protect themselves and demand accountability from decisionmakers and industry. A newly proposed update to regulations in the Clean Air Act is a significant step in the right direction.

New EPA proposal would help hold polluters accountable

The Environmental Protection Agency has proposed stronger regulations for some 200 petrochemical facilities throughout the country, more than half of which are concentrated in Texas and Louisiana. These proposed rules include safeguards against petrochemical pollution that advocates have long called for: more air-quality monitoring at the fence line of facilities, stronger protections against flaring, and actions to close loopholes that allow facilities to violate regulations during periods of startup, shutdown and malfunction.

Dedicated community leaders have been leading the fight against this pollution for decades, and it’s great to see the Administration meet these efforts with long overdue protections. We need stronger regulations at the local, state and federal levels to protect the health of residents and require regulators to hold polluters accountable to the communities where they’re operating.

The additional transparency and accountability that will come from these protections are especially critical because many of these facilities have a documented history of breaking the law: our analysis shows that more than half of the facilities expected to be impacted by this proposal are currently violating at least one environmental law, and more than 80 percent have been out of compliance in the last three years.

Strong federal protections are needed to safeguard community health

We urge EPA to adopt a strong final version of this rule that is truly protective of public health. Requiring fence line monitoring to cover a greater number of chemicals and facilities, for example, would help hold polluters accountable and prevent further harm to communities.

EPA’s proposal is a critical step in the right direction—a foundational safeguard that can ground additional layers of protection for communities impacted by petrochemical pollution. Strong federal protections should be part of a comprehensive strategy to help communities achieve a healthy, thriving future for generations to come.

Posted in Air pollution, Chemical exposure, Deep Dives, Environmental justice, Health policy, Health science / Authors: / Comments are closed