EDF Health

Unveiling EDF’s Chemical Exposure Action Map

U.S. map showing chemical facilities across the nationWhat’s New

Today, we are excited to introduce the Environmental Defense Fund’s (EDF) latest initiative—the Chemical Exposure Action Map. This tool is designed to spur the Environmental Protection Agency (EPA) to transform the assessment of risks posed by toxic chemicals in our communities.

Our map focuses on multiple high-priority chemicals—making visible the urgent and long-overdue need to assess the risks of chemicals together as they exist in the real-world. Unlike many current methods that look at risks one chemical at a time, our map offers a comprehensive view, highlighting the potential for cumulative risks from multiple high-priority chemicals.

Why It Matters

In a world where industrial facilities expose communities to multiple harmful chemicals daily, many have long called for a cumulative approach to assessing the risks from these chemicals. It is crucial that we wait no longer to reassess how we evaluate the health risks they pose.

Pregnant Latine woman gazing lovingly at young daughter who is hugging her belly.

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Also posted in Adverse health effects, Carcinogenic, Chemical exposure, Chemical regulation, Cumulative impact, Cumulative risk assessment, Developmental toxicity, Health hazards, Health policy, Public health, Risk assessment, Risk evaluation, TSCA, Vulnerable populations / Tagged , , , , , , | Authors: , / Comments are closed

ICYMI: Secret GRAS determinations may outnumber those FDA reviews

Quote from FDA Commissioner Robert Califf, MD. "I want to throw in chemical safety as another really, really important area for the future—for humankind, really—and where science is evolving rapidly."

NOTE: This blog was originally published on our Deep Dives blog on April 13, 2023. It predates the recent reorganization efforts at FDA.

What Happened?

FDA estimates that, each year, food companies designate 82 new food chemicals as “GRAS” (Generally Recognized as Safe) for use in food. On average, FDA reviews only 64 of those new chemicals for safety. For the remaining 18 chemicals in FDA’s estimate, the companies making and marketing them for use in food or in the food-production process choose not to seek a voluntary review by FDA.

In comments to the agency, we said we think FDA’s estimate may be too low – and the number of new chemicals added to food that bypass FDA review may be as high as 130 new food chemicals a year (significantly higher than 18). This is based on searches of company marketing claims. In an 8-week period, we identified 10 chemicals claimed as GRAS without a submitted notice to FDA seeking voluntary review. (Please see our comments for a full explanation of our estimate.) Read More »

Also posted in Broken GRAS, Chemical regulation, FDA, Food, GRAS, Health policy, Industry influence, Public health / Tagged , , | Authors: , / Comments are closed

EPA’s new chemical regulations: Backtracking on PBTs

NOTE: This is the fifth in a series about EPA’s regulation of new chemicals. See below under Go Deeper for links to the other blogs in the series.

What Happened?

The Environmental Protection Agency (EPA) recently proposed new regulations for its safety reviews of new chemicals under our nation’s primary chemicals law, the Toxic Substances Control Act (TSCA). One of the proposed provisions would govern which persistent, bioaccumulative,1 toxic chemicals (PBTs) should undergo a full safety review.

Why It Matters

This proposed approach would exclude certain PBTs from a full new chemical safety review. This is a concerning step backward in addressing the risks from these chemicals.

PBT chemicals do not break down readily from natural processes and raise special concern because of their ability to build up in both the environment and in people and other organisms. Even small releases of these long-lived and bioaccumulative toxic chemicals can pose long-term risks to human health and the environment. Notable PBTs—such as DDT, which affects reproduction, and methyl mercury, which is a powerful neurotoxin—impacted whole ecosystems across the United States, including the Great Lakes.

View of Lake Michigan

View of Lake Michigan Photo credit: Maria Doa

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Also posted in Adverse health effects, Chemical exposure, Chemical regulation, Health hazards, Health policy, Neurotoxicity, PBTs, Risk assessment, Rules/Regulations, TSCA / Tagged , , , , , | Authors: / Comments are closed

Now’s the Time—How EPA can use TSCA to turn off the PFAS tap

Faucet with the word PFAS flowing out of it

In the face of mounting evidence about the dangers posed by per- and polyfluoroalkyl substances (PFAS), one thing is clear: EPA needs to take urgent action to turn off the tap of these “forever chemicals” that have long-term consequences for our health and the environment.

As we discussed in a previous blog, it is imperative that the Environmental Protection Agency (EPA) use the Toxic Substances Control Act (TSCA) to regulate PFAS chemicals comprehensively—both those newly entering the market and those that have been in circulation for decades.

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Also posted in Chemical exposure, Chemical regulation, Cumulative impact, Cumulative risk assessment, Drinking water, Emerging science, Health policy, PFAS, Public health, Risk assessment, Risk evaluation, TSCA, TSCA reform, Vulnerable populations, Worker safety / Tagged , , | Authors: / Read 2 Responses

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 »

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

FDA’s squishy definition of adverse health effects of substances in food

Maricel Maffini, consultant, and Tom Neltner, Senior Director, Safer Chemicals

3 human figures showing stages of becoming ill. First figure is all white and standing up straight. Second figure is bent over and stomach area is red. Third figure is is all red, bent over, and appears to be vomiting.

What Happened

A recent peer-reviewed publication criticized FDA’s criteria for identifying adverse health effects associated with exposure to pathogens, chemicals, or allergens in foods. The authors gave two recent examples of the agency dismissing health concerns: a toxin created in spoiled fish that caused temporary, medically adverse health effects because they were short-term and reversible, and an additive where evidence from animal testing showed harm in only one sex. The authors concluded that the agency’s criteria are “inadequate because they are not science-based.”

Why It Matters

FDA is responsible for protecting food safety and the public’s health. In order to do that, it makes decisions whether a pathogen, chemical, or allergen causes an adverse health effect that must be avoided—so the agency’s definition of an adverse health effect is critically important. Unfortunately, FDA lacks a clear definition of the term, usually approaching it on a case-by-case basis in a manner that lacks transparency and scientific grounding.

Adverse Effects Dismissed by FDA

In 2020, the director of The Pew Charitable Trusts’ food safety project argued that FDA failed to “protect Americans from preventable illnesses” because it considered that the effects caused by the fish toxin were temporary or reversible. FDA described the toxin’s effects, which ranged from facial flushing and sweating, dizziness, nausea and headache to more severe cases of blurred vision, respiratory stress, and swelling of the tongue. The Pew director reasonably added that people may require hospitalization, medical treatment due to cardiac complications, and altered blood pressure–all of which are adverse health effects.

In a 2019 final rule approving the listing of leghemoglobin as a color additive, the Center for Food Safety objected that FDA dismissed statistically significant “changes in blood chemistry, blood clotting ability, and blood globulin values” as potential health effects. In its response to the objection, the agency argued that “statistical differences seen between control animals and treatment animals due to small changes in the value of the parameter are not likely to be of biological or toxicological significance.” FDA further stated that for the color additive to cause the blood changes to be “potentially adverse” it should:

  • Show a “clear dose-response,” described as a direct relationship between the dose given and the effect observed, in other words, the higher the dose, the higher the effect; and
  • Be observed in both sexes of the species in which the substance is tested.

This argument put forth by FDA’s food safety scientists would be summarily dismissed by their colleagues on the drug side because it ignores current scientific principles: dose responses can have different shapes and there are known sex differences in response to exposures from multiple chemicals.

Our Take

This is an ongoing issue. Other organizations have defined “adverse health effects.” For example, EPA’s Integrated Risk Information System (IRIS) defines adverse effect as “[a] biochemical change, functional impairment, or pathologic lesion that affects the performance of the whole organism, or reduces an organism’s ability to respond to an additional environmental challenge.”

FDA’s lack of a practical definition for adverse health effect and how the agency applies it in food safety assessments has likely contributed to inconsistencies in its decision making.

Next Steps

We will continue to press the agency for transparency about what health effects it considers important to prevent and protect the health of American families. FDA should publish clear, rational, science-based criteria for determining adverse effects and periodically review them as our knowledge base advances to better inform regulatory decisions.

Also posted in Adverse health effects, FDA, Health hazards, Health policy, Health science, Public health / Tagged , , , | Authors: , / Comments are closed