EDF Health

New guidelines to inform EPA’s approach to cumulative risk

What’s New?

The Environmental Protection Agency (EPA) recently released and solicited public comments on its draft Cumulative Risk Assessment (CRA) Guidelines for Planning and Problem Formulation. The purpose of a CRA is to determine the combined health and/or environmental risks from multiple stressors and chemicals that can cause the same harms. These guidelines, intended to be applied to all of EPA’s programs and regions, describe how the agency will determine when to use CRAs and the steps it will take to plan them.

Why It Matters

Currently, many EPA programs assess the health and environmental risks of single chemicals, without considering the multiple chemicals that cause the same harms and non-chemical stressors we are exposed to every day. Assessing risks cumulatively, and making regulatory decisions based on this, represents real-world exposures more accurately than single-chemical stressor risk assessments. Read More »

Also posted in Chemical exposure, Cumulative impact, Cumulative risk assessment, Public health, TSCA, Vulnerable populations / 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 »

Also posted in Adverse health effects, Chemical exposure, Chemical regulation, Frontline communities, Health hazards, 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 »

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

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.

Also posted in Air pollution, Chemical exposure, Deep Dives, Environmental justice, Health science / 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 science, Public health, Regulation / Tagged , , , | Authors: , / Comments are closed

Representatives Call For FDA Public Hearing on Phthalates

By. Joanna Slaney, Senior Director, Federal Affairs, and Maricel Maffini, PhD, Consultant

U.S. Capitol dome framed by trees

Source: A. Paige Baker, ShutterSights.com©

What Happened?

On May 19, Reps. Katie Porter, Steve Cohen, Nanette Diaz Barragán, Earl Blumenauer, and Raúl Grijalva issued a letter [PDF, 300KB] to FDA Commissioner Robert Califf calling on FDA to “act expeditiously to protect the public from the health risks posed by phthalates in food and food packaging.”

They asked the FDA to hold a public hearing on ortho-phthalates (phthalates), chemicals associated with disruptions to the development of the male reproductive system and neurodevelopment, among other health effects.

Why It Matters

In 2021, Reps. Porter and Lieu led a letter with 12 colleagues urging FDA to take action on phthalates in food and cosmetics. That letter, in part, called on FDA to take action on a 2016 petition filed by EDF and allied environmental health organizations asking FDA to revoke its approval for all uses of phthalates in food packaging and processing equipment.

In May 2022, after the petitioners sued, FDA denied the petition. The petitioners formally objected to the decision and requested a public hearing pursuant to FDA’s regulations. The agency has not provided any timeline for acting on the objections.

Request for a Public Hearing

The Representatives stated in the letter submitted last month that  FDA’s decision denying the petition was flawed. “[W]e are deeply concerned about the denial, which was made without deciding whether the remaining approved uses of phthalates in food and food packaging are safe.” (Emphasis original)

They reminded Commissioner Califf of his recent statement that chemical safety is a “really, really important area for the future – for humankind, really – and where science is evolving rapidly,” urging FDA to hold a public hearing on two areas of concern:

  • The agency’s failure to evaluate the safety of phthalates as it was legally required to do before denying the 2016 petition. The letter stated, “failing to evaluate the safety of phthalates is an abdication of the FDA’s continuing obligation to oversee the safety of the food supply.”
  • FDA’s failure to address new toxicity information that raises significant questions about the safety of phthalates. Phthalates are associated with numerous health issues, including reproductive and developmental toxicity, endocrine disruption, immune toxicity, and epigenetic alterations. The letter stated, “the denial of the petition fails to acknowledge, let alone analyze, the dozens of peer-reviewed studies that underscore the toxicity of the phthalates that remain approved for food contact use.”

Next Steps

EDF and our allies will continue to press FDA to hold a public hearing on the safety of phthalates used in food packaging and processing equipment.

Go Deeper

EDF blogs on phthalates

Also posted in Congress, Developmental toxicity, Endocrine disruptors, FDA, Food, Food packaging, Health science, Phthalates, Public health, Public hearing, Regulation, Reproductive toxicity / Tagged , , , , , | Authors: , / Comments are closed