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EPA Passes Regulations for Forever Chemicals: Good News and Bad News

Photo credit: Demphoto

By Stephen Lester.

Earlier month, the US Environmental Protection Agency (EPA) finalized drinking water standards for a group of substances known as Forever Chemicals. These chemicals include PFOA, PFOS, PFNA, PFHXs, PFBS, and GenX and are generally described as polyfluoroalkyl substances (PFAS). PFAS chemicals are present everywhere in the environment, degrade very slowly and posed health risks to people who are exposed to them. They are called forever chemicals because they break down so slowing that they are around for centuries, essentially forever.

This new regulation requires that these forever chemicals be added to the substances that EPA requires all public drinking water systems to routinely monitor. Some water companies will start testing for PFAS in drinking water as early as 2027 in 3 years, but these restrictions don’t go into effect until 2029, five years from now. This regulation does not apply to private or individual wells, just to large public water systems.

While it’s good news that PFAS chemicals will be restricted in drinking water by 2029, this decision also highlights the slow cumbersome way that chemicals are regulated in this country. Although EPA made clear that there are significant and severe adverse health effects associated with these chemicals, the agency did not restrict their production or use in consumer products, just their presence in drinking water, and not for another 5 years. So, Dupont, 3M as well as other companies will continue to make these chemicals for use in consumer products. Furthermore, this new regulation only applies to 5 of the thousands of different PFAS compounds that have been identified.

Why does this make any sense? It certainly does not make any public health sense. EPA acknowledges the adverse health effects of these chemicals at extremely low levels, to the point where some researchers feel that there is no safe level of exposure to PFAS chemicals, yet EPA takes no action to restrict the production of these substances and gives water companies five years to meet its new standards. And for the companies that manufactured these chemicals – primarily DuPont (and several subsidiaries) and 3M – there’s no action against them or accountability for producing these substances for more than 50 years, even though for decades they opposed any regulatory action by EPA.

Over these years of delay, these companies slowly began moving away from the  PFAS chemicals that were targeted as “bad actors” – PFOA and PFOS – and began producing and using other PFAS chemicals about which virtually nothing was known about their toxicity. EPA has allowed this to happen even though the adverse health effects for most of these substances are not known. Somehow EPA seems good with issuing no restrictions on the production of potentially toxic consumer products and instead offers general advice to the public on steps they can take to avoid PFAS chemicals if they choose to do so.

There is something seriously wrong with our system for regulating toxic chemicals when the companies that use dangerous toxic chemicals to make consumer products for profit get off Scot free and the EPA offers advice to individuals on how to avoid these toxic products.

Industry began using these polyfluoroalkyl substances in the 1940s in consumer products such as nonstick cookware (Teflon) and in food packaging, to waterproof clothes, stainproof furniture and in certain manufacturing processes. They were also widely used in firefighting foams to extinguished fires, especially at airports and on training grounds for firefighters. PFAS chemicals gained public notoriety about 10 years ago when they began showing up in drinking water at military bases, such as the Pease Air Force Base in Portsmouth, NH. The US military estimates that there are over 600 military bases with PFAS contamination.

The adverse health effects associated with these forever chemicals include reproductive effects; developmental effects such as low birth weight, bone variations, and behavioral changes; damaged immune function such as reduced ability to fight infections; interference with the body’s natural hormone functions, including the thyroid; kidney and testicular cancer; liver damage; and increased cholesterol.  

For specific details about EPA’s new PFAS drinking water regulation, click here.

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Commitment to Tackling Risks Posed by Toxic Chemicals

Photo credit:  Ivan Bandura/Unsplash

Reshare by EHN Curators

In a recent development highlighting a personal commitment to addressing the perils associated with toxic chemicals, the current administration has intensified efforts to mitigate environmental and health risks.

According to Chris D’Angelo’s coverage in The Huffington Post:

  • The administration has initiated measures to limit hazardous waste and chemical exposures, including restrictions on open burning of waste explosives and the evaluation of cancer-causing chemicals.
  • Despite these efforts, the handling of the East Palestine, Ohio, train derailment, involving the burning of vinyl chloride, has drawn criticism for its potential health and environmental impacts.
  • The EPA’s proposed rule to limit the open burning of waste explosives aims to protect communities but does not directly address the concerns raised by the East Palestine incident.

“Toxic smoke, thick with poison, spreading through the air and into the lungs of our troops. When they came home, many of the fittest and best warriors that we sent to war were not the same — headaches, numbness, dizziness, cancer. My son Beau was one of them.”

— President Joe Biden

Hazardous waste and toxic chemicals can wreak havoc on public health and ecosystems. Chemicals that seep into soil and waterways can disrupt habitats, harm wildlife, and contaminate food chains. This not only affects biodiversity but can also compromise the resources people rely on, like clean drinking water and productive agricultural land.

EHN visited residents still picking up the pieces four months after a catastrophic train derailment dumped toxics in East Palestine, Ohio.

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It’s Time to Do Right by the People in East Palestine, OH – and Elsewhere

Photo credit: CNN

By Stephen Lester.

Nearly 10 months ago, a Norfolk Southern train with more than 150 cars, many of which contained toxic chemicals, derailed in East Palestine, OH. Thirty-eight of the train cars derailed and a decision was made by Norfolk Southern to burn the contents of 5 tanker cars containing vinyl chloride and other toxic chemicals. This unleashed a huge black cloud full of particulates that enveloped the surrounding neighborhoods and farms in both OH and PA.

Immediately after the burn, people in East Palestine began reporting adverse health symptoms including headaches, nose bleeds, skin rashes, central nervous symptoms, thyroid problems and more. These and other adverse health problems have continued to plague the residents of this rural midwestern town.

EPA immediately responded by telling people that everything was alright and there was no cause for alarm. EPA’s testing found no levels of “concern.” But the people in East Palestine could not accept this narrative because they knew things were not right. They knew the health effects they were suffering from were real. They knew that EPA was not telling them the truth.

If EPA were honest with the people at East Palestine, they would have told them that they didn’t understand why people were continuing to report so many illnesses while their data told them otherwise. But if EPA did acknowledge how little is known about the link between adverse health effects and exposures to mixtures of chemicals, the people of East Palestine would demand action in the face of these uncertainties. Actions like paying for relocations so that they can stop being exposed to the toxic chemicals that are still in the air and getting the health care they need to move on with their lives.

The people in East Palestine deserve better. So do hundreds of other communities across this country where people have similarly been exposed to low levels mixtures of toxic chemicals. It is clear from the situation in East Palestine that very little is known about how people respond to chemical exposures, especially to low level mixtures. This is evident when the EPA and other public health agencies who rely on traditional toxicology and risk assessment are telling the people of East Palestine that everything is safe when it clearly is not.

It’s time to acknowledge that the scientific understanding does not exist to explain what is happening to the health of the people in East Palestine. It’s time to recognize that we cannot rely on traditional toxicology to answer the questions people have about their exposures to low level chemical mixtures. It’s time to do the right thing by the people in East Palestine and by hundreds of communities across the U.S. where people are being exposed to low level mixtures of toxic chemicals. It’s time to acknowledge that the tools we have are not able to answer the questions people raise about their exposure to toxic chemicals and give people the relief they are asking for, whether it’s cleanup, relocation, health care or something else.   

It’s what the government did for the Vietnam veterans exposed to Agent Orange; for the atomic bomb victims exposed to radiation fallout; for the 9/11 first responders in New York City; for the soldiers exposed to burn-pit smoke in Iran and Afghanistan and other overseas locations; and for the Marines at Camp Lejeune, North Carolina who drank contaminated water. Do the people of East Palestine deserve anything less than the soldiers and first responders who protect this country?

In each of these instances, the government recognized that the science linking exposure and health outcomes was incomplete and instead of requiring proof of cause and effect, they said, “Enough, we will take care of our own.” They moved to a presumptive scientific approach that allowed veterans and first responders to  health care and other compensation. We should do the same for the people of East Palestine and in hundreds of other communities that have been exposed to low level mixtures of toxic chemicals.

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It’s Time to Move Beyond Risk Assessment

Risk assessment is the standard method for evaluating exposure to toxic chemicals, despite the fact that it’s nearly impossible to do a risk assessment that is objective and accurate. There are just too many hard-to-measure factors affecting the chance that any one chemical will harm us and if so, how and to what extent, and too many ways for personal bias to change the results. For example, there’s been a long argument about whether arsenic causes cancer. We do know that it’s poisonous. It probably does cause cancer, but many people seem to be immune. So we’re not sure how many cases might occur, and what amount of arsenic might cause cancer. Also, it doesn’t seem to cause cancer in animals, so there’s no way to put the information together. When there are information gaps, the only thing we can do is build-in an extra safely factor, by making the “allowable” level a certain amount less than what we think the “safe” level is. But is that really the answer?

The public wants greater protection from exposure to toxic chemicals than provided by the traditional quantitative risk assessment approach which has many limitations and uncertainties. Instead, support has grown for use of a precautionary approach that promotes (1) preventive action, (2) democratic and transparent decision-making with the broadest possible public participation, and (3) a shifting of the questions being asked (e.g., instead of asking what level of risk is acceptable, asking how much risk can be avoided; what is the need; why is it needed; who benefits and who is harmed; and what are the alternatives?) as well as the presumptions used in decision-making (e.g., shifting the burden of proof to the proponents of potentially harmful activities, and placing public health above other considerations).

In its 2009 report, Science and Decisions, the National Resource Council (NRC) of the National Academies acknowledged that risk assessment is “at a crossroads” facing “a number of substantial challenges”, that “its credibility is being challenged”, and that the “regulatory risk assessment process is bogged down”.  The report made a number of recommendations that focused on improving the methodology of risk assessments (e.g., thorough evaluation of uncertainties and variability, unified dose-response approach to cancer and non-cancer endpoints, broadening the assessment of cumulative and interacting health risks and stressors), and improving the relevance or utility of risk assessments for decision-making (e.g., involving all stakeholders at the earliest stage of the planning, design and scoping of the risk assessment, and increasing the transparency of the assessment methods and process).

The NRC recommended two major shifts: (1) “that risk assessment should be viewed as a method for evaluating the relative merits of various options for managing risk”, with the risk management questions being “clearly posed, through careful evaluation of the options available to manage environmental problems at hand,” casting light on “a wider range of decision options than has traditionally been the case”; and (2) aligning closely the technical analysis with the problem at hand so that the risk assessment will be relevant to the needs of the decision-makers and stakeholders who are addressing the problem (e.g., a “one size fits all” approach to risk assessment will not be appropriate for such very different problems as regulating a chemical and deciding on a site remediation approach).

These recommendations are now more than 5 years old, and there’s little evidence that government is adopting these recommendations. Doing so should improve the ability to interpret hazards, contamination levels and population exposures, dose-response relationships, and cumulative risks (exposures from multiple pathways, complex mixtures, multiple stressors, and factors affecting vulnerability), as well as the evaluation of a wide range of alternative options (e.g., inherently safer technologies, alternative ways to achieve the same goal, etc.). It could also provide a way to integrate the risk assessment tool within a broader precautionary approach that seeks to reduce or avoid exposures to toxic chemicals, which the public is actively calling for. It’s time to stop accepting risk assessment as the best we can do to evaluate risks and adopt more a holistic approach to protecting public health and the environment.


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Staying Safe (Probably): Risk, Hazard and Chemical Regulation

‘Risk’ and ‘hazard.’

These two words are often used interchangeably, but they have distinct meanings in the context of chemical safety assessment. When we say a particular chemical is ‘hazardous,’ we are noting its mere potential to cause negative health or environmental effects. On the other hand, ‘risk’ describes the probability that these negative effects will actually occur under specific circumstances. In order to generate a measurable risk, some exposure to the hazard in question must occur.


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Both a hazard and an exposure are necessary for a risk to exist.


If you have followed my last several posts, you’ve probably caught on to the idea that attempting to declare a chemical ‘safe’ or ‘unsafe’ is an exercise in futility. To comprehensively determine risk, we must know not only the detailed structure and function of a chemical, but also understand the intricacies of its interactions with the environment and the human body. Current chemical regulation in the United States operates within a risk-based framework. We establish standards and criteria for acceptable levels of hazardous compounds in products, in the environment and in our bodies; we enact bans and restrictions on chemicals in order to limit our exposures. These regulations are the product of risk assessments, which report not only the hazardous properties of chemicals but also the likelihood of human exposure.

My recent post on BPA illustrates the complexity of risk assessment. Though BPA has demonstrated hazardous potential, the levels to which humans are exposed to the compound, and therefore the actual risks of its use, are uncertain. Exposure may seem like a simple factor to evaluate, but our understanding of exposure is continually evolving, particularly with consideration for the special vulnerability of developing babies and children.  The ban on BPA in baby bottles reflects this emerging awareness of long-term effects of chemical exposures. However, the replacement of BPA with BPS illustrates the shortcomings of an approach that controls risk by limiting exposure to specific high-profile hazardous compounds.

The replacement of BPA, a known hazard, with BPS – an untested and unregulated compound with a nearly identical structure – may be considered an example of what scientists and regulators refer to as “regrettable substitution.” Regrettable substitution occurs when we eliminate one hazardous chemical from consumer products, only to replace it with a similar or even more hazardous alternative. Our risk-based chemical regulation enables us to remove demonstrably dangerous chemicals from consumer products, but also leaves profound loopholes for new chemicals, untested and unregulated, to enter the market in their stead, as long as risk assessments have not proven them dangerous. In a 2010 post on his Environmental Defense Fund blog, Dr. Richard Denison refers to this process as playing “whack-a-mole” with chemicals. No sooner have we knocked one hazardous chemical back into its hole, than a replacement rears its likely-hazardous head…until we generate evidence of its actual risk and seek to replace it with another unknown quantity.

Is this game of “whack-a-chemical” inevitable, or do more precautionary approaches exist? In Europe, regulators are striving for a balance between risk assessment and the more protective approach of hazard classification. While risk assessment relies on scientific studies to determine the risks of chemicals under different exposure scenarios, hazard classification groups chemicals based on their inherent hazard potential. It is this potential to cause harm that guides regulation, not demonstrated adverse effects.  A hazard classification regulatory scheme might have prevented BPS from entering the market, since its structural similarities to BPA make it a likely health hazard.

Hazard classification is essentially a more precautionary approach to chemical regulations. And when we operate in a framework of precaution rather than risk, the regulatory question itself changes. “A precautionary approach asks how much harm can be avoided rather than asking how much is acceptable,” write Dr. Ted Schettler and coauthors in a 2002 essay on the role of the Precautionary Principle in regulation and policymaking.

How can we better incorporate the Precautionary Principle into the chemical regulation process in the US? This question has been at the epicenter of the debate on reforming the Toxic Substances Control Act (TSCA), which I will cover next time on Backyard Talk.

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For BPA, Does the Dose Make the Poison?

For those who keep up with environmental health research and chemical regulations, it is no surprise to come across conflicting reports on the safety or risk of various compounds. This week, in the case of the compound bisphenol A (BPA), these conflicting reports happened to emerge almost simultaneously. On January 21st, the European Food Safety Authority declared that BPA “poses no health risk to consumers of any age group…at current exposure levels.” The next day, a study published in the journal PLoS Genetics showed that even low and short-term exposures to BPA and other hormone-mimicking compounds could alter stem cells and lead to lower sperm counts.

BPA is a common ingredient in plastics used for food and drink containers. Its hormone-like properties allow it to disrupt the endocrine system, with potential health effects ranging from reproductive issues to cancer. Though BPA has been banned in baby bottles in the U.S., and BPA-free products have become widely available since concerns about the compound were first raised in 2008, it remains in products from water bottles to the inside coatings of cans.

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David McNew via Getty Images

‘The dose makes the poison’ is a well-known adage in toxicology, implying that even hazardous chemicals can be harmless at low enough concentrations. However, decades of research have shown this to be an overly simplistic way of analyzing toxic exposures.  Dr. Theo Colborn, who passed away on December 14th, 2014, was a pioneering researcher in the field of endocrine disruption and a tireless advocate for precautionary chemical regulation. Her research on endocrine disruption demonstrated that even very low concentrations of harmful chemicals could result in changes to the reproductive system, particularly in developing babies and children who have less of a tolerance for exposure than adults. She also demonstrated that not all effects of toxic chemicals are immediately apparent, but can occur decades and even generations later.

The study published last week focused on both questions of concentration and timing. The researchers tested estrogenic compounds including BPA on mice, and found that they alter the stem cells, or undifferentiated cells, which are responsible for sperm production later in life. Patricia Hunt, the researcher who led the study, told Environmental Health News that exposure to even low doses of estrogens “is not simply affecting sperm being produced now, but impacting the stem cell population, and that will affect sperm produced throughout the lifetime.”

Uncertainties remain in the wake of this study. For instance, the researchers are still investigating whether the changes observed can cross generations, or whether the same changes can occur in human reproductive stem cells. The EFSA also recognized uncertainties in non-dietary sources of BPA, and they are still conducting long-term studies in rats. While scientists and regulators continue to chase answers, this past week shines a spotlight on the complicated realm of environmental health risk assessment, and shows the continued relevance of Dr. Theo Colborn’s work and legacy. Dose is indeed important in making a poison, but so is timing of exposure, and time itself in revealing the chronic and transgenerational effects of chemicals.

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