Cookies help us run our site more efficiently.

By clicking “Accept”, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. View our Privacy Policy for more information or to customize your cookie preferences.

Search results

GoGreenNation News: Op-ed: After decades of disinformation, the US finally begins regulating PFAS chemicals
GoGreenNation News: Op-ed: After decades of disinformation, the US finally begins regulating PFAS chemicals

Earlier this month, the Environmental Protection Agency announced it would regulate two forms of PFAS contamination under Superfund laws reserved for “the nation’s worst hazardous waste sites.”EPA Administrator Michael Regan said the action will ensure that “polluters pay for the costs to clean up pollution threatening the health of communities.”That was an encore to the Food and Drug Administration announcing in February that companies will phase out food packaging with PFAS wrappings and the mid-April announcement by Regan that the EPA was establishing the first-ever federal limits on PFAS in drinking water. At that time, he declared, “We are one huge step closer to finally shutting off the tap on forever chemicals once and for all.”One can forever hope the tap will be eventually shut, since it took seemingly forever for the nation to begin to crack down on this class of per-and polyfluoroalkyl synthetic chemicals. The chemical bonds of PFAS, among the strongest ever created, resulted in an incredible ability to resist heat, moisture, grease and stains. PFAS chemicals seemed like miracle substances in the 20th-century quest for convenience. They became ubiquitous in household furnishings, cookware, cosmetics, and fast-food packaging, and a key component of many firefighting foams. “We are one huge step closer to finally shutting off the tap on forever chemicals once and for all.” - EPA Administrator Michael Regan The bonds are so indestructible they would impress Superman. They don’t break down in the environment for thousands of years, hence the “forever” nickname. Unfortunately for humans, the same properties represent Kryptonite. Today, the group of chemicals known as PFAS is the source of one of the greatest contaminations of drinking water in the nation’s history. Flowing from industrial sites, landfills, military bases, airports, and wastewater treatment discharges, PFAS chemicals, according to the United States Geological Survey, are detectable in nearly half our tap water. Other studies suggest that a majority of the U.S. population drinks water containing PFAS chemicals—as many as 200 million people, according to a 2020 peer-reviewed study conducted by the Environmental Working Group. PFAS chemicals are everywhereNo one escapes PFAS chemicals. They make it into the kitchen or onto the dining room table in the form of non-stick cookware, microwave popcorn bags, fast-food burger wrappers, candy wrappers, beverage cups, take-out containers, pastry bags, French-fry and pizza boxes. They reside throughout homes in carpeting, upholstery, paints, and solvents.They are draped on our bodies in “moisture-wicking” gym tights, hiking gear, yoga pants, sports bras, and rain and winter jackets. They are on our feet in waterproof shoes and boots. Children have PFAS in baby bedding and school uniforms. Athletes of all ages play on PFAS on artificial turf. PFAS chemicals are on our skin and gums through eye, lip, face cosmetics, and dental floss. Firefighters have it in their protective clothing.As a result, nearly everyone in the United States has detectable levels of PFAS in their bodies. There is no known safe level of human exposure to these chemicals. They are linked to multiple cancers, decreased fertility in women, developmental delays in children, high cholesterol, and damage to the cardiovascular and immune systems. A 2022 study by researchers from Harvard Medical School and Sichuan University in China estimated that exposure to one form of PFAS (PFOS, for perfluorooctane sulfonic acid), may have played a role in the deaths of more than 6 million people in the United States between 1999 and 2018.As sweeping as PFAS contamination is, exposures in the United States are also marked by clear patterns of environmental injustice and a betrayal to military families. An analysis by the Union of Concerned Scientists found that people of color and low-income people were more likely to live near non-military sources of PFAS contamination than wealthier, white people.Another study by UCS found that 118 of 131 military bases had PFAS contamination concentrations at least 10 times higher than federal risk levels. A federal study last year found a higher risk of testicular cancer for Air Force servicemen engaged in firefighting with PFAS foams.Tobacco-like disinformationIn the end, the whole nation was betrayed, in a manner straight out of the tobacco disinformation playbook. Behind the image of convenience, manufacturers long knew that PFAS chemicals were toxic. Internal documents uncovered over the years show how DuPont and 3M, the two biggest legacy makers of PFAS, knew back in the 1960s that the compounds built up in blood and enlarged the livers of laboratory animals. By 1970, a DuPont document referring to a PFAS chemical under its famed “Teflon” trademark said that it “is highly toxic when inhaled and moderately toxic when injected.”By the late 1970s, DuPont was discovering that PFAS chemicals were affecting the liver of workers and that plant employees were having myocardial infarctions at levels “somewhat higher than expected.” But that did not stop the industry from downplaying the risk to workers.One internal 3M document in 1980 claimed that PFAS chemicals have “a lower toxicity like table salt.” Yet, a study last year of documents by researchers at the University of California San Francisco and the University of Colorado found that DuPont, internally tracking the outcome of worker pregnancies in 1980 and 1981, recorded two cases of birth defects in infants. Yet, in 1981, in what the researchers determined was a “joint” communication to employees of DuPont and 3M, the companies claimed: “We know of no evidence of birth defects” at DuPont and were “not knowledgeable about the pregnancy outcome” of employees at 3M who were exposed to PFAS. The same suppression and disinformation kept government regulators at bay for decades. The San Francisco and Colorado researchers found internal DuPont documents from 1961 to 1994 showing toxicity in animal and occupational studies that were never reported to the EPA under the Toxic Substances Control Act. As one example, DuPont, according to a 2022 feature by Politico’s Energy and Environment News, successfully negotiated in the 1960s with the Food and Drug Administration to keep lower levels of PFAS-laden food wrapping and containers on the market despite evidence of enlarged livers in laboratory rats.A patchwork responseEventually, the deception and lies exploded in the face of the companies, as independent scientists found more and more dire connections to PFAS in drinking water and human health and lawsuits piled up in the courts. Last year, 3M agreed to a settlement of between $10.5 billion and $12.5 billion for PFAS contamination in water systems around the nation. DuPont and other companies agreed to another $1.2 billion in settlements. That’s not nothing, but it is a relatively small price to pay for two industrial behemoths that have been among the Fortune 500 every year since 1955.In the last two decades, the continuing science on PFAS chemicals and growing public concern has led to a patchwork of individual apparel and food companies to say they will stop using PFAS in clothes and wrapping. Some states have enacted their own drinking water limits and are moving forward with legislation to restrict or ban products containing PFAS. In 2006, the EPA began a voluntary program in which the leading PFAS manufacturers in the United States agreed to stop manufacturing PFOA, one of the most concerning forms of PFAS.But companies had a leisurely decade to meet commitments. Even as companies negotiated, a DuPont document assumed coziness with the EPA. “We need the EPA to quickly (like first thing tomorrow) say the following: Consumer products sold under the Teflon brand are safe. . .there are no human health effects to be caused by PFOA [a chemical in the PFAS family].”Two years ago, 3M announced it will end the manufacture of PFAS chemicals and discontinue their application across its portfolio by the end of next year. But the company did so with an insulting straight face, saying on its products are “safe and effective for their intended uses in everyday life.”EPA action finally, but more is neededThe nation can no longer accept the overall patchwork or industry weaning itself off PFAS at its own pace. The EPA currently plans to issue drinking water limits for six forms of PFAS and place two forms under Superfund jurisdiction. The Superfund designation gives the government its strongest powers to enforce cleanups that would be paid for by polluters instead of taxpayers.”But there are 15,000 PFAS compounds, according to the National Institute of Environmental Health Sciences. There is nothing to stop companies from trying to play around with other compounds that could also prove harmful. Cleaning up the PFAS chemicals that have already been allowed will take billions of dollars and water utilities around the country are already screaming, with some justification, that the federal government needs to provide more money than it is offering. And even the Superfund designation does not actually ban their use.It would be better if the United States were to follow the lead of the European Union, which is now considering a ban or major restrictions on the whole class of chemicals, fearing that “without taking action, their concentrations will continue to increase, and their toxic and polluting effects will be difficult to reverse.”The effects are scary to quantify. Regan said in his drinking water announcement that the new rules would improve water quality for 100 million people and “prevent thousands of deaths and reduce tens of thousands of serious illnesses across the country.” A draft EPA economic analysis last year predicted that tight standards could save more than 7,300 lives alone from bladder cancer, kidney cancer and cardiovascular diseases, and avoid another 27,000 non-fatal cases of those diseases.That makes it high time that the federal government borrow from DuPont’s arrogant assumption that it could push around the EPA. We need the EPA to quickly (like first thing tomorrow) say the following: Consumer products with PFAS are not safe and are causing unacceptable environmental consequences. We are shutting off the tap on ALL of them.”

GoGreenNation News: Op-ed: An open letter to the Food and Drug Administration Commissioner
GoGreenNation News: Op-ed: An open letter to the Food and Drug Administration Commissioner

The U.S. Food and Drug Administration (FDA) is going through a major reorganization to improve efficiency and protect public health. A recent hearing in front of the House Committee on Oversight and Accountability concluded that the agency stumbles from crisis to crisis, including drug shortages, tainted food and illicit tobacco scandals in recent years.Although crises such as the contamination of baby food with heavy metals like lead and mercury gain public attention, the scientific approach used by FDA to regulate chemical additives in food is much more opaque. While it largely flies under the public radar, the agency’s neglect to update its testing to reflect modern science and modern food chemical hazards is a decades-long crisis that impacts all of our health. The agency has fallen behind other nations’ testing and regulations and is not even following laws put in place nearly 70 years ago to keep us safe. We are calling on FDA Commissioner, Dr. Robert M Califf, to use the agency reorganization as an opportunity to overhaul its approach to chemicals in our food and put public health at the center of its work. How does the FDA evaluate the safety of food additives and contaminants?Recently, the FDA published a consumer update entitled, “Is food safe if it has chemicals?” In it, the agency says that it’s the amount of a chemical in food that determines its risk to our health. They use sodium as an example. While it largely flies under the public radar, the agency’s neglect to update its testing to reflect modern science and modern food chemical hazards is a decades-long crisis that impacts all of our health.We need sodium to live, but too much sodium can be bad, so they publish guidance on the safe level of sodium to be consumed each day. But many of the chemicals that wind up in our food are not required for us to live, such as bisphenols like BPA, phthalates or the group of chemicals known as PFAS or “forever chemicals”. In fact, many of these are not required for food production, but leach into food from packaging and equipment. FDA noncompliance The FDA discusses how they intentionally determine an “acceptable daily intake” for a chemical that includes a safety margin. The idea is that this safety margin is so conservative that it will always protect public health.However, we know chemicals in the diet can come from a variety of food sources and that different chemicals can have the same adverse effect. This is so well-known that the 1958 amendment to the Food, Drugs and Cosmetic Act of 1938 required that FDA evaluate the “cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet.”Sixty-six years later and the FDA has never complied with this part of the law. A good example: its guidance for lead in baby food, in which they set the suggested (not required) limit to be 20 parts per billion. However, there is no safe blood level of lead, which hurts children’s brains, resulting in lower IQ and behavioral problems among other harmful effects.It’s not just lead: recently, the Dutch risk assessment agency reported that the combined exposure to lead, methyl-mercury, arsenic, polychlorinated biphenyls or PCBs, polybrominated diphenyl ethers or PBDEs and fluoride were much more potent at reducing children’s IQ than any one of these chemicals alone.Similarly, the FDA continues to defend its ruling that current levels of BPA in food are safe despite the decision by the European Food Safety Authority, the EFSA, to reduce the “safe level” of BPA by 20,000 fold. The FDA defends its position by focusing on BPA as if it is the only chemical in foods that act like the female hormone estrogen. In contrast, it is well known that plastic food packaging contains a number of estrogen-like chemicals, like other bisphenols and phthalates, that can leach into foods.The failure of the FDA to comply with the 1958 amendment to food safety law is not just a violation of the law but presents a significant risk to American consumers. A citizen’s petition was filed with the agency in 2020 to attempt to cajole it into compliance. The FDA has never responded.Considering this, we wrote to Commissioner Califf to address this serious shortcoming of FDA’s Human Food Program. The Commissioner has not responded. The letter is re-printed below.March 11, 2024Robert M Califf, M.D., CommissionerUnited States Food and Drug AdministrationCc: James Jones, Ph.D., Deputy CommissionerFDA Human Foods Program Dear Commissioner Califf, We read with great interest your OpEd with Dr. Warraigh entitled, “Four steps toward meeting the challenge of chronic disease” (The Hill, 02/15/24). This is a particularly important issue considering that the United States is below average compared to peer economies in 9 health domains, including adverse birth outcomes, obesity and diabetes, heart disease and chronic lung disease. And this, as you point out, is despite US taxpayers spending nearly 18% of our GDP on healthcare.However, we are concerned that there was no mention of food-borne chemicals that are either added to food intentionally or that migrate into food from packaging or processing. The recent analysis by the New York Times of the failure of the food safety system that resulted in hundreds of children being poisoned by lead in applesauce illustrates in part how our system of food safety needs to be improved.More important to the issue of chronic disease is that of chemicals in the food supply that are being evaluated for safety in a one-by-one approach, rather than considering the “cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet” as required by the 1958 amendment to the Food, Drugs, and Cosmetic Act of 1938. Recent studies demonstrate that the cumulative effect of Americans’ exposure to endocrine-disrupting chemicals in the food supply contributes to harmful health impacts including chronic disease, increasing healthcare costs in the hundreds of billions of dollars annually, as well as affecting quality of life. Importantly, the scientific evidence is sufficient to conclude that the cumulative effects of biologically related substances in the food supply contributes to chronic diseases such as obesity or diabetes. We urge you to consider it as a critical “fifth step” in meeting the challenge of chronic disease in the United States, one that the agency is already mandated to conduct.For example, a recent study contributed by the Dutch risk assessment agency (RIVM) in collaboration with Professor Andreas Kortenkamp, a world-leader in the analysis of cumulative risk, demonstrated that in 9 countries in the EU, their populations exceeded combined tolerable levels of exposure to a mixture of chemicals at median exposure levels. Thus, the traditional way of identifying a “Tolerable Daily Intake” using a chemical-by-chemical basis is clearly underestimating the cumulative risk of chemicals with similar structure or observable effects.Despite the 1958 amendment requiring the FDA to evaluate cumulative effects of chemically related and biologically related substances in the diet, the agency has never performed this analysis for any chemical additives. Moreover, the FDA has not responded to citizen petitions or Congressional queries asking for the FDA to comply with the spirit and letter of this law. It simply is past time that the Agency stop ignoring the law and incorporate cumulative risk assessments in their regulatory approaches.We ask that FDA form a committee of its Science Board including external experts to guide the agency as it addresses this shortcoming in its current safety assessment methods. When it passed the 1958 law, Congress recognized that chemicals, even ones that are not chemically related, may impact organs such as the thyroid and systems such as the cardiovascular with different mechanisms of action but cumulatively have a greater negative effect on the health of the American people.Finally, we are happy to meet with you to provide further information and insight or to contribute to the changes that need to be made in any way that we can.Sincerely,Linda S. Birnbaum, Ph.D., D.A.B.T., A.T.S.Scientist Emeritus and Former DirectorNational Institute of Environmental Health Sciences and National Toxicology ProgramScholar in Residence, Nicholas School of Environment, Duke UniversityR. Thomas Zoeller, Ph.D.Professor EmeritusUniversity of Massachusetts Amherst

GoGreenNation News: EPA lists 2 common "forever chemicals" as Superfund hazardous substances
GoGreenNation News: EPA lists 2 common "forever chemicals" as Superfund hazardous substances

Two toxic, widely used "forever chemicals" are now classified as hazardous substances under a new rule that the Biden administration finalized on Friday. Why it matters: The rule, under the federal Superfund law, will require companies to report any leaks of the two chemicals and will allow the Environmental Protection Agency (EPA) to hold polluters accountable by forcing them to clean up their contamination.The rule builds on other recent actions that the Biden administration has taken to curb per- and polyfluoroalkyl substances (PFAS) pollution.The EPA recently announced the first-ever drinking water standards targeting some of the synthetic compounds.What they're saying: "Designating these chemicals under our Superfund authority will allow EPA to address more contaminated sites, take earlier action, and expedite cleanups, all while ensuring polluters pay for the costs to clean up pollution threatening the health of communities," EPA Administrator Michael Regan said in a statement on Friday.The other side: The American Chemical Council, which represents major PFAS producers, in a statement on Friday said it "strongly" opposes the EPA's action.It claimed the federal action was based on "severely flawed" science and was an "unworkable means to achieve remediation for these chemicals."Threat level: PFAS are dubbed "forever chemicals" because they resist degradation by repelling oil and water and withstanding high temperatures.Used extensively in nonstick, water- and oil-repellent and fire-resistant industrial and consumer products, PFAS can bioaccumulate in people, livestock, wildlife and fish if they enter the environment and water sources.The health effects of the chemicals are still being studied, but exposure to certain levels of PFAS has been linked to adverse health effects in humans and animals, including increased risk of kidney or testicular cancer.Driving the news: The EPA's new rule only applies to two specific types of PFAS — PFOA and PFOS — but there are over 12,000 different types of PFAS. While PFOA and PFOS have been the most widely used PFAS throughout history, they are no longer produced in the U.S., as chemical manufacturers and other companies have turned to other PFAS in recent years.However, PFOA and PFOS are still produced internationally and can be imported into the U.S. in consumer goods.Because there are so many PFAS, multiple Environmental groups have called on the EPA to regulate the substances as a class instead of taking action against individual chemicals.Zoom out: PFAS contamination is extensive throughout the U.S., with federal studies suggesting that the chemicals can be detected in almost half of the nation's tap water.Private studies have also shown widespread PFAS contamination in water systems, while other research has indicated that people living in Hispanic and Black communities are disproportionately exposed to PFAS. Since 1999, Centers for Disease Control and Prevention scientists have consistently detected multiple PFAS in blood serum samples from nearly all people who take part in its annual National Health and Nutrition Examination Survey.The big picture: In recent years, major chemical producers have agreed to pay billions to settle claims from U.S. water providers over their production and handling of PFAS.Other companies, like fast food corporations, have begun making promises to phase out the use of PFAS in their products.Several research teams in the U.S. and around the world are searching for new ways to destroy forever chemicals and filter them from water systems.Go deeper: EPA unveils new rules to curb toxic emissions at U.S. chemical plantsEditor's note: This story was updated with comment from The American Chemical Council.

GoGreenNation News: Q&A: Award-winning scientist Anne Starling on the latest PFAS research— and where she finds hope
GoGreenNation News: Q&A: Award-winning scientist Anne Starling on the latest PFAS research— and where she finds hope

EHN senior news editor Brian Bienkowski saw down with Dr. Anne Starling, winner of the 2023 Lou Guillette Jr Outstanding Young Investigator Award, to discuss her work on PFAS and other toxics, how this has shaped her consumer habits, and where she finds hope. The Lou Guillette Jr. Outstanding Young Investigator Award is an annual award given to an early career scientist who studies endocrine-disrupting chemicals — compounds like BPA and phthalates that alter the proper functioning of our hormones. Starling, an Assistant Professor in the Department of Epidemiology at the Gillings School of Global Public Health at the University of North Carolina, Chapel Hill and an adjunct Assistant Professor in the Department of Epidemiology at the Colorado School of Public Health, studies how chemical exposures, such as PFAS in drinking water, may increase the risk of chronic disease. The award is conducted by HEEDS — a program within Environmental Health Sciences, which publishes EHN.org. We talked to Starling about the award and her work. The interview has been lightly edited for brevity and clarity. First off, congrats on the 2023 Lou Guillette Jr. Outstanding Young Investigator Award. Where in your academic and research journey did you start investigating endocrine-disrupting chemicals?Thank you. I’m very honored by this award because I admire the work of HEEDS and also what I know of Dr. Guillette’s legacy as a scientist and a mentor. I’ve always been interested in environmental health, in how humans are influencing the natural environment, and how our own health may be affected by the way we construct and modify our environment. I began studying exposure to endocrine-disrupting chemicals when I was a graduate student in epidemiology at UNC Chapel Hill. I was fortunate to work with mentors both at UNC and at the National Institute of Environmental Health Sciences (NIEHS). At NIEHS, I worked with Dr. Jane Hoppin on the question of how exposure to agricultural pesticides may increase diabetes risk. Later, for my dissertation project, I worked with Dr. Stephanie Engel at UNC and Dr. Matthew Longnecker at NIEHS to investigate how exposure to certain persistent chemicals (per- and polyfluoroalkyl substances, or PFAS) during pregnancy can affect the health of the pregnant person and the outcome of the pregnancy.What is something you’ve uncovered in your time investigating these harmful chemicals that most people would find surprising?Many people that I talk to assume that chemical products that are widely used in the U.S. have gone through comprehensive safety testing, similar to what is required for prescription drugs and other medical treatments. But this is simply not the case. In our regulatory environment, the burden is on the regulators to demonstrate harm from exposure to chemicals, rather than a more precautionary approach. And it may surprise many people to know just how long it takes to accumulate enough scientific evidence to change policy. This is not necessarily due to any kind of conspiracy or political influence, but simply because science is slow, meticulous, and deliberate. It takes years to be confident that we have the right answers.Some of your research has focused on PFAS in drinking water and its impact on developing fetuses. What have you found?Yes, I’ve studied the effects of prenatal exposure to PFAS for several years now.There are now many studies that have reported that pregnant people with higher PFAS in their blood have babies that have, on average, somewhat lower weight at birth. This is concerning because we know that babies with low birth weight have a number of health challenges that may last throughout their lives. And even though the effects of PFAS exposure on birth weight may be small at the individual level, the impact could be large from a public health perspective because nearly everyone in the U.S. is exposed to these chemicals. My work has examined whether PFAS exposures at critical periods of development are linked with different patterns of child growth, that could potentially put them at greater risk of obesity, diabetes, and other chronic diseases. We’ve seen some evidence that exposures before birth may influence child growth, body weight and body composition (the amount of fat mass compared to lean body mass) through at least the age of school entry, and maybe longer.When we think of pollution exposure, we often think of acute impacts, but that’s not always the case. What have you found when it comes to endocrine-disrupting chemicals’ ability to create long-lasting impacts to our health?In general, we know a lot more about the acute effects of high doses of toxic chemicals than we know about the chronic or long-term effects of the low doses received daily by the general population. It’s challenging to study changes in people’s health related to exposures over many years, and that’s why epidemiology as a field is so interesting to me – we spend a lot of time thinking a bout how to overcome the challenges of observational research to draw valid and useful conclusions. When you don’t have a randomized controlled trial -which we almost never do in environmental health, for obvious ethical reasons –you have to be very strategic and rigorous in your study design to learn whether a certain exposure is actually causing harm.Has doing this research changed how you act as a consumer? If it has, how so?I think so. I am more wary of the chemical products that I bring into my home. I’m definitely a label-reader! But a major lesson that I have learned through this work is that we are not empowered as consumers to be able to avoid harmful chemicals in our daily lives. There are no ingredient labels on most of the products that we encounter every day, such as food packaging, clothing, furniture, and even the building materials and paint in our homes. It’s impossible for an individual to make well-informed decisions about all of these products. So rather than making recommendations about consumer choices, I advocate for policy changes to make sure that products that are known to be unsafe are not sold to consumers.What research are you working on now that excites you?In terms of impact, I’m excited to be contributing to a large, multi-site study of the health effects of PFAS exposure through drinking water, led by the Agency for Toxic Substances and Disease Registry. The study enrolled people from seven communities around the country, who all experienced high levels of PFAS in their drinking water at some point. I worked in one of these communities in Colorado for several years, and I have seen the level of worry and frustration that these contamination events can cause. It’s gratifying to be able to tell people who participated in these studies that we are now on the verge of having enforceable, national regulations on the maximum allowable amount of specific PFAS in drinking water. Scientifically, I’m also excited to be investigating other sensitive periods of exposure during the life course, beyond prenatal development. For example, puberty, pregnancy and menopause are dramatic periods of hormonal and physiological change, and they may also be critical windows during which exposure to endocrine-disrupting chemicals can cause lasting harm.We are consistently hearing about the chemical exposures in our lives and it can be daunting. What gives you hope when it comes to these exposures and our health?We are more educated than ever before about the trade-offs that we face in our industrial society. And we do make progress. Just think about how much healthier our children’s lives may be because they aren’t exposed to as much tobacco smoke or lead compared to previous generations. The science is moving at a remarkable pace, and we have to commit to adapting and changing as we learn more.

GoGreenNation News: What will the EPA’s new regulations for “forever chemicals” in drinking water mean for Pennsylvania?
GoGreenNation News: What will the EPA’s new regulations for “forever chemicals” in drinking water mean for Pennsylvania?

PITTSBURGH — Last month the U.S. Environmental Protection Agency (EPA) announced the first federal regulations for “forever chemicals” in drinking water. The chemicals, known as per- and polyfluoroalkyl substances or PFAS, are linked to kidney and testicular cancer, liver and thyroid problems, reproductive problems, pregnancy-induced high blood pressure, low birthweight and increased risk of birth defects, among other health effects. There are nearly 15,000 different PFAS and evidence of the chemicals has been found in everything from carpets and cookware to food wrappers, makeup and bandaids. PFAS don’t break down naturally and have been detected in drinking water at more than 5,000 sites in all 50 states. The new regulations, among the most protective health limits on PFAS in drinking water in the world, will go into effect on June 25 and set limits for six common PFAS — PFOA, PFOS, PFHxS, PFNA, PFBS and GenX. Many researchers who study these chemicals have called on regulators to restrict these chemicals as a class rather than individually. But because the chemicals build up in our bodies over time, any reduction in exposure is likely to be beneficial for health. “This is the first time the EPA has issued a rule on water contaminants in 28 years. So this is significant,” Michelle Naccarati-Chapkis, executive director of Women for a Healthy Environment, a nonprofit environmental health advocacy group based in western Pennsylvania, told EHN. Eleven states, including Pennsylvania, Maine, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Rhode Island, Vermont, Washington and Wisconsin have already adopted their own limits on PFAS in drinking water. The EPA’s new limits are stricter than any existing limits, so states are preparing to meet the new EPA standards. “PFAS exposures are toxic even at low concentrations,” Naccarati-Chapkis said. “We didn’t think Pennsylvania’s state regulations went far enough, so we’re glad these new federal rules will better protect residents across the Commonwealth.” What are the new limits and how will they protect our health?The EPA’s new PFAS limits are 4 parts per trillion (ppt) for PFOA and PFOS and 10 ppt for GenX, PFNA and PFHxS, all of which are newer PFAS that have been less extensively studied than PFOA and PFOS. The regulations also create a “hazard index” to address combined risks from mixtures of chemicals. For PFNA, GenX, PFHxS and PFBS, water system operators will determine if the combined levels of two or more in drinking water pose a potential risk and require action. The regulations also consider the levels of PFAS that can be detected by laboratories and the cost and feasibility of removing them. The EPA set “Maximum Contaminant Level Goals” for some PFAS, which represent the limit at which the agency has determined that no adverse health effects would occur. Whenever the EPA has identified a cancer risk associated with a pollutant, the Maximum Contaminant Level Goal is set to zero, which the agency has applied to PFOA and PFOS. While the Maximum Contaminant Levels of 4 ppt for PFOA and PFOS and 10 ppt for PFHxS, PFNA, and GenX are enforceable, the Maximum Contaminant Level Goals are aspirational. “Setting those goals to zero is an acknowledgement that there’s basically no safe level of exposure to these chemicals,” Carla Ng, an associate professor and PFAS researcher at the University of Pittsburgh, told EHN. The Biden administration expects the new regulations to “protect 100 million people from PFAS exposure, prevent tens of thousands of serious illnesses and save lives.” Additionally, the EPA recently classified PFOA and PFOS, two of the most common PFAS, as “hazardous substances” under the federal Superfund act, which gives the EPA the authority to clean up PFAS contamination and to recover the cost of these cleanups from polluters. “I think these two pieces are one two-punch,” Ng said. “With both, now we’ll have a way to clean up not only water, but also other mediums like soil. That’s important because PFAS exposure also happens through things like indoor air and contaminated food, and this will allow us to start addressing those exposures too.”What will this mean for Pennsylvania?One in three Pennsylvania drinking water systems had detectable levels of PFAS as of 2021. Additionally, PFAS have been detected in 76% of sampled rivers and streams throughout the state, many of which are used for drinking water.In January 2023, six years after initially pledging to regulate the chemicals, the Pennsylvania Department of Environmental Protection passed limits of 14 ppt for PFOA and 18 ppt PFOS in drinking water. Now, those limits must be tightened. “Pennsylvania is already working to revise its regulations to align with the federal rulemaking in places where the state rule is less stringent,” PA DEP spokesperson Neil Shader told EHN. Pennsylvania’s regulations need to be updated within two years of the start date for the new federal rules. The agency plans to help water authorities address any challenges and secure funding.“DEP will take every step to ensure water authorities in the Commonwealth can meet state and federal limits for PFAS – including increased training and to help local operators understand the new federal rule,” Shader said. “Additionally, [the Pennsylvania Infrastructure Investment Authority] has been able to fund 100% of all requests for the construction and installation of treatment facilities to date and has the financial capacity to address any additional requests for the foreseeable future.”The EPA also offers assistance programs for water authorities that need help implementing monitoring and treatment of contaminants like PFAS. The Biden’s administration dedicated $9 billion in funding to address PFAS and other emerging contaminants in drinking water through the $1 trillion infrastructure legislation that passed IN 2021, commonly known as theBipartisan Infrastructure Law. “Pennsylvania is already working to revise its regulations to align with the federal rulemaking in places where the state rule is less stringent." - Neil Shader, PA DEP spokesperson The new regulations do not apply to the approximately 2.5 million Pennsylvania residents whose water comes from private wells.“DEP recommends private residents who choose to test their water use a state-certified laboratory using EPA-approved testing methods,” Shader said, noting that the agency offers a list of accredited laboratories online.Ng said more resources are needed to help private well owners. “That has always been a big blind spot in Pennsylvania,” she said. “There’s very little protection for people with private wells, and we really need funds to help them do testing and treatment for PFAS and other contaminants as well.”For some water authorities, including the Pittsburgh Water and Sewer Authority, which provides drinking water to more than 500,000 people, the new rules won’t require many changes.“We always try to be proactive about looking at emerging contaminants,” Frank Sidari, chief environmental compliance and ethics officer at the Pittsburgh Sewer and Water Authority (PWSA), told EHN. “We’ve been monitoring for PFAS since 2014, so it won’t be too difficult for us to prepare for the new federal regulations.”So far, Sidari said, the municipal authority’s monitoring hasn’t detected levels of PFAS high enough to prompt removal of the contaminants. “We always try to be proactive about looking at emerging contaminants. We’ve been monitoring for PFAS since 2014, so it won’t be too difficult for us to prepare for the new federal regulations.” - Frank Sidari, Pittsburgh Sewer and Water AuthorityAt some smaller water authorities, the new regulations will require a bigger lift. The Wilkinsburg-Penn Joint Water Authority, which serves around 40,000 people in western Pennsylvania, began some voluntary monitoring for a list of 29 PFAS in both drinking water and source water in 2023 in anticipation of new EPA monitoring requirements, but the process is still new.“This is an extremely complex group of contaminants,” Lou Ammon, manager of purification at the Wilkinsburg-Penn Joint Water Authority, told EHN. “We have not received any resources to date and do not expect to receive any resources for our continued enhanced monitoring.”While the state’s environmental agency said resources are available for water authorities that reach out to and request help removing PFAS, both Ammon and Sidari said they hadn’t received any outreach from state regulators advertising or offering resources to help with PFAS monitoring or removal.To date, Ammon said, the Wilkinsburg-Penn Joint Water Authority hasn’t detected PFAS high enough to prompt new treatments, but “if we ever have to treat/remove PFAS from our water during treatment, I have not been informed of what resources we should expect to receive at that time.”“What I really think we need are regulations and remediation funding sources from businesses and corporations that have profited directly from the manufacture and use of these compounds,” Ammon said.As of April 2024, attorney generals in 30 states, including Pennsylvania, have initiated lawsuits against manufacturers of PFAS for contaminating water supplies, according to Safer States, a national coalition of environmental health organizations. “What I really think we need are regulations and remediation funding sources from businesses and corporations that have profited directly from the manufacture and use of these compounds.” - Lou Ammon, Wilkinsburg-Penn Joint Water AuthorityAmmon also called for regulation of PFAS in consumer products. Some states have begun banning PFAS in consumer products, but Pennsylvania has not.“Every day that these direct consumer contamination sources are unregulated is a day that these compounds can be affecting the public’s health or contaminating source water,” Ammon said, “[and] that will ultimately need to be treated and paid for by water treatment plant rate-payers and in federal/state tax dollars, paid by the public.”

GoGreenNation News: Everything you need to know for the fourth round of global plastic pollution treaty talks
GoGreenNation News: Everything you need to know for the fourth round of global plastic pollution treaty talks

The fourth session of the Intergovernmental Negotiating Committee to develop an international, legally binding plastic pollution treaty will take place from April 23 to April 29 in Ottawa, Canada.In the first three sessions of treaty talks, negotiators from about 175 countries — along with industry representatives, environmentalists and others — met to advance a treaty to address global plastic pollution. What’s at stake in the plastic treaty talks? The plastic crisis is threatening both the planet and human and wildlife health. Global plastic waste is set to almost triple by 2060.The world generates roughly 400 million tons of plastic waste each year.Less than 10% of plastic ever made has been recycled. The treaty is the first international attempt to address this. What’s the state of the plastic treaty? Consensus was elusive at the last round of talks in Kenya. There is a High Ambition Coalition of countries that wants an end to plastic pollution by 2040. There is also a Global Coalition for Plastics Sustainability — largely nations economically reliant on fossil fuels such as Saudi Arabia, Russia, Iran, Cuba, China and Bahrain — that has positioned itself as the counterbalance to the High Ambition Coalition and is pushing for a larger focus on addressing plastic waste (via chemical and mechanical recycling and other means) rather than plastic bans or production limits. The U.S. is not part of either. Some sticking points include: Regulating the chemicals in plastic productionPlastic production capsThe role of chemical recycling and bioplastics Where can I learn more about the plastic treaty?You can see all of the details of the upcoming treaty meeting at the UN Environment Programme website. Want to learn more broadly about the treaty and how plastic pollution impacts our health? Our newsroom has been hard at work on exploring these issues. Below we have articles to help you understand the treaty process and progress, plastic impacts to our health and chemical recycling and bioplastics.And follow our newsroom on X, Instagram or Facebook to stay up-to-date on this historic treaty.Plastic treaty coverage “Plastic will overwhelm us:” Scientists say health should be the core of global plastic treaty Opinion: Pete Myers discusses the "Health Scientists' Global Plastic Treaty" Plastics treaty draft underway, but will the most impacted countries be included? Opinion: UN plastics treaty should prioritize health and climate change Op-Ed: How the United Nations could avoid silencing voices during Plastic Treaty negotiations Scientists: US needs to support a strong global agreement to curb plastic pollutionPlastic and our healthWhat is plastic pollution? Plastic chemicals are more numerable and less regulated than previously thought Recycling plastics “extremely problematic” due to toxic chemical additives Every stage of plastic production and use is harming human health Massive new database on how plastic chemicals harm our healthChemical recycling and bioplasticsWhat is chemical recycling? Bioplastics: sustainable solution or distraction from the plastic waste crisis? Chemical recycling grows — along with concerns about its environmental impacts This will be a big year in shaping the future of chemical recycling Chemical recycling “a dangerous deception” for solving plastic pollution: Report Paused Ohio chemical recycling plant puts spotlight on Appalachia as “prime target” for the controversial practice Residents fear Pennsylvania, West Virginia chemical recycling proposals will deepen fossil fuel ties and pollution problems Q&A: Director of sustainability at Eastman Chemical Company talks chemical recyclingLatest chemical recycling plant closing spurs concern over the industry’s viability

GoGreenNation News: Companies Legally Use Poison to Make Your Decaf Coffee
GoGreenNation News: Companies Legally Use Poison to Make Your Decaf Coffee

Do you drink decaffeinated coffee? Are you aware that it’s often made by applying a chemical so dangerous it was banned for use in paint stripper five years ago? And are you aware that companies think banning this chemical is really, really unfair?This week the Environmental Protection Agency finalized a rule prohibiting all but “critical” uses of methylene chloride, a highly toxic liquid that is believed to have killed at least 88 people since 1980—mostly workers refinishing bathtubs or doing other home renovations. Methylene chloride can cause liver damage and is linked to multiple cancers, among other health effects. Amazingly, while the EPA banned its sale for paint stripping in 2019 for this reason, it continues to be used for a lot of other purposes. And one of those is decaffeinating coffee, because the Food and Drug Administration decided in the 1980s that the risk to coffee drinkers was low given how the coffee was processed.The EPA’s ban on noncritical use of methylene chloride is one of many rules the Biden administration has announced or finalized ahead of the Congressional Review Act deadline. (The CRA, essentially, makes it easier for an unfriendly Congress to nix any administrative regulations finalized in the last 60 days of a legislative session.) A lot of the recently announced rules ban or curtail toxic substances that have made their way into everyday life and are poisoning people. The EPA has limited long-lasting chemicals called PFAS in drinking water, requiring water utilities within five years to build treatment systems that remove it. The agency has categorized two types of PFAS as hazardous substances under the Superfund law, requiring manufacturers to monitor whether they’ve been released into the environment and, if so, clean them up. It has also—finally—fully banned asbestos. It’s finalized a rule to further restrict fine particulate pollution in the air, which has been linked to heart disease, heart attacks, asthma, low birth weight, Alzheimer’s, and other forms of dementia. It’s in the process of finalizing a rule reducing lead in drinking water, which would require the replacement of lead pipes throughout the nation.Banning poison is good politics. As mentioned in last week’s newsletter, while only 47 percent of respondents in a recent CBS News poll supported reentering the Paris climate agreement, 70 percent said they supported reducing toxic chemicals in drinking water. That’s consistent with other polls showing that a majority of people think the federal government is doing too little to protect “lakes, rivers and streams,” and that an overwhelming majority of people—even 68 percent of Republicans—believe the federal government should play some role in “addressing differences across communities in their health risks from pollution and other environmental problems.”But every single time one of these rules is announced, companies and industry groups respond with the most ridiculous statements. Let’s look at just a few recent examples.“A group of coffee makers against banning methylene chloride,” Boston radio station WBUR reported in early April, “recently wrote the FDA saying, ‘True coffee aficionados in blind tastings’ prefer coffee decaffeinated with the chemical.” Who knows how this study was done—“True coffee aficionados” are not known for preferring decaf, period, hence a recent P.R. push to improve decaf’s image. Nick Florko, a reporter for health news website Stat, told WBUR that the coffee makers’ letter to the FDA was a “pretty funny claim if you consider the fact that we’re talking about coffee here that’s essentially rinsed in paint thinner.” And this says nothing at all about what happens to workers involved in the decaffeination process. (Methylene chloride has previously been shown to poison even trained workers wearing protective gear.)National Coffee Association president William Murray said something even weirder, telling CNN via email that banning methylene chloride “would defy science and harm American[s’] health.” His logic appeared to be that since all coffee consumption, including decaf, shows signs of reducing cancer risk overall, it’s not really a problem to decaffeinate coffee using a known carcinogen. That’s loopy even for industry pushback. For one thing, it’s easy to imagine that coffee could be good in general, and less good if you add poison to it. For another, coffee can also be decaffeinated without methylene chloride, using only water. Now let’s look at PFAS pushback. Knowing the EPA rules were in progress, the U.S. Chamber of Commerce in March launched the “Essential Chemistry for America” initiative, with the goal of “protecting ‘forever chemicals’ it deems ‘critical,’” according to E&E News. “We’re increasingly concerned that overly broad regulatory approaches threaten access to modern fluorochemistries, so we’re taking action to ensure their availability,” chamber vice president Marty Durbin said. Given that “access” language is typically used in a social and environmental justice context, restyling the regulation of poisons as threatening “access to modern fluorochemistries” is gutsy, to say the least. The private water industry is meanwhile throwing a fit about being asked to filter out PFAS. The rule will “throw public confidence in drinking water into chaos,” Mike McGill, president of water industry communications firm WaterPIO, told the AP. (You’d think the existence of PFAS in the water is what would tank public confidence, not the requirement that it be removed.) Then there’s the common threat from private water utilities—which, remember, turn a profit off providing a substance people can’t live without—that removing PFAS will increase people’s water bills. Robert Powelson, the head of the National Association of Water Companies, said that the costs of the federal regulation “will disproportionately fall on water and wastewater customers,” according to The Washington Post. “Water utilities do not create or produce PFAS chemicals,” Powelson added. “Yet water systems and their customers are on the front lines of paying for the cleanup of this contamination.”It’s true enough that water utilities are not the ones creating PFAS chemicals. On the other hand, there are lots of water contaminants that water utilities are responsible for filtering out if they want to keep making money from providing people with drinking water. Is there really any reason PFAS shouldn’t be among them? Saying that the cost of this regulation “will disproportionately fall on water and wastewater customers” shouldn’t be read as an expression of sympathy for disadvantaged households. The burden will fall on customers because the utilities will make sure of it. It’s a threat, and one that doesn’t mention the federal money from the Inflation Reduction Act that is being made available to help shoulder that burden. Those funds may well fall short, but that doesn’t change the fact that they’re paying for-profit entities to transition to removing something they ought to have been filtering out long ago. And even if this federal rule hadn’t been made, companies would probably have to start removing PFAS anyway, because they are facing increasingly expensive lawsuits over not doing so. (The water utilities, in turn, are suing polluters to cover remediation costs—another source of funding.)It’s worth emphasizing what PFAS chemicals actually do to people, particularly in light of the American Water Works Association’s assertion to the AP that the cost of removing the chemicals “can’t be justified for communities with low levels of PFAS.” Researchers are now pretty sure that PFAS exposure increases the risk of dying from cardiovascular disease. Studying people in northern Italy who drank PFAS-contaminated water, researchers also saw increased rates of kidney and testicular cancer. The Guardian report on this contained this disturbing finding too: Women with multiple children had lower levels of PFAS only because pregnancy transferred PFAS into their children’s bodies instead.Don’t let that get in the way of a good comms statement from industry groups, though. Remember: Forcing companies even to report their PFAS pollution, or remove PFAS from the water, is unfair.Good News/Bad NewsTwenty-nine-year-old Andrea Vidaurre has won the Goldman Environmental Prize for her work in environmental justice, pushing California to adopt new standards for truck and rail emissions that will curtail the air pollution harming working-class Latino communities in California’s Inland Empire. The United States has sided with petrostates in opposing production controls on plastic at the negotiations in Ottawa for a U.N. treaty to reduce plastic pollution. (Two weeks ago, I wrote about these negotiations, noting that the number of plastics industry lobbyists attending this session was not yet known. Now it is: 196 lobbyists from the fossil fuel and chemical industries registered for this round, according to the Center for International Environmental Law—a 37 percent increase from the number at the last session.)Stat of the Week9.6%That’s the percentage of the 250 most popular fictional films released between 2013 and 2022 in which climate change exists and a character depicted on screen knows it, according to a new “Climate Reality Check” analysis from Colby University and Good Energy. Read Sammy Roth’s newsletter about why climate change in movies is so important here.What I’m ReadingBig Oil privately acknowledged efforts to downplay climate crisis, joint committee investigation findsCongressional Democrats this week released a report confirming what news outlets have previously reported: Companies like Exxon knew about climate change very early on and covered it up. They also found in subpoenaed emails that Exxon tried to discredit reporting of its duplicity, while privately acknowledging that it was true:The new revelations build on 2015 reporting from Inside Climate News and the Los Angeles Times, which found that Exxon was for decades aware of the dangers of the climate crisis, yet hid that from the public.At the time, Exxon publicly rejected the journalists’ findings outright, calling them “inaccurate and deliberately misleading.” … But in internal communications, Exxon confirmed the validity of the reporting. In a December 2015 email about a potential public response to the investigative reporting, Exxon communications advisor Pamela Kevelson admitted the company did not “dispute much of what these stories report.” … “It’s true that Inside Climate News originally accused us of working against science but ultimately modified their accusation to working against policies meant to stop climate change,” Alan Jeffers, then a spokesperson for Exxon, wrote in a 2016 email to Kevelson. “I’m OK either way, since they were both true at one time or another.”Read Dharna Noor’s report in The Guardian.This article first appeared in Life in a Warming World, a weekly TNR newsletter authored by deputy editor Heather Souvaine Horn. Sign up here.

GoGreenNation News: Op-ed: When it comes to food chemicals, Europe’s food safety agency and the FDA are oceans apart
GoGreenNation News: Op-ed: When it comes to food chemicals, Europe’s food safety agency and the FDA are oceans apart

The U.S. Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA) are two major global agencies in charge of food chemical safety. It is common to hear that food chemical regulations in the EU are more protective of human health than in the U.S. The latest example is the recent ban of four food additives in California. The state’s Governor, Gavin Newsom, noted that the chemicals were already banned in the EU, implying that the lack of action by the FDA was putting the health of Californians at risk. We examined the FDA and EFSA’s responsibilities on food chemical safety to better understand why EFSA decisions are in general more protective of health. We specifically looked at the agencies’ approach to the safety of bisphenol-A (BPA) as an example of disparate decision-making.We found that in the EU the risk assessment and risk management of food chemicals are made by different entities: EFSA focuses on science and the European Commission decides on how the risk is managed. EFSA is independent to follow the science on BPA, for example, which resulted in three risk assessments with the last one showing greater harm to human health. In contrast, the FDA conducts both risk assessment and management and it is unclear how decisions are made. Over the years, the FDA has reviewed BPA studies but continued to maintain that its uses are safe.As the FDA undergoes a reorganization, the agency has a prime opportunity to increase transparency, collaborations and update its approach to evaluating food chemical safety. Separation of risk assessment and management Both in the EU and the U.S., the safety of chemicals allowed in food is based on the chemical’s inherent hazard and the level of exposure. If the risk is such that public health must be protected, a risk management decision is made, often via regulation. These decisions could range from banning chemicals to establishing a consumption level that would not increase health risks. "EFSA focuses on science and the European Commission decides on how the risk is managed ... In contrast, the FDA conducts both risk assessment and management and it is unclear how decisions are made."In the EU, the risk assessment and the risk management decisions are made by different entities. EFSA conducts risk assessments and the European Commission then makes the risk management decision based on EFSA’s findings. This separation allows the risk assessment to be grounded in science and the risk management to consider not only the science but also social, political, technological and economic factors, as well as the precautionary principle.In the U.S., the FDA conducts both risk assessment and management.Striking differences in assessing and managing riskThe EFSA relies on scientific panels composed of independent experts with high standards to limit conflicts of interest and bias. There are ten permanent panels and a scientific committee that supports their work. The scientific opinions are often unanimous, but when they’re not, minority reports are published in the EFSA Journal and also inform the European Commission’s risk management decisions.Unlike the EFSA, FDA staff review safety assessment and information provided by manufacturers. In a safety assessment there usually are four sections: toxicology, chemistry, environmental impact and policy; but it is unclear whether there is an epidemiologist among the reviewers. One FDA staff member from each section writes a memo with a summary of information and the conclusions. These memos inform the risk management decision about the use of a substance. The scientific evaluation is not always publicly available. It is also unclear how and by whom risk management decisions are made and whether the risk assessors are also involved in risk management. Prioritization of chemicals for reassessmentThe EFSA is mandated by law to re-evaluate all food additives authorized for use before 2009. The EFSA also identifies emerging risks and collects data about things like consumption, exposure and biological risk and responds to similar requests from member states.In the U.S., there is no legal mandate for the FDA to re-evaluate the use of the approximately 10,000 chemicals allowed in food, many of them authorized decades ago with little or no safety data. It is unclear if there is a process to identify emerging risks. The first reevaluation of chemicals was in response to President Nixon’s 1969 directive to reassess hundreds of substances the FDA determined to be generally recognized as safe. Only recently, the FDA took the initiative to re-evaluate the safety of partially-hydrogenated oil, Irgafos 168 and brominated vegetable oil. Other reevaluations have been in response to petitions from public interest organizations. BPA: A tale of two agenciesThe risk assessment of BPA — which has been linked to myriad health problems including cancer, diabetes, obesity, reproductive, immune system and nervous and behavioral problems — in food-contact materials is a good example of how two science-based agencies have made very different risk management decisions.EFSA conducted risk assessments of BPA in 2006, 2015 and 2023, each time at the request of the European Commission in response to new science. The second and third re-evaluations resulted in reductions in the daily allowed exposure of BPA due to new evidence showing greater harm to human health. To complete the process, the Commission recently published its proposed regulation of BPA, which includes a ban of most common uses in polycarbonate plastic and metal can coating.The FDA assessment of BPA has been riddled with missteps and lack of transparency. The FDA approved BPA for use in food contact applications in the early 1960s. It didn’t a draft safety assessment until 2008, at the request of its commissioner in light of findings by the National Toxicology Program and ongoing evaluations in Europe. FDA then asked its Science Board to review the draft and establish a subcommittee; there was also a public meeting and a report. The subcommittee, which included some members of the board and external experts, had several concerns about FDA’s assessment. In 2014, the FDA published a memo summarizing an updated safety assessment of BPA. The five-page memo cites the toxicology evaluation conducted in previous years and exposure assessment using an unpublished model. The agency concluded that the estimated consumption amount of BPA was safe to protect children and adults. This was the FDA's last safety assessment. Unlike the EFSA, the FDA process is less structured and open. At the FDA "it is also unclear how and by whom risk management decisions are made and whether the risk assessors are also involved in risk management."The FDA has conducted its own studies on BPA at different life stages and in different species. The agency was a member of the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). Launched in 2012 by the National Institute of Environmental Health Sciences, the National Toxicology Program and the FDA, the aim of CLARITY was to combine a traditional regulatory toxicology study from the government and investigational studies from academics who wield more modern techniques. As part of CLARITY, the FDA also conducted a two-year guideline compliant study on BPA toxicity. In 2018, FDA concluded that “currently authorized uses of BPA continue to be safe for consumers.” This statement was based on the results of only the first year of the CLARITY two-year study conducted by FDA according to its toxicity guideline and did not include analysis of data produced by the multiple academic laboratories involved in the project. Furthermore, it was not based on an assessment of risk which also necessitates exposure data. Meanwhile, the results of CLARITY, including the academic studies largely ignored by the FDA, played an important role in EFSA’s latest BPA risk assessment. Unlike EFSA, the FDA has not made public the criteria applied to select the data, to evaluate and appraise the studies included in the hazard assessment, or the weight of evidence methodology used in its current reassessment of BPA. The lack of transparency was a concern previously expressed by FDA’s Science Board subcommittee in 2008.A “deep misunderstanding” of the risk assessment and management distinctionEFSA’s independence from risk management decisions and recruitment of independent experts to conduct risk assessments gives the agency the freedom to follow the science. By comparison, the FDA has stagnated.One explanation for such a difference would be FDA’s strong adherence to its historical decisions, rather than considering more recent science. This bias toward their own work is not conducive to change. Another explanation would be FDA scientists conflating risk assessment and risk management. In 2013, the FDA conducted a review of its chemical safety program and an external consultant noted that there appeared to be a “deep misunderstanding of the risk assessment – risk management distinction” among the staff. This observation is apparent in a commentary in Nature in 2010, where FDA toxicologists said that dismissing “out of hand” risk management factors such as economics, benefits of existing technologies, cost of replacing banned technologies and the toxic risk of any replacement “is, to say the least, insular, and surely imprudent in a regulatory setting.” The consultant added that FDA staff suggested that the agency “should not be too quick to adopt new scientific approaches.” Such an approach has likely deterred its scientists from acting on new evidence.FDA is undergoing a reorganization, including the creation of a new Human Food Program. Almost a year ago, the agency announced it was “embarking on a more modernized, systematic reassessment of chemicals with a focus on post-market review.” For this to be successful, the FDA should adopt updated processes and methods, include outside experts when it encounters challenging scientific or technical issues, increase collaboration with other agencies, and engage with stakeholders including consumers, academic institutions, public interest organizations and industry. But above all, the FDA must restore the public’s trust in the agency with a strong commitment to transparency in decision-making and clear separation between risk assessment and risk management.For more information check these summary tables.

Join us to forge
a sustainable future

Our team is always growing.
Become a partner, volunteer, sponsor, or intern today.
Let us know how you would like to get involved!

CONTACT US