A recent study published in Nature Food found plastic baby bottles can expose infants to thousands or even millions of particles of microplastics per day, higher than previously thought. Pediatricians say parents would be right to be alarmed by the study findings.
Europe's chief policy-making body Wednesday called for a safer, more sustainable chemicals market, plotting a zero-tolerance approach that nearly eliminates hormone mimicking compounds.
'Once-in-a-decade opportunity'<p>Environmental health advocates hailed the effort as "the most transformative chemical policy initiative" in 20 years and a "once-in-a-decade opportunity to rethink Europe's approach to chemicals management."</p><p>"Every day, our exposure to cocktails of harmful chemicals is translating in real-life health conditions and diseases for current and future generations," said Natacha Cingotti, senior policy officer for health and chemicals at the Brussels-based <a href="https://www.env-health.org/eu-chemicals-strategy-speedy-implementation-steps-key-to-truly-protect-peoples-health/" target="_blank">Health and Environment Alliance</a>. </p><p>"While we welcome this significant step forward, the reality leaves no room for self-complacency and it is urgent the Commission gets to work to implement the promises made to effectively protect people from harm and support safe innovation for non-toxic material cycles."<br></p>
Five main thrusts<p>The new European plan, dubbed the Chemicals Strategy for Sustainability, is part of the broader Europe Green Deal, a sweeping proposal for the European Union to achieve carbon neutrality by 2050, eliminate pollution, and promote a sustainable economy.</p><p>The strategy released Wednesday has five main thrusts:</p><ol><li>Tighter scrutiny of hormone-mimicking compounds, along with an early warning system for chemical risks before such compounds hit the market.</li><li>A "one substance, one assessment" approach to increase chemical testing transparency.</li><li>Incentives for green chemistry and non-toxic materials development.</li><li>Information and tools for citizens to understand chemical risks.</li><li>Pressure on international markets to improve chemical safety globally.</li></ol>At its core, the strategy makes use of the precautionary principle—forcing companies or manufacturers to prove chemicals are safe before they go to market, and making them pay when there is pollution.
Concern from business<p>While environmental and health advocates lauded the move, business interests cautioned it will stifle commerce and innovation.</p><p>"Production cycles and supply chains are complex ... (and) not always well understood by decision makers," wrote EuroCommerce, representing the continents' retail and wholesale business sectors, in a position paper as the policy was being crafted this summer. "We ask the Commission to keep a close eye on the impact of individual initiatives, and its cumulative effects on the retail and wholesale sector and how it affects their economic viability."</p>
Contrast with United States<p>The Commission's plan stands in sharp contrast to the United States. Despite decades of warnings from academic scientists, U.S. regulators have largely ignored independent, non-industry science about the dangers of chemicals that impact our hormones, often at very low doses. </p><p>Endocrine-disrupting compounds are a particular concern, based on science from research labs worldwide. The compounds—added to a broad range of products such as plastics, toys, cosmetics, food packaging—have been linked to myriad health problems, including birth defects, obesity, diabetes, certain cancers, as well as impacts to the brain and reproductive and immune systems. </p><p>The highest profile—and highest dollar— effort by the U.S. Food and Drug Administration to get on the same page of academic scientists and Europe on endocrine disruptor science has only deepened divides. An <a href="https://www.ehn.org/is-bpa-dangerous-for-health-2641153205.html" target="_blank">EHN investigation</a> of the FDA's effort on just one chemical, BPA, found the agency stacked the deck against findings from independent scientists studying BPA. It also found that many chemicals used to replace BPA in "BPA-free" products have the same adverse health impacts as the original chemical.<br></p>
Separate focus on PFAS<p>Also released Wednesday was an EU strategy that specifically takes aim at PFAS, compounds so persistent they're called "forever chemicals." PFAS, used in products including firefighting foam, non-stick cookware and some clothing, have been found in the water of roughly 2,230 U.S. communities in 49 states, affecting more than 100 million people. </p><p>The new European strategy would only allow for PFAS use when the chemicals are "essential for society." In addition, it will fund research for safe alternatives and for monitoring and cleanup. <br></p>
Toward 'zero pollution'<p>The framework stems from political guidelines laid out at the end of 2019 by European Union President Ursula von der Leyen that pointed Europe toward "zero pollution."</p><p>"I will put forward a cross-cutting strategy to protect citizens' health from environmental degradation and pollution, addressing air and water quality, hazardous chemicals, industrial emissions, pesticides and endocrine disruptors," President von der Leyen wrote <a href="https://op.europa.eu/en/publication-detail/-/publication/43a17056-ebf1-11e9-9c4e-01aa75ed71a1" target="_blank" rel="noopener noreferrer">in the report. </a> </p><p>The Commission plans to release a Zero Action Pollution Action Plan on air, water and soil next year to complement the chemicals strategy.</p>
Mary Beth Kirkham hadn't studied microplastics when she was invited to co-edit a new book about microplastics in the environment—but something stood out to her about the existing research.
Mary Beth Kirkham (left) in her lab at Kansas State University. (Credit: k-state.edu)<p>Microplastics, loosely defined as plastic pieces smaller than 5 millimeters across, or roughly the size of a small grain of rice, have made their mark on both the global ecosystem and the popular consciousness, famously killing seabirds and <a href="https://www.ehn.org/plastic-pollution-in-national-parks-2646169327.html" target="_self">raining down on wilderness areas</a>. And while the impacts of ocean microplastics have been the subject of significant media and scientific attention, researchers say that most microplastics are actually accumulating on land, including agricultural areas. One <a href="https://pubs.acs.org/doi/pdf/10.1021/acs.est.6b04140" target="_blank">estimate</a> suggested that 107,000 to 730,000 tons of microplastics could be dumped onto agricultural soils in the U.S. and Europe every year, compared to the 93,000 to 236,000 tons that enter the oceans.</p><p>Microplastics arrive on farms through processed sewage sludge used for fertilizer, plastic mulches, and are even intentionally added as slow-release fertilizers and protective seed coatings. In just the last few years, an uptick in research has uncovered alarming potential impacts of this contamination on all aspects of agricultural systems from soil quality to human health. </p>
Microplastics can also enter agricultural soils through the degradation of plastic materials used by farmers, such as black plastic mulch. (Credit: Charles Dawley/flickr)
Sewage sludge, mulch, and slow-release fertilizers<p>Luca Nizzetto, a research scientist at the Norwegian Institute for Water Research, began studying microplastics in agricultural soils after he noticed that most research on microplastics focused on oceans.</p><p>"Most of the marine sources are actually land-based," Nizzetto told EHN. "No one was looking at what was happening close to the source." When his team began evaluating potential land sinks for microplastics they "immediately [identified] agriculture as one of the hot areas."</p><p>Microplastics can enter agricultural lands via sewage sludge, the solids that are filtered out of wastewater, which are commonly used to fertilize agricultural fields. Microplastics get into the wastewater originally through laundry, personal care products, and urban runoff. </p><p>Nizzetto said that most of the microplastics are retained in the sludge as the water is cleaned in treatment facilities and, in a 2016 <a href="https://pubs.acs.org/doi/pdf/10.1021/acs.est.6b04140" target="_blank">paper</a>, his team estimated that between 125 and 850 tons per million people are annually dumped on European agricultural lands via sewage sludge. Nizzetto also reported in the same paper that roughly 50 percent of sewage sludge is processed for agricultural application in both Europe and the United States.</p><p>Microplastics have been <a href="https://link.springer.com/content/pdf/10.1023/A:1004908110793.pdf" target="_blank">reported</a> in U.S. sewage sludge as early as 1998, and in 2020 researchers <a href="https://docs.google.com/document/d/1pMPrzNPHua5793fZBiBM-faCgRUmqdL-rLrge0tOO0U/edit" target="_blank">estimated</a> roughly 21,249 metric tons of microplastics are released to U.S. agricultural lands from sewage sludge annually. Because of their recalcitrance in soils, U.S. researchers have even <a href="https://www.sciencedirect.com/science/article/pii/S0269749105002290?casa_token=OecdDBRs0H8AAAAA:YGmePbwr-uO_bH_VVGczAZhzLcF-Wk2pv9dmJ8SjJJZa-yasygmdTY5b2Gb82TQsYXixw766_A#tbl1" target="_blank">investigated</a> the possibility of using the contemporary microplastics profile of soils as an indicator of past sewage sludge application.</p><p>Microplastics can also enter agricultural soils through the degradation of plastic materials used by farmers. Kirkham said that in the 1950s, plastic covering replaced glass in greenhouses. Plastic mulches were also popularized, becoming commonplace across much of the world. These mulches, sheets of plastic laid out on the ground to suppress weeds, warm the soil, and retain moisture, are challenging to recycle and costly to dispose of. </p><p>According to Kirkham, farmers may end up piling them up on their land or burning them to avoid disposal costs. Nizzetto said that in some areas, the mulches are simply left to break down into the soil.</p><p>Intentionally manufactured microplastics are another source of microplastic emissions to agricultural soils, according to Nizzetto and other researchers that EHN spoke with. These can include plastic encapsulated slow-release fertilizers and plastic coatings intended to protect seeds from microorganisms.</p><p>A 2017 <a href="https://ec.europa.eu/environment/chemicals/reach/pdf/39168%20Intentionally%20added%20microplastics%20-%20Final%20report%2020171020.pdf" target="_blank">report</a> compiled for the European Commission estimates that up to 8,000 metric tons of plastic from slow-release fertilizers are broadcast onto Western European agricultural soils annually (although they said that a percentage of this may not be microplastics). A 2019 European Chemicals Agency <a href="https://echa.europa.eu/documents/10162/05bd96e3-b969-0a7c-c6d0-441182893720" target="_blank">report</a> listed emission amounts as 10,000 metric tons for slow-release fertilizers, and 500 metric tons for treated seeds every year. Figures for the U.S. were not available. </p>
Microplastics can arrive on farms through processed sewage sludge used for fertilizer. (Credit: CityofGeneva/flickr)
Microplastics alter the physical and biological properties of soils<p> Sixteen days into Kirkham's microplastics and cadmium experiment, her plastic-treated wheat plants began to yellow and wilt. Water had been pooling on the top of the soil in the plastic treated plants, but to keep her experiment consistent, she had to give all the plants the same amount of water. </p><p> "The particulate plastic appeared to clog the soil pores, prevent aeration of the soil, and cause…the roots to die," said Kirkham. Plants without microplastics, even the cadmium-contaminated ones, were in much better shape. "It was the plastics that were controlling the growth more than the cadmium." </p><p> Another team of researchers <a href="https://www.nature.com/articles/s41565-020-0707-4" target="_blank">reported</a> similar results. They found that exposure to plastics resulted in reduced weight, height, chlorophyll content, and root growth of <em>Arabidopsis thaliana, </em>a relative of cabbage and broccoli. In this study, the researchers used nanoplastics, which are plastic pieces that are less than 100 nanometers in size. For scale, the novel coronavirus measures 60 to 140 nanometers. </p><p> The full impact of microplastics contamination in agricultural soils, particularly as concentrations increase with time, is unknown. However, <a href="https://pubs.acs.org/doi/pdf/10.1021/acs.est.8b02212" target="_blank">studies</a> have shown that microplastics possess physical and chemical characteristics that have the potential to alter soil bulk density, microbial communities, water holding capacity, and other properties that influence plant development. </p><iframe src="https://ourworldindata.org/grapher/cumulative-global-plastics" loading="lazy" style="width: 100%; height: 600px; border: 0px none;"></iframe>
Earthworm impacts<p>Esperanza Huerta Lwanga, a soil scientist affiliated with both Wageningen University & Research in the Netherlands and El Colegio de la Frontera Sur in Mexico, has investigated the effects of microplastics on earthworms, creatures widely considered a boon to farming because of their ability to aid decomposition, add organic nutrients to the soil through their waste castings, and increase the aeration of soil.</p><p>"When I was doing research on soil invertebrates' distribution at different home gardens in Tabasco, Mexico, I found microplastics. And in those soils with microplastics, there were not earthworms," Huerta Lwanga told EHN.</p><p>This observation motivated her to study earthworms directly. In her subsequent experiments, she found that worms attempted to avoid microplastics, but when the soil concentration reached 7 percent, they began to ingest them along with the soil, concentrating the plastics in their castings, and transporting them through different layers of soil. In their 2018 <a href="https://www.publish.csiro.au/EN/pdf/EN18161" target="_blank">paper</a>, Huerta Lwanga's team cautioned that rainwater flows through earthworm burrows into groundwater, creating a clear conduit for microplastics to enter groundwater systems. </p><p><em></em>Huerta Lwanga also said that microplastics caused an 8 percent to 25 percent mortality rate in earthworms depending on the dose. In their <a href="https://pubs.acs.org/doi/pdf/10.1021/acs.est.5b05478" target="_blank">paper</a>, she and her colleagues hypothesized that mortality may be partly caused by microplastics abrading the digestive tracts of earthworms, making it more difficult for them to absorb nutrients. Damage to the digestive tracts of earthworms that ingested microplastics has been <a href="https://www.sciencedirect.com/science/article/pii/S0269749116315500" target="_blank">documented</a> by other researchers. </p><p>Once microplastics enter an ecosystem, they can proliferate through trophic levels, such as when a bird eats an earthworm. </p><p>Or when a person eats an apple.</p>
Images microbead localization in the root, stem and leaf of a wheat plant. (Credit: Effective uptake of submicrometre plastics bycrop plants via a crack-entry mode)
Passing through plant—and human—tissue<p>Earlier this year, Yongming Luo, a professor at the Yantai Institute of Coastal Zone Research and the Nanjing Institute of Soil Science in China, and colleagues <a href="https://www.nature.com/articles/s41893-020-0567-9" target="_blank">reported</a> microplastics accumulation in wheat and lettuce plants exposed to microplastics in a laboratory setting. The researchers grew the plants in hydroponic and soil systems with microplastics that had been laced with fluorescent dyes. The researchers analyzed cross sections of the plants under a microscope outfitted to detect the fluorescence. The roots, stems, and leaves lit up.</p><p>"For decades scientists have believed that plastic particles are too large to pass through the physical barriers of intact plant tissue. But our new study disproves this assumption," Luo told EHN.</p><p>Luo's team reported that the microplastics seemed to be entering the plants through cracks in the roots where lateral branching occurs as well as diffusing through cells at the developing root tips. </p><p>A team of scientists also <a href="https://www.sciencedirect.com/science/article/pii/S0013935120305703" target="_blank">reported</a> earlier this year that they had detected microplastics in Italian supermarket produce including carrots, lettuce, broccoli, potatoes, apples, and pears. The researchers wrote that they found the most microplastics contamination in apples and the least in lettuce, and speculated that the perennial nature of a fruit tree allowed microplastics to accumulate more than in annual crops. </p><p>"If microplastics are getting into our vegetables, they are getting into everything that eats vegetables…which means they are in our meat and dairy as well," said Luo.</p><p>Microplastics have previously been detected in honey, beer, and seafood. </p><p>With clear and uncontrolled pathways into human food systems, ingestion of microplastics by humans is practically unavoidable, but the consequences of ingestion are as of yet unknown.</p><p>Plastic microfibers have been <a href="https://pubs.acs.org/doi/pdf/10.1021/acs.est.7b00423" target="_blank">found</a> in malignant lung tissue biopsies of cancer patients. These plastics were probably inhaled rather than swallowed, but the concern that microplastics can become lodged in tissue and cause dangerous inflammation remains. Studies of mammals forced to ingest microplastics in laboratories have also provided evidence that microplastics can pass through cell walls, move through the body, accumulate in organs, and impact the immune system. </p><p>Microplastics are chemically active materials, capable of attracting and binding to compounds known to harm human health. In addition to cadmium, microplastics have been shown to accumulate lead, PCBs, and pesticides. Further, plastics are manufactured with their own suite of toxic compounds, which can include BPA, an endocrine disruptor. Researchers have suggested that both acquired and endogenous compounds could leach out of degrading plastics into their environment, whether that be soil or human tissue.</p><p>"Because we are concerned that microplastics may harm our health…we find it interesting that the precautionary principle is not [being] applied," Sophie Vonk, a researcher at the Plastic Soup Foundation in the Netherlands, a group dedicated to ending plastic pollution, told EHN. "So as long as there's no proof, we just find it okay that we're being exposed to these particles every single day, by our food, water, the air we breathe."</p>
Scientists have detected microplastics in supermarket produce (Credit: loonyhiker/flickr)
What to do?<p>Since microplastics enter agricultural systems through a variety of means, addressing this issue would require a multi-tiered approach.</p><p>The Plastic Soup Foundation has a long standing campaign to eliminate the use of plastic microbeads in personal care products. This would likely reduce the amount of plastic that ends up in sewage sludge. The group also supports limiting single-use plastics generally, as these will ultimately break down to microplastics that end up polluting both ocean and terrestrial environments. "We're not anti-plastic," said Vonk. "We feel like plastic can be very useful for certain purposes, but the way we're using it now is just really, really not clever."</p><p>The European Chemicals Agency has proposed an EU-wide ban on intentionally introduced microplastics, including those in personal care products as well as the slow-release fertilizers and seed coatings used in agriculture. Some <a href="https://www.ncel.net/microbeads/#microlegislation" target="_blank">states</a> in the U.S. have also moved to ban microbeads from personal care products.</p><p>To address the plastic mulch issue, Nizzetto said that one helpful step would be to make companies that manufacture plastic mulch films responsible for their recycling and disposal. This would help reduce inappropriate disposal at farms. </p><p>The use of biodegradable plastics for mulch has also been proposed, but these polymers potentially come with their own set of problems. For instance, one of Huerta Lwanga's <a href="https://www.sciencedirect.com/science/article/pii/S0048969718327219" target="_blank">studies </a>found that a biodegradable plastic negatively impacted wheat growth more than a conventional plastic used in the study. Also, there has been controversy over whether some "biodegradable" plastics actually degrade into harmless compounds, or whether they just break down into microplastics faster. Such controversy surrounds oxo-biodegradable plastics, which the EU moved to <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019L0904&from=EN" target="_blank">ban</a> in 2019.</p><p>Another alternative to plastic mulch, developed by researchers at the Rodale Institute in Pennsylvania, involves growing nutrient-sequestering cover crops and then rolling them down to form a thick mat. Farmers then plant into the mat, which itself persists and inhibits weeds, lets water through, and adds nutrients instead of microplastics to the soil. According to the researchers' <a href="https://rodaleinstitute.org/science/articles/beyond-black-plastic/" target="_blank">report</a>, the technique can replace more than 90 pounds of plastic mulch per acre.</p><p>Gladis Zinati, director of the vegetable systems trial at Rodale and co-author on the report, told EHN that the strategy is scalable to large farms and emphasized the importance of building up healthy soils on farmlands to support long term resiliency. </p><p>Much more research is needed to paint a complete picture of the scope and impacts of microplastic pollution of agricultural soils. But in the meantime, the plastics will continue to accumulate. </p><p>"This is a kind of irreversible contamination," said Nizzetto. "There's no way to remediate this kind of contamination at the scale of agricultural soils."</p>
Exposure to minuscule amounts of bisphenol-A can cause a multitude of health problems, including effects on the developing brain, heart, and ovaries, according to a paper published on Thursday that integrates data from several animal studies.
An article written by a group of 19 toxicologists has been published verbatim in eight toxicology journals in the last four months.
An “unethical attempt to foster the views of the chemical industry”<p>Their views disregard the huge body of evidence in the peer-reviewed scientific literature as developed by independent scientists working in the endocrine-disrupting chemical field, and supported by international medical and scientific societies, including the Endocrine Society, the world's largest professional medical and scientific association dedicated to endocrinology.</p><p>It is curious that these editorials have emerged just before the European Parliament's vote on their resolution on the European Chemicals Strategy for Sustainability <a href="https://www.europarl.europa.eu/doceo/document/B-9-2020-0222_EN.html" target="_blank">taking place today</a>. </p><p>This resolution is the EU Parliament`s input in the ongoing discussions for the European Chemicals Strategy for Sustainability promised for autumn 2020. It is expected that the results from the <a href="https://ec.europa.eu/info/policies/endocrine-disruptors_en" target="_blank">European Commission's Fitness Check</a> on endocrine disrupters will be included.</p><p>Another issue stands out about the editorials: Six of the eight journals are published by Elsevier Publishing Company and the journal editors are themselves among the 19 authors. </p><p>When I asked Elsevier about the ethics of publishing same article in multiple journals, they responded via email: "Please note that it is a quite a common practice for editors of several journals to agree to share information such as this. In principal Editors have the right to publish Editorials as opinion pieces or guidelines, even if controversial, by means of the same text/Editorial Note in several journals, with the aim to reach the widest possible audience." </p><p>In my many decades as a researcher publishing in peer-reviewed journals, I have seen this occur only once before and it was done by these same writers in 2013. As with this editorial, they published the same article in four of these same toxicology journals. </p><p>This editorial and its repeat publication are an unethical attempt to foster the views of the chemical industry at the expense of human health.</p><p>Toxicologists around the globe should be outraged that this band of scientists-as-lobbyists are undermining the field of toxicology—an independent, unbiased and legitimate field of science. Honest scientists must speak up now in support of maintaining ethical standards of publication in the field of toxicology.</p><p>I call on toxicologists everywhere to stand up for their field and follow Edmund Burke's guidance: "The only thing necessary for the triumph of evil is for good men (sic) to do nothing." </p>
Exposure to endocrine-disrupting chemicals in medicine and medical devices is grossly underestimated, and physicians have an ethical obligation to talk about these exposures with their patients, according to a new study.
It's an uncomfortable, often embarrassing problem—having to pee a lot, but not getting relief when you go.
What affects how likely you are to die from the novel coronavirus?
A global public health threat<p>A huge body of research into a family of chemicals that alter hormone action, called endocrine-disrupting chemicals, has increasingly established them as significant contributors to the risk of these very diseases: diabetes, obesity, heart disease, high blood pressure, reduced immunity, and more.</p> <p>There is always uncertainty in science, but the evidence has become strong enough that the Endocrine Society, the world's largest professional association of medical and research endocrinologists, considers reducing endocrine-disrupting chemicals' impacts to be one of their highest public health goals. Endocrinologists are the go-to health professionals for these diseases, both for figuring how to treat them and understanding how they cause effects. </p> <p>In 2012, the World Health Organization and the United Nations Environment Program released a report concluding that endocrine-disrupting chemicals are a global public health threat. </p> <p>The science has only grown stronger since then.</p> <p>Thousands of scientific papers have been published in the last 20 years linking endocrine-disrupting chemical exposure to the very comorbidities that increase the risk of dying from COVID-19. </p> <p>Some of the chemicals highlighted in this research are bisphenols like BPA, phthalates (plasticizers), perfluorinated (forever) chemicals, flame retardants, PCBs and a variety of new and old pesticides. </p> <p>One of the most disturbing studies found that vaccines don't work as well in children who had high levels of perfluorinated chemicals, PFOS and PFOA, in them as infants </p> <p>In 2020 each of us carries a collection of these chemicals in our bodies, including in our blood, tissues and organs. </p> <p>There is much more in us now than there was even 30 years ago. No one is uncontaminated, including unborn babies. </p> <p>Given what the research tells us, it's not surprising that with higher levels of endocrine-disrupting chemical exposure, the endocrine-related adverse health effects noted above have surged as public health threats. </p> <p>Nor is it surprising that the effects are being seen in younger and younger adults, and now even in teenagers.</p>
Hitting the “trifecta” of health, money, and fewer deaths<p>What will that take to weather the next pandemic, and the next?</p><p>First, regulatory agencies like the U.S. Food and Drug Administration and the Environmental Protection Agency need to use modern science to establish what is safe and what is not. Their approaches today do not reflect modern endocrinological science. They are mired in science from a previous century. </p><p>Second, we need the next generation of materials used in consumer products to be inherently safer than what we have today, because many of those products contain, and emit, endocrine-disrupting chemicals. </p><p>The good news is that endocrine-disrupting chemical science has advanced so substantially over these past two decades that chemists can use it to design safer materials. </p><p>And they can make money in the process, because, increasingly, consumers want to be confident that what they are bringing into their homes and their bodies is safe.</p><p>This is a clear path forward. Chemical inventors and chemical companies make money. People are healthier. Fewer people die in the next pandemic. Sounds like we can hit the trifecta.</p>
Endocrine-disrupting chemicals masquerade as hormones. These insidious contaminants increase the diseases that cause the underlying conditions that result in susceptibility to COVID-19.
An unhealthy nation<p>The U.S. is currently one of the unhealthiest nations in the world. <a href="https://www.cdc.gov/obesity/data/adult.html" target="_blank">An astonishing 42.4 percent of Americans</a> aged 20 and over (roughly 130 million people) are obese, an underlying condition for a more serious case of COVID-19. Compare obesity in the U.S. to other countries that have high rates of COVID-19, like Japan (3.7 percent), Korea (5.3 percent) China (7.0 percent), and Italy (9.8 percent).</p><p>A healthy immune system is needed to fight off COVID-19. <a href="https://www.statista.com/statistics/418328/diagnosed-autoimmune-conditions-prevalence-in-selected-countries/" target="_blank">Common immune system</a> diseases that weaken your defenses to bacterial and viral infections include asthma, chronic obstructive pulmonary disease (COPD), rheumatoid arthritis, lupus, multiple sclerosis, psoriasis, type 1 diabetes, and Crohn's disease. According to the National Institutes of Health, about 23.5 million Americans (about 7 percent of the population) suffer from one or more autoimmune diseases, and 25 million people have asthma. The U.S. ranks 43rd out of 183 countries for deaths due to lung disease. </p><p>The U.S. leads developed nations in numbers of type 2 diabetes—11 percent of the population aged 20-79 years; about 34 million people have diabetes. People with diabetes have an increased risk of COVID-19 infection and complications. They have high and fluctuating blood glucose levels, making it harder to treat viral infections. Uncontrolled blood glucose levels also contribute to heart and kidney problems, which also worsen the prognosis for those with<a href="https://www.usatoday.com/story/news/health/2020/03/12/tom-hanks-coronavirus-actor-has-covid-19-diabetes-heres-risk/5030111002/" target="_blank"> COVID-19</a>.</p><p>Since 85 percent of diabetics are overweight or obese, and 30 percent of overweight/obese people have type 2 diabetes, these two underlying conditions alone interact to make Americans particularly <a href="https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30116-8/fulltext" target="_blank">susceptible to COVID-19</a> and its complications.</p><p><a href="about:blank" target="_blank">The U.S</a>. has the third-highest mortality rate for diseases of the circulatory system, including high blood pressure, overall, the second-highest mortality rate for heart attacks and <a href="https://www.cdc.gov/heartdisease/facts.htm" target="_blank">heart disease</a> is the leading cause of death in the U.S. While there has been a <a href="https://www.healthsystemtracker.org/chart-collection/mortality-rates-u-s-compare-countries/#item-percentage-decrease-in-age-adjusted-circulatory-diseases-mortality-rate-1990-2015" target="_blank">global decline</a> in mortality due to circulatory disorders, the U.S. decline is smaller than any other country measured.</p><p>While we can't pin the elevated U.S. disease numbers solely on exposures to endocrine disrupting compounds, it is clear that all of the disease and health conditions listed above (diabetes, obesity heart disease, immune system diseases/dysfunction and respiratory diseases) have been linked to exposure to a variety of endocrine disrupting compounds in animal models and human epidemiology studies. </p>
Time to prepare and reduce exposure<p>Although the focus today must be on reducing the immediate impact of this pandemic, it is essential to realize that other epidemics and pandemics will undoubtedly come our way. Now is the time to prepare.</p><p>What is the best thing we can do now to protect ourselves? </p><p>All the diseases discussed above have both <a href="https://www.nature.com/articles/s41586-019-1411-0" target="_blank">genetic and environmental</a> components. We cannot change our genes, but we can change our environment. </p><p>Improving our diet and nutritional status and reducing our exposure to endocrine disrupting chemicals are pivotal changes that will profoundly benefit our health and welfare.</p><p>Just as COVID-19 brings a sharp focus to pathogens that can quickly injure or kill us, slower-acting endocrine disruption needs longer-term solutions that prevent the chemicals from wearing down our health, vitality, and resistance. </p>
While the plastics crisis has largely played out on the administrative level in the U.S., burdening local governments with the growing costs and logistics of managing plastic garbage, in developing countries that have no government-funded waste collection or recycling systems, those burdens fall on individuals.
From cell phones to bicycle helmets to IV bags, plastic has molded society in ways that make life easier and safer. But the synthetic material also has left harmful imprints on the environment and perhaps human health.
Plastic manufactured in the first 10 years of this century eclipses the total produced in the entire last century<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzE0NTM5Mi9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYzMzc5MzMxOH0.B9gvkZFRXn-RLWmIL57WNSHwkQYvFnE5SRublHKK8uc/img.jpg?width=1245&coordinates=0%2C18%2C0%2C18&height=700" id="cd503" class="rm-shortcode" data-rm-shortcode-id="44b045131d7191401796bacf20e42619" data-rm-shortcode-name="rebelmouse-image" alt="polyethylene plastic bottle stock" />
High BPA and phthalate exposure by premature infants in neonatal intensive care units is 'of great concern'<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzE0NTM4NS9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYyOTI1ODAyOH0.eGG5VbHTrm7eEGCbazVSaByJa8zasiN31xO12WhWQPA/img.jpg?width=1245&coordinates=0%2C320%2C0%2C320&height=700" id="ce58b" class="rm-shortcode" data-rm-shortcode-id="126ef57f4495a368e650ca645f7906fc" data-rm-shortcode-name="rebelmouse-image" alt="Medical officers helping a premature baby in a neonatal intensive care unit." />
Flickr.com<p>Polybrominated diphenyl ethers or PBDEs, which are flame-retardants added to polyurethane foam furniture cushions, mattresses, carpet pads and automobile seats, also are widespread.</p><p>The plastics industry maintains that its products are safe after decades of testing.</p><p>"Every additive that we use is very carefully evaluated, not just by the industry, but also independently by government agencies to look at all the materials we use in plastics," said Mike Neal, a consumer and environmental affairs specialist at PlasticsEurope, an industry trade association, and a co-author of the report.</p><p>But some of these chemicals have been shown to affect reproduction and development in animal studies, according to the report. Some studies also have linked these chemicals with adverse effects in people, including reproductive abnormalities.</p><p>"We have animal literature, which shows direct links between exposure and adverse health outcomes, the limited human studies, and the fact that 90 to 100 percent of the population has measurable levels of these compounds in their bodies," said John Meeker, an assistant professor of environmental health sciences at the University of Michigan School of Public Health and a lead author. "You take the whole picture and it does raise concerns, but more research is needed."</p><p>Shanna Swan, director of the University of Rochester's Center for Reproductive Epidemiology, conducted studies that found an association between pregnant women's exposure to phthalates and altered genital development in their baby boys.</p><p>Also, people with the highest exposure to BPA have an increased rate of heart disease and diabetes, according to one recent study. Animal tests studies of PBDEs have revealed the potential for damaging the developing brain and the reproductive system. </p><p>Yet the effects on human health remain largely unknown. To help shed more light on the issue, the report recommends more sophisticated human studies.</p><p>"It's tough to have a smoking gun with a single animal study or observational human study," Meeker said. "We need to have different types of studies indicating a consistent pattern to more definitively determine health effects resulting from these chemicals."</p><p>But testing humans for endocrine disruptors can be tricky because phthalates and BPA pass through the body so quickly. In addition, tests for each chemical cost about $100 a pop.</p><p>Deciding which chemicals to test and at what dose is also an issue. To date, most studies have addressed single chemicals, and there are limited data on the interactions between chemicals. Compounding the problem is the discovery that endocrine disrupting chemicals may have effects at doses lower than those used in the Environmental Protection Agency's standard toxicity tests.</p>
Current testing efforts should be thrown out. The new goal? Tests that mimic real human exposure.<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzE0NTM4Ny9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY1NDUxMDI1OX0.wkO8RFGrlF_wjkakoj5a9-pNe0edBRDGioG-uPiqqxw/img.jpg?width=1245&coordinates=113%2C0%2C113%2C0&height=700" id="a0847" class="rm-shortcode" data-rm-shortcode-id="2fbae35e5ddb2ec82c3365c25d9500a3" data-rm-shortcode-name="rebelmouse-image" alt="Researchers looking at BPA samples" />
Amy Soto<p>"It's a very complicated picture and the laboratory model of just taking one isolated chemical and giving it to a genetically pure strain of rats in clean cages, clean air and clean water and seeing what it does just doesn't come close to mimicking the human situation," Swan said.</p><p>Many researchers recommend studies that test pregnant women as well as their children. The National Children's Study will do just that by examining environmental influences on more than 100,000 children across the United States, following them from before birth until age 21.<br><br>"There are so many questions now with these chemicals in relation to cardiovascular disease, age and puberty, obesity, developmental disorders," said Swan. "We don't know what's causing it, only hints, so the beauty of the National Children's Study is that we can look at all of these endpoints and it should reveal a lot of answers."</p><p>Plastic's problems extend beyond the human body, according to the report. More than one-third of all plastic is disposable packaging like bottles and bags, many of which end up littering the environment.</p><p>Although the image of a bird tangled in a plastic necklace is by now burned into the public's eye, ingestion of plastic fragments is much more common. Once inside, plastic can pack a one-two punch by both clogging an animal's stomach and poisoning it with chemicals that have concentrated in the plastic. Some chemicals are then transferred to the food web when animals eat them.</p><p>More than 180 species of animals have been documented to ingest plastic debris, including birds, fish, turtles and marine mammals, according to the report.</p><p>Unfortunately, collecting data on plasticizers' impacts on wildlife suffers the same pitfalls as studying human health. Still, there is already evidence that chemicals associated plastics might harm wildlife.</p><p>For example, laboratory studies have shown that phthalates and BPA affect reproduction in all studied animal groups and impair development in crustaceans and amphibians.</p><p>"While there is clear evidence that these chemicals have adverse effects at environmentally relevant concentrations in laboratory studies, there is a need for further research to establish population-level effects in the natural environment," according to the report.</p><p>Charles Tyler, a professor at the University of Exeter School of Biosciences in the United Kingdom and a senior author of the report, said that scientists have shown that "some of these chemical compounds are getting into the environment and are in some environments at concentrations where they can produce biological effects in a range of wildlife species."</p><p>Traveling from coast to coast, plastic can endure for thousands of years due to the reduced UV exposure and lower temperatures of aquatic habitats.</p><p>Barnes demonstrates plastic's mobility with his account of a plastic sighting during an expedition to the Amundsen Sea where he took biological samples, the first there ever. The Amundsen, located in the Pacific Sector of Antarctica, is the only sea in Antarctica with no research station on its coast and the nearest urban center thousands of miles away.</p><p>"Even for us, getting in was a challenge because there's so much ice and it's so difficult to get there," said Barnes. "But even in that remotest of environments, there was plastic floating on the sea surface.</p><p>Plastic also serves as a floating transportation device that allows alien species to hitchhike to unfamiliar parts of the world, threatening biodiversity. Global warming further aids the process by making previously inhospitable areas like the Arctic livable for invasive species, which can be detrimental to local species.</p><p>For example, plastic items are commonly colonized by barnacles, tubeworms and algae. Along the shore of Adelaide Island, west of the Antarctic Peninsula, ten species of invertebrates were found attached to plastic strapping that was littering the ice.</p><p>"Raising the temperature just one degree can make the difference between getting to someplace and actually surviving once you get there," said Barnes.</p><p>Plastic is so resilient that even burying it deep within the earth doesn't keep it from impacting the environment. Currently it accounts for approximately 10 percent of generated waste, most of which is landfilled. But, as the report notes, placing plastics in a landfill may simply be storing a problem for the future, as plastic's chemicals often sink into nearby land, contaminating groundwater.</p>
Plastics as a major user of fossil fuels<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzE0NTM5OC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY0NjE3ODM3NX0.2oiTeDr48P_HzTVCSQGXvZkicMiAFoiKAAAOmGBPrK4/img.jpg?width=980" id="49aba" class="rm-shortcode" data-rm-shortcode-id="6999665e8b70e21a3939a357e93a8980" data-rm-shortcode-name="rebelmouse-image" alt="refinery industry plastic production" />
A responsible way to help solve environmental problems<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzE0NTM5OS9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY1NDQxODIxNn0.0Y5a-Ncaa3gbnMWTOQsUj6QIungL208lnbco8n2ywzM/img.jpg?width=1245&coordinates=0%2C110%2C0%2C110&height=700" id="94a36" class="rm-shortcode" data-rm-shortcode-id="db8f88ded433b236f2500286a28182a0" data-rm-shortcode-name="rebelmouse-image" alt="Green forest in the fog" />
A fight is brewing over just how polluted our bodies are by BPA, the plastic additive found in everything from canned food to thermal paper receipts and water bottles.
Bisphenol A and its substitute chemicals—pervasive in food and beverage containers, canned goods and store receipts—are showing up in mothers' wombs at "unexpectedly high levels," according to a new study published in the journal Environmental Science and Technology.
Market expands, leaving children at highest risk<p>BPA still made up the highest concentrations detected in the new research. Despite thousands of studies that highlight its health effects, the global BPA market continues to increase at about 3 percent per year and is projected to top <a href="https://www.prnewswire.com/news-releases/global-bisphenol-a-market-report-2018-analysis-2013-2017--forecasts-2018-2023-300757673.html" target="_blank">seven million tons</a> by the end of 2023.</p><p>"They are still expanding BPA into every imaginable product," said Collins. "BPA should not be produced. Period."</p><p>Meanwhile, the U.S. Food and Drug Administration maintains that the chemical poses no harm at levels to which people are exposed.</p><p>In November 2019, <a href="https://www.ehn.org/is-bpa-dangerous-for-health-2641153205.html" target="_blank">EHN published a year-long investigation of the FDA's handling of BPA science</a>. It found that U.S. regulators have stacked the deck against findings from independent scientists that BPA, as well as many BPA substitutes, can harm people at very low doses. </p><p>Cheryl Rosenfeld, a biologist at the University of Missouri, published a study of mice in February that found both BPA and BPS exposure lowered serotonin production in the placenta, the primary source of the critical neurotransmitter for developing offspring. The effect could have "dramatic consequences" on brain development, Rosenfeld told EHN.</p><p>The bisphenol concentrations that the <a href="https://www.pnas.org/content/117/9/4642" target="_blank">researchers</a> found in the placenta and cord blood are both troubling, she said, as impacts may come through the placenta or by directly affecting the brain itself. "Yes, it can cross the placenta and that's important because it tells you that whatever mom is exposed to can reach the developing fetus," said Rosenfeld. "But we're even seeing effects before it gets there."</p><p>Still, not all bisphenols necessarily behave the same way. For example, BPAF crossed the placenta more readily than other bisphenols highlighted in the new study. "We can't assume that what we know about BPA will translate to the other bisphenols," said Hunt.</p>
Searching for a safe replacement<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjg4MDczOC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY2MTQxNzQ3N30.OCiOGbnBWtVlfYx6iY0rXmBX64o0MRywY27vF7vPiVE/img.jpg?width=980" id="40b8f" class="rm-shortcode" data-rm-shortcode-id="3aa73247b405e0840eab915aa608c398" data-rm-shortcode-name="rebelmouse-image" alt="BPA replacements" />
Valspar cans. (Credit Lynne Peeples)<p>One newly developed bisphenol might prove a welcome change from its chemical cousins. Valspar, recently acquired by Sherwin-Williams, has created a <a href="https://www.ehn.org/bpa-substitutions-solutions-2641150667.html" target="_blank">replacement for food and beverage can linings historically made with BPA</a>.</p><p>Rather than just slightly tweaking the chemical structure of BPA, they assessed safety alongside functionality throughout the process. They enlisted academic scientists to test the compound, tetramethyl bisphenol F (TMBPF), for a range of endocrine disruptive activities. "The evidence is very encouraging," said Collins. </p><p>"Endocrine disruptors are having a dreadful impact on civilization," he added. "We need to give Valspar its due. But we also need to know more."</p>
The chemical BPA, an endocrine disruptor, is widely used in food packaging. Environmental Health News published a reported series showing that the U.S. Food and Drug Administration has stacked the deck against findings from independent scientists that link BPA to harmful human health effects, ranging from birth defects to cancer. Science journalist Lynne Peeples joins Host Steve Curwood to discuss this investigation and why even BPA alternatives may also not be safe.
Sometimes plastic recycling is so much worse than just letting trash be trash.
1. The plastic itself<p>Some toxics come from the plastic itself: The basic building block that is the core of a plastic molecule is sometimes demonstrably toxic. Bad for babies. Bad for adults. Bad for libido. Bad for fertility, brain function and a lot of other adverse effects people care about. For example, BPA is widely used as the "monomer" that is connected in a chemical chain to make a polymer, the very definition of plastic. So are BPS and many other "BPA-free" alternatives. The monomer BPA (and BPS etc.) is a <a href="http://bit.ly/BPA-CLARITY-CMU" target="_blank">notorious endocrine disrupting chemical.</a></p>
2. The additives<p>Some of the sources are additives (like phthalates that chemical engineers ooze into the plastic to force the plastic to attain specific characteristics, like softness or resistance to UV light or microbes). These additives aren't bound to the polymer so they ooze out of phthalate-softened <a href="http://bit.ly/RubberDuckDeath" target="_blank">PVC based Rubber Duckies</a>. Just right for infants to suck on if your goal is to <a href="http://bit.ly/2y2MvVX" target="_blank">suppress sperm count</a> once they become adults.</p>
3. The unintended ingredients<p>Then there is a complicated morass called "<a href="http://bit.ly/FPFonNIAS" target="_blank">nonintentionally added substances (NIAS)</a>." Some of these have been identified. Others we know are there but we don't know what they are. These usually are byproducts of reactions that take place as plastic is made. One problem is that to make plastic out of a feedstock that is absolutely 100% pure would be wildly expensive. So in the real world there are impurities. And these impurities react during the making of plastic to form NIAS. But other chemical processes produce NIAS even with pure feedstock. We know some NIAS are toxic, like formaldehyde and acetaldehyde in PET plastic. But for most we are ignorant. They could be safe, or they could be toxic.</p>
4. The environment<p>Lastly, <a href="http://bit.ly/2A04st4" target="_blank">plastic materials absorb toxic substances from the environment</a>, for example from ocean water. Some of these are notorious, like PCBs, DDT (still), dioxins, and others.</p>
Ignorance about toxicity<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjgwNjU5OC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY0Mzk2NjI1OX0.6siWGzgMgZuyAPMZuJihLU9L3ddn9AR8urICgaij_cU/img.jpg?width=1245&coordinates=0%2C260%2C0%2C260&height=700" id="7f9e0" class="rm-shortcode" data-rm-shortcode-id="a6a2ea5719d1b68b06ce03856ec416ec" data-rm-shortcode-name="rebelmouse-image" />
An epidemic of hormonally related diseases<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjgwNjkxMi9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYxMjg3MDE2Mn0.luIUq3kxPLkYqx4zdtcoym5marNmBqfufiwYEPOx4mY/img.jpg?width=1200&coordinates=0%2C110%2C0%2C110&height=600" id="92caa" class="rm-shortcode" data-rm-shortcode-id="7e57011e76f723ee514431f03067a026" data-rm-shortcode-name="rebelmouse-image" />
Not safe for food?<p>That means programs like Lidl's bring you food packaging that is unavoidably toxic.</p><p>Unless they have tested each batch. In which case, Lidl, show us the data.</p><p><a href="http://bit.ly/EHNJPMplastic" target="_blank">Many of the plans to gather plastic from the ocean and make something out of it fall victim to this basic truth</a>. Recycling possibly safe and toxic plastics together winds up with unquestionably toxic materials. We don't want that in our food supply because stuff in packaging migrates into the food we eat. Plastic recycling solutions that don't address the toxicity of the recycled product are part of future problems. Any entrepreneur or reporter who pretends otherwise is creating a serious problem for tomorrow.</p>
A serious problem<p>And this is why it's such a serious problem. The toxics in plastics are associated with declines in sperm counts so precipitous that the developed world may wind up with <a href="https://www.gmo.com/americas/research-library/chemical-toxicity-and-the-baby-bust/" target="_blank">4 out of 5 men infertile by 2040</a> or 1 out of 2 boys autistic by 2042.</p><p>This is a problem we have to take seriously, despite the feel-good sense we get from short-term solutions. Lidl investors should beware of the financial exposure this creates for the company. As we begin to understand the long-term consequences of plastic exposures, Lidl on its current path will not be on the right side of science, or history.</p>
Congresswoman Grace Meng (D-NY) was pregnant with her second child when she became concerned about the toxic chemicals that she and her kids — and nearly all of us — encounter every day.
BPA research in the lab of University of Missouri researcher and professor Cheryl Rosenfeld, who was a participating Clarity project scientist. (Credit: Cheryl Rosenfeld)<p> "It's disconcerting that the FDA is defending a position that doesn't reflect the newest science," David Michaels, a professor of environmental and occupational health at The George Washington University, told EHN. "At a minimum, they should be acknowledging the tremendous difference among scientists. Instead they are digging in and rejecting thousands of studies that aren't consistent with their position." </p><p> So, why the discrepancies, doubt and denial? For one thing, if the FDA were to acknowledge the low-dose health effects of BPA it could open a Pandora's box. Tens of thousands of manufactured chemicals are on the market, with hundreds such as BPA suspected to be endocrine disruptors, capable of scrambling hormone signals and, therefore, raising risks of health problems such as cancer, diabetes, obesity, infertility and behavioral problems. "It would force the agency to reevaluate its past work and would raise tremendous challenges to its work in the future," added Michaels. </p><p> The agency's behavior, he said, mirrors what he witnessed while serving as the U.S. Assistant Secretary of Labor for Occupational Safety and Health Administration between 2009 and 2017. "In general, the FDA often takes positions which are consistent with those demanded by industry," said Michaels. </p><h3><a href="https://www.ehn.org/bpa-chemical-comic-2640636344.html" target="_blank"><em>Related: Clouded in Clarity—A comic on chemicals & controversy</em></a></h3><p> The regulation of mercury levels in fish is one example highlighted by Michaels. While earlier consumption recommendations from the U.S. Environmental Protection Agency had reflected the newest scientific literature at the time, acknowledging that very low levels of organic mercury can affect the neurodevelopment of fetuses and young children exposed to contaminated fish, the FDA's position for many years was "much more consistent with the fossil fuel and fuel-burning industries responsible for much of the mercury that gets in the food chain," he said. </p><p> Further, while addressing issues related to cosmetics and beauty care products during his tenure with OSHA, Michaels recalled how hesitant the FDA was to "make any effort to control exposures to formaldehyde, which arises from exposure to Brazilian blowout," a hair-smoothing chemical treatment. </p><p> "We generally found FDA to be less responsive to public health concerns than we would have expected," he added. </p><p> The FDA declined to comment for this story. The agency was also reluctant to comment during "Exposed" reporting, frequently delaying responses and answering only select questions. </p>
A good idea, in theory<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjY3OTA3Ny9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYxMTYwNzI2NX0.nONrVDXIaKTa2s_-EHs_y3vwTdxY7Lhb5oE26wsVyM4/img.jpg?width=980" id="a6d6e" class="rm-shortcode" data-rm-shortcode-id="664710e5c1832006b785923378ae1a0c" data-rm-shortcode-name="rebelmouse-image" />
BPA is used in food can linings.<p>Wendy Wagner, a professor of law at the University of Texas at Austin who studies the use of science by policymakers, cheered the Clarity concept, but lamented its execution. The project may just be "round one of an experiment that needs more tweaking," she told EHN.</p> <p>Wagner emphasized the need to "break open the black box" and take a "hard look" at the process by which the FDA does science. On multiple occasions over the last few decades, she said, the government has manipulated the synthesis of the science. </p> <p>"I've seen dozens of reported incidences of that kind of political meddling," said Wagner. "It's usually not at the bench research stage, but in the literature stage — in the synthesizing for a report." EHN's reporting, too, found hints of how the FDA may spin results across studies. Of 36 studies identified as related to neurological endpoints in a 2014 risk assessment of BPA, for example, the agency chose to only include one. That study was funded by industry.</p> <p>Genna Reed, lead science and policy analyst in the Center for Science and Democracy at the Union of Concerned Scientists, echoed the same hope and concern. "It's important not just to fund these efforts but be thoughtful about the process by which these efforts are implemented and guided," she told EHN. </p> <p>Reed's team conducted a <a href="http://ucsusa.org/sites/default/files/images/2018/08/science-under-trump-report.pdf" target="_blank">survey</a> in 2018 that found FDA employees generally felt the agency adhered to its scientific integrity policies. However, they expressed feelings that it could "better insulate scientists from undue influence from political and business interests." </p> <p>The survey highlighted several issues regarding the agency's science-based decision-making processes, including evidence of the improper influence of political leadership and constraints resulting from workforce reductions.</p> <p>The Union of Concerned Scientists has also looked at the agency's Good Laboratory Practice regulations. While the guidelines were designed in an effort to reduce industry misconduct, Reed argued that studies following these practices "should not be given preferential weight over studies validated by other scientific review processes." Again, in the case of BPA, the FDA has excluded from its risk assessments a large body of studies from academics, who validate their studies through different means such as peer review. </p> <p>"We see so much BPA-free packaging all the time," said Reed. "The more questions that are raised by the public about these chemicals that are in our bodies and in the environment, and why they aren't being regulated by our government, the more likely it is for members of Congress in some key committees to take up this issue and figure out what the next steps are."</p>
Seeking oversight<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjY3OTA2Mi9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY1NTY2NDc1Nn0.D6ygOtMCJ62qpLvX3_sexhJ9H73PqLzjl4ImI6PQOsg/img.jpg?width=980" id="ff0e8" class="rm-shortcode" data-rm-shortcode-id="f1e7a04e2e3499b6d5d8f391c7ea8858" data-rm-shortcode-name="rebelmouse-image" />
Sen. Tom Udall, (D-N.M.) "The FDA should be using the best available tools, including expert career staff and scientific findings, to protect public health," he told EHN. (Credit: Senate Democrats)<p>Some political movement is underway.</p><p>Senator Tom Udall (D-NM) stated in an email to EHN that "Congress needs to provide strong oversight to ensure that the executive branch is serving the public good – and we must assert ourselves as a co-equal branch to ensure the public interest is the first priority in every decision that is made."</p><p>"The FDA should be using the best available tools, including expert career staff and scientific findings, to protect public health. However, under this administration we've seen agencies including the FDA and EPA do the bidding of special interests – at the expense of the public interest," he said. "As a member of the appropriations committee and as the ranking member of the Senate Appropriations Subcommittee on the Interior, Environment and Related Agencies, I will continue to provide oversight to ensure that our federal agencies are serving the American people."</p><p>Udall's spokesperson added that his team "will look into this issue more to see if there are actions Congress can take to better protect public health."</p>
We all want to live longer, healthier lives. We wish this, not only for ourselves, but for our children and grandchildren, too.
I'm the founder and chief scientist of Environmental Health Sciences, a nonprofit launched in Charlottesville, Virginia, that publishes Environmental Health News and engages in scientific research and outreach to help the public and policy makers understand that we have many opportunities to prevent diseases and disabilities that are afflicting our families, friends and neighbors today.
Risky investments<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjIxMTgyMC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY0NDQwOTgzMX0.CtcozyMN5TB4aHGj83E1lKpn9rvuHiV9y0gnt9kgGk8/img.jpg?width=980" id="4f49d" class="rm-shortcode" data-rm-shortcode-id="05b729eb87ed2fbd3cd3d85c9e2635fc" data-rm-shortcode-name="rebelmouse-image" />
3M made headlines this year for their manufacture and use of PFAS chemicals, which are contaminating water supplies across the U.S. (Credit: Holger.Ellgaard/Wikimedia Commons)<p> I am not anti-chemical, nor anti-chemist. We need chemicals, including plastics, to make modern civilization work. What we need, however, is to do a much better job at designing the next generation of inherently safer materials, safer than the mix we have today, which has been deployed with far too little attention to its inherent toxicity. </p><p> I've spent a significant part of my work over the last decade <a href="http://rsc.li/1It10BW" target="_blank">helping chemists design safer chemicals</a>. I want to help them grab market share in the booming demand for safer materials. I want to help them make money. </p><p> Some people claim that chemical regulations stifle innovation. Just the opposite is true. It will require tremendous innovation to move away from hazardous chemicals and toward materials that are safer. It can be done. The scientific knowledge we possess today about what causes chemical harm is deep and wide, so much better than what we knew when hazardous materials in widespread use today were designed. Let's use that knowledge to innovate. </p><p> What's the long-term landscape? A series of events and scientific discoveries over the last two decades are revealing that not only have long-standing chemical industry practices harmed people's health, investors taking positions in chemical companies may be exposing their wealth to unexpected and large financial risks. </p><p> These risks arise from a core reality of the business of establishing what is safe and what is not: Chemicals are not thoroughly tested—if at all—for safety before being released into the market, resulting in widespread if not universal exposure, including to highly vulnerable populations like babies still in the womb. Serious harmful effects often are not detected until decades later. </p><h3><em>Related: <a href="https://www.ehn.org/bpa-science-health-2641150585.html" target="_blank">Deciphering the real message about BPA</a></em></h3><p> All too often, as effects are discovered the responsible party—which made the initial mistake to incorporate a poorly understood chemical in products and take them to global scale—doubles down in efforts to hide or dismiss concerns about safety, using toolkits to <a href="http://bit.ly/MichaelsDoubt" target="_blank">manufacture doubt</a> developed by the tobacco and lead industries. </p><p> Internal memos obtained through legal discovery reveal that the companies, sometimes decades earlier, had ignored or hidden scientific evidence that raised safety concerns. Three prominent examples emerged in in the past few years alone: Monsanto/Bayer with the Roundup herbicide, Johnson & Johnson with asbestos in its talc baby powder, and 3M and DuPont with their manufacture and use of perfluorinated Teflon-related "forever" chemicals, PFAS. </p><p> Thousands of lawsuits are being heard against those companies now. Shareholder values plummet as juries reach decisions. Billions of dollars are at stake. And there will be more. </p><p>Monsanto had earned a bad rap for misbehavior with its chemicals for decades. But Johnson and Johnson, 3M and DuPont didn't. They had been widely regarded as good corporate citizens. If even <em>they</em> have laundry this dirty in their past, how many other companies have pursued similar practices? Unquestionably many.</p>
Weaponized data<p>But with the practices so widespread, perhaps the pertinent question is, can any company within this sector be presumed innocent? It's just too common a business practice. It's standard operating procedure.</p><p>Another example: Bill Moyers' 2001 documentary <a href="http://bit.ly/MoyersTradeSecrets" target="_blank">Trade Secrets </a>unveiled an early 1970s conspiracy by several seemingly respected chemical companies to hide devastating scientific discoveries about the health risks of vinyl chloride, one of the most important chemicals for the plastics industry. The conspiracy involved Conoco, BF Goodrich, Dow, Shell, Ethyl and Union Carbide, some of the founding fathers of the chemical revolution.</p><p>A new weapon against these bad practices has emerged and matured since the tobacco settlements of the late 1980s: the creation of large, searchable databases of internal documents obtained through legal discovery in lawsuits, showing what the companies knew and when they knew it, and also how they conspired with federal agencies to derail needed safety regulations. </p><p>The two biggest databases are the <a href="https://www.library.ucsf.edu/archives/industry-documents/" target="_blank">Chemical Industry Documents Library at the University of California San Francisco</a>, and <a href="http://bit.ly/ToxicDocsCUNY" target="_blank">ToxicDocs</a>, a similar database of 20 million internal documents dating back as far as 1920, hosted by Columbia University and City University of New York. The UCSF library now includes a large set of documents released by the Attorney General of Minnesota upon settlement of an $850 million suit against 3M last February.</p><p>The lawsuits currently underway against Monsanto/Bayer, 3M and Johnson & Johnson will undoubtedly add additional documents that provide yet more evidence of cover-ups that commenced long ago. It already is a positive feedback loop, as new documents add to the body of evidence, which then stimulate more lawsuits.</p>
Science of harm<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="242c23f913b8472697544cdd8fcefeca"><iframe lazy-loadable="true" src="https://www.youtube.com/embed/RvAOuhyunhY?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span><p>Financial risks arise for chemical industry investments from a different direction as well: the advance of science demonstrating harm, and the evolution of science to determine what is safe.</p><p>The discovery of harm can be slow arriving—sometimes decades after a chemical is first put on the market—but impacts of harm can nonetheless be devastating. </p><p><a href="http://bit.ly/PFASGrandjean" target="_blank">For example</a>, 3M's and DuPont's forever chemicals (perfluorinated compounds, or PFAS, which degrade very slowly in the environment, if at all) were first used in products in the 1940s. Scientific concerns about them started to appear in the 1990s, although internal documents indicate the companies had known decades earlier. Most of the concerns have been about cancer, low birth weights, immune system function and birth defects.</p><p>Last year, a science team in Italy <a href="http://bit.ly/PFASpenissize" target="_blank">unveiled results</a> revealing a new, different set of adverse impacts, this time on male reproduction. They include decreased penis size, reduced sperm count and structural changes in the reproductive tract, classic signs of endocrine disruption. And the team's research confirmed that the contaminants interfere with testosterone action.</p><p>Even without the penis effect, 3M settled that $850M suit with the State of Minnesota. DuPont settled a case in West Virginia for $671 million in 2017 and this month the film <em>Dark Waters</em> starring Mark Ruffalo tells the story of the company's decades-long treachery. New Hampshire, New Jersey and New York have ongoing lawsuits.</p><p>As of the end of 2019, research by the U.S. military, the Environmental Working Group and others have documented PFAS contamination in more than 400 sites around the U.S. According to one analysis, 110 million Americans have drinking water contaminated by unsafe levels of these chemicals. This estimate is likely to grow substantially with the discovery of <a href="http://bit.ly/TurfPFAS" target="_blank">PFAS in artificial turf and leaching therefrom into surface water</a>, and the <a href="http://bit.ly/JPMturfPFAS" target="_blank">haphazard disposal of untold tons of artificial turf</a> once it wears out and must be replaced.</p><p>Many other suits will unquestionably be filed. And that's just in the U.S. These chemicals have already created furors about public health in Australia and Canada.</p>
Upending dangerous assumptions<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjIxMTgyNi9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY1NTk3MDA1NX0.ExiTO_lFxXF0jylUZHB0ShkGMED8b9ibrLQsAVmAbz8/img.jpg?width=980" id="3a355" class="rm-shortcode" data-rm-shortcode-id="b9417f8c6972934768cb8caa26d3d86e" data-rm-shortcode-name="rebelmouse-image" />
Lab materials from the lab of Cheryl Rosenfeld, a University of Missouri professor and researcher who studies BPA. (Credit: Cheryl Rosenfeld)<p>But if there is an existential threat on the horizon for the chemical enterprise, it's the compelling evidence that two of the most basic assumptions used by regulatory agencies to determine what is safe and what is not are flat out wrong. One assumption is that it's sufficient to examine chemicals one at a time. The second bedrock assumption is that high dose testing can be used to detect low dose effects. These assumptions have underpinned literally every single risk assessment (what's safe and what's not) of a chemical that has ever been done anywhere in the world.</p><p>"One at a time" fails because it doesn't acknowledge that no one is ever exposed to just one chemical at a time. We are exposed to hundreds if not thousands. </p><p>What does every physician ask a patient for whom the doc is about to prescribe a drug? What medicines are you already taking? That's because chemicals interact. One of the most ridiculous uses of this assumption is perhaps in testing pesticides. The EPA tests the "active" ingredient of a pesticide. Yet the pesticide that is available for purchase is a mixture of dozens of chemicals, many of which are added to the product sold explicitly to <em>ENHANCE THE IMPACT OF THE ACTIVE INGREDIENT</em>. </p><p>How can you assess pesticide safety without considering the whole product, not just the active ingredient? You can't.</p><p>"High dose testing" falls on the sword of what endocrinologists call "<a href="http://bit.ly/NMDRCVandenberg" target="_blank">non-monotonicity</a>." Many syllables, but a simple concept: Hormones, and chemicals that behave like or interfere with hormones, do different things at different doses. There are many examples of this in the scientific literature of endocrinology, the study of hormones. This is an anathema to traditional and regulatory toxicology, because that "science" maintains that "the dose makes the poison," which the regulatory agencies interpret to mean "higher doses have bigger effects."</p><p>EHN recruited a reporter, Lynne Peeples, <a href="https://www.ehn.org/is-bpa-dangerous-for-health-2641153205.html" target="_blank">to investigate the FDA's execution of the roughly $30 million</a> project to reconcile their conclusions with the work of 14 independent academic labs showing harm at low levels for over a year. The investigation found that the FDA worked to ignore or discredit independent evidence of harm while favoring pro-industry science despite significant shortcomings. Key to their conclusions was rejecting statistically significant non-monotonic patterns in their own data, because, they asserted, the non-monotonic findings were not biologically meaningful. In other words, non-monotonic patterns aren't real. </p><h3><em>Related: <a href="https://www.ehn.org/is-bpa-dangerous-for-health-2641153205.html" target="_blank">How willful blindness keeps BPA on shelves and contaminating our bodies</a></em></h3><p>"The dose makes the poison" seems like common sense, but common sense has failed us many times in the past. Think about quantum physics or plate tectonics. Our understanding of the modern world depends upon the practical implications of those discoveries. Non-monotonicity isn't nearly as revolutionary as those scientific fields, but it is profoundly important for human health. And it is a standard, widely accepted concept in endocrinology and pharmacology. In 2012, the then-Director of NIEHS, Linda Birnbaum, <a href="http://bit.ly/BirnbaumNMDRC" target="_blank">editorialized</a> that non-monotonicity should be the default assumption in the study of EDCs.</p><p>While there are multiple molecular mechanisms leading to non-monotonicity, the easiest (but incomplete) way to think about it is this: Hormones and endocrine disrupting compounds turn on one set of genes at one dose, and another at higher. Sometimes the higher dose turns on genes that shut down the genes that were stimulated by the low dose. In this case, the effect of the low dose is not visible when using high doses. It's analogous to the way a thermostat works. If the room is cold, the furnace is on. But when the temperature hits the desired temperature, the thermostat turns the furnace off.</p><p>Sometimes the high dose is so high that instead of turning on genes it becomes overtly toxic. Here's an example: doses of one part per billion of a specific endocrine disrupting chemical delivered to an infant rat causes morbid obesity as the animal matures. This is research by the U.S. National Institute of Environmental Health Sciences. In contrast, a dose of the same compound 1,000 times higher causes weight loss.</p><p>The vital piece of information needed to understand why this invalidates today's chemical safety testing requires understanding how the regulatory tests are performed. The lab doing the safety testing starts at high doses and then delivers lower and lower doses to different test groups. Once they find a dose that no longer causes a difference between the exposed and the control animals, testing stops. They use a series of safety factors, usually dividing that no effect dose by 1,000, to estimate the safe dose.</p><p>Seems logical. Seems common sense. If dose X doesn't cause an effect, dose X divided by 1,000 is surely safe. But endocrinology doesn't work that way. That might defy common sense, but it is scientific reality.<br><br>And unfortunately, because it seems so logical, the regulatory agencies in standard mode NEVER test at the estimated safe dose. 1,000-fold below? Why bother.</p><p>To save money and time, they assume that the dose 1,000-fold lower is safe.</p><p>Unfortunately, <a href="http://bit.ly/NMDRCVandenberg" target="_blank">many published scientific papers</a> now show that doses way below the "no effect" dose can cause serious adverse effects. It isn't that the high doses are safer. They, too, cause problems. It's that the effects are different. The low dose effects are serious too—like morbid obesity and reduced fertility.</p><p>Here's the one very practical implication I mentioned at the beginning: If the FDA were to acknowledge statistically significant non-monotonicity in their test of BPA—which analysis by independent scientists has confirmed—the safe dose of would be reduced by a factor of more than 20,000-fold. BPA would become virtually unusable.</p><p>For a webinar from Carnegie Mellon University featuring four of the world's leading experts on BPA explaining this calculation, go <a href="http://bit.ly/BPA-CLARITY-CMU" target="_blank">here</a>. This webinar contains four presentations all focused on the FDA-NIEHS collaboration called CLARITY-BPA. The presentations work through why CLARITY was launched, what was found by the FDA 'guideline' study (conducted like a standard regulatory test but including low doses), what was found by 14 independent academic laboratories who also were part of CLARITY, and analysis of what it means.</p><p>Bisphenol A is one of the plastics industry's most important molecules. Incredibly cheap to make, incredibly abundant in production, incredibly important to the bottom line. Also—incredibly dangerous to human health. </p><p>Removing that one molecule alone would send tectonic signals throughout the chemical enterprise. And yet BPA is but one of at least a hundred or more molecules that have <a href="http://bit.ly/NMDRCVandenberg" target="_blank">non-monotonic patterns</a>. The replacement chemicals for BPA currently touted as 'BPA-free' are likely to be among them, although many have not been tested. 'BPA-free' does not mean 'safe.'</p><p>Non-monotonicity is truly an existential threat to today's chemical enterprise. If that enterprise is to become sustainable, it must embrace this basic endocrinological reality.</p><p>Embracing it is a path to reversing today's epidemics of chronic diseases that are driven, at least in part, by chemical hacking of the hormone messaging system by endocrine disrupting compounds. </p><p><em>Pete Myers, is board chair and chief scientist of Environmental Health Sciences. He is also the founder of EHN, though the publication is editorially independent.</em></p>
Tests used by the federal government to determine how much of the chemical bisphenol A is in people's bodies have "dramatically underestimated" our exposure, according to an analysis published today.
Latest concern on federal testing<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjEzMzgzNi9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYwNzg2Njg2OH0.ZdCm8oVcj6kQ3X5k_fE3JnW7vZQV5OQsGFSFQNIwP_8/img.jpg?width=980" id="648be" class="rm-shortcode" data-rm-shortcode-id="b24525dd36e5408cceacb76ad81a5047" data-rm-shortcode-name="rebelmouse-image" />
Researcher Pat Hunt with lab mice. (Credit: Lynne Peeples)<p>EHN last month published a <a href="https://www.ehn.org/is-bpa-dangerous-for-health-2641153205.html" target="_blank">year-long investigation</a> of the U.S. Food and Drug Administration's handling of BPA science. It found a "willing blindness" to modern science techniques on endocrine disrupting compounds, concluding U.S. regulators may be operating at the fringes of scientific integrity, possibly with the intent to keep the current testing and regulatory regime intact and to avoid scrutiny.</p><p>The investigation, using hundreds of emails obtained via the Freedom of Information Act and dozens of interviews, showed:</p><ul><li>FDA and industry scientists continue to use decades-old study methods that fail to detect effects known to be associated with BPA exposure;</li><li>Emails between federal employees suggest an effort to ignore evidence of harm;</li><li>Biased data interpretation methods by the FDA;</li><li>Sharp disagreement between the FDA regulators and health officials at the National Institutes of Health on the safety of BPA and what messages are relayed to the public.</li></ul>
Tests yield wide disparity<p>The new analysis found wide gaps in BPA exposure levels when comparing the direct testing versus the old method. For example, the researchers compared the urine of 29 pregnant women in their second trimester using both methods. Using the direct testing, they found the average level of BPA was 44 times higher than the average for adults in the latest National Health and Nutrition Examination Survey. When they used the old, indirect method of testing, the average BPA level was 19 times lower than the direct test. "Importantly, disparity between indirect and direct results increased substantially as exposure increased," the authors wrote.</p> <p>The indirect tests have provided the "bulk of data on human BPA levels," the authors added. So, the new analysis puts a question mark on a large chunk of the data that has been used to tell us we're safe from a chemical that is pervasive in our lives, our bodies, and the bodies of our developing children. </p> <p>Vandenberg said chemicals in the U.S. undergo three major steps in testing: a hazard assessment to see at what levels it causes health impacts; an assessment to see how much of the chemical is in food and products and how much we're exposed to; and then a lab assessment—based on people's exposures—to again check for health effects. </p> <p>"If exposure assessment say people are exposed to piddly amounts and they're not" it throws off the entire assessment, she said. </p> <p>Hunt said this highlights the "need for standards to measure [metabolites] directly. We always have standards for parent compounds, but having standards for metabolites is key to measuring them as accurately as possible." </p> <p>"Like everything else, science moves forward, and the new direct method is the best method available," Hunt said. "There's an urgent need to go back and reanalyze the data from [previous national surveys] or conduct new studies to see how highly exposed humans are." </p>
We all are exposed daily to bisphenol-A (BPA) and other bisphenols – estrogen-like substances added to food can liners, paper receipts and plastic containers.
Part 1: Scientific stalemate over BPA impacts on our body<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA1MjE5NC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY2MjE2NzYxOH0.V8HM7lloKcT1JcbDwSlSM9C81XdQ5_CcJvuCdHEggYg/img.jpg?width=980" id="d6ac9" class="rm-shortcode" data-rm-shortcode-id="43234b09633b4d8c676febf605f3e369" data-rm-shortcode-name="rebelmouse-image" alt="Researcher pipets scientific sample" /><h3><a href="https://www.ehn.org/bpa-impact-on-human-health-2641134273.html" target="_blank">A scientific stalemate leaves our hormones and health at risk</a></h3><p>American industry, aided by federal regulators, is conducting a large-scale, consequential experiment with our hormones and the developing brains and reproductive systems of our children.</p><p><br></p>
Part 2: BPA explained, as a mini graphic novella<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0OTg2OS9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY0NjkyMTM5OH0.nAw3cqo3-nBsYEFUSV5zD2VWyN9EUH-mR3fxvqyHCRc/img.jpg?width=980" id="b0f94" class="rm-shortcode" data-rm-shortcode-id="8bdcff5eac60d6b02a564bba0ef56a99" data-rm-shortcode-name="rebelmouse-image" /><hr><h3><a href="https://www.ehn.org/bpa-chemical-comic-2640636344.html" target="_blank">Clouded in Clarity: A comic on chemicals & controversy</a></h3><p> The ongoing health concerns and mixed messaging over the chemical BPA<br> </p><p><br></p>
Part 3: BPA research honesty<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0OTg0NC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYxNTQ1MDg5OX0.uiPUmnwlyJu0PZ_RZpSAopIWd3C7mzer5O0DacPs1oQ/img.jpg?width=980" id="272f1" class="rm-shortcode" data-rm-shortcode-id="5f4b9868b86f84a3e126f0ff79059f46" data-rm-shortcode-name="rebelmouse-image" /><h3><a href="https://www.ehn.org/bpa-science-fda-safe-2641150483.html" target="_blank">On the edge of research honesty</a></h3><p>Is a federal study of BPA contaminated by questionable motives, methods?</p><p><br></p>
Part 4: Federal BPA standards decades past their expiration date<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0OTg0Mi9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYyMTYyNzYzNX0.UGBDSFJWrEDY3Flz9fCy4BLvZiKU_y7VBI4hGTgGbHA/img.jpg?width=980" id="93016" class="rm-shortcode" data-rm-shortcode-id="b7e6c887f8828939c710593f164282e1" data-rm-shortcode-name="rebelmouse-image" /><h3><a href="https://www.ehn.org/bpa-science-health-2641150585.html" target="_blank">Deciphering the real message about BPA</a></h3><p>"The government keeps testing chemicals for safety using the same old approaches developed 50 years ago"</p><p><br></p>
Part 5: A BPA-free future<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0OTg0MC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY2MjEyMzg4NH0.CKQWWony53Ed6g1pej_RmpWUHxVmrwGU4wnp9eHWSGY/img.jpg?width=980" id="2c3ad" class="rm-shortcode" data-rm-shortcode-id="e64d74c296132a73dd441311c4f21585" data-rm-shortcode-name="rebelmouse-image" /><h3><a href="https://www.ehn.org/bpa-substitutions-solutions-2641150667.html" target="_blank">Toward a BPA-free future</a></h3><p>What will it take to rid our store shelves of BPA and its equally hazardous cousins?</p><p><br></p>
Follow up BPA coverage<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjEzNjAyNi9vcmlnaW4ucG5nIiwiZXhwaXJlc19hdCI6MTY1MjkxMTc5N30.w2GjVqF8hnA1YTtfguSfj2bhIaCHt1i6jStEfdu467c/img.png?width=980" id="8975e" class="rm-shortcode" data-rm-shortcode-id="b65a9ea3205de483c50c120e5efd8b4a" data-rm-shortcode-name="rebelmouse-image" /><h3><a href="https://www.ehn.org/how-much-bpa-in-our-bodies-2641524955.html" target="_blank">Federal tests 'dramatically' undercount BPA and other chemical exposures</a></h3><p>Researchers say federal agencies use highly inaccurate tests to estimate exposure to BPA—findings that extend to multiple other harmful chemicals that get into our bodies</p><p><br></p>
This is part 1 of a 4-part investigation of the science surrounding the chemical BPA and the U.S. regulatory push to discredit independent evidence of harm while favoring pro-industry science despite significant shortcomings.
University of Massachusetts-Amherst environmental health scientist Laura Vandenberg. (Credit: Umass.edu)<p>"Endocrine disruptors are harming people and we're not regulating them to any extent right now," Carol Kwiatkowski, executive director of The Endocrine Disruption Exchange, a nonprofit research institute that advocates against the production and use of chemicals that interfere with healthy hormone function, told EHN. </p><p>"A lot of endocrine scientists have been banging their heads against that wall for a long time and haven't made any progress in changing the risk assessment process."</p><p>It is clear that the FDA is not using modern science in protecting the public from potentially toxic chemicals. It is also clear that BPA and other endocrine disruptors threaten to disrupt the status quo of toxic chemical regulation. "BPA creates a tipping point," Laura Vandenberg, an environmental health researcher at the University of Massachusetts-Amherst's School of Public Health, told EHN. "If the FDA finds out that they have been wrong about BPA — or wrong about how they evaluate chemicals for safety — that means they are wrong about the 10,000 other chemicals behind BPA in line for the same sort of evaluation."</p><p>Vandenberg, who is not involved in Clarity, is among scientists skeptical that the groundbreaking effort will result in a fair assessment of BPA. The FDA, she said, has "a vested interest in not being wrong."</p>
Imposter's poster child<p>In the 1930s, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2774166/" target="_blank">a British medical researcher discovered</a> that BPA could mimic the activity of estrogen — a female sex hormone — in the human body. The chemical was briefly considered for use as a pharmacological hormone but ultimately lost to another synthetic estrogen, diethylstilbestrol (DES). While DES was prescribed to millions of pregnant women over the next 30 years before its own health risks became known, BPA was never turned into a drug.</p><p>Its future would instead be in the chemical industry.</p>
Cheryl Rosenfeld, a biologist at the University of Missouri and another Clarity investigator. (Credit: University of Missouri)<p>Beginning in the 1950s, BPA became a key ingredient in polycarbonate plastic and epoxy resins — finding its way into everything from Tupperware to the lining of food cans. "That's where the problem starts," Ana Soto, an endocrinologist at Tufts University and another Clarity investigator, told EHN.</p><p>The FDA officially approved BPA for use in food and beverage containers in 1963. They classified it as a "generally regarded as safe" (GRAS) compound, since it had already been around for a few years and there was no obvious evidence of harm. By the late 1980s, the U.S was producing nearly a billion pounds of BPA a year. Even scientific laboratories began working with BPA-laden instruments. In 1993, endocrinologists at Stanford University discovered that BPA was leaching from polycarbonate flasks in their laboratory.</p><p>The first published studies to raise concern about BPA's low-dose health effects came a few years later, in 1997. Frederick vom Saal and his colleagues had found exposure to tiny amounts of BPA altered the prostates and reproductive systems of laboratory mice. Vom Saal, a professor of biology at the University of Missouri-Columbia and another Clarity investigator, warned viewers in a February 1998 episode of <a href="https://www.pbs.org/wgbh/pages/frontline/shows/nature/interviews/vomsaal.html" target="_blank">PBS's Frontline about the threat posed by endocrine-disrupting chemicals</a> used in plastics and other consumer products.</p><p>"We understand now, with new techniques, that, in fact, cells are extremely responsive to these chemicals," vom Saal stated on the show. "What you have now is clearly enough scientific information to warrant concern and a change in the regulatory approach to these chemicals." Concern grew, as did the body of research.</p><p><a href="https://ntp.niehs.nih.gov/ntp/ohat/bisphenol/bisphenol.pdf" target="_blank">By 2008</a>, enough evidence had accumulated that the NTP labeled the chemical as possibly harmful for babies. Canada responded by declaring BPA toxic and manufacturers across North America, including baby bottle and sippy cup makers, started phasing it out of their products. Wal-Mart, REI, Lululemon, Toys-R-Us and other retailers, too, began pulling products with BPA off their shelves. The market was soon flooded with BPA-free products — although most of the substitutes that landed in stores share similar chemistry with BPA and pose similar health concerns.</p><p>"The science is growing exponentially. We can't keep up with it," said Kwiatkowski, of The Endocrine Disruption Exchange. "And we have to take it all very seriously, because the preponderance of endocrine-related disorders in humans today is just skyrocketing."</p>
Researchers Fred vom Saal and Wade Welshons at their University of Missouri lab. (Credit: Brian Bienkowski)<p> Jennifer Sass, a senior scientist with the Natural Resources Defense Council, said that the guidelines are "a good starting point to see if there's evidence of harm," and "allow regulators from Japan to Sweden to North Africa to look at data the same way." However, she added, these guidelines "should not be used to eliminate evidence of harm." </p><p> Such standardized studies can also be pricey to conduct, often beyond the budgets of academics. And the FDA's traditional targets for tests, such as weighing organs and looking for other overt signs of toxicity, generally do not consider the unique effects of endocrine-disrupting chemicals — some of which can be subtle such as behavioral changes or infertility years down the road. </p><p> "You can't weigh a brain to find out what is going on in there," Soto said. </p><p> In 2001, the <a href="https://ntp.niehs.nih.gov/ntp/pressctr/mtgs_wkshps/2000/lowdosepeerfinalrpt.pdf" target="_blank">NTP appeared to agree</a>. They concluded in a report that published studies had provided evidence for the effects of BPA exposure at or below the safety standard set by the FDA. And they recommended a reconsideration of the current testing paradigm. </p><iframe src="https://e.infogram.com/e9cd60bd-fe58-4634-b91c-668d293885aa?src=embed" title="BPA swimming pool" width="700" height="273" scrolling="no" frameborder="0" style="border:none;" allowfullscreen="allowfullscreen"></iframe><p> The plastics industry pushed back, funding the Harvard Center for Risk Analysis, a group that had received financial support from chemical companies in the past, to do a separate review of the literature on BPA. That assessment determined that only two large studies—both funded by industry—were relevant and reliable enough to consider. Both studies would go on to make regular appearances in subsequent FDA reports. </p><p> Doerge was a co-author on FDA's most recent safety assessment of BPA, released in 2014, which reaffirmed its position that the chemical is safe at levels of exposure from food contact uses. "No new information was identified to suggest revision of the existing safety assessment level," <a href="https://www.fda.gov/media/90582/download" target="_blank"> wrote the authors</a>. </p><p> The report was an update of the agency's <a href="http://docplayer.net/102806848-Scientific-peer-review-of-the-draft-assessment-of-bisphenol-a-for-use-in-food-contact-applications.html" target="_blank">2008 assessment</a>, for which the FDA relied heavily on the same two industry-funded guideline studies considered in the Harvard group's analysis and discarded hundreds of non-GLP studies published by academics that nonetheless found low-dose effects of BPA. </p><p> An external <a href="https://www.researchgate.net/publication/237734993_Scientific_peer-review_of_the_draft_assessment_of_bisphenol_A_for_use_in_food_contact_applications" target="_blank">FDA committee had even reviewed the 2008 report and disagreed</a> with the agency's decision to exclude those other peer-reviewed papers. "The draft FDA report does not articulate reasonable and appropriate scientific support for the criteria applied to select data for use in the assessment," they wrote. "Specifically, the Subcommittee does not agree that the large number of non-GLP studies should be excluded from use in the safety assessment." </p><iframe src="https://e.infogram.com/f013adea-774f-4e13-86e8-8408f9cdcd61?src=embed" title="Annual health costs" width="700" height="676" scrolling="no" frameborder="0" style="border:none;" allowfullscreen="allowfullscreen"></iframe><p> Of note: A <a href="https://www.ncbi.nlm.nih.gov/pubmed/16256977" target="_blank">2006 analysis</a> found that 11 out of 11 industry-funded studies found BPA had no significant action, while 109 of 119 studies that had no industry funding did find effects of BPA. </p><p> Yet those industry-funded studies tend to use more expensive GLP protocols and qualify as guideline studies. "The non-guideline studies are basically ignored. To me, that's like wearing blinders," said Birnbaum. "Science has continued to advance, and I think there are questions that we really didn't know about 30, 40, 50 years back that people are asking today." </p><p> "If you don't ask the question, you're not going to get the answer," she added. </p><p> Jerry Heindel, the health scientist administrator at the National Institute for Environmental Health Sciences (NIEHS) when Clarity was initiated, agreed. "Maybe these guideline studies aren't as gold standard and terrific as people have thought," he told EHN. "Problem is, the endpoints are so simplistic and old-fashioned." </p><p> But he and other scientists also acknowledge that the FDA has an extremely high bar to justify adoption of new approaches, let alone bans on a chemical. Regulatory agencies are in a tight spot and have to first ensure they can't be sued, added Heindel, who retired from NIEHS in 2016 and founded Commonweal's Healthy Environment and Endocrine Disruptor Strategy (HEEDS), a hub for scientists working on endocrine disruptors. "If they come out and say a chemical is toxic and we need to ban it," he said, "then they have to feel confident they have the data that will stand up in the court of law." </p>
Deepened divide<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0ODU5NC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYyNDQ0MDU0Mn0.khmBkEbxU5QMefYsIoFB56pO1nQ8T_PFtxd1YOJ2bdU/img.jpg?width=980" id="8f5c4" class="rm-shortcode" data-rm-shortcode-id="33edf4dd8bc3fc4a517710831108edeb" data-rm-shortcode-name="rebelmouse-image" />
Gail Prins, a researcher at the University of Illinois at Chicago and Clarity investigator (right). (Credit: uic.edu)<p> On February 23, 2018, upon completion of the draft version of the government's Clarity Core Study, <a href="https://www.fda.gov/news-events/press-announcements/statement-stephen-ostroff-md-deputy-commissioner-foods-and-veterinary-medicine-national-toxicology" target="_blank" rel="noopener noreferrer">the FDA released a public statement</a>, suggesting that the findings supported its position that "currently authorized uses of BPA continue to be safe for consumers." </p><p> The move stirred significant press, mostly reassurances to the public of the chemical's safety; FDA's collaborators were not pleased. Some suggested that the very agency responsible for ensuring our safety is actively working to avoid dealing with a massive experiment that is disrupting our hormones from birth. </p><p> "I smell a big fat rat here," Gail Prins, a researcher at the University of Illinois at Chicago and Clarity investigator, wrote in an email to Nigel Walker of NIEHS after learning of the statement. "The FDA is not playing fair." </p><p> Walker, a toxicologist who helped lead Clarity, responded by sending a scathing email to officials at the FDA. Members of that agency's upper management, he wrote, were "reneging on their own values in regulatory science," and "using the Clarity core study as a quasi-definitive human risk assessment document to affirm the current FDA policy on safety of BPA." In additional emails obtained by EHN, Walker went on over subsequent days to write of FDA officials' "shenanigans," calling their actions "disingenuous" and "disrespectful." He referred to himself as "peeved." </p><p> He also made a point to state that he had no conflicts of interest himself: "I don't have a horse in this race," wrote Walker. </p><p> The FDA declined to comment on the statement, or on the subsequent criticisms from collaborators. A culture clash of sorts continues between the FDA and NIEHS. Multiple scientists with the latter agency shared similar sentiments about the FDA's conduct in Clarity. Walker declined a phone interview but stated in an email to EHN that "there may from time to time be disagreements on various issues or topics." </p><p> Birnbaum said that while she was not surprised by the FDA's conclusions from the government's portion of Clarity — it was, after all, consistent with their historic stance on the chemical's safety — she did not share their opinion. "I think we reserve the right to disagree, respectfully," she said. And Bucher of the NIEHS and NTP offered his take: "The FDA conclusions are the FDA's view of how they look at data from these kinds of studies... To us, it would be more valuable to try to integrate this information and then come up with statements as to interpretations." </p><p> In September 2018, the government released the final version of its Core Study report. The FDA also advertised and hosted a webinar to detail their findings, which was preempted by outside academics who held their own webinar to present contrasting conclusions. The academic webinar was organized and moderated by Myers of Environmental Health Sciences.</p>
Webinar: CLARITY-BPA: Achieving clarity on low dose effects of bisphenol A<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="45e4d88777bd7a42be7214f9b244c404"><iframe lazy-loadable="true" src="https://www.youtube.com/embed/Dkiefk-hGps?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span><p>As expected, the <a href="https://www.ehn.org/bpa-harmful-at-low-levels-2604683710.html" target="_self">government's report stated that exposing rodents to BPA resulted in some health effects at high doses but not at the low doses</a> to which people are generally exposed. <br></p><p>Hentges, of the ACC, praised the report. "The scope and magnitude of the FDA study are unprecedented for BPA, and the results clearly show that BPA has very little potential to cause health effects, even when people are exposed to it throughout their lives," he told EHN in an email. (The ACC declined multiple requests for a phone interview.)</p><p>But that is not exactly what the government's data said, even if that sentiment was reflected in the FDA's early press release.</p><p>"They have a bunch of data that says BPA is doing something. But they're ignoring that data," Patisaul, the North Carolina State University biologist and Clarity investigator, said.</p><p>This March, Vandenberg co-authored an opinion paper with two other scientists also not involved in Clarity, to see what data the feds may be missing. After a close look at the government's Core Study results, they identified 41 endpoints with statistically significant effects. As with the academics' studies, the lowest doses were associated with the greatest number of effects, such as mammary gland cancer, kidney damage, increased body weight and altered gene expression in the brain. "There are a lot more effects at low doses than high doses. A lot more," Vandenberg said. "It's hard to ignore that and say everything is fine here. Even the FDA's own data suggests there is harm."</p><p>During another session at last September's EFSA meeting in Italy, Barry Delclos, a biochemical toxicologist with the FDA, responded to a question from Patisaul regarding these low-dose results. He answered that his team had looked to see if "consistent responses" would explain the statistically significant results they had found. "We didn't feel that was the case," he said. Delclos also stated in the September 2018 webinar that his team questioned the biological significance of findings that didn't fit a consistent dose-response relationship.</p><p>The frustrations of academics and health advocates, as well as of FDA scientists, is tangible. Patisaul argued that Delclos, Doerge and their colleagues are in their "own echo chamber," doing the "same thing they are accusing everyone else of doing," and unwilling to recognize that their science might be outdated. Doerge went on during the EFSA panel discussion: "You come to someone that has all the responsibility mandated by law to protect the public from this or that, and you're saying, 'Oh, these basic tenets that you've used to do your job for all these years is no longer valid. Dose-response doesn't exist any longer,'" he said. "This is a fundamentally unbreachable barrier, in my opinion."</p><p>In the 1998 PBS interview, vom Saal detailed a "distinct pattern" that comes with any paradigm shift in science — especially one, he said, that could impact billions of dollars of profits for chemical companies. "The first thing is absolute denial," he said. "The second is a feeling that it may be true, but it's only true in very limited circumstances. The third is, it's true but the economic consequences are so great that we can't do anything about it."</p><p>Lisette van Vliet, a senior policy coordinator with Breast Cancer Prevention Partners, a San Francisco-based nonprofit, likened it to the times of Galileo. "A bunch of scientists were saying the Earth is the center of the universe; other scientists were saying the sun is the center," she told EHN. "They were using very different ways of ascertaining reality."</p><p>"These paradigm fights tend to be long and protracted and don't always have a complete 'aha' moment," said van Vliet. "The Clarity study was as good of a stab as anyone could make… The integrated final version of the study is going to be a really important point in this discussion, but it is not going to be the end of the story. And, meanwhile, public health will suffer because of continued exposure to this harmful chemical."</p><p><em>In <a href="https://www.ehn.org/bpa-science-fda-safe-2641150483.html" target="_blank">part 2</a> of this series, EHN details how the FDA operates on the edge of research honesty, inconspicuously misleading the public with regard to the testing and regulation of BPA.</em></p>
Harmful chemicals are difficult to understand. So, to pair with our investigation, "Exposed" we present EHN's first comic, "Clouded in Clarity," which focuses on BPA and the controversy around an ongoing, massive study on it.
This is part 2 of a 4-part investigation of the science surrounding the chemical BPA and the U.S. regulatory push to discredit independent evidence of harm while favoring pro-industry science despite significant shortcomings.
Strains on relationships<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0ODc4MC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY2MDExMzI4OX0.8pvn4LXTlU9pEgh_AMVzUDh0HKjOOa9CRUlMDbDP-U0/img.jpg?width=980" id="07122" class="rm-shortcode" data-rm-shortcode-id="3578f1f88e62f6c909047c95c7875996" data-rm-shortcode-name="rebelmouse-image" />
The lab of Cheryl Rosenfeld, a biologist at the University of Missouri and another Clarity investigator. (Credit: Cheryl Rosenfeld)<p> Ila has just returned from her first puppy training class as I arrive at Hunt's home in Moscow, Idaho. Labradoodles are known to have a lot of energy, and Ila's bouncy greeting of this newcomer corroborated that reputation. Hunt tells me she is surprised Ila has yet to hurdle the childproof gate that separates the mudroom from the dining room. "I keep thinking she could hop over it so easily, but she just never does," says Hunt. </p><p> Other dog breeds may be calmer, but Hunt and her husband had good reason to go with a labradoodle: The breed sheds less fur and other allergy-triggering substances than other breeds. "We had a lab once before and the hair was everywhere, and our allergies were terrible," she says. Sure enough, I made it out of her house without any of Ila's dark brown fur. </p><p> Like dogs, lab animals can be diverse in their behavior and biology. </p><p> To determine the impact of a chemical, scientists track various changes, called endpoints, in an animal such as organ weight, tumor development, changes in behavior or insulin levels. Different strains of different rodents are often used in different studies. Hunt and many others who investigate the impacts of hormones and hormone mimics often opt for strains of mice. For one, the animals can be more practical — they eat less and take up less space than rats. Certain strains of mice are also known to be particularly sensitive to hormone changes. </p><p> "If your animal model can't respond to your experimental manipulation, then you can never determine if the manipulation does anything, ever," Scott Belcher, a biologist at North Carolina State University, and a Clarity investigator, told EHN. </p><p> Belcher, too, tends to use mice in his studies of impacts on the heart. "Rats and mice aren't the same things," he said. </p><p> The FDA's go-to animals for chemical toxicity testing are Sprague-Dawley rats bred at the FDA's National Center for Toxicological Research in Jefferson, Arkansas. These were the animals chosen for Clarity, despite objections from some academic investigators. The rats <a href="https://academic.oup.com/biolreprod/article/89/5/108,%201-10/2513941" target="_blank">have long been used</a> in government regulatory studies, and they have long been known to have low sensitivity to BPA. </p><h3><em>Related: Want this story in comic strip form? Check out <a href="https://www.ehn.org/test-comic-post-2640636344.html" target="_blank" rel="noopener noreferrer">"Clouded in Clarity"</a></em></h3><p> Jerry Heindel, the health scientist administrator at NIEHS when Clarity was initiated, noted one particularly unusual characteristic of the rats. "Estrogen stimulates puberty in a female animal. You can generally make puberty come up two, three days earlier by giving an animal extra estrogen," he told EHN. "But in this animal, you can't." A couple days early is relatively significant for an animal that, on average, hits puberty at 38 days. </p><p> "So some endpoints are going to be insensitive or much less sensitive. There's no getting around that," said Heindel. (The FDA did not respond when asked about the choice of study animal.) </p><p> Of course, animal studies all have their limitations. The only way to be relatively sure of a chemical's effect in humans would be to study the effect of that chemical in humans. In a first-of-its-kind study published in 2018, <a href="https://www.ehn.org/bpa-linked-to-diabetes-2604258226.html" target="_blank">researchers exposed a small group of people to a very small amount of BPA</a> and saw a link to a precursor of type 2 diabetes. The researchers first lowered participants' BPA levels and then brought those levels back up to the normal range. (Myers was an author on the paper.) Still, to knowingly expose people to something suspected of being harmful can raise some ethical concerns. Epidemiological studies do the next best thing — they take advantage of the natural experiment currently underway by estimating levels of exposure and health outcomes in people and then determining if and how the measures might be related. </p><p>In his epidemiological studies, John Meeker, an environmental health scientist at the University of Michigan School of Public Health, has uncovered evidence that BPA may alter circulating levels of hormones and birth outcomes. He laments how regulators have remained reliant on animal toxicology studies. "We need more harmonization of animal and human research in the regulatory setting," he told EHN.</p><p>Both research methods have their place. Toxicology studies allow scientists to directly compare exposed and unexposed animals, control the experimental environment and precisely measure outcomes. Meeker noted that his epidemiological findings do not always match up with toxicology studies. "When they do match up, it gives you more confidence," he said. "When they don't, it could be due to chance in human studies or due to species differences in their responses to exposure."</p>
Thomas Zoeller, a biologist at the University of Massachusetts, Amherst, and Clarity investigator in his lab. (Credit: Umass.edu)<p>Thomas Zoeller, a biologist at the University of Massachusetts, Amherst, suggested such species differences resulted in what he called "unprecedented" findings in his Clarity study. "This is a very odd strain of animal," he told EHN.</p><p>For a century, explained Zoeller, researchers including himself have studied the impact of thyroid hormone insufficiency on brain development in animal models. "Nobody sees a lack of effect," he said. Zoeller treated some of his Clarity rats with a medication used for hyperthyroidism, propylthiouracil, that suppresses thyroid activity. And while it did succeed in altering thyroid hormone levels, as expected, the brains of his rats appeared almost unfazed.</p><p>"The data that we have show that these animals are different," added Zoeller. "They may just be different with respect to the thyroid system. But I doubt that." He suggested that because the strain was selectively bred to be prolific breeders over many generations, other changes likely accompanied the increased fecundity.</p><p>The impact of species differences can go both ways, explained Patrick McKnight, a measurement scientist at George Mason University in Fairfax, Virginia. Using a model animal that is overly sensitive to the agent of interest can artificially inflate the size of an effect, he told EHN.</p><p>Still, Linda Birnbaum, former director of the NIEHS and the NTP, shared the academics' concerns. "When we started this study, I remember having nightmares thinking, 'What happens if we don't find anything?' Because we really didn't have much data on using this strain of rat and BPA," she told EHN. "In retrospect, if I were to do this study again, I probably would've done it in mice and I probably would've used a strain which had been reported to have clear effects."</p><p>Vandenberg added her worries. "Why are we using this strain to test all chemicals if we now have evidence that it is not the right strain?" she added. "Have we made a mistake on everything?"</p>
Power struggles<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0ODgxMy9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY2NTg3MDk1MX0.Ajkue-WmoQs_fHxoHv0n2JV0tN_6rMJeMQjAfflLoOI/img.jpg?width=980" id="8ad57" class="rm-shortcode" data-rm-shortcode-id="2616c241866658111b05c13b25d6a407" data-rm-shortcode-name="rebelmouse-image" />
Linda Birnbaum, former director of the NIEHS and the NTP, speaking at Northeastern University's Our Environment, Our Health event in 2016. (Credit: Matthew Modoono/Northeastern University)<p>Even when assuming a chosen animal is a reasonable model to test a chemical of interest, the next critical factor for a successful study is enlisting a large enough number of those animals to detect health effects if there are effects to be detected. The more animals, the more so-called statistical power a study has to reveal the true effects of a chemical. </p><p> Prins believes that the FDA shortchanged her on animal numbers. She had determined prior to the study that she would need at least 18 animals per treatment group to have adequate power to detect differences between the groups. Yet for one of her treatment groups she received just four animals. "When you get that number of animals, you can't get a significant effect," Prins told EHN. "I would go out on a limb and say this was done intentionally." </p><p> In a 2008 federal review of the evidence on BPA, the FDA excluded a study of hers from their risk assessment because, in part, her study didn't include enough animals. That FDA assessment, which ended up relying on just two studies — both funded by industry — restated the agency's stance that BPA is safe. </p><p> "The FDA wants to tell a story," said Prins. "They want to tell the story that BPA is fine. And it's not." </p><p> Another Clarity researcher, Jodi Flaws, struggled with a similar power problem in her Clarity research. She ended up with just three animals in one of her treatment groups, Flaws told EHN, because the tissue sent to her by the government was not collected on the same day of the animals' menstrual cycle — a critical detail that she had requested. </p><p> Her team still managed to publish a paper with their results, which indicated that BPA exposure at some doses altered hormone production and the number of developing eggs in female rats. But she told EHN that the small number of animals underpowered them to see the stronger results in Clarity that they had seen in their prior studies. </p><p> "There was no way to make sense of anything," said Flaws, who studies genetic and environmental factors that affect the female reproductive system at the University of Illinois at Urbana-Champaign. (The FDA did not respond to a question regarding the number of study animals provided some researchers.) </p><p> John Bucher, a senior scientist with NTP and NIEHS, and one of the Clarity leads, acknowledged this shortcoming of Clarity. "We recognize that some of the investigators didn't get as many samples as they would have liked. And that's regrettable," he told EHN. "This was an enormously complicated study and we tried to accommodate as many requests as possible.... We probably overpromised." </p>
Heather Patisaul, a professor of biology at North Carolina State University and a Clarity investigator. (Credit: NCSU)<p>"The fact is, they don't know where the contamination came from and they don't know if the Clarity controls were contaminated," said Zoeller. "They didn't measure it."</p><p>"If you can't ferret it out, it's like shooting yourself in the head before you even start the study," added Hunt.</p><p>Birnbaum expressed little concern about that potential contamination. "When we deal with environmental chemicals, almost everyone — or every animal — has some exposure," she said. "Control doesn't have to mean zero — it means you know what you have and it is lower than the intentionally exposed."</p><p>Hunt still maintained that contamination with an endocrine-disrupting chemical could derail a study. "If you have contamination, you don't have a control. There's no way around it," she said. "It puts a shadow over the whole thing."</p>
Food issues<p> It was unlikely a pleasant experience to be a Clarity rat. Every day, while restrained, a lab technician stuck a tube down its throat and into its stomach to deliver a solution. For the experimental animals, the solution contained BPA. For the controls, it either contained a dose of ethinyl estradiol, the synthetic estrogen in oral contraceptives, or nothing. The method is called gavage. </p><p> FDA scientists argue that gavage is a better way to ensure the correct dose is getting into an animal than putting the chemical in its food. Academic scientists counter that gavage triggers chronic stress and can therefore significantly alter hormone levels — another means by which any actual differences between experimental and control animals could be artificially diminished. Because the control animals were also exposed to the stress of gavage, they argue, there was no true control group of rats in Clarity. </p><p> Heather Patisaul, a professor of biology at North Carolina State University and a Clarity investigator, co-authored a 2013 study in which she found that gavage alone was enough to change the expression of hormone receptors and other genes in areas of the brain that are <a href="https://www.ncbi.nlm.nih.gov/pubmed/23457122" target="_blank">known to respond to stress</a>. </p><p> "Clearly animals gavaged and not gavaged are not the same," she told EHN. </p><p> During the planning of Clarity, the FDA made it clear that use of gavage was non-negotiable, noted Heindel, the former NIEHS health scientist administrator. The academics could accept that or simply not participate. </p><p> So, many reluctantly signed on, despite believing that gavage and other design factors dictated by the FDA would make it extra difficult to show effects that many of them had identified in their previous studies. Use of gavage was among the criteria adopted by the government decades ago for studies that evaluate the safety of chemicals. In addition to standardizing the number and type of animal used, and levels of exposure to the chemical of interest, these so-called "guideline" studies also generally focus only on traditional endpoints such as overt signs of toxicity, rather than the unique effects of endocrine-disrupting chemicals that academics tend to investigate. </p><p> Academics usually use other means of administering chemicals to animals. Prins delivers BPA into a mouse's mouth with a pipette tip. Andrea Gore, a neuroendocrinologist at the University of Texas at Austin, said her lab is starting to administer chemicals to animals via vegetable oil placed on a piece of cookie. "There is evidence that gavage is stressful," Gore, who was not involved in Clarity, told EHN. "When you're talking about low doses of endocrine-disrupting chemicals, that is extremely relevant." </p><p> Hunt, too, feeds her mice BPA via corn oil. "We gently pipette oil into the mouth and the animals actually like it," she said. </p>
Losing control<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0OTA5OC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY1MDM5NDA3NH0.yle7wszkcyurVaT3YEYneWovi6Db_AMin_AwRspTXKQ/img.jpg?width=980" id="d19c9" class="rm-shortcode" data-rm-shortcode-id="9df56bb017b1900604c2899418e77336" data-rm-shortcode-name="rebelmouse-image" />
Researcher Pat Hunt with lab mice. (Credit: Lynne Peeples)<p> Whenever it is wet outside, Hunt makes sure to clean off Ila's four paws before they come inside. "We pause for paws," she said. Given the puppy's high energy, it is a given that the outside mud would end up just about everywhere inside her house. Yes, Hunt is familiar with both dirty dogs and dirty data — and the struggle to keep puppies and studies under control. </p><p>Contamination is one of the ways in which a study and its results might become tainted; a lack of control is another. </p><p>Standard protocol for research on endocrine disruptors demands the inclusion of both "positive" and "negative" controls — groups of animals that researchers can then use as a baseline comparison against their exposed group of animals. A negative control is your typical study control animal that doesn't receive any exposure. (Again, in the case of Clarity, academics argue that this purity was spoiled by potential contamination.) A positive control is exposed to something with a known response. </p><p>For example, <a href="https://www.maryvillecollege.edu/media/dsx/manager/Faculty/NaturalSciences/dcrain/publications/Vom%20Saal%20et%20al%202010.pdf" target="_blank" rel="noopener noreferrer">academic studies of BPA</a> have generally included a group of animals exposed to a synthetic hormone for which effects are well known: ethinyl estradiol, the estrogen mimic in oral contraceptives. This positive control helps scientists decipher whether or not a lack of an effect in BPA-exposed rats compared to negative controls was because the experiment simply did not have the sensitivity to detect estrogen-like effects or because BPA really had no such effect. </p><p>When the government initially declared their plan not to include positive controls in Clarity, according to emails reviewed by EHN, 11 of the academic researchers pleaded for them to reconsider. In one of the emails from April 2012, Frederick vom Saal, a professor of biology at the University of Missouri-Columbia and a Clarity investigator, stated that without these controls, the experiment could "waste millions of dollars and generate uninterpretable data."</p><p>Positive controls were eventually provided and used for most, but not all, of the Clarity studies. Kim Boekleheid, a toxicologist at Brown University, was the only academic scientist not to use a positive control in his study of male reproduction. His decision ignited ire among some of his Clarity co-investigators, especially upon the release of his results. While previous academic studies have found that male reproduction is very sensitive to BPA, Boekleheid's study concluded that exposure to BPA did not harm the testes or sperm in rats. Hunt and others question how he could be so sure without a positive control. Boekleheid declined to be interviewed for this story. </p><p>An additional type of control was enlisted by the government in their Core Study. When they found higher rates of mammary cancer in rats exposed to low doses of BPA compared to negative controls, the FDA authors then also looked to a control group from a somewhat similar study conducted about a decade earlier. Turned out those non-BPA-exposed animals, considered "historical" controls, developed more mammary tumors than the non-BPA-exposed rats in the Clarity study. The government used this as one of their reasons to disregard the mammary cancers as a true BPA effect. </p><p>Outside scientists questioned their motives and noted, for example, that the animals not exposed to BPA in the old study would have been housed in plastic cages made partially of BPA. So, those rats may, too, have been inadvertently exposed to small doses of BPA. Gore added that "things change over 10 years." In work in her own lab, she has found that animals vary across generations — "even if they are the same strain, fed the same food and all animal husbandry is done the same."</p>
Ana Soto, an endocrinologist at Tufts University and a Clarity investigator, with fellow Tufts researcher, Carlos Sonnenschein (Credit: Tufts University).<p>Ana Soto, an endocrinologist at Tufts University and a Clarity investigator suggested that historical controls are typically only used when a difference is not seen between an experiment group and control group. "They are doing the opposite. They seem to be trying to minimize the fact that they found differences between BPA-treated and the simultaneous control," she told EHN. "That is where you start wondering whether this choice is plainly inept or disingenuous."</p><p>Vandenberg too was curious about the government's use of historical controls in guideline studies, such as the Clarity Core Study. So she took a closer look at how the government dealt with other outcomes. For example, they found a significant increase in pituitary cancer in female rats exposed to ethinyl estradiol and used that as support that the positive control worked in Clarity. However, the same historical controls the government referenced for cases of mammary cancer also had a rate of pituitary tumors comparable to the ethinyl estradiol group. "If they had applied the same logic to the ethinyl estradiol pituitary data in Clarity as they did to the BPA mammary gland data, they would have had to conclude that the positive control had no effect," she said.</p><p>And that would have called into question the rest of their results.</p><p>"When the FDA didn't like the data they got, they went back into their own lab to try to dismiss it," added Vandenberg. "But then they don't do that for the data they like. This asymmetric treatment of data is one more example of how the FDA seemed to manipulate the interpretation of the Clarity data."</p><p>Zoeller agreed. "They at least appear — by their inconsistency — to have a preconceived conclusion that they arrive at by selective logic," he said.</p><p><em>In <a href="https://www.ehn.org/bpa-science-health-2641150585.html" target="_blank">part 3</a> of this series, EHN further details critical questions surrounding how the FDA assesses the evidence and frames their conclusions on BPA, as illustrated in the agency's handling of Clarity.</em></p>
This is part 3 of a 4-part investigation of the science surrounding the chemical BPA and the U.S. regulatory push to discredit independent evidence of harm while favoring pro-industry science despite significant shortcomings.
On the hunt<p>Hunt abruptly stops during our stroll through the arboretum, which is just across the state border and a few miles from her lab at Washington State University. "Look, a wild orchid," she said. Pink petals pop in the otherwise predominantly green landscape.</p><p>Unexpected discoveries may be a relatively frequent occurrence for Hunt: She has twice found bisphenols coursing through the bodies of animals not intentionally dosed with a chemical in her studies, a result of degrading plastic cages housing the mice. Generally, however, scientific research tends to be a bit more prescribed. To find any particular effect of a chemical, you usually need to look for it — or at least recognize it. The problem is, government regulators and academics tend to look for and recognize different things: Regulators look for the obvious – changes in body weight, or a fast-growing tumor. Endocrinologists look for subtle changes – learning behavior, anxiety, memory – that may not appear until years later, or even subsequent generations. This has been another major point of contention in the ongoing debate over the testing and regulation of endocrine-disrupting chemicals.</p><p>"Typically, the tests they use for regulatory purposes are a little more rigid. They are not as cutting edge as you might see from academic labs doing it on their own," said John Meeker, an environmental health scientist at the University of Michigan School of Public Health, who is not involved in Clarity. "This can lead to big differences in study conclusions, as well as the overall view of the toxicity of a particular agent." </p><h3><em>Related: <a href="https://www.ehn.org/bpa-impact-on-human-health-2641134273.html" target="_blank" rel="noopener noreferrer">A scientific stalemate leaves our hormones and health at risk</a></em></h3><p>In one of University of Illinois at Chicago researcher Gail Prins' studies, for example, she found that while BPA didn't appear to stimulate prostate cancer by itself, if there was an early life exposure to BPA, an additional estrogen or testosterone exposure later in life then significantly increased the risk of prostate cancer. The most significant effects appeared in the lowest dose groups. </p><p>Other Clarity studies by academic investigators found a number of low-dose BPA effects, including changes in gene expression within specific regions of the brain, ovarian follicle development and spatial navigation. "The government keeps testing chemicals for safety using the same old approaches developed 50 years ago, and then they tell us that everybody is good to go," said Laura Vandenberg, an environmental health researcher at the University of Massachusetts-Amherst's School of Public Health and who was not involved in Clarity. "You don't have to see a tumor to determine something adverse is going on."<strong> </strong></p><p>In an email to National Institute of Environmental Health Sciences (NIEHS) colleagues in February 2018, Nigel Walker, a toxicologist at NIEHS who helped lead the study, highlighted one of the key questions that Clarity aimed to answer: "Are we missing any signals using 'traditional' approaches that newer technologies and approaches pick up"?</p>
High bars<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0OTI2MC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY0Njc1MTY3Nn0.1CyzwTcyEXosukuLFTZBFEc_JhERoOOuI8kQr0pEaRM/img.jpg?width=980" id="5034b" class="rm-shortcode" data-rm-shortcode-id="467c1b1ebb5891ff6c5a5b03744eee76" data-rm-shortcode-name="rebelmouse-image" />
University of Missouri researchers Fred vom Saal and Wade Welshons. (Credit: Brian Bienkowski)<p>Which is worse, deeming something as safe when it's not or saying something causes harm when it doesn't?</p><p>The two scenarios are referred to, respectively, as false negatives and false positives. "The FDA uses very, very conservative statistics with a low risk of false positives," said Patisaul. "That's always been a sticky wicket with the FDA versus academic scientists."</p><p>By applying conservative statistics throughout the Clarity Core Study that generally minimize false positives, noted Patisaul, the government increased the risk of false negatives — or the chance of deeming a chemical innocent when it was actually guilty of harm. </p><p>It is a balancing act, explained Bailer. With conservative methods, you may be less likely to see real effects. "But the counter response is: You are less likely to see false effects," he told EHN.</p><p>Even with a high bar, statistically significant effects emerged from the government's data. In tests for mammary gland cancerous growths, for example, the Core Study detected significant effects at the lowest dose of BPA in the part of the study where exposure stopped when the rats were weaned. But through the government's "weight-of-evidence approach," they discounted the finding as "unlikely" to be a "plausible BPA treatment-related lesion." </p><p>Their rationale: similar effects were not observed at the highest doses, the effect was not observed in animals exposed over their entire lifetimes and, as noted earlier, lesions were found in historical controls. (EHN gave the FDA a chance to comment, but the agency declined.)</p>
Researchers Ana Soto, Carlos Sonnenschein and Silva Krause looking at mammary glands from a BPA experiment at Tufts University. (Credit: Ana Soto)<p>Patisaul disagreed with their methods and rationale. "There are certainly cases where developmental-only exposure has different effects than lifelong exposure," she said. "Just because you don't know why something is happening doesn't mean that the phenomenon is erroneous or 'not biologically plausible.'"</p><p>"This attitude is certainly not precautionary nor protective of public health and emphasizes the lengths to which this group will go to bury potentially important outcomes," added Patisaul.</p><p>Vom Saal said he faced a particularly high bar to uncover potentially important outcomes in his Clarity study. The weights of the rats that the FDA provided him for analysis of the effects of BPA on the development of the urogenital system, he explained, ranged widely — the heaviest rat weighed at least 250 percent more than the lightest rat. To prevent bias, all Clarity scientists were blinded to the BPA exposure levels of the animals and tissues that they received for study. Once the data were unblinded, vom Saal learned that his BPA-unexposed rats also weighed significantly less than the BPA-unexposed rats in the government's Core Study.</p><p>Increased variability in weights could cause increased variability in other measures of interest. A statistical fallout of that variability can be a watering down of the differences between exposed and unexposed rats. "This was just not done correctly," said vom Saal.</p>
Deciphering data<p> On the winding walk through a densely wooded portion of the arboretum, Hunt points out an abundance of money plants — their bright magenta blooms scattered across the forest floor. "They are weeds," she says. "Or wildflowers, depending on your point of view." </p><p> Again, two different people can be looking at the same thing yet call it two very different things — whether out in the world or in the lab. And it can be a result of bias, noted Bailer. "The eye wants to see what the eye wants to see," he said, suggesting that a scientist might, for example, see a non-monotonic pattern in data where such a dose-response effect does not actually exist. </p><p> Further, two different scientists may also take the same findings and make a number of different choices that ultimately weave a very different story for the public. What results do they include and how do they interpret those results? Which of the results do they emphasize in the study's conclusions, abstract and title? How do they publicize that end product to the rest of us? </p><p> Prins argued that the FDA has repeatedly come up with study results that show effects of BPA, "but then spin it in the discussion section to say there are no BPA effects." </p><p> Critics suggest that the FDA may spin results across studies as well. For example, FDA risk assessments have generally relied largely on a small number of older industry-funded guideline studies. "The playing field is slanted. Industry gets more input," said Hunt. </p><p> The FDA's 2014 risk assessment of BPA is one such example. Of the 36 studies that they identified as related to neurological endpoints, the FDA chose only one to include in the risk assessment. That study was funded by industry. Then, of 25 reproduction-related studies, they determined that none were appropriate for the risk assessment as they did not follow the validated protocols traditionally accepted by the FDA. </p><p> "If you cherry pick for the answer you want, you can get it," said Patisaul. "I would argue that's not in the interest of public health." When the FDA declared BPA "safe" in its previous <a href="http://wayback.archive-it.org/7993/20180126150108/https:/www.fda.gov/ohrms/dockets/ac/08/briefing/2008-0038b1_01_02_FDA%20BPA%20Draft%20Assessment.pdf" target="_blank">2008 risk assessment</a>, reporters at the Milwaukee Journal Sentinel <a href="http://archive.jsonline.com/watchdog/watchdogreports/34469194.html/" target="_blank" rel="noopener noreferrer">dug up evidence</a> that the decision was influenced by the American Chemistry Council, a leading industry trade group. </p><p> Further, the FDA's <a href="http://wayback.archive-it.org/7993/20180126150105/https:/www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4386b1-05.pdf" target="_blank" rel="noopener noreferrer">science review board rejected</a> the conclusions in that assessment. </p><p> By 2008, more than 1,000 studies of BPA health effects had been published yet the FDA based its conclusion of BPA's safety on only two studies, which were funded by the plastic industry and had been deemed flawed by outside scientists and government officials. </p><iframe src="https://cdn.knightlab.com/libs/timeline3/latest/embed/index.html?source=1qWh3aMBC2innBIXWMxCZrV19JbrGtYka2_ylKLKYOTA&font=Default&lang=en&initial_zoom=2&height=650" width="100%" height="650" webkitallowfullscreen="" mozallowfullscreen="" allowfullscreen="" frameborder="0"></iframe><p> The agency defends their risk assessments of BPA. "Guideline and academic studies are independently evaluated on a case by case basis to determine if enough information is available to have confidence in the data to address the relevant risk assessment question," Naum, the FDA spokesperson, wrote in an email to EHN. "The FDA's conclusions were based on a comprehensive, transparent, review using predefined scientifically supported criteria for evaluating the available science." </p><p> Clarity provides yet another opportunity to combine a lot of data into a more comprehensive assessment of BPA. An analysis of all the data from the collaboration remains in the works. "This is where we are going to get the most compelling evidence," added Hunt. </p><p> Still, just what the feds will do with that evidence remains unclear. The FDA did not respond to questions concerning how it will use the Clarity findings, or what it would take for the results or conclusions to prompt the agency to revise its view on the safety of BPA or the criteria for determining a safe dose of a chemical. Naum only stated that the agency will "continue to monitor developments in the field," including previous reviews and the results of the Clarity Core Study, and will "take steps appropriate to protect public health." </p><p> In an email on May 8, 2012, Retha Newbold, a developmental endocrinologist with NIEHS, wrote to Walker, the toxicologist at NIEHS, of her disappointment in not getting more assurance from Jason Aungst, the toxicology branch chief at the FDA, that the agency would use the data generated from Clarity. "He is already planning his reasons why they may not use it," she wrote. Aungst helped lead that 2014 risk assessment.</p><p> Walker responded: "Like most data for FDA one can only ensure data 'can be used' for decision making, not that it 'will be.'" In February 2018, he emailed other NIEHS colleagues lamenting a lack of a "plan, timeframe or strategy" from the FDA on how it "plans to do an update to its assessment of data on BPA." </p>
The final word<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0OTI1NS9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY2MzYyMDcwNn0.rcsy1wB65eA0_NSRJ8bfbSNrqFT0DLuvTgR7imIq2Tc/img.jpg?width=980" id="a7662" class="rm-shortcode" data-rm-shortcode-id="499366d94edf24b01cdf1199aa7077aa" data-rm-shortcode-name="rebelmouse-image" />
Mice from Pat Hunt's lab. (Credit: Lynne Peeples)