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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.
<p>"I had read in the literature that...cadmium and other toxic trace elements [are] increased when we have these particulate plastics in the soil. So, that was of concern to me," Kirkham, a plant physiologist and distinguished professor of agronomy at Kansas State University, told EHN. </p><p>Kirkham's expertise is in water and plant relations and heavy metal uptake, so she decided to conduct her own research in which she cultivated wheat plants exposed to microplastics, cadmium, and both microplastics and cadmium. Then she compared these plants to those grown without either additive. She chose cadmium because it's poisonous, carcinogenic, and ubiquitous in the environment due to human activity—it's shed from batteries and car tires, and is naturally found in the phosphate rock used to make <a href="https://www.sciencemag.org/news/2018/04/european-union-debates-controversial-plans-limit-cadmium-fertilizer#:~:text=Fertilizers%20made%20from%20phosphate%20rock,present%20in%20some%20agricultural%20soils." target="_blank">agricultural fertilizers</a>.</p><p>"Cadmium is everywhere," said Kirkham. </p><p>At the end of the experiment she sent her wheat plants off for analysis, and, validating previous reports, the plants grown with microplastics were more cadmium-contaminated. "The plastics really were acting as the vector for uptake of the cadmium," she said. </p><p>Her experiment <a href="https://books.google.com/books?hl=en&lr=&id=XsHyDwAAQBAJ&oi=fnd&pg=PA193&dq=water+relations+and+cadmium+uptake+of+wheat+grown+in+soil+with+particulate+plastics&ots=BQp3cEGQYV&sig=Va6KnxPGAR2gi8fZ0NhlEhjOTlM#v=onepage&q=water%20relations%20and%20cadmium%20uptake%20of%20wheat%20grown%20in%20soil%20with%20particulate%20plastics&f=false" target="_blank">became a chapter in the new book,</a> <em>Particulate Plastics in Terrestrial and Aquatic Environments.</em> </p><p>"I think people just haven't felt that microplastic uptake by plants is an issue," said Kirkham. "It just hasn't been in the public eye."</p>
<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzU5NDczOS9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYzMTcxMjM2M30.Bpw73T3AU3TGIKynud2M3V8TIZzFto5BFJzexxyx3OI/img.jpg?width=980" id="cee42" class="rm-shortcode" data-rm-shortcode-id="04cb2e3a1de7161973a9cb9f6cde1396" data-rm-shortcode-name="rebelmouse-image" alt="Kansas State University 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><img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzU5NDc2NC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY1MzgwNDk1MH0._kVYeJZ4m-dEIrPO6A17WVInZWO7q5uDLwnwe0kYxZQ/img.jpg?width=980" id="b9b43" class="rm-shortcode" data-rm-shortcode-id="36591d5c5192b21dd7e8bbf495112f55" data-rm-shortcode-name="rebelmouse-image" alt="Plastic mulch" />
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><img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzU5NDc3NC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYzMDM4NjcwN30.0t8Ozu9Jl2PjWKgiBHuybxHlNEfaey4PhiR1-orubjw/img.jpg?width=980" id="64fc3" class="rm-shortcode" data-rm-shortcode-id="d1a8fb8aaa4e1f4a2df6e48497b1f70c" data-rm-shortcode-name="rebelmouse-image" alt="biosolids sewage sludge farm fertilizer" />
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><img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzU5NDg0Mi9vcmlnaW4ucG5nIiwiZXhwaXJlc19hdCI6MTYxOTM1ODg5OH0.4Y4vPxD9xhObWhvH3WgBpnCXXsqLJ2sIZk2IKX_0emU/img.png?width=980" id="6b435" class="rm-shortcode" data-rm-shortcode-id="8d5ab3772bd52537f32c6ff4f59475f1" data-rm-shortcode-name="rebelmouse-image" />
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><img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzU5NDg4My9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYwNjY1NDMwM30.AY6wHq0lRXgVqxSsrT3R1tx4_K9m9Ms-LDlNtKMUUUw/img.jpg?width=980" id="903cc" class="rm-shortcode" data-rm-shortcode-id="39a8ff27a7a0adea7be046fe95fdf5b3" data-rm-shortcode-name="rebelmouse-image" />
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><p><em>Banner photo credit: Shutterstock </em></p>
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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.
<p>
The findings build on a body of evidence that absorbing or ingesting the ubiquitous chemical may harm people at doses 20,000 times lower than what the U.S. Food and Drug Administration (FDA) says is safe — doses comparable to levels at which most of us are exposed.
</p><p>
"This should change how the FDA and other people look at the safety of BPA," Jerry Heindel, former health scientist administrator at the National Institute of Environmental Health Sciences and a co-author on the new paper, told EHN.
</p><p>
The studies were part of an unprecedented $30 million-dollar project co-led by the FDA called the Consortium Linking Academic and Regulatory Insights on BPA Toxicity, or Clarity for short. Launched in 2012, Clarity combines a traditional regulatory guideline study from the government and investigational studies from academics with the aim of reconciling a long-standing dispute over data and conclusions on the health effects of BPA.
</p><p>
Academic scientists for decades have linked the chemical—found in plastic containers, food can liners, and paper receipts—to a wide array of health problems including cancer, diabetes, obesity, infertility, and behavioral problems. BPA does its damage, in large part, by mimicking and messing with hormones in the body. And it is just one of hundreds of such endocrine-disrupting chemicals we encounter every day.
</p><h3><em>Related: </em><a href="https://www.ehn.org/is-bpa-dangerous-for-health-2641153205.html" target="_blank"><em>How willful blindness keeps BPA on shelves and contaminating our bodies</em></a></h3><p>
However, despite this mounting evidence of harm, the FDA has maintained BPA's safety and dismissed findings from independent scientists that BPA can harm people at very low doses—even when relatively high doses prove innocuous. </p><p>"Guideline studies have not provided much evidence of harm. But academics are finding harm all over the place," Pat Hunt, a geneticist at Washington State University in Pullman, Wash., who was not involved in Clarity, told EHN.
</p><p>
So far, the Clarity effort has fallen well short of its goal to bridge that gap.</p><p class="shortcode-media shortcode-media-rebelmouse-image">
<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzQ2MDg0Ni9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYxNzg0MTA3MH0.CDE57C2L98iceRU0vr8DEn-_x9CfsnzBjAvJ0AILJk0/img.jpg?width=980" id="b3557" class="rm-shortcode" data-rm-shortcode-id="fdd1f65b8b9852c15b6df18c4664c011" data-rm-shortcode-name="rebelmouse-image" alt="Cheryl Rosenfeld">
<small class="image-media media-photo-credit" placeholder="Add Photo Credit..."> Cheryl Rosenfeld, a biologist at the University of Missouri, author of the new paper, and a Clarity investigator. (Credit: University of Missouri)</small></p><p>In November 2019, EHN <a href="https://www.ehn.org/is-bpa-dangerous-for-health-2641153205.html" target="_blank">published a year-long investigation</a> of the FDA's handling of BPA science, including Clarity. It found a "willing blindness" among U.S. regulators to modern science on endocrine-disruptors, and concluded that they may be operating on the fringes of scientific integrity, possibly with the intent to keep the current testing and regulatory regime intact. </p><p>The FDA's traditional targets for tests, such as weighing organs and looking for overt signs of toxicity, are generally insensitive to the unique and often subtle effects of BPA and other endocrine disruptors, such as behavioral changes or infertility years down the road.<br></p><p>
"The difference in regulation that would be required to account for this low-dose effect is huge. I'm not sure the FDA has the courage to do that," Thomas Zoeller, a biologist at the University of Massachusetts Amherst, and an author on the new paper, told EHN. "BPA is big money. The FDA is sensitive to that."
</p><p>
The FDA released its Clarity Core study, a comprehensive report from the government's side of the project, in 2018. But no comparable publication has combined the academics' independently published findings. A government-led integrated report that pulls together findings from both the government and academic scientists was scheduled for completion by the end of 2019. It has yet to be released.
</p><p>
"We felt we needed to make our own report, to be sure our voices would be heard," Cheryl Rosenfeld, a biologist at the University of Missouri, Clarity investigator, and an author on the new paper, told EHN.
</p><p>
Eight of the 10 academics who have published studies as part of Clarity contributed to the new paper. Because all of the Clarity investigators shared tissues from the same rats and followed the same study protocols, much of the noise that typically makes comparisons between studies difficult was eliminated. The team leveraged this opportunity to apply a novel statistical approach to look for patterns across different datasets generated in the laboratories of multiple investigators using organs from the same animals.
</p><h3><em>Related: </em><a href="https://www.ehn.org/bpa-chemical-comic-2640636344.html" target="_self"><em>Clouded in Clarity: A comic on chemicals & controversy</em></a></h3><p>
"We combined everyone's data to see what the picture showed," said Rosenfeld. "It's correlation, not causation. But, ultimately, we were able to show that low doses of BPA don't just target one system, they go after multiple systems." If there was a low-dose effect on the mammary glands, for example, there was likely also a low-dose effect on the spleen in the same animals.
</p><p>
In all, the new paper links BPA to interrelated impacts on the brain, prostate, urethra, mammary gland, uterus, ovary, spleen, heart, and body fat. </p><p>In an emailed response, an FDA spokesperson said the agency "along with other global food safety authorities, has extensively evaluated the totality of available evidence on the safety of BPA. The weight of the evidence shows that BPA is safe for its authorized uses in food packaging." </p><p>The spokesperson said the agency has not reviewed the new study but "will continue to monitor scientific developments and take steps as appropriate to protect public health."</p><p>Hunt and others said the new study should be a red flag for the FDA.</p><p>"It's easy for a regulator to dismiss a study or handful of studies. But when you have this series of studies of the same animals and see correlations across the studies, that gives you much more confidence," said Hunt. "This strengthens the conclusion that these low dose effects are real, and can't be dismissed as spurious."<br>
</p><h3>Low doses matter
</h3><p>
Most effects across the studies appeared at the lowest dose tested in Clarity: 2.5 micrograms per kilogram of body weight per day, which falls in the upper range of what an average person is believed to be exposed to.
</p><p>
However, human biomonitoring studies may underestimate actual exposures. Hunt co-authored a paper published in December that found the tests used by federal agencies to estimate exposure to BPA are
<a href="https://www.ehn.org/how-much-bpa-in-our-bodies-2641524955.html" target="_self">woefully inaccurate.</a> "If we are being exposed to much higher levels than we think we are, and if these animal studies are finding effects at increasingly lower doses," she said, "then that suggests we have a real need to reconsider the safety issues here."
</p><p>
In the U.S., what the government considers a safe exposure level for BPA — 50 micrograms of BPA per day per kilogram of body weight — has remained untouched for more than 30 years. Europe dropped its safety limit to 4 micrograms of BPA per kilogram of body weight per day in 2015.
</p><p>
The FDA generally assumes an increasing-dose-increasing-harm relationship in its evaluation of chemicals. A dose-response curve should therefore always be monotonic, according to the agency, which means it will never change direction from positive to negative, or vice versa.
</p><p class="shortcode-media shortcode-media-rebelmouse-image">
<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzQ2MDg0NC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY1MjY0NTY4MX0.byy4QVoeVaeQiaKWFsjzDN1Z7SV0Tk1Kcy-Y32FGjlk/img.jpg?width=980" id="8d2f8" class="rm-shortcode" data-rm-shortcode-id="4a2fe960dc034a5690965e02ed2b5eb1" data-rm-shortcode-name="rebelmouse-image" alt="BPA Pat Hunt ">
<small class="image-media media-photo-credit" placeholder="Add Photo Credit..."> Researcher Pat Hunt with lab mice in her Washington State University lab. (Credit: Lynne Peeples)</small>
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When they deem a dose of a chemical safe, their investigation typically follows an efficient, seemingly common-sense method. They start by exposing lab animals to extremely high doses of the chemical, incrementally drop the doses until they no longer detect obvious harm, then cut that last number down by a margin of safety to create a "safe" exposure limit. As a result, they may not necessarily have tested health effects at that dose — or at any lower doses.<br>
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"How many additional studies will be required for all chemicals since we haven't been going low enough?" Bernard Robaire, a reproductive toxicologist at McGill University in Montreal, who was not involved in Clarity, told EHN. His own research dating back to the 1970s identified effects of hormones and hormone mimics that were not monotonic. "Non-monotonicity is not new," he said. Robaire suggested that the new findings do lend credence to the growing concerns about the health effects of BPA and other endocrine disruptors.
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Laura Vandenberg, an environmental health researcher at the University of Massachusetts Amherst's School of Public Health, who was not involved in Clarity, also noted the agency's reluctance to accept new science and independent evidence of harm. "The FDA has suggested that all the effects that occur at lowest dose — whether in the academic studies or in their Core study — are spurious effects," she told EHN. "This analysis would suggest that they can't just hold their nose and pretend something is not real."
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BPA is also just the tip of a very large iceberg. Many other endocrine-disrupting chemicals, including BPA replacements such as bisphenol-S (BPS), may raise the risk of health problems. Evidence suggests that these chemicals may even be exacerbating the effects of COVID-19. The people at most risk from the virus have underlying conditions such as obesity or diabetes.
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"We can't say endocrine disruptors are why people are getting fatter or have diabetes," said Hunt. "But we can see from animal models that this is what we would predict from exposure."
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It remains unclear as to how the new paper will play into the final Clarity report, or if the government will respond with any changes in how they assess the safety and regulation of endocrine-disrupting chemicals. </p><p>"We need to hear from the FDA," said Vandenberg. "If they are going to decide that the academic work was not helpful, I want them to explain why."</p>
<p><em>Banner photo: </em><em>BPA testing in the lab of Cheryl Rosenfeld, a University of Missouri researcher. (Credit: Cheryl Rosenfeld)</em></p>
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An article written by a group of 19 toxicologists has been published verbatim in eight toxicology journals in the last four months.
<p>The article is titled, <em>"Human exposure to synthetic endocrine disrupting chemicals (S-EDCs) is generally negligible as compared to natural compounds with higher or comparable endocrine activity. How to evaluate the risk of the S-EDCs?"</em> </p><p>It was published in <em>Environmental Toxicology and Pharmacology</em>, Elsevier; <em>Chemico-Biological Interactions</em>, Elsevier; <em>Food and Chemical Toxicology</em>, Elsevier; <em>Toxicology Letters</em>, Elsevier; <em>Toxicology in Vitro</em>, Elsevier; <em>Computational Toxicology</em>, Elsevier; <em>Archives of Toxicology</em>, Springer; and <em>Journal of Toxicology and Environmental Health Part A</em>, Taylor Francis.</p><p>From the title, one might believe this is an important and original article, or an in-depth review in the field of endocrine-disrupting chemicals (EDCs). Such chemicals are the focus of much research as they interfere with normal hormone function and are thereby linked to a wide variety of human diseases, including infertility, endocrine cancers, obesity, type 2 diabetes, learning disorders and immune problems. </p><p>However, their article is neither important nor original. It is not an in-depth review. </p><p>It is an opinion piece. </p><p>The authors decided their opinion was so important to the field that it must be published in multiple journals at once. But important to what field? </p><p>The focus of the article is on endocrine-disrupting chemicals, so one might think it was written by experts on such compounds. </p><p>Not true. </p><p>None of the authors are endocrinologists or biologists who study endocrine-disrupting chemicals. </p><p>They are all toxicologists, and none has "hands on" expertise in the endocrine-disrupting chemical field. </p><p>The authors are not just ordinary toxicologists, but toxicologists with ties to the chemical industry. </p><p>One cannot deduce this from the editorial because the authors claim "no conflicts of interest." But a recent article in <a href="https://bit.ly/19editorsLeMonde" target="_blank"><em>Le Monde</em></a> (which EHN <a href="https://www.ehn.org/european-parliament-endocrine-disruptors-2646227143.html" target="_self">translated into English</a>) details their actual conflicts of interest, which are considerable. </p><p>So, we have a group of scientists with no expertise in the endocrine-disrupting chemical scientific field, with undisclosed ties to the chemical industry, who have written an editorial so important it needed to be published in eight journals simultaneously. </p><p>But is the science accurate? Unfortunately, no. </p><p>With regard to the science there are three important issues. </p>
<ul><li>First, the endocrine-disrupting chemical field is a fast-moving field, and to understand the current state of the science one should focus on the latest research. Only five of the 45 references in the opinion piece are from 2018-2020, and the current state of the science cannot be represented when most of the references are more than five years old. </li><li>The second issue is lack of citation of publications with actual data. The editorial is based largely on opinion pieces, rather than peer-reviewed research. </li><li>And third, the authors mostly cite their own publications, referring to their own reviews in 17 of 45 references. Their point of view is that exposure to endocrine-disrupting chemicals poses no concern; this has been their focus in their articles over the last 20 years. </li></ul>
<p>How can one assess the state of a field with references this old, no up-to-date original articles or recent reviews upon which to base their opinions, and no real expertise in the field? </p>
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><p><em>Jerrold J. Heindel, Ph.D. retired Program Administrator from the National Institute of Environmental Health Sciences has submitted this commentary on behalf of HEEDs Elders (<a href="http://www.heeds.org/" target="_blank">www.HEEDS.org</a>), a group of pioneering senior scientists in the endocrine disruption field who focus on improving the health of all the world's inhabitants.</em></p><p><em>Editor's note: Pete Myers, Ph.D. and founder of Environmental Health Sciences, publisher of </em><em><a target="_blank" href="http://ehn.org/">EHN.org</a></em><em>, is a member of the HEEDs Elders.</em></p><p><em><em>His views do not necessarily represent those of Environmental Health News, The Daily Climate or publisher, Environmental Health Sciences.</em></em></p>
<p><em>Banner photo: Berlaymont building, headquarters of the EU Commission in Brussels. (Credit: <a href="https://www.flickr.com/photos/11742539@N03/5230669605/in/photolist-8YdxQH-G13y2-C7wrH-2siVPL-7ubY14-3j9u-qUUZ-8nCxN9-8g4PqX-rdsWuz-4juf4J-QfHKVH-2dWpJrf-5AKFQ1-P25kg2-5AFqvv-5AKETN-5YC4Q-5AFqiK-5AFqsF-C7BaF-bhK8L-oxmiL2-nsMZeV-bcUj7-boXKUc-5WRaRc-qnvTf4-Bkmbdv-5AFq9B-Mmx5D-5AKFe5-5AFqfM-aBCcHC-nLaFsc-5AFqmK-5AFqCg-nf61Bw-5bBjK8-7iGvjk-5AFqEP-aBzwjv-5AFqd6-aBzwGv-P25jwM-o4bCzX-3PTrx7-oiCxLb-6ttGPZ-bcUja" target="_blank">Eoghan OLionnain/flickr</a>)</em></p>
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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.
<p>Authored by researchers at the University of Illinois at Chicago, the paper synthesizes scientific literature on the presence and potential health impacts of endocrine disruptors in medication and in the many plastic devices (e.g., catheters and blood bags) used in medical procedures. Such chemicals can mimic the body's hormones and have been linked to multiple health impacts, including infertility, cancer, heart disease and stroke, neurodevelopmental problems and immune system dysfunction. </p><p>The study, published today in the Endocrine Society's<em> <a href="https://academic.oup.com/jcem/article-abstract/doi/10.1210/clinem/dgaa358/5862419?redirectedFrom=fulltext" target="_blank">Journal of Clinical Endocrinology & Metabolism</a>,</em> finds strong evidence that these chemicals found in health care might not only be promoting disease, but antagonizing the efficacy of treatment, and concludes that failure to disclose this information to patients violates core medical ethics. The authors acknowledge the life-saving and health promoting benefits of these medicines and treatments, but say the risks must be weighed against the benefits.</p><p>"There's this ethical obligation for physicians to actually do something about it," said lead author Robert Michael Sargis, an endocrinologist in the Department of Medicine at the University of Illinois at Chicago. </p><p>"Health care becomes this exposure paradigm," he added. "It's not just pollutants in the air and water, and it's not [just] personal care products. Now it's something that physicians are actually doing to patients." </p><p>Many physicians, however, remain unaware of the risks of endocrine disruptors, or the extent of the problem in medical care, Sargis and colleagues warned. </p><p>"They're so right, there's an ethical issue here," said Ted Schettler, Science Director of the Science and Environmental Health Network, which was not involved in the study. </p><p>The chemical dangers in medical devices is "a story that doesn't seem to want to end," he added, recalling his work with Health Care Without Harm 20 years ago to remove polyvinyl chloride tubing from medical devices because it contained the plasticizer diethylhexyl phthalate (DEHP). </p><p>Among the findings of the new research review:</p>
<ul><li>Dibutyl phthalate (DBP) and diethyl-phthalate (DEP) were found in a broad spectrum of over-the-counter and prescription medication, and are commonly added to drugs for gastrointestinal disorders, such as omeprazole.</li></ul><ul><li>Parabens are added to drugs for their antimicrobial activities and were similarly found in many medications, including fluoxetine (Prozac), ibuprofen and acetaminophen.</li></ul><ul><li>Parabens are incorporated in intravenous solutions, ultrasound gels and heparin lock solutions for their broad-spectrum antimicrobial activity. </li></ul><ul><li>Phthalates were found in some strengths of the drug Cardizem CD, but not all, and one butterfly blood draw kit released significantly higher levels of parabens than others, suggesting that safer options are possible. </li></ul><ul><li>Studies document the release of phthalates, bisphenol A (BPA), parabens, perfluoroalkyl substances (PFAS) and triclosan from medical supplies, such as syringes, endotracheal tubes, blood bags and catheters. Phthalates account for 30 to 40 percent of the weight of medical use plastics.</li></ul><ul><li>A 2019 study on 52 common neonatal intensive care unit (NICU) items found that three-fifths contained BPA and four-fifths contained parabens.</li></ul>
<p>Many of the studies detected endocrine disruptor metabolites in urine following medical interventions.</p><p>Given the complex, and oftentimes delayed, ways in which these chemicals impact health, few studies have been able to connect those exposures to health endpoints. However, Sargis did point out one study that found thyroid hormone changes when people were put on a certain set of medications.</p><p>Exposure to endocrine disruptors in neonatal intensive care units is "most concerning" said Sargis, "because the children are some of the most vulnerable patients that we ever see," and they receive a lot of medical interventions that use plastic devices found to contain endocrine disruptors. Low levels of exposure to endocrine disruptors during development is associated with impacts years later in life. </p><p>The authors stress that the risk from these medical exposures is likely understated because our knowledge is restricted to a few known classes of endocrine disruptors and a limited set of medical devices. </p><p>They call on physicians to learn about their role in exposing patients to these chemicals, and urge them to live up to their ethical mandates to discuss the risks with their patients. They also call on regulatory agencies and manufacturers to identify and eliminate endocrine disruptors in medications and medical devices and develop safer alternatives. </p><p>While Schettler agrees that raising awareness is important, he said, "there's only so much you can do in that regard and, at some point, the regulatory agencies really need to step in and do their job."</p><p>Sargis emphasized the importance of proper medical care. "These devices and [medicines] … save life and improve health. This is really meant to be a moment to reflect on what we're doing, and try to identify ways to move forward in a better way."<br></p><p>Our goal is "to ensure that we're doing best by our patients…in essence what we're asking for is a shift in the system such that we can ensure that the meds and medical devices we use protect endocrine health," he added. </p>
<p><em>Banner photo credit: </em><em><a href="http://homedust.com/" target="_blank">Homedust.com/flickr</a></em><a href="http://homedust.com/" target="_blank"></a></p>
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More than 50 different chemicals are now pumped into consumer products in place of BPA. These BPA-free alternatives can be as bad as — or worse than — the original.
It's an uncomfortable, often embarrassing problem—having to pee a lot, but not getting relief when you go.
<p>For older men, this problem is increasingly common and can go beyond the awkward and cause real damage to the bladders or kidneys. In extreme cases it can be fatal. </p><p>New research out this month may have uncovered a dangerous combination of chemical exposure and hormone changes later in life as a culprit in obstructive voiding disorder, which refers to "urgency [and] increased frequency of urination, low urine flow pressure, and incomplete bladder emptying, which can lead to acute kidney injury," the authors wrote in the <a href="https://pubmed.ncbi.nlm.nih.gov/32486162/" target="_blank">study published this month in the International Journal of Molecular Sciences</a><em><a href="https://pubmed.ncbi.nlm.nih.gov/32486162/">International Journal of Molecular Sciences</a></em>. </p><p>As men age they develop benign prostatic hyperplasia, which is enlargement of the prostate. Nearly all men, if they live long enough, will develop it and "if left unchecked they will have urinary retention" problems, William Ricke, professor, researcher and Director of the University of Wisconsin O'Brien Center of Research Excellence in Benign Urology and co-author of the new study, told EHN. </p><p>"Acute urinary retention if left unchecked by a urologist, urine can back up into kidneys and, in mouse models, those kidneys start to look like another bladder," Ricke said. "You don't have kidneys, you die."</p><p>In the new study of lab mice, Ricke and colleagues have linked the combination of exposure to the ubiquitous chemical bisphenol-A (BPA) around the time of birth and elevated estrogen levels as an adult to urinary disorders, kidney problems and enlarged prostates and bladders.</p><p>The study in mice is the first to show that BPA—a chemical that mimics the hormone estrogen—along with the elevated natural estrogen levels men experience as they age can collectively combine to induce prostate, bladder and kidney problems. This one-two punch of exposure during genital development and hormone changes with age can leave men with urinary issues and prostate enlargement, which can wreak havoc on their health.</p><p>BPA is a key ingredient in polycarbonate plastic, making the plastic much more durable and stronger. It is pervasive in food and beverage containers, canned goods and store receipts—and us. More than 90 percent of people in the U.S. have BPA in their bodies. And that may be an underestimate, as recent research has found that tests used by federal scientists<a href="https://www.ehn.org/how-much-bpa-in-our-bodies-2641524955.html" target="_self"> "dramatically" undercount BPA and other chemical exposures</a>.</p><p>BPA has been linked to a range of health problems including cancer, diabetes, obesity, infertility and behavioral problems.<a href="https://pubmed.ncbi.nlm.nih.gov/9460178/" target="_blank"> Previous research</a> has also shown BPA can disrupt proper development of male genitals. Health professionals have long known that as men age, levels of the hormone testosterone decrease and levels of estrogen increase.</p><p>Elevated levels of estrogen can spur enlarged prostates in men, which is a major cause of urinary issues. But not all men experiencing urinary issues have an enlarged prostate, Fredrick vom Saal, senior author of the new study and a professor of biology at the University of Missouri-Columbia, told EHN.</p><p>But it does seem that excess estrogen—whether it's the natural hormone increasing with age or the synthetic estrogen mimic BPA—feeds into urinary issues.</p><p>Vom Saal and colleagues exposed some mice to BPA during fetal development, and then checked for bladder, kidney, prostate and urinary issues in the mice as they aged later and hormone balances changed.</p><p>"Animals exposed to BPA … during perinatal development were more likely than negative controls to have urine flow/kidney problems and enlarged bladders, as well as enlarged prostates," vom Saal and co-authors wrote.</p><p>Vom Saal said BPA exposure during development "hypersensitized the whole system for subsequent exposure to those hormones." So, when estrogen levels naturally start increasing as the male mice age, those exposed to BPA as fetuses and babies were more susceptible to experience the urinary and health issues.</p><p>"These critical periods of exposure [during development] are setting up those individuals for sensitivity to those hormones for the rest of their life," vom Saal said.</p><p>"All of the estrogens you're exposed to combine to impact the severity of this disease as you age," vom Saal said. "And the most abundant external source of estrogenic activity is BPA."</p><p>Ricke said "time will tell" how much the new study will inform us about humans' development of prostate and urinary issues. However, <a href="https://pubmed.ncbi.nlm.nih.gov/11295621/" target="_blank">previous studies</a> in humans confirm that additional estrogen exposure can be associated with prostate issues later in life, he said.</p><p>"We've seen that higher estrogen levels often occur in African American boys developing in pregnant woman—the estrogen levels are higher in circulation—and in those men prostate cancer is much more aggressive, and incidences are higher," Ricke said, adding that next research steps would include trying to further understand what the mouse model they used would mean for humans.</p><p>He added that, while most men in the U.S. have access to medical care that can address the problems identified in the study, these are still potentially fatal issues in most of the world.</p><p>"We're fortunate to live in the Western world, for many men throughout the world, particularly in developing countries, they still don't have access to urologists."<em></em></p><p><em>Banner photo: Credit: darshan1234/flickr</em></p>
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Organization and consumer demand for products that don't harm people or pollute the environment are moving forward-thinking brands toward safer ingredients.
Eat less plastic
03 May
We all consume thousands of microplastic particles in food, water, and air, and plastic use can expose us to harmful chemicals. Consumer Reports explains how to eat less plastic and try to reduce your risk.
What affects how likely you are to die from the novel coronavirus?
<p>The answer is clear: The older you are and the more health problems that afflict you, the more likely you won't make it.</p><p>We can't do anything about getting older except age with grace and tolerate the excesses of youth (as long as they honor social distancing). Health problems, however, are another thing, because they may have causes that can be prevented and/or treated.</p><p>Which health problems stand out as likely to make your COVID-19 experience deadly? </p><p>Diabetes, obesity, heart disease, high blood pressure, and reduced immunity, among others. These are diseases that develop over a lifetime, and so you won't be able to change them in the course of the current pandemic. If you have one or more of these diseases, protect yourself by taking your meds as directed, and follow all the social distancing recommendations issued by public health officials.</p><p>But if there's one certainty about this, it is that this will not be the last pandemic. That's guaranteed by a growing human population, global integration of society (especially by airplanes), and features of today's civilization that make it more likely that animal diseases will infect humans. Among these are habitat destruction which brings wild animals closer to humans, wild animal food markets like those in Wuhan, and industrial confinement of livestock in close quarters as occurs throughout the U.S. as well as elsewhere in the world.</p><p>What can we do in anticipation of the next pandemic to lower the mortality rate once it gets underway? We need to reduce the frequency and severity of the health problems that make us more likely to die.</p><p>These are complex, multifactorial diseases that have been surging in their own epidemics over the last half-century. More people suffer from them, and they strike younger and younger people. They are proving to be tough nuts to crack for traditional public health approaches.</p><p>That said, over the past two decades we have seen a tremendous increase in the types of disease that makes us more vulnerable to pathogens.</p>
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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><p><em>Banner Photo: Louisiana National Guard Soldiers and Airmen test first responders for COVID-19 infections at Louis Armstrong Park, New Orleans, Louisiana, March 20, 2020. (Credit: The National Guard) </em><em></em></p><p><em>Pete Myers is the founder and chief scientist of Environmental Health Sciences, publisher of EHN.org and DailyClimate.org</em></p>
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Endocrine-disrupting chemicals masquerade as hormones. These insidious contaminants increase the diseases that cause the underlying conditions that result in susceptibility to COVID-19.
<p>Hormones determine our development, and our behavior—all at tiny concentrations. Hormone-impersonating chemicals can rob us of otherwise healthy lives. </p><p>Most Americans have endocrine disrupting chemicals in their bodies. We are exposed to them via our food, the air we breathe, our drinking water, and the products we allow into our homes and lives. Plastics, personal care products, drugs, pesticides, flame retardants, air pollution, household products, food additives, nonstick cookware, and many other products contain endocrine disrupting chemicals.</p><p>Typically, the earlier in life that endocrine disruption occurs, the more severe and permanent the damage, leading to diseases like <a href="https://www.diabetes.org/resources/statistics/statistics-about-diabetes" target="_blank">diabetes</a>, heart disease, and reproductive cancers.</p><p>Human epidemiological studies and experiments in laboratory animals establish without question that such exposures can increase susceptibility to these diseases and many more. Exposures can also cause immunosuppression, which increases vulnerability to infections.</p>
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><p><em>Linda S. Birnbaum, Ph.D., DABT, ATS, Scientist Emeritus (Retired) Former Director, National Institute of Environmental Health Sciences and National Toxicology Program and Jerrold J. Heindel, Ph.D. retired Program Administrator from the National Institute of Environmental Health Sciences submit this commentary on behalf of HEEDs Elders (</em><a href="http://www.heeds.org" target="_blank"><em>www.HEEDS.org</em></a><em>), a group of pioneering senior scientists in the endocrine disruption field who focus on improving the health of all the world's inhabitants.</em></p><p><em>Their views do not necessarily represent those of Environmental Health News, The Daily Climate or publisher, Environmental Health Sciences.</em></p><p><em>Banner photo: Lt. Kayla Marthy and Lt. Brianna Garcia treat a patient in the intensive care unit aboard the hospital ship USNS Mercy April 13. (Credit: U.S. Pacific Fleet) </em><br></p>
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Africa's exploding plastic nightmare
20 April
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.
Environmental toll of plastics
09 April
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.
<p>More than 60 scientists from around the world contributed to a 2009 <a href="http://rstb.royalsocietypublishing.org/content/364/1526.toc" target="_blank">report</a>, the first to offer a comprehensive review of the impact of plastics on the environment and human health, and to present possible solutions.
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"One of the most ubiquitous and long-lasting recent changes to the surface of our planet is the accumulation and fragmentation of plastics," wrote David Barnes, a lead author and researcher for the British Antarctic Survey. The report was published a special issue of <em>Philosophical Transactions of The Royal Society B</em>, a scientific journal.
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As the scrutiny of the environmental toll of plastic increases, so has its usage, the scientists reported.
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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" /><p>Since its mass production began in the 1940s, plastic's wide range of unique properties has propelled it to an essential status in society. Globally almost 360 million tons of plastic were produced in 2018. The amount of plastic manufactured in the first ten years of this century will approach the total produced in the entire last century, according to the report.</p><p>"Plastics are very long-lived products that could potentially have service over decades, and yet our main use of these lightweight, inexpensive materials are as single-use items that will go to the garbage dump within a year, where they'll persist for centuries," Richard Thompson, lead editor of the report, said in an interview.</p><p>Evidence is mounting that the chemical building blocks that make plastics so versatile are the same components that might harm people and the environment. And its production and disposal contribute to an array of environmental problems, too. For example:</p><ul><li>Chemicals added to plastics are absorbed by human bodies. Some of these compounds have been found to alter hormones or have other potential human health effects.</li><li>Plastic debris, laced with chemicals and often ingested by marine animals, can injure or poison wildlife.</li><li>Floating plastic waste, which can survive for thousands of years in water, serves as mini transportation devices for invasive species, disrupting habitats.</li><li>Plastic buried deep in landfills can leach harmful chemicals that spread into groundwater.</li><li>Around 4 percent of world oil production is used as a feedstock to make plastics, and a similar amount is consumed as energy in the process.</li></ul><p>People are exposed to chemicals from plastic multiple times per day through the air, dust, water, food and use of consumer products.</p><p>For example, phthalates are used as plasticizers in the manufacture of vinyl flooring and wall coverings, food packaging and medical devices. Eight out of every ten babies, and nearly all adults, have measurable levels of phthalates in their bodies.</p><p>In addition, bisphenol A (BPA), found in polycarbonate bottles and the linings of food and beverage cans, can leach into food and drinks. The U.S. Centers for Disease Control and Prevention reported that 93 percent of people had detectable levels of BPA in their urine.</p>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%2C321&height=700" id="a6c67" 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" /><p>In addition, production of plastics is a major user of fossil fuels. Eight percent of world oil production goes to manufacturing plastics.</p><p>As plastics grow in volume at a rate of about nine percent each year, the authors emphasize that tackling its problems means addressing its sustainability.</p><p>One solution is to treat plastic as a reusable material rather than as a disposable commodity that's quickly discarded. That means making plastic more easily recyclable from the get-go by using fewer materials in the manufacturing process and increasing recycling facility availability.</p><p>"The recycling message is simple; both industry and society need to regard end-of-life items, including plastics, as raw materials rather than waste," stated the report.</p><p>Increasing the availability of biodegradable plastic, which can be made from renewable materials from plants such as corn and soy, is another option.</p><p>"Biodegradable plastics have the potential to solve a number of waste-management issues, especially for disposable packaging that cannot be easily separated from organic waste in catering or from agricultural applications," according to the report.</p><p>However, currently production capacity for biodegradable plastics worldwide is around only 350,000 tons, representing less than 0.2 percent of petrochemical-based plastic. In addition, "most of these materials are unlikely to degrade quickly in natural habitats, and there is concern that degradable, oil-based polymers could merely disintegrate into small pieces that are not in themselves any more degradable than conventional plastic," stated the report.</p><p>To help mitigate the potentially harmful chemicals in plastics, the authors recommend that more studies be conducted on the biological mechanisms that may be affected by plastic additives and in particular, low-dose chronic exposures.</p><p>In the meantime, the report recommends reducing the use of these chemicals and developing safer alternatives, a strategy known as green chemistry.</p><p>"Had this approach been in place 50 years ago it would probably have prevented the development of chemicals that are recognized as likely endocrine disruptors," the report said.</p><p>The report also suggests that plastic waste can be reduced by using labels that allow consumers to choose packaging based on a lifecycle analysis that includes all components of the manufacturing process. For example, if the product were made of mostly recycled materials, used minimal packaging and could be easily recycled, it would get a green dot. If the product were made of excessive packaging that used a lot of virgin materials, it would get a red dot.</p><p>"Personally, I feel that's the way to do it, rather than a knee jerk reaction where legislation says we can't use certain types of plastic," said Thompson. "Having that information will help drive the system because I think consumers are keen to make the right choice when provided with all the information."</p><p>Neal of PlasticsEurope said consumers, not the industry, are responsible for making sure plastics don't wind up littering the environment.</p><p>"In my view the responsibility is fairly and squarely on the consumer," he said. "People tend to pick on plastics because perhaps it's the most visible form of litter and because it's lightweight so it can move around a bit, but actually it's only a small part of the litter problem."</p>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%2C35&height=700" id="d82a5" class="rm-shortcode" data-rm-shortcode-id="db8f88ded433b236f2500286a28182a0" data-rm-shortcode-name="rebelmouse-image" alt="Green forest in the fog" /><p>The authors said that if plastics are made and used responsibly, they can help solve some environmental problems.</p><p>For example, one study found that packaging beverages in PET (a type of plastic) versus glass or metal reduces energy use by 52 percent and greenhouse gas emissions by 55 percent. And, solar water heaters containing plastics can provide up to two-thirds of a household's annual hot water demand, reducing energy consumption.</p><p>Plastics, if used wisely, "have the potential to reduce mankind's footprint on the Earth," Thompson said.</p><p><em>Editor's note: This article was first published in July 2009 by <a href="http://www.environmentalhealthnews.org/ehs/news/EHN.org" target="_blank">Environmental Health News</a> and updated April 2020. It is licensed under a <a href="http://creativecommons.org/licenses/by-nc-nd/3.0/" target="_blank">Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported License</a>.</em></p>
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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.
<p>In December researchers declared that the method used by federal regulators <a href="https://www.ehn.org/how-much-bpa-in-our-bodies-2641524955.html" target="_blank">dramatically undercounted the amount of bisphenol-A (BPA) in our blood and urine</a>. This week two dozen scientists weighed in both challenging and defending the work.</p><p>BPA is a key ingredient in polycarbonate plastic and epoxy resins. It's used to keep acidic foods like tomatoes from interacting with the metal in tin cans, is absorbed by the skin and digestive tract and rapidly transformed and passed by the body. But since the additive – along with "BPA-free" substitutions like BPZ and BPS – is ubiquitous in everyday products, traces of the chemical and its breakdown products, called metabolites, are found in almost every person on the planet.</p><p>When BPA enters the liver most of it is converted to metabolites. These metabolites are then excreted. </p><p>To accurately measure a chemical, scientists need to be able to compare what they are measuring to a known amount of the same chemical, called a standard. A 'standard' has been available for BPA for a long time. </p><p>Until recently, however, there have not been standards for the metabolites, so it was not possible to test for them directly. </p><p>To get around this the current federal test for total BPA exposes BPA metabolites from urine to a snail enzyme which in theory converts it back to the original form. They then measure the total BPA after that conversion. </p><p>The December study, published in <a href="https://www.thelancet.com/journals/landia/article/PIIS2213-8587(19)30381-X/fulltext" target="_blank"><em>The Lancet Diabetes & Endocrinology</em></a> journal, measured the metabolites and BPA directly. The researchers discovered that the snail enzyme doesn't work how the federal scientists think it does. It does alter the metabolites chemically but not all of it to BPA. The more metabolite there is, the more it is converted to something else, not BPA.</p><p> The researchers found the average level of BPA in test subjects was 44 times higher than using the federal standard. </p><p>"This would indicate the old method is highly inaccurate," Pat Hunt, co-author of the December analysis and researcher at Washington State University, told EHN in December, referencing the U.S. Food and Drug Administration's method. "It's a case of having better tools in our hands. Tools we were using were cruder and highly inaccurate."</p><p class="shortcode-media shortcode-media-rebelmouse-image">
<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjg4NDI4NS9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYwOTM4NDI2Mn0.kYbqRPJXkOicPpsHXzElw8ElPuSI36RQ9GGZPnXzfr0/img.jpg?width=980" id="a2f82" class="rm-shortcode" data-rm-shortcode-id="6c2623961aa2a9180c39941386223215" data-rm-shortcode-name="rebelmouse-image">
<small class="image-media media-photo-credit" placeholder="Add Photo Credit...">Pat Hunt in 2019. (Credit: Lynne Peeples) </small></p><p>Four letters published this week in <em><a href="https://www.thelancet.com/journals/landia/issue/current" target="_blank">The Lancet Diabetes & Endocrinology</a></em> journal carry that debate forward.<br></p><p><a href="https://www.thelancet.com/journals/landia/article/PIIS2213-8587(20)30070-X/fulltext" target="_blank">The first, from U.S. Centers of Disease Control and Prevention scientist Antonia Calafat and 18 other researchers at university and government labs</a> across Europe, Australia and the United States, defended the indirect, or status quo, method. </p><p>"Both human pharmacokinetic and laboratory studies have demonstrated the validity of the indirect method, the approach used by most laboratories routinely measuring BPA," they said. "Current population levels of BPA in urine are accurately and precisely measurable." </p><p>According to the response to this by Hunt and colleagues, proper vetting could not have been done without the standards needed to accurately determine the metabolites' concentration. And neither the FDA nor the CDC used those standards.</p><p>BPA interferes with our hormone system at extremely low doses. Researchers have linked it to a range of health problems, including cancer, diabetes, obesity, infertility and behavioral problems. </p><p>A year-long investigation by EHN.org found that federal agencies discount cutting-edge science that shows worrisome results at low, everyday exposures. Instead, the investigation found, regulators favor industry-backed studies and research methods that are decades old.</p><p>Two other letters counter that the new approach<a href="https://www.thelancet.com/journals/landia/article/PIIS2213-8587(20)30068-1/fulltext" target="_blank"> needs attention</a>—and <a href="https://www.thelancet.com/journals/landia/article/PIIS2213-8587(20)30069-3/fulltext" target="_blank">should be applied to chemical testing beyond BPA</a>. </p><p>"We believe that measurement of 'real' BPA is the best tool to assess risks to human health," wrote Antoine Dupuis and three other biomonitoring experts at the University of Poitiers in France. </p><p>According to Hunt and colleagues, this misses the point that BPA levels in urine have been used in risk assessments, where total BPA levels of exposure are assessed by looking at BPA levels plus the levels of metabolites. Because of the enzymatic degradation of BPA in the liver and the excretion of metabolites in urine, the amount of BPA observable in blood is only one piece of the puzzle.</p><p>Incorrect exposure readings could have profound public health ramifications, cautioned Kerri Palmer and Valerie Speirs of the University of Aberdeen in a third letter. "Perceptions that BPA is present in low levels has led regulators to be dismissive about its potential adverse health effects, even though there is potential for continuous, low-level exposure throughout our lifetime."</p><p>Responding to the debate, the December study's three authors—Pat Hunt, Roy Gerona of the University of California, San Francisco; Fred vom Saal of the University of Missouri—<a href="https://www.thelancet.com/journals/landia/article/PIIS2213-8587(20)30071-1/fulltext" target="_blank">noted in the fourth and final letter</a> that their data are never disputed. </p><p>"Calafat and colleagues provide no criticism of our methodology, findings, or the profound implications for BPA risk assessment," they said. "To echo Palmer and Spiers: Regulators are urged to take note."</p><p><em>See the latest edition of the <a href="https://www.thelancet.com/journals/landia/issue/current" target="_blank">The Lancet Diabetes & Endocrinology</a> journal for all of the letter referenced above. </em></p>
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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.
<p>The study builds on previous evidence that BPA and its common replacement BPS can pass through a mother's placenta and is the first to show the same for a range of other replacements, suggesting that fetuses are being exposed to a cocktail of chemicals linked to behavioral and reproductive disorders, among other health problems.</p><p>"We are very clearly seeing these compounds going straight to the baby at totally unacceptable concentrations," Terrence Collins, a green chemist at Carnegie Mellon University, who was not involved in the study, told EHN. </p><p>The study, published in March, looked for 15 different bisphenols—including a BPA, BPS and other popular substitutes—in 60 pairs of maternal plasma, cord plasma and placenta samples from pregnant women in South China. Four bisphenols were frequently detected in all three samples: BPA, BPS, BPAF and BPE. </p><p>BPSIP, a relatively new compound commonly used in thermal paper for store receipts, appeared at high levels in all maternal plasma samples. The researchers note that BPSIP "exhibits a similar estrogenic potency and greater reproductive toxicity than BPA." </p><p>"This is another shriek from nature, 'Stop throwing BPA, or things like it, at me,'" added Collins.</p><p>The study is concerning as BPA is a known endocrine disruptor, meaning it is capable of scrambling hormone signals, and has been linked to cancer, diabetes and infertility. In-utero BPA exposure has been shown to derail the normal growth of the brain and other organs and manifest later in life as early puberty or an increase in anxiety-related behaviors or attention deficit hyperactivity disorder (ADHD). Some replacements have been tied to similar issues including obesity and reproductive problems. The new study linked BPAF concentrations in cord plasma with both premature birth and low birth weight. </p><p>Most BPA replacements are created by tweaking the BPA molecule to form similar compounds. As a result, most pose similar health concerns. A <a href="https://academic.oup.com/toxsci/article/158/2/431/3849675" target="_blank">2017 study</a> found that six substitutes used in products promoted as BPA-free had as much, if not more, of an estrogen-mimicking effect on human breast cancer cells as BPA. </p><p>Pat Hunt, a geneticist at Washington State University in Pullman, Wash., suggested that the latest BPSIP finding reflects an ongoing pattern of regrettable replacements. </p><p>"Oh great, another one. When is this going to end?" she told EHN. "We need to worry about all these new players that come onto the scene."</p>
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>
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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.
<p>But first, let's thank <a href="https://corporate.lidl.co.uk/media-centre/pressreleases/022020_oceanboundplastic" target="_blank">European supermarket chain Lidl</a> for trying. We all must. Plastic pollution is an enormous challenge. Unfortunately they, like many, are ignoring the toxic dimension of plastic recycling. Until efforts to solve the plastic crisis fully understand plastic toxicity, they risk making today's solutions into tomorrow's problems. And not just tomorrow's minor problems—we're talking societal-disruption and extinction-scale problems.</p><p>Our research team this week found <a href="http://bit.ly/LIDLrecycled" target="_blank">a story in </a><em><a href="http://bit.ly/LIDLrecycled" target="_blank">The Daily Mail</a></em> about Lidl's plan to wrap fish in plastic recycled from "ocean-bound plastic" collected off beaches in Southeast Asia.</p><p>Sorry. It may be well-intentioned, but for someone who understands plastic toxicity, it's a horrifying idea.</p><p>Here's why: Plastic contains many toxic substances. Scientists think about four sources:<em></em></p>
<p class=""><em>Pete Myers is the founder and chief scientist of Environmental Health Sciences, publisher of EHN.org and DailyClimate.org. Opinions are his own and not that of the organization's.</em></p>
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" /><p>The result is that virtually all plastics are likely to contain toxic ingredients, especially those taken from the ocean. Some may not, but they are never fully tested. A remarkable <a href="http://bit.ly/ToxicityOfPlastics" target="_blank">scientific study last year</a> made clear how ignorant we are. After the basic finding that most plastic materials tested were toxic in one way or another, the most surprising finding in their work was that a widely acclaimed bio-based plastic was among the most toxic. Oops. In that case, it was probably due to the additives.</p><p>While chemical engineers try to make food-grade plastic packaging material out of a jumble of old plastic picked off the beach, their products will unquestionably contain toxic chemicals. It's not something you want wrapped around your fish. Or finding its way into your fetus via food packaging. Very bad idea.</p>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" /><p>What are some of these toxic substances? They are a litany of what doctors have identified as <a href="http://bit.ly/TESEDC2" target="_blank">endocrine disrupting compounds</a>, including bisphenols, phthalates and perfluorinated (or "forever") chemicals, PCBs, DDT (banned in the 1970s but, still, found everywhere). This nasty stuff is now associated with today's epidemic of hormonally related diseases, like type 2 diabetes, heart disease, obesity, infertility, ADHD and autism. And there are other types of toxicity imbedded in these plastics, as well: Carcinogenicity, oxidative stress, etc.</p><p>Some of those beach plastics in Lidl's recycled packaging may be safe, although literally none (really, none) have been fully tested for safety. But some of them are definitely toxic. When you mix safe plastics with toxic plastics the recycled result is always toxic. And forget hiding behind the old adage that "the dose makes the poison." Endocrine science has established that <a href="http://bit.ly/VandenbergEDCs" target="_blank">exceedingly small doses can have big effects</a>.</p>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>
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Fake science is a real danger
21 February
Paul Thacker: I once thought these scientists were being paranoid. Then I learned about the tobacco, pesticide, and climate disinformation industry targeting their research and reputations.
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.
<p>
It was 2009, and she had recently been elected to the New York State Legislature as it considered a bill prohibiting bisphenol-A (BPA) from infant and children's products sold in the state. She voted yes on the bill, which passed in 2010.
</p><p>Now she wants to see similar action on the national level. </p><p>
"The FDA needs to be more transparent about what additives and chemicals are in our foods and products and how they could potentially impact us — just as we do for cigarettes," Meng told EHN.
</p><h3><em>Read the full investigation: <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>
Meng, who has since co-introduced federal legislation to ban BPA from food and beverage containers, is among policymakers who have reacted to a four-part series published in November 2019 by EHN. The year-long investigation found that the U.S. Food and Drug Administration has stacked the deck against findings from independent scientists that BPA, as well as many compounds used in "BPA-free" products, can harm people at very low doses.
</p><p>
EHN contacted 18 policymakers for comment after publication of the series. Despite numerous requests, eight did not respond at all, and seven failed to follow up or declined to comment. The three policymakers that shared their reactions expressed concern about FDA's behavior with regard to the testing and regulation of BPA, among other toxic chemicals.</p><p>We reached out due to an outcry from scientists and advocates after our investigation who say the FDA seems to be willfully ignoring science that shows BPA is harming our health and the health of our children. </p><p>The stakes are high. The chemical is used in the production of goods that pervade our lives and the manufacturing of BPA remains on the rise. The global BPA market is increasing about 3 percent per year, and is projected to reach <a href="https://www.prnewswire.com/news-releases/global-bisphenol-a-market-overview-2016-2022---market-is-projected-to-reach-us225-billion-by-2022-up-from-156-billion-in-2016---research-and-markets-300303934.html" target="_blank">$22.5 billion by 2022</a> and 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">7 million tons by the end of 2023</a>.</p><p>And, in the face of these major financial implications, the FDA keeps relying on industry studies to maintain BPA's safety — though plastic manufactures and others industries that are reliant on BPA have obvious reasons to mount a strong defense of its safety. </p><p>
"We can see that there have been, to some extent, inconsistencies or lack of transparency in the information that the average American consumer is able to obtain on BPA. Obviously, that is just one chemical," said Meng, who is currently revising her BPA bill for reintroduction this year. The <a href="https://www.congress.gov/bill/114th-congress/house-bill/6269" target="_blank">bill</a> had previously stalled out in committee. </p><p>She is also pursuing federal legislation on food additives, such as Yellow 5 and Red 40, as well as potentially harmful ingredients in feminine pads and tampons.</p>
A pattern of denial
<p> The EHN investigation took a close look at an unprecedented $30 million-dollar project co-led by the FDA, the Consortium Linking Academic and Regulatory Insights on BPA Toxicity, or Clarity for short. </p><script id="infogram_0_70001ab2-47e4-4ac0-bb95-1aa6f386eba7" title="BPA in people" src="https://e.infogram.com/js/dist/embed.js?fKV" type="text/javascript"></script><p> The ongoing effort aims to reconcile the long-standing dispute between government and academic scientists over the health effects of BPA, which is used in the production of goods that pervade our lives — from reusable water bottles and food containers to store receipts and dental sealants. While the FDA claims that BPA poses no risks in the amounts it is used, thousands of peer-reviewed studies from academics suggest otherwise: Absorbing or ingesting the ubiquitous chemical may harm people at doses 20,000 times lower than what the agency says is safe, comparable to levels at which most of us are exposed. An integrated report that pulls together findings from both the government and academic scientists, who based their studies on the same population of rats, is currently being prepared. </p><p> The project — originally scheduled for completion by the end of 2019 but yet to be released — has so far fallen short of its goal. </p><p> Through interviews and emails obtained via Freedom of Information Act requests, EHN uncovered various deficiencies in the FDA's science on BPA and its handling of Clarity. While each sign alone could be considered a red flag, viewed as a whole, they suggest that the FDA is missing some big warning signs about BPA and, therefore, likely misleading the public in its insistence that the common chemical poses no real health hazard. </p><img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjY3OTAxOC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY1NTYyNTI5M30.sXx_pldSsWVHQ5xqnEeHxWXzhcyPqgZJchaMAdXefp4/img.jpg?width=980" id="db301" class="rm-shortcode" data-rm-shortcode-id="d2d26b260dff2fa2b43be8feddab7a24" data-rm-shortcode-name="rebelmouse-image" />
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><img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjY3OTA2Ny9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYwNDA4ODkzMn0.57WepZU-aybCFncUkdCpVO7uXKTmzxU0dBru8Ws7ykk/img.jpg?width=980" id="dbdbd" class="rm-shortcode" data-rm-shortcode-id="73c0533da3bdee2c811060ba157c74b9" data-rm-shortcode-name="rebelmouse-image" />
Senator Patty Murray (D-WA). "I hope the FDA and all agencies involved will continue working to evaluate and take appropriate action to address any risks associated with BPA," Murray told EHN. (Credit: Peter Stevens/flickr)
<p> Senator Patty Murray (D-WA), too, noted that she was "closely monitoring the situation regarding the regulation of chemicals like BPA." </p><p> "I encourage the FDA to follow the best available science and data to help ensure public health and safety," she told EHN in a statement. "I hope the FDA and all agencies involved will continue working to evaluate and take appropriate action to address any risks associated with BPA." </p><p> Meng's BPA bill, as previously drafted, would outlaw the use of BPA from food packaging and require BPA alternatives to undergo extensive review to avoid replacing one chemical with another that may pose similar health risks. </p><p> Meanwhile, <a href="http://www.saferstates.com/toxic-chemicals/chemicals-in-plastic/" target="_blank">several states are adopting bills</a> that ban BPA, popular BPA substitutes and other endocrine-disrupting chemicals from a range of products, including receipt paper and nail polish. </p><p> While an oversight hearing might not drive change overnight, Michaels underscored its potential usefulness in "raising issues to the public and alerting the leadership of agencies that these controversies really do need to be addressed." Tobacco hearings led by Representative Henry Waxman (D-CA) in 1994 did just that, as did a series of hearings beginning in 2009 on the damage from brain injuries among NFL players. </p><p> "Up until that point, the NFL minimized the neurological effects of repeated brain hits," said Michaels. "After that hearing, the commissioner of the NFL changed his position and the league took the problem much more seriously." </p><p> He urged the same to be done for Americans exposed to toxic chemicals. "The mindless clinging to outdated science is detrimental to public health and to the development of good science and to the progress of science," said Michaels. </p><p> "Historically, many out-of-date scientific paradigms are overturned or disappear only over time, as the scientists who cling closely to them retire and new scientists take over their positions," he added. "But, given the importance of protecting the public from endocrine-disrupting chemicals, it would be a great shame if we have to wait decades for that change to occur." </p><script id="infogram_0_56c7c112-51c4-4107-9e26-f44054a32419" title="Exposed BPA Reaction" src="https://e.infogram.com/js/dist/embed.js?I1L" type="text/javascript"></script>
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We all want to live longer, healthier lives. We wish this, not only for ourselves, but for our children and grandchildren, too.
<p> Yet, we are hit daily with news about health epidemics that affect human populations: <a href="https://www.cdc.gov/obesity/data/adult.html" target="_blank">obesity</a> rates continue to climb; more than a million new <a href="https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2019.html" target="_blank">cancer</a> cases are diagnosed in the US each year; one in every six American children has a <a href="https://www.cdc.gov/ncbddd/autism/data.html" target="_blank">developmental disability</a>, and one in 59 have autism spectrum disorder. Many of these conditions are linked to hormones and endocrine health.</p><p>This week, the Endocrine Society will roll out new materials, <a href="https://www.endocrine.org/topics/edc/talking-edcs" target="_blank">freely available online</a>, to help educate physicians, other medical professionals, and patients with hormone-related diseases about chemicals that <a href="https://www.endocrine.org/topics/edc" target="_blank">disrupt hormones</a> in the body. These "endocrine disruptors" can mimic, block, or otherwise affect the actions of hormones that are responsible for development, reproduction, metabolism, growth, and the general coordination of cells, tissues and organs in the body. </p><p>The <a href="https://youtu.be/D2IKYKlJCDg" target="_blank">first video</a> provides an introduction to endocrine disruptors and discusses how endocrine disruptors interfere with hormone biology. The <a href="https://youtu.be/0UXN5-RS22k" target="_blank">second video</a> examines how endocrine disruptors contribute to metabolic diseases including obesity, and discusses why action is needed to reduce disparities in exposures to endocrine disruptors. Finally, the <a href="https://youtu.be/8CD6ZxE0JyA" target="_blank">third video</a> provides straight-forward and cost-effective tips to reduce exposures to endocrine disruptors.</p>
<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="db0486604778f5a1610dcc13da9b7619"><iframe lazy-loadable="true" src="https://www.youtube.com/embed/0UXN5-RS22k?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 research scientists and clinicians focused on diseases of the endocrine system, we have collectively spent several decades studying how environmental chemicals contribute to these diseases and others.</p><p>Our work has revealed that chemicals found in the bodies of most Americans can affect metabolic health, fetal growth and development, neurological diseases, reproductive cancers, kidney function, and respiratory diseases like asthma. We believe that talking about endocrine disruptors is important because even simple steps can help people avoid these chemicals. Avoiding exposure to environmental chemicals may reduce the risk of diseases including <a href="https://www.washingtonpost.com/national/health-science/an-organic-diet-may-lower-cancer-risk-heres-why/2019/01/04/a02cdcce-fff2-11e8-83c0-b06139e540e5_story.html" target="_blank">cancer</a>, <a href="https://www.epa.gov/sciencematters/links-between-air-pollution-and-childhood-asthma" target="_blank">asthma</a>, and others.</p><p>Endocrine disruptors continue to receive attention from government agencies charged with protecting public health. Endocrinologists will continue to engage with these agencies, pushing them to use the <a href="https://www.endocrine.org/news-and-advocacy/news-room/2018/endocrine-society-experts-express-concern-with-fda-statement-on-bpa-safety" target="_blank">best available evidence</a> to regulate chemicals that contribute to human disease. We will continue to remind decision-makers in the US EPA and FDA that they must <a href="https://www.who.int/ceh/risks/cehemerging2/en/" target="_blank">protect people</a>, and especially the most vulnerable among us, from endocrine disruptors.</p><p>We will not shy away from pointing out that exposures to endocrine disruptors are <a href="https://care.diabetesjournals.org/content/41/1/193" target="_blank">not equal</a> across age, sex, racial, or socioeconomic lines. And we will continue to show how exposures to endocrine disruptors come with high <a href="https://med.nyu.edu/departments-institutes/pediatrics/divisions/environmental-pediatrics/research/policy-initiatives/disease-burden-costs-endocrine-disrupting-chemicals" target="_blank">costs</a>, so that reducing exposures could produce significant healthcare savings.</p>
<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="f567a2c20f6968b90c1762e700282754"><iframe lazy-loadable="true" src="https://www.youtube.com/embed/8CD6ZxE0JyA?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span><p>Americans have become much more aware of environmental contaminants: from <a href="https://www.motherjones.com/kevin-drum/2019/05/a-brand-new-look-at-lead-contamination-in-flint/" target="_blank">lead contamination</a> in Flint and other communities, to "<a href="https://www.cnn.com/2020/01/24/health/forever-chemicals-drinking-water-supplies-trnd/index.html" target="_blank">forever</a>" chemicals in America's drinking water, to <a href="https://www.ehn.org/listen-ehns-pittsburgh-reporter-discusses-air-pollution-from-u-s-steels-clairton-coke-works-2644726159.html" target="_self">air pollution</a> in Pittsburgh, to <a href="https://www.ehn.org/is-bpa-dangerous-for-health-2641153205.html" target="_self">BPA</a> in American bodies and consumer products. Indeed, more and more attention is being paid to environmental factors that affect human health.</p><p>We hope that these new resources will help medical professionals and others who are interested in better understanding endocrine disruptors and their adverse effects on individual and societal health.</p><p><em>Laura N. Vandenberg is an Associate Professor of Environmental Health Sciences at the University of Massachusetts Amherst School of Public Health and Health Sciences. Robert Sargis is an Associate Professor of Medicine in the Division of Endocrinology, Diabetes and Metabolism at the University of Illinois Chicago. Leonardo Trasande is a Professor in the Department of Pediatrics, Department of Environmental Medicine, and Department of Population Health at New York University's Grossman School of Medicine.</em></p><p><em>New educational resources on endocrine disruptors are available from the Endocrine Society at: </em><a href="https://www.endocrine.org/topics/edc/talking-edcs" target="_blank"><em>https://www.endocrine.org/topics/edc/talking-edcs</em></a><em>.</em></p><p><em>Founded in 1916, The Endocrine Society is the world's oldest, largest and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, The Endocrine Society's membership consists of more than 16,000 scientists, physicians, educators, nurses and students in more than 100 countries.</em></p>
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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.
<p>We can accomplish this by acting upon today's scientific understanding that chemical exposures are contributing to those problems.</p><p>I'm going to let you in on a scientific reality that is going to transform the chemical enterprise and upend today's unscientific approach to figuring out what's safe and what is not. The safe dose of one of the biggest volume chemicals in the world— bisphenol A (BPA)—will have to be reduced by at least 20,000-fold. </p><p>This calculation is based upon data the US Food and Drug Administration (FDA) obtained in an ambitious, roughly $30 million collaborative program called CLARITY-BPA. CLARITY was designed to reconcile differences between traditional regulatory science as practiced by the FDA and results obtained by independent academic scientists funded by the National Institute of Environmental Health Sciences (NIEHS). Many significant effects were observed at the lowest dose tested, including data obtained by the FDA. </p><p>That means: Take today's FDA reference dose and divide by at least 20,000.</p><p>That's the highest exposure that would be considered safe if regulated according to existing scientific understanding. The chemical would disappear from any uses that bring it into contact with food or drinking water, human skin, or result in it evaporating into the air or melting into water.</p><p>And the same would hold for many other chemicals that disrupt hormone signaling, that is, endocrine disrupting chemicals, which have been linked to multiple health impacts including prostate cancer, breast cancer, infertility, diabetes, ADHD and autism.</p><p>Maybe not all EDCs would require a 20,000-fold reduction. Perhaps only a 1000-fold. But there are at least several hundred endocrine disrupting chemicals (EDCs) in use today that could follow this pattern. All would see greatly heightened restrictions on their uses. </p><p>And that represents an existential threat to the chemical industry. </p>
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>
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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.
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The most common test methods for estimating people's exposure to BPA likely do not count a considerable percentage of the chemical in our bodies, researchers say. The federal government relies on those tests to conclude that current exposure levels are too low to harm our health.
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That basic assumption, researchers say, is no longer valid—a dramatic conclusion with implications for hundreds of other chemicals that are tested the same way and deemed safe.
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"Because negligible exposure levels have been a cornerstone of regulatory decisions, including the FDA conclusion that BPA poses little health risk, the present data raise urgent concerns that risks to human health have also been dramatically underestimated," the authors wrote in a letter published today in <em><a href="https://www.thelancet.com/journals/landia/article/PIIS2213-8587(19)30381-X/fulltext" target="_blank">The Lancet Diabetes & Endocrinology</a></em> journal.
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Everyday we are all exposed to BPA—used in food can liners, paper receipts and plastic containers. The chemical is the most infamous of a group called endocrine disruptors, which mimic and alter hormones in the body. BPA has been linked to a range of health problems including cancer, diabetes, obesity, infertility and behavioral problems.
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In examining the health risks from BPA, federal regulators and independent scientists need to know how much of it is in us. This is trickier than it seems—the body metabolizes BPA fast so they have to look for metabolites, or compounds that form after our body breaks down the parent compound.
</p><p>
Until the early 2000s, there were no standards for the metabolites, so scientists would use an enzyme solution to turn the metabolites back into the original BPA compound and then measure that, a process known as "indirect testing." However, scientists can now measure the metabolites directly, and they're finding that such direct measurements are much more accurate and show a lot more BPA in urine when compared to indirect testing.
</p><p>
The problem is that indirect testing remains the "gold standard" for assessing exposure levels for regulators worldwide, including the United States and the European Union.
</p><p>
"This would indicate the old method is highly inaccurate," Pat Hunt, co-author of the new analysis and researcher at Washington State University, told EHN, referencing the U.S. Food and Drug Administration. "It's a case of having better tools in our hands. Tools we were using were cruder and highly inaccurate."
</p><div class="infogram-embed" data-id="70001ab2-47e4-4ac0-bb95-1aa6f386eba7" data-title="BPA in people" data-type="interactive"></div><script>!function(e,i,n,s){var t="InfogramEmbeds",d=e.getElementsByTagName("script")[0];if(window[t]&&window[t].initialized)window[t].process&&window[t].process();else if(!e.getElementById(n)){var o=e.createElement("script");o.async=1,o.id=n,o.src="https://e.infogram.com/js/dist/embed-loader-min.js",d.parentNode.insertBefore(o,d)}}(document,0,"infogram-async");</script><p>
This testing discrepancy is important because the FDA still uses the indirect method of converting metabolites back to BPA via an enzyme and—against the advice of independent scientists like Hunt—has deemed BPA safe at the levels we're currently exposed to. And part of the reason the FDA maintains the chemical's safety is that the agency asserts human exposure to BPA is "negligible."
</p><p>
Laura Vandenberg, an environmental health researcher at the University of Massachusetts-Amherst's School of Public Health and who was not involved in the new analysis, said it's probably not some "nefarious reason" the FDA continues to use the old standard.
</p><p>
"If you think a method works, why create a new method?" she told EHN, adding that the cost of adding in additional standards could be another factor.
</p><p>
However, the new analysis has implications way beyond BPA, she said. Hundreds of other endocrine disrupting compounds—including phthalates in plastic food containers and personal care products; per- and polyfluoroalkyl substances (PFAS) added to nonstick cookware and other goods to repel oil and water; flame retardants; and other bisphenols such as BPS and BPZ—are currently tested via the same indirect method by the FDA.
</p><p>
"One of the major questions this study raises is how pervasive is this problem?" Hunt asked.
</p>
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><span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="85fa98eee47306784c9062e0b47ccdf2"><iframe lazy-loadable="true" src="https://www.youtube.com/embed/XesQeH8YU88?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span><p>The investigation focused on a multimillion-dollar project co-led by the FDA, called the Consortium Linking Academic and Regulatory Insights on BPA Toxicity, or CLARITY. The effort, launched in 2012, combines a traditional regulatory toxicology study from the government with studies from academic scientists.</p>
<p>Our reporting found sharp disagreement on study methods and data interpretation between the two camps and what was touted as a way to get on the same page has seemingly further cemented the scientific impasse over the controversial chemical. </p>
<p>Today's analysis bolsters the academics' argument that the FDA's tests are inadequate. In the CLARITY study, the FDA's own data showed evidence that there were impacts on rats at the lowest dose examined. However, the authors wrote in the new analysis, "based on the assumption that human exposure to BPA is negligible, the FDA has not taken into account the adverse low dose effects in CLARITY data and many other studies."</p>
<p>The FDA did not return our requests for comment on the new analysis. </p>
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>
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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.
<p>
That exposure, according to research that regulators are willfully ignoring, is increasingly linked to harmful health impacts ranging from birth defects to cancer.
<br>
</p><p>
A year-long investigation by Environmental Health News finds that the U.S. Food and Drug Administration has stacked the deck against such findings from independent scientists studying BPA – as well as many compounds used in "BPA-free" products.
</p><p><br></p><p class="shortcode-media shortcode-media-youtube">
<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="85fa98eee47306784c9062e0b47ccdf2"><iframe type="lazy-iframe" data-runner-src="https://www.youtube.com/embed/XesQeH8YU88?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span>
<small class="image-media media-caption" placeholder="Add Photo Caption...">Exposed: The BPA Experiment</small>
<small class="image-media media-photo-credit" placeholder="Add Photo Credit...">
<a href="https://www.youtube.com/watch?v=XesQeH8YU88" target="_blank">www.youtube.com</a>
</small>
</p><p><br></p><p>
Hundreds of emails obtained via the Freedom of Information Act and dozens of interviews show that science is being perjured:
</p><ul class="ee-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><p>
Significantly, the FDA's maneuvering to keep BPA unregulated extends a similar "get out of jail free" card to thousands of other suspected hormone-altering compounds.
</p><script id="infogram_0_e9cd60bd-fe58-4634-b91c-668d293885aa" src="https://e.infogram.com/js/dist/embed.js?ywx" title="BPA swimming pool" type="text/javascript"></script><p>
"Their failure to use modern science in examining the risk of BPA and other bisphenols leaves the health of the American public at significant risk," said Pete Myers, founder and chief scientist at Environmental Health Sciences, which publishes Environmental Health News.
</p><p>
Environmental Health News is an award-winning nonpartisan organization dedicated to driving science into public discussion and policy. Read the four-part series below, as well as a comic strip interpretation of the investigation.
</p><p>
And follow the fallout from this investigation on Twitter at the hashtag: #ExposedBPA<br>
</p>
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><img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjc3Njg0Mi9vcmlnaW4ucG5nIiwiZXhwaXJlc19hdCI6MTYxODgxMzEwMn0.VRRhwoim8SRANcZ8TnLVnSC-jGvHw4rwu-oN4dTfxfs/img.png?width=980" id="3ff4f" class="rm-shortcode" data-rm-shortcode-id="07514521698dcb084f271bac24d84774" data-rm-shortcode-name="rebelmouse-image" /><h3><a href="https://www.ehn.org/bpa-health-effects-policy-2645127783.html" target="_blank">FDA under scrutiny: Policymakers, advocates push for stronger science, regulation of the chemical BPA</a></h3><p>"The mindless clinging to outdated science is detrimental to public health and to the development of good science"</p><p><br></p>
<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjg4Mjc3MS9vcmlnaW4ucG5nIiwiZXhwaXJlc19hdCI6MTY1MTQ4OTc3MH0.qJzcpOahEIDMNZu4ZZyytTzDK3EqUcfdhOmR93qFp3w/img.png?width=980" id="f0629" class="rm-shortcode" data-rm-shortcode-id="a679608e38fe9c33961063db38904160" data-rm-shortcode-name="rebelmouse-image" alt="BPA and babies" /><h3><a href="https://www.ehn.org/is-bpa-free-plastic-safe-2645509688.html" target="_blank">BPA and babies: Controversial chemical and substitutes pollute the womb</a></h3><p>Babies are being exposed to "totally unacceptable concentrations"</p><p><br></p>
<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzQ2MDg4OS9vcmlnaW4ucG5nIiwiZXhwaXJlc19hdCI6MTY0MjEwNDE1N30.AtX5buXzjWcwx5m0J3BL2SRXrghxJkPoNVNtcSoFswc/img.png?width=980" id="135a5" class="rm-shortcode" data-rm-shortcode-id="aad1942159243f0cba010e20cbd46d68" data-rm-shortcode-name="rebelmouse-image" /><h3><a href="https://www.ehn.org/bpa-effects-on-human-health-2646417888.html" target="_blank">More bad news for BPA: Novel analysis adds to evidence of chemical's health effects</a></h3><p>"This should change how the FDA and other people look at the safety of BPA."</p>
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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.
<p>
SEATTLE — Bisphenol A is likely coursing through your body right now. Every day, you're inadvertently consuming and absorbing trace amounts as it migrates from can and bottle linings into your food and drink, and from thermal paper receipts onto your skin.
</p><p>
Scientists have found BPA in more than
<a href="https://www.cdc.gov/exposurereport/pdf/FourthReport_ExecutiveSummary.pdf" target="_blank">90 percent of Americans tested.</a> Yet whether exposures to such small amounts of the common chemical pose any real health hazard remains highly controversial. On one side of a deep rift are academics who are adamant about the adverse effects; on the other side are U.S. Food and Drug Administration scientists who declare there are no dangers. Only one side has any control over what actually makes its way into your body.
</p><p>
"This is a chasm that is not going to be breached," Daniel Doerge, a biochemical toxicologist with the FDA for nearly 30 years, said during a panel at the European Food Safety Authority (EFSA) conference in Parma, Italy, last September.
</p><p>
<span></span>Doerge and other federal scientists were attending the conference to share details of an unprecedented multimillion-dollar project co-led by the FDA, the Consortium Linking Academic and Regulatory Insights on BPA Toxicity, or Clarity for short. The effort aims to settle the long-standing dispute between government and academic scientists over the health effects of BPA.
</p><p>
Yet Doerge's words did not indicate any hope for such a reconciliation. He wore a green polo shirt, dark glasses and a grey mustache. And he exuded frustration — if not also a bit of arrogance — as he spoke. "Tribal dynamics," he said, are at play among the academics. Doerge alleged they were creating their "own narrative," and "staying in a bubble that turns into an echo chamber."
<a target="_blank"></a>
</p><p>
The struggle has been fermenting below the surface for years: Academics with modern methods and a sophisticated understanding of human physiology versus government and industry scientists who lean on decades-old established science in their evaluation of industrial chemicals.
The suite of traditional toxicology tests recommended by the FDA for assessing a chemical's health risks hasn't been meaningfully updated since the early 1980s, before Doerge took his job and well before scientists began to understand how minuscule concentrations of certain chemicals common in consumer products, such as BPA, could mimic and mess with hormones in the body.
</p><p>
Scientists have long known that a tiny change in a natural hormone concentration — the equivalent of one drop of water in 20 Olympic-sized swimming pools — is enough to trigger instructions via the human endocrine system that impact growth, metabolism, sleep, reproduction and other critical functions of the body.
</p><h3><em>Related: See our comic strip version of this story, <a href="https://www.ehn.org/bpa-chemical-comic-2640636344.html" target="_blank">"Clouded in Clarity"</a> </em></h3><p>
BPA is just the tip of the iceberg. Tens of thousands of manufactured chemicals are on the market; hundreds are believed 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. Other pervasive hormone imposters include phthalates, which are found in plastic food containers and personal care products, and per- and polyfluoroalkyl substances (PFAS), which are added to nonstick cookware and other goods to repel oil and water. Also on the list are flame retardants and pesticides such as DDT, glyphosate and chlorpyrifos. Even bisphenol S and dozens of other BPA replacements have been found to tinker with hormones.
</p><p>
Yet the FDA has remained reluctant to accept new science and independent evidence of harm. While the agency clings to the claim that BPA poses no health risks in the amounts it is used, thousands of peer-reviewed studies from academics suggest otherwise: Absorbing or ingesting the ubiquitous chemical may harm people at doses
<a href="https://www.nature.com/articles/s41574-019-0173-y" target="_blank">20,000 times lower</a> than what the FDA says is safe, comparable to levels at which most of us are exposed.
</p><p> <a href="https://onlinelibrary.wiley.com/doi/full/10.1111/1541-4337.12020" target="_blank">Even back in 1982</a>, a scientific committee established by the FDA had warned of the potential for very low concentrations of chemicals to bind to hormone receptors and that technology in the future might find this interference alters the endocrine system's influential messages. The agency continues to miss opportunities to keep pace with scientific developments, noted Maricel Maffini, an independent consultant based in Germantown, Maryland. Instead, she told EHN, they primarily rely on tests devised decades ago that aren't designed to detect some significant effects that chemicals can have on our health.</p><p>
If we followed the academics' science, BPA and its close relatives would effectively have to be banned, not reduced, in order to protect our health. "Really, if you look at the data, we shouldn't be making these compounds, period," Terrence Collins, a green chemist at Carnegie Mellon University, told EHN.
</p><script id="infogram_0_70001ab2-47e4-4ac0-bb95-1aa6f386eba7" src="https://e.infogram.com/js/dist/embed.js?sa3" title="BPA in people" type="text/javascript"></script><p>
An investigation by EHN has uncovered a pattern of dissonance between academic scientists and federal agencies, as well as between the agencies themselves, regarding the evaluation and regulation of BPA and other endocrine disruptors. No one smoking gun surfaced. Yet putting together all the pieces creates a persuasive picture of willful blindness. Based on hundreds of emails obtained via Freedom of Information Act requests — along with dozens of studies and reports, and more than 50 conversations with scientists, regulators and other stakeholders — evidence suggests that 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. EHN's findings include:
</p><p>
●Insistence by the FDA on a study design that limited Clarity's robustness to reveal health effects, including the use of a strain of animal that had been shown to be insensitive to hormone disruptors, the choice of a stressful means to deliver BPA to the animals, and the allocation of small numbers of animals provided to some of the participating academic scientists.
</p><p>
●Potential BPA contamination of the control animals, which may have further masked true differences in health effects between control animals and animals receiving administered doses of BPA.
</p><p>
●Statistical approaches in the government's side of Clarity, a traditional regulatory toxicology study dubbed the Core Study, that set a high bar to detect differences and disregarded patterns in the data that did not fit outdated assumptions on the relationship between a dose of an endocrine-disrupting chemical and its health effects.
</p><p>
●Framing of the government's Clarity Core Study draft report and corresponding press release that downplayed the health effects that did emerge in the data.
</p><p>
●Hints of potential industry influence, such as the FDA's reliance on industry-funded studies.
</p><p>
Clarity, the intended remedy for the government-academics impasse, was launched in 2012 by the FDA, the National Institute of Environmental Health Sciences (NIEHS) and the National Toxicology Program (NTP). The effort combines a traditional regulatory toxicology study from the government and investigational studies from academics.
</p><p>
The FDA took the lead on raising and treating the study animals and on performing the Core Study, which was published under the auspices of the NTP. The NIEHS awarded grants to participating academics and worked with the NTP to coordinate the study. The government and most of the 14 participating academic scientists completed their respective studies for the collaborative project in the months preceding the September 2018 EFSA conference in Italy.
</p><p>
Everyone used the same breed of lab rats, and followed government-approved standards as they investigated possible health impacts. To prevent bias, all Clarity scientists were blinded to the BPA exposure levels of the animals and tissues that they received for study.
</p><p>
Earlier in the Italy meeting, Doerge and his federal colleagues presented the government's Core Study. Once again, they relayed results that they said generally absolved BPA. They did not discuss findings from the participating academics. In fact, during the panel, Doerge seems to dismiss those studies, many of which challenged BPA's safety. "I don't see a lot of advantages in, so far anyway, in what the extramural research funding initiative has brought into the Clarity project," he said. (The FDA did not make Doerge available for an interview.)
</p><p>
Sitting in the audience in Italy was Heather Patisaul, a biologist at North Carolina State University and one of the academics participating in the massive BPA study. "I was screaming in my chair," she told EHN. "He said it so smugly."
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An integrated report that pulls all of the Clarity studies together is underway, co-authored by the FDA and other participants. John Bucher, a senior scientist with NTP and NIEHS, told EHN that he expects the report to be completed by the end of this year. It will then be up to the FDA whether or not those results will spur any reshaping of U.S. regulations.
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Several of the academic scientists are concurrently working on their own independent review of the Clarity data. Cheryl Rosenfeld, a biologist at the University of Missouri and another Clarity investigator, is among the co-authors on that report. "Many of us are not happy with the FDA," she told EHN, adding that she and others are skeptical of what will end up in the official integrated report and if it will have any impact on policy.
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In the U.S., what the government considers a safe exposure level for BPA — 50 micrograms of BPA per day per kilogram of body weight — has remained untouched for more than 30 years, leaving us all exposed daily to the chemical. Meanwhile, other countries represented at the EFSA meeting have begun reaching agreements and acting on BPA.
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France has enacted the strictest regulations, banning the use of the chemical in all food and beverage packaging and utensils after an assessment by the French Agency for Food, Environmental Health and Safety determined that it is hazardous at much lower doses than the FDA considers hazardous. A Danish Food Institute Clarity-like study, too, recognized effects at low doses.
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Many more countries are keeping a close eye on Clarity. EFSA, which is funded by the European Union to conduct risk assessment but not to create policy, told EHN that it will consider the results as part of its ongoing evaluation of BPA. In January 2015, based on the latest information,
<a href="https://www.efsa.europa.eu/en/topics/topic/bisphenol" target="_blank">EFSA dropped its safety limit</a> from 50 to 4 micrograms of BPA per day per kilogram of body weight.
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The scientific, economic and political stakes are high. For decades, modern commerce across the Western world has depended on BPA. The chemical is used in the production of goods that pervade our lives: reusable water bottles, food containers, canned goods, store receipts, medical devices and dental sealants. And despite growing concerns, the manufacturing of BPA remains on the rise. The global BPA market is increasing about 3 percent per year, and is projected to reach
<a href="https://www.prnewswire.com/news-releases/global-bisphenol-a-market-overview-2016-2022---market-is-projected-to-reach-us225-billion-by-2022-up-from-156-billion-in-2016---research-and-markets-300303934.html" target="_blank">$22.5 billion by 2022</a> and 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">7 million tons by the end of 2023</a>.
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"BPA is very cheap to make," said Collins. "I believe the regulatory bodies of the country are locked up by the monetary implications of addressing endocrine disruption."
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While the clash continues over how endocrine-disrupting chemicals are tested and thereby regulated, irreversible changes to our bodies and health may be happening now. Collins pointed to declining sperm counts and rising rates of endometriosis, which he suggested could be a consequence of these exposures given that the chemicals have been shown to induce such effects in animals.
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<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0ODY5My9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYyODc2NTMyMn0.EraYLqYJztPgD3vzRlwekEfIhrwsKAvFG4ZmHHgTHSM/img.jpg?width=980" id="737be" class="rm-shortcode" data-rm-shortcode-id="ce82f09f7fb4ee1f378901138d585268" data-rm-shortcode-name="rebelmouse-image" />
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><img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0OTM1Ni9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY0NzkzOTgxMn0.1KqYsYVqvirkVAgTKCib2xW8FKUxsspgcOaAsNwIMuk/img.jpg?width=980" id="e83a5" class="rm-shortcode" data-rm-shortcode-id="1c60970321514da5b79b06bd7666f583" data-rm-shortcode-name="rebelmouse-image" />
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><p>Pregnant women, infants and young children face the greatest risks, as a healthy functioning endocrine system is especially critical during development. "If you perturb it, it is not going to be reversible," Linda Birnbaum, former director of the NIEHS and the NTP, told EHN. "Whatever happens, it is done."<br></p><p>
In-utero BPA exposure, for example, may derail the normal growth of the brain and other organs and manifest later in life as early puberty or
<a href="https://www.ehn.org/does-bpa-cause-hyperactivity-adhd-2543584567.html" target="_blank" rel="noopener noreferrer">an increase in anxiety-related behaviors or attention deficit hyperactivity disorder (ADHD)</a>.
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And, again, BPA is just one of many chemical threats to our hormones. We are exposed daily to a cocktail of stuff suspected of altering our endocrine system. "When we talk about endocrine-disrupting chemicals, it might be that the real story is in the mixture," Chris Gennings, the director of biostatistics and an environmental medicine researcher at the Icahn School of Medicine at Mount Sinai in New York, told EHN. While the level of exposure to any single chemical might not surpass a safety threshold, she explained, "if you put all of them together, then the mixture can reach a level of concern."
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It is not only the potential health consequences that are leading many scientists to urge a more substantial overhaul of the testing and oversight of endocrine-disrupting chemicals. There are economic concerns: In 2014, researchers conservatively estimated that just the cases of childhood obesity and adult heart disease attributable to BPA cost the U.S. $3 billion annually. <a href="https://www.ncbi.nlm.nih.gov/pubmed/27765541" target="_blank">A 2016 study</a> that considered a few endocrine-disrupting chemicals and a few specific diseases calculated an annual $340 billion in U.S. health costs and lost wages — or about 2.3 percent of the GDP. (Editor's note: Pete Myers, CEO and chief scientist of Environmental Health Sciences, was a co-author on the paper. He is also the founder of EHN, though the publication is editorially independent.)
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"This is an underestimate of an underestimate of an underestimate," Dr. Leonardo Trasande, a researcher at New York University, author of the book,
<em>Sicker, Fatter, Poorer</em>, and an author on both studies, told EHN.
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Trasande noted his initial hope that Clarity would result in "progress toward a consensus" on methods to evaluate BPA. But the FDA, he said, "has taken the approach that its science and its mindset are superior to that which has been published in peer-reviewed scientific literature."
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Maurice Whelan, head of the Chemical Safety and Alternative Methods Unit of the Directorate for Health, Consumers and Reference Materials of the European Commission's Joint Research Center, shared similar thoughts while sitting next Doerge on the panel in Italy. Clarity was "institutionally biased," he said, with "the science strategy dictated" and a "very clear mindset about how to go about this."
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Recipe for a poison
<p> Core to the discord is a historical assumption about toxic chemicals. Nearly 500 years ago, Swiss physician and chemist Paracelsus coined an adage that would become a basic principle of toxicology: "The dose makes the poison." In other words, the higher the concentration of a toxic chemical, the more toxic it is. </p><p> The FDA generally assumes this increasing-dose-increasing-harm relationship in its evaluation of chemicals that come into contact with food, whether directly or indirectly through production, processing, packaging and distribution. A dose-response curve should therefore always be monotonic, according to the agency, meaning it will never change direction from positive to negative, or vice versa. </p><p> As a result, when the agency deems a dose of a chemical safe, their investigation has not necessarily tested health effects at that dose — or at any lower doses. Rather, industry and government scientists typically follow an efficient, seemingly common-sense method. They start by exposing lab animals to extremely high doses of the chemical, incrementally drop the doses until they no longer detect obvious harm, then cut that last number down by a margin of safety to create a conservatively "safe" exposure limit. </p><p> Endocrinologists, on the other hand, expect craziness in their data. At least for hormone-mimicking chemicals, a relatively high dose might prove innocuous while a far lower dose wreaks havoc on the body. And they've observed that different doses can cause different effects. Such a non-monotonic dose-response curve might take the shape of a "U" or a bell. Take, for example, a 1997 paper co-authored by vom Saal. At 200 nanograms of DES per gram of body weight per day, the prostates of the mice in his study were significantly smaller than prostates in the control mice and prostates in mice receiving other doses. </p><p> At a mid-range of 20 nanograms of DES, no effect was seen. And that, under traditional toxicology, is where regulators would stop testing. But drop the dose further, to 2.0, 0.2 and 0.02 nanograms, and vom Saal found prostates were significantly larger than prostates in all of the other animals. The <a href="https://www.pnas.org/content/pnas/94/5/2056.full.pdf" target="_blank">resulting dose-response relationship</a> resembled a bell.</p><p>"What we've learned from literally tens of thousands of papers, is that endocrine activity is stimulated by very tiny quantities of endocrine hormones," said Collins, the green chemist. "If you raise the concentrations, you turn the effect off."</p><script id="infogram_0_8abe54eb-d6e4-4710-8b53-ac271ec9cb4d" title="Pull quote" src="https://e.infogram.com/js/dist/embed.js?zGP" type="text/javascript"></script><p> His guess as to why: "Nature has decided it doesn't want to have an overreaction to an endocrine hormone." </p><p> Birnbaum compared the phenomenon to the body's response to vitamins and minerals, where "too little is a problem and too much is a problem." And <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4429934/" target="_blank" rel="noopener noreferrer">scientists have identified</a> potential biological mechanisms for non-monotonic dose-responses, such as opposing effects from multiple hormone receptors. </p><p> Still, others push back on the notion of non-monotonicity. "It's illogical. It flies in the face of every mechanism we know in science," Patrick McKnight, a measurement scientist at George Mason University in Fairfax, Virginia, told EHN. "In toxicology you really have to demonstrate that there's an effect of some sort, and I think a lot of these investigators are searching for these effects." (McKnight is on the advisory board at Sense About Science USA, formerly the Statistical Assessment Service, which has industry ties and a record of downplaying the dangers of products.) </p><p> Steven G. Hentges, senior director of the Polycarbonate/BPA Global Group at the American Chemistry Council, an industry trade group, stated that "experimental evidence" to support non-monotonic dose-response has been "limited." He pointed to a recent European review that supported that view. Of 179 datasets evaluated in the paper, the authors concluded that only 10 met criteria for a non-monotonic dose response. They acknowledged difficulty in identifying relevant studies and applied strict rules for inclusion in the review, including a requirement that studies include at least five dose groups. This is rare. Even guidelines for traditional regulatory toxicology studies recommend just three dose groups.</p><p> The FDA, meanwhile, has stuck to its guns, repeatedly dismissing data on low-dose effects or non-monotonicity. Marianna Naum, an FDA spokesperson, told EHN in an email that the FDA and other federal agencies have determined that non-monotonicity "is not often found in toxicology of the endocrine system," and that "current regulatory testing methods are sufficient" to pick it up. (EHN tried for months through multiple emails and phone calls to arrange a phone interview with someone at the FDA. The agency repeatedly ignored and denied those requests.) </p><p> The agency also has a history of brushing off study results because they did not fit its strict study criteria adopted in the 1980s to calculate doses of chemicals that are expected to be safe for humans. These traditional "guideline" studies, as they are called, follow validated "good laboratory practice" (or GLP) protocols. Together, the rigorous study guidelines and lab rules dictate the number and type of animal used, levels of exposure to the chemical of interest, the outcomes to evaluate and record-keeping methods, among other details. And these studies remain the evidence preferred by the FDA, because they "provide risk assessors and risk managers with reproducible results upon which science-based decisions and policy may be based," Naum stated in the email.</p><img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0ODY0NS9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY0OTU2MjkwMH0.R4rjJFhetnhAYNZwgIeVoOXPDkDHG1hnH0OiNhIiYf0/img.jpg?width=980" id="102d2" class="rm-shortcode" data-rm-shortcode-id="8408f6a25ff7407d4b8dfafcd825c6f0" data-rm-shortcode-name="rebelmouse-image" />
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>
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Clouded in Clarity: A comic on chemicals & controversy
15 November 2019
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.
<p>We hope you read the <a href="https://www.ehn.org/is-bpa-dangerous-for-health-2641153205.html" target="_blank">entire series</a> — it's worth it. But we know your time is valuable and, hey, comics are cool! </p><p>With words from our editor Brian Bienkowski and art from the incomparable <a href="http://www.inkiv.com/" rel="noopener noreferrer" target="_blank">Andrew Towl</a>, Clouded in Clarity is a true story, though some quotes have been added, amended or edited for brevity and context. </p><p>Enjoy! </p>
<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMTE1MTQ0OC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYyNzI1MTMzNn0.Q9zFJUImDhriWQSLLgS59VlnN8QxOmHV6wTaeYfaqMo/img.jpg?width=980" id="c9f92" class="rm-shortcode" data-rm-shortcode-id="0f328418e0f0c44e3a1ed1cbcbdee8ae" data-rm-shortcode-name="rebelmouse-image" />
<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMTE1MTQ1MC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYxMDI1MDk5NX0.l7rGaXne5NlK3v8D8HHeRVzendf7-KjRCczijiggi4Q/img.jpg?width=980" id="a7e96" class="rm-shortcode" data-rm-shortcode-id="7b1bc0c6bb9514afc7f6ba116254c66f" data-rm-shortcode-name="rebelmouse-image" />
<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMTE1MTQ1MS9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYzMTAwNjM2NH0.nJZHs5YmIv5Hc7Bl6UbYsfuNo2Ft5vFD5fWTo5zPonI/img.jpg?width=980" id="9b509" class="rm-shortcode" data-rm-shortcode-id="912101476790670fb955bec460e55086" data-rm-shortcode-name="rebelmouse-image" />
<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMTE1MTQ1NC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY1NjQyODE3Mn0.bPNBqlU-5GMyaR37oohPtQP0S_Xw2S0mOoHTlyK9cmw/img.jpg?width=980" id="150a3" class="rm-shortcode" data-rm-shortcode-id="26e3139a04d35ff6d300dbce24f7f3f5" data-rm-shortcode-name="rebelmouse-image" />
<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMTE1MTQ1My9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY1MjE4ODQxOX0.T520jD5eyOJ-GIVJe4Id6eCz0wQOlx_vSHOqeJEfacc/img.jpg?width=980" id="97e0e" class="rm-shortcode" data-rm-shortcode-id="104c75911a2c097f34caa4bc1513ae56" data-rm-shortcode-name="rebelmouse-image" />
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Exposed: On the edge of research honesty
15 November 2019
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.
<p>
PULLMAN, Wash.—Tiny pink lab mice disappear then quickly reappear again from within a cage's hardwood chip bedding. The squirmy newborns are part of Patricia Hunt's latest series of experiments on the health impacts of industrial chemicals widely found in products we all use.
</p><p>
Here, in a dim basement at Washington State University, where metal shelves are stacked high with rows of plastic cages, Hunt has made multiple discoveries that call into question claims made by U.S. federal regulators about the safety of one of those chemicals: bisphenol A, or BPA.
</p><p>
<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2920080/" target="_blank">Virtually all of us have tiny amounts of it in our blood and bodies</a> – at least two millionths of a gram per liter of blood, the equivalent of about
14 pinches of table salt in an Olympic-sized swimming pool. The Food and Drug Administration maintains that the chemical, known to mimic and mess with natural hormones, poses no real health threat at such levels.
</p><p>
<a href="https://www.sciencedirect.com/science/article/pii/S0960982203001891" rel="noopener noreferrer" target="_blank">Hunt's results</a> say otherwise. Since being among the first scientists to report on the harmful effects of BPA on mice in 2003, Hunt has further identified genetic abnormalities, fertility problems and other health impacts in animals at very low doses.
</p><p>
We encounter the chemical every day in food and beverage cans, plastic packaging and cash register receipts. And it doesn't appear to be going away anytime soon: The global BPA market is predicted to surpass $30 billion by the mid 2020s. "I'd like to vote the bisphenols off the planet. But that's not likely to happen," Hunt later tells me in an upstairs room flanked with microscopes used to view tissues from the mice. "The more immediate goal should be to change the way we do toxicity testing for these types of chemicals."
</p><h3><em>Related: <a href="https://www.ehn.org/bpa-impact-on-human-health-2641134273.html" rel="noopener noreferrer" target="_blank">A scientific stalemate leaves our hormones and health at risk</a></em></h3><p>
Her findings—and those of others—have implications far beyond BPA to the hundreds of other chemicals capable of wreaking similar havoc on our hormones.
</p><p>
Discoveries in Hunt's lab also hint at how an evaluation of a chemical can easily conclude that it is safe even if it may cause harm. Twice now, Hunt has found BPA or one of its equally troublesome replacements, such as bisphenol S, coursing through the bodies of her control mice — animals not intentionally dosed with a chemical in her experiments. The source: those plastic cages housing the mice.
</p><p>
Natural wear and tear of Hunt's cages and, more recently, potential cross-contamination in a shared wash area from another facility's damaged plastic cages, likely led to tiny amounts of the chemicals getting into the animals. She has had similar misadventures with contamination from phytoestrogen-laden mice chow, wildfire smoke and cleaning products. Such unplanned exposures could dilute differences in health outcomes between a study's experimental and control animals, making it difficult to detect if a chemical truly poses a health risk and, ultimately, making it all the easier for hazardous things to continue finding their way into our bodies.
</p><p>
Both times Hunt found bisphenol contamination, she essentially lost her experiment. "It was a whole lot of déjà vu all over again," said Hunt, who is in her mid-60s, her face framed by rimless glasses, cropped gray hair and small hoop earrings.
</p><p>
Hunt's repeated frustrations point to just one of the myriad ways a study's design, implementation, analysis, interpretation and presentation can diminish, obscure or even totally hide any true health effects of a chemical. The risk of such oversights may be especially high for BPA and other chemicals that interfere with the action of hormones in the body, a class called endocrine disruptors.
</p><iframe allowfullscreen="" frameborder="0" height="650" mozallowfullscreen="" src="https://cdn.knightlab.com/libs/timeline3/latest/embed/index.html?source=1qWh3aMBC2innBIXWMxCZrV19JbrGtYka2_ylKLKYOTA&font=Default&lang=en&initial_zoom=2&height=650" webkitallowfullscreen="" width="100%"></iframe><p>
An investigation by Environmental Health News suggests that an ongoing multimillion-dollar project called Consortium Linking Academic and Regulatory Insights on BPA Toxicity, or Clarity, includes a number of these potentially harm-hiding elements. Launched in 2012 by the U.S. Food and Drug Administration (FDA), the National Institute of Environmental Health Sciences (NIEHS) and the National Toxicology Program (NTP), Clarity combines a traditional regulatory toxicology study from the government and investigational studies from academics who wield more modern techniques. The goal is to reconcile a long-standing dispute over data and conclusions on BPA's health effects. But it's bigger than BPA—the collaboration aims to determine if the study methods used by government regulators are sufficient to determine the safety of the hundreds of chemicals suspected of being endocrine disruptors. The implications could reverberate through the entire U.S. chemical regulatory structure.
</p><p>
FDA officials continue to claim that concerns over low-dose effects of BPA are unfounded; academic scientists continue to publish studies that underscore risks such as altered brain development, cancer and diabetes.
</p><p>
Through interviews and emails obtained via Freedom of Information Act requests, EHN has uncovered various signs of deficiencies in the FDA's science on BPA and its handling of Clarity. While each sign alone could be considered a red flag, viewed as a whole, they suggest that the FDA is missing some big warning signs about BPA and, therefore, likely misleading the public about its safety.
</p><p>
Some of these signs can be traced back to before the study began. For example, evidence of BPA contamination emerged during a preliminary Clarity study. If the animals in the main Clarity study had been contaminated, that would dilute any true differences between exposed and unexposed groups. And during the study's design, the FDA insisted on using a specific type of rat that had been shown to be insensitive to the effects of estrogen and its mimics, including BPA. Michael Hansen, a senior scientist for Consumer Reports, compared using this rat to operating a radar gun that doesn't detect speeds under 100 mph and then concluding that no one is speeding. "It is almost as though they were trying not to find differences," Hansen told EHN.
</p><p>
Other potential red flags popped up during the course of the study, such as the small number of animals provided to some of the academic scientists — also limiting their ability to detect differences — and a public statement on BPA's safety made by the FDA before all the data was in.
</p><p>
"Is it total incompetence or fraud? I don't know their thinking. But neither choice is pleasant, and it represents the waste of about $15 million in public funding," Pete Myers, CEO and chief scientist of Environmental Health Sciences, told EHN. (Editor's note: Myers is also the founder of Environmental Health News, though the publication is editorially independent.)
</p><p>
An integrated report that pulls together government and academic findings is in preparation and
expected by the end of 2019. Eight of the 14 academic investigators have so far published 14 papers based on their findings in a scattering of different peer-reviewed journals such as <em>Endocrinology</em> and <em>Toxicological Sciences</em>. Many found health effects in rats exposed to very low levels of BPA. "There isn't one big publication coming out with the academics' results," Gail Prins, a researcher at the University of Illinois at Chicago and Clarity investigator, told EHN. "I'm afraid that significant findings across academic studies are going to be buried."
</p><p>
Federal regulators have also now published their part of Clarity, one big publication known as the Clarity Core Study that was widely publicized. Their results, too, reveal some effects at low doses. Yet they again concluded in their report — and in the accompanying press — that exposing rodents to BPA did not result in health effects at the low doses to which people are generally exposed.
</p><p>
"I think that a lot of this is failure by design," Laura Vandenberg, an environmental health researcher at the University of Massachusetts-Amherst's School of Public Health and who was not involved in Clarity, told EHN.
</p>
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><img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0OTA0Ny9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYxNzI4NTMzM30.bzydhkgsSa-qCZhjzTJtFHHuuYfIkKQgP3X4W1yfq0E/img.jpg?width=980" id="0ae64" class="rm-shortcode" data-rm-shortcode-id="560da7db926792cbca73882e346f7f4f" data-rm-shortcode-name="rebelmouse-image" />
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.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0ODgxMy9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYwMjc5ODk1MX0.U7eI4wRkEq5qXVrxjksGO_wMsU8m1DR2lPTBL2FE0og/img.jpg?width=980" id="5051b" 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>Dirty data
<p> On Hunt's office wall in Pullman hangs a framed quilt made by the Sarum Quilters of Salisbury, England. The primary-color design depicts the DNA double helix, genes, eggs and sperm that have been the primary characters in her 40-plus years of research. Other genetics references fill the room — there is the thick blue Dictionary of Genetics, and the half-moon table braced by arms and a back that are shaped as x and y chromosomes. </p><p> Human-made chemicals only began to take center stage in the latter half of Hunt's research career. In fact, before 1998, Hunt knew nothing about BPA. She was simply investigating at the time how hormonal changes in mice might affect the quality of a female's eggs. Then, some unexpected data began to emerge: Abnormal eggs appeared in both her experimental and control animals. "We knew we had a problem," said Hunt, wearing a dog-fur-free blue long-sleeve t-shirt and dark blue jeans, along with a multi-colored stone pendant. "It took me a month to track down what was going on." </p><script id="infogram_0_24590e35-148f-4e04-8224-e3d659b4c5f7" title="Copy: Pull quote 2" src="https://e.infogram.com/js/dist/embed.js?ZfE" type="text/javascript"></script><p> At first, she suspected everything — from construction project debris to pesticides sprayed nearby. Then she took a closer look at the plastic cages. As they were repeatedly washed and autoclaved, she could see that the cages were starting to degrade. Across the street from her lab was the university's polymer sciences building. She recalled running over to those scientists and learning from them that BPA was likely leaching out of her cages. </p><p> While some health effects of BPA were already suspected by the late 1990s, impacts on female eggs — and, therefore, potentially increased risks of miscarriages and birth defects — were not yet among them. Hunt spent the next three years confirming her data. Today, female reproductive problems are included with the published risks associated with BPA exposure. Hunt has continued to investigate how BPA and other endocrine disruptors might further affect genes and reproduction. And, while not a participating scientist, she is also keeping a close eye on Clarity. </p><p> In emails and PowerPoint slides obtained by EHN, FDA scientists acknowledged as far back as <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4038784/" target="_blank">July 2013</a> that contamination occurred in a study done to determine Clarity's feasibility. During this preliminary study, which was carried out at the same facility that later housed the animals used in the large-scale Clarity study, tests had revealed that BPA levels in control rats were similar to those in the four lowest exposure groups. </p><p> That's a problem: Endocrine disruptors, like natural hormones themselves, can impact the body at extremely low levels. So, unintentionally exposing controls to a tiny dose of a chemical may result in those animals showing similar effects as experimental animals intentionally exposed. In a comparison of health effects between the control and experimental animals, any true differences between the groups would be diluted. </p><p> In January 2014, Barry Delclos, a biochemical toxicologist with the FDA, wrote in an email that, while data from the preliminary study revealed "the potential for significant effects in the low BPA dose range," the BPA contamination "confounds the interpretation of the changes observed in the lowest BPA exposure groups." </p><p> Marianna Naum, an FDA spokesperson, told EHN in an email that data suggesting contamination of the control rats might have been due to "the housing of the animals in the same room as animals treated with high BPA doses." Although Naum also noted that the agency has still not confirmed the source of contamination, and that it remains unclear to what extent any contamination might have affected the rats in Clarity. Still, the government's Core Study report asserts that contamination was not an issue. </p><img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0OTEwNS9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY1NDIzNjMzMH0._FCh7U8fquyG2Cz9X3TxGKFTP1flxj5BA5HniOGvM9c/img.jpg?width=980" id="6fab5" class="rm-shortcode" data-rm-shortcode-id="c6a2b2d299e519b669529630cb36ac7d" data-rm-shortcode-name="rebelmouse-image" />
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><img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0OTEyMS9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYyODc1MzMxMH0.5p6z7RqPOmq9i9SW-L9_qcODRKTNnuPbEpVLcGqt8Qk/img.jpg?width=980" id="75738" class="rm-shortcode" data-rm-shortcode-id="6f55dc6dd08c7a7b335332a991591f67" data-rm-shortcode-name="rebelmouse-image" />
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>
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Exposed: Deciphering the real message about BPA
15 November 2019
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.
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MOSCOW, Idaho—Patricia Hunt, a geneticist at Washington State University, and I walk a long, curved route through the arboretum at the University of Idaho — past the big red barn, through the woods and up a hill by the water tower painted with a big yellow "I". It's the same water tower we could see directly out from her back patio. Yet our path back to the house was a far more natural course than any straight-line path.
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Such a lack of linearity, Hunt explained, can also describe the relationship between the dose of a chemical — say, bisphenol A (or BPA) — and its level of impact on the body.
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Historically, government toxicologists have assumed that the greater the exposure to a toxic chemical, the greater the harm — or, as the old adage goes, "the dose makes the poison." A dose-response curve should therefore always be monotonic, meaning it will never change direction from positive to negative, or vice versa. But academic scientists, especially those who study endocrinology, are finding that this principle is not always true, at least not for chemicals such as BPA that mimic and mess with our hormones. These endocrine-disrupting chemicals, studies show, can wreak havoc at extremely small doses.
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<a target="_blank"></a>This disagreement is just one of many front lines in an ongoing conflict between federal regulators and academics, which intensified with the launch in 2012 of a multimillion-dollar government-led project called Consortium Linking Academic and Regulatory Insights on BPA Toxicity, or Clarity for short. The project combines a traditional regulatory toxicology study from the government — dubbed the Core Study — and investigational studies from academics. The government and most of the 14 participating academic scientists have completed their respective studies for the collaborative project. An integrated report that pulls together all the findings is currently underway and expected to be completed by the end of 2019.
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The goal of Clarity is to reconcile a long-standing dispute over data and conclusions on BPA's health effects, although the implications could be far broader. BPA is just one of hundreds of chemicals we're exposed to in our everyday lives that are suspected of scrambling the natural hormone messages in our bodies.
</p><h3><strong><em>Related: Check out <a href="https://www.ehn.org/bpa-chemical-comic-2640636344.html" target="_blank">"Clouded in Clarity,"</a> a comic strip adaptation of this series </em></strong></h3><p>
Through interviews and emails obtained via Freedom of Information Act requests, EHN found a series of red flags concerning deficiencies in the FDA's science on BPA, including how it dictated much of the Clarity study design and methods. As EHN detailed, a number of these factors limited Clarity's robustness to detect health effects — from insistence by the FDA to use of a strain of animal that had been shown to be insensitive to hormone disruptors, to the choice of a stressful means to deliver BPA to the animals, to the provision of small numbers of animals to some of the academic scientists.
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But then there's the question of what happened as the data came in. What patterns did researchers look for when plotting the dose of the chemical versus the response of the animals? Where did they draw the line on what is considered significant evidence of an effect? And how did they present what they found? Once again, a number of contentious issues emerged in the course of EHN's investigation.
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Take North Carolina State University biology professor Heather Patisaul's research on the brain: In three studies now, including one that was published as part of Clarity, she has found effects of BPA on the developing rodent brain at just 2.5 micrograms per kilogram of body weight. For context, that is approximately 120,000 times below the lowest dose that has been shown in other studies to alter uterine weight — one of the traditional tests looked at by the FDA.
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In some cases of what scientists call non-monotonicity, a chemical may have effects at low doses and no effects at higher doses; in others, further effects may only appear as doses get really high. In either case, the result is a curve that changes direction, such as a U-shape. But if researchers were to only look for a strictly increasing line, by enlisting the statistical methods best suited to identify a linear trend, then their calculations would likely conclude that the chemical has no impact on that endpoint of interest.
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It's also possible that the health effects of a chemical differ across doses. "Very high and very low doses can do entirely different things," Frederick vom Saal, a professor of biology at the University of Missouri-Columbia and a Clarity investigator, told EHN. Take, for example, diethylstilbestrol (DES), the estrogenic drug that was once commonly prescribed to pregnant women. Studies have found that exposures in the womb to 100 parts per billion of DES can cause mice to become scrawny as adults, while exposures to <a href="https://www.ncbi.nlm.nih.gov/pubmed/15959888" rel="noopener noreferrer" target="_blank">1 ppb can result in severe obesity</a>. There is only one way to fairly evaluate a dose-response relationship, Richard Stahlhut, a biologist at the University of Missouri-Columbia, told EHN. "You look for straight lines, you look for curves," he said. "Then you tell people what you found."
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However, A. John Bailer, chair of the department of statistics at Miami University in Ohio, is among scientists not fully convinced of non-monotonic dose responses. He underscored a need to better understand their biologic basis. "A mechanistic understanding would give us the real insights," he told EHN.
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Scott Belcher, a biologist at North Carolina State University, and a Clarity investigator, pointed to a <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4429934/" rel="noopener noreferrer" target="_blank">number of studies</a> that provide evidence for <a href="https://www.ncbi.nlm.nih.gov/pubmed/24569941" rel="noopener noreferrer" target="_blank">cellular mechanisms</a> driving these <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4260535/" rel="noopener noreferrer" target="_blank">non-monotonic responses</a>, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3275382/" rel="noopener noreferrer" target="_blank">including opposing effects from multiple hormone receptors</a> and negative feedback loops, a key regulatory mechanism in living things. </p><p>"Most simply put, biological systems are complicated and are controlled by multiple types of regulation," he told EHN.</p><p>Despite the large body of evidence from vom Saal and others, the FDA continues to deny the relevance of very low dose exposures and non-monotonicity. In an email to EHN, Marianna Naum, an FDA spokesperson, said that the agency had "extensively reviewed the low-dose BPA literature and was "unable to construct a plausible or logical comprehensive toxicological profile or explanation for the many claimed effects of BPA, largely due to the inconsistencies that currently exist within this literature." </p><p>This attitude keeps the stalemate alive, while we all remain Guinea pigs in a grand experiment on our hormones. "We thought Clarity would help, but the way the results turned out, it has kind of exacerbated the difference between people who think of low-dose effects as important and non-monotonic dose-responses as real and physiologically important, and those that don't," said Jerry Heindel, the health scientist administrator at NIEHS when Clarity was initiated. "That's the biggest hurdle we still have to get through."</p>
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><img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0OTI4Ni9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYzNjA5MDg2MH0.sUn7fXOGut39SgcaMObgt3Zw_mpJ3l3UNTBGi6mhG5o/img.jpg?width=980" id="2732b" class="rm-shortcode" data-rm-shortcode-id="2f36c63c32be04af8b3fefba5deb86ba" data-rm-shortcode-name="rebelmouse-image" />
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)
<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMjA0OTI5NC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYxNjc3MjA4Nn0.cTurjWCQK9opNqL_XCPsCsP-b0ZK1vvRX2vwVXKaD70/img.jpg?width=980" id="e2e7d" class="rm-shortcode" data-rm-shortcode-id="86e49f1dc7793974196393c168c53093" data-rm-shortcode-name="rebelmouse-image" />
Degraded cages from Pat Hunt's lab. (Credit: Lynne Peeples)
<p> Leaving a room filled with plastic cages of mice — big brown ones and tiny pink ones — Hunt and I step onto a sticky mat and change out of the Crocs we had worn inside. The process helps to ensure further contaminants including pathogens are not spread to the mice in the lab. We place the Crocs back on shoe racks just as one of Hunt's colleagues walks by holding an empty reusable pod for a Keurig coffee machine. She looks knowingly at Hunt and says, "unfortunately, it's plastic." </p><p> Hunt reassures her that, actually, this one is made of silicone. "So, you're ok," she says. "But good on you to think about that." </p><p> Not everyone thinks about the potential health risks of BPA, let alone the hundreds of other endocrine-disrupting chemicals found in common consumer products. Not surprisingly, scientists who study the chemicals for a living are more apt to consider exposures. Hunt, for example, now opts for email receipts on her stops by the Moscow Food Co-op. She knows that most cash register receipts, too, are among the everyday things that can leach BPA or one of its substitutes, such as bisphenol S, onto the skin and into the body. </p><p> Some scientists fear that the public has not been receiving accurate information on BPA. A curious consumer might look for answers online. Yet the top hit in a Google search of "bisphenol A safety" is a link to an industry-sponsored website titled "Facts About BPA." In fact, the search result appears in a stand-out box filled with material pulled from the site. Without having to click a link, you could read that BPA has a "safety track record of 50 years," and that no "cause-and-effect relationship between BPA and any human health effects" has been shown. </p><p> Patisaul suggested that the public has also not been receiving the "correct message," because "the FDA has been issuing statements before research has been done and before they've had a chance to comprehensively look at all the data." </p><p> The most recent case-in-point was a late <a href="https://www.fda.gov/news-events/press-announcements/statement-stephen-ostroff-md-deputy-commissioner-foods-and-veterinary-medicine-national-toxicology" target="_blank">February 2018 statement</a> from Stephen Ostroff, the deputy commissioner for foods and veterinary medicine at the FDA, which highlighted the agency's interpretations of the just-released draft of the Clarity Core Study. It did not mention the significant findings of effects at low doses of BPA in both the Core Study and in the peer-reviewed studies from academic collaborators that had been published by that time. National headlines appeared shortly thereafter. From NPR to Newsweek, the media was once again relaying the message from the FDA that the public need not worry about BPA. </p><p> Clarity participants had agreed at the start of the project that they would not make any policy statements, nor any conclusions, without considering all of the data. Even NIEHS was caught off-guard by the FDA's move. Earlier in February, Virginia Guidry, of the NIEHS Office of Communications and Public Liaison, emailed Walker and other colleagues about a conversation she had with a communications official at the FDA regarding the Core Study release. "I told her we were planning a reactive approach, ready for questions but no press release. They are doing the same," she wrote. </p><p> "The announcement from the FDA that has spread like wildfire is in direct contrast with that agreement," said Patisaul. "We had published four papers. Other Clarity participants had published papers. And the FDA said nothing. Then, when they issued their draft report — which was not even peer-reviewed — they made this big sweeping statement that BPA is fine. That's disingenuous." </p><script id="infogram_0_9251e230-fa7f-422a-9923-2da21c4de0d6" title="Pull quote 2" src="https://e.infogram.com/js/dist/embed.js?3df" type="text/javascript"></script><p> Pete Myers, CEO and chief scientist of Environmental Health Sciences, suggested that the move was a tactic by the FDA to control the media. The press — and the public — would pay less attention when the full report is unveiled, he told EHN. "The second wave doesn't receive the same coverage," said Myers. (Editor's note: Myers is also the founder of EHN, though the publication is editorially independent.) </p><p> A fury of emails between NIEHS colleagues followed the FDA statement. In one of those emails, Walker suggested that FDA officials had drafted "a statement to reiterate their current policy stance on the safety of BPA." The FDA did not respond to EHN's questions regarding why they issued the statement. They further declined to respond to the subsequent criticisms. </p><p> On that industry website, which belongs to the American Chemistry Council, three key findings from the government's research on BPA are listed. One of them has been front-and-center in Clarity: "No risk of health effects at typical consumer exposure levels." Hunt and other non-government scientists have co-authored a paper currently under peer review that also calls into question the other two: "Consumer exposure to BPA is extremely low" and "BPA is rapidly eliminated from the body." </p><p> "We are woefully underestimating exposure levels," said Hunt. "All of our regulatory decisions have been based on assumptions about metabolism and levels of human exposure that are questionable." </p><p> The stakes are high. With BPA just the tip of the iceberg, any conclusions and admission by the FDA of BPA's problems could cause the dominoes to really fall. It would be "like a death knell for industry," she added. "I think the feds are very sensitive to that." </p><p> <em>In <a href="https://www.ehn.org/bpa-substitutions-solutions-2641150667.html" target="_blank">part 4</a>, EHN takes a look toward the future of BPA, its alternatives and what experts suggest still needs to be done regardless of the outcome of the integrated Clarity report.</em> </p>
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Exposed: Toward a BPA-free future
15 November 2019
This is part 4 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.
<p>PITTSBURGH — A percussion of metal-on-metal echoes through the lab as empty food cans drop one by one off a conveyor belt and into rounded pockets of a rotating blue cogwheel. </p><p>As the cog circles counterclockwise, the can spins rapidly. Two spray guns blast a liquid lining inside before the can falls onto another conveyor belt and then shoots up a chute to a final belt that carries it down into a large curing oven. </p><p>These now freshly baked cans, their interiors a toasted brown, are part of a series of validation tests at the coatings company Valspar, recently acquired by Sherwin-Williams. For more than a decade, Valspar has worked to develop safe and effective replacements for food and beverage can linings historically made with bisphenol A. </p><p><a target="_blank"></a>Until about a decade ago, a layer of BPA-based epoxy about 20 times thinner than a human hair coated the inside of nearly all food and beverage cans. This shield excelled at preventing corrosion and, therefore, protecting us eaters and drinkers from deadly spoilage. But evidence has piled up that bits of the substance can leach from that lining and into soda, soups, Spam and sardines, among other canned products. And studies from academic laboratories show that BPA may mimic and mess with our hormones even at the tiniest of doses — increasing risks of cancer, diabetes and infertility, as well as derailing the normal development of a child's brain. That science suggests that our bodies are so sensitive to this compound that the use of BPA needs to be eliminated, not just reduced, to protect our health.</p><p>"The regulatory agencies are saying BPA is just fine," Tom Mallen, global director of packaging regulatory affairs at Sherwin-Williams, told EHN. "But there is a large voice contradicting that."</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>Despite this insistence from regulatory agencies of BPA's safety, some companies have been moving ahead with alternatives. With help from developments in green chemistry, and driven largely by consumer demand and policy-making outside of Washington, they are beginning to remove BPA and other endocrine-disrupting chemicals from store shelves. Still, progress is slow as the stakes are high. The global BPA market continues to grow and is predicted to surpass 7 million tons by the end of 2023. In addition to cans, the chemical is found in cash register receipts, dental sealants and the polycarbonate plastic used in reusable water bottles, among other products. Adding to the challenge: a safe and effective BPA replacement for one product may not be a suitable swap for others. And many of the alternatives that allow a manufacturer to proclaim a product "BPA free" show health effects that are just as bad, if not worse, than BPA. What will it take to ensure only our natural hormones are running the show in our bodies?</p><p>An investigation by EHN has uncovered details of a stand-off between academic scientists and federal regulators that intensified with the launch in 2012 of a multimillion-dollar government-led project called Consortium Linking Academic and Regulatory Insights on BPA Toxicity, or Clarity. Academics had increasingly voiced disagreement with the actions, or lack thereof, of the U.S. Food and Drug Administration with regard to the hormone imposter. The methods used by FDA regulators to assess the safety of chemicals, they have argued, remains decades behind the science. Clarity aims to help these critics and regulators reach a consensus on BPA's potential health harms, and to inform future testing and regulation of BPA and hundreds of other endocrine-disrupting chemicals including BPA replacements such as bisphenol S, or BPS. </p><p>So far, no such luck. As <a href="https://www.ehn.org/is-bpa-dangerous-for-health-2641153205.html" target="_blank">EHN detailed</a>—via hundreds of emails obtained through Freedom of Information Act requests, along with dozens of studies and reports, and more than 50 conversations with scientists, regulators and other stakeholders—the FDA appears to have made up its mind on BPA before Clarity even began. "They already put a stake in the ground and they don't want to budge," Heather Patisaul, a professor of biology at North Carolina State University and a Clarity investigator, told EHN.</p><p>Here at Sherwin Williams' Packaging Global Technical Center in Pittsburgh, the tone is more positive. The company is among those actively pursuing BPA alternatives that won't disrupt our hormones. Mallen and four others sit around a table in the center's conference room, a short walk from the building with the Rube Goldberg-like can machinery. This room's walls display collections of consumer products that Valspar has coated over the decades, grouped by color of the brand's label. </p><p>There is the red assemblage: a metal bottle of Budweiser Select, a can of Campbell's Chunky BBQ seasoned pork, a Coca-Cola can. Further down the wall are shelves showcasing cans of San Pellegrino Limonata, Bumblebee solid white albacore tuna and Friskies Shreds with ocean whitefish and tuna — all with varying shades of yellow. Nearly every product displayed is lined with BPA. The substance has been an integral component of modern commerce for decades. Yet a major shift is underway for the half a billion or so food and beverage cans currently made each day in North America. </p><p>Over a lunch of sandwiches, chips and blue cans of water, Mallen goes on to describe his company's decision to not wait on regulators and to enlist the help of some of the staunchest BPA critics in the development of their next generation of BPA-free can linings. Starting in 2008, through a process they call "safety by design," Valspar went looking for a high-performing chemical compound that was not only less likely to leach from the inside of a can but also lacked the hormone-mimicking behavior of BPA or BPS. The winning compound: tetramethyl bisphenol F (TMBPF). </p><p>Academic scientists have tested the compound for a range of endocrine disruptive activities — effects that regulators do not typically consider in their safety assessments — and Valspar is now using TMBPF as the basis for ValPure V70, its newest family of can linings. The BPA-free epoxy lines those oven-cured cans, our blue cans of water and a small but increasing share of the food and beverage can market across the United States. Sherwin-Williams is applying for approval in the European Union. </p><p>"The industry's thinking was to not talk to critics, and to marginalize them," said Mallen. "We decided that wasn't a productive approach."</p>
"This is the only time I've seen a company reach out to people with expertise." – Thomas Zoeller, UMass Amherst
Not kicking the can down the road
<p>Thomas Zoeller, a biologist at the University of Massachusetts, Amherst, recalled his surprise when Valspar sought his collaboration. "This is the only time I've seen a company reach out to people with expertise," he told EHN, applauding Valspar's recognition of the modern toxicity testing techniques used by academics.</p><p>When evaluating a chemical that will come into contact with food, federal regulators generally look for obvious health effects such as changes in the weight of the brain and other organs in laboratory animals, or a fast-growing tumor. Academics search for more subtle changes that can be induced by small fluctuations in hormones such as attention deficit disorders or infertility. Such impacts may not even appear for years or until subsequent generations.</p><p>Not only was Zoeller free to use his modern scientific methods to evaluate TMBPF, but he was free to report whatever his science uncovered — even if it was unwelcome news for the company. "They were big on none of this work being private," he said. "I didn't have to sign an agreement."</p><p>Zoeller's collaboration with the government as part of the Clarity project, however, has not elicited the same warm feelings. "I don't think they have dealt with us in good faith," he said. An integrated Clarity report that pulls together findings from the government's study and studies conducted by participating academics is underway and expected to be completed by the end of 2019. Zoeller said that he doesn't anticipate the report will inspire any significant moves by the FDA to increase protections for public health.</p><p>The agency's website poses and answers the seemingly simple question: <a href="https://www.fda.gov/food/food-additives-petitions/questions-answers-bisphenol-bpa-use-food-contact-applications" target="_blank">"Is BPA safe?"</a> The agency goes on: "Yes. Based on FDA's ongoing safety review of scientific evidence, the available information continues to support the safety of BPA for the currently approved uses in food containers and packaging."</p><p>Linda Birnbaum, former director of the NIEHS and the National Toxicology Program, which are leading Clarity alongside the FDA, noted that knowledge of endocrine-disrupting chemicals and their actions has expanded in recent years — including just how a tiny dose of a chemical could affect the body even while a higher dose might do little or nothing. "I think we have to understand that science changes and advances and we need to be open to those changes," Birnbaum told EHN.</p><h3><em>Related: <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></em></h3><p>EHN's investigation has uncovered various signs of deficiencies in the FDA's science on BPA, including in its handling of Clarity, that seem to have stalled any chance of progress. There was the agency's insistence on aspects of Clarity's design that limited the study's robustness to detect health effects, and its premature public statements downplaying evidence of BPA's effects in the study. But while the FDA doesn't appear to be budging, industry responses to consumer concerns may signal a paradigm shift. Michael Hansen, a senior scientist for Consumer Reports, pointed to growing public awareness and demand for products free of BPA as well as phthalates, another family of endocrine-disrupting chemicals we encounter every day. Phthalates are used to soften the plastics in food packaging and as solvents in cosmetics, fragrances and other personal-care products.</p><p>"The market is starting to respond to that," he told EHN. "But more action has to be taken."</p><p>Most BPA replacements currently used in cash register receipts and plastics were created by rapidly tweaking the BPA molecule to form similar compounds such as BPS. The focus was on functionality, as opposed to looking at safety. And only after BPS was on the market did <a href="https://www.ncbi.nlm.nih.gov/pubmed/24886603" target="_blank">independent researchers began to find</a> that it has endocrine-disrupting effects very similar to, or possibly even greater than, BPA.</p><p>A similar scenario has played out for some of BPA's other chemical cousins. A 2017 study found that six BPA substitutes—all used in products promoted as "BPA free"—had as much, if not more, of an <a href="https://academic.oup.com/toxsci/article/158/2/431/3849675" target="_blank">estrogen-mimicking effect on human breast cancer cells</a> as BPA.</p><p>And it's not only replacement bisphenols that are of concern. A bisphenol-free material called Tritan, developed by the company Eastman Chemical, <a href="https://www.eastman.com/Markets/Tritan_Safe/Pages/FAQs.aspx" target="_blank">is now widely used in plastic water bottles and food containers</a>. The material is marketed as not having any hormone-related effects, yet some tests have found that stuff leaching from Tritan products — including products made for babies — <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4063249/" target="_blank">could interfere</a> with <a href="https://www.ncbi.nlm.nih.gov/pubmed/25407881" target="_blank">our hormones.</a></p><p>Kristin Parker, a spokesperson with Eastman, stated in an email to EHN that tests conducted by the company and by other third parties confirm that "Tritan is safe for its intended uses."</p><p>One of the studies that called Tritan's safety into question also found that some BPA-free plastic products didn't show any endocrine-disrupting properties. Those products contained BPA alternatives such as glycol-modified polyethylene terephthalate or cyclic olefin polymer.</p><p>But George Bittner, a neurobiologist at the University of Texas at Austin and lead author on the paper, is not among those expressing optimism. He did not identify what specific products contained those alternatives, noting that companies are constantly changing their formulations and may well be using different chemicals now. Bittner blamed a weak-to-nonexistent regulatory and consumer push on the lack of motivation for companies to prioritize getting endocrine activity out of their products.</p><p>Companies seem content with just "BPA-free." "It is like if Johnson & Johnson were selling a bandage that says it doesn't have <em>Staph.</em> <em>aureus</em>," said Bittner, who also founded CertiChemi, a company that tests products for endocrine activity, and PlastiPure, a company involved in making plastics without estrogenic chemicals. "That's nice. But how about <em>Streptococcus</em> or <em>E.</em> <em>coli</em>? And their response is only, 'There is no <em>Staph.</em> <em>aureus</em>.'"</p><p>"'BPA-free' is a fantastic marketing tool, but it is not evidence to the consumer of a safe product," Pat Hunt, a geneticist at Washington State University in Pullman, told EHN.</p><p>Of course, TMBPF, the basis for V70, is itself a bisphenol. This fact has made convincing people of its safety an uphill battle, according to Mallen. He underscored that Valspar has taken a novel approach, assessing the compound's safety alongside functionality throughout the entire process.</p><p>Some researchers seem to vet his stance that we may not need to immediately toss out every BPA relative. "Are all bisphenols bad? Maybe the answer is yes, until you can show certain ones are better," Joel Tickner, a pioneer in green chemistry at UMass Lowell, told EHN. Terrence Collins, another green chemist at Carnegie Mellon University, added that V70 is a "step in the right direction."</p><p>"They are providing a model for changing the chemical enterprise to deal more adequately with endocrine disruption," he said. Still, Collins told EHN that he is waiting on further data regarding the compound's potential endocrine-related activity: "I'm optimistic, but I want more convincing."</p>Can-do attitude
<p> In a lab upstairs from the conference room, chemist Nusrah Hussain wears a pink and black headscarf and blue lab coat. She stands over a five-liter glass vessel, mixing an epoxy resin and other ingredients together to formulate a new polymer. If all goes well, the polymer could ultimately be used in a can coating for a new recipe of Campbell's Chunky soup. </p><p> Valspar is developing various versions of its ValPure V70 coating with specific characteristics for various foods and beverages. "Different end uses need different properties," Hussain told EHN. The expanding variety of products sold in cans today — from water to wine, even coffee and cannabis-infused alcoholic drinks — has added to the challenge. </p><p> Of course, cans are just one of the many sources of BPA in our everyday lives. And, unfortunately, V70 doesn't make a good polycarbonate for that array of other bisphenol-loaded plastics on the market, noted Collins. Beyond BPS and Tritan, few alternatives are in the works for plastics. A <a href="https://pubs.rsc.org/en/content/articlelanding/2019/GC/c9gc02253h#!divAbstract" target="_blank">Korean research team</a> is currently investigating a glucose-derivative bioplastic, for example. </p><p> Although, to date, bioplastics haven't proven to be a panacea. Martin Wagner, a biologist at the Norwegian University of Science and Technology, told EHN that <a href="https://pubs.acs.org/doi/10.1021/acs.est.9b02293" target="_blank" rel="noopener noreferrer">he found "strong and abundant" toxic effects</a> in the bioplastics he recently tested. </p><p> And bioplastics may provide <a href="https://aip.scitation.org/doi/pdf/10.1063/1.4942294" target="_blank" rel="noopener noreferrer">lower quality</a> at a <a href="https://phys.org/news/2017-12-truth-bioplastics.html" target="_blank" rel="noopener noreferrer">higher cost</a>. </p><p> Just how well a material serves its intended purpose, along with affordability, are requisite for replacements pushing out toxic predecessors. And that's a central challenge with all BPA substitutes. </p><p> The first beverage can was made back in 1935, shortly after the end of Prohibition. That can of red Krueger Beer was comprised of three steel pieces with a solvent-based PVC coating supplied by Valspar. But it wasn't long before BPA emerged as the superior substance for protecting the quality and flavor of whatever was inside a can. By the late 2000s, the majority of food and beverage cans were lined with BPA epoxy. </p><p> Consumer concern over BPA had begun escalating by that time — a result of accumulating research by academic scientists. In 2015, California responded by adding BPA to its Proposition 65 list of chemicals known to cause cancer or reproductive harm. That same year, France banned the use of BPA in all food packaging and containers. Because it's inefficient for manufacturers to use different products for different markets, industry was motivated to look for alternatives, Jeff Niederst, marketing director for beverage at Valspar, told EHN. </p><p> As makers of plastics looked to BPS and other chemical cousins, most can coating companies including Valspar initially sought non-bisphenol alternatives such as polyesters and acrylics. But those materials have significant performance limitations. Niederst wanted a better solution. He convinced his upper management that they had to look back to bisphenols, and work from the ground up to find one that did not have endocrine-disrupting characteristics. </p><p> Valspar scientists started by screening hundreds of molecules, searching for a bisphenol that would not physically fit into hormone receptors. One strong candidate, TMBPF, emerged. They then began working with environmental health advocates and academic scientists, including Zoeller, to determine how much of the compound might migrate from coated cans and make sure that whatever did make it into our bodies wouldn't scramble our hormones. </p><p> Although there are well-established tests for signs of a chemical causing cancer, there is "no widely accepted tests for androgen or estrogen activity and so forth," said Mallen. "We had to depend on people in academia to help educate us and guide us." </p><p> Scientists found that very little TMBPF could leach out of a can and into food: less than the 0.2 parts per billion that their testing method could even detect. Ana Soto, another Clarity participant and an endocrinologist at Tufts University, however, suggested that the more pertinent information came in testing endocrine activity of can extracts. It's not necessarily a single compound but rather a chemical cocktail that could leach out of a can lining. The additional substances may, too, have endocrine activity. So, she <a href="https://pubs.acs.org/doi/abs/10.1021/acs.est.6b04704" target="_blank">tested samples of the can extracts, for estrogenic activity.</a> None. </p><p> Further tests, included in a paper published in October, looked to see if TMBPF could disrupt the delicate levels of androgen and aromatase, an enzyme that converts testosterone to estrogen, in the body. Some subtle anti-androgenic activity was seen at the highest dose studied; otherwise, all appeared clear. </p><p> "I don't eat anything canned," said Soto. "But I understand people do that. And a person who eats canned food is better off, in principle, with this one than the conventional one." </p>Bigger changes needed
<p> Companies that are shifting away from BPA, such as Coca-Cola and Campbell's Soup, still referenced FDA's continued assurance of its safety. Mallen, too, was hesitant to suggest that more regulation is needed from the government on BPA. And he never said that low-dose BPA exposures actually posed a threat to public health. "The problem with the whole endocrine thing is there is no consensus," said Mallen. "We have to, as a society, get to a consensus on that first. Then the regulators would be able to do something with that." </p><p> Nevertheless, Valspar appears motivated to phase out BPA and avoid its equally troublesome cousins. The company is responding to consumer demand, much like the Campbell Soup Company. "Although the FDA has determined that BPA is safe to use in food packaging, we understand that some people would prefer to avoid it," Amanda Pisano, a spokesperson with Campbell's, told EHN in an email. <a target="_blank"></a> </p><p> As more companies follow their lead, scientists hope they will also do the extra legwork to ensure any replacement is not just another endocrine disruptor. Rachel Simon, a researcher at the Lowell Center for Sustainable Production at UMass Lowell, is optimistic. "We're seeing companies move more quickly to trying to find innovative solutions. It doesn't matter what the driver is — regulatory or consumer demand," she told EHN. "Previously, people spent energy trying to fight about whether it is or it isn't safe. By focusing on innovation, we're able to find solutions faster than if trying to defend the legacy incumbent. I think we're seeing a shift." </p><p> Simon and Tickner are working to propel that shift, developing methods for chemists and toxicologists to evaluate potential substitutions for chemicals of concern, including the other thousand or so chemicals on the market that <a href="https://www.saferalternatives.org/about" target="_blank">are believed to have endocrine-disrupting properties.</a> Multiple strategies exist for creating chemical substitutes. </p><p> "You can look at less hazardous, structurally-similar molecules, or you could look at totally new molecules that achieve the same function, or you could make process changes that eliminate the need for a chemical," said Tickner. "Or you could just find another way to get the service that the chemical provides." </p><p> For example, there are efforts to bypass plastics in packaging, such as Tetra Brik, the paper-based liquid cartons used for various soups and beverages. A substitution toolbox has been expanding over the last several years. In 2013, a team of biologists, chemists and toxicologists developed a <a href="http://www.tipedinfo.com/" target="_blank" rel="noopener noreferrer">"Tiered Protocol for Endocrine Disruption"</a> to help industrial scientists detect endocrine-disrupting tendencies early in the chemical development process. (Editor's note: Pete Myers, CEO and chief scientist of Environmental Health Sciences, was involved in the development of the protocol. He is also the founder of Environmental Health News, though the publication is editorially independent.) </p><p> Among the most useful tests to detect potential effects on the human endocrine system, according to the 23 authors, involves zebrafish. The tiny fish are fast to develop, transparent and absorb compounds through water. "It's a very powerful assay for signaling a lot of effects. And it's not expensive," said Collins, one of the authors of the protocol. "It is now possible to the highest levels of contemporary science to say whether or not you've got an endocrine disruptor." A separate nonprofit, <a href="http://advancinggreenchemistry.org/tag/bpa/" target="_blank">Advancing Green Chemistry</a>, helps connect people wanting to have chemicals tested and the experts to do the appropriate testing. </p><p> "Using this framework, chemists could refine chemicals and design toxicities out of those molecules," said Wagner of the protocol. "It takes a lot of time and resources, but eventually you end up with chemicals that you know right from the start are not toxic." </p><script id="infogram_0_82643633-1286-482b-8ac4-7ea239f1e50f" title="Copy: Pull quote" src="https://e.infogram.com/js/dist/embed.js?ANB" type="text/javascript"></script><p> In addition to bioplastics, Wagner's recent paper analyzed the chemical mixtures in a range of plastics products and found that most showed some potential toxicity. His team found far more androgen-blocking effects across chemicals than the more well-known estrogenic impacts associated with BPA. The usual suspects, bisphenols and phthalates, played only a minor role. In fact, many of the suspect chemicals were unknown. Of the 1,400 substances they detected in a sample of plastic products, his team could identify only 260 compounds. "It's impossible for consumers to know what plastic contains what chemicals, and what's safe," he added. "It should be on the producers' responsibility to make sure their products are safe." </p><p> Wagner acknowledged that manufacturers are unlikely to start doing that by themselves given the added costs. Pressure is needed from the public and from regulators. "Industry has to strive to prevent the problem, but we will always need the regulatory part," added Soto. "The way the FDA does regulation has to change." </p><p> Tickner and Simon are among those arguing that the federal government should take advantage of the tools now available to build a regulatory framework for industry that includes the appropriate assays to detect low-dose endocrine-disrupting effects. Meanwhile, Europeans are already starting to employ assays very similar to those detailed in the tiered protocol. And they're creating incentives for its use. EU's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation states that endocrine disruptors can be identified as substances of very high concern alongside chemicals known to cause cancer, mutations and toxicity to reproduction. <a href="https://www.ehn.org/bisphenol-a-2639174350.html" target="_blank" rel="noopener noreferrer"></a> </p><p> <a href="https://www.ehn.org/bisphenol-a-2639174350.html" target="_blank" rel="noopener noreferrer"> In July, the General Court of the European Union confirmed that BPA must be listed as such a substance</a>, potentially subjecting the chemical to further regulation and restrictions under REACH. The implications could reach back to the U.S., much like how California's stricter rules impact markets across the country. "EU's regulations shape the world's regulations," said Simon. </p><p> Collins underscored the urgency, calling for a global movement with regard to endocrine disruptors that parallels the one for climate change. As machines continue to print cash register receipts, mold hard plastic bottles and spin metal cans, we remain part of a massive experiment with far greater implications than any designed by Rube Goldberg. </p><p> "It's just as bad as the climate in terms of its impact on living things," he said. "It's arguably faster acting, and hardly anyone knows about it." </p><p> <em>Miss any of our "Exposed" series? <a href="https://www.ehn.org/is-bpa-dangerous-for-health-2641153205.html" target="_blank">See the entire four parts</a>, as well as our comic <a href="https://www.ehn.org/bpa-chemical-comic-2640636344.html" target="_blank">"Clouded in Clarity."</a> </em> </p>
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