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Despite more than two decades of evidence, advocacy and education around the issue, PVC products containing this harmful phthalate chemical still dominate the neonatal intensive care unit (NICU) environment.
Feeding tubes, fluid bags, syringes, respiratory support tubes, intravenous lines, nasal cannulas, catheters, incubators – this is only a short list of the PVC medical supplies that assist in everything from eating, to breathing, to sleeping for premature infants in NICU. The majority of these devices contain DEHP, a class of chemical called phthalates, which are used to make plastic softer and more flexible. Phthalates mimic the body’s hormones and can disrupt important processes during an infant's rapid development. Scientists have linked phthalate exposure for newborn infants, also known as neonates, with several toxic endpoints including damage to the developing brain, liver, heart, lungs, male reproductive tract and more.
While training as a clinical neonatology fellow and pursuing a masters of public health in the early 2000s, Dr. Annemarie Stroustrup Smith, the vice president and director of neonatal services at Northwell Health in New York, started to draw connections between the emerging research on prenatal phthalate exposure and the health outcomes observed among premature infants.
“We tend to chalk up health challenges that children born preterm have as due to prematurity, but that's not really a mechanism,” Stroustrup Smith told EHN, “So my question was, are some of those [health challenges] due to phthalate exposure? And if it is, that’s something we can fix because we totally control the NICU environment.”
Stroustrup Smith’s research adds to a growing body of studies seeking to understand levels of neonatal exposure to DEHP, health effects and the benefits and drawbacks of alternatives. And the science is making a difference — there is positive movement in the marketplace with phthalate-free devices becoming increasingly available. However, cost remains an issue and the contaminated medical devices continue to fall through the regulatory cracks.
Lack of medical device regulation
Feeding tubes, fluid bags, syringes, respiratory support tubes, intravenous lines, nasal cannulas, catheters and incubators are just some of the medical devices that often contain DEHP.
Credit: abbamouse/flickr
Some DEHP-free medical supplies, such as feeding tubes, are readily available on the market. However, it is impossible to have a completely phthalate-free NICU in the U.S. due to unavailability and the high cost of alternative options. While the U.S. Food and Drug Administration (FDA) released a guidance document for the pharmaceutical industry on avoiding DEHP in 2012, they have yet to ban or restrict its use in medical supplies, like the European Union has done. This is despite ongoing research, advocacy and a direct ask from members of Congress who wrote a letter to the FDA last year.
"Patients should not be exposed to phthalates and [endocrine-disrupting chemicals] when they seek medical treatment," the representatives wrote in a letter to acting Food and Drug Administration chief Dr. Janet Woodcock.
According to Joel Tickner, a chemical policy expert and professor at the University of Massachusetts Lowell, two big reasons industry hasn’t switched from DEHP are cost and resistance to change, but regulation would solve that. “It’s policy,” he told EHN, “if the FDA put their foot down and said, ‘we need to move in the next five years,’ that would change things very quickly.”
The FDA says that DEHP is on their radar and they issued a discussion paper last year for the public and stakeholders to comment. However, the paper does not specifically mention DEHP. In addition, the FDA only approves devices in their final form. “The FDA does not clear or approve individual materials that are used in the fabrication of medical devices, but does take the chosen components and materials into consideration,” FDA media representative Audra Harrison wrote to EHN.
Market-based medical device solutions
The international organization Healthcare Without Harm started working with researchers in the late 1990s to raise awareness about phthalate exposure in the NICU. Today, their sub-organization Practice Greenhealth focuses on leveraging the purchasing power of more than 1,500 healthcare organizations in their network and helping health systems make informed purchaces. “At the end of the day, I think the most expedient and long-lasting impact is a market-based solution,” John Ulman, director of safer chemicals and procurement at Healthcare Without Harm, told EHN.
Related: Lawmakers urge action on safer medical products
For example, In 2012, Kaiser Permenante, one of the largest U.S. healthcare companies, switched to non-DEHP and non-PVC IV bags. According to Seema Wadhwa, the executive director for environmental stewardship, Kaiser made this switch in six months, including product performance testing, and saved $5 million in annual costs. In 2021, the medical supplier B. Braun launched CARESAFE, the first PVC-and-DEHP-free IV sets on the U.S. market. The three-year process from development to launch was rigorous and resource intensive, requiring creative engineering, process validation, testing and FDA clearance. “Four decades ago we recognized environmental and safety risks from DEHP and PVC,” Scott Moyer, the associate director of research and development at B. Braun, told EHN. “The goal is from the bag to the patient making sure that pathway is free from harmful chemicals overall.”
In order to bolster the market around safer NICU medical devices, Stroustrup Smith said researchers need more data to prove to clinicians that switching materials will improve infant health outcomes, which takes time. “If you look at making changes in medical care, typically from the first point an intervention is shown to be effective, it often takes a decade before you actually get that change,” she said, “and that’s when it's a slam dunk, totally obvious visible change…this is not that straightforward.”
Key considerations for swapping phthalate-contaminated medical devices
All DEHP substitutions are not created equal. “We have to be wary of regrettable substitutions,” said Ulman when describing the dangers of replacement chemicals that are not well studied and could have similar effects. For example, some alternative plasticizers, such as DINH, have thorough toxicological data, but others have little to none.
Some experts argue that the material itself, PVC, is problematic and that instead of swapping DEHP for another plasticizer, manufacturers should switch to materials that don't require plasticizers. The entire life cycle of PVC is harmful — production requires a lot of energy and releases toxic chemicals such as mercury and asbestos into water and air. For disposal, PVC is the least recyclable plastic and is often incinerated by healthcare facilities, creating highly toxic and persistent pollutants called dioxins and furans. For this reason, PCV-free materials, such as the thermoplastic polyurethane in B. Braun’s CARESAFE line, are the preferred substitutes.
Toward phthalate-free
Outside of medical supplies, phthalates are found in a wide range of products including building materials, cosmetics, furniture, food packaging and more. Thus, there are several opportunities across a person’s lifespan to come into contact with phthalates, starting from the womb. A 2022 study linked prenatal phthalate exposure to an increased risk of preterm birth – meaning there is a chance infants born preterm due to phthalate exposure are then exposed to even more phthalates in the NICU.
Since scientists first raised concern about DEHP, progress towards reducing exposure to children and infants in the U.S. has inched along. In 2008, Congress banned DEHP and two other phthalates in toys and in 2017 the U.S. The Consumer Product Safety Commission banned five additional phthalates in toys. Prominent health organizations, such as the American Public Health Association and the American Academy of Pediatrics have published policy statements on the issue. NICU’s across the country have committed to buying DEHP-free products whenever possible.
Individuals can also play a role. Healthcare professionals can advocate for DEHP-free products with healthcare administration, researchers can continue to study the impact of DEHP exposure and the benefit of replacements, and patients can ask their doctors about exposure to phthalates during care.
Change takes time, but some argue that we shouldn't wait to act on protecting the most vulnerable patients. “The science was there 20 years ago,” Tickner said, “Why is it taking so long to act on this?”
Editor’s note: Environmental Health Sciences, which publishes EHN.org, is working with B. Braun and others to create a phthalate-free health care sector.
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An analysis of U.S. government data derived from more than 500 fish samples revealed that the majority of fish living in streams, rivers and lakes across the country are contaminated with per- and poly-fluoroalkyl substances (PFAS) at levels almost 300 times higher than found in fish from other sources, including ocean and farmed fish, according to the paper published recently in the journal Environmental Research.
Importantly, perfluorooctanesulfonic acid (PFOS), a type of PFAS known to be particularly harmful, was the largest contributor to total PFAS levels found in freshwater fish samples, averaging 74% of the total, according to the study.
The U.S. Environmental Protection Agency (EPA) considers PFOS specifically to be a hazardous substance that “may present a substantial danger to human health” due to its links to cancer and effects on reproductive, developmental, and cardiovascular health, and warns that the chemical “may present a substantial danger to human health.” Other PFAS have also been linked to cancer, immune deficiencies, thyroid disease, and other health problems.
The research found that eating one serving of fish at the median PFOS contamination level was equivalent to consuming one month’s worth of drinking water contaminated at 2,400 times the recommended health advisory limit set by the EPA. The study determined that “even occasional consumption” of wild, freshwater fish would likely be a significant source of exposure.
Freshwater fish represent an important U.S. food source, especially for people living on a low income. About 660,000 people in the U.S. eat fish they catch themselves three or more times per week.
“Consuming a single freshwater fish could measurably increase PFAS levels in your body,” said David Andrews, a senior scientist at the Environmental Working Group (EWG) and one of the authors of the paper. “These fish are incredibly contaminated.”
Many studies have shown that PFAS chemicals are pervasive in the environment and the new analysis underscores the growing understanding that humans and animals have little avenue for escaping contamination. The research paper found that fish from all 48 continental U.S. states showed PFAS contamination, and only one of the samples did not contain any detectable PFAS.
The study also found higher levels of PFAS among fish from the Great Lakes as compared to water bodies elsewhere, indicating that the Great Lakes are particularly vulnerable to contamination. According to Andrews, this could be because the water in the Great Lakes empties into the ocean much more slowly than other water bodies, aiding the accumulation of PFAS.
Heidi Pickard, a PhD candidate at Harvard University who studies PFAS in aquatic ecosystems and was not involved in the new study, said the results are likely an underestimate of the actual contamination present in fish, given the lack of ability to test for all of the thousands of PFAS chemicals and PFAS precursors — chemicals that break down to form PFAS once they enter the environment.
“We’re only starting to be able to measure and quantify [other PFAS compounds],” she said.
A ubiquitous pollutant
About 660,000 people in the U.S. eat fish they catch themselves three or more times per week.
Credit: Ohio Sea Grant
PFAS are also often referred to as “forever chemicals” because they do not break down in the environment and bioaccumulate, persisting in the bodies of humans and animals. There are more than 4,000 man-made PFAS compounds used by a variety of industries for such things as electronics manufacturing, oil recovery, paints, fire-fighting foams, cleaning products and non-stick cookware.
According to one nationwide study, 97% of Americans have detectable levels of PFAS in their blood, and the chemical is a ubiquitous pollutant in water and soil across the country.
The Biden Administration is implementing a series of steps to try to restrict PFAS from contaminating water, air, land, and food as well as to clean up PFAS pollution and speed up research on other PFAS issues.
Related: PFAS on our shelves and in our bodies
The findings are “very concerning” to communities that frequently consume fish from local waterways, said Andrews. The general U.S. population varies greatly in their frequency of fish consumption; anglers, individuals living near water bodies, and immigrant communities coming from cultures with high fish consumption are usually considered the highest consumers.
These people are at higher risk of PFAS contamination; for example, a 2017 study found that higher consumption of fish and shellfish was associated with elevated levels of some PFAS. A 2022 study of Burmese immigrant anglers in New York State found elevated levels of PFOS in the anglers compared to the general population. Some people, said Pickard, rely on freshwater fish for subsistence and may not be able to afford substituting store-bought fish for locally caught fish.
Catching and eating fish is also a sovereign right for Indigenous tribal nations that “must be honored and respected,” according to the paper’s authors.
Regulation lacking
Freshwater fish represent an important U.S. food source, especially for people living on a low income.
Credit: G Witteveen/flickr
While the EPA recognizes that eating U.S. freshwater fish exposes fishers to PFOS, there are currently no federal fish consumption regulations to protect fishers from these or other PFAS chemicals. Only 14 of 50 states have implemented PFAS-specific fish consumption advisories, which does not reflect the full extent of the contamination problem, according to the research paper.
For example, many states in the Great Lakes region use guidelines set by the Great Lakes Consortium for Fish Consumption Advisories to determine regulations. Those guidelines are based on the Environmental Protection Agency’s 2016 drinking water standards.
Related: What are PFAS?
In 2022, the EPA substantially lowered the drinking water standards — by about three orders of magnitude — with new interim guidelines. If fish advisories across the country were updated to reflect the EPA’s interim guidelines, nearly all fish from rivers, lakes and streams could be considered unsafe, according to the research paper.
Sean Strom, an environmental toxicologist at the Wisconsin Department of Natural Resources, said a lack of funding and scientific capacity among state agencies is likely hindering the creation of new consumption advisories. States that have been monitoring PFAS for longer are more able to enact public health measures in response to changing science, according to Strom.
There is growing evidence that PFAS are affecting other wildlife across the country. The results for freshwater fish, said Andrews, is “just scratching the surface” of the likely contamination by industrial chemicals happening in ecosystems worldwide.
Pickard agreed and said more research is needed to show how PFAS are impacting the lives and health of wildlife.
“We have a significant challenge in being able to assess ecological risk for all these PFAS and what that’s going to mean for species,” she said. “What are the biological effects going to be for them?”
Cleaning up the country’s water bodies is unlikely, according to Ranier Lohmann, a professor of marine chemistry who studies PFAS at the University of Rhode Island.
“There’s not an easy solution to widespread, low-level contamination,” he said.
Editor's note: This story was produced in collaboration with The New Lede.
“In the last few months, we’ve seen a huge surge in nurdles,” James Cato, a community organizer at the Mountain Watershed Association, told Environmental Health News (EHN) in November. “Where we’ve normally been detecting about 10 nurdles per sample, we’re now seeing 100.”
Cato and other citizen scientists have regularly conducted “nurdle patrol” since 2020, taking to the river in boats to collect nurdles from water and sediment samples. Their goal is to establish a rough baseline for how many and what types of nurdles are in the water before Shell opened its massive new plastics plant along the Ohio River in southwestern Pennsylvania.
But these particular nurdles represent just a tiny fraction of the microplastics plaguing the Ohio River and other freshwater bodies across Pennsylvania and the country. Broken down pieces of plastic packaging, bottles, or bags, and plastic fibers used in synthetic textiles (like nylon) — basically any pieces of plastic that are less than five millimeters long — are also considered microplastics.
What’s happening with the influx of nurdles in the Ohio River exemplifies how hard it is to track down the sources of such pollution and determine who is responsible for cleaning it up. And amid the confusion, scientists are just beginning to understand the consequences to wildlife and human health.
“When I started looking into this a couple years ago, freshwater environments weren’t really on the radar because most research on microplastics had been focused on marine environments,” Lisa Emili, a researcher and associate professor at Penn State University Altoona, told EHN. “That’s starting to change as we increasingly recognize that freshwater environments have the ability not only to transport microplastics, but also to accumulate them.”
Tracking down the source of plastic nurdles
A leaf along the Ohio River. Citizens scientists have seen an influx of the pollution.
Credit: James Cato
Nurdles found in the Ohio River by Mountain Watershed Association and Three Rivers Waterkeeper
Credit: James Cato
Shell’s plant, which came online in November, will produce up to 1.6 million metric tons of plastic nurdles every year to be used in many consumer products, including single-use plastic packaging and bags. But the influx of new nurdles showed up before the plant opened, and the nurdle patrollers think they’ve traced many of them to a different source.
“These nurdles are really tiny, about the size of a poppy seed and about an eighth the size of regular nurdles,” Cato said. That unique appearance allowed them to track a trail of them to an outfall on Racoon Creek, a tributary of the Ohio.
The outfall belongs to a company called Styropek, which manufactures expandable polystyrene pellets, or EPS — rigid plastic pellets that are later expanded with air to double their size, then used to manufacture insulation and packaging products similar to Styrofoam. According to its website, Styropek is the largest manufacturer of these pellets in North America.
“We found thousands of these nurdles downriver of Styropek’s outfall and just two upriver,” Cato said. “There were also lots of nurdles on the riverbanks — so much that it looked like snowfall, coating plants in white — and they basically formed a bull’s eye around the plant, so we’re pretty confident they’re coming from there.”
The groups first noticed the nurdles in September. As private citizens, they couldn’t investigate further without trespassing on Styropek’s property, so they alerted regulators at the U.S. Environmental Protection Agency (EPA). About a month later, the EPA referred them to the Pennsylvania Department of Environmental Protection (PA DEP), at which point the groups filed a complaint with that state agency and the Pennsylvania Fish and Boat Commission to ask them to investigate.
Their contact at the Fish and Boat Commission wanted to help, but didn’t think they had legal jurisdiction to do so. Jamar Thrasher, a spokesperson for the Department of Environmental Protection, said the agency had performed an inspection at Styropek about a week prior to receiving the complaint, and “found nothing floating near the facility’s outfall or in the stream and identified no violations.” Still, in response to the complaint, he said the agency “requested that Styropek develop and integrate a more expansive plastic pellet/nurdle housekeeping plan to prevent potential discharge through any outfalls.”
The groups doing nurdle patrol alerted Styropek to the problem. In response, the company hired an environmental consultant, verified that they'd had an accidental release of plastic nurdles into Racoon Creek, and began working to identify causes of the spill and plan remediation efforts. In late December, the Department of Environmental Protection issued a notice of violation to Styropek for the nurdles.
"We are working closely with [the Department of Environmental Protection] and are actively investigating, and we are committed to implementing necessary corrective actions," Styropek spokesperson Danielle Kephart told EHN. "We remain dedicated to the health and safety of the communities in which we operate, and I plan on keeping Three Rivers Waterkeeper updated on our investigation as I am able."
This incident proves that the nurdle patrollers are doing essential work — and indicates that without their vigilance, releases of plastic nurdles into waterways would likely go unnoticed by regulatory agencies.
Nurdle pollution is largely unregulated. There are no international regulations on it, but in 2022 the United Nations resolved to create an international treaty aimed at restricting microplastic pollution in marine environments. A draft of the rule is expected to be complete in 2024.
In the U.S., no agency is charged with preventing or cleaning up nurdle pollution — nurdles aren’t federally classified as pollutants or hazardous materials, so unlike oil spills or other toxic substances in waterways, the Coast Guard doesn’t clean up nurdle spills.
Most state governments don’t have rules in place related to nurdle monitoring or cleanup, and in other parts of the country, it has sometimes been unclear who bears responsibility for regulating its pollution, resulting in an alarming lack of cleanup when spills do occur.
Pennsylvania Department of Environmental Protection spokesperson Lauren Camarda said nurdles are prohibited from entering waterways under Pennsylvania’s Clean Streams Law and the Solid Waste Management Act, both of which should enable the agency to hold polluters accountable for cleaning up nurdle spills.
Microplastics pervasive in fresh water
Plastic pollution in oceans has gotten lots of attention, but researchers are now discovering that microplastic pollution in fresh water is also pervasive.
A study published by the nonprofit environmental advocacy group PennEnvironment in October found microplastics in all 50 of the “pristine” Pennsylvania waterways the group sampled — all of which are classified by Pennsylvania’s Department of Environmental Protection as “exceptional value,” “high quality” or Class A trout streams.
Research on microplastics in fresh water across the U.S. is still limited, but scientists have found microplastics nearly everywhere they’ve looked, including many waterways that feed the Great Lakes and the lakes themselves, rivers throughout Illinois, and California’s Los Angeles and San Gabriel Rivers.
Microplastics can kill fish and other wildlife that ingest them by making their stomachs feel full when they’re not, but emerging research suggests they can also enter fish through their gills or skin, poison their flesh and travel up the food chain, which has implications for other types of wildlife and human health.
“Microplastics piggyback other pollutants like bacteria, heavy metals, endocrine-disrupting chemicals and PFAS [per-and polyfluoroalkyl substances, a.k.a. ‘forever chemicals’],” Emili said. “We know they’re not good for us, but unlike other pollutants, we don’t even know how to set maximum daily loads for microplastics to avoid health consequences because they come in all different sizes, chemical compositions and levels of toxicity.”
Nurdles account for a large proportion of microplastics in waterways — by weight they’re the second-largest source of micropollutants in the ocean (after tire dust).
Microplastics in human blood
"The study that really scared everyone found microplastics in human blood."
Credit: Oregon State University
Microplastics have been found virtually everywhere on the planet — from the top of Mount Everest, the highest elevation on Earth; to the Marianas Trench at the very bottom of the Pacific Ocean; in fresh rain and snow, in the cells of fruits and vegetables, in the bodies of animals and humans and even in placentas and newborn babies.
“But the study that really scared everyone found microplastics in human blood,” Emili said. That study, published in May 2022, was the first to detect microplastics in human blood. They showed up in 80% of people who were tested.
“This means we’re starting to see not just ingestion of microplastics by animals and people, but also absorption of really, really small microplastics at a cellular level.”
It’s not yet entirely known how having microplastics in our bodies and blood impacts our health, but other research suggests the pollution can damage human cells, while other scientists have hypothesized they could increase cancer risk and cause reproductive harm, among other health problems. And we do know that some of the toxic substances that piggyback on microplastics, like heavy metals, PFAS and endocrine-disrupting chemicals are associated with numerous health problems including higher cancer risk and reproductive harm.
Researchers are also worried that an influx of microplastics in fresh water has the potential to disrupt natural carbon cycles, further fueling the climate crisis, according to Emili.
“If we’re substituting plastics for something like natural sediment, microbes may gravitate toward them more than natural sources, which could upset the larger carbon sequestration cycle,” she explained. “We don’t know for sure, but this is also something we really need to look at.”
Plastic nurdle libraries
The groups doing nurdle patrol in the Ohio River are working with researchers at Penn State University to build a “nurdle library” — an index of the various nurdles they’ve collected with information about where each one came from and what it’s made of.
These libraries could help them quickly identify large quantities of nurdles they spot down the line. But there are many potential sources for nurdles spills, and identifying where each piece of plastic came from poses its own challenges.
“Nurdles start to degrade once they’re in the environment,” Emili explained. “The way they started out their life looking, chemically, is not necessarily what they’ll look like after degrading. That makes it harder to say for sure where they came from.”
In May of 2022, a train derailment outside of Pittsburgh spilled approximately 120,000 pounds of plastic nurdles into the Allegheny River (along with approximately 5,723 pounds of oil). The Pennsylvania Department of Environmental Protection oversaw cleanup efforts conducted by contractors for Norfolk Southern Corporation, the owner of the rail line responsible for the spill.
The company estimated that 99% of the nurdles were recovered, according to the state agency, but the nurdle patrollers say they still regularly come across pieces of plastic they recognize from that spill. The company hasn’t yet been fined for the accident, and the activists worry that enforcement related to releases of nurdles is inadequate to deter them.
“The cleanup of this incident is ongoing and [the Department of Environmental Protection] DEP is reviewing revised plans for how the operator will clean up remaining pellets,” the agency’s spokesperson Lauren Camarda told EHN. “The remediation and DEP’s compliance and enforcement activities related to this incident are ongoing, and, as such, DEP has not yet assessed a civil penalty.”
A recent report by international conservation organization Fauna & Flora International noted that nurdle pollution isn’t something that can be controlled through individual consumers, and called for a “robust, coordinated regulatory approach from industry, governments, and the International Maritime Organization.”
“So far we haven’t seen satisfactory enforcement even for egregious violations,” Evan Clark, a boat captain and nurdle patrol leader with Three Rivers Waterkeeper, told EHN. “We’re going to keep an eye on Styropek, but for us the bigger picture is making sure we can get our regulators to do meaningful enforcement around plastics in our waterways.”
Editor's note: This story was updated on 1/13/23 to add a response from Styropek.
