Environmental Health News Spreads Falsehoods About PVC and Phthalates in Medicine

“Phthalate-contaminated” medical devices jeopardize the health of newborn babies, Environmental Health News (EHN) intern Ashley James asserts in a recent story titled, “What will it take to give babies a phthalate-free start in the world?”

While undoubtedly well-intentioned, her article misrepresents the available evidence and downplays PVC’s important health care applications, confusing and alarming EHN readers instead of educating them.

James’ thesis centers on a chemical called Di(2-ethylhexyl) phthalate, typically abbreviated to DEHP. It’s a plasticizer commonly added to some PVC products to make them more flexible, including blood bags, sterile tubing and other vital medical supplies used safely in hospitals the world over.

Evidence of harm? Context is key

James alleges a link between phthalate exposure for newborn infants with “several toxic endpoints” that cause harm to human health. Her claims aren’t supported by reliable scientific research. What’s more, they don’t tell the whole story. Studies have shown that infants are exposed to various chemicals, including phthalates. But no credible scientific evidence has found that these exposure levels are harmful. Writing for the Genetic Literacy Project last year, Dr. Sam Moxon helpfully summarized this important point:

“Studies have demonstrated detectable levels of phthalate metabolites in human urine and these are often viewed as concerning because phthalates can be toxic but likely at a much higher dose than observed in humans.”

The U.S. Centers for Disease Control and Prevention’s (CDC) Agency for Toxic Substances and Disease Registry (ATSDR) made an equally significant observation in 2022, explaining that:

“[H]uman epidemiology studies evaluating potential adverse effects from exposure to phthalates (including DEHP) are insufficient to draw firm conclusions regarding cause and effect or dose-response for individual phthalate esters.”

ATSDR made several other pertinent observations in an earlier analysis that James and other critics of phthalates often overlook. Specifically, the agency found that:

“DEHP, at the levels found in the environment, is not expected to cause adverse health effects in humans.”

Also missing from James’ story is a reference to a 2022 finding by the U.S. Food and Drug Administration on phthalates and direct contact with food packaging, where the agency stated:

“[W]e do not have a basis to conclude that dietary exposure levels from approved ortho-phthalates exceed a safe level.”

Any connection James tries to make between phthalate exposure and human health falls flat, as she draws conclusions which credible scientific studies do not support, and ignores findings by U.S. government agencies that contradict her thesis.

Risks vs benefits

Are there benefits to using phthalate-containing PVC medical supplies? And do those benefits play a major role in advancing public health? The answer is “yes” in both cases. Hospitals rely on blood bags containing DEHP because it “makes them robust to the manufacturing and sterilization process, and able to withstand the diverse challenges of processing and storage conditions,” the authors of this 2011 evidence review explained.

James counters in her EHN piece that PVC alternatives already exist. What she fails to mention is that these substitutes can’t deliver the same strength, durability and versatility as PVC. Bags made from other materials can hinder a hospital’s ability to preserve blood for extended periods, raising uncertainty about the availability of blood when it’s most needed.

PVC medical tubing offers another key example of DEHP's important role in healthcare. Clinicians require transparent, kink-resistant tubing to monitor fluid movement and ensure a consistent flow of fluid or oxygen to patients. That's why PVC is frequently specified for these applications; hospitals can't take a chance on other materials when their patients' lives are on the line. The American Academy of Pediatrics (AAP) agrees. In a 2003 report James cited (but did not quote) the APP wrote that:

“DEHP has important characteristics that improve the function of medical devices. Any substitutes must be shown to be toxicologically safer and functionally equivalent.”

We agree with James that protecting the health of young children is essential. We do that by giving medical professionals and healthcare facilities the tools they need to provide the best care possible. Making speculative claims about the dangers of phthalates does nobody any good.

HuffPost Refuses to Tell the Truth About Water Bottles

“The plastic packaging of your beloved bottled water may pose certain health risks,” HuffPost guest writer Daryl Austin reported in a September 2022 story. “Here's what experts want you to know.”

Although Austin marketed his story as an expert-guided analysis, his article misreported basic facts about phthalates and water bottles, cited irrelevant sources, and left readers with the impression that they face a serious health threat which the science doesn’t support. 

And when we reached out to Austin and his editors repeatedly to point out the flaws in his piece, they declined to respond to our inquiries.

In fact, we contacted them four separate times, politely asking that they correct the glaring errors in the story to avoid deceiving the public. Since these requests were ignored, we offer this rebuttal in an effort to do what HuffPost refused to do—tell the truth.

Austin’s mistakes began just three paragraphs into his story: “Phthalate exposure has been warned against because of how the chemicals affect a person’s endocrine system, which is the system that produces and releases hormones,” he wrote. He tried to support that claim with a link to two facts sheets, one from the U.S. Centers for Disease Control and Prevention (CDC), the other from the U.S. Environmental Protection Agency (EPA).

But the CDC document didn't even mention water bottles. And the EPA citation included a key point Austin left out of his story: “Several studies have shown associations between phthalate exposures and human health, although no causal link has been established.”

The U.S. Food and Drug Administration (FDA) went even further. In a May 20, 2022 regulatory decision, the agency declared phthalates safe for food contact, stating: “based on the information currently available to FDA, we do not have a basis to conclude that dietary exposure levels from approved ortho-phthalates exceed a safe level...”   

In his zeal to work the “dangers of phthalates” into his lede, Austin made another crucial error by assuming that these plasticizers are used to make water bottles. In reality, most water bottles are fashioned from polyethylene terephthalate (PET or PETE). Despite its name, PET is neither polyethylene nor a phthalate, nor does it contain phthalates.

In fact, PET is in the polyester family, which explains the relative ease with which used water bottles can be recycled into threads that can be made into shirts, tote bags and strapping materials, as well as new water bottles.

We tried to point these facts out to Austin and his editors. First we emailed Austin and HuffPost Life Section Senior Editor Janie Campbell on October 3, 2022, and they ignored us.

We emailed Campbell again on October 13, 2022, and she ignored us. 

We emailed HuffPost’s Head of the Life Section, Kristen Aiken, and she ignored us.

We then contacted HuffPost’s senior editors – Robyn Malcolm (Managing Editor), Paige Lavender (News Director), Whitney Snyder (Executive Editor), Kate Palmer (Executive Editor), Danielle Belton (Editor-in-Chief) – on December 15, 2022 and December 19, 2022.

They all ignored us.

Even a cursory search into how plastic water bottles are made would have confirmed the information we tried to bring to their attention.  The fact that Austin made such elementary mistakes in a story supposedly based on expert input is inexcusable.

Readers are right to wonder why editors at The HuffPost seemingly do not care that they are deceiving readers by failing to remove Austin’s story from their platform.

TOXIC-FREE FUTURE GETS IT ALL WRONG ON PVC

NSF Regulatory Manager Addresses Safety of Plastic Pipe Use in U.S.

NSF Regulatory Affairs Manager Jeremy Brown recently authored an important essay in wateronline.com to help the public understand the safety of using PVC pipe in replacing lead service lines in the United States. Mr. Brown’s timely piece confronts the misleading claims in a recent Scientific American article which misinforms the public about plastic pipe.

NSF is the leading independent certification organization which sets standards by which all materials that come into contact with drinking water must follow. These materials, which include PVC pipe, he writes, “are required to comply with NSF standards to ensure the materials will not contribute harmful levels of contaminants to the drinking water.”

He notes the NSF / ANSI / CAN 61 standard specifies health requirements “for all water contact materials including metals, plastics, elastomers, coatings, etc.”  He says NSF certification of water-contact materials, which include PVC pipe, “requires rigorous extraction tests that include chemical extraction, analysis, and toxicological assessment of potentially hundreds of contaminants, not just lead or other heavy metals.”

He goes on to say that “plastics piping, components, materials, and ingredients have been in the industry for over 55 years, even before the current standards were established.” He adds that “[i]n the modern era of product standards, plastics plumbing products have been studied extensively.”

He further writes that NSF / ANSI / CAN 61, with which PVC pipe complies, “is the legally recognized national standard in the United States and Canada for human health effects for drinking water contact materials, components, and devices.” And he clarifies that “[p]lumbing codes and state water utility regulations require certification to this standard to ensure products are safe for use.”

He concludes with this simple statement: “[c]onsumers can be assured that the certified products and materials used to replace lead service lines will meet the U.S. national standard requirements.”

That of course includes PVC pipe, which has been rigorously reviewed and tested by the NSF – and certified as an approved material for use in delivering clean, safe drinking water – under the NSF / ANSI / CAN 61 standard.

Read Mr. Brown’s full essay here.

The FDA States Phthalates are Safe, But Activists Continue to Deny the Science

The U.S. Food and Drug Administration (FDA) has declared phthalates used in food packaging are safe, but that hasn't stopped agenda-driven NGOs from continued attempts to mislead the public. Activists are doubling down on unscientific criticisms of the plastics used in commercial products, including food packaging. Unfortunately, they show no signs of curbing those criticisms.

On May 20, 2022, the FDA denied a petition from several environmental groups that contained a number of scientifically-unsupported accusations about phthalates and food packaging. The FDA stood firm in its findings, noting:

“ … the petition does not contain sufficient data to support finding that there is no longer a reasonable certainty of no harm from the currently approved uses.

“….based on the information currently available to FDA, we do not have a basis to conclude that dietary exposure levels from approved ortho-phthalates exceed a safe level...” (Source: Natural Resources Defense Council, et al.; Denial of Food Additive Petition; Denial Without Prejudice of Food Additive Petition)

Despite the FDA's declarative statements – and the absence of credible studies or evidence to support the petition’s claims – a group of agenda-driven phthalate opponents continue to insinuate that there is harm or risk from phthalates in food packaging. Earth Justice, Center for Environmental Health, and Environmental Defense Fund have made such assertions, in attempts to continue with their misleading narratives around the safety of ortho-phthalates, used in hundreds of common vinyl (PVC) products for decades.

But the real damage is when consumer-focused news outlets amplify activist claims without citing evidence or presenting fact-based information. Sources such as Eat This, Not That! want readers to believe they provide “accurate, timely, informative, and actionable content,” yet in the same breath, they source outdated news articles and advance only biased and uninformed views of phthalate opponents.

After years of comprehensive review, the FDA made its decision and spoke clearly on this matter. Rather than accept the FDA’s decision and move on, deep-pocketed activist groups have chosen to perpetuate distortions and junk science.

At Vinyl Verified, we deal with facts. And the facts are these: regulators in Europe and Australia have found no compelling evidence that phthalates used in food packaging harm human health. Now, the U.S. Food & Drug Administration has reached an equivalent safety conclusion.

Cities Break From Iron Pipes, Opting for More Reliable PVC Pipe

Our country’s iron pipes are crumbling — and more and more cities are turning to PVC pipes to replace their aging, outdated water systems.

Why? PVC pipes offer several advantages: longevity, durability – and strong value for U.S. taxpayers.

Cities are making the switch because PVC pipes are corrosion-resistant and designed to be in service decades longer than iron pipes. Utah State University researchers evaluated a cross-section of America’s existing water infrastructure systems and found PVC pipes to be the most durable option:

A major finding of the study is that PVC pipe has the lowest overall failure rate when compared to cast iron, ductile iron, concrete, steel and asbestos cement pipes. Another major finding is that corrosion is a major cause of water main breaks.

When it comes to taxpayer value, PVC pipe is unmatched. In Pleasanton, California, ductile iron pipe was found to cost 70 percent more than PVC pipe during a water line replacement project. In Tryon, North Carolina, taxpayers saved an estimated 30% by replacing their water lines with PVC pipe. In Burton, Michigan, PVC is projected to save taxpayers $2.2 million.

PVC pipe is designed to be in service for over 100 years. Because of its longevity, PVC pipe is a more sustainable material, as it requires fewer repairs and replacements over its lifetime. What’s more, its strength and durability result in fewer ruptures, minimizing loss of treated water.

The American Society of Civil Engineers estimates that across the country, a water main breaks every two minutes, losing roughly six billion gallons of treated water every day.

With regard to safety, since 1988, NSF International has maintained authorization for the use of PVC pipe in drinking water systems. The public can have confidence that the water they drink from PVC pipe systems is clean and safe.

On the other hand, iron pipes are susceptible to tuberculation, a form of internal corrosion and biofilm contamination, that can lead to leaks, bursts, and cracks. The National Academy of Sciences has even conducted a review that says legacy iron pipe materials may “contribute to Legionella growth in hot-water heaters.” As we see every day across the nation, especially during the cold winter months, aging iron pipe breaks can cause serious public health issues, including boiled water advisories, flooding, traffic congestion delaying the arrival of First Responders, among many other concerns.

Which cities are switching to PVC pipes?

A quick scan of public sources over the past two years found 45 instances where U.S. cities and townships have made the switch to PVC pipe. These regions have recognized that PVC pipe is the most durable, cost-efficient material available, offering the best value for taxpayers.

Trusting the process on EPA’s PVC petition consent decree

The US Environmental Protection Agency has agreed to a proposed timeline to assess alarmist claims about discarded PVC alleged by The Center for Biological Diversity. Vinyl Verified will follow this process closely — and set the record straight to ensure the facts prevail.

The innovation of PVC has transformed our world. It preserves blood longer and protects those on the front line who depend on PVC-made personal protective equipment (PPE) to keep them safe. It has revolutionized how medical care is administered, saving countless lives due to its material attributes that can withstand harsh disinfectants and reduce the spread of deadly infection. It delivers safe, clean drinking water to people around the globe. And it’s found in many of the products we rely on each and every day that make our lives better — from our televisions, computers, flooring, siding, windows, fabrics, car interiors. ... The list goes on.

The Center for Biological Diversity is irresponsibly advocating for the EPA to regulate discarded PVC. The organization continues to ignore the facts and vast scientific literature that shows the material is safe and sustainably managed. The Vinyl Institute (VI) responded to the recent EPA proposed consent decree, and VI’s President and CEO, Ned Monroe, issued this statement:

“The Vinyl Institute supports a timely EPA review process. The Vinyl Institute will continue to cooperate with EPA staff to provide science-based information on petitions regarding PVC. Government health and safety agencies worldwide have studied PVC and recognize the importance of products such as PVC pipe that delivers clean drinking water and landfill liners that prevent groundwater contamination. If the EPA follows the science, as we expect they will, CBD’s petition will be denied.”

Please visit Vinyl Verified and follow us on Twitter for the latest developments.

Healthy Building Network deceives on PVC roofing membranes

If you’re familiar with our work here at Vinyl Verified you’re likely aware the Healthy Building Network (HBN) has a prolific history of distorting the facts about polyvinyl chloride (PVC). We’ve had to correct them multiple times in this forum to ensure readers have accurate information. True to form, HBN recently published a ranking on roofing membranes that contains a host of flawed statements and bias-driven conclusions regarding PVC. We’ll break them down one by one …

HBN’s ranking system is entirely arbitrary.

HBN claims it “reviewed the chemicals and materials” in the roofing membranes they analyzed to form the basis of their recommendations. A rough translation of this approach is that HBN's own entrenched bias and agenda-driven outlook drove their ranking of the membranes in their story. It’s equivalent to them saying, “we know what’s best so trust us – we’re the experts.” Sorry, HBN: your word alone doesn’t pass the red face test.

HBN’s claims aren’t based on credible science.

HBN justifies ranking one membrane over others in their report by saying “fewer hazardous chemicals are required to make it.'' But any real scientist knows this has no bearing on the safety of the end product. Highly regulated chemicals are used to make thousands of consumer products where exposure concerns are minimal and present no human health risk. It’s a false premise to base the safety of roofing membranes on such flawed methodology.

HBN promotes old, outdated claims about PVC to attack its use in roofing membranes.

HBN opposes PVC membranes citing “hazardous materials used and released during raw material manufacturing.” Yet there have been no known workplace exposure incidents related to vinyl chloride monomer (VCM) used to make PVC since the 1970s due to the strong efforts by the PVC industry to comply with the rules and regulations that govern production.

What’s more, EPA’s own data confirms that VCM emissions to air & water have declined 86% since 1987 while vinyl resin production has increased 91% during the same time period. Emissions to air and water from ethylene dichloride (EDC) used to make VCM have declined by an even greater margin (97%) since 1987.

HBN further misleads by claiming phthalates leach from PVC (this time from roofing membranes). Credible research, however, proves that phthalates are held within the structure of PVC products – and do not leach under normal use and conditions.

Phthalates in PVC roofing membranes also received a Safe Use Determination from one of the toughest regulatory agencies in the nation – the California Office of Environmental Health Hazard Assessment.

HBN doesn’t want you to know any of this. They still want you to think it’s 1970 where PVC manufacturers have done nothing to change their processes over the past 50 years.

But that doesn’t change the fact that the industry has taken measurable strides to improve manufacturing, protect the environment and surrounding communities, and ensure the safety of the dedicated men and women who work at U.S. PVC facilities.

HBN ranks PVC above other roofing membrane alternatives – yet recommends it should be avoided at all costs.

For those still in need of more proof that HBN has an anti-PVC agenda, in their report they claim PVC is less hazardous than built-up roofing (BUR) – but they rationalize the continued use of BUR while recommending PVC be avoided entirely. This only validates HBN’s entrenched bias and well documented ideological opposition to everything PVC.

HBN’s long-standing agenda against PVC is precisely why the organization cannot be trusted as an independent or credible source of information about PVC.