FDA Thrice Rejects Ortho-Phthalate Ban Attempt by Activists With Nothing Better to Do

For the third time in three years, the Food and Drug Administration (FDA) has sided with science and rejected a petition from anti-plastic groups demanding that phthalates be banned from food contact uses. As Chemical Watch News reported on October 30:

“The FDA concluded that the NGOs’ objections ‘did not provide a basis’ to convince the agency to deviate from its earlier decision to allow for the continued use of some ortho-phthalates in food contact applications.” …

Phthalates are chemicals used to make some plastics more flexible and durable. They’ve been safely utilized since the 1930s in food-contact materials. This recent controversy over their application in food containers began in 2016, when the activist coalition initially filed its petition with the FDA.

After more than five years of reviewing the evidence, FDA rejected the petition in May 2022, then repudiated it again on appeal in July 2023. Refusing to take a hint, the NGO coalition reformulated its complaints and filed yet another appeal. The FDA was still having none of it, concluding that the petition treated all food-contact phthalates (most of which are no longer in use) as essentially a single chemical:

“Fundamental to the petition was the claim that all 28 phthalates could be reviewed together as a class, applying data from one chemical to the entire set of 28. The FDA assessment found that available information does not support grouping all 28 phthalate chemicals into a single class assessment.”

Of course, phthalates are a broad group of compounds with diverse chemical properties and applications. Evaluating any one of them based on data related to another makes little sense. Unfortunately, this is the kind of sophomoric reasoning we’ve come to expect from agenda-driven NGOs: make scientifically dubious assertions and hope that no one notices.

The proper way to identify the health effects of exposure to any chemical is to … assess the health effects of that chemical. Formally known as a “risk assessment,” this approach is widely endorsed by the science community as the most reliable method of evaluating the safety of any product. When public health agencies like the National Toxicology Program evaluate phthalates, this is the method they employ. 

Kevin Ott, executive director of the Flexible Vinyl Alliance, nicely summarized the situation: the activist assault on phthalates has forced the FDA to re-litigate settled science. As he told Chemical Watch:

“In overruling the latest objections, ‘FDA has once again relied on up-to-date data on these substances, again coming down on the side of science and safety,’ Ott said. The use of phthalates in food contact applications is minimal. And given limited FDA resources, these repeated citizen petitions are ‘detrimental’ to improving public health, he said.”

Repeated failed attempts to ban ortho-phthalates — by those who refuse to accept sound science — are a waste of taxpayer money and place a tremendous burden on the FDA’s limited resources. These petitioners are about themselves, not the public interest.

Media, Activists Should Stick To Facts On PVC Pipe

The United States is about to embark on a massive infrastructure project courtesy of the Biden Administration: replacing millions of lead water lines to protect the public from the known risks of exposure to the toxic metal. Facilitated by the water crisis in Flint, Michigan, the effort to eliminate lead pipes was boosted by research showing that lead can seep into drinking water and “cause irreversible developmental delays, difficulty learning and behavioral problems among children,” as the Washington Post reported recently. 

The project will likely cost several billion dollars and take a decade or more to complete, but before it can even begin, we have to ask an important question: what material should replace the lead pipes? We’ve argued, at length, that PVC is the optimal choice. 

With a lower price tag, smaller carbon footprint and longer service life than any other piping material, PVC is a perfect solution for municipalities looking to replace aging lead lines—which is why so many US towns and cities have turned to the material to supply their residents with clean drinking water.

But not everyone will acknowledge these facts.  Some environmental activists and their allies in the press have used the Biden Administration’s plan as an opportunity to rehash misleading claims about PVC pipe. To make sure the public has the best information at their disposal, we’d like to once again correct a handful of recent stories wrongly maligning PVC piping. 

Truthout buries the truth about drinking water

Written by a self-described “fact-checker,” Truthout’s coverage of the pipe-replacement project was mostly free of facts, alleging that “as many as 50 different chemicals [are] released into drinking water by PVC pipes, including hormone-disrupting organotin compounds and, potentially, phthalates.”

This is highly misleading. Contaminants in drinking water, regardless of the pipe material that transport the water, are tightly regulated by the Environmental Protection Agency (EPA). The agency’s drinking water regulations, authorized by Congress in 1974, are “legally enforceable primary standards” that “protect public health by limiting the levels of contaminants in drinking water.” [our emphasis].  

Phthalates, as we have explained previously, are additive plasticizers, chemicals used to manufacture flexible PVC products. Water pipes by contrast are rigid and engineered to withstand harsh environmental conditions for more than a century. Phthalates are not utilized in the production of plastic water pipe.

Truthout did correctly report two facts: PVC pipe is widely used in the US, and its popularity is only set to increase:

“Bluefield Research, a market research company focused on water, predicts that 80 percent of domestic water pipes will be made of plastic by 2030. Westlake Corporation, an international petrochemical manufacturer, plans to begin building a $134 million expansion to its PVC pipe plant in Wichita Falls, Texas, by the end of this year.”

Not-so-volatile PVC

Colorado Politics published an equally flawed op-ed on October 8 declaring that the city of Denver relies on water pipes “made from volatile chemicals.” This is factual but not truthful information. PVC pipes are made from vinyl chloride, a chemical that readily vaporizes (the definition of “volatility”). However, finished PVC products contain essentially no vinyl chloride, and PVC itself is inert, meaning it doesn’t react chemically with other substances. 

The public is simply not exposed to harmful levels of vinyl chloride or any other chemical through PVC water pipe. This includes benzene, a compound emitted by burning trees during wildfires that can enter damaged water lines. Colorado Politics insisted that benzene results from melted PVC pipe, but as experts have known for years, it “cannot be produced from PVC combustion in an open-air fire.”

Conclusion

PVC pipes deliver safe, clean drinking water to millions of Americans every single day. Why anyone would want to disparage a material that fulfills such an important public health function is beyond us. But spreading misinformation about PVC is unacceptable, and as long as misleading stories keep hitting the headlines, we’ll keep calling them out.

Desperate Times for Iron-Pipe Force Desperate Measures from DIPRA

One of the best books ever written, The Great Gatsby, tells the story of two men seeking affection from the same woman. Gatsby, the protagonist, relies on his own authentic attributes to express his love for her. Tom, the antagonist – realizing he is out-matched and unable to compete – engages in an underhanded campaign to try and disparage Gatsby’s credibility. 

Parallels from that storyline are ever-relevant today in the context of the iron pipe industry’s recent attacks on PVC pipe. As city managers show their affection for PVC pipe over ductile iron pipe in replacing their aging iron water systems, in an act of sad desperation, the Ductile Iron Pipe Research Association (DIPRA) has resorted to slinging mud at PVC instead of defending the merits of its own pipe material.      

With their backs against the wall, DIPRA in recent months published an op-ed in the Washington Times (WT), a newsletter blog, an ad in a trade publication and a sponsored op-ed, all casting aspersions on the safety and reliability of plastic piping. All deceive the public with long-refuted falsehoods about vinyl chloride, the chemical used to manufacture PVC. DIPRA irresponsibly distorts the public’s understanding of the important roles vinyl and PVC products play in modern life. 

Let’s take a closer look at DIPRA’s claims. 

Fibbing about PVC pipe

As we’ve noted on many occasions, PVC pipe has: a service life of more than a century; a failure rate lower than any other common piping material–ductile iron included, according to a recent study by Utah State University–and an impressively small carbon footprint. 

City managers are choosing PVC pipe over ductile iron pipe due to PVC pipe’s safety and reliability, and DIPRA doesn’t like it. The evidence is freely available to anyone who wants to see it:

“Among the utilities participating in the survey, PVC is the most used pipeline material, at 116,345 miles, according to the report. Other commonly used materials include ductile iron (108,670 miles), cast iron (90,657), asbestos cement (42,365), and steel (11,358).  Among these pipe materials, PVC was found to have the lowest annual failure rate, at 2.9 breaks per 100 miles, according to the report. 

… Corrosive soils appear to play a key role in contributing to failures in ductile iron pipe. ‘Analysis of soil corrosivity shows that ductile iron pipe in highly corrosive soil has over six times the break rate of ductile iron in low corrosive soil,’ the report states.”

In the WT piece, DIPRA asserts that plastic pipes are “fragile, with a high risk of failure and a short service life, and they cost more over the life-cycle of a project.” The evidence provided in support of these charges? None whatsoever. Readers were apparently supposed to take the claims of the iron-pipe lobby at face value. 

But that’s not how science works. “Trust us” doesn’t make it true. Claims should be based on verifiable evidence. That’s why municipalities around the US are ignoring DIPRA’s empty claims and increasingly turning to PVC to deliver safe, clean drinking water to their residents. Because upgraded PVC piping “will enhance our water distribution capabilities,” as one mayor in Texas put it. She’s not alone either: in the last two years, the US has invested some $55 billion in water delivery and wastewater infrastructure—most of which is PVC.

Bottom line: the material works, and everybody knows it.

More vinyl chloride myths

In a newsletter published the same week, and in a recent ad, DIPRA targets vinyl chloride with the same sort of deceptive claims. Yet another piece of DIPRA-sponsored content published on September 16 by Civil Engineering Source was equally misleading.

The newsletter article alleges that vinyl chloride can cause cancer in humans – but what it hides is that the last case of cancer linked to vinyl chloride exposure was diagnosed in 1974— that is, 50 years ago. 

These rare liver cancers occurred only in industrial workers exposed to very high levels of the chemical for extended periods of time. A combination of innovative safety measures implemented by industry and strict regulations have virtually eliminated this risk for workers, as the CDC explains. And of course, the EPA continues to regulate vinyl chloride emissions with stringent standards that ensure public safety.

The September 16 article cites an EPA fact sheet noting that “Drinking water may contain low levels of vinyl chloride released from contact with PVC pipes.” The implication DIPRA would like readers to draw is that these levels are potentially harmful, but that’s simply not true. In fact, independent auditors test PVC pipe materials in the facilities where they are produced to ensure they do not contain elevated levels of vinyl chloride. According to NSF International, which performs the inspections:

“All PVC pipe, fittings and materials are tested at least twice per year for residual vinyl chloride. Samples are selected randomly by NSF auditors during unannounced inspections of each production facility. Levels of [residual vinyl chloride] must pass the toxicology evaluation.”

All of this points to a clear conclusion: PVC pipes simply do not pose a risk to consumers. 

Disinformation unacceptable

Competition in any industry is important. It incentivizes companies to constantly innovate and better serve customers. But deceiving the public about a competitor’s products to gain a leg up? That’s unacceptable.

Learn Chemistry From Chemists, Not Activists: EDF’s ‘Cumulative Exposure’ Gambit

Every chemical the public is exposed to is thoroughly tested and carefully regulated to ensure it doesn’t pose a risk to public health. Whether it’s a food ingredient, industrial chemical or a weedkiller used in home gardens, the manufacturer is obligated to demonstrate its safety to federal officials. 

Environmental activists recognize this basic fact as a serious threat to their anti-chemical scare campaigns and concoct increasingly strained excuses to explain why exposure to low-risk chemicals is actually very dangerous. Their favorite sleight of hand in recent years has been what we call the “cumulative exposures gambit.”

The idea is that exposure to multiple chemicals can be dangerous, even if each one has been declared safe as used by the Environmental Protection Agency (EPA). It’s a highly misleading claim. Let’s use this recent blog post from the Environmental Defense Fund (EDF) to illustrate why. EDF’s key assertion is that:

“Communities near industrial facilities are often exposed to multiple chemicals that cause the same health effects. Evaluating the health risk of these chemicals individually, as currently done by [the EPA], often underestimates the true risks communities face.”

This is false for several important reasons.The first problem is that EDF wrongly assumes (rather than demonstrates) that some individual chemicals “cause the same health effects,” and therefore deceptively concludes that combining them is even more dangerous. 

Ignoring facts about vinyl chloride

For instance, the activist group asserts that vinyl chloride – a chemical used to manufacture PVC plastic – is carcinogenic, so exposure to it and “other carcinogenic chemicals” amplifies someone’s risk of cancer. But as we have explained too many times to count, the public is exposed to so little vinyl chloride that it can’t possibly pose a cancer risk.

 Even inside PVC manufacturing facilities – where workplace exposure to vinyl chloride would arguably be the highest of anywhere on the planet – cancers with a unique association to the chemical are nonexistent today.

If the activists at EDF believe that vinyl chloride contributes to some cumulative risk, they have an obligation to explain why. Speculations and assertions just aren’t good enough.

Second, the EPA has had an extensive framework in place to examine the impact of cumulative chemical exposures for many years. This approach “includes developing profiles of exposure, considering interactions (if any) among stressors, and predicting risks to the population or populations assessed,” the agency notes in a 130-page report published over two decades ago. EDF’s complaints are badly out of date in 2024.  

Finally, the EPA regulates chemicals under multiple federal laws.These regulations provide the agency with a wide variety of tools to protect public health by setting strict limits on chemical contaminants in drinking water, ambient air and commercially available products. Put simply, the EPA can and does limit the public’s cumulative exposure to chemicals.

Conclusion

EDF and other activist NGOs have misapplied a valid concept to advance their ideological goal of banning chemicals with important public health and industrial applications. Exposure to multiple substances can be dangerous.That’s why it’s usually a bad idea to mix cleaning products, for example, and why the EPA has issued chemical compatibility guidelines. But we only know about the potential harm of mixing different substances because experts have thoroughly tested these chemistries to see how they interact with each other. 

As usual, the lesson for interested members of the public is simple: learn science from scientists; ignore activists who exist only to scare you. 

Countering Food Wrap Fear Mongering With Facts

Fresh produce, safe meat, longer shelf life, lower prices, and less food waste. These are just some of the benefits made possible by PVC wraps used to package many of the products that line our supermarket shelves. If anybody knows how useful and eco-friendly plastic wraps are, it’s the grocery industry that relies on them to safely ship and store the foods it sells.  

Unfortunately, there are PVC competitors that would rather spread misinformation and appease fear-mongering politicians than tell the public why PVC is such a useful wrapping material. 

This was the take home message from a recent article published by the Progressive Grocer, which encouraged retailers to switch to a different wrapping material “out of an abundance of caution.” Indeed some brands, the article continued, are trying “to eliminate the use of PVC because it’s not easily reusable, recyclable or compostable.”

But that’s just false. A closer examination of the facts reveals that these concerns are misguided and based on outdated information. Let’s examine the evidence and dispel some common misconceptions about PVC food wraps.

PVC Overwrap: A Safe and Versatile Packaging Solution

PVC overwrap is a widely used packaging material in the food industry due to its excellent barrier properties, including protection from moisture, gasses, and contaminants. Contrary to the article's claims, PVC overwrap is safe for use in food packaging, as it is subject to rigorous testing and regulation by the U.S. Food and Drug Administration (FDA). The FDA has approved PVC for direct food contact applications, ensuring that it does not pose any significant health risks.

The Progressive Grocer also raised concerns about the “fear of phthalates” used to increase the strength and flexibility of PVC. However, it’s essential to note–as we have explained to the media many times–that phthalates used in food-grade PVC are carefully selected to ensure they meet stringent FDA safety standards. Popular concern about phthalates pertists because reporters refuse to accept the FDA’s science-based conclusions. 

Recyclability of PVC Overwrap

The Progressive Grocer also complained about the recyclability of PVC overwrap, the implication being that the material is not environmentally friendly. This, too, is very misleading. Contrary to the claims of anti-plastic groups, PVC overwrap is recyclable. In fact, major retailers like Walmart, Home Depot, Stapes, and the majority of grocery store chains often accept plastic wraps for recycling. The Vinyl Institute also maintains a directory of over 100 recycling centers that accept post-consumer PVC. 

PVC Overwrap vs Alternative Materials

The Progressive Grocer’s final suggestion was that alternative materials, such as biodegradable plastics, are environmentally superior to PVC overwrap. Again, though, this isn’t plausible when we consider all the relevant facts.

For instance, many biodegradable plastics require specific conditions to break down, such as specialized composting facilities. If these conditions are not met, the materials can persist in the environment and contribute to pollution. Moreover, it’s not clear that bioplastics even measure up to proven solutions like PVC in sustainability terms. As an extensive 2023 study explained: 

“It is difficult to determine definitively whether bioplastics are more practical and environmentally friendly than petroleum-based plastics because there is a lack of data.”

In contrast, PVC overwrap offers a combination of performance, safety, and recyclability that makes it an attractive solution for food packaging applications. Its versatility, durability, and compatibility with existing recycling infrastructure make it a valuable material that can contribute to a more sustainable future.

Conclusion

PVC overwrap remains a safe, reliable option for the food packaging industry. If we’re making decisions out of “an abundance of caution,” as Progressive Grocer recommends, sticking with a material with a long track record is the smart choice.

Reader Beware: The Guardian Spreads Phthalate Phobia

The Guardian was once recognized as an excellent source of science news. In recent years, though, the UK-based paper has earned the ire of independent fact-checkers for publishing heavily biased stories and misinforming readers about critical public health issues.

Unfortunately, that downward spiral continued earlier this month when The Guardian published an agenda-driven story about the health effects of microplastics. Specifically, the story featured – and failed to fact check – claims by Martin Wagner, a Norwegian academic, about phthalates that are especially dubious.

Wagner asserted that phthalates are a “chemical of concern” and should be regulated and labeled as a result. “Policymakers should force manufacturers to be transparent about what chemicals are in their products,” he reportedly told the outlet.

All three claims are patently false. Here’s why.

What Are Phthalates, and What Do They Do?

As we have noted previously, phthalates are a family of chemicals primarily used as “plasticizers” to increase the flexibility, performance and durability of plastics. They are commonly found in a wide range of consumer goods, medical devices and some types of food packaging and food processing equipment.

Over the past five decades, numerous studies have examined the alleged health effects associated with phthalates. Several large-scale studies have failed to find any evidence of harm due to real-world phthalate exposure. Regulators at the Food and Drug Administration (FDA) and independent experts have arrived at this conclusion as well. The Guardian excluded these key details from its reporting.

Facts about FDA regulation

The Guardian’s other key deception was the implication that phthalates are unregulated, but nothing could be further from the truth. In the U.S., operating under the federal Food, Drug, and Cosmetic Act, FDA officials determine which phthalates are allowed in the consumer products they oversee, and they can pull any product off the market that they determine poses a risk to public health.

The agency also evaluates the safety of phthalates used in food contact materials, medical devices, and other consumer products, taking into account factors such as exposure levels, toxicity data, and potential health effects. As we have explained to the press on many occasions, the agency has twice-rejected multiple activist demands driven by “citizen petitions” that sought a blanket ban on all FDA-authorized phthalates from food-contact, including food packaging. After exhaustive review, today four essential phthalates remain FDA-authorized for food contact.

Demanding product labels is a common tactic activists use to stir up public concern about chemical safety, though this too misunderstands the purpose of labeling. Some labels, such as those that contain nutrition and allergy information, are helpful because they provide useful health information and alert people to potential life-saving information. But putting a warning label on products that may contain trace amounts of phthalates would actually mislead people into thinking that phthalates pose a risk when they don’t.

Conclusion

Speaking of warnings, “buyer beware” is a lesson most consumers take to heart before they make a purchase, the goal being to avoid defective products and untrustworthy sellers. We suggest that Guardian subscribers receive a similar message: “reader beware,” as this once-respected outlet has become an untrustworthy source of defective science.

Did Carnegie Pay Fast Company to Publish CEO Essay Bashing Competing PVC Material?

Gordon Boggis, CEO of Carnegie, a textiles company that actively markets itself as a non-PVC company, and makes competing products to PVC, recently published a deceptive essay in Fast Company entitled, “7 non-PVC sustainable solutions in architecture and design.”

Citing a paper from entrenched anti-PVC groups Perkins & Will and Healthy Building Network, Boggis portrays PVC manufacturing as a problematic emitter of dioxin. Which is wrong: vinyl manufacturing accounts for less than 7% of total dioxin emissions, according to the U.S. EPA.

Boggis also claims PVC is a landfill issue. That, too, is inaccurate, as PVC represents less than three percent of all plastic in landfills.

And he promotes a number of unproven alternatives to PVC. Weaker ones too, like wood floors, which are far less durable, cost more money, and require more repairs, than vinyl.

Misrepresentations aside, we were curious why Fast Company would find Boggis’ piece remotely newsworthy to publish on its platform.

Then we spotted a curious notation at the top of Boggis’ article that says: “Impact Council.”

---

---

For those of you who didn’t know (like us), Fast Company’s “Impact Council” is a fee-based program where members are “invited to work directly with a member of our editorial team to submit pieces of thought leadership for publication on fastcompany.com.”

(Translation: Pay Fast Company $3,500 a year and you can apparently use their brand to trash your competitors with baseless claims on their pages.)

To be clear, Boggis’ essay is hardly “thought leadership.” It’s a marketing piece, evidenced by the fact it impugns PVC, which aligns with the company’s entire business model as a maker of “Forever PVC-free” products, and promotes the virtues of vinyl alternative wall coverings, which Carnegie sells.

In fact, Boggis recommends Fast Company readers opt for some of the very wall coverings Carnegie manufactures. In advocating for wall-covering vinyl substitutes, he writes, “[w]ell-established, high-performance alternatives include bio-based polyethylene (up to 85% biobased content), thermoplastic polyolefins (TPO), woven polypropylene (PP), and polyethylene terephthalate (PET).”

Many of these are precisely what Carnegie sells. For example, its “biobased Xorel” product line has “a remarkable bio content, between 60-85%,” the company’s website states. Carnegie also sells TPO products (like this one), and PET products (like this and this).

And if there are any lingering questions about Boggis’ motives behind his Fast Company essay, consider this statement taken directly from Carnegie’s website: “Carnegie was founded with the goal of creating PVC alternative products for the commercial industry.”Shouldn’t we expect more from a news outlet that self-proclaims to be the “world’s leading business media brand”?

You’d think, at a minimum, Fast Company would have a policy that prevents “members” from using the Impact Council to promote issues that benefit their business, or to spread misinformation about competing companies, issues, products, or in this case, materials.

Then again … Maybe not?

Fact-Checking The Washington Times on PVC Pipe

On May 22nd, an opinion piece in The Washington Times titled “Ductile iron pipes: A life partner for clean, safe drinking water” applauded historic federal investments in drinking water infrastructure.

We echo the author’s applause of this crucial funding, but we think the incomplete picture painted of PVC pipes warrants a rebuttal.

The need for improved water infrastructure is clear and present, as more than 2.6 trillion gallons of treated water leak from antiquated and corroded pipes each year.

Unlike some alternatives, PVC pipes do not corrode. As corrosion builds in pipes, more energy is needed to pump water to its destination, and the resulting buildup of bacteria can affect the quality of the water. Replacing corroded pipes with PVC allows towns and municipalities to lower their energy costs and keep bacteria out of their water. We’d call that a win-win.

Contrary to claims of PVC’s fragility, academic research shows that PVC pipe can remain in operation for more than 100 years – and has an extremely low failure rate. This durability, paired with PVC’s cost-effectiveness, will give local decision-makers more bang for their buck and allow for more extensive infrastructure improvements than alternative materials.

Replacing old pipes from coast to coast is a tall task, but the vinyl industry is up to the challenge. Over the past three decades, the industry has lowered carbon emissions while doubling PVC production. As communities can expect their energy usage to decrease with more efficient PVC pipes, the industry expects to increase output and improve sustainability.

We respect the author’s advocacy for improving our nation’s water infrastructure, but we want to ensure that all materials are given a fair shake in the decision-making process. PVC pipes offer long-lasting durability, corrosion resistance, and a reduced environmental footprint, making them reliable and sustainable for America’s new and improved water infrastructure. If the question is, “How do we provide clean water to more Americans?” PVC is undoubtedly a big part of the answer.