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Why ‘hazard based’ agricultural chemical regulation doesn’t work

In many ways, various governments have passed regulations with a “one size fits all” mentality. More often than not, however, this approach wrongly limits consumer choice, and more importantly creates tremendous externalities which are often left unaddressed. Our goal is to highlight instances where the “one size fits all” approach has failed consumers and explain why.

Concern over glyphosate in food has become a major topic the last couple of years and has gained a lot of media attention in a recent study where they found that organic beers and wines contained small traces of glyphosate – a pre-harvest herbicide and harvest aid used on cereal crops like wheat, oats and vegetable seed oils like canola and sunflower. However, the U.S. Environmental Protection Agency’s safety limit for glyphosate is 100 times greater than the amounts found in the beer and wine samples, and thus, the risk of human contamination is extremely low.Nevertheless, policymakers want to ban glyphosate which would reduce crop yields and make beer and wine even more expensive.

You probably heard about the “Beepocalypse” – the catastrophic scenario in which declining honeybee population is caused by pesticides. However, honeybees aren’t actually declining but increasing. Occasional reductions in honeybee populations are multifactorial, but varrora mites and the viruses they carry are likely the leading drivers, nutrition being another big factor. According to a USDA bee researcher: “If there’s a top ten list of what’s killing honey bee colonies, I’d put pesticides at number 11″. By creating a “one size fits all” regulation and thus banning pesticides, policymakers could make the mite problem worse which would actually harm honey bee colonies instead of protecting them.

Read more here

Understanding “hazard” and “risk”

A lot of the Brussels conversation over the precautionary principle is misguided.

By 2030, the European Union’s “Farm to Fork” strategy aims to reduce the use of pesticides significantly. The EU deals in percentages of the total use of chemical substances it wants to cut, whether or not their scientific safety assessment was in any shape or form negative. This in essence makes it a political ambition, not an evidence-based policy.

When reading articles, blog posts, or policy papers related to the use of pesticides, we often hear the word “hazard”. “Highly-hazardous” chemicals or substances are in the focus of many environmental groups, who demand that the EU cleans up its act on the alleged ‘poison’ in our food. Theirs is a misunderstanding of the scientific meaning of “hazard” and “risk”

Risk-based regulation manages exposure to hazards. For instance, the sun is a hazard when going to the beach, yet sunlight enables the body’s production of vitamin D and some exposure to it is essential to human health. As with everything else, it is the amount of exposure that matters. A hazard-based regulatory approach to sunlight would shut us all indoors and ban all beach excursions, rather than caution beach-goers to limit their exposure by applying sunscreen. The end result would be to harm, not protect human health. 

The same logic of hazard-based regulation is all too often applied in crop protection regulation, where it creates equally absurd inconsistencies. For instance, if wine was sprayed on vineyards as a pesticide, it would have to be banned under EU law, as alcohol is a known and quite potent carcinogen at high levels of consumption. All this is rationalized through an inconsistent and distorted application of the precautionary principle. In essence, hazard-based regulation advocates would endorse outlawing all crop protection methods that cannot be proven completely safe at any level, no matter how unrealistic — a standard which, if applied consistently, would outlaw every organic food, every life-saving drug, and indeed every natural and synthetic substance. 

By ignoring the importance of the equation Risk = Hazard x Exposure, hazard-based regulation does not follow a scientifically sound policy-making approach.

As risk-management expert David Zaruk writes on his blog The Risk-Monger:

“So why then are there individuals in Brussels who think that a regulator’s job is to remove all hazards, regardless of our ability to control exposure to the hazard, regardless of the limited exposure levels, regardless of the lost benefits? For these lobbyists (often activists for environmental-health NGOs), a hazard is considered as identical to a risk (regardless of exposure) and the regulatory goal (for them) is to remove all hazards. They support the approach known as: Hazard-based regulation.

Hazard-based regulation implies that the only way to manage risks is to remove the hazard. If synthetic pesticides are hazardous, remove them. If we cannot be certain that a chemical has no effect on our endocrine system (at any dose), then deny authorisation.”

This concept of differentiating hazard and risk in the scientific and regulatory language is also supported by EFSA — the European Food Safety Authority, which advises the European Union on things such as chemical approvals.

Understanding hazard and risk is essential when addressing all questions as they relate to the precautionary principle. Artificial intelligence is prone to fall victim to a similar level of over-regulation the advocates of extreme caution get their way. Instead, the European Union should choose the road to innovation. Evidence-based policy-making is about assessing risks, but it is also about managing risks for the sake of allowing for innovation while ironing out problems as they appear. 

We cannot allow ourselves to fall behind in the global race for innovative technology because we are too afraid of changes.

Originally published here.

Taiwan Is About to Ban the Use of Nicotine Vapes

Taiwan looks set to become the next country in Asia to ban nicotine vaping products.

On January 12, amendments to the Tobacco Hazards Prevention Act effectively cleared the legislative floor. Now, the legislation only awaits a presidential nod—a formality given that President Tsai Ing-wen is from the ruling Democratic Progressive Party that proposed it. 

The news, which arrives not long after the Philippines enacted relatively pro-vape regulations, has elicited strong reactions from consumers, policy experts and medical experts, who had some hopes that the tide might be turning in favor of tobacco harm reduction (THR). 

Taiwan appears to be emulating regulations in nearby Japan, where heated tobacco products (HTPs) are sold legally but nicotine vapes are prohibited. The availability of HTPs in Japan has seen a dramatic reduction in cigarette sales. But THR advocates will wonder why an option indicated to have an even lower risk profile—and shown to be a more effective smoking cessation aid than nicotine replacement therapy—is about to become formally illegal. Other Asian countries to have banned vapes include India and Thailand

In Taiwan’s strained governmental nomenclature, HTPs have been classified “designated tobacco products” and are subject to regulation, while vaping devices have been accorded the category of “tobacco-like products.” The imminent ban includes use of e-cigarettes, with penalties of up to $330 for violations. (Previously, vapes had existed in something of a legal gray area.)

This has ignited debate in Taiwan, a country of 24 million where 13 percent of the population smokes, including almost a quarter of men. While millions of upset vape users have been left in the lurch, anti-tobacco groups are meanwhile demanding HTPs be banned too. The law, which will likely come into effect in a month after the presidential assent, will inevitably force vape shops to close and a rapidly growing industry to shutter or go underground.

While it’s difficult to deduce the motivations for the legislative decision, Taiwan policy experts and vape users point to a combination of misinformation, financial considerations trumping public health, and the positions taken by World Health Organization’s Framework Convention for Tobacco Control (WHO FCTC) on novel nicotine alternatives.

“The issue did not have enough public discussion and the approach to harm reduction should be more thoroughly debated,” Simon Lee, the Taiwan policy fellow at Consumer Choice Center, a global consumer advocacy group in Washington, told Filter. “For instance, we have seen misinformation, especially with regard to nicotine, circulating among anti-tobacco activists. It is beyond reasonable doubt that Taiwan’s consumers deserve a much better outcome.”

Read the full text here

The farming sector faces national security threats

The Biden administration has released an updated security memorandum, which outlines the threats to the American agricultural system, as well as ways to address them. “To achieve this, the Federal Government will identify and assess threats, vulnerabilities, and impacts from these high-consequence and catastrophic incidents – including but not limited to those presented by CBRN (chemical, biological, radiological, or nuclear) threats, climate change, and cybersecurity – and will prioritize resources to prevent, protect against, mitigate, respond to, and recover from the threats and hazards that pose the greatest risk”, reads the document released last month.

The White House touches on an important topic by addressing the unique threats that face the farming sector, and to what extent the American food production system might be threatened by domestic or foreign actions. It addresses for instance, the impacts of toxic industrial chemicals, from a standpoint not only of the effects on humans, but also on the biological realm, which might impact the productivity of farms.

The memorandum comes at a time when supply chain disruptions have shown to consumers just to what extent a food system can destabilize the inner-workings of a country. Case in point, the Russian invasion of Ukraine is not just a military conflict that plays out on the battlefield – it is also a war of food, in which the Russian war machine holds Ukrainian grain exports hostage through its strategic vantage points. Continuous grain deals in the Black Sea have stood on rocky grounds, despite the vital importance for the Ukrainian economy. This war underlines how civilian infrastructure quickly becomes a military target, and how guaranteeing security is not merely about anti-aircraft missiles, but also about protecting strategic industrial elements.

For that reason it is not just laudable that the administration addresses these risks, but also that USDA has been at the forefront of arguing for food security through innovation. The USDA’s Agriculture Innovation Agenda (AIA) advances the notion that more innovation, through public and private research and investment, makes the food system more efficient and sustainable. Compared to the European Union’s approach – which seeks to reduce farm land use and livestock, to the detriment of the European food sector – the AIA takes a forward-looking approach.

The White House touches on an important topic by addressing the unique threats that face the farming sector, and to what extent the American food production system might be threatened by domestic or foreign actions. It addresses for instance, the impacts of toxic industrial chemicals, from a standpoint not only of the effects on humans, but also on the biological realm, which might impact the productivity of farms.

The memorandum comes at a time when supply chain disruptions have shown to consumers just to what extent a food system can destabilize the inner-workings of a country. Case in point, the Russian invasion of Ukraine is not just a military conflict that plays out on the battlefield – it is also a war of food, in which the Russian war machine holds Ukrainian grain exports hostage through its strategic vantage points. Continuous grain deals in the Black Sea have stood on rocky grounds, despite the vital importance for the Ukrainian economy. This war underlines how civilian infrastructure quickly becomes a military target, and how guaranteeing security is not merely about anti-aircraft missiles, but also about protecting strategic industrial elements.

For that reason it is not just laudable that the administration addresses these risks, but also that USDA has been at the forefront of arguing for food security through innovation. The USDA’s Agriculture Innovation Agenda (AIA) advances the notion that more innovation, through public and private research and investment, makes the food system more efficient and sustainable. Compared to the European Union’s approach – which seeks to reduce farm land use and livestock, to the detriment of the European food sector – the AIA takes a forward-looking approach.

Originally published here

Hey buddy, consumers don’t need protection from natural gas stoves

The degrowther cacophony of environmentalists, bureaucrats, and supposed consumer advocates has found a new enemy to protect you from: the gas stove in your kitchen.

As spelled out by U.S. Consumer Product Safety Commissioner Richard Trumka Jr. in a recent Bloomberg interview, a federal “ban on gas stoves is on the table amid rising concern about harmful indoor air pollutants.”

Trumka joins the chorus of enterprising journalists, academics, and green activists (and even the World Economic Forum) who have taken up the agency’s call to not only make a health case against kitchen stoves that heat food with natural gas, but also the environmental and moral one.

An article in New York Magazine asked, rather innocently, “are gas stoves the new cigarettes?” We all know what follows.

Humbly, Trumka later clarified the agency wouldn’t propose banning them, but would instead only apply strict regulations to “new products,” following cities like San Francisco and New York City, and entire states like New York (no surprise) that have already enacted bans on natural gas hook-ups for new construction. It should be noted that the majority of these proposed actions were based on environmental claims rather than health claims, and the most prominent advocates have been “environmental law” experts and the like.

Of course, they’ll say they don’t want to outlaw gas stoves in your home or dispatch agents to rip them from your kitchens and load them onto flatbeds. That’s silly. They just want to use the force of laws, guidance, and incentives to nudge consumers away from a natural gas standard. The federal government’s ineptly named Inflation Reduction Act will go a long way.

If you voluntarily swap your gas stove for an electric one, the IRA deems you eligible for a tax rebate of up to $840 — which would easily subsidize your lifestyle “choice”. This is similar to the law’s incentives for buying electric vehicles, installing solar panels, and fitting new construction with green-friendly tech.

While subsidies for your home kitchen may be all the rage, it’s understandable why this issue has become a cultural flashpoint.

For average consumers, the advantages of using a gas stove are plentiful. For one, they heat quickly and efficiently, reducing the time and energy used to cook a meal. They offer heat moderation that any meal would require. And because natural gas is a separate utility hook-up, it means that in the case of brownouts or power outages, you can still cook, boil water, and heat your food.

Restaurant chefs are slavishly reliant on natural gas to provide the best source of heat for lunchtimes and dinners for hungry patrons, as are Americans of more modest income who can more cheaply provide food at home using natural gas than increasing their electricity bill.

The disadvantages of natural gas stoves, according to the activists, are they could leak nitrogen oxides into your home, which, when wedded with improper ventilation, presents a risk for childhood asthma and other health concerns. In addition, that gas leakage could contribute to greenhouse emissions, which links it to climate change.

When Trumka first entertained a natural gas stove ban — on a December private Zoom meeting with the Public Interest Research Group Education Fund — the asthma risk was front and center. He went so far as to call it a “hazard,” which boggled our minds at Consumer Choice Center, considering the extent of our work clarifying the errors of legislating based on risks instead of hazards.

For a look into the studies, economist Emily Oster recently did this on her Substack, and her conclusion is that the risks claimed by researchers are actually so minimal that they aren’t worth taking seriously for anyone who has a properly vented kitchen and up-to-date appliances.

While indoor air pollution is indeed a serious hazard, it is not one that affects US households. Hood vents, air conditioning, and modern construction have avoided this issue for nearly all Americans, as the EPA admits. The effect on climate change is also negligent, considering that conversion to all-electric stoves does nothing to clean up the energy grid or move all electricity generation to carbon-neutral alternatives.

Why then is this issue gathering so much steam among consumer advocates like PIRG, which began a campaign against natural gas stoves early last year?

While they may be sincere in their aims, it amounts to yet another crusade against consumer choice. People know the risks of gas stoves and the cost-benefit analysis that comes with purchasing one. Having a gas stove with children running around isn’t ideal, and in most cases, an induction stove is likely even more efficient and desirable.

But the entire purpose of having a variety of stoves is to offer users — professional chefs and home cooks alike — the option that fits best with their lifestyle and budget. There are always risks when it comes to home appliances, energy applications, and what we bring into our homes.

But we would rather trust consumers to make this decision than a regulatory agency with its own agenda.

Intel’s microchip expansion could fail if Congress bans this crucial set of chemicals

Opinion: A bill before Congress calls for a heavy-handed ban of PFAS, a set of chemicals that are vital to semiconductor production.

A severe shortage in computer chips roiled the U.S. economy last year, costing auto manufacturers $210 billion in revenue alone as cars sat in lots waiting for chips to be installed.

Other sectors took hits, too, given that semiconductor are used in everything from computers, smartphones, consumer electronics to appliances and medical equipment. 

Luckily for consumers, in response to the shortages, Intel has broken ground on two chip manufacturing plants in Arizona to help secure supply chains and prevent further disruptions. When all is said and done, Chandler will be home to six semiconductor production facilities, employing around 15,000 people

The size and scope of these investments cannot be understated.

The growth experienced in Arizona’s chip manufacturing facilities may be stifled, however, if Congress proceeds with heavy-handed bans for perfluoroalkyls (PFAS) under the PFAS Action Act.

We need PFAS to make semiconductors

Perfluoroalkyls, a grouping of 4,000-plus manmade chemicals, are a vital part of the semiconductor production process – primarily because of their chemical resistance and surface tension-lowering properties. This makes the chips durable and resistant to liquids and erosion. 

The PFAS Action Act could seriously jeopardize chip manufacturing, and ultimately make the chip shortage much worse before it gets better. These chemicals are vital for the production of semiconductors, predominantly the use of coolant, and if Congress continues down the path of wanting to ban PFAS then consumers will be in a world of trouble.

What’s at stake:Separate semiconductor bill could be an economic boon

We know that this is a predictable outcome of heavy-handed PFAS policy because it is exactly what we are seeing in Europe, where officials in Belgium paused production at a chemical plant in response to the tightening of environmental regulations.

Reporting done by Business Korea highlighted that semiconductor producers had only 30 to 90 days of coolant inventory left before they would encounter serious production problems.

If Congress continues down the path it is on, it is naive to think that disruptions like this aren’t headed for the American market, with U.S. consumers bearing the brunt of the chaos. 

Keep them out of water. Don’t ban them outright

This isn’t to say that PFAS producers should be able to operate without any regard for the environment and PFAS exposure. In fact, the opposite is true.

Regulating PFAS has to be done from the perspective of clean drinking water, as opposed to declaring all PFAS chemicals hazardous. Ensuring proper production standards to avoid dumping or leakage helps solve the problem of contaminated water, without resorting to an outright ban of PFAS.

For chip production, this is vital, given that there are no viable alternatives to using PFAS in the production process.  

This is especially important in the context of everyday consumer products that rely on these chemicals in the manufacturing process. If production standards for PFAS are upheld, and enforced, we can tackle the clean drinking water issue while allowing for PFAS to be used where it presents little to no risk to consumers, like the production of semiconductors. 

This is the balancing act that Congress has to consider when deciding what is next regarding PFAS. It needs to evaluate the emerging science on PFAS, evaluating not just hazard but, more importantly, the exposure levels that make PFAS risky for Americans and from where those exposures come. 

PFAS Action Act could doom chip production

In December, the Australian National University published a study on PFAS. The findings provide some helpful insights into what anti-PFAS efforts should focus. 

One of the key findings was that exposure to PFAS in affected communities almost entirely came from water and firefighting foam. PFAS contamination was a result of poor production practices, or criminal dumping, and when PFAS firefighting foam leeched into the ground.

Those who drink contaminated water, or eat locally grown food that is contaminated, are at the highest risk of PFAS-associated health problems. This suggests that poor production processes carry most of the risk, while the risks associated with consumer items and other PFAS applications are limited, like the use of PFAS in the production of semiconductors. 

A clean drinking water approach to PFAS is entirely appropriate, but getting there cannot, and should not, result in outright production bans.

If Congress can narrow its sights on proper production processes, American consumers can avoid water contamination, without the chaos of an exacerbated semiconductor shortage and job losses in Arizona.  

But if Congress proceeds with the PFAS Action Act, Intel’s investment in Chandler and its plans to boost domestic chip production may be destined to fail. 

Originally published here

Bill Would Give US Production of Vital Electronics to China

The consequences of a bill in Congress will make you want to buy a new phone and laptop, provided that inflation leaves you with enough disposable income to do that.

While Americans are dealing with the effects of record-high gas prices, Democrats in Congress are suggesting the so-called PFAS Action Act, which would declare perfluoroalkyl and polyfluoroalkyl substances as hazardous chemicals. This legislation would open the gates for a ban on a large set of substances needed to produce everything from consumer electronics and vital medical equipment.

In an effort to preserve clean drinking water and protect consumer health, Democrats (and a handful of Republican co-sponsors of the bill) are throwing out the baby with the bathwater. PFAS, according to the CDC, englobes over 9,000 chemicals, which all have varying uses and severity.

Lawmakers in Washington are relying on cases of malpractice, when companies violated their duty to protect local communities by failing to ensure safe use, transport and disposal, to pull the rug out from this large set of substances.

Ultimately, why care? No citizen likes the idea of potentially toxic chemicals being in use at all, so why not just endorse this piece of legislation?

In fact, while within the set of 9,000 chemicals, some of them may very well need phasing out, others are essential to key American industries.

For instance, these chemicals are vital for the production of semiconductors, predominantly the use of coolant, and a ban would worsen the already existing chip shortage, which affects anything from mobile phones to electric cars. Computer chip shortages cost the U.S. economy $240 billion in 2021.

That said, waiting another six months for your electric vehicle or stomaching a significant price increase on your latest smartphone is just the tip of the iceberg. While regulators in the United States or Europe may decide to ban PFAS, manufacturers are unlikely to follow suit.

In fact, Beijing is famously less concerned than Western nations when it comes to chemical regulation, and would be more than happy to rake up the market shares made available by destructive environmental restrictions.

What message is Congress sending to American companies by considering this bill? Intel has announced it will spend $20 billion on a chip factory in Ohio, to stop the increasingly endemic lack of semiconductors. Presumably, Washington is thanking them by stripping the company of the tools to manufacture components and outsourcing the task to producers abroad.

When dealing with consumer goods, we should prefer that they are made with a transparent and reasonable regulatory framework that punishes wrongdoing to the full extent of the law, instead of relying on imports from nations that do not share our vision of safe manufacturing.

Originally published here

The conflict between government agencies regarding PFAS

As discussed by the Star Tribune’s June 27 editorial (“Needed action on ‘forever chemicals'”), the Environmental Protection Agency is seeking to create clean drinking water thresholds on per- and polyfluoroalkyl substances (PFAS). Given the history of egregious cases of chemical dumping, like what was done by Dupont, popularized by the film “Dark Waters” with Mark Ruffalo, one can see why the EPA is taking such an approach to how PFAS are regulated in the United States.

Strangely enough though, the EPA’s approach to PFAS is at odds with another government body, the Food and Drug Administration.

The FDA, the regulatory body responsible for ensuring that pharmaceuticals and medical devices work and that their health benefits outweigh their known risks, has continuously approved both drugs and devices that contain PFAS. Most don’t know that the medical community is heavily reliant on PFAS products. Take, for example, medical implants like vascular grafts, stent grafts, surgical meshes, catheter tubes/wire and heart patches. It is estimated that 8% to 10% of Americans have implantable medical devices, many of which rely on PFAS and are approved by the FDA. In fact, the implantable medical-devices market, valued at $72.2 billion, is expected to grow significantly as the American population continues to get older.

Drugs containing PFAS and conditions with treatments that introduce the presence of PFAS include, but are not limited to, tachyarrhythmias (flecainide), antidepressants (fluoxetine), nonsteroidal anti-inflammatories (celecoxib), antibiotics (levofloxacin), rheumatoid arthritis therapeutics (leflunomide), cholesterol-lowering agents (atorvastin) and even COVID-19 antivirals such as Paxlovid.

For all of those drugs and devices, the notoriously overcautious FDA has clearly stated that whatever PFAS exposure exists with these products, they are safe to the point where the benefits far outweigh the risks. Simply put, the presence of PFAS for these drugs and devices passes a safety check and a cost-benefit analysis.

What we have here is two government agencies taking drastically different approaches to the issue of PFAS. On one hand, the FDA is doing a cost-benefit analysis and approving the use of PFAS across the medical sector, while the EPA is seeking to enact drinking water standards that are mutually exclusive to the FDA’s conclusions.

So how should regulators proceed given that the left hand and right hand of the federal government appear to be at odds with each other? One key step forward would be to individually assess each chemical within the PFAS umbrella, identify where hazards exist and calculate where Americans are actually at risk — with “risk” being the hazard present multiplied by the exposure levels.

After doing so, regulators should focus on ensuring proper production practices to avoid instances of dumping, and severely punish those companies caught being reckless in the production or disposal process. That is the approach that can keep Americans safe and their drinking water clean, without running the risk of having the regulatory system be so stringent that production ceases and American patients are left without the lifesaving drugs and devices they need.

Luckily, some voices of reason have emerged in Congress, like that of Rep. Larry Buschon of Indiana. As a heart surgeon by trade, he has rightfully pointed out that the heavy-handed approach would put lifesaving medical technologies at risk. Hopefully, more will listen, and the federal government, in coordination with state regulators, can both limit PFAS exposure where it is dangerous and allow for it to continue to be used where safe.

Originally published here

The Counterfactual: Are e-cigarettes dangerous?

Republished from Clivebates.com with the consent of the author

The World Health Organisation continues to present misleading information about e-cigarettes that spreads doubt and confusion among the public, media and policymakers. This post reviews its latest Q & A and finds multiple errors of analysis, misleading statements, and obvious biases.

The World Health Organisation maintains a Q & A on e-cigarettes. It was updated on 25 May 2022. 

This has been updated several times (see history below). In each of its incarnations, this web page has presented a profoundly misleading account of the risks and benefits of e-cigarettes. It ignores the fact that eight million people are dying annually from smoking (around the same order as COVID-19) and that hundreds of millions of smokers could benefit from switching to low-risk alternatives to smoking. The Q & A is primarily a vehicle for promoting prohibition and generating hostility to the pragmatic public health strategy of tobacco harm reduction. It is anti-scientific, its information is misleading, and its effect or purpose is to sow confusion and doubt rather than to candidly explain e-cigarettes.

I have set out the main sections of the latest Q & A below with a short general commentary on each section followed by the main claims in each section drawn out in block quotes followed by comments.

The table of contents below follows the structure of the WHO’s Q & A. I have highlighted each statement in the WHO Q & A in a box quote and followed by a short commentary on each.

The very framing of the question reveals the problem. The real question is “how dangerous?” This question should be asked in two ways: 

(1) how dangerous compared to the product that dominates the market, that is cigarettes? 

(2) how dangerous compared to some sort of benchmark of acceptable risk, for example, occupational exposure standards or other comparable behaviours? 

If vaping is much less risky than smoking, then there is a large health benefit for people who switch from smoking to vaping. If the use of a product is at a level of risk that is within our normal tolerance of risk, then there is not much reason to mount a big public health response to it – as with caffeine and coffee or moderate alcohol consumption.

In the following paragraphs, WHO never addresses the “how dangerous?” questions. But without addressing them, it has no basis for informing or advising anyone or for suggesting appropriate policy responses.

Electronic cigarettes (or e-cigarettes) are the most common form of electronic nicotine delivery systems (ENDS) and electronic non-nicotine delivery systems (ENNDS) but there are others, such as e-cigars and e-pipes. ENDS contain varying amounts of nicotine and harmful emissions. 

E-cigarette emissions typically contain nicotine and other toxic substances that are harmful to both users, and non-users who are exposed to the aerosols second-hand. Some products claiming to be nicotine-free (ENNDS) have been found to contain nicotine.

Nicotine is the main reason why people smoke or vape. It is a relatively mild psychoactive drug that has several effects – such as helping to control stress and anxiety and improving concentration. That is why people use it. It is dependence-forming, but nicotine is not very harmful in itself. It is not a cause of intoxication, oblivion, violence or, over the long term, serious disease. 

The harm to health is mainly done by the smoke: the toxic gases and sticky particles inhaled into the lungs along with the nicotine (sometimes called ‘tar’). The hazardous chemicals in tobacco smoke that are the main cause of cancer, cardiovascular and respiratory disease are mainly products of combustion formed in the tip of the burning cigarette and as the smoke cools. In contrast, e-cigarettes heat a flavoured nicotine liquid to form an aerosol of tiny droplets, which contain nicotine. But because the liquid is heated but not burnt, there is no combustion and therefore no products of combustion. So the harmful agents in cigarette smoke are either present at much lower levels or not detectable or measurable at all. 

Biomarkers show much lower toxic exposures. This can be seen experimentally by measuring hazardous agents found in the blood, saliva and urine, so-called biomarkers of exposure. These measurements show dramatically reduced exposures to the main hazardous substance of concern compared to smoking. Experts commissioned by Public Health England reviewed the available biomarker literature in 2018 and concluded

Vaping poses only a small fraction of the risks of smoking and switching completely from smoking to vaping conveys substantial health benefits over continued smoking. Based on current knowledge, stating that vaping is at least 95% less harmful than smoking remains a good way to communicate the large difference in relative risk unambiguously so that more smokers are encouraged to make the switch from smoking to vaping. It should be noted that this does not mean e-cigarettes are safe. [link]

The consumption of nicotine in children and adolescents has deleterious impacts on brain development, leading to long-term consequences for brain development and potentially leading to learning and anxiety disorders.

WHO draws on speculative theories that are based largely on rodent studies and large doses of nicotine to make this claim. The key point is that despite many generations of adolescent nicotine users growing up as smokers since the 1950s, no one has so far identified any lasting cognitive impairments in those adults who started using nicotine as adolescent smokers over this long period. It is a difficult area to study, and it is possible there are some ill effects, but this is far from established and definitely not with the unequivocal confidence conveyed by WHO in this answer. 

Writing in the American Journal of Public Health in 2021, fifteen former presidents of the Society for Research on Nicotine and Tobacco summarised the state of knowledge as follows:

Balfour, D. J. K., Benowitz, N. L., Colby, S. M., (2021). Balancing Consideration of the Risks and Benefits of E-Cigarettes. American Journal of Public Health111(9), 1661–1672.

Nicotine is highly addictive …

It is wrong to make the general claim that “nicotine is highly addictive”, although this statement is common. It depends on what is meant by addiction and how the nicotine is taken. I have addressed the question about nicotine addiction under the question heading “Are ENDS addictive?” below.

…and some evidence suggest that never-smoker minors who use ENDS can double their chance of starting to smoke tobacco cigarettes later in life.

WHO falsely asserts the operation of a so-called gateway effect. These claims are often repeated as if there is some evidence that the prior vaping caused the subsequent smoking. There is no evidence to support a causal gateway effect and much to suggest the opposite, notably the dramatic decline in youth smoking in the United States that coincided with a rapid rise in youth vaping, sometimes referred to as the “youth vaping epidemic”. 

The decline in the adolescent use of combustibles (i.e. smoking) accelerated after 2018 – coinciding with the so-called “youth vaping epidemic” 

Common liability is the far more plausible explanation. There is a completely different and much more likely explanation for the observed association: that the same sort of things that incline people to vape also incline them to smoke. These would be things like genetics, parental smoking, mental health status, school performance and delinquency, rebelliousness, and aspects of the family and community context. This is known as confounding by common risk factors, or sometimes as “common liability”. The evidence strongly supports this explanation, not the gateway theory. It means that e-cigarette use is more likely to be concentrated in people who have smoked or would otherwise smoke – offering a significant health benefit concentrated within the population most at risk. 

Evidence reveals that these products are harmful to health and are not safe. However, it is too early to provide a clear answer on the long-term impact of using them or being exposed to them. Some recent studies suggest that ENDS use can increase the risk of heart disease and lung disorders. Nicotine exposure in pregnant women can have similar consequences for the brain development of the fetus.

There is no convincing evidence that ENDS are seriously harmful to health. Once again we see the use of “harmful to health” and “not safe”, without asking the “how harmful?” or “how unsafe?” questions. The (unstated) studies that supposedly show that ENDS increases the risks of lung or heart disease are highly problematic. Almost all ENDS users old enough to experience significant disease have been long-term smokers. It is impossible to separate the effects of their smoking history from the marginal effects of their time as vapers. Some studies even count heart or lung disease episodes that occurred before the vaping started in their calculations of vaping risk. There are many studies that show that ENDS have an observable effect on the body, but there is little to show that these effects amount to a clinically significant risk. 

This is how the US National Academies of Science, Engineering and Medicine summarised the risks in its 2018 report: 

National Academies of Science, Engineering and Medicine NASEM (US).  The Public Health Consequences of E-cigarettes. Washington DC. January 2018. [link]  Launch presentation summary (slide 44)  [link][link]

The long term effects may be negligible. The statement about the long-term is really a statement of the obvious – we do not have the luxury of time travel to observe with certainty what the long term effects will turn out to be. The health effects of long term use may well turn out to be trivial. We do know the toxic exposures involved with vaping are much lower than for smoking (the second point) and therefore we should default to expecting health burdens to be much lower too. Also, it is worth bearing in mind that people can smoke for two decades (from say age 15 to 35) or more and not suffer any noticeable loss of life expectancy. It takes a lot to get sick, even from smoking.

ENDS use can also expose non-smokers and bystanders to nicotine and other harmful chemicals.

There is no evidence of material risk to bystanders. WHO continues with its unquantified approach to risk. The framing “can also expose” is wholly misleading in this context. What matters is how much exposure and to what sort of hazard? I have responded to this assertion under WHO’s question 5. Are secondhand ENDS emissions dangerous?

Electronic delivery systems have also been linked to a number of physical injuries, including burns from explosions or malfunctions, when the products are not of the expected standard or are tampered with by users.

E-cigarette use is likely to substantially reduce injuries. Again, some context is required. Yes, there are isolated incidents involving battery malfunctions or short circuits (e.g. through contact with coins in pockets). But this comes nowhere close to the carnage caused by smoking-related fires. The US National Fire Protection Association gives some perspective: 

  • During 2012-2016, an estimated annual average of 18,100 (5%) reported home structure fires started by smoking materials killed an average of 590 (23%) people annually, injured 1,130 (10%) per year, and caused $476 million in direct property damage (7%) per year.
  • One in 20 home (5%) home structure fires were started by smoking materials. These fires caused almost one in four (23%) home fire deaths, and one in 10 (10%) home fire injuries.
  • Smoking was the leading cause of home fire deaths for the five year period from 2012-2016. Overall, one of every 31 home smoking material fires resulted in death.

Has it occurred to WHO that mass switching from smoking to vaping would dramatically reduce the problem of fires and burns? This is because they do not involve an ignition source.

Accidental exposure of children to ENDS e-liquids pose serious risks as devices may leak, or children may swallow the poisonous e-liquid.

Nicotine e-liquids pose a minor risk to safety. Again, what matters is the scale of this problem and other problems that it offsets. There are accidents caused by almost everything – not least medicines, cleaning fluids, cosmetics and alcohol. Again what matters is the “how much harm?” question. A look at the reports of US Poison Control Centers data (Annual report 2020 – PDF) gives some perspective: 

Pediatric poison exposures and deaths by exposure substance 2020 data 
Table 17C & 17D

Tobacco, nicotine and e-cigarettes combined are ranked at 25 in pediatric exposure reports (17C) and don’t figure in the top 25 for deaths (17E). But this combines tobacco and e-liquid exposure. Table 22 in the report shows that tobacco products account for 72% of the combined total pediatric exposures for tobacco, nicotine and e-cigarettes. Not mentioned by WHO: nicotine medications accounted for 1,608 poison exposures in 2020.

Written by Clive Bates

The PFAS Packaging Predicament: McDonald’s Isn’t Loving It

The packaging of a number of popular food items has attracted the attention of Consumer Reports, given the presence of per-and polyfluoroalkyl substances (PFAS), because of which fast-food giant McDonald’s is currently facing class-action lawsuits. Claimants are citing health risk concerns, yet McDonald’s is currently abiding by industry standards. So let’s review what PFAS are, some contradictions for this case, and the overall implications of PFAS for business practices.

What are PFAS and what are the concerns?

PFAS is a chemical family of over 9,000 man-made substances, ranging from gas to liquids, which have a variety of applications, from being a moisture barrier for tech gadgets to serving as a means for improving the durability of medical implants

PFAS are present in numerous household items, and are often referred to as ‘Forever Chemicals’ given the difficulty in breaking down their concocted components. It is precisely this lasting power that makes PFAS appealing for food containers. Packaging with PFAS can handle heat, steam, saturation, and grease – making it quite the innovation. 

The superior functionality of PFAS, however, doesn’t mean they should be used in excess. Just because someone has a fast car doesn’t mean he should recklessly speed down the highway. 

To be sure, there are significant health risks when overexposure to PFAS occur and spillovers sometimes happen. Fortunately though, a 2018 Toxicological Profile for Perfluoroalkyls by the Agency for Toxic Substances & Disease Registry says that “industrial releases have been declining since companies began phasing out the production and use of several perfluoroalkyls in the early 2000s.” In addition to that, a CDC report shows that since 2000, “mean blood levels of PFOS have declined approximately 84 percent and mean blood levels of PFOA have declined about 70 percent,” and recent reports are showing that bodies of water contain only trace amounts of PFAS, and they have been declining.

When higher levels of PFAS are found to be present in ground materials and waterways, it is often connected to communities with nearby military bases and fire training sites. PFAS are a major component for firefighting foam, and although this foam does pose serious health hazards, there is currently no alternative that is as effective

Given this understanding, it seems obvious that the focus should be on how to prevent the need for using firefighting foam rather than the banning of PFAS altogether. Just like that fast car, it is handy to have in an emergency (and blanket bans rarely result in positive outcomes).

What’s next and what was already in the works?

It should be noted that if McDonald’s could have more environmentally friendly packaging, it likely would. According to its 2020-2021 Purpose and Impact Progress Reportlast year, it made great strides in ensuring that a majority of its food packaging (99.6 percent) was derived from recycled or sustainable fiber. The report states “Improving the sustainability of our packaging and moving toward a circular economy are top priorities for our business.” 

But change takes time, and it is not clear as to what the lawsuit claimants would have McDonald’s do in the meantime – revert to Styrofoam? And to be frank, McDonald’s founding core competencies were in serving customers burgers and fries, not sustainable sourcing or package manufacturing.

PFAS will likely remain a core component of containerization strategies for food retailers until something better comes along that is either comparable or superior. And actually, McDonald’s may help lead the charge with funding to find alternative options given its previous pledge to continuously improve in this realm. 

In a statement given to Today, McDonald’s asserted that it “stands behind its commitment to the safety of its food and food packaging” and that the process of taking steps to remove PFAS use in packaging began in 2008 with a target to completely eliminate it by 2025.

So to get slammed with a lawsuit for its packaging seems like a slap in the face, particularly since many restaurant chains are aspiring to recoup lost profits as pandemic policies are lifted. And for restaurants aspiring for a rebound, calls for modifying packaging purchases may be too much to bear during a time of supply chain constraints.

What are the intentions and contradictions?

For those truly scared of PFAS presence at McDonald’s, it is important to remember that no one is forcing anyone to eat there (and those concerned should probably refrain from fast food altogether, given that a majority of restaurants from Panera to Popeyes have PFAS levels found in their packaging).

The hard truth is that being good for the environment isn’t always conducive to current needs. Take for example the extreme use of single-use plastics throughout the pandemic, let alone the pollution generated from disposable masks

It is also important to remember that when we pressure firms to do what is thought to be better, it can sometimes turn out to be worse – take how the banning of plastic straws can backfire, or how cotton tote bags can be a bigger problem than their plastic counterparts, or how even tree-planting campaigns can become environmentally costly.

As with all in life, there are tradeoffs – which is why PFAS use should be assessedaccording to the risk-related exposure for each chemical as well as the purpose of its use. Effort should also be placed on how best to test and treat PFAS presence when it does reach hazardous levels and any discovery of the misuse of these chemicals should be punished. 

And this brings us to the irony of the McDonald’s packaging problem. It is doing nothing wrong since the FDA has approved the use of PFAS in food packaging. 

As noted by the FDA, “the FDA does not have any indication that these substances are a human health concern, in other words a food safety risk in human food, at the levels found in this limited sampling.”

As such, the present lawsuits are not only a curious occurrence, but impose unwarranted pressure on any retailer tied to PFAS presence. 

And for those jumping on the bandwagon as a contributor to the fast-food court case claims, consideration should be given to the collateral damage that may occur. Over 90 percent of McDonald’s restaurants are franchises, meaning most McDonald’s stores are owned and operated by small business owners within your community. 

Smaller shops unaffiliated with McDonald’s may also be affected and fearfully pivot their packaging purchases despite the fact that what is being used is safe and approved, which is an important point: McDonald’s must consider more than the safety of the environment; it also must ensure the safety (as well as satisfaction) of its customers. For example, although PLA (polylactic acid)-coated paper could be an alternative packaging choice for McDonald’s, this material is not well-suited for heat transfer, and so someone ordering a hot beverage may feel the burn (and McDonald’s is no stranger to coffee-related court cases). 

What is the role for the consumer?

Before complaining in court or accusing wrongdoing, customers should cool it with the sue-happy culture and take accountability for the role they play, since history has shown that regardless of whether an organization wishes to do good for the planet, it is all for naught if consumers are not on board. 

And perhaps no firm knows this better than Frito Lay. For four years, it invested in the creation of a fully compostable bag for its SunChip snacks, only to have it be phased out in a matter of 18 months due to consumer complaints. The reason for shunning the SunChip sustainability effort was simply because consumers didn’t like the noise it made. 

Just imagine the number of complaints that McDonald’s would receive from boisterous buyers if its packaging failed to keep grease drippings at bay, or the heat of coffee contained. 

Considerations and Implications

New inventions are making the world better and safer every day, and given that PFAS impact numerous industries, there is a strong incentive for alternative innovations to come about over time to appease the various stakeholders present – thereby leading to safer options. 

Take for instance, vaping, which is 95 percent less harmful than cigarettes. Vaping has proved to be a worthwhile alternative for those seeking to quit but have found little success in kicking their smoking habit. Although it’d be best not to ingest any nicotine from the start, vaping is certainly a step in the right direction for those eager to transition away from tobacco consumption. 

And, while on the subject of consumption, most people would probably be better off not eating Big Macs on a regular basis. Even McDonald’s acknowledges this and has rolled out the McPlant – a vegan friendly alternative. And for now, McPlant sales are proving strongand PFAS packaging concerns don’t seem to be a deterrent. 

At the end of the day, experimentation is necessary for firms to advance their offerings, which can lead to an improved society. A marketplace that binds entrepreneurs with rules and rulings will hardly encourage exploration for innovations – and firms will grow to fear their customer base rather than have a desire to cater to them. Consumers should be wary of using the power of the courts rather than the power of their purse to influence business practices.

Originally published here

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