Landmark Public Health Law Reforms from Australia: Plain Tobacco Packaging, Vaping Regulation, and the Banning of Engineered Stone | Research Article

About the Author

Ian Freckelton AO KC, BA Hons LLB (Syd), PhD (Griff). LLD (Melb), Dip Th M (ANH),  FAAL, FASSA, FAHMS, FACLM (Hon) Barrister, Castan Chambers, Melbourne, Victoria, Australia; Professor of Law and Professorial Fellow in Psychiatry, University of Melbourne; Honorary Professor of Forensic Medicine, Monash University.

I.Freckelton@vicbar.com.au

https://ianfreckelton.com.au 

Note: This research work was submitted to Legitimate Scrutiny on 24th February 2024. Accordingly, the content, data, and analysis presented herein are based on reports and research materials available up to that date.

Abstract

This chapter reflects on the role of regulation in public health law as a means of protecting the vulnerable, as well as the corollary that inevitably such regulation encroaches on the entitlement of commercial institutions to manufacture, trade and advertise and has impacts upon individual and corporate autonomy. The chapter summarises and reflects upon the balances involved in these issues by reference to three landmark, albeit controversial, public health law reforms in Australia – in relation to plain paper packaging of tobacco products to reduce consumption;  a ban on vaping products to inhibit initiation of use of nicotine products by young people; and a prohibition on engineered stone to protect workers’ health. It argues that each of these law reform measures has been justified in the broader community interest and that each has a constructive role to play in protecting vulnerabilities and reducing the noxious effects of products made, distributed and promoted for a profit motive without due regard for their effects. It contends that each initiative provides an important precedent upon which international law reform in the broader health interest of the community can be based.

Key words: Public health law; Law reform; Tobacco packaging, Big Tobacco; Engineered stone, Silicosis; Occupational health and safety; Workers’ rights

1.      Introduction

 

Public health law plays a vital role, often through legislative intervention but also through governmental regulation and policy formulation, to effect changes to protect, preserve and advance community health. Gostin and Wiley define public health law as:

 

            the study of the legal powers and duties of the state to assure the conditions for people to be healthy (to identify, prevent, and ameliorate risks to health in the population) and the limitations on the power of the state to constrain the autonomy, privacy, liberty, proprietary, or other legally protected interests of individuals for the common good. The prime objective of public health law is to pursue the highest possible level of physical and mental health in the population, consistent with the values of social justice.[1]

 

For Gostin and Wiley, public health law is concerned with government powers and duties to protect the health of the population, and the limits of how and when those powers should be exercised by government.[2] Public health law has been described too as:

 

·         the specific, often long-standing, statutory responses that assist and empower public health regulators in the range of areas that they work;

·         the body of law and legal practice that affects public health practice and the public’s health more generally;

·         recognising that changing existing laws and practices that damage the public’s health is as significant a task for those involved in public health law, as the supporting of laws which stand to improve public health.[3]

 

Importantly too, public health law has a focus on prevention, and a commitment to social justice.[4]

 

This chapter reviews three contentious and landmark public health law reforms pioneered in Australia. The first was implemented by the Tobacco Plain Packaging Act 2011 (Cth) (“the TPP Act) which regulated the retail and packaging of tobacco products to discourage people from purchasing them in the interest of reducing the threat to health posed by tobacco consumption. This made Australia the first country in the world to require plain and standardised packaging of tobacco products.  It was challenged in Australia, then emulated in other jurisdictions and survived curial challenges in many and diverse jurisdictions. The second initiative took the form from the start of 2024 of a ban on vaping products to protect against adolescents being induced to commence tobacco consumption and addiction to e-cigarettes. The third was the imposition of a ban, commencing in mid-2024, on engineered stone for kitchen and bathroom benchtops after reports established risks for workers in the industry and the ineffectiveness of softer touch forms of regulation.

 

The three Australian initiatives constitute internationally significant measures to reduce harm from consumption of tobacco products recognised by health authorities as noxious and a workplace reform to eliminate a source of proven risk for workers undertaking a variety of forms of work with an artificial substance with high levels of respirable dust foreseeably likely to cause the fatal disease of silicosis. Each initiative had prompted international debate about the extent to which it is appropriate for governments to intrude upon consumers’ autonomy by overt measures to intrude upon commercial processes in the interest of community health. Each, however, constitutes an important public health law precedent for reform in other countries.

 

2.      The Plain Paper Packaging Initiative

 

The 2011 TPP Act imposed significant restrictions upon the colour, shape and finish of retail packaging for tobacco products sold in Australia. It prohibited the use of trade marks on such packaging, other than as permitted, which allowed the use of a brand, business or company name for the relevant tobacco product. Embellishments on cigarette packs and cartons were proscribed.[5] Packs and cartons were required to be rectangular,[6] have only a matt finish[7] and bear on their surfaces the colour prescribed by the TPP Regulations.[8] Absent regulation, the colour of the package was prescribed to be a drab, dark brown.[9] The use of trade marks on retail packaging of tobacco products was prohibited other than as permitted by s 20(3) which provides that:

The following may appear on the retail packaging of tobacco products:

• (a) the brand, business or company name for the tobacco products, and any variant name for the tobacco products; 

• (b) the relevant legislative requirements; 

• (c) any other trade mark or mark permitted by the regulations.

  Pre-existing regulatory requirements for health messages and graphic warnings remained in place and included a requirement for the inclusion of the Quitline logo of the Victorian Anti-Cancer Council and a telephone number for the Quitline service. The combination of measures was significant internationally for the future of tobacco advertising and promotion.[10]

 

The purposes of the legislative intervention was overtly articulated. By s3(1) of the TPP Act, the objects were stated to be:

 

 (a)  to improve public health by: 

1. Discouraging people from taking up smoking, or using tobacco products; and 

2. Encouraging people to give up smoking, and to stop using tobacco products; and 

3. Discouraging people who have given up smoking, or who have stopped using tobacco products, from relapsing; and 

4. Reducing people's exposure to smoke from tobacco products; and 

 (b)  to give effect to certain obligations that Australia has as a party to the Convention on Tobacco Control.  It was stated too (by s3(2)) that it was the legislative intention contribute to achieving the objects of the Act by regulating the retail packaging and appearance of tobacco products in order to: 

1. Reduce the appeal of tobacco products to consumers; and 

2. Increase the effectiveness of health warnings on the retail packaging of tobacco products; and 

3. Reduce the ability of the retail packaging of tobacco products to mislead consumers about the harmful effects of smoking or using tobacco products.

 

It was also an object of the TPP Act to give effect to obligations that Australia had and continues to have as a party to the Convention on Tobacco Control.[11] The Act thereby relied upon the power of the Commonwealth Parliament to make laws with respect to external affairs. Part 3 of Ch 1 of the TPP Act Entitled "Constitutional provisions" provides for the Act's additional operation in reliance upon the corporations power, the trade and commerce power, and the Territories' power.  Section 15(1) provides for the non-application of the TPP Act to the extent (if any) that its operation would result in an acquisition of property from a person otherwise than on just terms. Section 15(2) provides that if, apart from s 15, the TPP Act would result in such an acquisition of property because it would prevent the use of a trade mark or other sign on or in relation to retail packaging of tobacco products, the trade mark or sign may be so used. The validity of that subsection was challenged by the major manufacturer and distributor of tobacco products, British American Tobacco and multiple aspects of the legislation was the subject of a constitutional challenge by tobacco companies.[12] The challenge contended that the TPP Act effected an acquisition of the tobacco companies’ intellectual property rights and goodwill on other than just terms contrary to section 51(xxxi) of the Australian Constitution. However, the High Court of Australia rejected the challenges to the legislation, among other things rejecting the proposition that section 15 of the TPP Act resulted in an acquisition of the tobacco manufacturers’ property comprising the trade marks, the copyright works, the get-up, the licensing goodwill, the design, the patents, the packaging rights, the packaging goodwill and the intellectual property licence rights on terms that were not just.

 

Australia’s initiative was the subject also of international challenges from Big Tobacco and also from countries that had a substantial cultivation and manufacturing industry in the tobacco sector. For instance, an investor-state dispute was brought by Philip Morris Asia under a bilateral investment treaty with Hong Kong. This was dismissed in 2015.[13] Other countries, in varying degrees, emulated Australia’s initiative. In turn these prompted challenges which also failed – in the United Kingdom,[14] Ireland,[15] France,[16] and Norway.[17] 

 

Ultimately, the Appellate Body of the World Trade Organization found that Australia’s tobacco plain packaging laws contributed to the objective of reducing tobacco use and exposure, that it was not more trade-restrictive than necessary to achieve that public health objective, and that it did not infringe any intellectual property rights under the WTO Agreements.[18] Australia relied upon amici curiae submissions provided by the World Health Organization (WHO) and the Framework Convention on Tobacco Control Secretariat; the Healthy Caribbean Coalition; the Union for International Cancer Control (UICC) and Cancer Council Australia (CCA). The challenge to Australia was brought by a consortium of countries – Honduras, the Dominican Republic, Cuba, Indonesia and Ukraine.

 

Honduras argued that Australia’s restrictions in The Trans-Pacific Partnership Agreement (“TPP”) were inconsistent with Article 2.1 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”) and Articles 15.4, 16.1, 17, 20, 22.2(b) and 24.3 of the TRIPS Agreement. It also contended that Australia had acted inconsistently with Article 10bis of the Paris Convention (1967), as incorporated into the TRIPS Agreement by Article 2.1, and Articles 2.2(b) of the TRIPS Agreement. The Dominican Republic and Cuba advanced similar arguments. Indonesia also sought a finding that the TPP measures, collectively and individually were inconsistent with international law.

 

The Appellate Body concluded that the parties challenging the Australian legislation had failed to demonstrate that the TPP measures were not apt to make a contribution to Australia’s objective of improving public health by reducing the use of, and exposure to, tobacco products. It accepted that the TPP measures were trade-restrictive in that by reducing the use of tobacco products they reduced the volume of imported tobacco products on the Australian market and thereby had a limiting effect on trade. However, it was not satisfied that the TPP-measures were more trade-restrictive than necessary to fulfil a legitimate objective.

 

The Appellate Body noted that Article 16.1 of the TRIPS Agreement grants a trademark owner the exclusive right to preclude unauthorised third parties from using, in the course of trade, identical or similar signs for goods or services that are identical to those with respect to which the trademark is registered. It affirmed that the owner of a registered trademark can exercise its “exclusive right” against an unauthorised third party but not against the World Trade Organization Member in whose territory the trademark is registered. It found that neither the TRIPS agreement nor the provisions of the Paris Convention (1967) that are incorporated by reference into the TRIPS Agreement confer upon the trademark owner a positive right to use its trademark or a right to protect the distinctiveness of that trademark through use. This meant that to show that the TPP measures violate Australia’s obligations, it was necessary for the complainants to demonstrate that, under Australia’s domestic law, the trademark owner did not have the right to prevent third party activities that met the conditions set out in Article 16.1 of the TRIPS Agreement. The Appellate Body found that the possibility of a reduced occurrence of a likelihood of confusion in the market did not constitute a violation of Article 16.1 because Members’ compliance with the obligation to provide the right to prevent trademark infringements under Article 16.1 is independent of whether such infringements actually occur in the market – it does not require Members to refrain from regulatory measures that may affect the distinctiveness of individual trademarks or provide a “minimum opportunity” to use a trademark to protect such distinctiveness.

 

The Appellate Body noted that Article 20 in the TRIPS Agreement includes the modifying adverb, “unjustifiably”, which gives to Members a degree of discretion in imposing encumbrances on the use of trademarks under Article 20 of the TRIPS Agreement. It found that in determining whether use of a trademark in the course of trade is being encumbered “unjustifiably” by special requirements should include a consideration of three factors:

 

(a)    The nature and extent of the encumbrance from the special requirements, bearing in mind the legitimate interest of the trademark owner in using its trademark in the course of trade and thereby allowing the trademark to fulfil is intended function;

(b)   The reasons for which the special requirements are applied, including any societal interests they are intended to safeguard; and

(c)    Whether these reasons provide sufficient support for the resulting encumbrance.[19]

 

Thus the Appellate Body found that the complainants had not demonstrated that the TPP measures were inconsistent with Australia’s obligations under Article 20 of the TRIPS Agreement.[20]

 

After the introduction by Australia of plain paper packaging of tobacco products Ireland (2015), France (2017), the United Kingdom (2017), New Zealand (2018), and Norway (2018) passed similar legislation. International plain packaging reforms were given a further fillip by the Appellate Body decision of 2019 – a series of countries introduced plain paper packaging legislation, including Thailand 92019), Uruguay (2019), Saudi Arabia (2020), Slovenia (2020), Turkey (2020), Israel (2020), Canada (2020), Singapore (2020), Belgium (2021), Netherlands (2021), Hungary (2022), Denmark (2022),  Guernsey (2022), Jersey (2022), Finland (2023), Armenia (2024), Myanmar (2024) and Georgia (2024).

 

However, the legislation that has been passed internationally has not been uniform.[21] In some countries the legislation is more wide-ranging than in others. For instance, plain packaging laws are more comprehensive in some countries than in others, expanding coverage beyond traditional tobacco products to include heated tobacco, tobacco accessories (rolling papers) and other nicotine-containing products (e-cigarettes).[22] Laws in some countries have also become more innovative: some now ban non-biodegradable filters, include provision for a periodic change of the pack colour or require both plain packaging and health-promoting pack inserts.[23] Health advocates internationally have applauded Australia’s plain packaging reforms as having laid a basis for depriving Big Tobacco of a major advantage that it had in advertising its products without properly acknowledging their risks to health. Cohen et al, for instance, have argued that:

 

Plain packaging has great potential globally to change societal perceptions and thereby denormalise use of tobacco products especially among youth, who are vulnerable to tobacco industry marketing strategies. This is particularly important in LMICs (low and middle income countries) where the tobacco industry is aggressively marketing their products. Many LMICs therefore have a unique opportunity to prevent further growth of the tobacco epidemic through plain packaging along with other evidence-based tobacco control measures. It is now time for all countries to move forward with tobacco plain packaging to help save lives by reducing tobacco-related death and disease.[24] 

 

 

3.      The Vaping Regulation Initiative

 

Electronic cigarettes (e-cigarettes) are battery-operated devices that use an electric pulse to heat and aerosolise a flavoured liquid that typically contains nicotine. Their introduction constitutes a major repositioning by Big Tobacco in face of losses, including those in relation to plain paper packaging and mandatory health warnings.

The first e-cigarette was patented in 2004.[25] Since then there has been an exponential in the use of e-cigarettes (also known as vaping) globally.[26] The escalation in vaping has been well documented in many countries[27] and is dominated by well-known and established tobacco companies.[28] Big Tobacco has specifically targeted adolescents during this time and has achieved spectacular successes in marketing vaping as socially acceptable as part of a renormalisation of smoking which otherwise had become significantly stigmatised. Vaping has allowed market development by tobacco companies by attracting young smokers and product development has involved customers to engage in dual use – traditional cigarette consumption and also vaping - enabling strategic diversification, including by the suggestion that vaping is a form of responsible harm reduction by Big Tobacco.[29]

Such inroads on the anti-smoking initiatives by public health advocates are potentially very significant. Laucks and Salzman have usually synthesised some of the health risks of vaping:

The conventional solvents for the dissolution of nicotine or THC have been propylene glycol and glycerol, and these are the best studied. Initially thought to be benign, there is now some research demonstrating that propylene glycol when vaporized causes significant respiratory irritation and even increases the incidence of asthma. The breakdown products from heating propylene glycol and glycerol to target temperatures include formaldehyde and hemiacetals such as acetaldehyde. Formaldehyde is a Group 1 carcinogen that contributes a 5–15 times higher lifetime risk of cancer. It is present in traditional smoked tobacco in much lower quantities. Hemiacetals such as acrolein and acetone have been implicated in nasal irritation, cardiovascular effects, and lung mucosal damage and these byproducts are produced in higher quantities with higher voltage devices. Basically, as the temperature of the coil increases, the carcinogenic risk of vaping approaches that of traditionally smoked cigarettes.[30]

Delivery of tobacco by vaping occurs in different ways, including by nicotine salt (benzoic acid added) as against nicotine free-based (without benzoic acid), the former being rated by users as having more appeal, sweetness and smoothness.[31] Integral to the attractiveness of vaping to users, especially young users, is the involvement of novel flavours; a United States study, for instance, found that flavour was a common reason for vaping initiations, including fruit, mint/menthol, sweet, candy, and coffee.[32] A fruit flavour was found especially likely to motivate young adults to commence vaping.

Important and not fully resolved questions exist, though, about the extent of harm caused by vaping of both tobacco and cannabis.[33] There are also threshold social policy questions about the promotion of a noxious and addictive product to minors.

The United States Food and Drug Administration (FDA) has emphasised that there are no safe tobacco products, including electronic nicotine delivery systems (ENDS):

In addition to exposing people to risks of tobacco-related disease and death, FDA has received reports from the public about safety problems associated with vaping products including overheating, fires, and explosions; lung injuries; and seizures and other neurological symptoms.[34]

A study has published dramatic results in relation to the uptake of vaping in the United States.[35] Among disposable e-cigarettes sold between January 2017 and September 2022, average volume capacity increased 518% from 1.1 mL to 5.7 mL and average nicotine strength increased 294% from 1.7% to 5%. Sales-weighted average price per disposable unit and millilitres of e-liquid both remained relatively constant until January 2020 but from January 2020 to September 2022, average unit prices increased 165.7% from US$8.49 to US$14.07, while the average price of 1 mL of e-liquid decreased 69.2% from US$7.96 to US$2.45. The authors concluded that the current regulatory regime in relation to e-cigarettes had resulted in disposable e-cigarette manufacturers providing consumers with bigger, cheaper disposable e-cigarettes that were coming in increasingly higher nicotine strengths. They argued that “Tobacco policy recommendations such as restricting e-liquid capacity and minimum price laws as well as regulations on product characteristics that affect nicotine emissions and delivery such as nicotine strength, nicotine output, device power, and puff duration should be considered in regulating the e-cigarette market.”[36]

 

A 2023 Australian study[37] also found a marked increase in the six-monthly population prevalence of current vaping (defined as having vaped in the past month) that began in late 2020 and continued throughout 2022. This increase in vaping was particularly apparent among those aged under 25. This, of course, was unsurprising given the focus of vaping marketing. While annual prevalence of overall smoking prevalence was relatively stable in Australia, the study showed that annual prevalence of exclusive smoking appeared to gradually trend downwards, but the prevalence of exclusive vaping and dual use of tobacco and e-cigarettes both trended upwards with large increases from 2020 to 2022. The increase in exclusive vaping and dual use from 2020 to 2022 was most observable among those aged under 25.

In November 2022 the Australian Government intervened to create a research base in relation to potential law reform and to engage in a thorough community consultative process. The Therapeutic Goods Administration (“TGA”) published  a consultation paper on potential reforms to the regulation of vaping products.[38] It noted that the regulatory requirements for nicotine vaping products (NVPs) had already changed in Australia on 1 October 2021, when a TGA decision to classify NVPs as prescription medicines (Schedule 4 to the Standard for the Uniform Scheduling of Medicines and Poisons (Poisons Standard)) took effect, meaning that NVPs became subject to the regulatory controls for prescription medicines (“the 2021 reforms”). The aim of these reforms was to prevent children and adolescents from accessing NVPs, whilst allowing smokers to access such products for smoking cessation with a doctor’s prescription. However, it stated that evidence had emerged that the reforms were not meeting these aims and that there was a need to consider other measures to inhibit access to vaping products.

The consultation document identified that children and adolescents were continuing to obtain NVPs in high numbers. Commonwealth law in Australia prevented the importation of such products, and State and Territory laws prevented the domestic supply, of NVPs without a prescription. However, there was evidence that many adults were accessing NVPs without a prescription, rather than through lawful supply channels with a prescription from an Australian doctor.

This led the TGA, as the regulator of NVPs (since 2021), to consider whether refinements to the existing requirements for NVPs should be introduced to support the intent of the earlier legislative reforms more effectively – to prevent children and adolescents from accessing NVPs while supporting access to products of known composition and quality for smoking cessation with a doctor’s prescription. The TGA identified four areas for potential reform:

1. changes to border controls for NVPs;

2. pre-market TGA assessment of NVPs against a product standard;

3. strengthening of the product standard regarding minimum quality and safety standards for NVPs; and

4. clarifying the status of NVPs as ‘therapeutic goods’.

In response to its call for feedback, the TGA received almost 4,000 submissions.[39]

In relation to border controls, the preferred option of the TGA had been to strengthen border controls by requiring importers to obtain an import permit and by closing off the personal importation scheme. All State and Territory governments supported this stance with most also supporting closing the personal importation scheme and requiring import permits. Health professional bodies, public health associations, individual health professionals, university researchers and companies marketing prescription NVPs to Australian pharmacies overwhelmingly supported tightening border controls for NVPs. Many (but not all) of these groups also submitted that border controls should be placed on non-nicotine vaping products (which went further than the proposed option in the consultation paper). Predictably, individual vapers, vaping retailers, vaping manufacturers/importers, and pro-vaping associations did not generally support any import controls.

The TGA proposed requiring pre-market TGA assessment of NVPs against a product standard specifying certain quality and safety requirements. Companies supplying to the prescription pharmacy market supported this approach, as did about half of State and Territory governments, half of health professional bodies and nearly half of individual health professionals. Nearly half of public health associations and health professional bodies proposed instead that all NVPs be registered in the Australian Register of Therapeutic Goods and opposed pre-market assessment as they were concerned it could be misinterpreted as TGA approval. A large number of individual vapers, vaping retailers, vaping manufacturers/importers and pro-vaping associations supported at least some regulation to ensure NVP quality and safety (but with NVPs regulated as consumer goods, instead of as prescription medicines). 

There was strong support for the TGA’s preferred option from State and Territory governments, health professional bodies, individual health professionals, public health associations and university researchers to strengthen Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 to introduce warning statements (although this was opposed by some), require pharmaceutical-like packaging, lower the maximum allowable nicotine concentrations, prohibit/restrict flavours and certain other ingredients and limit NVP volume and overall nicotine content. Many of these submissions also called for the imposition of similar controls on non-nicotine vaping products. There was significant support for banning disposable NVPs from all categories of submitters (including individual vapers), but some opposed this because of concerns a ban could affect accessibility for smoking cessation and because of the risks of using some alternative products.

There was general support too for the proposal to clarify that all vaping products containing nicotine are therapeutic goods from all categories of submitters except individual vapers, vaping retailers, vaping manufacturers/importers, and pro-vaping associations.

A second, targeted consultation was conducted between 7 September 2023 and 21 September 2023 on proposed reforms to the regulation of vapes generally. The consultation paper requested feedback on four proposals:

Proposal 1 – restrictions on importation, manufacture and supply of all vapes

Proposal 2 – changes to market accessibility requirements for therapeutic vapes

Proposal 3 – heightened quality and safety standards for therapeutic vapes

Proposal 4 – strengthened domestic compliance and enforcement mechanisms.[40]

The TGA received 291 responses on this occasion.

Government agencies, health professional peak bodies, public health associations, university researchers, public health experts, pharmacy groups, and therapeutic vape importers and manufacturers supplying to the pharmacy market were nearly all supportive of the proposed ban on the importation, manufacture, and supply of disposable, single use and non-therapeutic, vapes. Vape manufacturers and importers not part of the pharmacy supply chain strongly opposed the ban, arguing that it would increase the black market. Consumer groups and retail associations did not generally support the proposal.

Government agencies, health professional peak bodies and public health associations strongly supported the cessation of the personal importation scheme for therapeutic vapes. Approximately two-thirds of academic experts and vape manufactures and importers supplying to the pharmacy market expressed support, while those not part of the pharmacy supply chain, and consumer groups, were mostly unsupportive of the proposed change.

Government agencies, health professional peak bodies, public health associations and academic experts expressed strong support for retaining the travellers’ exemption, although concerns were raised that the proposed quantity limits were too generous. More than half of vape retailers, manufacturers, and importers were opposed to retaining the travellers’ exemption. Numerous respondents from a diverse cross-section of stakeholders expressed concerns relating to specifying the precise evidence required for the travellers’ exemption to apply, noting that no other country required the prescribing of therapeutic vapes. Most respondents across all stakeholder groups supported the proposed restrictions on the advertisement of vapes.

Nearly all government agencies, health professional peak bodies, public health associations, and academic experts supported the proposed pre-market notification process. Vape manufacturers and importers supplying to the pharmacy market generally supported the proposal, while retailers and importers not part of the pharmacy supply chain strongly opposed the proposal.

Government agencies, public health associations, and vape manufacturers were highly supportive of instituting a pathway to facilitate access to therapeutic vapes for smoking cessation and the treatment of nicotine dependence, arguing that it would reduce the burden on prescribers.

Government agencies, health professional peak bodies and vape manufacturers supplying to the pharmacy market were very supportive of medicine and device components being regulated together where possible. Conversely, the proposal received mixed support amongst consumer groups and associations.

Government agencies, public health organisations, health professional peak bodies and school related groups strongly supported limiting flavours in which vapes may be legitimately supplied. These groups submitted that a limited number of flavours would reduce the appeal of vapes to youth.

Stakeholders had mixed views in relation to nicotine concentration limits. Some argued that higher concentrations could be appropriate, while others supported a 20mg/mL concentration limit to align with international approaches based on the best evidence for smoking cessation that is currently available.

Government agencies, public health associations and health professional peak bodies strongly supported the proposed upper limit on menthol. Health care professionals and public health organisations highlighted that menthol, and some isomers of menthol, are known for their pharmacological action causing lung injury, with some suggesting menthol should not be allowed at all.

Government agencies, university researchers, public health associations, health professional peak bodies, and school related groups supported plain packaging requirements. There was less support amongst vape manufacturers, retailers, and consumer groups. Apart from vape users, vape retailers, importers and manufacturers, there was support for a permitted ingredient list across all other stakeholder groups.

Ultimately, the Australian government took the major step of deciding to introduce thoroughgoing reforms to the regulation of vapes  to address the significant public health issues caused by vaping, particularly among young people.[41] For this purpose vapes were deemed to include vaping substances, vaping accessories and vaping devices.

From 1 January 2024 the importation of all disposable vapes was banned, with very limited exceptions, although a pathway was permitted to facilitate legitimate patient access to therapeutic vapes, for smoking cessation and the management of nicotine dependence.

From 1 March 2024 a ban was instituted on the importation of all vapes without an import licence and permit from the Office of Drug Control.  The Personal Importation Scheme for vapes was closed and a new medical device standard was stipulated for therapeutic vaping devices that were previously excluded from the therapeutic goods framework. A decision was made to implement the changes through therapeutic goods and customs legislation.

The Minister for Health and Aged Care summarised the Australian Government’s position straightforwardly:

We are taking on Big Tobacco so they can't succeed in getting a new generation addicted to nicotine. The truth is the only groups who want to regulate and sell vaping products are those who profit from kids getting hooked on nicotine – Big Tobacco and tobacco retailers. That's why on January 1, the Albanese Government brought in the first stage of our world-leading reforms to protect young Australians.

These disposable, single-use vapes can no longer be imported. Stopping these vapes from coming into the country is the first step in turning the tide on vaping in Australia.

There will be more changes in March. Flavours will be restricted, nicotine concentration will be reduced and pharmaceutical packaging will be used, to make vapes less appealing to young people.

We'll be introducing laws to effectively make it illegal to make, advertise or sell single-use disposable or non-therapeutic vapes anywhere in Australia. Reducing the widespread availability and accessibility of vaping products will be critical to the success of the reforms. We want to ensure that vaping products are only available from pharmacies for therapeutic purposes.

It is important to know that under these reforms young people and other users of these products will not be punished for possessing a vape. The focus will be to stop the commercial supply and sale outside of therapeutic settings to protect young people.[42]

The Australian government’s public health initiatives in relation to vaping have attracted considerable international attention.[43] However, it is not the first country to inhibit the use of vapes. A forerunner in this regard was India which in September 2019 banned sales of vaping products.[44] The World Health Organization has been emphatic in its public health position in support of such initiatives:

The tobacco industry profits from destroying health and is using these newer products to get a seat at the policy-making table with governments to lobby against health policies. The tobacco industry funds and promotes false evidence to argue that these products reduce harm, while at the same time heavily promoting these products to children and non-smokers and continuing to sell billions of cigarettes. 

Strong decisive action is needed to prevent the uptake of e-cigarettes based on the growing body of evidence of its use by children and adolescents and health harms.[45]

Australia’s public health stance in relation to vaping is likely to be internationally influential in encouraging other countries to take a similarly strong position.

 

 

4.      The Engineered Stone Initiative

 

There is a lengthy history that is thoroughly documented of the risks posed to workers from asbestos and from coal mining dust. However, the dangers posed by dust-induced silicosis are not as well known. They first came to prominence as a result of the Hawk’s Nest tragedy in West Virginia in the United States in the early 1930s[46] but are also well recognised in countries such as India.[47] For instance, in 2013 it was estimated that over three million Indian workers were exposed to silica[48] and it has been hypothesised that by 2025-2026 52 million workers in India will be employed in an occupation associated with silica.  Notably, too, the introduction of a pneumoconiosis policy in 2019 led to a diagnosis of 23,436 cases of silicosis out of 192,143 persons screened.[49]

 

Silicosis is a progressive, irreversible and incurable fibrotic pulmonary disease caused by inhalation of respirable crystalline silica (RCS) dust.[50] Factors influencing the risk of developing silicosis include lifetime cumulative exposure, total amount of inhaled RCS, and individual susceptibility. It is diagnosed by chest radiography and pulmonary function tests.[51] The only life-saving therapeutic option in end-stage silicosis is lung transplantation.[52] Silicosis is characterised by a significant interval between initial exposure to the hazardous dust and the emergence of the first signs of the disease (discovered clinically or by the administration of tests) – the latency period. It is common for silicosis to be well advanced by the time that it is diagnosed.

In the twenty first century there has been a further development. A troubling increase in silicosis has been detected in a number of countries.[53]  A significant component of this increase has been identified as attributable to workers being exposed to high concentrations of silica dust from working with artificial or engineered stone[54] which is distinctive by reason of being made up of finely crushed rocks that are mixed with a polymeric resin.[55] For this purpose, “engineered stone” has been defined as:

an artificial product that is created by combining and curing natural stone materials (such as quartz or stone aggregate) with chemical constituents (such as water, resins or pigments), and can be manipulated through mechanical processes to manufacture other products (such as kitchen benchtops). Engineered stone does not include natural stone that has not been combined with other products or cured (e.g. granite and quartz in their natural state).[56]

The dangerous aspect of engineered stone is its silica content which can be over 90%,[57] a substantially higher percentage than the silica content of natural marble (under 5%) or granite (10-45%).[58] Highly respirable silica dust is produced by mechanical cutting, crushing, drilling, grinding, sawing or polishing, especially when the work with silica is done in dry conditions.

In addition to silicosis, other diseases are associated with silica dust exposure. These include myobacterial diseases, airway obstruction and lung cancer, tuberculosis and kidney disease,[59] as well as autoimmune diseases, such as systemic lupus erythematosus,[60] systemic sclerosis[61] and rheumatoid arthritis.[62] While there is no curative treatment for silicosis,[63] management strategies can slow deterioration and improve quality of life.[64] However, anxiety and depression can be experienced by persons identified as at risk of developing silicosis during the latency period.[65]

 

In 2009 and 2012 there were reports about workers contracting silicosis in Spain and Italy after working with engineered stone[66]. It was also recognised from 2012 in workers in Israel[67] where the market leader, Caesarstone, is headquartered in Caesarea.[68] In addition, it was identified at disproportionate levels in workers at a countertop fabrication facility in California in the United States.[69]

However, it has been most prominently in Australia that a concerning incidence of silicosis amongst engineered stone workers has been established and been the subject of investigation and reports. In Australia the first description of the phenomenon was published by the Medical Journal of Australia in 2017.[70] After silicosis was found in engineered stone benchtop workers,[71] Queensland screened 1053 workers. The audit revealed that 98 workers had contracted silicosis, 15 of them terminally, and also exposed 552 workplace health and safety breaches, including for workplace cleaning practices, dry-cutting of engineered stone and inadequate protective equipment.[72] This led the Industrial Relations Minister, Ms Grace, to urge a national response to the problem.[73]

Victoria added to the Queensland data with the result that screening of a total of 1,509 engineered stone workers in Queensland and Victoria, a sample of over 50% of engineered stone workers, revealed that 362 workers (almost one in four) had contracted silicosis, albeit some as yet asymptomatically. “Complicated” cases demonstrated progressive disease as early as four months from diagnosis although some cases meeting the radiological criteria for “progressive massive fibrosis” (PMF) at diagnosis did not progress during two years of follow-up. These observations are consistent with a growing body of literature: León-Jiménez et al, for instance, emphasised the distinctive and rapid progression observed in their cohort of artificial stone-associated silicosis: 56% of their patients progressed two or more ILO subcategories within their four-year follow-up.[74] 

 

In the interim, Queensland established Australia’s first Notifiable Dust Lung Disease Register[75] and allocated $AU5 million to dust diseases research. It implemented a code of practice for the engineered stone industry in 2019 and a code of practice for silica in the construction industry on 1 May 2023.[76]

 

In 2019 the National Dust Disease Taskforce was asked to develop a national approach to the prevention, early identification, control and management of occupational dust diseases. The terms of reference for the Taskforce

requested that it provide advice on:

 

·         Actions that have been taken to date to address occupational dust disease across all

Australian jurisdictions;

·         Existing policy and regulatory arrangements in Australia to protect those at-risk from

occupational dust disease, more specifically reviewing what controls are in place and

how these are applied and monitored;

·         Opportunities for improvement across the system to ensure protection of those at-risk

Populations;

·         Options for sustainable approaches for the future prevention, detection and

management of occupational dust diseases, including the consideration of the establishment of a National Occupational Respiratory Disease register, including its

scope and anticipated outcomes; and

·         Options for potential new research required to support understanding, prevention and

treatment of preventable occupational respiratory disease.[77]

 

In its final report in June 2021 it noted that “nearly one in four engineered stone workers who have been in the industry since before 2018, are suffering from silicosis or other silica related dust related diseases. Existing WHS [work health and safety] regulatory frameworks have not effectively protected people working with engineered stone.”[78] After what it described as “careful consideration”, it did not recommend a product ban but stated that “all parties need to consider themselves to be on notice: the majority of the Taskforce members agree that if measures we have recommended do not achieve the expected significant improvements in worker safety within the next three years, the immediate action must be taken to ban the product. Industry and governments must urgently demonstrate that engineered stone can, in fact, be used safely.”[79] For the time being it recommended a regulatory impact analysis to consider specific measures to address policy and implementation gaps, “including the introduction of licensing schemes to ensure that only those persons conducting a business or undertaking such a scheme, have access to the product. Enforcement activities must also be adequately resourced to ensure compliance with WHS laws.”[80] It also proposed the establishment of a National Occupational Respiratory Disease Registry and additional funding to build the evidence base about silicosis as well as the capability of the research sector.

 

In May 2023 the Model Work Health and Safety Regulations (Engineered Stone) Amendment 2023 introduced a specific prohibition on the uncontrolled processing of engineered stone products, setting out the duty on persons conducting a business or undertaking (PBCU) to eliminate risks to the health and safety of workers from engineered stone (including by reference to Australian Standards) and, if that is not reasonably practicable, to minimise the risk so far as is reasonably practicable.[81] Regulation 184A(2) states that the processing of engineered stone will be controlled if at least one of the following systems is used:

 

·         a water delivery system that supplies a continuous feed of water over the area being cut to suppress the generation of dust

·         an on-tool extraction system - this typically includes a shroud, an on-tool hose attachment connected to a vacuum extraction system, or

·         a local exhaust ventilation system.

All workers who process engineered stone must also be provided with “respiratory protective equipment” (defined as personal protective equipment designed to prevent a person wearing the equipment from inhaling airborne contaminants, and that complies with the relevant Australian Standard) for the processing to be controlled.

 

Regulation 184A(3) defines engineered stone as an artificial product which contains crystalline silica, is created through combining natural stone materials with other chemical constituents and undergoes a process to become hardened. However, engineered stone does not include concrete and cement products, bricks, pavers and other similar blocks, ceramic and porcelain wall and floor tiles, roof tiles, grout, mortar and render or plasterboard. Processing in relation to engineered stone is defined as cutting, grinding, trimming, sanding, abrasive polishing and drilling using power tools or another form of mechanical plant. The note to the regulation sets out that regulations 44 and 46 apply to the use of personal protective equipment, including respiratory protective equipment. These regulations deal with the provision by a persons conducting a business or undertaking (“PCBU”) of personal protective equipment to workers (including in relation to its suitability, maintenance and use) and the duties of workers who are provided with personal protective equipment.

 

In August 2023 Safe Work Australia published a regulation impact statement (“the Statement”) in relation to the prohibition on the use of engineered stone.[82] It was this publication that constituted the key influence upon the 2023 decision by Ministers of Australian governments to ban engineered stone.

 

The Statement noted that there had been “robust and consistent laws in place requiring PCBUs, including designers, importers and manufacturers, to eliminate or minimise the risks to workers and others from [respirable crystalline silica] (RCS) so far as is reasonably practicable, including that generated from engineered stone”.[83] It observed too that:

 

the model WHS laws have been amended to remove any doubt in relation to the applicable control measures when working with engineered stone, for example, the prevention of dry cutting. The workplace exposure level for RCS has also been reduced from 0.1 mg/m3 to 0.05 mg/m3 (8-hour time weighted average), with Members recently agreeing to recommend a further reduction to WHS ministers (to 0.025 mg/m3). Safe Work Australia and Commonwealth, state and territory governments have also undertaken increased compliance activities, education and awareness campaigns and health screening programs to prevent further unlawful exposure to RCS.[84]

 

However, it concluded that there had been insufficient compliance activities by the engineered stone industry in light of the level of risk that it posed and there had been and continued to be non-compliance with the obligations imposed by workplace health and safety laws by both PCBUs, many of which were small businesses, and workers.[85] It noted that many improvement notices, prohibition notices and penalty/ infringement notices had been issued, accompanied in respect of the latter with fines for a variety of forms of non-compliance, including:

 

·         failure to undertake air and health monitoring;

·         failure to provide training and instruction;

·         failure to provide or ensure proper use of personal protective equipment (PPE) including proper fit of respiratory protective equipment (RPE);

·         failures in housekeeping leading to further exposure to silica dust;

·         failure to make available safety data sheets;

·         uncontrolled/dry processing of engineered stone; and

·         evidence of airborne silica dust.

 

It also identified that multiple prosecutions had taken place for occupational health and safety breaches in relation to PCBUs’ obligation to provide a safe and healthy workplace but that these had not resulted in a notable improvement in standards.

 

Another issue identified in the Statement was the fact that in the 2018-2019 to 2020-2021 period 46% of all worker’s compensation silicosis claims were made by young workers, defined as under the age of 35.[86] 

 

In light of the extent of non-compliance with work health and safety laws, the unlikelihood that a lower silica content of engineered stone would improve compliance, and the fact that there was an absence of evidence that lower silica engineered stone would pose less risk to worker health and safety, it concluded that a precautionary approach was appropriate:

 

At present an unknown number of Australian workers will go on to develop silicosis because of their prior exposure to RCS from working with engineered stone. The only way to ensure that another generation of Australian workers do not contract silicosis from such work is to prohibit its use, regardless of its silica content. The cost to industry, while real and relevant, cannot outweigh the significant costs to Australian workers, their families and the broader community that result from exposure to RCS from engineered stone.[87]

 

The Regulation Impact Statement identified three options for provision of protection to workers:

 

Option 1: Prohibition on the use of all engineered stone;

Option 2: Prohibition in the use of engineered stone containing 40% or more crystalline silica;

Option 3: As for Option 2, with an accompanying licensing scheme for PCBUs working with engineered stone containing less than 40% crystalline silica.[88]

 

Ultimately it recommended Option 1 on the basis that:

 

The risks posed by working with engineered stone are serious and the possible consequences of being exposed to RCS generated by engineered stone are severe and sometimes fatal. To date, we – PCBUs, workers, regulators and policy agencies – have failed to ensure the health and safety of all workers working with engineered stone.

To ensure prevention is effective, it is vital all participants in the WHS system discharge their duties:

o   importers, manufacturers and suppliers must provide adequate information on the risks posed by engineered stone

o   PCBUs must do all that is reasonably practicable to eliminate or minimise those risks

o   workers must take reasonable care for their own health and safety, and WHS regulators must adequately regulate the industry.[89]

The ban decided upon by Australia’s Work Health and Safety Ministers, announced on 13 December 2023, extends to persons conducting a business or undertaking from carrying out work directing or allowing a worker to carry out work on or with engineered stone, including manufacturing, supplying, processing and installing engineered stone, applying from 1 July 2024. Safe Work Australia will draft amendments to the Model Work Health and Safety Regulations[90] to prohibit the use of engineered stone for consideration by WHS Ministers. The prohibition will not apply to the repair, minor modification, removal or disposal of engineered stone installed prior to the prohibition. For the amendments to the Model WHS Regulations to apply, each jurisdiction will need to implement them separately through amendments to their jurisdictional WHS regulations.

The ban was warmly received by health practitioner organisations in Australia, unions that campaigned for the changes and health regulators.[91] However, the extent to which it will be emulated in other countries is as yet unclear. In Aotearoa New Zealand the Council of Trade Unions Te Kauae Kaimahi responded to the Australian announcement by redoubling its call for a total ban on engineered stone, describing it as “the modern-day asbestos”.[92] 

By contrast, in response to a question in the House of Lords Viscount Younger of Leckie, the Parliamentary Under-Secretary of State, Department for Work and Pensions, in the United Kingdom stated that:

the Health and Safety Executive, HSE, is not currently considering restricting the use of engineered stone. The Control of Substances Hazardous to Health Regulations already require employers to put in place measures to prevent workers being exposed to respirable crystalline silica. This includes adequate controls ensuring compliance with the workplace exposure limit and health surveillance identifying potential ill health. HSE keeps requirements for reporting occupational diseases under review and is not currently making silicosis reportable.[93]

It is likely that engineered stone employers will pivot into using other silica-free substances, such as porcelain, in order to avoid the preclusions on silica use for kitchen and benchtops. Whether work with such substances will carry its own risks and will need to be monitored attentively by occupational health and safety inspectors.  Stones that are not engineered, including marble, granite and quartzite, contain not insubstantial amounts of silica, and therefore need to be subject to close regulation. In addition, it may be that components other than silica in engineered stone (which exist in other substances) can also cause harm to workers.[94] Finally, the engineered stone saga needs to be a waken-up call for other industries where silica is encountered by workers in conditions that are not accompanied by adequate health and safety vigilance. There are many occupational roles in which workers are exposed silica dust inhalation. The sandblasting of jeans, particularly in Turkey, has been well publicised in the medical literature[95], as has artificial jewellery work in India.[96] In the United States the Occupational Safety and Health Administration (OSHA) has made the important point atht there is a wide range of occupational risks arising from silica:

Activities such as abrasive blasting with sand; sawing brick or concrete; sanding or drilling into concrete walls; grinding mortar; manufacturing brick, concrete blocks, stone countertops, or ceramic products; and cutting or crushing stone result in worker exposures to respirable crystalline silica dust. Industrial sand used in certain operations, such as foundry work and hydraulic fracturing (fracking), is also a source of respirable crystalline silica exposure.[97] 

5.      Conclusions

The three examples of public health law reform in Australia canvassed in this chapter have the potential to save large numbers of lives. Each has been based on extensive medico-scientific research; consultation with health practitioners, industry and the general community; and graduated and well publicised incremental steps, leading to the ultimate legislative intervention by government. This has enabled a balance to be reached between achieving health objectives by the robust measures adopted (including the banning of products and presentations) and the impacts upon freedom of trade and individual and corporate autonomy that underpin such law reform measures. Ultimately, it has been determined that public health considerations should take primacy over profit-taking by corporations and over individuals’ preparedness to engage in risk-taking behaviours.

Archetypally, public health law is an international discipline in which what is found to be efficacious in one country can constitute a template or a precedent for initiatives that can be applied in a salutary way in other countries.[98] Alternatively, what is attempted in one jurisdiction can be amended so as to be suitable in another. Matters of health regulation, to guard against threats and dangers, generally are not confined within national boundaries and what is learned by crises or close, empirical analyses of patterns of pathology or behaviour has the potential to lead to public health measures, including banning of substances, limitations on permitted promotion of products, or changed work practices which can result in major improvements in public health.

 

Each of the Australian initiatives - in relation to plain paper packaging of tobacco products, in respect of vaping, and in relation to engineered stone - is worthy of close governmental attention as a contribution to global public health law reform.

 

[1] LO Gostin and LF Wiley, Public Health Law: Power, Duty, Restraint (3rd ed, University of California Press, 2016) 4 Gostin and Wiley, 2016); see too L Gostin, ‘Public Health Law in a New Century, Part 1: Law as a Tool to Advance the Community’s Health (2000) 283(21) Journal of the American Medical Association 1837; B Bennett and I Freckelton, Australian Public Health Law: Contemporary Issues and Challenges (The Federation Press, 2023)

[2] Gostin and Wiley, 2016, n1.

[3] C Reynolds with G Howse, Public Health: Law and Regulation (The Federation Press, 2004) 7.

[4] B Bennett, I Freckelton and G Wolf, “COVID-19 and the Future of Australian Public Health Law” (2022) 43(1) Adelaide Law Review 403.

[5] TPP Act, s18(1)(a).

[6] TPP Act, s18(2)(b)(i).

[7] TPP Act, s19(2)(a).

[8] TPP Act, s19(2)(b)(i).

[9] TPP Act, s19(2)(b)(ii).

[10] See JE Cohen, S Zhou, M Goodchild et al, “Plain Packaging of Tobacco Products: Lessons for the Next Round of Implementing Countries” (2020) 198 Tobacco Induced Diseases 94.

[11] TPP Act, s3(1)(b).

[12] JT International SA v Commonwealth of Australia (2012) 250 CLR 1; [2011] HCA 43; < http://classic.austlii.edu.au/au/cases/cth/HCA/2012/43.html#fn16> ; see C Bond, “Tobacco Plain Packaging in Australia: JT International SA v Commonwealth and Beyond” (2017) 17(2) QUT Law Review 1.

[13] Philip Morris Asia Limited v The Commonwealth of Australia, UNCITRAL, PCA Case No 2012-12: https://www.italaw.com/cases/851: see, in particular Award on Jurisdiction and Admissibility (17 December 2015): < https://www.italaw.com/sites/default/files/case-documents/italaw7303_0.pdf>.

[14] British American Tobacco UK Ltd, R (on the application of) v The Secretary of State for Health [2016] EWCA Civ 1182; https://www.bailii.org/ew/cases/EWCA/Civ/2016/1182.html.

[15] JTI Ireland Ltd v Minister for Health [2015] IEHC 481; https://www.bailii.org/ie/cases/IEHC/2015/H481.html.

[16] Conseil d'Etat Décision n° 399117, 399789, 399790, 399824, 399883, 399938, 399997, 402883, 403472, 403823, 404174, 404381, 404394, Société JT International SA, Société d'exploitation industrielle des tabacs et des allumettes, Société Philip Morris France SA et autres (23 December 2016):  <https://www.conseil-etat.fr/fr/arianeweb/CRP/conclusion/2016-12-23/399117?download_pdf>.

> 

[17] Oslo County Court. Swedish Match Ltd. v  Ministry of Health and Care Services et al. Case No.: 17-110415TVIOBYF. Campaign for Tobacco-Free Kids (6 November  2017): https://www.tobaccocontrollaws.org/litigation/decisions/no-20171106-swedish-match-v-the-ministry-o..

[18] Australia — Certain Measures Concerning Trademarks, Geographical Indications and Other Plain Packaging Requirements Applicable to Tobacco Products and Packaging. WT/DS435/AB/R, WT/DS441/AB/R (9 June 2020): https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/WT/DS/435ABR.pdf&Open=True.

[19] Ibid, at [7.12].

[20] Ibid, at [7.13].

[21] See C Moodie, J Hoek, D Hammond et al, “Plain Tobacco Packaging; Progress, Challenges, Learning and Opportunities” (2022) 31 Tobacco Control 263.

[22] See below.

[23] See Moodie, Hoeck, Hammond et al, n21.

[24] JE Cohen, S Zhou, M Goodchild et al, “Plain Packaging of Tobacco Products: Lessons for the Next Round of Implementing Countries” (2020) 18 Tobacco Induced Diseases 94.

[25] See J Foulds, S Veldheer and A Berg, “Electronic Cigarettes (E-cigs): Views of Aficionados and Clinical/Public Health Perspectives” (2011) 65 International Journal of Clinical Practice 1037.

[26] See L Honeycutt, K Huerne, A Miller et al, “A Systematic Review of the Effects of E-Cigarette Use on Lung Function” (2022) 32 npj Primary Care Respiratory Medicine  art 45.

[27] K Jones and GA Salzman, “The Vaping Epidemic in Adolescents” (2020) 117(1) Missouri Medicine 56.

[28] EJ Cornish, LS Brose and A McNeill, “The Use of Tobacco Industry Vaping Products in the UK and Product Characteristics: A Cross-Sectional Survey” (2022) 24(7) Nicotine Tobacco Research 1003.

[29] See T Dewhirst, “Co-optation of Harm Reduction by Big Tobacco” (2020) 30(1) Tobacco Control e1.

[30] P Laucks and GA Salzman, “the Dangers of Vaping” (2020) 117(2) Missouri Medicine 159, 162.

[31] See AM Leventhal, DR Madden, N Peraza et al, “Effect of Exposure to e-Cigarettes with Salt vs Free-Base Nicotine on the Appeal and Sensory Experience of Vaping” (2021) 4(1) JAMA Netw Open e2032757.

[32] RL Landry, AL Groom, T-HT Vu et al, “The Role of Flavors in Vaping Initiation and Satisfaction among US Adults” (2019) 99 Addiction Behavior art 106077.

[33] See E Banks, A Yazidjoglou, S Brown et al, Electronic Cigarettes and Health Outcomes: Systematic Review of Global Evidence (Report for the Australian Department of Health, April 2022) <https://www.nhmrc.gov.au/sites/default/files/documents/attachments/ecigarettes/Electronic_cigarettes_and_health_outcomes_%20systematic_review_of_evidence.pdf>, pix,who have contended, though, that: “There is conclusive evidence that e-cigarettes and their constituents cause poisoning, injuries and burns and immediate toxicity through inhalation, including seizures, and that their use leads to addiction and that they cause less serious adverse events, such as throat irritation and nausea. There is conclusive evidence that e-cigarettes cause acute lung injury, largely linked to e-liquids containing THC and vitamin E acetate, although around 1 in 8 cases in the largest study to date were from reported use of nicotine only products. Their environmental impacts include waste, fires and indoor airborne particulate matter, which, in turn, are likely to have adverse health impacts, the extent of which cannot be determined.”

[34] US Food and Drug Administration, “E-Cigarettes, , Vapes, and other Electronic Nicotine Delivery Systems (ENDS)” (29 January 2024) https://www.fda.gov/tobacco-products/products-ingredients-components/e-cigarettes-vapes-and-other-electronic-nicotine-delivery-systems-ends.

[35] MC Diaz, NA Silver, A Bertrand and BA Schillo, “Bigger, Stronger and Cheaper: Growth in e-Cigarette Market Driven by Disposable Devices with More e-Liquid, Higher Nicotine Concentration and Declining Prices” (2023) Tobacco Control, doi: 10.1136/tc-2023-058033

[36] Ibid.

[37] M Wakefield, A Haynes, M Scollo and S Durkin, Current Vaping and Current Smoking in the Australian Population Aged 14+ Years: February 2018-September 2022 (Report prepared for the Department of Health and Aged Care, January 2023) < https://www.health.gov.au/sites/default/files/2023-06/current-vaping-and-smoking-in-the-australian-population-aged-14-years-or-older-february-2018-to-september-2022.pdf>.

[38] Department of Health and Aged Care, Australian Government, Potential Reforms to the Regulation of Vaping Products (Consultation Paper, November 2022) < https://consultations.tga.gov.au/medicines-regulation-division/proposed-reforms-to-the-regulation-of-nicotine-vap/user_uploads/tga-consultation-paper---nicotine-vaping-products---nov-22-1.pdf>.

[39] Department of Health and Aged Care, Australian Government, Proposed Reforms to the Regulation of Vaping Products (23 March 2023) < https://consultations.tga.gov.au/medicines-regulation-division/proposed-reforms-to-the-regulation-of-nicotine-vap/>.

[40] Department of Health and Aged Care, Australian Government, “Proposed Reforms to the Regulation of Vapes” (14 December 2023) < https://consultations.tga.gov.au/medicines-regulation-division/df36e4a0/>.

[41] Department of Health and Aged Care, Australian Government, Reforms to the Regulation of Vapes < https://www.tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub/reforms-regulation-vapes#:~:text=Reforms%20to%20the%20regulation%20of%20vapes%20seek%20to%20address%20the,banned%2C%20with%20very%20limited%20exceptions>.

[42] The Hon M Butler, “Taking on Big Tobacco to Protect Our Kids from Vapes” (7 February 2024) <https://www.health.gov.au/ministers/the-hon-mark-butler-mp/media/taking-on-big-tobacco-to-protect-our-kids-from-vapes>.

[43] See eg T Kirby, “Australia to Ban Disposable Vapes in 2024” (3 January 2024) Lancet Respiratory Medicine, https://doi.org/10.1016/S2213-2600(23)00489-7.

[44] See L Martin and J Reihill, “An Increasing Number of Countries are Banning e-Cigarettes – Here’s Why” (24 September 2019) The Conversation <https://theconversation.com/an-increasing-number-of-countries-are-banning-e-cigarettes-heres-why-123055>

[45] World Health Organization, “Urgent Action Needed to Protect Children and Prevent the Uptake of e-Cigarettes” (14 December 2023)< https://www.who.int/news/item/14-12-2023-urgent-action-needed-to-protect-children-and-prevent-the-uptake-of-e-cigarettes>.

[46] See M Cherniack, The Hawk’s Nest Incident: America’s Worst Industrial Disaster (Yale University Press, 1986); C Stalnaker, “Hawk’s Nest Tunnel: A Forgotten Tragedy in Safety’s History” (2006) 7 Professional Safety;  CR Thomas and TR Kelley, “A Brief Review of Silicosis in the United States” (2020) 4(1) Environmental Health Insights.

[47] See generally P Howlett, H Mousa, B Said et al, “Silicosis, Tuberculosis and Silica Exposure Among Artisanal and Small-Scale Minters: A Systematic Review and Modelling Paper” (2023)  3(9) PLOS Global Public Health e002085.

[48] SK Jindar, “Silicosis in India: Past and Present” (2013) 19(2) Curr Opin Pulm Med 163.

[49] S Dhatrak and S Nandi, “Assessment of Silica Dust Exposure Profile in Relation to Prevalence of Silicosis in Sandstone Mine Workers: Need for Review of Standards” (2019) 63 American Journal of Industrial Medicine 277; SS Nandi, SV Dhatrak and K Sarkar, “Silicosis, Progressive Massive Fibrosis and Silico-Tuberculosis Among Workers with Occupational Exposure to Silica Dusts in Sandstone Mines of Rajasthan State: An Urgent Need for Initiating National Silicosis Control Programme in India” (2021) 10(2) Journal of Family Medicine Primary Care 686; see too RF Hoy, MF Jeebhay, C Cavalin et al, “Current `Global Perspectives on Silicosis – Convergence of Old and Newly Emergent Hazards” (2022) 27(6) Respirology 387.

[50] See V Leso, L Fontana, R Romano et al, “Artificial Stone Associated Silicosis: A Systematic Review” (2019) 16(4) International Journal of Environmental Research and Public Health 568; CR Thomas and TR Kelly, “A Brief Review of Silicosis in the United States” (2010) 4 Environmental Health Insights 21.

[51] EK Austin, C James and J Tessier, “Early Detection Methods for Silicosis in Australia and Internationally: A Review of the Literature” (2021) 18(15) International Journal of Environmental Research and Public Health art 8123; T Li, X Yang, H Xu and H Liu, “Early Identification, Accurate Diagnosis, and Treatment of Silicosis” (2022) Canadian Respiratory Journal art 3769134.

[52] D Rosengarten, V Rusanov, O Fruchtewr et al, “Lung Transplantation for Silicosis, Report of 17 Patients” (2014) 44 European Respiratory Journal 271; K McEwen and L Brodie, “Lung Transplantation for Silicosis and Recovery: An Australian Case Study” (2021) 30(3) British Journal of Nursing 178.

[53] See JT Hua, CS Rose and CA Redlich, “Engineered Stone-Associated Silicosis: A Lethal Variant of an Ancient Disease” (2023) 183(9) JAMA Internal Medicine 908; B Penrose, “’Re-emergence’ of Silicosis and Coal Workers Pneumoconiosis in Australia” (2020) 119 Labour History 65; see too in Canada Y Zhang, N Rajaram, A Lau et al, “Silicosis, Asbestosis, and Pulmonary Fibrosis in Ontario, Canada from 1996 to 2019” (2023) 66(8) American Journal of Industrial Medicine 670.

[54] See D Yates, A Frankel, S Miles et al, “Artificial Stone Workers’ Silicosis: Australia’s New Epidemic” (26 November 2018) Insight + < https://insightplus.mja.com.au/2018/46/stone-workers-silicosis-australias-new-epidemic/>;  S Ennis and D Yates, “Why Silicosis is on the Rise = and What to Do About it” (19 December 2019) The Medical Republic < https://www.medicalrepublic.com.au/why-silicosis-is-on-the-rise-and-what-to-do-about-it/3117>; V Leso, L Fontana, R Romano, “Artifical Stone Associated Silicosis: A Syzstemjatic Review” (2019) 16(4) International Journal of Environmental Research and Public Health 568

[55] See A Leon-Jiminez, JM Manuel, M Garcia-Rojo, “Compositional and Structural Analysis of Engineered Stones and Inorganic Particles in Silicotic Nodules of Exposed Workers” (2021) 18 Particle and Fibre Toxicology art 41.

[56] Australian Government, Department of Health, National Guidance for Doctors Assessing Workers Exposed to Respirable Crystalline Silica Dust with Specific Reference to the Occupational Respiratory Diseases Associated with Engineered Stone (2022) < https://www.health.gov.au/sites/default/files/documents/2022/07/national-guidance-for-doctors-assessing-workers-exposed-to-respirable-crystalline-silica-dust.pdf>, v. Regulation 184A(3) of the Model Work Health and Safety Regulations (Engineered Stone) Amendment 2023 defines engineered stone as “an artificial product which contains crystalline silica, is created through combining natural stone materials with other chemical constituents and undergoes a process to become hardened.”

[57] See N Ophir, AB Shai, Y Alkalay et al, “Artificial Stone Dust-Induced Functional and Inflammatory Abnormalities in Exposed Workers Monitored Quantitatively by Biometrics” (2016) 2(1)  ERJ Open Research art 00086-2015.

[58] See Occupational Safety and Health Administration and the National Institute for Occupational Safety and Health, “Worker Exposure to Silica During Countertop Manufacturing, Finishing and Installation” (Publication Number 2015-106) <chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.osha.gov/sites/default/files/publications/OSHA3768.pdf>; Safe Work Australia, Managing the Risks of Respirable Crystalline Silica from Engineered Sone in the Workplace: Code of Practice (October 2021) < chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.safeworkaustralia.gov.au/sites/default/files/2021-11/Model%20Code%20of%20Practice%20-%20Managing%20the%20risks%20of%20respirable%20crystalline%20silica%20from%20engineered%20stone%20in%20the%20workplace.pdf>.

[59] R Raanan, O Zack, M Ruben et al, “Occupational Silica Exposure and Dose-Response for Related Disorders—Silicosis, Pulmonary TB, AIDs and Renal Diseases: Results of a 15-Year Israeli Surveillance” (2022) 19(22) International Journal of Environmental Research and Public Health  art 15010..

[60] See K Fukushima, HA Uchida, Y Fuchimoto et al. “Silica-Associated Systemic Lupus Erythematosus and Lupus Pneumonitis” (2022) 101(7) Medicine (Baltimore) art e28872.

[61] GL Slui-Cremer, PA Hessel, EH Nizdo et al, “Silica, Silicosis, and Progressive Systemic Sclerosis” (1985) 42 Occupational and Environmental Medicine 838.

[62] See Y-S Min, M-G Kim and Y-S Ahn, “Rheumatoid Arthritis in Silica-Exposed Workers” (2021) 18(23) International Journal of Environmental Research and Public Health  art 12776.

[63] However, there may be some opportunities to prevent progressive disease, founded in growing cellular and molecular understanding of the immunopathology of silicosis: RF Hoy and DC Chambers, “Silica-Related Diseases in the Modern World” (2020) 75(11) Allergy 2805.

[64] CC Leung, ITS Yu and W Chen, “Silicosis” (2012) 379 (9830) Lancet 2008-18; SM Pollard, “Silica, Silicosis and Autoimmunity” (2016) 7 Frontiers in Microbial Immunology < https://doi.org/10.3389/fimmu.2016.00097>.

[65] F Hore-Lacy, J Hansen, C Dimitriadis et al, “Predictors of Psychological Stress in Silica-Exposed Workers in the Artificial Stone Benchtop Industry” (2022) 27(6) Respirology 455.

[66] See A Pérez-Alonso, JA Córdoba-Doña, JL  Millares-Lorenzo et al, “Outbreak of Silicosis in Spanish Quartz Conglomerate Workers” (2014) 20(1) International Journal of Occupational and Environmental Health 26. In relation to silicosis in engineered stone workers in north-eastern Italy, see G Guarnieri, S Mauro, P Lucernoni, “Silicosis in Finishing Workers in Quartz Conglomerate Processing” (2020) 111(2) La Medecina del Lavoro 99; V Paolucci, R Romeo, AG Sisinni, “Silicosis en trabajadores expuestos a conglomerados artificiales de cuarzo: ¿es distinta a la silicosis crónica simple?” (2015) 51(12) Archivos de Bronconeumologia e57.

[67] See eg MR Kramer and E Fireman, “CaesarStone Silicosis Disease Resurgence Among Artificial Stone Workers” (2012) 142(2) Chest 419.

[68] See A Obel, “Australia Moves to Ban Israeli-Made Countertops Linked to Lung Disease in Workers” (6 March 2023) Times of Israel < https://www.timesofisrael.com/australia-moves-to-ban-israeli-made-countertops-linked-to-lung-disease-in-workers/>.

[69] A Henzerling, KJ Cummings, J Flattery et al, “Radiographic Screening Reveals High Burden of Silicosis Among Workers at an Engineered Stone Countertop Fabrication Facility in California” (2021) 203(6) American Journal of Respiratory and Critical Care Medicine 764; see too JC Fazio, SA Gandhi, J Flattery et al, “Silicosis Among Immigrant Engineered Stone (Quartz) Countertop Fabrication Workers in California” (2023) 183(9) JAMA Internal Medicine 991.

[70] E Matar, A Frankel, LCM Blake et al, “Complicated Silicosis Resulting from Occupational Exposure to Engineered Stone Products” (2017) 206(9) Medical Journal of Australia 385; see also RF Hoy, T Baird, G Hammerschlag et al, “Artificial Stone-Associated Silicosis: A Rapidly Emerging Occupational Lung Disease” (2018) 75(1) Occupational and Environmental Medicine 3.

[71] See J Bavas and K Silva, “terminal Silicosis: Six Cases in Three Weeks Prompts Urgent Government Warning to Workers” (18 September 2018) ABC News < https://www.abc.net.au/news/2018-09-18/silicosis-warning-kitchen-bench-trade-workers/10262958>.

[72] See A Horn, “Silicosis Death Dust Audit Reveals ‘Major Epidemic Worse than Asbestos’” (21 February 2019) ABC News < https://www.abc.net.au/news/2019-02-21/silicosis-death-dust-audit-reveals-major-epidemic-worse-asbestos/10830452?fbclid=IwAR3dNs22rLdgYHQMV>; see also the later figures published by the Department of Health, Australian Government, National Dust Disease Taskforce, Final Report to Minister of Health and Aged Care (June 2021) < https://www.health.gov.au/sites/default/files/documents/2022/07/national-dust-disease-taskforce-final-report.pdf>, at p16: “WorkCover Queensland had completed the health screening of 1,053 stonemasons exposed to crystalline silica dust from engineered stone – 238 people were diagnosed with a work-related condition. Of the workers screened, 229 (21.4 per cent) have silicosis, including 32 with a diagnosis of progressive massive fibrosis (a more severe form of silicosis), and 13 have a respiratory condition that is not silicosis” .

[73] Ibid.

[74] A León-Jiménez, A Hidalgo-Molina, MA Conde-Sánchez et al, “Artificial Stone Silicosis: Rapid Progression Following Exposure Cessation” (2020) 158 Chest 1060.

[75] Queensland Health, “About the Notifiable Dust Lung Disease Register” < https://www.health.qld.gov.au/public-health/industry-environment/dust-lung-disease-register/about-the-register>.

[76] Office of Industrial Relations, Workplace Health and Safety Queensland, Managing Respirable Crystalline Silica Dust Exposure in the Stone Benchtop Industry: Code of Practice 2019 (2019) < https://www.worksafe.qld.gov.au/__data/assets/pdf_file/0013/32413/managing-respirable-crystalline-silica-dust-exposure-in-the-stone-benchtop-industry-code-of-practice-2019.pdf>; see too Work Safe Victoria, Compliance Code for Managing Exposure to Crystalline Silica: Engineered Stone (2nd edn) (November 2022) < https://content-v2.api.worksafe.vic.gov.au/sites/default/files/2022-10/ISBN-Compliance-code-managing-exposure-crystalline-silica-engineered-stone-2022-10.pdf>; SafeWork NSW, Managing the Risks of Respirable Crystalline Silica from Engineered Sone in the Workplace: Code of Practice (February 2022) < https://www.safework.nsw.gov.au/__data/assets/pdf_file/0005/1042367/managing-the-risk-of-silica-from-engineered-stone-in-the-workplace-COP.pdf>; WorkSafe Western Australia, Managing the Risks of Respirable Crystalline Silica from Engineered Stone ion the Workplace: Code of Practice (2nd edn) (2022) < https://www.commerce.wa.gov.au/sites/default/files/atoms/files/231186_cp_silica.pdf>; WorkSafe Tasmania, Managing the Risks of Respirable Silica from Engineered Stone in the Workplace (19 January 2022) < https://worksafe.tas.gov.au/topics/laws-and-compliance/codes-of-practice/cop-folder/managing-the-risks-of-respirable-crystalline-silica-from-engineered-stone-in-the-workplace>. 

[77] National Dust Disease Taskforce, Department of Health, Australian Government, Final Report to Minister for Health and Aged Care  (June 2021) < https://www.health.gov.au/sites/default/files/documents/2022/07/national-dust-disease-taskforce-final-report.pdf>.

[78] National Dust Disease Taskforce, n77, p7.

[79] National Dust Disease Taskforce, n77,  at pp7-8.

[80] National Dust Disease Taskforce, n77, at p8.

[81] See Explanatory Statement, Model Work Health and Safety Regulations (Engineered Stone) Amendment 2023. It superseded the attempts to manage the risk set out in the requirements found in Safe Work Australia, Managing the Risks of Respirable Crystalline Silica from Engineered Sone in the Workplace: Code of Practice (October 2021) <https://www.safeworkaustralia.gov.au/sites/default/files/2021-11/Model%20Code%20of%20Practice%20-%20Managing%20the%20risks%20of%20respirable%20crystalline%20silica%20from%20engineered%20stone%20in%20the%20workplace.pdf>.

[82] Safe Work Australia, Decision Regulation Impact Statement: Prohibition on the Use of Engineered Stone (August 2023) < https://www.safeworkaustralia.gov.au/sites/default/files/2023-10/decision_ris_-_prohibition_on_the_use_of_engineered_stone_-_27_october_2023.pdf> (Safe Work Australia, Regulation Impact Statement).

[83] Safe Work Australia, Regulation Impact Statement, n82, p6.

[84] Safe Work Australia, Regulation Impact Statement, p6.

[85] Safe Work Australia, Regulation Impact Statement, p14.

[86] Safe Work Australia, Regulation Impact Statement, p24.

[87] Safe Work Australia, Regulation Impact Statement, p10.

[88] Safe Work Australia, Regulation Impact Statement, p9.

[89] Safe Work Australia, Regulation Impact Statement, pp9-10.

[90] Model Work Health and Safety Regulations: <https://www.safeworkaustralia.gov.au/doc/model-whs-regulations>.

[91] See I Freckelton, “Banning Engineered Stone: A Landmark Australian Public Health Law Reform” (2024) 31(1) Journal of Law and Medicine (in press).

[92] “NZ Union Urges Govt to Ban Engineered Stone for Worker Safety” (25 January 2024) Mirage < https://www.miragenews.com/nz-union-urges-govt-to-ban-engineered-stone-for-1160925/>.

[93] House of Lords, Hansard, vol 835, 15 January 2024.

[94] See C Ramkissoon, Y Song, S Yen ==et al, “Understanding the Pathogenesis of Engineered Stone Silicosis: The Effect of Particle Chemistry on Lung Cell Response” (2024) 29(3) Respirology 217.

[95] See eg M Akgun. M Gorgumer, M Meral et al, “Silicosis Caused by Sandblasting of Jeans: A Report of Two Concomitant Cases” (2005) 47(4) Journal of Occupational Health 346; A. Çimrin, T. Sigsgaard, B. Nemery, “Sandblasting Jeans Kills People”  (2006) 28 European Respiratory Journal 885;  F Alper, M Akgun, O Onbas and O Araz, “CT Findings in Silicosis Due to Denim Sandblasting” (2008) 18 European Radiology 2739; H Bayram, “Killer Jeans and Silicosis” (2011) American Journal of Respiratory and Critical Care Medicine 1321; S Barmania, “Deadly Sandblasting-Induced Silicosis in the Jeans Industry” (2016) 4(7) Lancet Respiratory Medicine 543.

[96] See P Panchadhyayee, K Saha, A Biswas et al, “Rapidly Fatal Acute Silicosis among Jewellery Workers Attending a District Medical College of West Bengal, India” (2015) 57(3) Indian J Chest Dis Allied Sci 165.

[97] Occupational Safety and Health Administration, “Silica, Crystalline” < https://www.osha.gov/silica-crystalline>. 

[98] See D Bettcher and K Lee, “Globalisation and Public Health” (2002) 56 J Epidemiol Community Health 8; LO Gostin and AL Taylor, “Global Health Law: A Definition and Grand Challenges” (2008) 1(1) Public Health Ethics 53; AL Taylor, “Global Public Health; International Law and Public Health Policy” (2017) International Encyclopedia of Public Health 268;