Australian Regulation Research Articles

An Overview of Per- and Polyfluoroalkyl Substances (PFAS) in the Environment: Source, Fate, Risk and Regulations

The current article reviews the state of art of the perfluoroalkyl and polyfluoroalkyl substances (PFASs) compounds and provides an overview of PFASs occurrence in the environment, wildlife, and humans. This study reviews the issues concerning PFASs exposure and potential risks generated with a focus on PFAS occurrence and transformation in various media, discusses their physicochemical characterization and treatment technologies, before discussing the potential human exposure routes. The various toxicological impacts to human health are also discussed. The article pays particular attention to the complexity and challenging issue of regulating PFAS compounds due to the arising uncertainty and lack of epidemiological evidence encountered. The variation in PFAS regulatory values across the globe can be easily addressed due to the influence of multiple scientific, technical, and social factors. The varied toxicology and the insufficient definition of PFAS exposure rate are among the main factors contributing to this discrepancy. The lack of proven standard approaches for examining PFAS in surface water, groundwater, wastewater, or solids adds more technical complexity. Although it is agreed that PFASs pose potential health risks in various media, the link between the extent of PFAS exposure and the significance of PFAS risk remain among the evolving research areas. There is a growing need to address the correlation between the frequency and the likelihood of human exposure to PFAS and the possible health risks encountered. Although USEPA (United States Environmental Protection Agency) recommends the 70 ng/L lifetime health advisory in drinking water for both perfluorooctane sulfonate (PFO) perfluorooctanoic acid (PFOA), which is similar to the Australian regulations, the German Ministry of Health proposed a health-based guidance of maximum of 300 ng/L for the combination of PFOA and PFOS. Moreover, there are significant discrepancies among the US states where the water guideline levels for the different states ranged from 13 to 1000 ng L−1 for PFOA and/or PFOS. The current review highlighted the significance of the future research required to fill in the knowledge gap in PFAS toxicology and to better understand this through real field data and long-term monitoring programs.

Impact of the COVID-19 Pandemic on Manual Therapy Service Utilization within the Australian Private Healthcare Setting

The COVID-19 pandemic has impacted a wide range of health services. This study aimed to quantify the impact of the COVID-19 pandemic on manual therapy service utilization within the Australian private healthcare setting during the first half of 2020. Quarterly data regarding the number and total cost of services provided were extracted for each manual therapy profession (i.e., chiropractic, osteopathy, and physiotherapy) for the period January 2015 to June 2020 from the Australian Prudential Regulation Authority. Time series forecasting methods were used to estimate absolute and relative differences between the forecasted and observed values of service utilization. An estimated 1.3 million (13.2%) fewer manual therapy services, with a total cost of AUD 84 million, were provided within the Australian private healthcare setting during the first half of 2020. Reduction in service utilization was considerably larger in the second quarter (21.7%) than in the first quarter (5.7%), and was larger in physiotherapy (20.6%) and osteopathy (12.7%) than in chiropractic (5.2%). The impact varied across states and territories, with the largest reductions in service utilization observed in New South Wales (17.5%), Australian Capital Territory (16.3%), and Victoria (16.2%). The COVID-19 pandemic has had a profound impact on manual therapy service utilization in Australia. The magnitude of the decline in service utilization varied considerably across professions and locations. The long-term consequences of this decline in manual therapy utilization remain to be determined.

Supporting Drug Regulators Through Simple Rapid Cycle Analyses

IntroductionDrug regulators require timely, relevant information to address questions about the safety of prescribed medicines. Some questions can be informed by initial rapid and simple analyses of linked exposure/outcome data. These analyses will establish how many individuals have received the drug, their characteristics, the availability of follow up time and the frequency of the event of interest in the exposed cohort. This approach does not enable causal inferences but establishes the need for, and feasibility of, more complex controlled analyses. Discovery that the exposure or outcome are uncommon can allay initial fears about the extent of a problem.
 Objectives and ApproachA pilot network to support the Australian drug regulator (TGA, Department of Health) was established among three research institutions in Australia and Canada. Initial queries were identified and prioritised by staff at the TGA. Academic staff at the partner institutions performed a rapid feasibility assessment based on existing knowledge and expertise. Following this, initial exposure/outcome analyses were undertaken on selected queries using routinely collected data from Canada and Australia. Updates were provided to the TGA at each stage to ensure that decision-makers were fully informed and participated in decision making.
 ResultsTo date, the network has assessed 20 queries. Seven were deemed infeasible and 4 queries were being addressed by studies that were already planned or underway; in these cases, arrangements were made to provide early results directly to the regulator. The final four queries progressed to an initial exposure/outcome analysis, and one such study was expanded to a fully adjusted controlled analysis.
 Conclusion / ImplicationsThis framework has proven to be agile and responsive and has strengthened the relationship between academia and the TGA. It may serve as a model for others who wish to engage more closely with governments or other decision makers.

Effects of enterprise bargaining and agreement clauses on the operating cost of airline ground crew scheduling

Labour conditions in enterprise agreements dictate airline worker rostering and affect operating costs. By using an airline ground crew shift optimisation model in the context of Australian labour regulations, this paper explores how labour agreements could affect costs and potential options to improve labour conditions for mutual benefits. Results found that a reduction of shift length could save 30 percent of airline employee costs. The ratio of full-time and part-time staff could significantly affect staffing costs. A portion of staff cost savings could be redirected to employees as wage rises, while maintaining job security and benefiting both parties.

E-Cigarette Promotion on Twitter in Australia: Content Analysis of Tweets.

BackgroundThe sale of electronic cigarettes (e-cigarettes) containing nicotine is prohibited in all Australian states and territories; yet, the growing availability and convenience of the internet enable the promotion and exposure of e-cigarettes across countries. Social media’s increasing pervasiveness has provided a powerful avenue to market products and influence social norms and risk behaviors. At present, there is no evidence of how e-cigarettes and vaping are promoted on social media in Australia.ObjectiveThis study aimed to investigate how e-cigarettes are portrayed and promoted on Twitter through a content analysis of vaping-related tweets containing an image posted and retweeted by Australian users and how the portrayal and promotion have emerged and trended over time.MethodsIn total, we analyzed 1303 tweets and accompanying images from 2012, 2014, 2016, and 2018 collected through the Tracking Infrastructure for Social Media Analysis (TrISMA), a contemporary technical and organizational infrastructure for the tracking of public communication by Australian users of social media, via a list of 15 popular e-cigarette–related terms.ResultsDespite Australia’s cautious approach toward e-cigarettes and the limited evidence supporting them as an efficacious smoking cessation aid, it is evident that there is a concerted effort by some Twitter users to promote these devices as a health-conducive (91/129, 70.5%), smoking cessation product (266/1303, 20.41%). Further, Twitter is being used in an attempt to circumvent Australian regulation and advocate for a more liberal approach to personal vaporizers (90/1303, 6.90%). A sizeable proportion of posts was dedicated to selling or promoting vape products (347/1303, 26.63%), and 19.95% (260/1303) were found to be business listings. These posts used methods to try and expand their clientele further than immediate followers by touting competitions and giveaways, with those wanting to enter having to perform a sequence of steps such as liking, tagging, and reposting, ultimately exposing the post among the user’s network and to others not necessarily interested in vaping.ConclusionsThe borderless nature of social media presents a clear challenge for enforcing Article 13 of the World Health Organization Framework Convention on Tobacco Control, which requires all ratifying nations to implement a ban on tobacco advertising, promotion, and sponsorship. Countering the advertising and promotion of these products is a public health challenge that will require cross-border cooperation with other World Health Organization Framework Convention on Tobacco Control parties. Further research aimed at developing strategies to counter the advertising and promotion of e-cigarettes is therefore needed.

Characteristics of inorganic matter from Australian municipal solid waste processed under combustion and gasification conditions.

The presence and composition of ash in solid waste streams produced by the thermochemical processes can affect the further disposal or use of the waste. This study characterised the chemical species, mineralogy and trace element mobilisation in laboratory-produced ashes arising from different municipal solid waste (MSW) streams processed under reducing and oxidising atmospheres.The composition of cumulative ash samples produced under oxidising conditions was very similar to the composition of the industrial bottom ash samples produced during MSW incineration. We identified differences in mineral phase compositions and in some trace element concentrations of ashes produced under combustion and gasification conditions. Differences in concentrations of boron, barium, cadmium, chromium, copper, chlorine, molybdenum, antimony, lead, thorium and zinc in ashes associated with different MSW streams were also observed. On the basis of the concentrations of trace elements in ashes, we evaluated each MSW stream in terms of potential management strategies and use of the mineral matter remaining after combustion and gasification. Most of ashes produced from MSW can be at least classified as Class IV (secure) waste according to an Australian standard regulation guideline.

An Analysis of the Mineral Composition of Pink Salt Available in Australia.

Little is known about the mineral composition of pink salt. The aim of this study was to evaluate for the first time the mineral composition of pink salt available for purchase in Australia and its implications for public health. Pink salt samples were purchased from retail outlets in two metropolitan Australian cities and one regional town. Color intensity, salt form, and country of origin were coded. A mass spectrometry scan in solids was used to determine the amount of 25 nutrients and non-nutritive minerals in pink salt (n = 31) and an iodized white table salt control (n = 1). A wide variation in the type and range of nutrients and non-nutritive minerals across pink salt samples were observed. One pink salt sample contained a level of lead (>2 mg/kg) that exceeded the national maximum contaminant level set by Food Standards Australia New Zealand. Pink salt in flake form, pink salt originating from the Himalayas, and darker colored pink salt were generally found to contain higher levels of minerals (p < 0.05). Despite pink salt containing nutrients, >30 g per day (approximately 6 teaspoons) would be required to make any meaningful contribution to nutrient intake, a level that would provide excessive sodium and potential harmful effects. The risk to public health from potentially harmful non-nutritive minerals should be addressed by Australian food regulations. Pink salt consumption should not exceed the nutrient reference values for Australia and New Zealand guidelines of <5 g of salt per day.

Regulation, migration and expectation: internationally qualified health practitioners in Australia\u2014a qualitative study

BackgroundThe global movement of internationally qualified health practitioners (IQHPs), seeking to live and work outside of their place of origin, is subject to considerable study and scrutiny. Extensive published material exists, from government enquiries and print news media articles to peer-reviewed papers, reporting on the views and impacts of migration and practitioner registration. Unsurprisingly much of the research focuses on the two largest groups of health professionals, international medical graduates (IMG) and internationally qualified nurses (IQN). This paper presents a unique case study examining the challenges and complexities of navigating the regulatory processes for skilled migration and practitioner registration in Australia.DiscussionThe study comprised a review and analysis of the current policy frameworks, standards and assessment models applied by regulators affecting skilled migration and registration of IQHPs. To target the triangulated themes of regulation, experience and expectations, a phenomenological component was also conducted with the mapping of shared experiences of four key participant groups comprising the following: assessors operationalising the current policies and processes governing skilled migration and registration, educators offering preparatory and training programs to IQHP, workforce agencies engaging with and recruiting IQHP and internationally qualified doctors, nurses and midwives. The study was informed by rich qualitative data extracted from twenty-eight in-depth semi-structured participant interviews. Key themes and points of intersection between participant experiences and the regulatory frameworks were identified using theory and data-driven coding and thematic analysis via the NVivo 12 plus software.ConclusionFrom studying the complexities of the current regulatory processes for skilled migration and practitioner registration and informed by participants with first-hand knowledge and experience, this research found a clear argument for a re-examination and update of the current regulatory requirements for IQHP. Without greater innovation, harmonisation, evidence-based solutions and reform, it is likely that Australian regulators, policymakers, employers, and the nursing, midwifery and medical professions at large will continue to experience challenges in registering, employing and supporting IQHP, while maintaining the safety of the public requiring care in the Australian healthcare system.

Service utilisation trends in the manual therapy professions within the Australian private healthcare setting between 2008 and 2017

BackgroundBetter understanding of the dynamics and temporal changes in manual therapy service utilisation may assist with healthcare planning and resource allocation. The objectives of this study were to quantify, describe, and compare service utilisation trends in the manual therapy professions within the Australian private healthcare setting between 2008 and 2017.MethodsData regarding the number of services, total cost, and benefits paid were extracted for each manual therapy profession (i.e. chiropractic, osteopathy, and physiotherapy) for the period 2008–2017 from the Australian Prudential Regulation Authority. The number of registered providers for each profession were obtained from the Australian Health Practitioner Regulation Agency. Descriptive statistics were produced for two time periods (i.e. 2008–2012 and 2013–2017) for each manual therapy profession. Annual percentage change during each time period was estimated by fitting Poisson regression models. Test for the equality of regression coefficients was used to compare the trends in the two time periods within each profession, and to compare the trends across professions within a time period.ResultsA cumulative total of 198.6 million manual therapy services with a total cost of $12.8 billion was provided within the Australian private healthcare setting between 2008 and 2017. Although service utilisation and total cost increased throughout the ten-year period, the annual growth was significantly lower during 2013–2017 than 2008–2012. Whereas osteopathy and physiotherapy experienced significant annual growth in the number of services and total cost during 2013–2017, negative growth in the number of services was observed for chiropractic during the same period. The annual number of services per provider declined significantly for chiropractic and physiotherapy between 2013 and 2017.ConclusionService provision under private health insurance general treatment cover constitute a major source of revenue for manual therapy professions in Australia. Although manual therapy service utilisation increased throughout the ten-year period from 2008 to 2017, the annual growth declined. There were diverging trends across the three professions, including significantly greater decline in annual growth for chiropractic than for osteopathy and physiotherapy.

Switching between superannuation funds: Does performance and marketing matter?

This study examines the roles of fund performance and marketing in superannuation members' fund switching activity in Australia. Using member-nominated transfers from a unique data set of Australian Prudential Regulation Authority (APRA)-regulated superannuation funds from 2005 to 2014, our results indicate that members who switched funds do not chase after superior short-term returns but they do punish bad performers by withdrawing investments. We find a consistent positive relation between marketing effort and investor choice for retail funds, which engage in extensive marketing. However, marketing does not appear to be an effective strategy for industry-based funds to attract investments.

Pre-Fermentation Water Addition to High-Sugar Shiraz Must: Effects on Wine Composition and Sensory Properties.

Changes to Australian regulations now allow the limited addition of water to high-sugar musts pre-fermentation. In light of these changes, this study explored how water addition affects Shiraz wine composition and sensory properties. Wines were made from grapes at ≈13.5, 14.5 and 15.5° Baume. Water was added to musts from the ripest fruit by direct addition, or by using a juice substitution (run-off and replace) approach. To compare the effect of juice run-off independently, saigneé treatments were included. Wines made from the fruit that was harvested earlier generally had a lower “opacity” and higher “red fruit” aroma as the defining sensory attributes. Undiluted wines made from riper fruit had higher phenolics, and were characterised by “dark fruit” and “dried fruit” attributes, and “spice”, a “brown colour” and “opacity”. These attributes were accentuated in wines from the same fruit which received saigneé treatments and reduced in all of the water addition treatments. In particular, higher levels of water addition without juice substitution increased the “cooked vegetable” and “drain” attributes in the wines. This indicates possible negative effects of larger water additions, such that a low to moderate adjustment in Shiraz winemaking is suggested.

Education agent standards in Australia and New Zealand – government’s role in agent-based international student recruitment

ABSTRACT Australia and New Zealand have enacted legislation to protect international students’ rights and the long-term sustainability of their export education sectors. A pivotal, but under-researched, sub-domain of these legislative frameworks is education agent-based international student recruitment. The principal-agent relationships between governments, education providers and education agents involve complex agency problems that regulators need to consider to safeguard the interests of government and international students. This article evaluates the longitudinal development of Australian and New Zealand education agent standards and other government regulation through the analysis of legislation, policy and other documentary sources. The findings demonstrate how, over time, Australia and New Zealand governments have adopted a more active principal role, seeking to steer and control education providers’ engagement with education agents, predominantly through legislation. The agent standards now contain a wide array of requirements for education providers to fulfil. However, there are a number of limitations that diminish a government’s ability to mitigate providers’ opportunistic behaviour and protect international students. This article concludes by discussing potential future avenues for government regulation in this policy domain.

Enforceable undertakings’ practices across Australian regulators: lessons learned

ABSTRACT An enforceable undertaking is a regulatory sanction available to a range of Australian Federal and State regulators. This sanction takes the form of a settlement that allows the regulator to remedy alleged breaches of the law. It had been deemed a success in Australia and as such has been introduced in other jurisdictions such as the United Kingdom and New Zealand. However, this sanction has been heavily criticised over the last few years in Australia due to its lack of accountability and opaqueness in certain settings. In view of the fact that enforceable undertakings have been relied on in Australia for over a decade (in certain instances closer to three decades) this article compares 18 Australian Federal and State regulators’ practices, to put forward recommendations on best practices that may be adopted by these and other agencies that have this power at their disposal.

FINTECH REGULATORY SANDBOXES IN AUSTRALIA AND MALAYSIA: A LEGAL ANALYSIS

With the era of digitalization, regulatory sandboxes have been the trend adopted by most financial regulators around the world in regulating financial technology (fintech). Regulatory sandboxes act as a pilot programme to regulate fintech services and products with several legal exemptions given to the service providers within established parameters. In 2016, the Australian Securities and Investments Commission and the Malaysian Central Bank followed the United Kingdom’s Financial Conduct Authority (FCA) to introduce regulatory sandboxes within their legal framework. To date, previous literature has only provided a minimal analytical overview of the Malaysian and Australian regulatory sandbox. Hence, this article aims to fill that gap in literature. The methodology used for this study is both doctrinal and comparative legal analysis. The main objective of this study is to analyse the key characteristics of fintech regulatory sandboxes by comparing the Australian and Malaysian regulatory structures of these sandboxes. Due to nascent nature of Malaysian and Australian fintech regulations, this contributes to the growing knowledge in the financial regulation literature. Moreover, the findings on the operation of the regulatory sandboxes in both jurisdictions is expected to bring practical value for further research.

Rates of PRN Medication Administration in Australian Residential Aged Care

ObjectiveTo investigate administration of pro re nata (PRN) medications and nurse-initiated medications (NIMs) in Australian aged care services over a 12-month period. DesignTwelve-month longitudinal audit of medication administrations. Setting and participantsThree hundred ninety-two residents of 10 aged care services in regional Victoria, Australia. MethodsRecords of PRN and NIM administration were extracted from electronic and hard copy medication charts. Descriptive statistics were used to calculate medication administration per person-month. Poisson regression was used to estimate predictors of PRN administration. ResultsOver a median follow-up of 12 months (interquartile range 10–12 months), 93% of residents were administered a PRN medication and 41% of residents an NIM on 21,147 and 552 occasions, respectively. The mean number of any PRN administration was 5.85 per person-month. The most frequently administered PRN medications per person-month were opioids 1.54, laxatives 0.96, benzodiazepines 0.72, antipsychotics 0.48, paracetamol 0.46, and topical preparations 0.42. Three-quarters of residents prescribed a PRN opioid or PRN benzodiazepine and two-thirds of residents prescribed a PRN antipsychotic had the medication administered on 1 or more occasions over the follow-up. Conclusions and ImplicationsMost residents were administered PRN medications. Administration was in line with Australian regulations and institutional protocols. However, the high frequency of PRN analgesic, laxative, and psychotropic medication administration highlights the need for regular clinical review to ensure ongoing safe and appropriate use.

Has the Australian Prudential Regulation Authority Done Enough to Meet Its Legislated Objectives and Prepare Australia for the Next Financial Crisis?

This article examines APRA’s performance against its legislated objectives and the policy rationales and legal theories underlying the supervision of prudential regulation and promotion of financial system stability. The article will investigate the prudential framework in place and actions taken by APRA in the period beginning January 2014 to the end of June 2018, focusing on APRA’s oversight of residential property lending standards because the quality of these loans will be the single largest determinant of the future health of the Australian financial system. The current study’s findings and broader evidence suggest that APRA’s responses to ongoing lax and risky home lending standards were ad hoc, conservative, and reactive.

Use of analgesics following rescheduling of codeine in Australia: An interrupted time series analysis in the veteran population

BackgroundThe Australian medicines regulator, the Therapeutic Goods Administration (TGA), rescheduled all codeine-containing medicines to be available only on prescription on 1 February 2018. This study was conducted to determine whether use of analgesics changed following codeine re-scheduling to prescription only status, and whether there was a change in the use of codeine preparations and a therapeutic shift to stronger opioids or other analgesics in the Australian veteran population following the change. MethodsInterrupted time series analysis using Repatriation Pharmaceutical Benefits Scheme (RPBS) claims data from the Australian Government Department of Veterans’ Affairs (DVA) for clients with dispensing of opioid and non-opioid analgesics between January 2015 and April 2019. Trends in the monthly rate of analgesic dispensings (opioid and non-opioid) were compared for the period between January 2015 and January 2018 with the period February 2018 to April 2019. ResultsParacetamol with codeine 8mg was the only analgesic with an increased rate of dispensing following the February 2018 codeine scheduling changes. Prior to codeine re-scheduling, the rate of dispensing of paracetamol with codeine 8mg was decreasing by 0.9% each month. Immediately after the scheduling changes, dispensing of paracetamol with codeine 8mg increased by 45% (95%CI=1.282-1.676, p<0.001) and in the fifteen month period thereafter (February 2018 to April 2019), the rate of dispensing increased by 4% each month (95%CI=1.027-1.054, p<0.001). Therapeutic shift from over-the-counter codeine products to other opioids was not observed, with no increase in the rate of dispensing of any of the other opioid (or non-opioid) analgesics following the codeine scheduling changes. ConclusionA significant increase in prescription use of paracetamol with codeine 8mg was observed after the February 2018 codeine re-scheduling. Therapeutic shift to stronger opioid analgesics was not observed in the study population.

Genetic identity concerns in the regulation of novel reproductive technologies

Confusion concerning a child’s genetic identity is a common objection to the application of novel technologies to human embryos. Unsurprisingly then, concern for genetic identity has been used to justify successive waves of regulatory activity and is again appearing in debates about regulatory responses to emerging reproductive technologies. By examining the history of Australian law’s understanding and responses to so-called genetic identity in the context of past and current scientific developments in reproductive technology, this paper investigates regulatory reform needed for still emerging reproductive technologies. While this paper presents and analyzes in some detail Australian regulation and the policy deliberations and scientific developments that led to them, the identified inconsistencies in the regulatory responses, and recommended reforms to address emerging reproductive technologies offered, address issues relevant to many countries responding to the same technologies.

Corruption in business

Purpose This paper aims to critically analyse the Criminal Code Amendment (Bribery of Foreign Public Officials) Act 1999 and Crimes Legislation Amendment (Combating Corporate Crime) Bill 2017 with special focus on the facilitation payment (FP) defence by referring to the UK Bribery Act 2010. The study will showcase how FP promotes disrespect for a good corporate culture inevitable for responsible and sustained business and as to why FP must be abolished to make the Australian regulation consistent with the international standards. Design/methodology/approach This research is based on primary and secondary sources including the Senate Committee Reports and recent legislative developments in Australia, and the relevant law of the UK. Findings Australia is lagging far behind comparative jurisdictions including the UK, and the FP defence must be abolished to make the Australian regulation consistent with the international standards and to foster international business backed up by globalisation, competition and interconnectedness of national economies. Originality/value This paper is the original work of the author and has not been submitted elsewhere for publication.

Equity Crowdfunded Companies in the United Kingdom: What Factors Determine Post-campaign Success?

Equity crowdfunding (ECF) is a relatively new phenomenon in the market for equity finance: Australia only introduced a dedicated ECF regulatory framework in 2017. While it is too soon to confidently evaluate the post-fundraising campaign success of companies in Australia that have raised funds through the ECF process, research on the United Kingdom’s (UK) ECF market, the largest in the world, may offer some useful insights into the successes and failures of ECF. The purpose of this research note, therefore, is to consider the research on the post-campaign performance of companies in the UK that have raised funds through ECF to see if this offers any early guidance for the Australian ECF market and regulation. The research note: (a) reviews and contrasts key aspects of the current UK and Australian ECF regulatory frameworks; (b) surveys the literature on the post campaign performance of UK ECF companies and analyses what factors may contribute to the success or failure of ECF companies post-campaign; and (c) concludes with a discussion of whether the UK’s experience offers any lessons for Australia.