Packaging Regulations Research Articles

Eye movement data reveal increased attention to combined health warnings on cigarette packs

IntroductionIn 2016 the UK introduced standardised pack design regulations, limiting branding and aiming to increase the salience of health warnings. Existing evidence suggests that the effectiveness of pack design in focusing a smoker’s attention toward warnings may depend on how much they smoke. Our study aimed to directly compare attention to branding and warnings between the pre-regulation and post-regulation packs in smokers, and to determine whether this was affected by the amount smoked, to assess the effectiveness of the new policies. Method47 adult smokers were recruited, including daily and non-daily smokers to ensure a wide range in cigarettes smoked per week. Eye movement data were recorded while images of cigarette packs were displayed sequentially on screen. Each trial presented one of two types of cigarette pack; pre-regulation packs with a text health warning, or post-regulation packs compliant with governmental guidance introduced in 2016, with plain branding and a combined pictorial and text health warning. Eye movement data were compared between packs, covarying the number of cigarettes smoked per week. ResultsEye movement analysis revealed that smokers attended more to health warnings and less to branding when looking at post-regulation packs compared with pre-regulation packs. These effects did not relate to number of cigarettes smoked per week. ConclusionStandardised regulations for cigarette packs successfully direct smokers’ attention away from branding, and towards health warnings, with no association with cigarettes smoked per week. This study adds to the growing body of evidence advocating broader uptake of similar packaging regulations.

A novel critical role for CD46 in chromatin packaging and direct gene regulation

A novel critical role for CD46 in chromatin packaging and direct gene regulation

‘Choking smokers, don’t you think the joker laughs at you’: European Union competence and regulation of tobacco products packaging under the new Tobacco Products Directive

Directive 2014/40 updated and repealed Directive 2001/37. As with the previous Directive, the new Tobacco Products Directive’s legal basis, proportionality, and subsidiarity were at issue in three recently decided cases, an action for annulment and two preliminary rulings, upholding the Directive’s validity, as well as in another pending preliminary reference. The new TPD once again raises questions of EU competence and recourse to the Article 114 TFEU general internal market legal basis for health measures. This article examines the dual nature of internal market legislation and interaction between internal market and public health objectives, analysing means of justifying the legal basis and proportionality of health-related internal market measures: the high level of health protection envisaged by mainstreaming provisions and the ‘decisive factor’ formula; the EU legislature's discretion as to the most appropriate method of approximation; and its broad discretion in areas involving complex assessments. This article examines the legal basis, proportionality, extent and relevance of labelling and packaging provisions on health warnings, TNCO labelling, misleading features and packet standardization. It suggests further adaptation of the public health legal basis, to reflect the evolution of EU competences in practice and avoid contrived reliance on the internal market objective, which should not, however, entail excessive risk-regulation.

Flavor Capsule Variants' Performance in a "Dark Market": Implications for Standardized Packaging.

By increasing excise taxes, eliminating tobacco marketing, and requiring standardized (plain) packaging of tobacco products, governments internationally have reduced smoking's allure. Yet product innovations, such as flavor capsule variants (FCVs), remain unregulated and may appeal to non-smokers. We examined the growth of FCVs in a country with a progressive policy environment. Each year, New Zealand tobacco companies must provide details of the number of cigarette sticks released for each brand and variant to the Ministry of Health. We used this information to analyze FCVs' performance for British American Tobacco (BAT) and Philip Morris International (PMI), which account for a large proportion of New Zealand tobacco sales. We report the quantity released of each variant and share of parent brand portfolio, and examine growth patterns within the premium, everyday, and value market subsections. BAT introduced FCVs in 2012 and by 2014 offered FCVs in all market subsections; PMI introduced a Marlboro FCV in 2014. FCVs grew rapidly relative to unflavored variants and, by 2017, represented nearly 10% of BAT's product portfolio and more than 3% of PMI's product portfolio. By 2017, FCVs accounted for more than a third of the Dunhill sticks released, 14% of Holiday, and 17% of Pall Mall. FCVs' rapid growth may have reduced declines in the numbers of sticks released. Policy makers should disallow FCV innovations, which offer no health benefits to smokers and may instead attract non-smokers to smoking. Where timely, these regulations could be incorporated into standardized packaging policies. FCVs have grown quickly in countries with comprehensive tobacco marketing restrictions, which suggests tobacco companies are now focusing on novel product designs to attract new smokers. Standardized packaging regulations could address both external packaging and stick design innovations, such as FCVs; alternatively, specific regulations prohibiting FCVs may be required.

Ribosome Shunting, Polycistronic Translation, and Evasion of Antiviral Defenses in Plant Pararetroviruses and Beyond.

Viruses have compact genomes and usually translate more than one protein from polycistronic RNAs using leaky scanning, frameshifting, stop codon suppression or reinitiation mechanisms. Viral (pre-)genomic RNAs often contain long 5′-leader sequences with short upstream open reading frames (uORFs) and secondary structure elements, which control both translation initiation and replication. In plants, viral RNA and DNA are targeted by RNA interference (RNAi) generating small RNAs that silence viral gene expression, while viral proteins are recognized by innate immunity and autophagy that restrict viral infection. In this review we focus on plant pararetroviruses of the family Caulimoviridae and describe the mechanisms of uORF- and secondary structure-driven ribosome shunting, leaky scanning and reinitiation after translation of short and long uORFs. We discuss conservation of these mechanisms in different genera of Caulimoviridae, including host genome-integrated endogenous viral elements, as well as in other viral families, and highlight a multipurpose use of the highly-structured leader sequence of plant pararetroviruses in regulation of translation, splicing, packaging, and reverse transcription of pregenomic RNA (pgRNA), and in evasion of RNAi. Furthermore, we illustrate how targeting of several host factors by a pararetroviral effector protein can lead to transactivation of viral polycistronic translation and concomitant suppression of antiviral defenses. Thus, activation of the plant protein kinase target of rapamycin (TOR) by the Cauliflower mosaic virus transactivator/viroplasmin (TAV) promotes reinitiation of translation after long ORFs on viral pgRNA and blocks antiviral autophagy and innate immunity responses, while interaction of TAV with the plant RNAi machinery interferes with antiviral silencing.

Physical properties of DNA may direct the binding of nucleoid-associated proteins along the E. coli genome

Nucleoid-associated proteins (NAPs) play important roles in both chromosome packaging and gene regulation in bacteria. The underlying mechanisms, however, remain elusive particularly for how NAPs contribute to chromosome packaging. We report here a characterization of the binding sites for several major NAPs in E. coli, namely HNS, IHF, Fis, Dps and a non-NAP protein, FNR, in terms of the physical properties of their binding DNA. Our study shows that (i) as compared with flanking regions, the binding sites for IHF, Fis and FNR tend to have high intrinsic curvature, while no characterized pattern of intrinsic curvature distribution around those of HNS and Dps; (ii) all the binding sites analyzed in this study except those of HNS are characterized by high structural flexibility; (iii) the intrinsic curvature and flexibility at the binding sites for Fis and IHF are found to be coupled with the sequence specificity required in their binding, while the physical properties of the binding regions for both Dps and FNR are independent of sequence specificity. Our data suggest that physical properties of DNA sequence may contribute to binding of NAPs and mediate genome packaging and transcriptional regulation of the downstream genes. Our results should be informative for prediction of NAPs binding sites and understanding of the bacterial chromosome packaging.

Analysis of the causes of the seizure and destruction of carcasses and organs in a slaughterhouse in central Italy in the 2010-2016 period.

Meat safety and hygiene are fundamental issues for producers and endusers. To achieve these goals, the inspection of carcasses and organs at slaughter is critical. The results of post-mortem inspection are the basis for planning preventive measures against consumer risks and for limiting economic losses. In this retrospective study, the causes of the seizure and destruction of carcasses and organs were analysed at a slaughterhouse in central Italy from 2010 to 2016. 436,646 slaughtered animals were taken into consideration, for a total of 61,799 seizures (73.29% pigs, 23.87% cattle, 2.77% sheep and 0.07% horses). The organs or groups of organs that most frequently showed lesions in pigs were liver (72.38%), heart (10.77%) and pluck (10.20%); in cattle, lungs (64.86%), liver (31.20%) and stomachs (11.63%); in sheep, liver (77.15%), pluck (18.70%) and lung (3.80%); in horses, liver (75.56%), kidney (68.89%) and lung (31.11%). Among the diagnoses, parasitic diseases of the liver (ascariasis and distomatosis) were especially frequent in all species, followed by pericarditis and polyserositis in pigs and diseases affecting the respiratory system in cattle. The data obtained show that postmortem inspection is of fundamental importance for limiting risks for the consumer and ensuring meat safety. It is also evident, even more than ten years after the coming into force of the so-called hygiene package regulations, that the slaughterhouse can still act as an epidemiological observatory to provide the data needed for the development of plans for the control and eradication of the most frequent diseases in the area.

Potential of circulating nucleosome-associated histone modifications in cancer

Posttranslational modifications of histone proteins (PTHMs) are involved in the regulation of chromatin packaging and gene expression thus affecting cellular homeostasis. Enzymatic machinery that set PTHMs is often deregulated in cancer resulting in altered global patterns of PTHMs in various cancer types. Detection of cancer-related histone marks in biological fluids such as plasma and serum could serve as useful biomarkers in cancer detection, diagnosis and management. Such biomarkers offer many advantages, such as being minimally invasive and easily accessible. Reflecting this, increasing amounts of data on the impact of circulating histone marks are being published. Here we provide a short insight into PTHMs and their potential utility as circulating cancer biomarkers.

Misleading descriptors on cigarette packs in Indonesia, the Philippines and Vietnam: before and after implementation of misleading packaging regulations

Misleading descriptors on cigarette packs in Indonesia, the Philippines and Vietnam: before and after implementation of misleading packaging regulations

Applicability of the fish embryo acute toxicity (FET) test (OECD 236) in the regulatory context of Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH).

In 2013 the Organisation for Economic Co-operation and Development (OECD) test guideline (236) for fish embryo acute toxicity (FET) was adopted. It determines the acute toxicity of chemicals to embryonic fish. Previous studies show a good correlation of FET with the standard acute fish toxicity (AFT) test; however, the potential of the FET test to predict AFT, which is required by the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation (EC 1907/2006) and the Classification, Labelling and Packaging (CLP) Regulation (EC 1272/2008), has not yet been fully clarified. In 2015 the European Chemicals Agency (ECHA) requested that a consultant perform a scientific analysis of the applicability of FET to predict AFT. The purpose was to compare the toxicity of substances to fish embryos and to adult fish, and to investigate whether certain factors (e.g., physicochemical properties, modes of action, or chemical structures) could be used to define the applicability boundaries of the FET test. Given the limited data availability, the analysis focused on organic substances. The present critical review summarizes the main findings and discusses regulatory application of the FET test under REACH. Given some limitations (e.g., neurotoxic mode of action) and/or remaining uncertainties (e.g., deviation of some narcotic substances), it has been found that the FET test alone is currently not sufficient to meet the essential information on AFT as required by the REACH regulation. However, the test may be used within weight-of-evidence approaches together with other independent, relevant, and reliable sources of information. The present review also discusses further research needs that may overcome the remaining uncertainties and help to increase acceptance of FET as a replacement for AFT in the future. For example, an increase in the availability of data generated according to OECD test guideline 236 may provide evidence of a higher predictive power of the test. Environ Toxicol Chem 2018;37:657-670. © 2017 SETAC.

Smoke 'Em If You Got 'Em: Discussing the WTO Dispute Settlement Panel's Decision to Uphold Plain Packaging in Australia and Its Impact on the Future

This Article discusses the landmark decision by the WTO Dispute Resolution Panel that the Australian Tobacco Plain Packaging Act 2011 (“TPPA”) is consistent with its obligations to the TBT Agreement, the TRIPS Agreement, and the GATT. It argues that Indonesia’s claim that the TPPA is discriminatory and contrary to its obligation of national treatment is unfounded. Further, it contends that the decision could lead to more products being subjected to plain packaging regulations in the future. Tobacco is, however, unique because of the great health risk involved, and plain packaging of other products to this extent is unlikely. The Article presents evidence of the health risks involved with tobacco use, and discusses why the TPPA falls under an exception to its obligations to the WTO Agreements cited. To conclude, the Article investigates several different products and explains why it is unlikely that the products will be subjected to stringent packaging regulations in the future.

The New EU Tobacco Products Directive and Standardized Packaging: [in the Name of ‘Smooth Functioning of the Internal Market’

This article conducts a selective legal analysis of the new Tobacco Products Directive 2014/40/EU, which was formally adopted in April 2014 and which, except for a few provisions, should be implemented in all EUMember States by 20 May 2016. The dominant focus of the article is on the labelling and packaging requirements (including standardized packaging). The labelling and packaging measures, despite ambitious and noble targets, have raised controversial debates about their effect in decreasing tobacco consumption. It has also begged the question whether these rules will contribute to facilitating free movement of tobacco products in the internal market as planned. In light of recent legal challenges and the ECJ’s Preliminary Ruling in Philip Morris Brands SARL and Others v. Secretary of State for Health, the article assesses the validity of the proposed measures under the principles of subsidiarity, proportionality and fundamental rights, as well as the chosen legal basis for the Directive. It continues with the examination of the minimum requirement of the Directive and the possibility for Member States to introduce further requirements relating to packaging. Overall, the article concludes that the Directive’s chosen model of partial harmonization presents a fresh approach to the regulation of labelling and packaging of tobacco products in the internal market. However, it might generate the same results as in the case of minimum harmonization. Namely, further standardization of packaging of tobacco products at the national level will lead to the lack of a harmonized approach, thereby affecting the smooth functioning of the internal market. As a result, new harmonizing rules will be required in the future.

Smoke 'em If You Got 'em: Discussing the WTO Dispute Settlement Panel's Decision to Uphold Plain Packaging in Australia and its Impact on the Future

Author(s): Kelly, Lucas G. | Abstract: This Paper discusses the landmark decision by the WTO Dispute Resolution Panel that the Australian Tobacco Plain Packaging Act 2011 (“TPPA”) is consistent with its obligations under the TBT Agreement, the TRIPS Agreement, and the GATT, all of which are WTO Agreements.It argues that Indonesia’s claim that the TPPA is discriminatory and contrary to its obligation of national treatment is unfounded. The Paper presents evidence of the health risks involved with tobacco use, and discusses why the TPPA falls under an exception to its obligations to the cited WTO Agreements. Further, this Paper contends that the decision could lead to strict plain packaging regulations for other products in the future. However, tobacco has unique and significant health risks, and by comparing it to several products, the Paper explains why it is unlikely that these products will be subject to similar stringent packaging regulations in the future.

Regulatory Chill in a Warming World: The Threat to Climate Policy Posed by Investor-State Dispute Settlement

AbstractThe system of investor-state dispute settlement (ISDS) found in over 3,000 bilateral investment treaties and numerous regional trade agreements has been criticized for interfering with the rights of sovereign states to regulate investment in the public interest, for example, to protect the environment and public health. This article argues that while much of the public debate around ISDS has focused on a small number of cases that have arisen over the regulation of tobacco packaging, there is a far greater threat posed by the potential use of ISDS by the fossil fuel industry to stall action on climate change. It is hypothesized that fossil fuel corporations will emulate a tactic employed by the tobacco industry – that of using ISDS to induce cross-border regulatory chill: the delay in policy uptake in jurisdictions outside the jurisdiction in which the ISDS claim is brought. Importantly, fossil fuel corporations do not have to win any ISDS cases for this strategy to be effective; they only have to be willing to launch them. The article concludes with three options to reform trade and investment agreements to better align them with climate change mitigation efforts: (i) exclude ISDS provisions; (ii) prohibit fossil fuel industries from accessing ISDS; or (iii) carve out all government measures taken in pursuit of international obligations (for example, under the Paris Agreement on climate change) from challenge under ISDS.

LIBRARY DOCUMENTS ON REGULATION OF PROCESSES OF BOOK ARTIFACTS USAGE SAFETY

Purpose. The subject of the research is to justify the need for development of special documents that stipulate all activities connected with usage of book artifacts and their safety. Such documents are necessary in libraries, where big amounts of book artifacts are stored. The topic is essential taking into consideration facts of stealing old-printed editions from state libraries. The aim of the article is to draw attention of experts to this issue and to recommend the development of the complex of documents, which would contain main approaches to preservation of rare and valuable books and demands for organization of work with them. That would make impossible the facts of rarities stealing. Methodology. The main methodological basis of the research is a prognosis of risks in preservation and usage of book artifacts and general ways to solving the problem through strict regulation of working processes.Finding. The result of the work are development of documentation package (Regulations on book artifacts, rare and valuable funds (collections), which are stored in institutes of National Academy of Science (NAS) of Ukraine; The rules of usage of book artifacts, rare and valuable book and manuscript funds in libraries and institutes of NAS of Ukraine; Instruction on actions of personnel in cases of emergencies) and submitting for discussion the issues of practicability of development of such documents in network of Ukrainian universities scientific libraries. Practical value of research results is development of documents, which regulate the work with book artifacts at university libraries and, what is more important, the safety of book artifacts during their usage by readers Results. On the basis of author`s experience and experience of other experts on work with book artifacts it is stressed the conclusion of effectiveness of development of general Regulations for book artifacts in network of university libraries, as well as development of special rules and instructions, strict following to which should avoid stealing of rare and valuable books from library funds.

Chantal M. Boulanger: Exploring the Endothelium.

The scientific evolution of Chantal M. Boulanger, PharmD, PhD, has taken her from a French village’s one-room schoolhouse to the Mayo Clinic to a leadership position at the Institut National de la Sante et de la Recherche Medicale (Inserm) in Paris. Chantal M. Boulanger While completing pharmacy studies at the Universite de Lorraine, Boulanger leapt at the chance to spend summers in research laboratories with the aim of pursuing a PhD. Her molecular pharmacology doctoral work, on the intracellular mechanisms associated with vascular smooth muscle relaxation, was conducted at the Universite de Strasbourg in the program headed by Jean-Claude Stoclet. Boulanger’s research career has focused on the role of endothelial cells as a key player in vascular disease development and as a target of cardiovascular risk factors. While she was a research associate at the University Hospital of Basel, Switzerland, Boulanger and T.F. Luscher demonstrated that production of the vasoconstrictor endothelin is downregulated by nitric oxide1 and stimulated by oxidized lipids2 in isolated endothelium, findings that were later confirmed in intact animals and provided new pharmacological targets to address endothelial dysfunction. In a change that required a major shift in laboratory techniques and models, since 2000 Boulanger’s research team at Inserm has investigated the extracellular microvesicles produced by endothelial cell activation. The team demonstrated that circulating microvesicles from patients with myocardial infarction triggered endothelial dysfunction, even in angiographically normal arteries.3 They identified microvesicles in human atherosclerotic plaque as potent prothrombogenic mediators that might represent a major determinant of plaque neovascularization and vulnerability.4 Later, they showed that circulating endothelial microvesicles were associated with cardiovascular and metabolic risk factors in participants in the Framingham offspring study who had no history of cardiovascular disease.5 Currently, Boulanger’s research addresses the regulation of micro-RNA packaging in extracellular vesicles and resulting …

The GARD platform for potency assessment of skin sensitizing chemicals.

Contact allergy induced by certain chemicals is a common health concern, and several alternative methods have been developed to fulfill the requirements of European legislation with regard to hazard assessment of potential skin sensitizers. However, validated methods, which provide information about the potency of skin sensitizers, are still lacking. The cell-based assay Genomic Allergen Rapid Detection (GARD), targeting key event 3, dendritic cell activation, of the skin sensitization AOP, uses gene expression profiling and a machine learning approach for the prediction of chemicals as sensitizers or non-sensitizers. Based on the GARD platform, we here expanded the assay to predict three sensitizer potency classes according to the European Classification, Labelling and Packaging (CLP) Regulation, targeting categories 1A (strong), 1B (weak) and no cat (non-sensitizer). Using a random forest approach and 70 training samples, a potential biomarker signature of 52 transcripts was identified. The resulting model could predict an independent test set consisting of 18 chemicals, six from each CLP category and all previously unseen to the model, with an overall accuracy of 78%. Importantly, the model was shown to be conservative and only underestimated the class label of one chemical. Furthermore, an association of defined chemical protein reactivity with distinct biological pathways illustrates that our transcriptional approach can reveal information contributing to the understanding of underlying mechanisms in sensitization.

Child-resistant and tamper-resistant packaging: A systematic review to inform tobacco packaging regulation

Child-resistant and tamper-resistant packaging: A systematic review to inform tobacco packaging regulation

Briefing: The future of the packaging waste recovery note system

In October 2016, the Environmental Services Association enunciated a discussion of the UK PRN/PERN system for packaging waste and possible alternatives to examine whether the existing system for proving compliance with the Packaging Regulations will need to be modified to meet the higher targets that might be imposed either through EU requirements or domestic legislation. The EU Commission's Circular Economy package of December 2015 has a set of proposals for extended producer responsibility schemes which would require extensive changes to the packaging waste recovery system currently operational in the UK.

International arbitration: the jurisdictional award inPhilip Morris v Uruguay, and enforcement of arbitration awards

In Philip Morris v Uruguay , the claimants have claimed damages for alleged breaches of the Switzerland-Uruguay bilateral investment treaty in relation to packaging regulations Uruguay has implemented for tobacco products. These include certain plain packaging rules and a requirement to include prominent health warnings on tobacco products. In its 2nd July 2013 decision, the tribunal found jurisdiction to hear the dispute. The decision provides useful guidance on a number of important jurisdictional issues such as the application of certain pre-conditions to arbitration and the interpretation of “investment” in light of political motives. This case note article also is a consideration of Harry Matovu QC’s opinion on the recognition and enforcement of awards under the OHADA Arbitration regime for the common law principles for analysis of commercial dispute resolution issues in relation to the international law in Africa as an example. Arbitration has recently become one of the preferred methods for resolving international commercial disputes in South America and South Africa.