European Union policy on smokeless tobacco: a statement in favour of evidence based regulation for public health

Rationale: This statement is an updated version of one released by the same authors in February 2003. The statement was produced to follow up the Royal College of Physicians (RCP) Tobacco Advisory Group report "Protecting smokers, saving lives: the case for a tobacco and nicotine regulatory authority",¹ which argued for an evidence based regulatory approach to smokeless tobacco and harm reduction and posed a series of questions that regulators must address in relation to smokeless tobacco.

The purpose of this statement is to provide arguments of fact and principle to follow the RCP's report and to outline the public health case for changing existing European Union (EU) regulation in this area. A review of regulation in relation to harm reduction and regulation of tobacco products other than cigarettes is required in Article 11 of EU directive 2001/37/EC,² and this is a contribution towards forming a consensus in the European public health community about what policy the EU should adopt in the light of this review, or following ongoing legal action that may potentially strike out the existing regulation altogether.

Public health case: We believe that the partial ban applied to some forms of smokeless tobacco in the EU should be replaced by regulation of the toxicity of all smokeless tobacco. We hold this view for public health reasons: smokeless tobacco is substantially less harmful than smoking and evidence from Sweden suggests it is used as a substitute for smoking and for smoking cessation. To the extent there is a "gateway" it appears not to lead to smoking, but away from it and is an important reason why Sweden has the lowest rates of tobacco related disease in Europe. We think it is wrong to deny other Europeans this option for risk reduction and that the current ban violates rights of smokers to control their own risks. For smokers that are addicted to nicotine and cannot or will not stop, it is important that they can take advantage of much less hazardous forms of nicotine and tobacco—the alternative being to "quit or die"... and many die. While nicotine replacement therapies (NRT) may have a role in harm reduction, tobacco based harm reduction options may reach more smokers and in a different, market based, way. Chewing tobacco is not banned or regulated in the EU but is often highly toxic, and our proposal could remove more products from the market than it permitted.

Regulatory options: We believe that the EU policy on smokeless tobacco should adapt to new scientific knowledge and that the European Commission should bring forward proposals to amend or replace Article 8 of directive 2001/37/EC with a new regulatory framework. Canada has developed testing regimens for tobacco constituents and these could be readily adapted to the European situation. A review of EU policy in this area is required no later than December 2004, and we believe the Commission should expedite the part of its review that deals with harm reduction and regulation of tobacco products other than cigarettes so as to reconsider its policy on smokeless tobacco. We held this view before Swedish Match brought its legal proceedings to challenge EU legislation and we will continue to hold these views if its action fails.

     

Evaluation and validation of a novel Arxula adeninivorans estrogen screen (nAES) assay and its application in analysis of wastewater, seawater, brackish water and urine

A novel Arxula adeninivorans yeast estrogen screen (nAES) assay has been developed for detection of estrogenic activity in various liquid samples such as wastewater, seawater, brackish water and swine urine. Two bio-components were engineered to co-express the human estrogen receptor α (hERα) and an inducible reporter gene; either the non-conventional phytase gene (phyK, derived from Klebsiella sp. ASR1) or the non-conventional tannase gene (ATAN1, derived from Arxula). Both reporters were put under the control of an Arxula derived glucoamylase (GAA) promoter, which was modified by the insertion of two estrogen-responsive elements (EREs). The Arxula transformation/expression platform Xplor® 2, which lacks resistance markers and E. coli elements, was used to select stable mitotic transformants. They were then analyzed for robustness and suitability as the bio-component for the nAES assay. Two types of the nAES assay based on the reporter proteins phytase and tannase (nAES-P, nAES-T) were used in this work. The nAES-P type is more suitable for the analysis of seawater, brackish water and urine whereas the nAES-T type exhibited higher robustness to NaCl. Both assay types have similar characteristics for the determination of estrogen in sewage and urine samples e.g. 6-25 h assay period with detection and determination limits and EC₅₀ values for 17β-estradiol of 2.8 ng L^− 1, 5.9 ng L^− 1, 33.2 ng L^− 1 (nAES-P) and 3.1 ng L^− 1, 6.7 ng L^− 1 and 39.4 ng L^− 1 (nAES-T). Substrate specificity and analytical measurement range (AMR) for both assay types are also similar. These characteristics show that the nAES assay based on non-conventional salt tolerant yeast is applicable for a high throughput estrogen analysis in the environmental and regulatory control sectors.     

Chiasmus, Artificial Memory, and the Arts of Arrangement

Few figures of classical rhetoric can claim more spatial relevance than “chiasmus,” the figure of symmetrical convergence used by poets, novelists, rhetoricians, mnemonicists and others. Is chiasmus a tool of literati who appropriate spatial forms to pull their plots to closure, or is there an independent architectural tradition of chiasmus? If one pulls together the clues about metonymy, the logic of arrangement, one can discover an intriguing link to Jacques Lacan’s similar design of the human psyche and his topological investigations. The Vitruvian sequence of venustas, utilitas and firmatas may suggest to some nothing more than an arbitrary division of architectural interests. Ritually, however, the relation of firmitas not just to material stability but to the traditional rituals required to secure buildings from both collapse and curse, even if figurative, offers connections to the chiastic design of foundation rites, where sacrifice secures the life and security of structure.     

Investigation of the Formation of Iron-Rich Intermetallic Phases in Al–Si Alloys via Thermal Analysis Cooling Curves,Including a Real-Time Detection for Filtration Process

The formation of iron (Fe)-containing intermetallics during solidification is challenging due to the influences of cooling rate and chemical composition. Differential scanning calorimetry (DSC) is an accurate analysis method but merely replicates adjustable cooling conditions. Thereby, the solidification range is traversed several times before DSC measurement. For this purpose, thermal analysis cooling curves with double thermocouple are conducted to investigate the formation temperature of Fe-rich intermetallics in different AlSi casting alloys. In addition, the influence of chemical composition is examined by increasing the initial contents of iron, manganese, and chromium to 0.8 wt% each. The double thermocouple setup allows determining feeding points and solid fractions of the alloy compounds. To evaluate the data sets, the statistical program R is used to improve data processing and smoothing. The signature of Fe-rich intermetallics in the temperature–time plots corresponds to the detected phases in optical micrographs. In addition, scanning electron microscopy with energy-dispersive spectroscopy and electron backscattering diffraction are used to measure the local chemical composition and identify the iron-rich intermetallics. Real-time evaluation (differential calculation, first derivative, incl. smoothing) for an applicable filtration process can be performed using thermocouples with analog-to-digital converter and Python programs with an interactive graphical interface.