Maritime safety in the Gulf of Finland. Evaluation of the regulatory system

Growing traffic is believed to increase the risk of an accident in the Gulf of Finland. As the consequences of a large oil accident would be devastating in the vulnerable sea area, accident prevention is performed at the international, regional and national levels. Activities of shipping companies are governed with maritime safety policy instruments, which can be categorised into regulatory, economic and information instruments. The maritime regulatory system has been criticised for being inefficient because it has not been able to eliminate the violations that enable accidents. This report aims to discover how maritime governance systems or maritime safety policy instruments could be made more efficient in the future, in order to improve the maritime safety level. The results of the research are based on a literature review and nine expert interviews, with participants from shipping companies, interest groups and authorities. Based on the literature and the interviews, a suggestion can be made that in the future, instead of implementing new policy instruments, maritime safety risks should be eliminated by making the existing system more efficient and by influencing shipping companies’ safety culture and seafarers’ safety related attitudes. Based on this research, it can be stated that the development of maritime safety policy instruments should concentrate on harmonisation, automation and increasing national and cross-border cooperation. These three tasks could be primarily accomplished by developing the existing technology. Human error plays a role in a significant number of maritime accidents. Because of this, improving companies’ safety culture and voluntary activities that go beyond laws are acknowledged as potential ways of improving maritime safety. In the future, maritime regulatory system should be developed into a direction where the private sector has better possibilities to take part in decision-making.

Seletividade de herbicidas aplicados em pós-emergência para a cultura da mandioquinha-salsa

A suscetibilidade da cultura de mandioquinha-salsa a herbicidas aplicados em pós-emergência foi avaliada, cultivando-se três mudas pré-enraizadas e uniformes por vaso de cinco litros de capacidade, preenchidos com solo Podzólico Vermelho-Amarelo Câmbico, fase terraço, coletado na camada de 0-20 cm. Utilizou-se o delineamento de blocos ao acaso, com três repetições e 39 tratamentos obtidos do arranjo fatorial (13 x 3), sendo 12 herbicidas e uma testemunha sem herbicida e três doses (uma dose baixa, uma média e uma alta). As doses dos herbicidas (em g ha-1) foram: bentazon (600, 720 e 960), clethodim (84, 96 e 108), fenoxaprop-p-ethyl (68, 90 e 110), flazasulfuron (50, 75, 100), fluazifop-p-butil (94, 187 e 250), halosulfuron (75, 112 e 150), imazamox (28, 35 e 42), linuron (900, 1.350 e 1.800), oxadiazon (500, 750 e 1.000), propaquizafop (100, 125 e 150), sethoxydim (184, 230 e 276) e amônio-glufosinato (200, 300 e 400). A colheita das plantas foi realizada aos 49 dias após a aplicação dos tratamentos (DAA). Os herbicidas halosulfuron, flazasulfuron, imazamox e bentazon causaram alta toxicidade e prejuízos para as características avaliadas, sendo considerados não-seletivos para a cultura. O linuron e oxadiazon, nas doses baixa e média, e o amônio-glufosinato, na dose baixa, proporcionaram toxicidade às plantas de mandioquinha-salsa no início das avaliações, porém observou-se boa recuperação a partir de 28 DAA. O fluazifop-p-butil foi seletivo nas menores doses utilizadas. Os herbicidas clethodim, fenoxaprop-p-ethyl, propaquizafop e sethoxydim foram os mais seletivos.

Períodos de interferência de plantas daninhas na cultura da mandioquinha-salsa

A mandioquinha-salsa é normalmente cultivada em espaçamentos largos e a emergência das plantas e o crescimento inicial são lentos, favorecendo o surgimento de plantas daninhas e onerando o custo de produção. Este trabalho teve como objetivo determinar os períodos de interferência de plantas daninhas - período crítico de prevenção da interferência (PCPI), período anterior à interferência (PAI) e período total de prevenção da interferência (PTPI) - na cultura da mandioquinha-salsa, clone 'Amarelo de Carandaí', cultivada no espaçamento de 1,0 x 0,4 m, no período de maio de 2001 a abril de 2002. Os tratamentos foram constituídos por dois grupos de controle: em um manteve-se a cultura na ausência das plantas daninhas em períodos iniciais após o plantio das mudas e, em outro, a cultura foi mantida na presença das plantas daninhas em períodos iniciais após o plantio. Os períodos estudados foram: 0, 21, 42, 63, 84, 105, 126, 147, 168, 189, 210 e 315 dias após o plantio (DAP), totalizando 24 tratamentos, que foram dispostos em blocos casualizados, com quatro repetições. O PCPI de plantas daninhas na cultura da mandioquinha-salsa, considerando as perdas de raízes comerciais de 5% como aceitáveis, localizou-se entre o 58º e o 120º DAP. A interferência das plantas daninhas reduziu em 98% a produtividade de raízes comerciais quando a cultura conviveu com as plantas daninhas por todo o ciclo. O PAI foi de 58 dias; o PTPI, de 120 dias; e o PCPI, de 58 a 120 dias.

Turvallisuusjohtamisen vaatimukset rautatieympäristössä toimiville yrityksille

Diplomityön tavoitteena on selvittää rautatiealalla toimivien yritysten turvallisuuden hallinnan nykytilaa ja löytää keinoja sen parantamiseen. Tutkimuksen kannalta olennaisia teemoja ovat turvallisuuskulttuuri, turvallisuusjohtaminen ja turvallisuusvaatimukset. Työ tarkastelee rautatiealalla toimivia Liikenneviraston palveluntuottajayrityksiä ja heidän näkemyksiään turvallisuuden hallinnan nykytilanteesta edellä mainittujen teemojen ja työn teoriatutkimuksen avulla. Työn teoriaosuus esittelee laajasti rautatiealalla vallitsevia sääntöjä, määräyksiä, ohjeita ja standardeja. Näiden vaatimusten lisäksi teoriaosuus esittelee rautatiealan turvallisuusjohtamisjärjestelmää (TJJ), joka jaetaan turvallisuuden hallinnan osa-alueiksi. Näitä osa-alueita käytetään apuna tunnistettaessa rautatiealalla toimivien yritysten kannalta tärkeimmät turvallisuuden hallinnan osa-alueet. Työn empiirisessä osuudessa toteutetaan haastattelututkimus rautatiealalla toimiville yrityksille. Haastattelujen perusteella tunnistetaan turvallisuuden hallinnan kannalta tärkeitä kehittämiskohteita ja toimivia käytäntöjä turvallisuuteen liittyen. Näiden avulla luodaan kuva turvallisuuden nykytilasta, joka esitetään työn turvallisuusteemojen avulla. Työn tuloksena esitetään malli viidestä, rautatiealalla toimivien yritysten näkökulmasta keskeisestä, turvallisuuden hallinnan osa-alueesta. Mallia soveltamalla rautatiealalla toimivat yritykset pystyvät vastaamaan paremmin turvallisuusvaatimuksiin, kehittämään turvallisuustoimintojaan ja lisäämään koko yrityksen tietoisuutta turvallisuudesta rautatieympäristössä.

Dam safety guide

A new Dam Safety Act (494/2009) came into force on 1st October 2009 and a Government Decree on Dam Safety (319/2010) on 5th May 2010. This Dam Safety Guide replaces the Dam Safety Code of Practice (Publication of the Ministry of Agriculture and Forestry 7/1997), removed from circulation on 1st October 2009. The Dam Safety Guide is not binding on the dam owner; the purpose is to complement and elucidate the relevant law and and decree through examples and descriptions. The Guide takes up questions concerning dam design, for instance hydrological dimensioning and technical safety requirements, dam construction and use, the dam break hazard analysis and the dam owner’s emergency action plan, maintenance, use, monitoring as well as the annual and periodic inspections. Dams are classified according to the hazard they pose into class 1, 2 or 3 dams. The classification is not needed, if, according to the dam safety authority, the dam poses no danger. The owner of a classified dam must prepare a monitoring programme, to be approved by decision of the dam safety authority. To establish the hazard caused by a dam, the owner of a class 1 dam must prepare an analysis of the dam hazard to humans and property as well as to the environment. The dam safety authority may also require a dam break hazard analysis for a dam other than class 1 dam if deemed necessary for classification. The owner of a class 1 dam must prepare a plan of measures in case of emergency or operational failure. The plan shall present the dam owner’s state of preparedness to act on their own initiative in the situations described above. In each case, the rescue authorities make a separate assessment for the need to prepare a plan as set out in the Rescue Act. The dam owner must provide the information specified in the Dam Safety Decree to be entered into the dam safety information system. The dam safety authority and the owner of the dam must keep up-to-date printouts in their own dam safety files from the information system for each dam as well as other important documents connected with dam safety to ensure that these are readily available in case of disturbance.

Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents)

This review highlights the current advances in knowledge about the safety, efficacy, quality control, marketing and regulatory aspects of botanical medicines. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants which contain as active ingredients plant parts or plant material in the crude or processed state. A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach about $7 billion and $5 billion per annum, respectively, in 1999, and has thus attracted the interest of most large pharmaceutical companies. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of them are very toxic, such as the most cytotoxic anti-cancer plant-derived drugs, digitalis and the pyrrolizidine alkaloids, etc. However, the adverse effects of phytotherapeutic agents are less frequent compared with synthetic drugs, but well-controlled clinical trials have now confirmed that such effects really exist. Several regulatory models for herbal medicines are currently available including prescription drugs, over-the-counter substances, traditional medicines and dietary supplements. Harmonization and improvement in the processes of regulation is needed, and the general tendency is to perpetuate the German Commission E experience, which combines scientific studies and traditional knowledge (monographs). Finally, the trend in the domestication, production and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advantages, since it will be possible to obtain uniform and high quality raw materials which are fundamental to the efficacy and safety of herbal drugs.

Suorituskykymittariston rakentaminen ja kehittämisen haasteet öljyliiketoiminta-alan logistisessa organisaatiossa

Yrityksen oman toiminnan ja tehokkuuden analysointi mittaamalla sen suoritus-kykyä on yritysjohdolle oiva keino saada parempi tietoisuus resurssikäytöstä ja strategian toteutumisesta. Aiemmat tutkimukset ovat osoittaneet, että perinteinen taloudellisen tiedon seuranta ei itsessään riitä liiketoiminnan kattavassa seuran-nassa. Tutkimuksen tavoitteena oli rakentaa suorituskykymittaristo öljyliiketoiminta-alan logistiseen organisaatioon siten, että mittaristo täyttää organisaation mittaamisen päämäärät mahdollisimman tehokkaasti. Suorituskykymittariston osa-alueet ra-kennettiin kohdeorganisaation kriittisten menestystekijöiden perusteella luotujen näkökulmien avulla. Kohdeorganisaation erityspiirteenä oli toiminta osana toimi-tusketjua, johon kuuluivat öljytuotteiden varastointi ja hallittu logistinen operointi perustuen alan standardeihin. Rakennettu suorituskykymittaristo keskittyi turvalli-suus-, kustannustehokkuus- ja tuotehallintatekijöihin tähtäimenä organisaation strategiset tavoitteet. Tutkimus jakaantui teoria- ja empiriaosuuteen. Teoriaosassa tarkasteltiin suoritus-kyvyn mittaamisen merkitystä, suorituskykymittariston rakentamista ja suoritus-kyvyn mittaamisen keskeisiä haasteita. Empiriaosuudessa kerrottiin kohdeorgani-saation erityispiirteet ja kuvattiin suorituskykymittariston kehittäminen kohdeor-ganisaatiossa. Käytetyn tapaustutkimusmenetelmän avulla nostettiin esiin suori-tuskyvyn mittaamisen haasteita ratkaisuineen. Kohdeorganisaation suorituskyvyn mittaamisesta kerätty tieto päädyttiin koosta-maan kerran kuukaudessa päivitettävälle tuloskortille organisaation controllerin toimesta. Tuloskortin rakentamis- ja kehitystyö toteutettiin kahden vuoden aikana. Sen tärkeimmät mittarit pohjautuivat turvallisuuden, kustannustehokkuuden ja käyttöomaisuuden kriittisiin menestystekijöihin, jotka heijastuivat organisaation strategiasta. Tuloskortista saatiin toimiva työkalu johdon käyttöön. Tutkimuksen jatkokehityskohteiksi jäivät tuloskortin kevyempi kuukausipäivitys ja ennustemit-tareiden kehittäminen strategian seurannan tueksi.

Rigorous development of safety-critical systems

Nowadays, computer-based systems tend to become more complex and control increasingly critical functions affecting different areas of human activities. Failures of such systems might result in loss of human lives as well as significant damage to the environment. Therefore, their safety needs to be ensured. However, the development of safety-critical systems is not a trivial exercise. Hence, to preclude design faults and guarantee the desired behaviour, different industrial standards prescribe the use of rigorous techniques for development and verification of such systems. The more critical the system is, the more rigorous approach should be undertaken. To ensure safety of a critical computer-based system, satisfaction of the safety requirements imposed on this system should be demonstrated. This task involves a number of activities. In particular, a set of the safety requirements is usually derived by conducting various safety analysis techniques. Strong assurance that the system satisfies the safety requirements can be provided by formal methods, i.e., mathematically-based techniques. At the same time, the evidence that the system under consideration meets the imposed safety requirements might be demonstrated by constructing safety cases. However, the overall safety assurance process of critical computerbased systems remains insufficiently defined due to the following reasons. Firstly, there are semantic differences between safety requirements and formal models. Informally represented safety requirements should be translated into the underlying formal language to enable further veri cation. Secondly, the development of formal models of complex systems can be labour-intensive and time consuming. Thirdly, there are only a few well-defined methods for integration of formal verification results into safety cases. This thesis proposes an integrated approach to the rigorous development and verification of safety-critical systems that (1) facilitates elicitation of safety requirements and their incorporation into formal models, (2) simplifies formal modelling and verification by proposing specification and refinement patterns, and (3) assists in the construction of safety cases from the artefacts generated by formal reasoning. Our chosen formal framework is Event-B. It allows us to tackle the complexity of safety-critical systems as well as to structure safety requirements by applying abstraction and stepwise refinement. The Rodin platform, a tool supporting Event-B, assists in automatic model transformations and proof-based verification of the desired system properties. The proposed approach has been validated by several case studies from different application domains.

Efficacy and safety of combined piroxicam, dexamethasone, orphenadrine, and cyanocobalamin treatment in mandibular molar surgery

Third molar extraction is a common procedure frequently accompanied by moderate or severe pain, and involves sufficient numbers of patients to make studies relatively easy to perform. The aim of the present study was to determine the efficacy and safety of the therapeutic combination of 10 mg piroxicam, 1 mg dexamethasone, 35 mg orphenadrine citrate, and 2.5 mg cyanocobalamin (Rheumazin®) when compared with 20 mg piroxicam alone (Feldene®) in mandibular third molar surgery. Eighty patients scheduled for removal of the third molar were included in this randomized and double-blind study. They received (vo) Rheumazin or Feldene 30 min after tooth extraction and once daily for 4 consecutive days. Pain was determined by a visual analogue scale and by the need for escape analgesia (paracetamol). Facial swelling was evaluated with a measuring tape and adverse effects and patient satisfaction were recorded. There was no statistically significant difference in facial swelling between Rheumazin and Feldene (control group). Both drugs were equally effective in the control of pain, with Rheumazin displaying less adverse effects than Feldene. Therefore, Rheumazin appears to provide a better risk/benefit ratio in the mandibular molar surgery. Since the side effects resulting from nonsteroidal anti-inflammatory drug administration are a severe limitation to the routine use of these drugs in clinical practice, our results suggest that Rheumazin can be a good choice for third molar removal treatment.

Raising awareness of chronic kidney disease in a Brazilian urban population

The incidence and prevalence of chronic kidney disease have been increasing in recent years in developing countries. The aim of this study was to report the results of a general chronic kidney disease awareness program applied to an urban population in a large Brazilian city. From January 2002 to January 2005 a total of 8883 individuals in the city of Curitiba (PR, Brazil) were screened for hypertension, body mass index, hematuria, and proteinuria. A family history and previous medical diagnosis of hypertension and diabetes mellitus (DM) were also recorded. Of the 8883 individuals assessed, 56% were women, subject median age was 47 years (range: 17-93 years) and more than 90% were Caucasian. Thirty percent had signs of hematuria, 6% had proteinuria, and 3% had hematuria and proteinuria. The median of mean arterial pressure values was 93 mmHg (range: 71-135 mmHg) and 16% of the population screened had a history of hypertension. A significant positive family history of both hypertension or DM was present in 42% (P < 0.0001; chi-square = 83.18) and 7% (P < 0.0001; chi-square = 161.31) of the hypertensive group, respectively. Finally, the prevalence of hypertension and DM was significantly higher in older individuals with proteinuria. In the present study, a higher prevalence of hematuria and proteinuria was found in older individuals with hypertension and diabetes compared to the general population. These data confirm the need for public awareness of renal disease in high-risk individuals.

A safety and feasibility study of cell therapy in dilated cardiomyopathy

The aim of this study was to determine if bone marrow mononuclear cell (BMMC) transplantation is safe for moderate to severe idiopathic dilated cardiomyopathy (IDC). Clinical trials have shown that this procedure is safe and effective for ischemic patients, but little information is available regarding non-ischemic patients. Twenty-four patients with IDC, optimized therapy, age 46 ± 11.6 years, 17 males, NYHA classes II-IV, and left ventricular ejection fraction <35% were enrolled in the study. Clinical evaluation at baseline and 6 months after stem cell therapy to assess heart function included echocardiogram, magnetic resonance imaging, cardiopulmonary test, Minnesota Quality of Life Questionnaire, and NYHA classification. After cell transplantation 1 patient showed a transient increase in enzyme levels and 2 patients presented arrhythmias that were reversed within 72 h. Four patients died during follow-up, between 6 and 12 weeks after therapy. Clinical evaluation showed improvement in most patients as reflected by statistically significant decreases in Minnesota Quality of Life Questionnaire (63 ± 17.9 baseline vs 28.8 ± 16.75 at 6 months) and in class III-IV NYHA patients (18/24 baseline vs 2/20 at 6 months). Cardiopulmonary exercise tests demonstrated increased peak oxygen consumption (12.2 ± 2.4 at baseline vs 15.8 ± 7.1 mL·kg-1·min-1 at 6 months) and walked distance (377.2 ± 85.4 vs 444.1 ± 77.9 m at 6 months) in the 6-min walk test, which was not accompanied by increased left ventricular ejection fraction. Our findings indicate that BMMC therapy in IDC patients with severe ventricular dysfunction is feasible and that larger, randomized and placebo-controlled trials are warranted.

Human prophylactic vaccine adjuvants and their determinant role in new vaccine formulations

Adjuvants have been considered for a long time to be an accessory and empirical component of vaccine formulations. However, accumulating evidence of their crucial role in initiating and directing the immune response has increased our awareness of the importance of adjuvant research in the past decade. Nevertheless, the importance of adjuvants still is not fully realized by many researchers working in the vaccine field, who are involved mostly in the search for better target antigens. The choice of a proper adjuvant can be determinant for obtaining the best results for a given vaccine candidate, but it is restricted due to intellectual property and know-how issues. Consequently, in most cases the selected adjuvant continues to be the aluminum salt, which has a record of safety, but predominantly constitutes a delivery system (DS). Ideally, new strategies should combine immune potentiators (IP) and DS by mixing both compounds or by obtaining structures that contain both IP and DS. In addition, the term immune polarizer has been introduced as an essential concept in the vaccine design strategies. Here, we review the theme, with emphasis on the discussion of the few licensed new adjuvants, the need for safe mucosal adjuvants and the adjuvant/immunopotentiating activity of conjugation. A summary of toxicology and regulatory issues will also be discussed, and the Finlay Adjuvant Platform is briefly summarized.

Comparative efficacy and safety of the left versus right radial approach for percutaneous coronary procedures: a meta-analysis including 6870 patients

The radial approach is widely used in the treatment of patients with coronary artery disease. We conducted a meta-analysis of published results on the efficacy and safety of the left and right radial approaches in patients undergoing percutaneous coronary procedures. A systematic search of reference databases was conducted, and data from 14 randomized controlled trials involving 6870 participants were analyzed. The left radial approach was associated with significant reductions in fluoroscopy time [standardized mean difference (SMD)=-0.14, 95% confidence interval (CI)=-0.19 to -0.09; P<0.00001] and contrast volume (SMD=-0.07, 95%CI=-0.12 to -0.02; P=0.009). There were no significant differences in rate of procedural failure of the left and the right radial approaches [risk ratios (RR)=0.98; 95%CI=0.77-1.25; P=0.88] or procedural time (SMD=-0.05, 95%CI=0.17-0.06; P=0.38). Tortuosity of the subclavian artery (RR=0.27, 95%CI=0.14-0.50; P<0.0001) was reported more frequently with the right radial approach. A greater number of catheters were used with the left than with the right radial approach (SMD=0.25, 95%CI=0.04-0.46; P=0.02). We conclude that the left radial approach is as safe as the right radial approach, and that the left radial approach should be recommended for use in percutaneous coronary procedures, especially in percutaneous coronary angiograms.