兽用疫苗管理与控制的国际标准

兽用疫苗是兽医医学产品,需接受像医学产品相同或相似的管理和控制标准,这意味着动物疫苗必须满足复杂的要求,保障产品在预期使用条件下的质量、安全性和免疫效力.在动物医药领域中,欧盟和美国的动物疫苗管理和控制体系发展早,制度完整,为其他国家和地区建立良好的动物疫苗管理与控制标准提供了有价值的参考信息.另外,统一各个国家和地区...     

Virtual water and water footprints do not provide helpful insight regarding international trade or water scarcity

Many authors have estimated the virtual water content of good and services traded internationally, and many have calculated national water footprints that account for the volumes of virtual water imported and exported. Some authors have suggested that international trade of virtual water has been harmful to selected exporting countries with limited water endowments. Some suggest also that current patterns of international trade should be rearranged to make better use of global water resources. Yet, countries do not actually trade in virtual water. They trade in goods and services for which water is one of many inputs. Wise choices regarding water resources and smart strategies regarding international trade cannot be determined by focusing on water alone. The notions of virtual water and water footprints are not helpful indicators of optimal strategies regarding water resources, particularly when considering issues such as water scarcity or international trade. I describe four perspectives regarding virtual water and water footprints, with the goal of demonstrating the inadequacies of these notions in policy discussions and in efforts to determine the optimal allocation and use of water resources. The four perspectives are: (1) international trade should not be modified or regulated to reflect the virtual water content of traded commodities or water footprints in the countries of trading partners, (2) countries do not save water by engaging in virtual water trade, (3) consumers in one country cannot alleviate water scarcity or improve water quality in other countries, and (4) water footprints are not analogous to carbon or ecological footprints.     

How to address the ethics of reproductive travel to developing countries: a comparison of national self-sufficiency and regulated market approaches

One of the areas of concern raised by cross-border reproductive travel regards the treatment of women who are solicited to provide their ova or surrogacy services to foreign consumers. This is particularly troublesome in the context of developing countries where endemic poverty and low standards for both medical care and informed consent may place these women at risk of exploitation and harm. We explore two contrasting proposals for policy development regarding the industry, both of which seek to promote ethical outcomes and social justice: While one proposal advocates efforts to minimize cross-border demand for female reproductive resources through the pursuit of national self-sufficiency, the other defends cross-border trade as a means for meeting the needs of vulnerable groups. Despite the conflicting objectives of the proposed strategies, the paper identifies common values and points of agreement between the two, including the importance of regulations to safeguard those providing ova or surrogacy services.     

Plasma-collection plant has to overcome tainted-blood fallout in search for donors

Canada''s lack of self-sufficiency in blood products has led to the opening of a blood-plasma collection centre in Thunder Bay, Ont.--the first of its type in Canada. In convincing donors to donate plasma, the new centre had to overcome some lingering public concern about the safety of the blood-collection system.     

Simple rules for the coexistence and competitive dominance of plants mediated by mycorrhizal fungi

Mycorrhizal fungi have been demonstrated to be important in the makeup of plant communities. Likely, their most important role is in altering mineral nutrition of plants, which, in turn, is thought to be among the most important determinants of plant competitive ability. Using mathematical models we examine what role these fungi can play in determining the competitive outcome between two plants in competition for one mineral resource. Depending on different relationships between the benefit accrued to the plant and the fungi, the presence of mycorrhizal fungi can (i) have no impact on which plant wins in competition, (ii) change the order of competitive dominance or (iii) enable coexistence when compared with the system in the absence of mycorrhizal fungi. Furthermore, environmental conditions, such as light and nutrient levels, can determine if coexistence is possible. We describe the necessary biological trade‐offs for coexistence and experimental tests for these trade‐offs.     

A stated preference investigation into the Chinese demand for farmed vs. wild bear bile

Farming of animals and plants has recently been considered not merely as a more efficient and plentiful supply of their products but also as a means of protecting wild populations from that trade. Amongst these nascent farming products might be listed bear bile. Bear bile has been exploited by traditional Chinese medicinalists for millennia. Since the 1980s consumers have had the options of: illegal wild gall bladders, bile extracted from caged live bears or the acid synthesised chemically. Despite these alternatives bears continue to be harvested from the wild. In this paper we use stated preference techniques using a random sample of the Chinese population to estimate demand functions for wild bear bile with and without competition from farmed bear bile. We find a willingness to pay considerably more for wild bear bile than farmed. Wild bear bile has low own price elasticity and cross price elasticity with farmed bear bile. The ability of farmed bear bile to reduce demand for wild bear bile is at best limited and, at prevailing prices, may be close to zero or have the opposite effect. The demand functions estimated suggest that the own price elasticity of wild bear bile is lower when competing with farmed bear bile than when it is the only option available. This means that the incumbent product may actually sell more items at a higher price when competing than when alone in the market. This finding may be of broader interest to behavioural economists as we argue that one explanation may be that as product choice increases price has less impact on decision making. For the wildlife farming debate this indicates that at some prices the introduction of farmed competition might increase the demand for the wild product.     

The control of chemicals used in aquaculture in Europe

A range of chemicals are used in European marine aquaculture and these may be categorized as disinfectants, antifoulants and medicines (includes vaccines). This article provides a review of chemicals used in aquaculture in Europe, their regulatory status, and a checklist of points considered best practice in the use (and avoidance of use) of medicines in marine aquaculture. The release of antifoulants and disinfectants into the marine environment is controlled by local and/or national waste discharge regulations that may in turn be guided by wider environmental quality objectives. The authorization of veterinary medicines, biologicals (vaccines) and pharmaceuticals (chemicals), in Europe is the subject of several EC Directives. Registration dossiers address the issues of product quality, safety and efficacy and include environmental and consumer safety where the product is destined for use in a food‐producing animal. Fish farmers, like all livestock producers, must have access to a range of properly authorized medicines to safeguard animal health and welfare. The distribution and supply of medicines must be appropriately controlled and their authorization appropriately includes environmental risk assessment to a common European Union (EU) or international standard. There is progress towards the harmonization of the authorization process within the EU and this will help to ensure the continued availability of medicines for fish. Consumer safety is addressed by the setting of maximum residue limits (MRLs) derived through toxicological risk assessment and by surveillance of food for residues of veterinary medicines. The system for the environmental risk assessment of chemicals used in aquaculture is being developed and is outlined in the present article. It is recommended that the supply and use of fish medicines is uniformly regulated in the EU and supported by appropriate codes of best practice. A number of codes of practice that include reference to the use of medicines have been produced both at a European level and in member states. It is recommended that all European marine aquaculture producers adopt a code of best practice for the use of medicinal and other chemicals their industry. Medicines are one part of an integrated package in dealing with animal health. This includes environmental conditions, nutrition and hygiene. The best practice guidelines presented here are based on the outcome of three European workshops as part of the EU MARAQUA project that involved industry, government and research scientists. They cover the avoidance and minimizing of the need to use medicines and other chemicals, to recording and monitoring their use and effectiveness (in case of resistance development), exchange of experiences within the industry, and staff training. Recommendations are also included for manufacturers of medicines and other chemicals, and for regulatory authorities. Minimizing the need to use medicines and other chemicals requires attention to a healthy source of fish stock. Staff must be appropriately trained in fish husbandry (to minimize stress), hygiene and disease recognition and treatment, including management of the farm site to keep it disease free. The latter may require single generations of fish per site to allow a fallow period during which a disease or parasite cycle is broken. These recommendations and guidelines are in accordance with the current codes of practice being developed by different sectors of the aquaculture industry in different countries. They do not necessarily involve significantly higher production costs and indeed are more likely to save costs as medicines and disease impacts are very costly to industry.     

From Food Insufficiency towards Trade Dependency: A Historical Analysis of Global Food Availability

Achieving global food security is one of the major challenges of the coming decades. In order to tackle future food security challenges we must understand the past. This study presents a historical analysis of global food availability, one of the key elements of food security. By calculating national level dietary energy supply and production for nine time steps during 1965–2005 we classify countries based on their food availability, food self-sufficiency and food trade. We also look at how diets have changed during this period with regard to supply of animal based calories. Our results show that food availability has increased substantially both in absolute and relative terms. The percentage of population living in countries with sufficient food supply (>2500 kcal/cap/d) has almost doubled from 33% in 1965 to 61% in 2005. The population living with critically low food supply (<2000 kcal/cap/d) has dropped from 52% to 3%. Largest improvements are seen in the MENA region, Latin America, China and Southeast Asia. Besides, the composition of diets has changed considerably within the study period: the world population living with high supply of animal source food (>15% of dietary energy supply) increased from 33% to over 50%. While food supply has increased globally, food self-sufficiency (domestic production>2500 kcal/cap/d) has not changed remarkably. In the beginning of the study period insufficient domestic production meant insufficient food supply, but in recent years the deficit has been increasingly compensated by rising food imports. This highlights the growing importance of food trade, either for food supply in importing countries or as a source of income for exporters. Our results provide a basis for understanding past global food system dynamics which, in turn, can benefit research on future food security.     

The competition–dispersal trade‐off exists in forbs but not in graminoids: A case study from multispecies alpine grassland communities

Much theoretical evidence has demonstrated that a trade‐off between competitive and dispersal ability plays an important role in facilitating species coexistence. However, experimental evidence from natural communities is still rare. Here, we tested the competition–dispersal trade‐off hypothesis in an alpine grassland in the Tianshan Mountains, Xinjiang, China, by quantifying competitive and dispersal ability using a combination of 4 plant traits (seed mass, ramet mass, height, and dispersal mode). Our results show that the competition–dispersal trade‐off exists in the alpine grassland community and that this pattern was primarily demonstrated by forbs. The results suggest that most forb species are constrained to be either good competitors or good dispersers but not both, while there was no significant trade‐off between competitive and dispersal ability for most graminoids. This might occur because graminoids undergo clonal reproduction, which allows them to find more benign microenvironments, forage for nutrients across a large area and store resources in clonal structures, and they are thus not strictly limited by the particular resources at our study site. To the best of our knowledge, this is the first time the CD trade‐off has been tested for plants across the whole life cycle in a natural multispecies plant community, and more comprehensive studies are still needed to explore the underlying mechanisms and the linkage between the CD trade‐off and community composition.     

Global effects of non‐native tree species on multiple ecosystem services

Non‐native tree (NNT) species have been transported worldwide to create or enhance services that are fundamental for human well‐being, such as timber provision, erosion control or ornamental value; yet NNTs can also produce undesired effects, such as fire proneness or pollen allergenicity. Despite the variety of effects that NNTs have on multiple ecosystem services, a global quantitative assessment of their costs and benefits is still lacking. Such information is critical for decision‐making, management and sustainable exploitation of NNTs. We present here a global assessment of NNT effects on the three main categories of ecosystem services, including regulating (RES), provisioning (PES) and cultural services (CES), and on an ecosystem disservice (EDS), i.e. pollen allergenicity. By searching the scientific literature, country forestry reports, and social media, we compiled a global data set of 1683 case studies from over 125 NNT species, covering 44 countries, all continents but Antarctica, and seven biomes. Using different meta‐analysis techniques, we found that, while NNTs increase most RES (e.g. climate regulation, soil erosion control, fertility and formation), they decrease PES (e.g. NNTs contribute less than native trees to global timber provision). Also, they have different effects on CES (e.g. increase aesthetic values but decrease scientific interest), and no effect on the EDS considered. NNT effects on each ecosystem (dis)service showed a strong context dependency, varying across NNT types, biomes and socio‐economic conditions. For instance, some RES are increased more by NNTs able to fix atmospheric nitrogen, and when the ecosystem is located in low‐latitude biomes; some CES are increased more by NNTs in less‐wealthy countries or in countries with higher gross domestic products. The effects of NNTs on several ecosystem (dis)services exhibited some synergies (e.g. among soil fertility, soil formation and climate regulation or between aesthetic values and pollen allergenicity), but also trade‐offs (e.g. between fire regulation and soil erosion control). Our analyses provide a quantitative understanding of the complex synergies, trade‐offs and context dependencies involved for the effects of NNTs that is essential for attaining a sustained provision of ecosystem services.     

Raising the Barriers to Access to Medicines in the Developing World – The Relentless Push for Data Exclusivity

Since the adoption of the WTO‐TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional ‘regulatory’ protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to be submitted to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry's arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry's appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from ‘free‐riding’ encounters some important problems: Neither legitimize excluding all others.     

Ecological specialization and trade affect the outcome of negotiations in mutualism

By definition, mutualisms involve the exchange of goods or services between partners. It has been shown that mutualism can grade into parasitism, but even when exchange is mutually beneficial, a conflict of interest remains because each partner benefits from reaping more benefits at a lower cost. Metaphorically, the partners negotiate the conditions of trade, the outcome of which will determine the net benefit to each partner. Each partner can adjust its allocation to self-provisioning while negotiating the ratio at which benefits are exchanged. To understand how these two features of trade affect mutualisms, we used the example of the plant-arbuscular mycorrhizal mutualism and modeled uptake and trade of two resources, phosphorus and carbon. In most contexts, the fungus specialized on phosphorus uptake while the plant took up both phosphorus and carbon. However, when phosphorus was abundant and light was scarce, the plant specialized, taking up only carbon and relying on trade for phosphorus. Resource availability was the most important factor determining specialization and the outcome of negotiation and trade, but other aspects of the context were also important. These results suggest experiments to link these two key features of trade with environmental conditions to determine the outcome of mutualism.     

Regulatory issues concerning the safety, efficacy and quality of herbal remedies

Herbal remedies and alternative medicines are used throughout the world, and in the past herbs were often the original sources of most drugs. Today we are witnessing an increase in herbal remedy use throughout the Western world raising the question as to how safe are these preparations for the unborn fetus? Many women use herbal products during pregnancy. The dilemma facing most regulatory authorities is that the public considers these products as either traditional medicines or natural food supplements. The user sees no reason for regulation. Most countries have laws concerning foods, drugs, and cosmetics, the details of which seldom clearly define to what section of the law and regulations alternative remedies belong. In most countries alternative remedies are regulated as foods, provided that no medicinal claim is made on the label. The global regulatory sector, however, is changing rapidly. The Therapeutic Goods Administration (TGA) in Australia created a Complimentary Medicines Evaluation Committee in late 1997 to address this issue, and Canada has created a new Natural Health Products Directorate in the realigned Therapeutic Products and Foods Branch in 2000. In parallel, the European Agency for the Evaluation of Medicinal Products has drafted test procedures and acceptance criteria for herbal drug preparations and herbal medicinal products. In the US, the Food and Drug Administration classifies these natural products as dietary supplements. Manufacturers must label a dietary supplement thus: “this statement has not been evaluated by the FDA [, and] this product is not intended to diagnose, treat, cure or prevent any disease.” Whether these products are foods or drugs is undecided. To add complexity to this issue, most of the potential deleterious effects of natural products on the unborn may be related to hormonal effects (e.g., phytoestrogens) and nutriceutical drug interactions (e.g., St. John's Wort and antidepressants), rather than direct embryotoxicity per se. We suggest that ensuring quality of herbal products should receive immediate attention by regulatory authorities, before embarking on the more arduous tasks of safety and efficacy. Birth Defects Res B 68:505–510, 2003. © 2003 Wiley‐Liss, Inc.     

Haemolysis during sample preparation alters microRNA content of plasma

The presence of cell-free microRNAs (miRNAs) has been detected in a range of body fluids. The miRNA content of plasma/serum in particular has been proposed as a potential source of novel biomarkers for a number of diseases. Nevertheless, the quantification of miRNAs from plasma or serum is made difficult due to inefficient isolation and lack of consensus regarding the optimal reference miRNA. The effect of haemolysis on the quantification and normalisation of miRNAs in plasma has not been investigated in great detail. We found that levels of miR-16, a commonly used reference gene, showed little variation when measured in plasma samples from healthy volunteers or patients with malignant mesothelioma or coronary artery disease. Including samples with evidence of haemolysis led to variation in miR-16 levels and consequently decreased its ability to serve as a reference. The levels of miR-16 and miR-451, both present in significant levels in red blood cells, were proportional to the degree of haemolysis. Measurements of the level of these miRNAs in whole blood, plasma, red blood cells and peripheral blood mononuclear cells revealed that the miRNA content of red blood cells represents the major source of variation in miR-16 and miR-451 levels measured in plasma. Adding lysed red blood cells to non-haemolysed plasma allowed a cut-off level of free haemoglobin to be determined, below which miR-16 and miR-451 levels displayed little variation between individuals. In conclusion, increases in plasma miR-16 and miR-451 are caused by haemolysis. In the absence of haemolysis the levels of both miR-16 and miR-451 are sufficiently constant to serve as normalisers.     

化学发光检测试剂鲁米诺的安全使用策略

鲁米诺是一种对于不可见血迹进行增强显示的试剂,是法医科学中最敏感的显色试剂之一,同时也可作为发光试剂应用于各种生物检测体系中。出于对安全与健康的担心,该试剂在英国和其他一些欧洲国家的使用一直受到限制。本文综述了有关鲁米诺试剂对于健康的影响的研究进展,分析显示只要采取适当的防护措施,在犯罪现场或在实验室使用鲁米诺试剂的安全风险可控。     

Interference competition between an invasive parakeet and native bird species at feeding sites

Interference competition has proved to be a factor of successful establishment of invasive species. This type of competition may have a stronger impact when native species have temporal niche overlap with the invasive species. The ring-necked parakeet Psittacula krameri has been successfully introduced in many countries and its interspecific agonistic behavior has already been reported. The purpose of this study is to analyze the territorial and preemptive interference competition between the ring-necked parakeet and native bird species in a recently colonized area. We used an empirical approach by recording video sequences in gardens equipped with bird feeders in winter. Our results showed that the ring-necked parakeet was the most frequent species at the feeders. Several native species showed temporal niche overlap with the ring-necked parakeet, the highest overlap being with the starling Sturnus vulgaris. The starling was also the species most impacted by interference competition with the parakeet. Our study suggests that, by being most frequently present at the feeders, by demonstrating the most agonistic behavior and by hindering access to food of the other species, the ring-necked parakeet is a superior competitor and may compete with native bird species.     

Purification of intravenous immunoglobulin G from human plasma--aspects of yield and virus safety

Plasma-derived intravenous immunoglobulin (IVIG) preparations have been successfully applied for the prophylactic prevention of infectious diseases in immunodeficient patients. In addition to its replacement therapy of primary and secondary antibody deficiencies, IVIG has found increased use in autoimmune and inflammatory diseases. IVIG has become the major plasma product on the global blood product market. The world wide consumption nearly tripled between 1992 and 2003, from 19.4 to 52.6 tons. Classical manufacturing processes of IVIG, but also new strategies for purification are discussed with respect to practicability and yield. Ethanol fractionation is still the basis for most IVIG processes, although isolation and purification of immunoglobulin G (IgG) by chromatography has gained ground. The efficiency of virus inactivation methods and virus removal techniques in terms of logarithmic reduction factors are analyzed, but also the IgG losses are taken into consideration. Some of these methods also have the ability to separate prions. High pathogen safety and high yields have become the dominant goals of the plasma fractionation industry.     

A BIOLOGICAL MARKET ANALYSIS OF THE PLANT‐MYCORRHIZAL SYMBIOSIS

It has been argued that cooperative behavior in the plant‐mycorrhizal mutualism resembles trade in a market economy and can be understood using economic tools. Here, we assess the validity of this “biological market” analogy by investigating whether a market mechanism—that is, competition between partners over the price at which they provide goods—could be the outcome of natural selection. Then, we consider the conditions under which this market mechanism is sufficient to maintain mutualistic trade. We find that: (i) as in a market, individuals are favored to divide resources among trading partners in direct relation to the relative amount of resources received, termed linear proportional discrimination; (ii) mutualistic trade is more likely to be favored when individuals are able to interact with more partners of both species, and when there is a greater relative difference between the species in their ability to directly acquire different resources; (iii) if trade is favored, then either one or both species is favored to give up acquiring one resource directly, and vice versa. We then formulate testable predictions as to how environmental changes and coevolved responses of plants and mycorrhizal fungi will influence plant fitness (crop yields) in agricultural ecosystems.