Gallerucida bifasciata (Coleoptera: Chrysomelidae), a potential biological control agent for Japanese knotweed (Fallopia japonica)

Host specificity of foreign natural enemies are becoming more and more critical in classical biological control programs, as concerns about potential risk from introduced biocontrol agents have been increasing recently. Understanding the insect's fundamental and ecological host ranges is the first step in determining the potential for introduction of an insect to control invasive plants. Japanese knotweed, Fallopia japonica (Houttuyn) Ronse Decraene (Polygonaceae) is an invasive weed in the United States and Europe. A leaf beetle, Gallerucida bifasciata (Coleoptera: Chrysomelidae) is an important natural enemy attacking this plant in Asia. However, its host range records were ambiguous. This study examined the beetle's host specificity through a set of choice and no-choice tests in the laboratory and field in its native China. Gallerucida bifasciata larvae were able to complete development on seven of 87 plant species in larval development tests, while adults fed and oviposited on 10 plants in no-choice tests. Multiple choice tests showed adults strongly preferred Fallopia japonica, Persicaria perfoliata (L.) H. Gross and Polygonum multiflorum Thunb over all other plants. Open field tests and field surveys further revealed that these three species were in its ecological host range. The results of this study suggest that G. bifasciata is a potential promising agent for control of Japanese knotweed in the United States and Europe, although additional host specificity tests and risk assessment should be completed.     

The practice of health risk assessment in the united states (1975–1995): How the U.S. and other countries can benefit from that experience

The process of quantitatively predicting the likelihood of an adverse response in humans or wildlife due to exposure to one or more chemicals is collectively known as environmental risk assessment. Quantitative risk assessment has been practiced in the United States and Canada for nearly 20 years and is the basis for most environmental and many occupational health regulations in North America. However, only since 1990 has it begun to receive serious consideration in Europe, Australia, Asia, and other regions. This paper reviews the historical evolution of health risk assessment in the United States and the scientific shortcomings in the process that have been introduced due to various regulatory policies. Despite these limitations and the reluctance of some countries to implement risk‐based policies, risk assessment will undoubtedly grow in importance within the international arena as other countries search for an ideal balance between cost and risk reduction. With the emergence of risk analysis as an international tool for understanding environmental issues, several improvements to the risk assessment process are recommended here that the United States and other countries could immediately incorporate into hazard identification, dose‐response and exposure assessments, and risk characterization. Examples of these improvements include use of a weight‐of‐evidence approach, physiologically‐based pharmacokinetic (PB‐PK) modelling, Monte Carlo techniques, and uncertainty analyses. These recommendations could, if coupled with an understanding of the historical experience in the United States, lead to superior environmental risk assessment policies for all countries as they enter the 21st century.     

Cell and tissue therapy regulation: worldwide status and harmonization

Rapid developments in scientific and technological aspects in stem cell biology and tissue engineering have led to the increased use of human cells and tissues for the treatment of various diseases and injuries. The regulatory environment for CTT products is rapidly evolving and drug regulatory agencies are working towards establishment of a risk-based system with some common features. Various drug regulatory agencies in many countries/regions have implemented regulatory controls in the last few years. This article will highlight some of works done till date to regulate CTT products in Australia, Canada, Europe, Japan, Korea, Singapore and United States of America.     

GM crops: science, politics and communication

As the public debate in Europe about genetically modified (GM) crops heats up and the trade row between the United States and the European Union over GM food escalates, what better time to examine the issues with an international group of experts (Box 1). Their views are diverse, but they all agree that we need more impartial communication, less propaganda and an effective regulatory regime that is based on a careful case-by-case consideration of GM technology. It seems that GM crops are here to stay, so let us hope that these requirements are met and that the developing nations that perhaps have the most to gain from this technology can start to reap its benefits.     

An analysis of historical trends in classical biological control of arthropods suggests need for a new centralized database in the USA

The documentation of biological control agents targeting arthropods in the United States has historically been subject to less regulation relative to weed biological control releases. This study reviews publicly available databases to track environmental releases of biological control agents targeting arthropods in the United States. It then presents available data for the states with the most releases between 1962 and 2005: Hawaii, California and Florida. These data indicate a clear decline in rates of introduction since 1982 or 1994, depending on the source. Existing record-keeping systems offer incomplete or inconsistent data for evaluation because they were designed with limited goals, attempt to capture excessive detail and are thus impractical, or are insufficiently resourced. Existing databases cannot be used to answer meaningful questions regarding non-target effects of introduced control agents. Current databases are inappropriately designed and insufficiently resourced to meet today's research and regulatory needs. We propose and describe a new database system for classical biological control of arthropods.     

Compositional similarity among urban floras within and across continents: biogeographical consequences of human-mediated biotic interchange

Anthropogenic activities have weakened biogeographical barriers to dispersal resulting in the global spread and establishment of an increasing number of non‐native species. We examine the broad‐scale consequences of this phenomenon based on an analysis of compositional similarity across urban floras in the northeastern United States and Europe. We test the prediction that homogenization of species composition is uniquely defined within vs. between continents based on the time and place of origin of non‐native species. In this case, for archaeophytes and neophytes in Europe (introduced before and after ad 1500, respectively) and non‐native species originating from within and outside the United States. More species in urban floras were shared within than between continents. Within Europe, archaeophytes shared more species across urban floras compared with neophytes; strong associations were not observed for non‐native species across US urban floras. Between the two continents, non‐native species in the United States that originated from outside the United States shared species primarily with archaeophytes but also with European natives and neophytes. These results suggest that the direction of biotic interchange was unidirectional with species moving primarily from Europe to the United States with archaeophytes playing a primary and non‐native species originating from outside the two continents a secondary role as a homogenizing source. Archaeophytes, based on combination of biogeographical, evolutionary, and ecological factors in association with a long history of anthropogenic influence, appear to have played a prominent role in the continental and intercontinental homogenization of species composition. This suggests that the uniform homogenization of the Earth's biota is not imminent and is presently directed by a combination of biogeographically defined anthropogenic and historical factors.     

Population structure and migration of the Tobacco Blue Mold Pathogen,Peronospora tabacina,into North America and Europe

Tobacco blue mold, caused by Peronospora tabacina, is an oomycete plant pathogen that causes yearly epidemics in tobacco (Nicotiana tabacum) in the United States and Europe. The genetic structure of P. tabacina was examined to understand genetic diversity, population structure and patterns of migration. Two nuclear loci, Igs2 and Ypt1, and one mitochondrial locus, cox2, were amplified, cloned and sequenced from fifty‐four isolates of P. tabacina from the United States, Central America–Caribbean–Mexico (CCAM), Europe and the Middle East (EULE). Cloned sequences from the three genes showed high genetic variability across all populations. Nucleotide diversity and the population mean mutation parameter per site (Watterson's theta) were higher in EULE and CCAM and lower in U.S. populations. Neutrality tests were significant and the equilibrium model of neutral evolution was rejected, indicating an excess of recent mutations or rare alleles. Hudson's S_nn tests were performed to examine population subdivision and gene flow among populations. An isolation‐with‐migration analysis (IM) supported the hypothesis of long‐distance migration of P. tabacina from the Caribbean region, Florida and Texas into other states in the United States. Within the European populations, the model documented migration from North Central Europe into western Europe and Lebanon, and migration from western Europe into Lebanon. The migration patterns observed support historical observations about the first disease introductions and movement in Europe. The models developed are applicable to other aerial dispersed emerging pathogens and document that high‐evolutionary‐risk plant pathogens can move over long distances to cause disease due to their large effective population size, population expansion and dispersal.     

Environmental Contaminants in the Botanical Dietary Supplement Ginseng and Potential Human Risk

Botanical dietary supplements have a long history of use in Europe and Asia, but the use of these products is becoming increasing popular in the United States. Because these products are classified as dietary supplements, the U.S. Food and Drug Administration does not routinely monitor them for environmental contaminants. Ginseng served as a model botanical dietary supplement and was purchased from suppliers in the United States, Europe, and Asia. Samples were analyzed for metals (e.g., cadmium, nickel) and chlorinated pesticides (e.g., PCNB, DDT, and metabolites). Flame and furnace atomic absorption spectrophotometry were utilized for analysis of metals, while gas chromatography (GC) and GC-mass spectrophotometry were utilized for analysis of chlorinated pesticides. Because no formalized guidelines exist to determine risk of botanical dietary supplements, U.S. Environmental Protection Agency guidelines for protection of human health were used. Metals and chlorinated organics were found in Ginseng samples, but the concentrations posed no noncarcinogenic hazard; however, a 1000?mg/d dose for 350?d/yr resulted in 1 × 10^?6 carcinogenic risk in 19% of the Ginseng samples analyzed. At a lower usage rate (42?d/yr), no samples exceeded 1 × 10^?6 risk. Chlorinated organics, such as aldrin and heptachlor epoxide, accounted for the carcinogenic risk (1 X 10-6) in the Ginseng samples.     

Bacteriophage applications: where are we now?

Bacteriophages are bacterial viruses and have been used for almost a century as antimicrobial agents. In the West, their use diminished when chemical antibiotics were introduced, but they remain a common therapeutic approach in parts of eastern Europe. Increasing antibiotic resistance in bacteria has driven the demand for novel therapies to control infections and led to the replacement of antibiotics in animal husbandry. Alongside this, increased pressure to improve food safety has created a need for faster detection of pathogenic bacteria. Hence, there has been a resurgence of interest in bacteriophage applications, and this has encouraged the emergence of a large number of biotech companies hoping to commercialize their use. Research in Europe and the United States has increased steadily, leading to the development of a range of applications for bacteriophage agents for the healthcare, veterinary and agricultural sectors. This article will attempt to answer the question of whether bacteriophages are now delivering on their potential.     

报春花属植物的育种研究进展

本文对报春花属植物引种的历史和现状、育种途径和育种成果进行了综述。报春花属是报春花科最大的属, 全世界约500余种, 我国有296种。国外在杂交育种、多倍体育种、组织培养和体细胞融合等方面取得了许多研究成果, 而国内有关报春花属植物育种的研究相对较少。目前通过杂交育种或多倍体育种等手段已培育出众多花色丰富、花型各异或不含报春碱的报春花新品种。今后我国应在保护种质资源的基础上, 加强报春花新品种的培育, 并尽快实现产业化生产。     

Saw Palmetto Berry as a Treatment for BPH

Phytotherapeutic agents are often prescribed in Europe for the treatment of benign prostatic hyperplasia with lower urinary tract symptoms and are commonly used in the United States in over-the-counter preparations. Saw palmetto berry is the most popular of these agents, and in vitro some studies suggest that liposterolic extract of the plant has antiandrogenic effects that inhibit the type 1 and type 2 isoenzymes of 5alpha-reductase; however there are no clinical studies that show any decrease in serum dihydrotestosterone or prostate-specific antigen. Its efficacy in the treatment of lower urinary tract symptoms has not been conclusively proven. Clinical efficacy was suggested by a meta-analysis of Permixon, a formulation of saw palmetto, but the meta-analysis was done on suboptimal studies. One trial supports the equivalency of Permixon to finasteride in treating moderate to severe symptoms of benign prostatic hyperplasia, with less decrease in sexual function. However, without a control/placebo arm, the actual efficacy of the agents cannot be determined. Other than occasional gastrointestinal upset, no other side effects have been reported.     

报春花属植物的育种研究进展

本文对报春花属植物引种的历史和现状、育种途径和育种成果进行了综述.报春花属是报春花科最大的属,全世界约500余种,我国有296种.国外在杂交育种、多倍体育种、组织培养和体细胞融合等方面取得了许多研究成果,而国内有关报春花属植物育种的研究相对较少.目前通过杂交育种或多倍体育种等手段已培育出众多花色丰富、花型各异或不含报春碱的报春花新品种.今后我国应在保护种质资源的基础上,加强报春花新品种的培育,并尽快实现产业化生产.     

Patentability of life and ethics

Patent law has relied in part on ethical considerations since its inception in Europe. Such considerations have been introduced more recently in the United States. Whereas the EU Directive on the protection on the occasion of the Human Genome Project of biotechnological inventions was intended to foster economic development in Europe, its implementation is outweighted by controversy about patenting life and commercialization of science. The confusion created must be cleared at the international level through harmonization of patent office policies preventing abusive commercial practices in the absence of inventiveness.     

Genetic variation in eastern North American and putatively introduced populations of Ceratocystis fimbriata f. platani

The plant pathogenic fungus Ceratocystis fimbriata f. platani attacks Platanus species (London plane, oriental plane and American sycamore) and has killed tens of thousands of plantation trees and street trees in the eastern United States, southern Europe and Modesto, California. Nuclear and mitochondrial DNA fingerprints and alleles of eight polymorphic microsatellite markers of isolates of C. fimbriata from these regions delineated major differences in gene diversities. The 33 isolates from the eastern United States had a moderate degree of gene diversity, and unique genotypes were found at each of seven collection sites. Fingerprints of 27 isolates from 21 collection sites in southern Europe were identical with each other; microsatellite markers were monomorphic within the European population, except that three isolates differed at one locus each, due perhaps to recent mutations. The genetic variability of C. fimbriata f. platani in the eastern United States suggests that the fungus is indigenous to this region. The genetic homogeneity of the fungus in Europe suggests that this population has gone through a recent genetic bottleneck, perhaps from the introduction of a single genotype. This supports the hypothesis that the pathogen was introduced to Europe through Naples, Italy during World War II on infected crating material from the eastern United States. The Californian population may also have resulted from introduction of one or a few related genotypes because it, too, had a single nuclear and mitochondrial genotype and limited variation in microsatellite alleles.     

Lactic acid bacteria in a changing legislative environment

The benefits of using lactic acid bacteria in the food chain, both through direct consumption and production of ingredients, are increasingly recognised by the food industry and consumers alike. The regulatory environment surrounding these products is diverse, covering foods and food ingredients, processing aids, feed additives and dietary supplements. On a global basis, there are different approaches taken by the various regulatory authorities. While in Europe, the national legislation is gradually being harmonised, predominantly through the Novel Foods Regulation, there is still a wide disparity between the stringency of regulation of microbial products fed to animals and the comparatively relaxed approach to non-novel microbial products intended for human consumption. In the United States, the onus is on self-regulation of the manufacturer, with the Generally Recognised As Safe (GRAS) and Dietary Supplement Health Education Act (DSHEA) notification schemes encouraging industry to be more open about the ingredients they market. In Japan, the Foods for Special Health Use system continues to gain recognition as more products are approved, and is a potential model for other countries in regulating functional foods. Despite the different approaches to regulating these products, safety of microorganisms such as lactic acid bacteria in the food chain is paramount in all countries. This paper discusses the regulatory requirements of microbial products, predominantly lactic acid bacteria within the global markets, focusing mainly on the developments in Europe.     

Excess weight and sleep-disordered breathing.

Excess weight is a well-established predictor of sleep-disordered breathing (SDB). Clinical observations and population studies throughout the United States, Europe, Asia, and Australia have consistently shown a graded increase in the prevalence of SDB as body mass index, neck girth, or other measures of body habitus increases. Clinical studies of weight loss and longitudinal population studies provide strong support for a causal association. The role of excess body weight, a modifiable risk factor, with SDB raises many questions relevant to clinical practice and public health. The topic takes on added importance with the alarming rate of weight gain in children as well as adults in industrialized nations. Among adults ages 30-69 yr, averaging over the estimated United States 2003 age, sex, and BMI distributions, we estimate that approximately 17% of adults have mild or worse SDB (apnea-hypopnea index > or = 5) and that 41% of those adults have SDB "attributable" to having a body mass index of > or =25 kg/m(2). Similarly, we estimate that approximately 5.7% of adults have moderate or worse SDB (apnea-hypopnea index > or = 15) and that 58% of those adults have SDB attributable to excess weight. Clearly, if the expanding epidemic of obesity seen in the United States continues, the prevalence of SDB will almost certainly increase, along with the proportion of SDB attributable to obesity.     

Environmental enrichment for laboratory rodents

Modernization of housing and husbandry techniques for rodents has minimized confounding variables. The result has been vastly improved health maintenance and reproducibility of research findings, advances that have decreased the numbers of animals needed to attain statistically significant results. Even though not all aspects of rodent manipulation have been strictly defined, as housing and handling procedures have become increasingly standardized, many animal care personnel have recognized the lack of complexity of the rodents' environment. Concern for this aspect of animal well-being has led many research facilities to provide "environmental enrichment" for rodents. Additionally, regulatory agencies in the United States and Europe have also been increasingly concerned about this issue relative to laboratory animal husbandry. However, little is known about the influence such husbandry modifications may have on biological parameters. In this article, laws and guidelines relating to rodent enrichment are reviewed, the natural behaviors of select rodent species are discussed, and an overview of widely used types of enrichment in laboratory rodent management is provided. The literature evaluating effects of rodent enrichment is reviewed both in terms of neurological development and as an experimental variable, and results of a study evaluating the effect of enrichment on immune and physiological parameters are reported. Survey data on current enrichment practices in a large multi-institutional organization are presented, and practical aspects requiring consideration when devising a rodent enrichment program are discussed.     

Blood transfusion and hepatitis: still a threat?

The incidence of post-transfusion hepatitis (PTH) in recipients of blood products is reviewed. PTH was observed in 10%-12% of recipients of blood products in the United States, 2%-4% in northern Europe and 15%-20% in southern Europe. All studies indicate that 80%-90% of all PTH cases are attributed to non-A/non-B. At least 40% of the patients with PTH non-A/non-B will develop chronic hepatitis or cirrhosis. No specific tests for the detection of the non-A/non-B agent(s) exist. However, several independent studies indicate that part of the donors carrying the infectious non-A/non-B agent have increased levels of alanine amino transferase (ALT). When donors are excluded with elevated ALT values, it is estimated that about 30% of the PTH non-A/non-B cases would be prevented. Some studies indicate that anti-hepatitis B core (anti-HBc) positive donors may carry an increased risk to transmit the non-A/non-B agent, but more recent studies do not confirm this. There is hope that a specific non-A/non-B test will be developed soon.     

Assessing the Effects of Climate Change on Waterborne Microorganisms: Implications for EU and U.S. Water Policy

Despite advances in water treatment, outbreaks of waterborne diseases still occur in developed regions including the United States and Europe Union (EU). Water quality impairments attributable to elevated concentrations of fecal indicator bacteria, and associated with health risk, are also very common. Research suggests that the impact of such microorganisms on public health may be intensified by the effects of climate change. At present, the major regulatory frameworks in these regions (i.e., the US Clean Water Act [CWA] and the EU Water Framework Directive [WFD]), do not explicitly address risks posed by climate change. This article reviews existing U.S. and EU water quality regulatory legislation for robustness to climate change and suggests watershed modeling approaches to inform additional pollution control measures given the likely impacts on microbial fate and transport. Comprehensive analysis of future climate and water quality scenarios may only be achievable through the use of watershed-scale models. Unless adaptation measures are generated and incorporated into water policy, the potential threat posed to humans from exposure to waterborne pathogens may be amplified. Such adaptation measures will assist in achieving the aims of the EU WFD and US CWA and minimize impacts of climate change on microbial water quality.     

Sex,gender, and pharmaceutical politics: From drug development to marketing

Background: Biological sex differences and sociocultural gender norms affect the provision of health care products and services, but there has been little explicit analysis of the impact of sex differences and gender norms on the regulation of pharmaceutical development and marketing.Objectives: This article provides an overview of the regulation of pharmaceuticals and examines the ways that regulatory agencies account for sex and gender in their review of scientific data and marketing materials.Methods: The primary focus is on the US context, but information is also included about regulatory models in Europe, Canada, and Japan for comparative purposes. Specific examples show how sex differences and gender norms influence scientific and policy decisions about pharmaceuticals.Results: The United States and Canada were found to be the only countries that have explicit requirements to include women in clinical trials and to perform sex-based subgroup analysis on study results. The potential influence of politics on regulatory decisions may have led to an uneven application of standards, as seen through the examples of mifepristone (for abortion) and sildenafil citrate (for erectile dysfunction). Three detailed case studies illustrate the importance of considering sex and gender in pharmaceutical development and marketing: Phase I clinical trials; human papillomavirus quadrivalent vaccine; and tegaserod, a drug for irritable bowel syndrome.Conclusions: Sex and gender play important roles in pharmaceutical regulation, from the design of clinical trials and the approval of new drugs to advertising and postmarketing surveillance. However, regulatory agencies pay insufficient attention to both biological sex differences and sociocultural gender norms. This disregard perpetuates inequalities by ignoring drug safety problems that predominate in women and by allowing misleading drug marketing that reinforces gender stereotypes. Recommendations have been made to improve the regulation of pharmaceuticals in regard to sex and gender.