Assessment of the food safety issues related to genetically modified foods

International consensus has been reached on the principles regarding evaluation of the food safety of genetically modified plants. The concept of substantial equivalence has been developed as part of a safety evaluation framework, based on the idea that existing foods can serve as a basis for comparing the properties of genetically modified foods with the appropriate counterpart. Application of the concept is not a safety assessment per se, but helps to identify similarities and differences between the existing food and the new product, which are then subject to further toxicological investigation. Substantial equivalence is a starting point in the safety evaluation, rather than an endpoint of the assessment. Consensus on practical application of the principle should be further elaborated. Experiences with the safety testing of newly inserted proteins and of whole genetically modified foods are reviewed, and limitations of current test methodologies are discussed. The development and validation of new profiling methods such as DNA microarray technology, proteomics, and metabolomics for the identification and characterization of unintended effects, which may occur as a result of the genetic modification, is recommended. The assessment of the allergenicity of newly inserted proteins and of marker genes is discussed. An issue that will gain importance in the near future is that of post-marketing surveillance of the foods derived from genetically modified crops. It is concluded, among others that, that application of the principle of substantial equivalence has proven adequate, and that no alternative adequate safety assessment strategies are available.     

The potential of microalgal biotechnology: a review of production and uses of microalgae

An overview of the various aspects, promises and limitations of microalgal biotechnology is presented. The factors of importance in microalgal cultivation as well as the culture systems are briefly described. Microalgal biomasses can fulfil the nutritional requirements of aquatic larvae and organisms. The biochemical composition of algae can be improved by the manipulation of culture conditions. The nutritive value of the microalgal biomasses for human and animal consumption is also commented upon as well as some socio-economical aspects. Among the sources of required nutrients (N, P), wastewaters and manures can upgraded as culture media for microalgae the safety of which has to be evaluated. Harvesting of the biomass is one of the bottlenecks. The various techniques, physical, physico-chemical and biological are outlined and their feasibility and economic interest examined. Microalgal biomasses can be submitted to various technological transformations. Various processes are reviewed in the light of their effects on safety and nutritional value. The possible extraction of fine chemicals and the preparation of protein concentrates is also reported on. The various uses of microalgae lead to a possible competition, to be evaluated, between systems for the production of food, energy and chemicals. The review finally covers the application of genetic manipulation to microalgae.     

Surface‐enhanced Raman spectroscopy for on‐site analysis: A review of recent developments

On‐site identification and quantification of chemicals is critical for promoting food safety, human health, homeland security risk assessment, and disease diagnosis. Surface‐enhanced Raman spectroscopy (SERS) has been widely considered as a promising method for on‐site analysis due to the advantages of nondestructive, abundant molecular information, and outstanding sensitivity. However, SERS for on‐site application has been restricted not only by the cost, performance, and portability of portable Raman instruments, but also by the sampling ability and signal enhancing performance of the SERS substrates. In recent years, the performance of SERS for on‐site analysis has been improved through portable Raman instruments, SERS substrates, and other combined technologies. In this review, popular commercial portable Raman spectrometers and the related technologies for on‐site analysis are compared. In addition, different types of SERS substrates for on‐site application are summarized. SERS combined with other technologies, such as electrochemical and microfluidics are also presented. The future perspective of SERS for on‐site analysis is also discussed.     

CRISPR-Cas系统在植物中的研究进展与监管政策

基因编辑技术作为一种颠覆性新技术,现已广泛应用于作物的遗传改良,显示出巨大的发展潜力和应用价值。各国在加快技术研发的同时也十分关注其可能带来的安全性问题,相继出台了基因编辑作物的安全监管政策。综述了目前常用的CRISPR基因编辑系统的原理, 最新开发的一系列CRISPR变体,CRISPR系统在植物中的应用,基因编辑植物检测方法及国际上的相关监管政策,以期为我国基因编辑作物监管政策的制定提供理论数据。     

英国脱欧后基因技术监管趋势及对中国的启示*——基于英国《基因技术报告》的分析

英国脱欧后加快了生物技术领域的立法进程,迫切希望通过革新原先欧盟的保守监管模式,在保障技术安全的前提下充分发挥基因技术的应用价值。为实现该目标,英国发布了《基因技术报告》,旨在重新构建更加全面的基因技术监管体系。这一报告不仅分析了既有基因技术治理实践的不足,还指明了未来英国基因技术监管的方向。当前基因编辑、合成生物学等新型基因技术正处于高速发展时期,英国的报告也为这些技术的应用提供了一条可供参考的治理路径。     

In vitro gametogenesis and reproductive cloning: Can we allow one while banning the other?

In vitro gametogenesis (IVG) is believed to be the next big breakthrough in reproductive medicine. The prima facie acceptance of this possible future technology is notable when compared to the general prohibition on human reproductive cloning. After all, if safety is the main reason for not allowing reproductive cloning, one might expect a similar conclusion for the reproductive application of IVG, since both technologies hold considerable and comparable risks. However, safety concerns may be overcome, and are presumably not the sole reason why cloning is being condemned. We therefore assess the non‐safety arguments against reproductive cloning, yet most of these can also be held against IVG. The few arguments that cannot be used against IVG are defective. We conclude from this that it will be hard to defend a ban on reproductive cloning while accepting the reproductive use of IVG.     

蜈蚣草中砷超富集的分子机制研究进展

砷是一种毒性很强的类金属元素,土壤砷污染可引发一系列食品安全问题,进而威胁人类健康。蜈蚣草具有极强的富集砷的能力,在砷污染土壤的植物修复中具有重要的应用价值。深入阐释蜈蚣草超富集砷的分子机制是植物修复技术的核心理论基础。文中综述了蜈蚣草超富集砷的组学研究进展,以及目前鉴定到的砷富集过程中的重要分子元件,并对未来的研究方向和趋势进行了展望。     

Current status of regulating biotechnology-derived animals in Canada: animal health and food safety considerations

Development of an effective regulatory system for genetically engineered animals and their products has been the subject of increasing discussion among researchers, industry and policy developers, as well as the public. Since transgenesis and cloning are relatively new scientific techniques, transgenic animals are 'novel' organisms for which there is limited information. The issues associated with the regulation of transgenic animals pertain to environmental impact, human food safety, animal health and welfare, trade and ethics. It is a challenge for the developers to prove the safety of the products of biotechnology-derived animals and also for regulators to regulate this increasingly powerful technology with limited background information. In principle, an effective regulatory sieve should permit safe products while forming a formidable barrier for those posing an unacceptable risk. Regulatory initiatives for biotechnology-derived animals and their products should be able to ensure high standards for human and animal health, a sound scientific basis for evaluation; transparency and public involvement, and maintenance of genetic diversity. This review proposes a regulatory regime that is based on scientific risk based assessment and approval of products or by-products of biotechnology-derived animals and its application in context to Canadian regulations.     

DNA疫苗研究进展

DNA疫苗是20世纪90年代初出现的一种新型疫苗,近年来发展迅速,在预防和治疗病毒性疾病及肿瘤等方面效果显著。同传统的疫苗相比,DNA疫苗具有免疫效果好、生产成本低、临床应用方便等优点,但同样存在安全性的担忧。对DNA疫苗的发展及其作用机制、优势进行了综述,并对DNA疫苗的安全性提出了自己的观点与看法,可供DNA疫苗的研究者参考。     

Identity, traceability, acceptability and substantial equivalence of food.

The numerous food crises that Europe has experienced during the past five years have raised new consumer demands concerning the characterization, traceability, and safety of foods which are proposed on the market. The consumer has, at the same time, vigorously placed into question the modes of agricultural production in industrialized countries, as well as the structures and means of evaluating the food risks and the conditions of the consumer's participation in the public debate in these domains. For certain groups of consumers, one also attends a contestation of the expertise and the application to the food domain of the considerable progress that has taken place in the field of biotechnology. So it is that the development of genetically modified organisms (mainly plants, the raw material of food products) has experienced a slowing down in the European Union. The answers afforded to these new exigencies of consumers in matter of identity, traceability, and acceptability of the foods are dealt with in this paper, as well as the elements which may concur with the evaluation of their safety. The positive role that biotechnology can afford to the different domains is emphasized. A source of uneasiness, biotechnology is also a powerful tool for ameliorating the evaluation of the sanitary risks and for answering the hopes of the citizen in the food domain.     

Pesticides for locust control.

The factors influencing the choice of insecticides for locust control are effectiveness, safety in use, relative cost, and the formulations available. The relative importance of these factors varies with the scale of control. In small scale control by farmers safety and simplicity are paramount and a BHC dust is commonly used, but in large scale control operations by specialized organizations more toxic formulations ultra-low-volume (u.l.v.) concentrates and methods of application requiring considerable skills can be used. The remarkable effectiveness of dieldrin as a stomach poison appears to be due to its conversion to photodieldrin after application. Cases of poisoning following large scale control operations are rare, and fatalities in man unknown. Alternatives to organochlorine insecticides include fenitrothion, already recommended and used on a large scale against adults. Against nymphs the correct dosage of fenitrothion would cost nearly 11 times as much as that of dieldren. Recent experimental work with new insecticides has included safety tests with domestic animals and measurements of persistence. 1 microgram deposits of cyanofenphos, decamethrin and mecarphon, as well as of dieldrin and photodieldrin, on wheat seedlings left in the open under tropical conditions for two days, killed 80% or more first instar nymphs of the Desert Locust which fed on them.     

腺相关病毒作为基因治疗载体在生殖系统中的分布及影响的研究进展

腺相关病毒(adeno-associated virus,AAV)作为一种基因治疗载体被广泛应用于医学相关的各个领域。大量以AAV为载体的基因治疗被应用于药物研究,但目前国内外没有相关的基因药物应用于临床,原因在于其安全性问题有待进一步研究。AAV具有器官靶向性,易于分布在靶器官,但在非靶器官也会分布。AAV在生殖系统的短暂分布降低了对其功能的影响,但不排除潜在影响。就目前的研究结果来看,AAV不会整合在生殖细胞,从而不会对子代产生影响。本文将综述目前以腺相关病毒介导的基因治疗中对生殖系统安全性的研究进展,从载体在生殖系统的分布、对生殖系统功能的影响以及对子代影响的三个方面进行阐述。     

Allen Denver Russell Memorial Lecture, 2006. The use of microbicides in infection control: a critical look at safety, testing and applications

Microbial pathogens continue as major threats to health. Indeed, many ongoing societal changes are enhancing our vulnerability and exposure to several frank and opportunistic pathogens. This, together with rampant antimicrobial resistance and reduced prospects for newer drugs and vaccines, is forcing a higher reliance on microbiocides in infection prevention and control. That this reliance may not be well-founded becomes apparent from a closer look at current ways of testing and registering microbiocides, their label claims as well as human and environmental safety of certain widely used microbicidal chemicals. Many methods to test microbiocides for registration are flawed and/or entail test conditions irrelevant to field use. Pathogens listed on product labels may not be among those amenable to interruption through microbiocide use. The wide variations and discrepancies in existing national/regional regulations for registering microbiocides for sale stifle innovation. This is a critical look at the above-mentioned issues with emphasis on chemicals meant for use on environmental surfaces and medical devices. It highlights better ways to test microbiocides and to attain global harmonization of testing and product registration. It also details the known and potential dangers of microbiocide use and what to consider in choosing such formulations for optimal safety and effectiveness. End users are advised to be more critical and prudent in the selection and application of microbicidal chemicals, manufacturers are encouraged to explore infection control products and technologies that are safer in the workplace and for the environment, and regulators are urged to review and update the requirements and procedures for premarket review of microbiocide efficacy data and label claims. Independent investigations are also urgently needed to document the proportion of nosocomial infections that would be amenable to prevention through chemical disinfection of environmental surfaces.     

Plasmid DNA electrotransfer for intracellular and secreted proteins expression: new methodological developments and applications

In vivo electrotransfer is a physical method of gene delivery in various tissues and organs, relying on the injection of a plasmid DNA followed by electric pulse delivery. The importance of the association between cell permeabilization and DNA electrophoresis for electrotransfer efficiency has been highlighted. In vivo electrotransfer is of special interest since it is the most efficient non-viral strategy of gene delivery and also because of its low cost, easiness of realization and safety. The potentiality of this technique can be further improved by optimizing plasmid biodistribution in the targeted organ, plasmid structure, and the design of the encoded protein. In particular, we found that plasmids of smaller size were electrotransferred more efficiently than large plasmids. It is also of importance to study and understand kinetic expression of the transgene, which can be very variable, depending on many factors including cellular localization of the protein, physiological activity and regulation. The most widely targeted tissue is skeletal muscle, because this strategy is not only promising for the treatment of muscle disorders, but also for the systemic secretion of therapeutic proteins. Vaccination and oncology gene therapy are also major fields of application of electrotransfer, whereas application to other organs such as liver, brain and cornea are expanding. Many published studies have shown that plasmid electrotransfer can lead to long-lasting therapeutic effects in various pathologies such as cancer, blood disorders, rheumatoid arthritis or muscle ischemia. DNA electrotransfer is also a powerful laboratory tool to study gene function in a given tissue.     

We are what we eat: food safety and proteomics

In this review, we lead the reader through the evolution of proteomics application to the study of quality control in production processes of foods (including food of plant origin and transgenic plants in particular, but also meat, wine and beer, and milk) and food safety (screening for foodborne pathogens). These topics are attracting a great deal of attention, especially in recent years, when the international community has become increasingly aware of the central role of food quality and safety and their influence on the health of end-consumers. Early proteomics studies in the field of food research were mainly aimed at performing exploratory analyses of food (bovine, swine, chicken, or lamb meat, but also transgenic food such as genetically modified maize, for example) and beverages (wine), with the goal of improving the quality of the end-products. Recently, developments in the field of proteomics have also allowed the study of safety issues, as the technical advantages of sensitive techniques such as mass spectrometry have guaranteed a faster and improved individuation of food contaminating pathogens with unprecedented sensitivity and specificity.     

植物口服疫苗的研究进展

植物口服疫苗是通过转基因植物生产,通过口服的方式预防疾病的生物制品.作为一种新型疫苗,其研究开始于三十几年前.由于植物口服疫苗可以最大程度地降低传统疫苗的潜在风险,在疫苗生产中具有优势,因此拥有良好的商业生产前景.植物疫苗价格低廉,生产过程安全,可产生与注射疫苗相似效价效果,无论是在控制养殖业抗生素滥用的情况下作为替代...     

Screening of organic solvents for bioprocesses using aqueous-organic two-phase systems

The application of conventional organic solvents has been essential in several steps of bioprocesses in order to achieve sufficient economic efficiency. The use of organic solvents is frequently used either to partly or fully replace water in the reaction medium or as a process aid for downstream separation.Nowadays, manufacturers are increasingly requested to avoid and substitute solvents with hazardous potential. Therefore, the solvent selection must account for potential environmental hazards, health and safety problems, in addition to fulfilling the ideal characteristics for application in a process.For the first time, criteria including Environment, Health and Safety (EHS), as well as the technical requirements for reaction and separation have been reviewed, collected and integrated in a single organic solvent screening strategy to be used as a guideline for narrowing down the list of solvents to test experimentally. Additionally, we have also included a solvent selection guide based on the methodology developed in the Innovative Medicines Initiative CHEM21 (IMI CHEM21) project and applied specifically to water-immiscible solvents commonly used in bioprocesses.     

PHYTONET (http://www.dsa.unipr.it/phytonet), a Thematic Network Devoted to the Scientific,Economical, Environmental,and Social Aspects of Phytoremediation

Phytoremediation is a relatively new technology, whose practical application still requires more studies in various fields, including biology, sociology, legislation, and education. In order to establish a phytoremediation site, it is necessary that: (1) no detrimental effects are transferred to the surrounding environment, (2) the management of the site is effective from an economical and social point of view, and (3) the overall strategy is economically advantageous over other techniques. Waste management and treatment have a great social and psychological impact. Therefore, the public acceptance of phytoremediation application also depends on appropriate measures taken to inform people about the advantages and safety of this technology. Another very important aspect is the regulatory acceptance of phytoremediation as a valid alternative to other remediation or decontamination strategies. In this case the safety of the procedure utilized and the absence of environmental impacts is mandatory. In order to integrate these different aspects with modern strategies for phytoremediation, it is important that scientists, economists, lawyers, and managers from public and private agencies and institutions are able to share their own needs, experiences, and results. PHYTONET is a thematic network created with the purpose of addressing all of these issues and links with other networks operating on similar or complementary subjects.     

纳米银的抗菌机制及临床应用研究

纳米银因具备抗菌谱广、效果好、安全性高等特性,其医疗制品在临床治疗方面应用广泛。现普遍认为纳米银可通过释放银离子(Ag+)和诱导活性氧自由基的表达等方式达到杀菌目的,但其发挥抗菌作用的效果受到表面正电荷和粒子直径等因素影响。本文就纳米银的抗菌机制及临床实践应用进行综述,对现有的各种抗菌材料进行分类,重点探讨纳米银对金黄色葡萄球菌、大肠埃希菌、白假丝酵母菌和铜绿假单胞菌的杀菌和抑菌原理,以及其在抗菌过程中的影响因素,并阐述了纳米银及其复合材料在临床实践中的应用,以期为纳米银抗菌应用方面的后续研究提供一些参考。     

Suicide genes as safety switches in T lymphocytes

Broader application of adoptive transfer of tumor-specific T-lymphocytes is accompanied by the need for effective suicide genes to ensure the safety of this cell-based therapy. In vivo elimination of T-lymphocytes expressing the herpes simplex virus-derived thymidine kinase gene has demonstrated the feasibility of this suicide gene as safety switch. However, improvements are required to overcome initial problems, such as immunogenicity. Here, newly developed suicide genes, including inducible Fas, inducible caspase and CD20 are discussed. In addition, problems of clinical application of marker genes and gene transfer techniques, which are prerequisites for suicide gene therapy, are addressed.