Scientific perspectives on regulating the safety of genetically modified foods

Regulation is often seen as the dull end of science. The recent storm over the introduction of genetically modified foods and the calls to regulate their consumption have had a negative effect on development of the science. Assuring the safety of genetically modified foods might raise questions where existing scientific data is limited and underline the need for further research.     

转基因食品安全性研究进展

转基因食品的安全性在世界范围内备受关注,近年来,已经成为公众争论的焦点。本文简要综述了转基因食品的现状和安全性,并介绍了我国政府对转基因食品的态度。此外,还对转基因食品的发展前景作了简要展望。     

基因修饰小鼠饲养管理及使用过程中问题探讨

随着基因修饰小鼠的广泛使用,在饲养管理中必然会遇到一些新问题。文章以北京大学医学部实验动物科学部清洁级动物实验设施中饲养的基因修饰小鼠为对象,着重探讨其在饲养管理和使用中出现的问题,并加以分析,为建立基因修饰小鼠的管理规范奠定基础。     

理性认识转基因植物食品的安全性

讨论现代生物技术的几个基本概念 ,如转基因生物、基因修饰生物、重组DNA植物以及对转基因植物食品安全性评价框架 ,阐明作者对转基因植物食品安全性的理解。     

Safety Assessment of Genetically Modified Foods

The development of novel foods produced through agricultural biotechnology is a complex three-stage process: gene discovery, line selection, and product advancement to commercialization. The safety of genetically modified foods is an integral part of the overall developmental process throughout all of the stages. In the discovery stage, the safety of the gene, its source, and the gene products must be considered. If any questions arise at this stage, these questions must be answered later in the developmental process. During the line selection stage, the genetically modified seed progresses through a variety of greenhouse and field trials. At this stage, the biological and agronomic equivalence of the genetically modified crop to its traditional counterpart must be compared. While the evaluations made during this stage are not specifically directed toward a safety assessment, many potential products with unusual characteristics are eliminated during this stage of development. However, the elimination of products with unusual agronomic or biological characteristics enhances the likelihood that a safe product will be generated. Finally, in the pre-commercialization stage, the genetically modified product undergoes a detailed safety assessment process. This process focuses on the safety of the gene products associated with the introduced gene and any other likely toxicological or anti-nutrient factors associated with the source of the novel gene and the crop to which it was introduced. The safety of the genetically modified product for both food and feed uses is considered. Thus far, all of the genetically modified products brought into the marketplace have been subjected to such an intensive safety assessment. The safety assessment data have been reviewed by regulatory authorities around the world. The current generation of genetically modified products are quite safe for human and feed animal consumption.     

阿根廷转基因作物安全管理制度概况及进展

阿根廷是最早采用转基因技术的国家之一,目前已成为全球第三大转基因作物种植国。阿根廷是全球尤其是拉美国家在生物技术产品监管和审批方面的先驱,其在转基因作物监管问题方面的丰富经验以及联合国粮食及农业组织的认可使阿根廷成为全球转基因作物监管的领导者之一。介绍了阿根廷转基因作物研发和应用、转基因作物监管体系、新型育种技术监管体系、转基因作物进出口情况以及追溯体系,讨论了转基因技术的引进对阿根廷的影响,旨在全面了解阿根廷转基因作物及新型育种技术的监管体系,为我国转基因作物安全管理提供参考。     

推进我国转基因玉米产业化的思考

首先分析了全球转基因玉米产业化情况,进而从国内转基因玉米产品消费现状、玉米生产中的技术需求以及我国转基因玉米研发现状等方面论述了我国推进转基因玉米产业化的必要性,并从科学上和管理上分析了推动转基因玉米产业化亟待解决的问题,对转基因研发人和安全管理工作提出了建议,以促进转基因玉米产业化的进程。     

基于CRISPR/Cas原理的转基因产品检测技术研究进展

随着转基因产品商业化种植面积不断增加、国际贸易日趋频繁,对转基因生物安全管理提出了更高的要求。转基因产品检测技术作为安全评价的关键环节,逐渐引起了各国政府的关注。目前,针对转基因产品的快速检测方法层出不穷,但这些检测方法对于设备、试剂和专业的实验人员均有较高的要求。因此,为了有效支撑转基因相关产业的发展和管理,亟需建立一种高灵敏度、高特异性及高效的转基因检测技术。基因组编辑技术是近年来迅速发展的一类遗传修饰技术,其代表技术——CRISPR/Cas技术,更是极大地推动了生物技术的发展。CRISPR/Cas技术除了被应用于基因编辑领域,也逐渐被应用于核酸分子检测领域。基于此,以转基因产品检测技术为立足点,从CRISPR/Cas的检测原理、检测效果等技术层面分析了CRISPR/Cas检测技术发展的必然性,并对其在转基因产品检测上的应用前景进行展望,旨在为我国转基因产品快速检测和有效监管工作提供资料,对于保障我国转基因产品贸易的顺利进行具有重要意义。     

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.     

Examining the Gap between Science and Public Opinion about Genetically Modified Food and Global Warming

There is great uncertainty due to challenges of escalating population growth and climate change. Public perception that diverges from the scientific community may decrease the effectiveness of scientific inquiry and innovation as tools to solve these challenges. The objective of this study was to identify the factors associated with the divergence of public opinion from scientific consensus regarding the safety of genetically modified (GM) foods and human involvement in global warming (GW). Results indicate that the effects of knowledge on public opinion are complex and non-uniform across types of knowledge (i.e., perceived and actual) or issues. Political affiliation affects agreement with science; Democrats were more likely to agree that GM food is safe and human actions cause GW. Respondents who had relatively higher cognitive function or held illusionary correlations about GM food or GW were more likely to have an opinion that differed from the scientific community.     

New EU legislation for risk assessment of GM food: no scientific justification for mandatory animal feeding trials

This commentary focuses on the potential added value of and need for (sub)‐chronic testing of whole genetically modified (GM) foods in rodents to assess their safety. Such routine testing should not be required since, due to apparent weaknesses in the approach, it does not add to current risk assessment of GM foods. Moreover, the demand for routine testing using animals is in conflict with the European Union (EU) Commission's efforts to reduce animal experimentation. Regulating agencies in the EU are invited to respect the sound scientific principles applied to the risk assessment of foods derived from GM plants and not to interfere in the risk assessment by introducing extra requirements based on pseudo‐scientific or political considerations.     

Genetically modified T cells in cancer therapy: opportunities and challenges

Tumours use many strategies to evade the host immune response, including downregulation or weak immunogenicity of target antigens and creation of an immune-suppressive tumour environment. T cells play a key role in cell-mediated immunity and, recently, strategies to genetically modify T cells either through altering the specificity of the T cell receptor (TCR) or through introducing antibody-like recognition in chimeric antigen receptors (CARs) have made substantial advances. The potential of these approaches has been demonstrated in particular by the successful use of genetically modified T cells to treat B cell haematological malignancies in clinical trials. This clinical success is reflected in the growing number of strategic partnerships in this area that have attracted a high level of investment and involve large pharmaceutical organisations. Although our understanding of the factors that influence the safety and efficacy of these therapies has increased, challenges for bringing genetically modified T-cell immunotherapy to many patients with different tumour types remain. These challenges range from the selection of antigen targets and dealing with regulatory and safety issues to successfully navigating the routes to commercial development. However, the encouraging clinical data, the progress in the scientific understanding of tumour immunology and the improvements in the manufacture of cell products are all advancing the clinical translation of these important cellular immunotherapies.KEY WORDS: Immunotherapies, Gene modification, TCR, CAR, T cell, Oncology, Efficacy, Safety, Regulation, Manufacturing, Clinical trial     

Shall I compare thee to a GM potato?

A fundamental issue in the safety assessment of genetically modified crops is the question of whether unintentional changes have occurred in the crop plant as a consequence of the genetic modification. This question was addressed recently by using a powerful metabolite fingerprinting and metabolite profiling method to assess whether genetically modified potatoes are substantially similar to their corresponding conventional cultivars.     

农作物抗除草剂基因工程

概述抗除草剂作物基因工程抗性基因的来源,产生抗性的机理,抗除草剂外源基因的导入方法,并对目前普遍关注的抗除草剂作物的安全性问题进行了讨论,提出了抗除草剂作物研究及开发中应注意的问题。     

Molecular characterization for food safety assessment of a genetically modified late blight resistant potato: an unusual case

Standard food safety assessments of genetically modified crops require a thorough molecular characterization of the novel DNA as inserted into the plant that is intended for commercialization, as well as a comparison of agronomic and nutritional characteristics of the genetically modified to the non-modified counterpart. These characterization data are used to identify any unintended changes in the inserted DNA or in the modified plant that would require assessment for safety in addition to the assessment of the intended modification. An unusual case of an unintended effect discovered from the molecular characterization of a genetically modified late blight resistant potato developed for growing in Bangladesh and Indonesia is presented here. Not only was a significant portion of the plasmid vector backbone DNA inserted into the plant along with the intended insertion of an R-gene for late blight resistance, but the inserted DNA was split into two separate fragments and inserted into two separate chromosomes. One fragment carries the R-gene and the other fragment carries the NPTII selectable marker gene and the plasmid backbone DNA. The implications of this for the food safety assessment of this late blight resistant potato are considered.

     

美国与欧盟的转基因食品安全性政策演变比对

随着转基因食品的研究与发展,人们对待转基因食品的态度表现为主要以美国和欧盟为主的两种代表性政策.美国采取遵循可靠科学原则,坚决反对预防原则,即对转基因食品采取积极支持,自愿标识的宽松政策;欧盟采取谨慎预防原则,必须标识和可追溯.从管理原则出发,结合相应采取的监管措施和相关条例,对两国从开始颁布转基因食品政策到当下态势的发展,并结合最新出台的政策进行跟踪分析,比对美国及欧盟对这些指令和条例的执行情况.     

转基因玉米的研究进展和食用安全性评价

玉米是我国重要的粮食作物和饲料作物。目前转基因技术作为生物育种技术的代表,已成为国际上育种的前沿和核心技术。世界各国利用转基因技术相继研发了具有多种优良性状的转基因玉米,创造了巨大的经济效益;同时统一、有效的监管措施是转基因玉米研发、推广和商业化的重要基础。食用安全性评价是有效监管的前提。针对转基因玉米的商业化和控制玉米重要性状基因的研究进展进行了综述,并对转基因玉米的食用安全性评价进行归纳分析,以期为我国转基因玉米的研发、管理和推广提供理论参考。     

转基因植物疫苗研究进展

疫苗是当今世界上控制及预防疾病发生的有效方法,利用植物作为生物反应器生产转基因疫苗,成本低廉,方便安全等特点,被认为新型疫苗的研究热点。从4个方面综述了转基因疫苗的研究概况,分析了其优点及不足,并对其未来的发展进行了展望。     

科学视角下的转基因技术认知和发展

转基因技术是现代生物技术的核心,在缓解资源约束、保障食物安全、保护生态环境、拓展农业功能等方面呈现出重要作用和巨大潜力。我国和世界上许多国家都把转基因技术作为抢占科技制高点、增强农业国际竞争力的战略选择。通过介绍农业转基因技术目前发展概况、舆论环境成因、应用趋势和本质特征,以及农业转基因生物安全管理的要求和情况,并对我国农业转基因技术产业发展进行思考和探索,帮助人们更好地了解转基因技术、更为科学地对待其应用和发展。     

A design for the control of apoptosis in genetically modified Saccharomyces cerevisiae

We have engineered a system that holds potential for use as a safety switch in genetically modified yeasts. Human apoptotic factor BAX (no homolog in yeast), under the control of the FBP1 (gluconeogenesis enzyme) promoter, was conditionally expressed to induce yeast cell apoptosis after glucose depletion. Such systems might prove useful for the safe use of genetically modified organisms.