Genetically-Modified Organisms in United States Agriculture: Mandate for Food Labeling

The production of foods with genetically modified organisms (GMOs) has risen rapidly over the past three decades to comprise nearly 90% of crops grown in the United States today. Currently, there are no mandates for labeling foods containing GMOs. GMO agricultural crops contain the insertion of genes encoding for pesticides, pesticide resistance, growth factors, or other substances not normally present. In addition to the foreign genes that are inserted, hundreds to thousands of mutations disrupt normal genes in GMO plants. Recently, animal studies have demonstrated toxicity of GMO foods causing organ failure, infertility, carcinomas and death. The FDA requirement of ingredients added to foods be labeled on the product is not applied to GMO foods, precluding the consumer’s right to know. GMOs provide an economic incentive to companies because the seeds can be patented, driving up costs and creating the potential for monopolies. Herbicide-resistance conferred by GMOs has resulted in higher pesticide applications, which correlate with higher human cancer rates, and the emergence of pesticide-resistant weeds and insects. GMO toxins are spreading into to non-target insects, waterways and aquatic organisms, with toxicity to non-target organisms and resultant contamination of disparate ecosystems in the food chain. The appropriateness of mandatory GMO labeling of foods in the United States is discussed.

Detection of Genetically Modified Crops by Combination of Multiplex PCR and Low-density DNA Microarray

Objective To develop a technique for simultaneous detection of various target genes in Roundup Ready soybean by combining multiplex PCR and low-density DNA microarray. Methods Two sets of the multiplex PCR system were used to amplify the target genes in genetically modified （GM） soybean. Seventeen capture probes （PCR products） and 17 pairs of corresponding primers were designed according to the genetic characteristics of Rroundup Ready soybean （GTS40-3-2）, maize （MonS10, Nk603, GA21）, canola （T45, MS1/RF1）, and rice （SCK） in many identified GM crops. All of the probes were categorized and identified as species-specific probes. One negative probe and one positive control probe were used to assess the efficiency of all reactions, and therefore eliminate any false positive and negative results. After multiplex PCR reaction, amplicons were adulterated with Cy5-dUTP and hybridized with DNA microarray. The array was then scanned to display the specific hybridization signals of target genes. The assay was applied to the analysis of sample of certified transgenic soybean （Roundup Ready GTS40-3-2） and canola （MS1/RF1）. Results A combination technique of multiplex PCR and DNA microarray was successfully developed to identify multi-target genes in Roundup Ready soybean and MS 1/RF1 canola with a great specificity and reliability. Reliable identification of genetic characteristics of Roundup Ready of GM soybean from genetically modified crops was achieved at 0.5% transgenic events, indicating a high sensitivity. Conclusion A combination technique of multiplex PCR and low-density DNA microarray can reliably detect and identify the genetically modified crops.

Evaluation of genetically modified rice detection methods 2011/884/EU and 2008/289/EC proposed by the European Union

Increases in the number of cases of identified genetically modified （GM） rice contamination can be traced back to the first Rapid Alert System for Food and Feed （RASFF） in 2006. In response to the lack of reliable detection methods, Decision 2011/884/EU proposed that new screening methods replace Decision 2008/289/EC, to identify all possible GM rice products originating in China. However, the synergy brands （SYBR） Green real-time PCR assay proposed by Decision 2011/884/EU has been shown to lack conformity with other TaqMan methods currently in use. To evaluate the specificity and repeatability of the methods recommended in Decision 2011/884/EU and Decision 2008/289/EC, we collected 74 rice products originating from six countries or districts. The 74 rice samples were tested using the Decision 2011/884/EU and Decision 2008/289/ EC methods. The parallel use of different instruments and reagents were used for testing in parallel, and the results were analyzed statistically. To avoid the limitations of specific laboratories, eight GM organism detection laboratories in China participated in a collaborative trial. In our tests, 24.3% （18/74） of the samples tested were positive with the SYBR Green real-time PCR assay using the Decision 2011/884/EU method, but were negative with the TaqMan real-time PCR assay using the Decision 2011/884/EU and Decision 2008/289/EC methods. Sequencing the PCR-amplified CrylA（b/c） genes in three samples （6, 30 and 43） showed that the products consisted of primer dimers rather than the targeted sequence. The combined experimental results showed that testing for the nopaline synthase gene （NOS） of Agrobacterium tumefasciens terminator and CrylA（b/c） produced false-positive results when the Decision 2011/884/EU method was used. Because of the high rate of false-positive results, the Decision 2011/884/EU SYBR Green method to detect GM rice requires improvement.

Development of a Multiplex Ligation Dependent Probe Amplification (MLPA) Module for Simultaneous Detection of Five Genetically Modified Rapeseed Events

For the official surveillance of genetically modified crops, efficient and simple detection methods need to be on hand to implement the strict requirements regarding approval, labelling and traceability determined by the European Union. Therefore, a multiplex ligation dependent probe amplification (MLPA) module was developed for simultaneous detection of five genetically modified rapeseed events (MS8, RF3, GT73, Falcon GS40/90 and T45). Probes were designed and concentrations were adapted in order to obtain high sensitivity and specificity. This MLPA module was validated using certified reference materials and its applicability was tested analyzing routine honey, mustard and rapeseed samples. The limit of detection was determined by analyzing a dilution series (n = 16 for each concentration) of respective transgenic DNA. After optimization, the MLPA revealed limits of detection between 10 to 50 copies of the transgene DNA/assay. The method proved to be sensitive and highly reproducible. When analyzing routine samples, results obtained applying the MLPA module were similar compared to real-time PCR.

中国公众对异种肾移植接受度的预测模型构建及验证

目的通过构建和验证基于异种移植调查问卷的预测模型,探讨中国公众对异种肾移植的态度。方法使用问卷星平台对中国公众进行方便抽样调查,分析公众对异种肾移植的接受度及影响因素。使用随机分配法将所有纳入的问卷(2280份)按7∶3分为训练集和验证集,构建预测模型并进行验证。结果共纳入2280份调查问卷,公众对于异种肾移植的接受度为71.3%。多因素分析结果显示性别、婚姻状况、居住地区、医保状况、宗教信仰、是否素食主义、异种肾移植知晓情况、是否肾移植等待者是公众能否接受异种肾移植的独立影响因素(均为P<0.05)。训练集预测模型的受试者工作特征(ROC)曲线下面积(AUC)为0.773,验证集预测模型的AUC为0.785,训练集和验证集校准曲线均提示预测模型有较好的预测价值,决策曲线分析(DCA)均提示模型预测效能较好。结论中国公众对于异种肾移植的接受度相对较高且存在较大提升空间。基于问卷调查所构建的预测模型预测效能较好,为今后的研究提供了参考依据。

遗传修饰生物体(GMOs)生态风险的监测

遗传修饰生物体（GMOs）释放的生态学风险往往要在相当长的时期内才表现出来，因而必须对其进行长期监测。监测的内容和方法依对象的不同而有所不同。在短期和长期监测中，数学模型具有重要的作用。本文就监测的内容、原则和方法进行了全面的论述。

转基因产品(GMOS)的国际贸易:对WTO的有力挑战

巨大的经济利益、产品品质安全的不确定性和消费者认识上的差异,使转基因产品成为国际贸易争端的新领域。转基因产品的国际贸易,对WTO的非歧视原则、组织机构、争端解决机构、公平贸易等方面构成了严峻的挑战。欲在保护消费者、环保者权益的同时促进转基因产品的贸易,要么对现有的WTO某些规则进行修改,要么设立新的国际机构处理转基因产品的贸易问题。

GMO技术进步与环境管理对策

从GMO技术进步与产业化的前提出发,描述了GMO种子研制技术与经营的产业化、种植的规模化及其在全球的贸易状况,分析了GMO作物的快速全球化状况,从环境和生物多样性对GMO作物的不确定性出发,论述了在这一过程中出现的环境、生态和对人体本身的安全问题和潜在的隐患,以及GMO对生态系统可能存在的长期影响,指出了国际上对GMO产品的基于产品和基于生产过程的两种主要管理方式,鉴于保护我国的环境、生态安全需要,最后探讨了相应的环境管理对策与建议。

走向临床的异种器官移植

器官移植是治疗终末期器官衰竭的最佳方案,但器官短缺是全球性的问题,限制了器官移植的进一步发展。最新的研究表明,基因修饰猪可能很快成为临床器官移植供体的现实替代来源。异种移植可能是解决器官短缺问题的有效途径之一。2021年以来,全世界完成了2例活体异种器官移植、6例脑死亡异种器官移植,并启动了异种肾移植的Ⅰ期临床试验,取得了超出预期的结果。因此,本文在回顾、分析近几年活体及脑死亡受者异种移植临床试验结果的基础上,讨论与异种移植临床研究相关的科学、技术和伦理问题,希望为我国异种器官移植临床研究提供借鉴,促进临床异种移植的发展。

Comparison of GMO Safety Management Policies in Major Countries and Regions

With the rapid development of genetic technology,the application of genetically modified crops has brought revolutionary changes to the global agricultural production and agricultural trade patterns,and has played an important role in ensuring human health,environmental safety and sustainable agricultural development.In order to strengthen genetically modified organisms(GMO)safety management,countries around the world have formulated GMO safety management policies adapted to their own national conditions with reference to internationally accepted practices.In this study,we carried out comparative studies among the United States,the European Union,Japan and other developed countries or regions and China from the aspects of regulations and management institutions,safety evaluation systems,and label management,so as to provide references for the improvement of China's GMO safety management policies.

Effects of GMO Agricultural Products on Living Things

By obtaining changes on gene sequences of living things with the applied biotechnological methods;The idea of“Genetically Modified Organisms(GMO)”,which aims to bring the living creature in question the original gene combinations with the desired characteristics,came to life in the late twentieth century.Despite the high probability that hunger problems may increase with the increasing world population;It is thought that plant breeding with classical farming methods will be insufficient in solving these problems.With various GMO applications developed all over the world,it aims to produce solutions to these problems.With the presence of GMO,it was possible to increase the shelf life of qualitative and quantitative values of the existing foods.In addition,decreases in agricultural use of pesticides used in agricultural struggle and threatening human health with GMO production are noteworthy.However,some concerns about anomalies that may occur in living things fed GMO products remain on the agenda.Because,in the long term,there is no clear and precise information that GMO will not have negative effects on living things;There are many recorded incidents showing their negative effects.

美国农政体系与转基因商业化——兼论中国转基因作物推广的影响

尽管仍然存在争议,但是转基因技术从实验室技术到商业化发展是全球农业发展的重要进步。在这一历史进程中,美国农政体系发挥了重要作用,尤其是法律体系的谦抑性和政策体系的现实性。本文也正是由此入手,通过回溯美国转基因商业化相关的代表性法案和政策,讨论美国农政体系在科技进步与商业实现之间的关系。站在发展角度,美国的历史经验在中国推动转基因商业化的进程,尤其对经济社会影响及相关争议的处理是具备参考价值的。出于将问题具体化的考虑,本文以中国玉米品种转基因技术的全面推广和品种放开为例,评估中国转基因商业化的具体经济影响,其结果不仅包含转基因作物推广将大幅提升中国粮食产能裕度的事实,同时也可能改变国内农业生产结构和利益分配格局,甚至会间接影响中美农业贸易结构。这也对丰富和完善中国农政体制提出了全新的要求,在策略上谋划新的篇章。

转基因大豆低水平混杂定量检测及其不确定度分析

开展转基因大豆GTS-40-3-2低水平混杂定量检测及其不确定度研究。在95%置信区间和成本可接受、操作程序不复杂的条件下,建立实时聚合酶链式反应(polymerase chain reaction,PCR)和数字PCR定性检测方法可稳定检出含0.01%转基因大豆GTS-40-3-2的样品,而数字PCR定量检测方法可对含0.1%转基因大豆GTS-40-3-2的样品进行准确定量,即使转基因含量低至0.05%,定量误差仍不超过50%。通过分析数字PCR定量的不确定度来源,参考化学分析中计算模型,给出转基因定量的不确定度测算公式,并以转基因大豆GTS-40-3-2为试样进行室内验证,计算得到含0.1%和0.05%的转基因大豆GTS-40-3-2定量扩展不确定度分别为23.56%和107.29%(k=2)。

The Development and Standardization of Testing Methods for Genetically Modified Organisms and their Derived Products

As the worldwide commercialization of genetically modified organisms （GMOs） increases and consumers concern the safety of GMOs, many countries and regions are issuing labeling regulations on GMOs and their products. Analytical methods and their standardization for GM ingredients in foods and feed are essential for the implementation of labeling regulations. To date, the GMO testing methods are mainly based on the inserted DNA sequences and newly produced proteins in GMOs. This paper presents an overview of GMO testing methods as well as their standardization.

转基因作物检测技术研究进展

转基因作物的广泛种植为人类社会带来了巨大的经济利益和社会效益,有效缓解了因土地不足或病虫害导致的粮食减产和不足的现状。由于目前转基因食品的生物安全仍存在不确定性,随着其种植面积的逐年增加,转基因食品检测在转基因生物安全监管中的作用越来越重要。因此,建立简单、快速、适用性强的转基因检测方法对转基因食品监管、评估和风险防范等具有重大的意义。本文针对目前三大类,分别为基于核酸水平的检测、基于蛋白水平的检测和基于代谢物水平检测的具体转基因检测技术的原理、应用和研究进展进行概述,并对相关的检测方法及其适用范围进行了简单概括,对比不同检测技术的优势和劣势,指出了目前转基因生物检测技术存在的问题,展望了未来转基因检测技术的发展方向,以期使人们对转基因检测技术的现状和发展趋势有较为清晰和全面的了解。

Current advances of biocontainment strategy in synthetic biology

Synthetic biotechnology has led to the widespread application of genetically modified organisms(GMOs)in biochemistry, bioenergy, and therapy. However, the uncontrolled spread of GMOs may lead to genetic contamination by horizontal gene transfer, resulting in unpredictable biosafety risks. To deal with these challenges, many effective methods have been developed for biocontainment. In this article, we summarize and discuss recent advances in biocontainment strategies from three aspects: DNA replication, transcriptional regulation, and protein translation. We also briefly introduce the efforts in the biocontainment convention, such as the recent publication of the Tianjin Biosecurity Guidelines for the Code of Conduct for Scientists.

Public awareness,participation and attitude toward the national biosafety framework and genetically modified organisms in Ghana

Public engagement in the development,promotion,and utilization of innovation is an important part of any biosafety decision-making process.Under the Cartagena Protocol on Biosafety,the public is expected to be involved in the development and handling of genetically modified organisms(GMOs)and the implementation of a national biosafety framework(NBF),which governs and regulates the operations of modern biotechnology and GMOs.In this study,we explore the state of public knowledge and awareness regarding GMOs and attitudes toward the NBF in Ghana using a survey conducted in three elite communities in Accra,the capital of Ghana.We interviewed 130 people and found that while most of the respondents obtained information on GMOs through the media,academic papers,and agriculture awareness workshops,access to information on the technology and the NBF was often limited.Our results showed that despite the existence of GMOs and an NBF in Ghana for many years,awareness,understanding,and knowledge of GMOs and the NBF remain inadequate.We found that young,better-educated males are more likely to accept GMOs and be aware of the NBF.This suggests the need for more widespread public education,engagement,and awareness development regarding GMOs,the NBF,and governing institutions as a way of resolving the problems created by misinformation,distrust,and fear,and increasing public confidence in GMOs.

农业转基因参与全球卫生治理的知识架构:殖民医学及其遗产

西方殖民医学以及作为其延续的当代全球卫生治理,留下的作为遗产的知识架构表现为自上而下的疾病根除法、基于成本-效益原则的狭义效果评价、对卫生问题背后结构性要素的忽略等。二战后农业援助的兴起,全球卫生治理主体向营养和农业领域的挺进,农业转基因研发机构与当代全球卫生治理在组织结构上的趋同以及指导农业转基因研发的议程对全球卫生治理的覆盖,这些因素共同促成了农业转基因遵循这一知识架构干预全球卫生问题的技术风潮。但该知识架构所存在的诸种局限,使得农业转基因参与的全球卫生治理疏离生活世界中的既存秩序和真实需求。因此,全球卫生治理质量的提升有赖于对架构本身及其所根植于的“全球科学”的反思和超越。

转基因实验室环境影响评价研究

转基因技术具有显著的经济效益和生态效益,但同时存在一定的环境影响,如基因漂流引起的生物多样性影响。我国针对转基因生物管理建立了五阶段管理体系,在实验研究阶段,需要进行环境影响评价。转基因项目管理的重点是生物安全问题。在实验室环评中,生物安全问题转化为实验室产生的“生物性污染”问题,由此,环评的重点是含有生物活性因子的废水、废气和固废的评价。根据我国现行相关标准情况,环评以定性评价为主,以“保守”为原则,控制生物活性因子随废水、废气和固废外溢,进而设计相关环保措施。

GMO法律政策:各国的对比与经验借鉴

随着生物技术的持续进步,转基因生物(GMO)已在全球范围内得到广泛应用。各国对于GMO的接纳态度及其相应的法律政策制定存在明显的差异。本研究对比分析了不同国家的GMO法律政策,旨在找出其背后的经济、社会、文化等驱动因素,并从中提取有益的经验和教训。研究发现,公众的接受度、国内外经济需求、以及对生物安全的关注程度均影响着各国GMO法律政策的形成。通过对比分析,本研究旨在为国家制定更加科学、公正和有效的GMO法律政策提供参考和建议。