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.

基于联合验证数据评定转化体定量检测结果测量不确定度

随着转基因生物及产品定量标识制度的不断完善,大批转化体定量检测方法的建立迫在眉睫,为了在实验数据积累不足的情况下,在检测方法建立初期及时评定测量不确定度,本研究以耐除草剂大豆DBN9004定量检测方法为例,在检测实验室积累到足够检测数据之前,在8家实验室对5种转基因含量样品进行联合验证,分析试验数据的再现性标准偏差,形成“自上而下”的不确定度预评定方法。结果显示:经格拉布斯法和科克伦法检验8家实验室数据,实验室5的数据存在离群值和岐离值,故剔除,7家实验室5个含量样品的再现性相对标准差RSD jR为6.025%~11.532%,均小于规定的35%,说明该方法具有良好的精密度。根据上述分析数据绘制回归曲线方程为s jR=0.0783×c≡j-0.0104,计算的相对标准不确定度分量u r=0.0783,u 0=0.012,进而将试样检测结果的平均值(c=)带入公式,计算定量结果的标准不确定度u=u 20+(u r×c=)2=0.0122+(0.0783×c=)2。结果表明基于联合验证数据评定转化体定量检测结果测量不确定度,为转化体定量检测方法建立初期提供了科学有效的实验室自行评定方法,为转基因生物及产品的安全监管提供了技术保障。

异种器官移植排斥反应及其预防治疗策略

异种器官移植是解决人类器官短缺问题的潜在方案。在过去的上百年里,异种器官移植经历了早期尝试和不断进步,目前已进入新的高速发展阶段,取得了一系列的成果,但异种器官移植排斥反应的管理较同种异体器官移植排斥反应更为棘手。为此,研究者们开发出了一系列免疫抑制策略,如使用基因修饰猪供体、使用传统和新型免疫抑制药、将供体猪的胸腺与供器官一同移植等,以实现调整受体免疫系统反应,降低排斥反应强度并延长移植物存活时间。本文就异种器官移植排斥反应发生机制、预防和治疗策略的相关研究进行评述,以期为促进异种器官移植的进一步发展提供参考。

异种器官移植配型现状及解决思路

器官移植术前配型是器官移植成功与否的关键,当前的异种器官移植术前配型方法源于人类同种异体器官移植,但方法简单,不能准确预判移植术后是否会发生排斥反应。异种器官移植的一个显著特点是供体来源稳定、基因型明确,因此取材方便,可重复性强。充分利用异种器官移植中供体可控的优势,在完善传统细胞学配型基础上,拓展组织水平配型手段,重视内皮细胞在配型中的作用,开发器官水平配型方法,通过多环节、多维度的术前配型有利于精确筛选出合适的供体,有利于减少异种器官移植术后排斥反应的发生。为此,本文从同种异体器官移植配型方法,当前异种器官移植配型方法、存在问题及可能的突破点进行综述,以期为异种器官移植配型的进一步研究提供参考。

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。

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。

异种器官移植亚临床研究专家共识(2024版)

异种器官移植亚临床研究是利用脑死亡受者进行的异种器官移植试验,是异种器官移植从基础研究和动物实验,逐步走向临床应用的重要中间环节,为异种移植的安全性和有效性提供了必要的数据支撑。为推进异种器官移植亚临床研究安全有序、科学规范地开展,根据相关法律和规范,中华医学会器官移植学分会异种移植学组从供体猪的选择、受者的选择标准、法律法规及伦理要求、试验终止时间的确定、家属知情同意制度、脑死亡判定标准等方面,制定了《异种器官移植亚临床研究专家共识(2024版)》。

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)。

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。

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.

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。