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.

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.

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.

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_(0)^(2)+(u_(r)×c/=)^(2)=√0.012^(2)+(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。

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。

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)》。

Constructing the barley model for genetic transformation in Triticeae

Barley（Hordeum vulgare L.） is one of the oldest domesticated crops, showing dramatic adaptation to various climate and environmental conditions. As a major cereal crop, barley ranks the 4th after wheat, maize and rice in terms of planting area and production all over the world. Due to its diploid nature, the cultivated barley is considered as an ideal model to study the polyploid wheat and other Triticeae species. Here, we reviewed the development, optimization, and application of transgenic approaches in barley. The most efficient and robust genetic transformation has been built on the Agrobacterium-mediated transfer in conjunction with the immature embryo-based regeneration. We then discussed future considerations of using more practical technologies in barley transformation, such as the T-DNA/transposon tagging and the genome editing. As a cereal crop amenable to genetic transformation, barley will serve as the most valuable carrier for global functional genomics in Triticeae and is becoming the most practical model for generating value-added products.

Evaluation of the potential exposure of butterflies to genetically modified maize pollen in protected areas in Italy

Environmental impacts of genetically modified crops are mandatorily assessed during their premarket phase. One of the areas of concern is the possible impact on nontar- get organisms. Crops expressing Cry toxins might affect Lepidoptera larvae living outside cultivated fields, through pollen deposition on wild plants, which constitute their food source. While pollen toxicity varies among different events, possible exposure ofnontarget species depends on the agro-environmental conditions. This study was conducted in two protected areas in Italy, characterized by different climatic conditions, where many Lepi- doptera species thrive in proximity to maize cultivations. To estimate the possible exposure in absence of the actual stressor （e.g., Cryl-expressing maize plants）, we conducted a two-year field survey of butterflies and weeds. Indicator species were selected--Aglais （Inachis） io in the Northern site and Vanessa cardui in the Southern site--and their phe- nology was investigated. Pollen dispersal from maize fields was measured by collection in Petri dishes. Duration and frequency of exposure was defined by the overlap between pollen emission and presence of larvae on host plants. Different risk scenarios are expected in the two regions： highest exposure is foreseen forA. io in the Northern site, while minimal exposure is estimated for V. cardui in the Southern site. In the latter case, locally grown maize cultivars flower in mid-summer in coincidence with an aestivation period for several butterfly species due to hot and dry conditions. Moreover, host plants of V. cardui are at the end of their life cycle thus limiting food availability.

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。