美国生物工程食品信息披露制度的新变化及启示

2018年12月,美国农业部公布了《国家生物工程食品信息披露标准(实施细则)》,就美国生物工程食品信息披露制度的具体内容进行细化和完善,标志着美国生物工程食品信息披露制度基本建立。该文本主要包含以下几方面内容:增加可检测性条件、统一生物工程食品信息披露豁免条件、完善生物工程食品信息披露形式、设置自愿标识,以及生物工程食品信息披露主体的义务。通过分析发现,在法定标识的前提下,美国依旧秉持实质等同原则,在保护消费者知情权的同时确保标识制度的平稳过渡。针对我国转基因食品标识的乱象,借鉴美国经验,提出我国转基因食品标识制度在理念、标识对象、管理机构和豁免等方面的完善建议。     

国际转基因标识制度变动趋势分析及对我国的启示

转基因标识与消费者知情权和选择权密切相关,因而成为最受关注的转基因政策之一。从1997年第一个转基因标识制度诞生开始,全球已有70多个国家和地区开展了各具特色的转基因产品标识管理。2015年以来,受转基因产业发展政策、公众接受程度、农产品贸易需求、国家政治立场等多重因素的影响和作用,美国、韩国、俄罗斯、乌克兰和日本等国家相继着手调整转基因标识政策或改变实施细则,呈现出强制标识呼声高、标识范围扩大、标注方式更加明确、阴性标识更规范等特点。通过分析国际转基因标识制度及变动趋势,提出了我国转基因标识在扩大标识范围、设立标识豁免阈值和规范阴性标识等方面的管理建议。     

浅谈多国转基因产品标识制度对我国的启示

转基因产品（genetically modified organis, GMO）标识是为了表明该产品由转基因生物生产、加工而成的特殊标识,即标识产品中含有转基因成分。21世纪以来,全球共有60多个国家种植转基因作物,随之出现大量转基因产品。其标识问题关乎消费者的知情权和选择权而备受公众关注。一方面,随着全球转基因技术研发和应用的不断推进,国际上对转基因产品的标识管理更加关注与重视;另一方面,我国正处在有序推进生物育种产业化的关键期,转基因产品标识管理制度的与时俱进至关重要。2019年全球共有29个国家种植转基因作物,种植面积位列前十的国家依次是美国、巴西、阿根廷、加拿大、印度、巴拉圭、中国、南非、巴基斯坦以及玻利维亚,这10个国家的转基因作物总种植面积占全球总种植面积的97.9%。以其他9个国家的转基因标识管理制度为切入点,分析不同国家及不同标识类别的特点,旨在为我国的转基因产品标识管理工作提供启示与参考。     

非处方药的合理选用

1　非处方药的含义11　概念　非处方药简称ＯＴＣ,为英文ＯｖｅｒＴｈｅＣｏｕｎｔｅｒ的缩写,是国际上对非处方药的习惯称谓。意为某些不需要医师处方,病人及其家属可直接到药店自行判断、购买和使用的药品。非处方药制度在西方有些发达国家已实行四、五十年。据统计,目前约有40%的药物属于非处方药;而处方药则是必须凭执业医师或执业助理医师处方才可调配、购买,须在医师指导下使用的药品。12　标识　非处方药的专有标识图案为椭圆形背景下的ＯＴＣ3个英文字母。国家根据药品的安全性,将非处方药分为甲、乙两类。甲类非处方药专有标识为橙…     

欧盟在转基因产品的标识及其可追溯性上举棋不定

欧盟环境部长在最近的一次会议中未能就转基因产品的标识及其可追溯性的提议取得任何进展。由于七国政府都呼吁新的转基因产品的审批必须等待该提议的通过,看来,长时间的审批禁令还得至少持续到明年。一些部长争议说允许新的转基因产品的生产和进口的新规则的制订不可避免的将取消这个禁令。比利时、法国、卢森堡、希腊、澳大利亚、意大利和丹麦都表示在上述提议通过以前将继续支持禁令。在会议开始前,欧盟就说过,“该提议的目的是商议盟国成员对转基因产品的关注以及建立消费者的信心。修订的条例和两个新的规则的采纳将恢复欧盟对转基…     

护理标识在ICU护理安全管理中的应用

目的探讨护理标识在护理安全管理中应用的效果。方法制定全院统一、醒目的护理标识,在护理服务过程中规范、有针对性地使用护理标识,同时将护理标识作为护理质量考核的重要内容。结果应用护理标识后,护理人员风险防范意识增强,不良事件明显减少,患者对护理工作的满意度明显提高。结论护理标识的应用,有效控制了护理不良事件的发生,确保了护理安全。     

餐单营养标识的公众态度及认知状况——基于杭州城市居民的调查

目的：了解公众对餐馆餐单营养标识的态度及认知状况。方法：采用方便抽样的方法,对杭州市2 589名居民进行问卷调查,收集对餐单营养标识重要性、实用性和可推广性的态度以及对餐单营养标识内容、形式、存在的困难和推广范围的认知情况。数据清理及分析使用SAS 9.4统计软件包。结果：认为餐单营养标识重要、餐单营养标识会对点餐有影响和赞同推广餐单营养标识的人群比例分别为62.4%、80.7%和74.8%。通过微信参与调查者、女性、高教育程度者对餐单营养标识给予正面支持的人群比例更高（P<0.05）。受访者关注比例较高的营养信息包括原材料、能量和脂肪,分别为72.4%、50.4%和47.5%。支持率较高的餐单营养标识形式为营养素含量值和食物组成+营养素含量值,分别为57.3%和56.6%。推广餐单营养标识可能存在的困难主要有增加点餐时间、餐馆可能不配合和关注的人不多。67.2%的受访者希望未来先在中餐馆中推广使用餐单营养标识,支持率高于西式快餐店和中式快餐店。结论：公众对在我国推广餐单营养标识的支持度较高,比较关注在外就餐食物的原材料、能量和脂肪含量。未来应继续开展餐单营养标识相关研究,改善在外就餐的膳食质量。     

国际上主要国家和地区农业转基因产品的标识制度

转基因标识是表明产品含有转基因成分或者由转基因生物生产、加工而成的一种标识。随着全球转基因技术研发和应用的不断推进,国际上对农业转基因产品的标识管理更加关注与重视。通过阐述农业转基因产品标识制度的形成与发展过程,研究欧盟、美国、加拿大、日本、韩国等主要国家和地区的转基因产品标识管理制度,总结出成分关注标识、过程关注标识、自愿标识、强制性标识、定性标识、定量标识、全面标识、目录标识等不同标识类别的特点与利弊,并分析了国际上关于标识豁免及阴性标识等方面的政策规定,为我国的农业转基因产品标识管理工作提供了启示与参考。     

“未使用GM”标识成为妨碍消费者正确理解的原因

人们已经清楚“未使用转基因原料”的标识误导了消费者。“未使用”标识成为误导消费者的问题,这在世界范围内也很少见。虽有决心废止这种标识的动向,但是……[编者按]     

神经干细胞的研究进展及基因芯片技术的应用

神经干细胞(NSC)在发育过程中及治疗神经退行性疾病方面所起作用已引起广泛关注。体外实验证明,多种因素可调控神经干细胞的增殖及分化,但由于缺少特异的分子标识,我们对于体内的神经干细胞特性知之甚少。基因芯片技术的应用使寻找体内神经干细胞的特异标识成为可能,并且我们通过一种有效的数据分析方法(component plane presentation integrated self-organizing map,CPP-SOM)对神经干细胞的基因表达及调控机制进行了深入的研究。     

美国国家生物工程食品信息披露标准法案评析

美国“国家生物工程食品信息披露标准”法案出台的主要目的是统一转基因食品标识立法,避免出现州各自为政、部分州与联邦对立的局面,减少州际食品生产和交易的成本。法案优先于州标识立法,它在要求“强制”的同时,也为经营者提供了多种信息披露方式。披露要求及标准则由农业部在两年内制定规章予以确定。这一法案是美国各方妥协的结果,并未影响原有的生物技术政策和管理原则。在我国,转基因技术相关立法上亦存在矛盾和冲突,转基因食品标识问题尚未有定论。美国立法妥协的艺术值得我国借鉴,各方应当认可国家发展生物技术的目标。我国转基因食品标识立法需要高层次立法的明确授权,设置更多样的标识方式,并进行充分的法律实施评估。     

Product development strategies for foods in the era of molecular biotechnology

Breakthroughs in science and technology are accelerating development of new products that are impacting our regulatory systems. Genetically modified or bioengineering plant varieties have entered the food supply on a global basis, especially in the U.S. The U.S. Food and Drug Administration regulates on the premise of substantial equivalence and has developed premarket notification procedures and voluntary labeling guidelines. Japan's Ministry of Health, Labor and Welfare regulates biotechnology products and has imposed biotechnology labeling regulations. However, the EU continues to be in a regulatory gridlock between member states and has proposed strict traceability and labeling guidelines. These requirements are currently restricting imports of bioengineered foods and are creating an international debate. In contrast to bioengineered plant varieties, to our knowledge, there are no strains of lactic acid bacterial starter cultures on the market that contain rDNA. The majority of strains have been improved via selection and mutagenesis. However, conjugation and electroporation have been used to transfer native lactococcal phage resistance plasmids to industrial strains. In addition, plasmids have been introduced to allow for selection of certain characteristics and then been eliminated by curing. The potential benefits of bioengineered foods are far reaching and are one of the most important opportunities of this century. However, bioengineered foods remain an emotional debate that is affecting world trade.     

United States patents and fungal cultures

Summary Fungal biotechnology has generated a voluminous amount of technical literature and scientific data. Patents probably contain the most complete and detailed information about the use of fungal cultures in biotechnology. This article contains a brief review of the United States patent system where microorganisms form an integral part of the disclosure and explains the role of the American Type Culture Collection (ATCC) as a patent culture depository. A list based on the application of the ATCC fungal strains which have been cited or used in US patents and the names of the inventors, the titles of the inventions, and their patent numbers are included. This provides resource material particularly for developing countries as they begin to establish their own biotechnology.     

GM crops: science, politics and communication

As the public debate in Europe about genetically modified (GM) crops heats up and the trade row between the United States and the European Union over GM food escalates, what better time to examine the issues with an international group of experts (Box 1). Their views are diverse, but they all agree that we need more impartial communication, less propaganda and an effective regulatory regime that is based on a careful case-by-case consideration of GM technology. It seems that GM crops are here to stay, so let us hope that these requirements are met and that the developing nations that perhaps have the most to gain from this technology can start to reap its benefits.     

Environmental fate and behaviour of antibiotic resistance genes and small interference RNAs released from genetically modified crops

Rising global populations have amplified food scarcity across the world and ushered in the development of genetically modified (GM) crops to overcome these challenges. Cultivation of major crops such as corn and soy has favoured GM crops over conventional varieties to meet crop production and resilience needs. Modern GM crops containing small interference RNA molecules and antibiotic resistance genes have become increasingly common in the United States. However, the use of these crops remains controversial due to the uncertainty regarding the unintended release of its genetic material into the environment and possible downstream effects on human and environmental health. DNA or RNA transgenes may be exuded from crop tissues during cultivation or released during plant decomposition and adsorbed by soil. This can contribute to the persistence and bioavailability in soil or water environment and possible uptake by soil microbial communities and further passing of this information to neighbouring bacteria, disrupting microbial ecosystem services such as nutrient cycling and soil fertility. In this review, transgene mechanisms of action, uses in crops, and knowledge regarding their environmental fate and impact to microbes are evaluated. This aims to encapsulate the current knowledge and promote further research regarding unintended effects transgenes may cause.     

Generation of bioengineered feather buds on a reconstructed chick skin from dissociated epithelial and mesenchymal cells

Various kinds of in vitro culture systems of tissues and organs have been developed, and applied to understand multicellular systems during embryonic organogenesis. In the research field of feather bud development, tissue recombination assays using an intact epithelial tissue and mesenchymal tissue/cells have contributed to our understanding the mechanisms of feather bud formation and development. However, there are few methods to generate a skin and its appendages from single cells of both epithelium and mesenchyme. In this study, we have developed a bioengineering method to reconstruct an embryonic dorsal skin after completely dissociating single epithelial and mesenchymal cells from chick skin. Multiple feather buds can form on the reconstructed skin in a single row in vitro. The bioengineered feather buds develop into long feather buds by transplantation onto a chorioallantoic membrane. The bioengineered bud sizes were similar to those of native embryo. The number of bioengineered buds was increased linearly with the initial contact length of epithelial and mesenchymal cell layers where the epithelial‐mesenchymal interactions occur. In addition, the bioengineered bud formation was also disturbed by the inhibition of major signaling pathways including FGF (fibroblast growth factor), Wnt/β‐catenin, Notch and BMP (bone morphogenetic protein). We expect that our bioengineering technique will motivate further extensive research on multicellular developmental systems, such as the formation and sizing of cutaneous appendages, and their regulatory mechanisms.     

转基因食品安全性评价研究进展

自1996年全球转基因作物大规模商业化生产以来,转基因作物种植面积以年均10%左右的速度迅速增长,2013年种植面积已达1.75亿hm2。其在解决全球粮食问题、环境保护、提升粮食营养质量和品质、制药以及推动经济可持续发展方面展现了重要作用。但是,随着转基因商业化生产的深入,转基因技术的潜在风险性引起了社会以及国际上更广泛的关注。事实上,在转基因技术出现之初,科学家们就开始关注其安全性问题。相关国际组织（FAO、WHO、CAC、OECD等）经过数次研究制订了一系列与转基因食品安全性有关的评价原则、指南与措施等。随着转基因技术的发展,这些安全评价策略也在不断完善。我国目前已经基本建立了转基因食品的安全评价和管理体系。转基因食品在进入市场前要经过十分全面以及系统的安全性评价,包括营养学、毒理学、过敏性等方面,从而保障转基因食品的安全性。     

实质等同性原则和转基因食品的安全性评价

讨论转基因食品安全性评价中的一些热点话题：现代生物技术与传统育种比较,整体食物的动物毒性实验,实质等同性原则及其局限性,食品成分安全性评价,食品成分的预料外改变,抗生素抗性标记基因,过敏性问题,标签问题等。