Application of Failure Mode and Effect Analysis (FMEA), cause and effect analysis, and Pareto diagram in conjunction with HACCP to a corn curl manufacturing plant

The Failure Mode and Effect Analysis (FMEA) model has been applied for the risk assessment of corn curl manufacturing. A tentative approach of FMEA application to the snacks industry was attempted in an effort to exclude the presence of GMOs in the final product. This is of crucial importance both from the ethics and the legislation (Regulations EC 1829/2003; EC 1830/2003; Directive EC 18/2001) point of view. The Preliminary Hazard Analysis and the Fault Tree Analysis were used to analyze and predict the occurring failure modes in a food chain system (corn curls processing plant), based on the functions, characteristics, and/or interactions of the ingredients or the processes, upon which the system depends. Critical Control points have been identified and implemented in the cause and effect diagram (also known as Ishikawa, tree diagram, and the fishbone diagram). Finally, Pareto diagrams were employed towards the optimization of GMOs detection potential of FMEA.     

Governing GMOs in the USA: science,law and public health

Controversy surrounds the production and consumption of genetically modified organisms (GMOs). Proponents argue that GMO food sources represent the only viable solution to food shortages in an ever‐growing global population. Science reports no harm from GMO use and consumption so far. Opponents fear the potentially negative impact that GMO development and use could have on the environment and consumers, and are concerned about the lack of data on the long‐term effects of GMO use. We discuss the development of GMO food sources, the history of legislation and policy for the labeling requirements of GMO food products, and the health, environmental, and legal rationale for and against GMO food labeling. The Food and Drug Administration regulates food with GMOs within a coordinated framework of federal agencies. Despite mounting scientific evidence that GMO foods are substantially equivalent to traditionally bred food sources, debate remains over the appropriateness of GMO food labeling. In fact, food manufacturers have mounted a First Amendment challenge against Vermont's passage of a law that requires GMO labeling. Mandatory GMO labeling is not supported by science. Compulsory GMO labels may not only hinder the development of agricultural biotechnology, but may also exacerbate the misconception that GMOs endanger people's health. © 2015 Society of Chemical Industry     

Classification and recognition of genetically modified organisms by chemometrics methods using terahertz spectroscopy

The aim of this study was to evaluate the potential of terahertz (THz) spectroscopy to discriminate genetically modified (GM) and non‐GM organisms. In this study, eighty‐four sugar beet samples (thirty‐six GM sugar beets and forty‐eight of their parents, non‐GM ones) were investigated using terahertz time‐domain spectroscopy (THz‐TDS) system between 0.2 and 1.2 THz. Discriminant analysis (DA) based on principal component analysis (PCA) was used to discriminate sugar beet samples into two classes: GM organisms (GMOs) and non‐GMOs. Study results indicate that the DA method leads to an excellent classification. A total of 95.8% of the non‐GM samples were accurately classified, and no GM samples were misclassified, as there was 100% correctness. Results of this study demonstrate that THz spectroscopy combined with chemometrics techniques can provide a fast, nondestructive and reliable method to differentiate GMOs and non‐GMOs, which avoids time‐consuming, laborious and expensive sensory and chemical analyses.     

Real-Time PCR-Based Ready-to-Use Multi-Target Analytical System for GMO Detection

This paper describes the development, production, and testing of a high-throughput analytical system, i.e., a unique screening tool for the unequivocal simultaneous identification of all currently EU-approved and all unapproved genetically modified organisms (GMOs) known to the Community Reference Laboratory for GM Food and Feed (CRL-GMFF), established according to Regulation (EC) No 1829/2003. The rationale and comparative advantage of the strategy selected as well as the formulation, potentiality, and flexibility of the system are illustrated here. The approach, developed in response to the worldwide growing testing needs, allows the event-specific simultaneous detection of 39 single-insert GMOs and their derived stacked events. System performance (specificity, efficiency, etc) has been successfully confirmed by experimental testing conducted within the CRL-GMFF and in collaboration with European control laboratories. The limit of detection (LOD) has been determined to be at least 0.045% expressed in haploid genome copies, thus in full compliance with EU requirements for method LOD. The “real-time PCR-based ready-to-use multi-target analytical system for GMO detection” developed by the Joint Research Centre is the first analytical tool worldwide allowing the simultaneous detection of so many genetic modification events using event-specific targets.     

微滴式数字PCR和实时荧光PCR在豆奶饮料转基因成分检测中的应用

为探索数字PCR在转基因成分筛选检测中的应用,解决现行转基因食品标准实施中的问题,完善我国转基因食品的检测监管体系。本文选取转基因启动子Ca MV35s和终止子NOS基因为靶标,大豆内源基因Lectin为内标,以转基因大豆标准品分别测定数字PCR和实时荧光PCR的浓度和含量检测低限,并应用于30批次豆奶饮料转基因成分实测。结果表明,数字PCR在转基因筛查的浓度检测低限达到0.04ng/反应,含量检测低限达到0.05%,均优于实时荧光PCR(0.2ng/反应,1%),且能够满足最严欧盟转基因标识阈值0.9%的检测要求。在豆奶饮料实际应用中发现,26批次样品两个平台检测结果一致为阴性,1批次一致为阳性,3批次Ct值在34.59～38.28之间的样品经数字PCR检测得到确切结果,说明数字PCR可辅助确认RT-PCR可疑结果,解决现行标准判定难题。     

Detection of genetically modified organisms in foods by DNA amplification techniques

In this article, the different DNA amplification techniques that are being used for detecting genetically modified organisms (GMOs) in foods are examined. This study intends to provide an updated overview (including works published till June 2002) on the principal applications of such techniques together with their main advantages and drawbacks in GMO detection in foods. Some relevant facts on sampling, DNA isolation, and DNA amplification methods are discussed. Moreover; these analytical protocols are discuissed from a quantitative point of view, including the newest investigations on multiplex detection of GMOs in foods and validation of methods.     

欧盟最新转基因食品、饲料法规浅析

欧盟颁布并执行了最新的转基因食品、饲料管理法规,规定了转基因食品、饲料的标识和可追溯性生产的管理办法。对欧盟转基因食品的理解和认识,将有助于指导和促进我国非转基因农产品及其加工品的对外出口。     

Screening food products for the presence of CaMV 35S promoter and NOS 3′ terminator

Biotechnology has enabled the modification of agricultural materials in a very precise way, thereby improving productivity and yields of economically important crops. There are a number of methods available for detecting genetically modified organisms (GMOs). In the present investigation, a qualitative PCR technique has been adopted in order to discriminate between genetically modified and non‐modified food products. The qualitative PCR assay employs primers specific for genetic elements that are used to generate genetically engineered agricultural crops. Two of the most common primers used for the detection of GMOs, 35S promoter and NOS 3′ terminator, have been tested over a panel of 24 food products purchased from the local market. The results indicated that, out of the 24 food products tested, three products gave positive results with the 35S promoter. The NOS 3′ primers gave negative results with all tested samples. Copyright © 2005 Society of Chemical Industry     

Co-existence and traceability of GM and non-GM products in the feed chain

According to the European Regulations (EC) 1829/2003 and 1830/2003, products which are, consist of or contain GMOs should be labelled and traceable in each stage of production, processing and distribution. Only in cases where the GMO level is below 0.9% and this presence is due to accidental contamination or is technically unavoidable, no labelling is required. As it is very unclear how feed manufacturers have implemented these new regulations, a Belgian survey was held to evaluate the current situation at importer and feed production level. Several bottlenecks were encountered, at the level of acquisition of raw materials and at production level, such as carry over of GM with non-GM soy in the production lines. Next to this, some weaknesses in the analysis of GMOs were also revealed.     

Detection of eight GMO maize events by qualitative, multiplex PCR and fluorescence capillary gel electrophoresis

Specific legislation in the EU and several other countries requires that foods containing genetically modified organisms (GMOs) should be approved and labelled. This has necessitated the development of methods for detection of such materials. For screening purposes these methods should preferably enable detection of several different GMOs. Here we present a simple, robust, qualitative, nineplex PCR method for event-specific detection of maize T25, GA21, TC1507, MON863, MON810, NK603, construct specific detection of BT176, BT11 and detection of the endogenous hmga maize reference gene. PCR is carried out with primers labelled with fluorescent groups and the amplicons are detected using fluorescence capillary electrophoresis. Using mixtures of DNA from different certified reference materials, the detection limit was determined to approximately 0.1% for each GMO. Good agreement was observed in 85 of 88 determinations when eleven food and feed samples were analysed using the multiplex PCR assay and compared to results from quantitative real-time 5′-nuclease PCR. Discrepancies were only observed for one GMO at or close to the detection limit. The presented method is therefore suitable for screening purposes for food and feed containing the most common maize GMOs.     

Genetically Modified (GM) Foods and Ethical Eating

The ability to manipulate and customize the genetic code of living organisms has brought forth the production of genetically modified organisms (GMOs) and consumption of genetically modified (GM) foods. The potential for GM foods to improve the efficiency of food production, increase customer satisfaction, and provide potential health benefits has contributed to the rapid incorporation of GM foods into the American diet. However, GM foods and GMOs are also a topic of ethical debate. The use of GM foods and GM technology is surrounded by ethical concerns and situational judgment, and should ideally adhere to the ethical standards placed upon food and nutrition professionals, such as: beneficence, nonmaleficence, justice and autonomy. The future of GM foods involves many aspects and trends, including enhanced nutritional value in foods, strict labeling laws, and potential beneficial economic conditions in developing nations. This paper briefly reviews the origin and background of GM foods, while delving thoroughly into 3 areas: (1) GMO labeling, (2) ethical concerns, and (3) health and industry applications. This paper also examines the relationship between the various applications of GM foods and their corresponding ethical issues. Ethical concerns were evaluated in the context of the code of ethics developed by the Academy of Nutrition and Dietetics (AND) that govern the work of food and nutrition professionals. Overall, there is a need to stay vigilant about the many ethical implications of producing and consuming GM foods and GMOs.     

Comparison of High-throughput and Manual DNA Extraction Methods for the Qualitative and Quantitative Analysis of MON810 Maize

PCR-based methods are widely used in the European Union and in other countries for the detection, identification, and quantification of genetically modified organisms (GMOs). The preparation of good-quality DNA from plant samples for GMO detection can be a challenging task, particularly if the DNA will be used for quantitative analysis. Two DNA extraction methods, namely manual (NucleoSpin Food kit from Machery-Nagel) and high-throughput partially automated (NucleoMag Plant kit from Machery-Nagel) methods, which utilize different DNA separation principles, were used for the isolation of DNA from maize flour samples. Despite the higher DNA recovery obtained using the high-throughput isolation method, a lower PCR efficiency was achieved, most likely due to the presence of PCR inhibitors in the extracts. We found both DNA extraction methods suitable for GMO analysis.     

Presentation and comments on EU legislation related to food industries – environment interactions and waste management

Although environment remained for a long time at the very top of most advanced countries governments’ agenda priorities, and a series of protocols like Montreal (1987), Kyoto (2002), Conference in Rio de Janeiro (1992) and legislations (White and Green Paper, 2001 and 1996, respectively) were put forward among others, the global awareness towards the environment continues to be at a very low level. The main problem towards enforcing legislation is the high cost invoked by most industries and municipalities. However, recent advances in remediation, composting, recycling technology have shown that waste treatment can result in high added value products (i.e. biodiesel, fertiliser) and advantageous to the environment as well. European Union (EU) legislation is currently considered one of the well‐compiled and strict legislations compared with other advanced countries (USA, Canada and Japan). Although food industries are not included in the highly polluting ones, their great volume of waste materials generated, makes imperative their undertaking actions in this direction. This review aims at presenting all the EU laws (from the waste management perspective) in connection with the food industries and their interactions with the environment and vice versa.     

Presentation and comments on EU legislation related to food industries–environment interactions: organic contaminants (chemicals, pesticides, dioxins, furans, biocides and their waste management)

The first part of this review on European Union (EU) legislation related to food industries–environment interactions deals with chemicals which, in their majority, make their way to food. Such substances are the pesticides and fertilizers the residues of which abound in many agricultural produces (both of plant or animal origin). Another crucial issue is the unintentional release of dioxins and furans through combustion. Detergents or sanitizers in conjunction with compounds considered hazardous or corrosive or flammable stand for other topics falling in the general category of chemicals employed in the food industry. The aim of this review is to cover all the current EU legislation in the field of chemicals (dioxins, furans, pesticides, biocides products, fertilizers, sanitizers) coming directly or indirectly in contact with food and their waste management by providing six comprehensive and easy‐to‐use tables, and a synopsis of the main points of the currently in force EU legislation.     

The German Molecular Register Project

Currently, the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) is running the project ”Development of a German Molecular Register as a web-based software application”. The Molecular Register shall integrate regulatory, phenotypic and molecular information on GMO, and allow the use of established bioinformatics tools in support of the Competent Authorities in their responsibilities according to Directive 2001/18/EC and Regulations (EC) No 1829/2003 and (EC) No 1830/2003.     

Development of a real-time PCR protocol for the species origin confirmation of isolated animal particles detected by NIRM

At present, European legislation prohibits totally the use of processed animal proteins in feed for all farmed animals (Commission Regulation (EC) No. 1234/2003–extended feed ban). A softening of the feed ban for non-ruminants would nevertheless be considered if alternative methods could be used to gain more information concerning the species origin of processed animal proteins than that which can be provided by classical optical microscopy. This would allow control provisions such as the ban of feeding animals with proteins from the same species or intra-species recycling (Regulation (EC) No. 1774/2002). Two promising alternative methods, near-infrared microscopy (NIRM) and real-time polymerase chain reaction (PCR), were combined to authenticate, at the species level, the presence of animal particles. The paper describes the improvements of the real-time PCR method made to the DNA extraction protocol, allowing five PCR analyses to be performed with the DNA extracted from a single particle.     

环介导等温扩增技术在转基因成分检测中的应用

随着全球转基因作物商业化种植面积持续增长,转基因成分检测作为转基因作物安全管理的重要技术支撑受到越来越多的关注,世界各国与地区不断致力于转基因成分检测技术的开发。环介导等温扩增（loop-mediatedisothermal amplification,LAMP）技术由于简单快速等特点,近年来在转基因检测领域备受青睐。本文对LAMP技术在转基因成分检测中的最新研究与应用及其发展前景加以综述。     

Welfare of animals at slaughter and killing: a new regulation on the protection of animals at the time of killing

Recently, the European Commission (EC) has published a proposal for a Council Regulation on the protection of animals at the time of killing. The proposed regulation will enhance the technical requirements of Directive 93/119/EC on the protection of animals at the time of slaughter or killing, which have not been amended since 1993. The main specific problems identified with the present EU legislation are the lack of harmonized methodology for new stunning methods, the lack of clear responsibilities for operators on animal welfare, the insufficient competence of personnel handling animals and insufficient conditions for the welfare of animals during killing for disease control purposes. The adoption of the “Hygiene Regulation Package”, which emphasizes the responsibilities of the food business operators on food safety, has also changed the legal environment for slaughterhouses. Furthermore, the first Community Action Plan on the Protection and Welfare of Animals, adopted by the EC in 2006, introduced new concepts such as the welfare indicators and the need for further research programs and centres of reference on animal welfare. Also, the European Food Safety Authority (EFSA) adopted two scientific opinions in 2004 and 2006 on the different stunning and killing methods to be used for main farm species either for slaughter for human consumption or for disease control purposes. The World Organization for Animal Health (OIE) in 2005 also adopted two international guidelines on the welfare of animals at slaughter. After presenting a picture of situation of meat sector in EU, the Author provides a broad overview on the regulatory situation and considers the legislative and scientific perspectives that lead the EC to draft new rules in this regard.     

Determination of eight genetically modified maize events by quantitative, multiplex PCR and fluorescence capillary gel electrophoresis

Specific legislation in the EU requires that foods containing more than 0.9% of genetically modified organisms (GMOs) should be labelled. This has necessitated the development of methods for detection and quantification of such materials. Here we present a robust, quantitative, 9-plex PCR method for event-specific detection of maize TC1507, MON863, MON810, T25, NK603, GA21, construct specific detection of BT11, BT176 and detection of the endogenous hmga maize reference gene. The method is suitable for quantification in the 0–2% range with a detection limit of approximately 0.1%. PCR is carried out in two stages. In the first stage, bipartite primers containing a universal 5′-sequence and a GMO specific 3′-sequence are used. In the second PCR stage only a universal primer is used. Trypsin digestion between the first and second PCR stages enhances signal strength and reproducibility. Probes hybridising to the PCR amplicons are then labelled by primer extension and detected by fluorescence capillary electrophoresis. Good agreement was observed in 76 of 80 determinations when 10 food and feed samples were analysed using the multiplex PCR assay and compared to results from quantitative real-time 5′-nuclease PCR. The presented method is therefore suitable for quantification purposes for food and feed containing the most common maize GMOs.     

欧盟关于食品添加剂和食品制成品的使用、进口和营销法规

欧盟食品法规的主体由食品法律法规框架构成。此框架代码为：Regulstion 178/2002。该法律框架提供了以下几点：1、食品的定义；2、欧盟关于食品法律和食品贸易的原则和要求；3、欧洲食品安全机构（EFSA）的设立；4、快速警报系统和在食品安全危机时的危机管理和紧急应对机制。本文将对欧盟食品法规中的各种要求提供一个简要的概述。