scholarly journals Optimizing the Use of Zebrafish Feeding Trials for the Safety Evaluation of Genetically Modified Crops

2019 ◽  
Vol 20 (6) ◽  
pp. 1472 ◽  
Author(s):  
Isabelle Gabriëls ◽  
Lucia Vergauwen ◽  
Marthe De Boevre ◽  
Stefan Van Dongen ◽  
Ronny Blust ◽  
...  

In Europe, the toxicological safety of genetically modified (GM) crops is routinely evaluated using rodent feeding trials, originally designed for testing oral toxicity of chemical compounds. We aimed to develop and optimize methods for advancing the use of zebrafish feeding trials for the safety evaluation of GM crops, using maize as a case study. In a first step, we evaluated the effect of different maize substitution levels. Our results demonstrate the need for preliminary testing to assess potential feed component-related effects on the overall nutritional balance. Next, since a potential effect of a GM crop should ideally be interpreted relative to the natural response variation (i.e., the range of biological values that is considered normal for a particular endpoint) in order to assess the toxicological relevance, we established natural response variation datasets for various zebrafish endpoints. We applied equivalence testing to calculate threshold equivalence limits (ELs) based on the natural response variation as a method for quantifying the range within which a GM crop and its control are considered equivalent. Finally, our results illustrate that the use of commercial control diets (CCDs) and null segregant (NS) controls (helpful for assessing potential effects of the transformation process) would be valuable additions to GM safety assessment strategies.

2004 ◽  
Vol 87 (6) ◽  
pp. 1423-1432 ◽  
Author(s):  
Richard E Goodman ◽  
John N Leach

Abstract Global commercial production of genetically modified (GM) crops has grown to over 67 million hectares annually, primarily of herbicide-tolerant and insect protection crop varieties. GM crops are produced by the insertion of specific genes that either encode a protein, or a regulatory RNA sequence. A comprehensive safety evaluation is conducted for each new commercial GM crop, including an assessment of the potential allergenicity of any newly introduced protein. If the gene was derived from an allergenic organism, or the protein sequence is highly similar to a known allergen, immunoassays, e.g., Western blot assays and enzyme-linked immunosorbent assay tests, are performed to identify protein-specific IgE binding by sera of individuals allergic to the gene source, or the source of the sequence-matched allergen. Although such assays are commonly used to identify previously unknown allergens, criteria have not been established to demonstrate that a protein is unlikely to cause allergic reactions. This review discusses factors that affect the predictive value of these tests, including clinical selection criteria for serum donors, selection of blocking reagents to reduce nonspecific antibody binding, inhibition assays to verify specificity of binding, and scientifically justified limits of detection (sensitivity) in the absence of information regarding biological thresholds.


2012 ◽  
Vol 14 (02) ◽  
pp. 1250013 ◽  
Author(s):  
DENISE GALLO PIZELLA ◽  
MARCELO PEREIRA DE SOUZA

Brazil is the second largest producer of genetically modified crops (GM crops) and the National Technical Commission on Biosafety (CTNBio) the decision making agency on this matter. The country uses Risk Analysis (RA) and project EIA as tools for biosafety evaluation. This paper aims to review the appropriateness of these tools for evaluating the environmental impacts of GM crops, also considering institutional aspects. An overview of the process of release of GM crops in Brazil along with important operational and institutional aspects is provided. The results indicate that project EIA could be applied to GM crops in specific sites and RA could give support to the evaluation of GM crop itself. Regarding institutional issues, it is concluded that decisions should be made by the environmental bodies, and not by the CTNBio.


2020 ◽  
Vol 2020 ◽  
pp. 1-7 ◽  
Author(s):  
Parisa Keshani ◽  
Mohammad Hossein Sharifi ◽  
Mohammad Reza Heydari ◽  
Hassan Joulaei

Background and Objectives. With the increase in the growth of genetically modified (GM) crops, concerns as to the adverse effects of GM crops have risen in the community. The present systematic review seeks to assess the GM plants’ potential impacts on the sperm parameters, including sperm head, sperm motility, sperm abnormality, and fertility index. Materials and Methods. A structured literature search was independently performed by three authors on Scopus, Web of Science, PubMed, and Embase in January 2019. A total of 1467 publications were obtained by the search strategy after eliminating the duplicates. Moreover, the review only included articles written in English language. Other pertinent peer-reviewed publications were chosen (“snowballing”) from the reference lists in the selected publications. To assess the GM crop effects on infertility, experimental studies designed with the control group were selected. On the basis of abstract screening and full-text reviewing, 39 relevant publications were selected, seven of which were used in our review. To access the quality of articles, we used the Cochrane checklist. The collected articles were scored independently by three authors, and the publications with the eligibility criteria were included in our review. No article was excluded due to quality assessment. Results and Conclusion. Our findings indicated that GM products had no adverse effects on infertility indices such as the sperm head, sperm motility, sperm abnormality, and fertility indices. Long-term research still seems to be strongly necessary to ensure that the use of GM plants does not cause any harm to consumers, especially in infertility area.


2002 ◽  
Vol 61 (1) ◽  
pp. 25-29 ◽  
Author(s):  
I. R. Rowland

In contrast to the situation in the USA, where a wide range of genetically modified (GM) foods is available, in Europe very few GM products have been approved for marketing as foods, and there is widespread public concern about their safety and environmental impact. The marketing of a GM crop for food use in Europe falls under the EC novel foods regulations, and applications require the submission of an extensive dossier of information. The safety evaluation of GM foods presents considerable problems both in the conduct and interpretation of experimental studies, because conventional toxicity tests used in the evaluation of simple chemicals may not be appropriate for whole foods. To rationalise the safety evaluation process and to circumvent the difficulties in toxicological assessment of food materials, the concept of substantial equivalence has been developed. The concept is that if it can be demonstrated that the novel food is essentially similar to its conventional counterpart in terms of critical nutritional or anutritional components, then it is likely to be no more or less toxic than the latter. The possible introduction of unintended effects by the genetic modification process is particularly problematic for the safety evaluation process. The new genomic and post-genomic techniques are potentially valuable in the safety evaluation of GM foods, although they are as yet in their infancy.


Afrika Focus ◽  
2019 ◽  
Vol 32 (2) ◽  
Author(s):  
G. Gheysen ◽  
J. Maes ◽  
M. Valcke ◽  
E.I.R. Sanou ◽  
S. Speelman ◽  
...  

Genetically modified (GM) crops are cultivated globally on more than 185 million hectares, but the use of GM crops in Europe and Africa is very limited. Politicians are reluctant to allow such crops because they fear negative public reaction. The political hostility in the EU towards GM crops also has a significant impact on how African policy makers form their opinions for accepting GM crops in their own countries. However, studies reveal that specific types of GM food are welcomed by consumers and that few Europeans avoid GM labels when buying food. Similarly, African farmers and consumers are generally positive about GM crops. Policy makers should take these results into account when a decision needs to be made on whether or not to allow GM crop cultivation in their country. KEY WORDS: ACCEPTANCE, AFRICA, CONSUMERS, EUROPE, FARMERS, GM CROPS


2021 ◽  

Meeting future food needs without compromising environmental integrity is a central challenge for agriculture globally but especially for the Asia Pacific region – where 60% of the global population, including some of the world’s poorest, live on only 30% of the land mass. To guarantee the food security of this and other regions, growers worldwide are rapidly adopting genetically modified (GM) crops as the forerunner to protect against many biotic and abiotic stresses. Asia Pacific countries play an important role in this, with India, China and Pakistan appearing in the top 10 countries with acreage of GM crops, primarily devoted to Bt cotton. Genetically Modified Crops in Asia Pacific discusses the progress of GM crop adoption across the Asia Pacific region over the past two decades, including research, development, adoption and sustainability, as well as the cultivation of insect resistant Bt brinjal, drought-tolerant sugarcane, late blight resistant potato and biotech rice more specific to this region. Regulatory efforts of the Asia Pacific member nations to ensure the safety of GM crops to both humans and the environment are also outlined to provide impetus in other countries initiating biotech crops. The authors also probe into some aspects of gene editing and nanobiotechnology to expand the scope into next generation GM crops, including the potential to grow crops in acidic soil, reduce methane production, remove poisonous elements from plants and improve overall nutritional quality. Genetically Modified Crops in Asia Pacific provides a comprehensive reference not only for academics, researchers and private sectors in crop systems but also policy makers in the Asia Pacific region. Beyond this region, readers will benefit from understanding how GM crops have been integrated into many different countries and, in particular, the effects of the take-up of GM cropping systems by farmers with different socioeconomic backgrounds.


Global Jurist ◽  
2011 ◽  
Vol 11 (2) ◽  
Author(s):  
Alessandro Chiarabolli

The objective of the research is to analyse the way the European Union is addressing the issue of the coexistence between traditional, organic, and GM crops.In the European Union no form of agriculture, whether conventional, organic, GM, should be excluded. Farmers are free to choose the production type they prefer, without being forced to change patterns already established in the area, and without spending more resources.Today EU rules on genetically modified crops are very rigid; in particular, before starting a GM crops commercial cultivation, it is compulsory to obtain a specific European Commission authorisation (based on a safety risk assessment carried out by the European Food Safety Authority), and GM food and feed (threshold 0,9%) must be labeled (to inform consumers) and traced.Coexistence is the weak point of the European legislation in the field. The European Commission defines the term coexistence as the farmers’ ability to make a practical choice between conventional, organic and GM-crop production, in compliance with the legal obligations for labeling and/or purity standards. In simple terms, coexistence is a way of allowing farmers to choose between the three agricultural systems. Farmers’ choice to grow GM or non-GM crops depends not only on technical aspects related to the productivity gains and agronomic benefits to be gained from adopting this technology, but also on consumers’ preferences. Particularly in Europe, consumers continue to be concerned about the potentially adverse implications of widespread GM crop production for the environment and food safety. According to Directive 2001/18/EC (Article 26 bis), Member States may organise measures to avoid the unadventitious presence of GMOs in other non-GM products. In order to help the Member States to organise national coexistence measures, the European Commission adopted the Recommendation 2003/556/EC on the guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming. The act establishes that the approaches to coexistence need to be developed in a transparent way, based on technical guidelines and in co-operation with all stakeholders concerned. The guidelines are based on experiences with existing segregation practices and, at the same time, they ensure an equitable balance between the interests of farmers of all production types. Further, they state that management measures to ensure coexistence should be efficient and cost-effective, without going beyond what is necessary to comply with EU threshold levels for GMO labeling. Today it is accepted that total isolation of GM material, certainly once agricultural biotechnology is widespread in the EU, is impossible; coexistence focuses on the practices used to decrease the adventitious GM presence. The implementation of coexistence measures is a complex process owing to the diversity in field, farming and natural conditions extending over Europe.On 13 July 2010, the European Commission adopted a new coexistence package that consists of a coexistence Communication, a new Recommendation on co-existence of GM crops with conventional and/or organic crops, and a draft Regulation proposing a change to the GMO legislation. The new approach aims to achieve the right balance between maintaining an EU authorisation system and the freedom for Member States to decide on GMO cultivation in their territory. The new flexible European scenario will give to the Member States the possibility to decide whether to cultivate biotech crops, maintaining at the same time an EU wide science-based authorization system.


2021 ◽  
Author(s):  
Abolfazl Baghbani-Arani ◽  
Mona Poureisa ◽  
Hossein Alekajbaf ◽  
Rezvan Karami Borz- Abad ◽  
Khodadad Khodadadi-Dashtaki

Abstract Transgenic technologies expanded in many countries regarding the nutritional needs of the increasing population. There are, however, some concerns about possible risks in growing genetically modified (GM) food such as threats of biodiversity and food allergies making it a challenge. This study aimed at examining the economic effects and political scopes of GM food in the production sector and policies made by different countries in the world and Iran. Moreover, essential (practical and legal) solutions and guidelines for GM food production and consumption are provided, which are useful for governmental entities and Iranian politicians and consumers' rights. transgenic technology has been accepted by high-rank farmers to produce genetically modified crops due to an increase in net profit caused by improved yield in spite of the high cost of transgenic seeds. Among 11 countries producing GM crops in the world in 2018, the USA is the first country followed by Brazil and Argentina at second and third ranks. In 2018, 78, 76, 30 and 29% of soybean, cotton, corn and canola production areas respectively were under cultivation of GM varieties. Although Iran has been one of the leading Asian countries not only in the field of transfer of technical knowledge of genetic engineering, but also in the development of specialized knowledge of biosafety, and despite the production of several transgenic plant lines by Iranian researchers, no GM crop has obtained release and cultivation license except for genetically modified rice that its growing process was banned after government change. This study implies that GM crops growing and production process does not follow the global trend owing to scientific and legal infrastructures.


2002 ◽  
Vol 138 (3) ◽  
pp. 245-248 ◽  
Author(s):  
P. J. DALE

Evaluating environmental impact is more complex than statistical analysis; it requires value judgements about which kinds of environmental impacts are acceptable and which are not. The new EU Directive on the release and commercialization of genetically modified (GM) crops (2001-18-EC) includes a requirement for an assessment of indirect effects on the environment of farming practices associated with the introduction of a GM crop. There is also a requirement for post-commercialization monitoring to address impacts of scale and time. Both of these additions to the regulations present challenges in deciding how environmental impacts should be measured, and in judging their acceptability. Impacts can also be socio-economic. These frequently require scientific tools to help to resolve them. The demands by some food sectors for zero GM content in crop produce is likely to prove difficult or impossible to verify by analytical procedures. It will probably be necessary to agree on levels of tolerance of the presence of GM material in “non-GM” crop produce. It is important that the future use of biotechnology in agriculture is considered in the context of a broader discussion about our vision for agriculture and the environment over the coming decades.


2018 ◽  
Vol 12 (1) ◽  
pp. 240-250 ◽  
Author(s):  
Kiros Gebretsadik ◽  
Ashenafi Kiflu

Introduction:Genetically modified (GM) crop species were proven to be a solution for the increasing food consumption in many countries. The cultivation of transgenic plants is increasing from time to time. In 2017 alone, 27 different genetically modified (GM) crop species were produced in 40 countries.Explanation:Biotechnology is revolutionizing science, promising to solve hunger, malnutrition and production demands of industrial raw materials from plants. However, there are biosafety concerns that GM crops may have unintended and hazardous impacts on living organisms well-being and environment both on target and non-target organisms. To tackle such potential problems many countries are implementing international as well as national biosafety regulations. America, Brazil, Belgium, China and India are among the top GM crop users in the world, whereas Egypt, Sudan, South Africa and Burkina Faso are leading GM crop producers in Africa. Ethiopia has also developed its own policy and biosafety regulations for biotechnology products.Conclusion:The Ethiopian government has given due attention to GM crops as a tool for the transformation of agricultural productivity and quality. Before a couple of years, Bt cotton (cotton containing toxic protein fromBacillus thuringiensis) has been introduced to Ethiopia and is expected to bring fundamental change in the production of fibers for the textile industries and also will have crucial consequence to the forthcoming use of the modern biotechnological Science in the country. The introduction of Bt cotton is a typical example worth mentioning here which shows a relative flexibility of the current Ethiopian biosafety regulation. This paper reviews the possible challenges and opportunities of using GM crops in Ethiopia.


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