Assessment of the safety of food derived from genetically modified (GM) crops

Harvard Center for Risk Analysis, Harvard School of Public Health, Harvard University, 718 Huntington Avenue, Boston, MA 02115, USA.
Food and Chemical Toxicology (Impact Factor: 2.9). 08/2004; 42(7):1047-88. DOI: 10.1016/j.fct.2004.02.019
Source: PubMed


This paper provides guidance on how to assess the safety of foods derived from genetically modified crops (GM crops); it summarises conclusions and recommendations of Working Group 1 of the ENTRANSFOOD project. The paper provides an approach for adapting the test strategy to the characteristics of the modified crop and the introduced trait, and assessing potential unintended effects from the genetic modification. The proposed approach to safety assessment starts with the comparison of the new GM crop with a traditional counterpart that is generally accepted as safe based on a history of human food use (the concept of substantial equivalence). This case-focused approach ensures that foods derived from GM crops that have passed this extensive test-regime are as safe and nutritious as currently consumed plant-derived foods. The approach is suitable for current and future GM crops with more complex modifications. First, the paper reviews test methods developed for the risk assessment of chemicals, including food additives and pesticides, discussing which of these methods are suitable for the assessment of recombinant proteins and whole foods. Second, the paper presents a systematic approach to combine test methods for the safety assessment of foods derived from a specific GM crop. Third, the paper provides an overview on developments in this area that may prove of use in the safety assessment of GM crops, and recommendations for research priorities. It is concluded that the combination of existing test methods provides a sound test-regime to assess the safety of GM crops. Advances in our understanding of molecular biology, biochemistry, and nutrition may in future allow further improvement of test methods that will over time render the safety assessment of foods even more effective and informative.

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Available from: André H Penninks
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    • "Although more study is further needed to verify these conclusions, it at least indicates that the risk of the GM food crop is approaching in any time. And in the aspect that the GM food crop has influences on the biotic environment in a certain region (König et al., 2004), with the GM Bt rice and its homologous rice (Bt rice) as materials, the scientists at Jiangsu University in China have studied the influences of the bacteria, fungi, Actinomyces, denitrifying bacteria and phosphatesolubilizing microorganisms in degradation process and found that the Bt protein in the GM rice has negative effects on bacteria and denitrifying bacteria. According to Regulations on Administration of Agricultural Genetically Modified Organisms Safety and based on the hazard level of the human, flora and fauna, microorganism and ecotope, the Genetically-Modified (GM) organism in agriculture is divided into 4 levels, safety level I represents the inexistence danger, safety level II represents low degree of hazard, safety level III represents medium danger, safety level IV represents high danger (Wang, 2011 "

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    • "Moreover, the direct effects of Cry toxins on mammalian cells have not yet been fully studied. The possible health risks of consumption of genetically modified organisms (GMOs) is under controversial debate worldwide (Konig et al., 2004; Seralini et al., 2009). Doubts regarding the safety of GMOs are encouraged because of the presence of conflicts of interest with some of these studies, particularly with the study conducted under the responsibility of the Monsanto Company regarding the transgenic corn MON863 that was finally approved in 2005 (Seralini et al., 2007). "
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    ABSTRACT: Crystal proteins (Cry) produced during the growth and sporulation phases of Bacillus thuringiensis (Bt) bacterium are known as delta endotoxins. These toxins are being used worldwide as bioinsecticides to control pests in agriculture, and some Cry toxins are used against mosquitoes to control vector transmission. This review summarizes the relevant information currently available regarding the biosafety and biological effects that Bt and its insecticidal Cry proteins elicit in mammals. This work was performed because of concerns regarding the possible health impact of Cry toxins on vertebrates, particularly because Bt toxins might be associated with immune-activating or allergic responses. The controversial data published to date are discussed in this review considering earlier toxicological studies of B. thuringiensis, spores, toxins and Bt crops. We discussed the experimental studies performed in humans, mice, rats and sheep as well as in diverse mammalian cell lines. Although the term 'toxic' is not appropriate for defining the effects these toxins have on mammals, they cannot be considered innocuous, as they have some physiological effects that may become pathological; thus, trials that are more comprehensive are necessary to determine their effects on mammals because knowledge in this field remains limited. Copyright © 2015 John Wiley & Sons, Ltd.
    No preview · Article · Nov 2015 · Journal of Applied Toxicology
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    • "uous amino acids . The research by using six and seven contiguous amino acids revealed identity of known allergens with Mo - CBP 3 isoforms . However , with the criterion of eight contiguous amino acids no identity could be observed . The approach using six contiguous amino acids is often criticized for generating high rate of false positives ( K€ onig et al . , 2004 ) . Many random results that show no risk of cross - reaction is observed when a short sequence of amino acids is used ( Hileman et al . , 2002 ) . A research with eight contig - uous amino acids is probably more effective in detection of immunogenic epitopes ( ILSI HESI , 2001 ; Hileman et al . , 2002 ) . In addition , the peptides fou"
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    ABSTRACT: Mo-CBP3 is an antifungal protein produced by Moringa oleifera which has been investigated as potential candidate for developing transgenic crops. Before the use of novel proteins, food safety tests must be conducted. This work represents an early food safety assessment of Mo- CBP3, using the two-tiered approach proposed by ILSI. The history of safe use, mode of action and results for amino acid sequence homology using the full-length and short contiguous amino acids sequences indicate low risk associated to this protein. Mo-CBP3 isoforms presented a reasonable number of alignments (> 35% identity) with allergens in a window of 80 amino acids. This protein was resistant to pepsin degradation up to 2 h, but it was susceptible to digestion using pancreatin. Many positive attributes were presented for Mo-CBP3. However, this protein showed high sequence homology with allergens and resistance to pepsin digestion that indicates that further hypothesis-based testing on its potential allergenicity must be done. Additionally, animal toxicity evaluations (e.g. acute and repeated dose oral exposure assays) must be performed to meet the mandatory requirements of several regulatory agencies. Finally, the approach adopted here exemplified the importance of performing an early risk assessment of candidate proteins for use in plant transformation programs. Copyright © 2015. Published by Elsevier Ltd.
    Full-text · Article · May 2015 · Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association
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