U.S. Food and Drug Administration Policy for Foods Developed by Biotechnology

Maryanski, James H.

doi:10.1021/bk-1995-0605.ch002

Cited by 12 publications

(10 citation statements)

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“…If a new plant/food product is found to be substantially equivalent in composition and nutritional characteristics to an existing plant/food product, it can be regarded as being as safe as the conventional food; however, in practice extensive safety testing still gets done even for those transgenic crops that are considered substantially equivalent (FDA 1992;OECD 1993;Maryanski 1995). Evaluation of substantial equivalence includes considerations of the characteristics of the transgene and its likely effects within the host; measurements of protein, fat and starch content; amino acid composition and vitamin and mineral equivalency, together with levels of known allergens and other potentially toxic components.…”

Section: Substantial Equivalencementioning

confidence: 99%

Biosafety and risk assessment framework for selectable marker genes in transgenic crop plants: a case of the science not supporting the politics

et al. 2007

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Selectable marker gene systems are vital for the development of transgenic crops. Since the creation of the first transgenic plants in the early 1980s and their subsequent commercialization worldwide over almost an entire decade, antibiotic and herbicide resistance selectable marker gene systems have been an integral feature of plant genetic modification. Without them, creating transgenic crops is not feasible on purely economic and practical terms. These systems allow the relatively straightforward identification and selection of plants that have stably incorporated not only the marker genes but also genes of interest, for example herbicide tolerance and pest resistance. Bacterial antibiotic resistance genes are also crucial in molecular biology manipulations in the laboratory. An unprecedented debate has accompanied the development and commercialization of transgenic crops. Divergent policies and their implementation in the European Union on one hand and the rest of the world on the other (industrialized and developing countries alike), have resulted in disputes with serious consequences on agricultural policy, world trade and food security. A lot of research effort has been directed towards the development of markerfree transformation or systems to remove selectable markers. Such research has been in a large part motivated by perceived problems with antibiotic resistance selectable markers; however, it is not justified from a safety point of view. The aim of this review is to discuss in some detail the currently available scientific evidence that overwhelmingly argues for the safety of these marker gene systems. Our conclusion, supported by numerous studies, most of which are commissioned by some of the very parties that have taken a position against the use of antibiotic selectable marker gene systems, is that there is no scientific basis to argue against the use and presence of selectable marker genes as a class in transgenic plants.

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Section: Substantial Equivalencementioning

confidence: 99%

Biosafety and risk assessment framework for selectable marker genes in transgenic crop plants: a case of the science not supporting the politics

et al. 2007

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“…24,[27][28][29][30][31] Safety assessments for GM foods consider seven domains, namely composition; dietary intake; nutritional data; toxicology; allergenic properties; and characteristics of the donor and host organisms. [30][31][32] To establish substantial equivalence, extensive comparative studies in both the GM and conventional food have to be conducted.…”

Section: Safety Of Genetically Modified Foodsmentioning

confidence: 99%

Genetically modified foods and allergy

Lee

Leung

2017

Hong Kong Med J

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“…είναι η διάρροια (Maryanski, 1995, Davies, 2001. Για το λόγο αυτό πρέπει να αναπτυ χθούν μέθοδοι για την ταυτοποίηση και το χαρακτηρι σμό των πιθανώς αλλεργιογόνων πρωτεϊνών, δεδομέ νου ότι η πρόκληση αλλεργίας είναι ένα κρίσιμο ζήτη μα που αφορά στα ΓΤΤ και το οποίο διερευνάται ιδι αίτερα από τους επιστήμονες (Kuiper et al, 2001).…”

Section: αξιολογηση της επικινδυνοτητας των γενετικως τροποποιημενων unclassified

“…Η τεχνική μεταφοράς των γονίδιων ονο μάζεται Γενετική Μηχανική και οι οργανισμοί που προκύπτουν με τον τρόπο αυτό ονομάζονται γενετι κώς τροποποιημένοι οργανισμοί (ΓΤΟ ή ΓΤ) ή διαγο-νιδιακοι, τα δε προκύπτοντα τρόφιμα ονομάζονται γε νετικώς τροποποιημένα τρόφιμα (ΓΤΤ). Τα διαγονι-διακά φυτά και ζώα έχουν την ικανότητα να μεταβι βάζουν τις νέες ιδιότητες στους απογόνους τους (FDA, 1992, Maryanski, 1995.…”

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Genetically modified food

Pappas¹,

Stefanidou²

2017

J Hellenic Vet Med Soc

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International consensus has been reached on the principles regarding evaluation of the food safety of genetically modified plants. The concept of substantial equivalence has been developed as part of a safety evaluation framework, based on the idea that existing foods can serve as a basis for comparing the properties of genetically modified foods with the appropriate counterpart. Substantial equivalence is a starting point in the safety evaluation, rather than an endpoint of the assessment. The development and validation of new profiling methods, such as DNA microarray technology, proteomics and metabonomics for the identification and characterization of unintended effects, which may occur as a result of the genetic modification, is recommended. The assessment of the allergenicity of newly inserted proteins and of marker genes is discussed. Also, the post-marketing surveillance of the foods derived from genetically modified crops is imperative.

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U.S. Food and Drug Administration Policy for Foods Developed by Biotechnology

Cited by 12 publications

References 1 publication

Biosafety and risk assessment framework for selectable marker genes in transgenic crop plants: a case of the science not supporting the politics

Biosafety and risk assessment framework for selectable marker genes in transgenic crop plants: a case of the science not supporting the politics

Genetically modified foods and allergy

Genetically modified food

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