scholarly journals Safety Assessment of Food and Feed from GM Crops in Europe: Evaluating EFSA’s Alternative Framework for the Rat 90-day Feeding Study

2017 ◽  
Vol 65 (27) ◽  
pp. 5545-5560 ◽  
Author(s):  
Bonnie Hong ◽  
Yingzhou Du ◽  
Pushkor Mukerji ◽  
Jason M. Roper ◽  
Laura M. Appenzeller
Keyword(s):  
Safety Assessment ◽  
Gm Crops ◽  
Alternative Framework ◽  
Feeding Study ◽  
Food And Feed

scholarly journals Evaluation of the use of untargeted metabolomics in the safety assessment of genetically modified crops

Metabolomics ◽  
2020 ◽  
Vol 16 (10) ◽  
Author(s):  
Mohamed Bedair ◽  
Kevin C. Glenn
Keyword(s):  
Analytical Methods ◽  
Safety Assessment ◽  
Genetically Modified ◽  
Plant Biotechnology ◽  
Compositional Analysis ◽  
Untargeted Metabolomics ◽  
Gm Crops ◽  
Feed Composition ◽  
Analytical Technique ◽  
Food And Feed

Abstract Background The safety assessment of foods and feeds from genetically modified (GM) crops includes the comparison of key characteristics, such as crop composition, agronomic phenotype and observations from animal feeding studies compared to conventional counterpart varieties that have a history of safe consumption, often including a near isogenic variety. The comparative compositional analysis of GM crops has been based on targeted, validated, quantitative analytical methods for the key food and feed nutrients and antinutrients for each crop, as identified by Organization of Economic Co-operation and Development (OCED). As technologies for untargeted metabolomic methods have evolved, proposals have emerged for their use to complement or replace targeted compositional analytical methods in regulatory risk assessments of GM crops to increase the number of analyzed metabolites. Aim of Review The technical opportunities, challenges and strategies of including untargeted metabolomics analysis in the comparative safety assessment of GM crops are reviewed. The results from metabolomics studies of GM and conventional crops published over the last eight years provide context to enable the discussion of whether metabolomics can materially improve the risk assessment of food and feed from GM crops beyond that possible by the Codex-defined practices used worldwide for more than 25 years. Key Scientific Concepts of Review Published studies to date show that environmental and genetic factors affect plant metabolomics profiles. In contrast, the plant biotechnology process used to make GM crops has little, if any consequence, unless the inserted GM trait is intended to alter food or feed composition. The nutritional value and safety of food and feed from GM crops is well informed by the quantitative, validated compositional methods for list of key analytes defined by crop-specific OECD consensus documents. Untargeted metabolic profiling has yet to provide data that better informs the safety assessment of GM crops than the already rigorous Codex-defined quantitative comparative assessment. Furthermore, technical challenges limit the implementation of untargeted metabolomics for regulatory purposes: no single extraction method or analytical technique captures the complete plant metabolome; a large percentage of metabolites features are unknown, requiring additional research to understand if differences for such unknowns affect food/feed safety; and standardized methods are needed to provide reproducible data over time and laboratories.

Final Report on the Safety Assessment of Aldioxa

1993 ◽  
Vol 12 (3) ◽  
pp. 237-242
Keyword(s):  
Organic Compound ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Safety Data ◽  
Control Group ◽  
Final Report ◽  
Cosmetic Products ◽  
Feeding Study ◽  
Human Volunteers

Aldioxa is a heterocyclic organic compound used in cosmetic products as an astringent and skin conditioning agent. The oral LD50 for mice exceeds 23 mg/kg, and 8 g/kg for rats. All of the toxicologic parameters investigated in a 94-day subchronic feeding study in rats were similar in the test and the control group. No significant macroscopic adverse results were obtained in a three generation study in which rats were fed diets containing 10% Aldioxa. A suspension containing 25% Aldioxa was not a sensitizer when applied to the shaved backs of 3 male guinea pigs, nor when 10 animals were given intradermal injections of a 2% Aldioxa suspension on alternating days for a total of 10 applications and challenged after a 10-day nontreatment period. A hydrophilic unguent containing 4% Aldioxa was neither an irritant nor a sensitizer when evaluated on 200 human volunteers. The safety of Aldioxa has not been completely documented and substantiated. It cannot be concluded that this ingredient is safe for use in cosmetic products until the appropriate needed safety data cited in the report have been obtained and evaluated.

Application of food and feed safety assessment principles to evaluate transgenic approaches to gene modulation in crops

2010 ◽  
Vol 48 (7) ◽  
pp. 1773-1790 ◽  
Author(s):  
Wayne Parrott ◽  
Bruce Chassy ◽  
Jim Ligon ◽  
Linda Meyer ◽  
Jay Petrick ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Gene Modulation ◽  
Food And Feed ◽  
Feed Safety ◽  
Food And Feed Safety

New food from a potato somatic hybrid: nutritional equivalence and safety assessment by a feeding study on rats

2014 ◽  
Vol 95 (9) ◽  
pp. 1911-1917 ◽  
Author(s):  
Oumèma Nouri-Ellouz ◽  
Najiba Zeghal ◽  
Saloua Makni ◽  
Fatma Makni-Ayadi ◽  
Mouhanad Trigui ◽  
...  
Keyword(s):  
Somatic Hybrid ◽  
Safety Assessment ◽  
Feeding Study

scholarly journals Food and feed safety assessment of RNAi plants and products.

2021 ◽  
pp. 131-153
Author(s):  
Hanspeter Naegeli ◽  
Gijs Klete ◽  
Antje Dietz-Pfeilstetter
Keyword(s):  
Risk Assessment ◽  
Recombinant Proteins ◽  
Safety Assessment ◽  
Plant Metabolism ◽  
Specific Effects ◽  
Food And Feed ◽  
Feed Safety ◽  
Interfering Rna ◽  
Data Requirements ◽  
Food And Feed Safety

Abstract This paper evaluates the potential hazards of food and feed derived from RNAi plants including: adverse changes of plant metabolism; mechanisms and potential for non-target gene silencing in humans and livestock, including gut microbiome; bioinformatics tools for predictionof off-target sequences of interfering RNA; the possible non-specific effects of dsRNA and siRNA in mammals; and the comparison of data requirements for safety assessment of food and feed from RNAi plants and from plants expressing recombinant proteins. It also discusses exposure and RNAi-specific risk assessment.

scholarly journals Safety assessment of genetically modified milk containing human beta-defensin-3 on rats by a 90-day feeding study

2017 ◽  
Vol 100 ◽  
pp. 34-41 ◽  
Author(s):  
Xin Chen ◽  
Ming-Qing Gao ◽  
Dong Liang ◽  
Songna Yin ◽  
Kezhen Yao ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Genetically Modified ◽  
Feeding Study

scholarly journals Assessment of possible allergenicity of hypothetical ORFs in common food crops using current bioinformatic guidelines and its implications for the safety assessment of GM crops

2012 ◽  
Vol 50 (10) ◽  
pp. 3741-3751 ◽  
Author(s):  
Gregory J. Young ◽  
Shiping Zhang ◽  
Henry P. Mirsky ◽  
Robert F. Cressman ◽  
Bin Cong ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Gm Crops ◽  
Food Crops ◽  
Common Food

scholarly journals Hypothesis-based food, feed, and environmental safety assessment of GM crops: A case study using maize event DP-202216-6

2021 ◽  
Vol 12 (1) ◽  
pp. 282-291
Author(s):  
Jennifer A Anderson ◽  
Rod A. Herman ◽  
Anne Carlson ◽  
Carey Mathesius ◽  
Carl Maxwell ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Environmental Safety ◽  
Gm Crops
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