The Controversial Seralini GMO Maize rat experiments have been re-examined:

The Controversial Seralini GMO Maize rat feeding experiments have been re-examined:

At a Conference held in Bratislava, Slovakia, on 16 April 2018, G-TwYST presented draft conclusions and recommendations regarding guidance on the design, conduct, interpretation, and analysis of animal feeding studies and their value for GMO risk assessment. The draft conclusions and recommendations can be downloaded.

@ Draft G-TwYST Conclusions & Recommendations - G-Twyst:

Some snippets:

Scientific value of rat feeding studies with whole food/feed for GMO risk assessment

• 1.1 The G-TwYST project provided a broad set of data indicating that the performance of rat feeding trials with whole food/feed for the risk assessment of a GM plant would not result in additional information pointing at possible health risks of the GM maize NK603 when compared to the earlier risk assessment published by EFSA (EFSA 2003). This approach comprises molecular characterisation of the genetic modification, phenotypic, agronomic and compositional analysis of the GM line in relation to its conventional counterpart and other non-GM lines (reference lines) as well as the evaluation of all identified intended and potential unintended differences with regard to possible adverse effects to human and animal health and the environment.
•  1.2. No potential risk has been identified in the course of the initial molecular characterization or in the compositional, phenotypic and/or agronomic analyses of NK603. The G-TwYST data from 90-day and long-term animal studies did not identify potential risks as well, and therefore support the result from the initial analyses.
•  1.3. No potential risk has been identified in the course of the 90-day rat feeding study with NK603. The G-TwYST data from the long-term feeding rat study with NK603 did not identify potential risks as well, and therefore support the results from the analysis of the initial analyses and 90- day rat feeding studies. G-TwYST DRAFT CONCLUSIONS AND RECOMMENDATIONS Bratislava, April 16, 2018 3
• 1.4. Three in vitro immune function assays (proliferative activity of lymphocytes upon mitogen and protein stimulation, production of cytokines, and phagocytic activity and respiratory burst of leukocytes) not included in the OECD Test Guideline 408 for single substances were performed in the course of the two 90-day rat feeding trials with the GM maize NK603. The GM maize NK603 did not affect the immune functions tested in both studies. Many of the measured variables had a low precision and, therefore, only very large differences can be detected with 80% power. Taken together, the above-mentioned analyses did not increase the scientific value of the 90- day rat feeding trials.
• 1.5. The necessity to perform a feeding trial with whole food/feed should be carefully evaluated given the high number of animals needed (in the case of the G-TwYST project: 720, 172 and 268 in the combined chronic toxicity/carcinogenicity study, the 90-day feeding trial with the 11 and 33% inclusion rates of the GM maize NK603 and the 90-day feeding trial with the 50% inclusion rate of the GM maize NK603, respectively).

References cited

EFSA (2003) Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the safety of foods and food ingredients derived from herbicide-tolerant genetically modified maize NK603, for which a request for placing on the market was submitted under Article 4 of the Novel Food Regulation (EC) No 258/97 by Monsanto, The EFSA Journal (2003) 9, 1-14 EFSA (2011a)

EFSA Guidance on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed. EFSA J. 9: 2438.

EFSA (2011b) Statistical significance and biological relevance. EFSA J. 9: 2372. EFSA (2013) Considerations on the applicability of OECD TG 453 to whole food/feed testing. EFSA J, 11: 3347.

EFSA (2014) Explanatory statement for the applicability of the Guidance of the EFSA Scientific Committee on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed for GMO risk assessment. EFSA J. 12: 3871.

EFSA GMO Panel Working Group on Animal Feeding Trials (2008) Safety and nutritional assessment of GM plants and derived food and feed: the role of animal feeding trials. Food Chem. Toxicol. 46 Suppl. 1: S2-S70.

Goedhart PW, van der Voet H (2017) G-TwYST Study B: A 90-day toxicity study in rats fed GM maize NK603. Statistical report. Report 31.10.17, Biometris, Wageningen, The Netherlands.

Goedhart PW, van der Voet H (2018a) G-TwYST Study A: Combined chronic toxicity and carcinogenicity study in rats fed GM maize NK603. Main statistical report. Report 32.02.18, Biometris, Wageningen, The Netherlands.

Goedhart PW, van der Voet H (2018b) G-TwYST Study C: A 90-day toxicity study in rats fed GM maize NK603. Statistical report. Report 37.03.18, Biometris, Wageningen, The Netherlands.

Goedhart PW, van der Voet H (2018c) G-TwYST: Power analysis for 2-year and 90-days rat feeding studies with 33%-50% maize. Report 39.04.18, Biometris, Wageningen, The Netherlands.

Goedhart PW, van der Voet H (2018d) G-TwYST: Cross studies statistical comparisons of NK33- and NK33+ versus the control feed. Report 38.03.18, Biometris, Wageningen, The Netherlands.

OECD (1998) Test No. 408: Repeated dose 90-day oral toxicity study in rodents. OECD Publishing, Paris.

OECD (2009a) Test No. 451: Carcinogenicity Studies. OECD Publishing, Paris. OECD (2009b) Test No. 453: Combined chronic toxicity/carcinogenicity studies. OECD Publishing, Paris.

Schmidt K, Döhring J, Kohl C, Pla M, Kok EJ, Glandorf DCM, Custers R, van der Voet H, Sharbati J, Einspanier R, Zeljenková D, Tulinská J, Spök A, Alison C, Schrenk D, Pöting A, Wilhelm R, Schiemann J, Steinberg P (2016). Proposed criteria for the evaluation of the scientific quality of mandatory rat and mouse feeding trials with whole food/feed derived from genetically modified plants. Letter to the Editor. Arch. Toxicol. 90: 2287-291. G-TwYST DRAFT CONCLUSIONS AND RECOMMENDATIONS Bratislava, April 16, 2018 8

van der Voet H, Goedhart PW, Schmidt K (2017) Equivalence testing using existing reference data: an example with genetically modified and conventional crops in animal feeding studies. Food Chem. Toxicol. 109: 472-485.