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On 28-29 March 2018 G-TwYST organises a worskhop in Antwerp to discuss the draft results and preliminary conclusions of the 90-day whole-food animal feeding studies for subchronic toxicity and the combined chronic toxicity (1-year) and carcinogenicity (2-year) study.  One part of the 90-day studies was already addressed in a written consultation procedure in Februaty 2018. Also included in the scope of the workshop is the proposed quality criteria for whole-food animal feeding studies, and preliminary conclusions on the scientific value of such studies for GMO risk assessment. An additional agenda item will be insights from an analysis of scientific controversies around animal feeding studies including the GMO case. More than 700 stakeholder contacts representing Competent Authorities, both at the EU and the national level of all 28 Member States, industry, farming and professional organisations, civil society organisations (CSOs) and scientists received a first announcement in December 2017 followed by a more detailed invitation with a preliminary agenda in January 2018. Participation in the workshop was open to anyone representing one of the stakeholder categories mentioned above.

 

Documents

In the course of the final stage stakeholder consultation the following documents have been made available to registered stakeholders:

 

1. The 90-day animal feeding study with 11 and 33% GMO maize NK603 in the diet (study B)

  • Goedhart, .W. & 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, .W. & van der Voet, H. (2017). G TwYST Study B. a 90-day toxicity study in rats fed GM maize NK603. Statistical report Appendices.
  • Alison, R.H. (2018). Histopathology Phase Report 90-Day subchronic toxicity study 1 in rats fed GM maize NK 603.
  • G-TwYST Study B data: Study design, randomisation, outliers, feed consumption, haematology, organ weight, blood & urine, clinical chemistry, phagocytes, CD markers (spleen, thymus, lymph nodes, bone marrow), proliferative activity of lymphocytes

 

2. The 90-day animal feeding study with 50% GMO maize NK603 in the diet (study C)

  • Goedhart, P.W. & van der Voet, H. (2018). 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,P .W. & van der Voet, H. (2018). G TwYST Study C. a 90-day toxicity study in rats fed GM maize NK603. Statistical report Appendices.
  • Alison, R.H. (2018). Histopathology Phase Report 90-Day subchronic toxicity study 2 in rats fed GM maize NK 603.
  • G-TwYST Study C data: Study design, randomisation, outliers, feed consumption, haematology, organ weight, blood & urine, clinical chemistry.
  • Final study Plan 90-day subchronic toxicity study 2 in rats fed GM maize 50% NK603, with amendments.
 

3. The combined chronic toxicity and carcinogenicity study (study A)

  • Goedhart, P.W. & van der Voet, H. (2018). 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, P.W. & van der Voet, H. (2018). G TwYST Study A. Combined chronic toxicity and carcinogenicity study in rats fed GM maize NK603. Statistical report, 3 months. Report 33.02.18, Biometris, Wageningen, The Netherlands.
  • Goedhart, P.W. & van der Voet, H. (2018). G TwYST Study A. Combined chronic toxicity and carcinogenicity study in rats fed GM maize NK603. Statistical report, 6 months. Report 34.02.18, Biometris, Wageningen, The Netherlands.
  • Goedhart, P.W. & van der Voet, H. (2018). G TwYST Study A. Combined chronic toxicity and carcinogenicity study in rats fed GM maize NK603. Statistical report, 12 months. Report 35.02.18, Biometris, Wageningen, The Netherlands.
  • Goedhart, P.W. & van der Voet, H. (2018). G TwYST Study A. Combined chronic toxicity and carcinogenicity study in rats fed GM maize NK603. Statistical report, 24 months. Report 36.02.18, Biometris, Wageningen, The Netherlands.
  • G-TwYST Study A data:  Study design, feed consumption, haematology, organ weight, blood & urine, clinical chemistry,  white blood cell counts. Samples taken every 3 months.

 

4. Goedhart, P.W. & van der Voet, H. (2018). G-TwYST Cross studies statistical comparisons of NK33- and NK33+* versus the control feed

 

 

* NK33- and NK33+ = not treated with Roundup and treated with Roundup.

 

 

Workshop Presentations

Prior to the workshop the following presentations have been made available to registered stakeholders:

 

 

 

 

 

 

 

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G-TwYST Conclusions & Recommendations

29 April 2018

 

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. A final version of G-TwYST Conclusions and Recommendations can be downloaded here.

Final programme 28/29 March available

18 March 2018

The final programma for the G-TwYST stakeholder consultation workshop on March 28 and 29 in Antwerp is available now and can be downloaded here.

 

This workshop, which is open for interested stakeholders, will focus on the draft results of a 90-day feeding study with 50% inclusion rate of GM maize NK603, as well as a combined chronic toxicity and carcinogenicity feeding study and the overall draft conclusions. Also included in the scope would be proposed quality criteria for whole-food animal feeding studies, and preliminary conclusions on the scientific value of such studies for GMO risk assessment. An additional agenda item will be insights from an analysis of scientific controversies around animal feeding studies including the GMO case.

 

 

Written comments, including from interested parties not able to attend, are welcome, and should be submitted before 6 April. Please, note, due to the tight schedule of the final phase of the project, this will be a firm deadline.