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So far, we have received comments on the proposed scientific quality criteria from the Federal Office of Consumer Protection and Food Safety, Germany (BVL) on October 5th, 2016. The comments can be downloaded here.

 

The G-TwYST research team responded to the BVL comments on November 28th, 2016. The response can be downloaded here.

 

 

Members from the GRACE and G-TwYST research teams recently published “Proposed criteria for the evaluation of the scientific quality of rat and mouse feeding trials with whole food/feed derived from genetically modified plants” in Archives of Toxicology. We cordially invite all stakeholders to contribute to further developing these criteria by sending comments.

 

As one of its tasks G-TwYST developed and proposes criteria to evaluate the scientific quality of 2-year feeding trials. These criteria are now being published in order to trigger a broader discussion in the scientific community an among GMO risk assessment stakeholders. These quality criteria have been developed based on the experience and standards in other toxicity assessment contexts.

 

The proposed quality criteria are:

  1. The design of the feeding trial is based on internationally recognized test guidelines, but adapted for specific needs of whole food/feed studies and non-targeted testing.
  2. An analysis of the plant materials and diets including, among others, macro- and micronutrients, biological and chemical contaminants as well as the identification and quantification of the event, is performed.
  3. The highest level of the plant material that can be incorporated in the animal diets without leading to a nutritional imbalance is tested.
  4. A non-GM line with a comparable genetic background is used as a control.
  5. Specific aspects regarding the choice and housing of the laboratory animals used in the feeding trials are considered.
  6. Appropriate randomization techniques are applied.
  7. A reliable and appropriate sample collection and processing strategy is implemented.
  8. The staff performing the feeding trial and the analysis of the plant materials, diets and animal samples is “blind” with respect to the identity of the diets.
  9. Appropriate statistical methods are applied to evaluate the power of the study and to analyse the obtained results.

 

 

Comments to this and other recently published GRACE papers (http://link.springer.com/article/10.1007/s00204-016-1798-4, http://link.springer.com/article/10.1007/s00204-014-1374-8) can be sent either:

  • to for publication on the GRACE/G-TwYST website. These comments will be put without further peer-review or editorial polishing on our websites. Depending on the nature of the comment, The GRACE and G-TwYST teams will opt for a response at the project website, if deemed necessary. Offending or discrediting comments will not be accepted for publication,
  • directly to Archives of Toxicology. These comments will be answered by the respective project team in form of a Letter to the Editor, if deemed necessary and according to the publication policy of the journal.

 

Schmidt, K., Döhring, J., Kohl, C. et al. Arch Toxicol (2016) 90: 2287. doi:10.1007/s00204-016-1762-3, http://link.springer.com/article/10.1007/s00204-016-1762-3

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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.