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The experimental test groups chosen and the minimum number of animals per group to be used are shown in the following table:

Group

% of daily dietary intake (w/w)

No. of animals

Isogenic non-
GM (NK603)

NK603

NK603 +
Roundup

Males

Females

1

33

0

0

16

16

2

22

11

0

16

16

3

0

33

0

16

16

4

22

0

11

16

16

5

0

0

33

16

16

Total

 

80

80

 

The number of animals per group has been chosen based on the OECD Test Guideline 408 and as recommended by the EFSA Guidance (2011).

 

A statistical analysis will be performed prior to the beginning of the feeding trial to determine whether the number of animals per group chosen is adequate, and, if necessary, it will be adjusted. The data to be obtained will be compared with background data on variations in endpoint values for Wistar Han Rcc rats fed a standard lab chow from Harlan Inc. present in the public domain (http://webapps.harlan.com/wistarhannover).

 

A statistical analysis of the data obtained will be performed by WP4 by taking into account, among other documents, the EFSA Guidance (2011) and will be accompanied by an analysis report. A specific chapter on assumptions and uncertainties will be included in the study report.

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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.