GMOs: controversy and a new study by EFSA over the next 2 years

Written on September 19th, 2013 in politics Comments Off

Seralini validated by new EFSA guidelines on long-term GMO experiments – Published on GMwatch.org, Comment by Claire Robinson of GMWatch and Earth Open Source, 31 July 2013.

The European Food Safety Authority  (EFSA) has issued guidelines for two-year whole food feeding studies to assess the risk of long-term toxicity from GM foods: Considerations on the applicability of OECD TG 453 to whole food/feed testing, EFSA Journal 2013;11(7):3347 [18 pp.]. – doi:10.2903/j.efsa.2013.3347  

  • … Type: Scientific Report of EFSA
  • On request from: European Commission
  • Question number: EFSA-Q-2013-00316
  • Approved: 26 July 2013
  • Published: 31 July 2013
  • Affiliation: European Food Safety Authority (EFSA) Parma Italy

Abstract:

Upon request from the European Commission, the European Food Safety Authority prepared a scientific report that would aid the future establishment of protocols for chronic toxicity and/or carcinogenicity studies in rodents with whole food/feed. This scientific report provides a commentary on OECD TG 453 with considerations on its applicability to support the safety assessment of long term consumption of a given food with respect to its chronic toxicity or carcinogenicity potential. The decision to conduct chronic toxicity and/or carcinogenicity studies with whole food/feed should be taken on a case-by case basis. It should be based on the evaluation of all the available information on the whole food/feed resulting from compositional analyses and any other available nutritional and toxicological studies … //

… Summary: … //

… OECD Test Guideline 453 was established for the chronic toxicity and carcinogenicity testing of chemicals including the provision of dose-response data on chemicals. Its adaptation to whole food/feed presents limitations that should be considered when developing the test protocol such as: limitations in the maximum whole food/feed dose that can be incorporated into the experimental diet; the fact that toxic effects can be detected only if these are present at levels compatible with a balanced diet formulation; and the availability of proper historical control data.

The evaluation of potential hazards identified by compositional analyses and any other available nutritional and toxicological studies on the whole food/feed would provide indications on the decision to conduct chronic toxicity and/or carcinogenicity testing of a whole food/feed. The study should be carried out according to Good Laboratory Practice (GLP) standards and should take into account animal welfare issues.

Rodents are the preferred test animals and should be housed in cages in pairs of the same sex throughout the duration of the study. The starting material and the diet should be thoroughly characterised and the storage conditions and stability of the feeds should be documented over the course of the whole test.

The decision on the most appropriate study design should be made on a case-by-case basis according to the objectives of the study and the particular hypotheses to be tested. The number of animals per group depends upon the specific objectives of the study and should be adequate to conduct a thorough biological and statistical evaluation. Statistical considerations are discussed that aid the derivation of appropriate sample sizes for continuous and categorical variables.

The parameters to be considered for both the chronic toxicity phase and the carcinogenicity phase should be in line with those detailed in OECD TG 453. Additional markers of potentially adverse nutritional and/or metabolic effects should be considered on a case-by-case basis, according to the available body of evidence and the type of whole food/feed under investigation.

All details of the design, the conduct and the analysis should be clearly justified, documented and reported. A specific chapter on assumptions and uncertainty analysis should be included in the study report.

Keywords:

2-year feeding study, whole food/feed, carcinogenicity, chronic toxicity, experimental design, statistical analysis.

(full text).

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