Biologicals/GMOs can serve both as a test item and as a test system, depending on the circumstances, and this distinction can only be made on a case-by-case basis. For example, there are studies in which a GMO is used as a test system for characterising properties of a chemical test item, e.g. an Ames test under area of expertise No. 3 – “Mutagenicity testing”.
There are also other studies in which biologicals/GMO, or parts thereof, are used as test items such as when environmental or health effects of a biological/GMO are being investigated. Some other examples include wild-type biological agents in virus validation studies, environmental fate studies of a GMO product and feeding studies. Another example of a biological/GMO being used as a test item would be in a study to determine the concentration of a known gene product of a transgenic sequence.
The identification of the test item is one of the pivotal aspects of GLP studies. Due to the biological nature of such test items (e.g. stem cells or viral vectors) the unequivocal identification may require a more complex analysis than for a chemical substance. Nevertheless, the characterisation of a biological test item would not qualify for a new area of expertise.
It should also be noted that it is not within the remit of the OECD Working Group on GLP to give guidance on the expectations of regulators with regard to biologicals/GMOs. The national/local receiving authority should be contacted regarding this. It is however acknowledged that some countries have established rules on the content of dossiers for the authorisation of novel foods or GMO (e.g. Regulation (EU) Nr. 503/2013 of the European Commission).
