Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p48
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 129460–132449

of relevance to the food;
       (ii) history of use of the organism in the food supply or history of human exposure to the organism through other than intended food use (e.g. as a normal contaminant).

(b) For the host organism into which the genes were transferred:

       (i) its history of safe use for food
       (ii) the part of the organism typically used as food
       (iii) the types of products likely to include the food or food ingredient
       (iv) whether special processing is required to render food derived from the organism safe to eat.

     A.3 The nature of the genetic modification

This must include all of the following:

    (a) a description of the method used to transform the host organism
    (b) a description of the construct and the transformation vectors. used, including:

       (i) the size, source and function of all the genetic components including marker genes, regulatory and other elements
       (ii) a detailed map of the location and orientation of all the genetic components contained within the construct and vector, including the location of relevant restriction sites.

    (c) A full molecular characterisation of the genetic modification in the new organism, including:

       (i) identification of all transferred genetic material and whether it has undergone any rearrangements
       (ii) a determination of the number of insertion sites, and the number of copies at each insertion site
       (iii) full DNA sequence of each insertion site, including junction regions with the host DNA
       (iv) a map depicting the organisation of the inserted genetic material at each insertion site
       (v) details of an analysis of the insert and junction regions for the occurrence of any open reading frames (ORFs).

    (d) A description of how the line or strain from which food is derived was obtained from the original transformant (i.e. provide a family tree or describe the breeding process) including which generations have been used for each study.

    (e) Evidence of the stability of the genetic changes, including:

       (i) the pattern of inheritance of the transferred gene(s) and the number of generations over which this has been monitored
       (ii) the pattern of inheritance and expression of the phenotype over several generations and, where appropriate, across different environments.

(g) an analysis of the expressed RNA transcripts, where RNA interference has been used.

     B Characterisation and safety assessment of new substances

The application must address the following sections:

     B.1 Characterisation and safety assessment of new substances

This must include all of the following:

    (a) a full description of the biochemical function and phenotypic effects of all new substances (e.g. a protein or an untranslated RNA) that are expressed in the new GM organism, including their levels and site of accumulation, particularly in edible portions
    (b) information about prior history