Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p50
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 135034–138028

allergenicity of a newly expressed protein is also not required if:

    (a) the protein is expressed from a transferred gene that is derived from the same species as the host or a species that is cross-compatible with the host, provided evidence is provided to demonstrate the following:

       (i) the gene donor belongs to a species that is commonly used as food and has a history of safe use
       (ii) the protein is expressed at levels in the new food produced using gene technology that are consistent with the levels in the gene donor.

    (b) evidence is provided to demonstrate the absence of the newly expressed protein from the parts of the host organism consumed as food.

     B.3. Other (non-protein) new substances

If other (non-protein) substances are produced as a result of the introduced DNA, information must be provided on the following:

    (a) the identity and biological function of the substance
    (b) whether the substance has previously been safely consumed in food
    (c) potential dietary exposure to the substance
    (d) where RNA interference has been used:

        (i) the role of any endogenous target gene and any changes to the food as a result of silencing that gene
        (ii) the expression levels of the RNA transcript
        (iii) the specificity of the RNA interference

     B.4 Novel herbicide metabolites in GM herbicide-tolerant plants

Note:

Novel metabolites are those not normally found in non-GM crops sprayed with the same herbicide.

Data must be provided on the identity and levels of herbicide and any novel metabolites that may be present in the food produced using gene technology.

If novel metabolites are present then the application should address the following, where appropriate:

(a) toxicokinetics and metabolism
(b) acute toxicity
(c) short-term toxicity
(d) long-term toxicity and carcinogenicity
(e) reproductive and developmental toxicity
(f) genotoxicity.

     B.5 Compositional analyses of the food produced using gene technology

This must include all of the following:

    (a) the levels of relevant key nutrients, toxicants and anti-nutrients in the food produced using gene technology compared with the levels in an appropriate comparator (usually the non-GM counterpart). A statistical analysis of the data must be provided.
    (b) information on the range of natural variation for each constituent measured to allow for assessment of biological significance should any statistically significant differences be identified
    (c) the levels of any other constituents that may potentially be influenced by the genetic modification, as a result, for example, of downstream metabolic effects, compared with the levels in an appropriate comparator as well as the range of natural variation.

In the case of herbicide-tolerant plants, the levels of each constituent in the food produced using gene technology must be determined using plants sprayed with the herbicide.

     C Information related to