Division 1 Problem formulation including hazard identificationF1

The problem formulation shall:

1. (a)

   identify any changes in the characteristics of the organism, linked to the genetic modification, by comparing the characteristics of the GMO with those of the chosen non-genetically modified comparator under corresponding conditions of release or use;

2. (b)

   identify potential adverse effects on human health or the environment which are linked to the changes that have been identified under point (a) above;

   Potential adverse effects shall not be discounted on the basis that they are unlikely to occur.

   Potential adverse effects will vary from case to case, and may include:

   • effects on the dynamics of populations of species in the receiving environment and the genetic diversity of each of these populations leading to a potential decline in biodiversity,

   • altered susceptibility to pathogens facilitating the dissemination of infectious diseases or creating new reservoirs or vectors,

   • compromising prophylactic or therapeutic medical, veterinary, or plant protection treatments, for example by transfer of genes conferring resistance to antibiotics used in human or veterinary medicine,

   • effects on biogeochemistry (biogeochemical cycles), including carbon and nitrogen recycling through changes in soil decomposition of organic material,

   • disease affecting humans, including allergenic or toxic reactions,

   • disease affecting animals and plants, including toxic, and, in the case of animals, allergenic reactions, where appropriate.

   Where potential long-term adverse effects of a GMO are identified, they shall be assessed in the form of desk based studies using, where possible, one or more of the following:

   1. (i)

      evidence from previous experiences;

   2. (ii)

      available data sets or literature;

   3. (iii)

      mathematical modelling;

3. (c)

   identify relevant assessment endpoints.

   Those potential adverse effects that could impact the identified assessment endpoints shall be considered in the next steps of the risk assessment;

4. (d)

   identify and describe the exposure pathways or other mechanisms through which adverse effects may occur.

   Adverse effects may occur directly or indirectly through exposure pathways or other mechanisms which may include:

   • the spread of the GMO(s) in the environment,

   • the transfer of the inserted genetic material to the same organism or other organisms, whether genetically modified or not,

   • phenotypic and genetic instability,

   • interactions with other organisms,

   • changes in management, including, where applicable, in agricultural practices;

5. (e)

   formulate testable hypotheses, and define relevant measurement endpoints, to allow, where possible, a quantitative evaluation of the potential adverse effect(s);

6. (f)

   consider possible uncertainties, including knowledge gaps and methodological limitations.