A. Characteristics of the donor, recipient or (where appropriate) parental organism(s)
B. Characteristics of the modified micro-organism
C. Health considerations
D. Environmental considerations

A. Characteristics of the donor, recipient or (where appropriate) parental organism(s)

• names and designation;

• degree of relatedness;

• sources of the organism(s);

• information on reproductive cycles (sexual/asexual) of the parental organism(s) or, where applicable, of the recipient micro-organism;

• history of prior genetic manipulations;

• stability of parental or of recipient organism in terms of relevant genetic traits;

• nature of pathogenicity and virulence, infectivity, toxicity and vectors of disease transmission;

• nature of indigenous vectors:

  sequence,

  frequency of mobilization,

  specificity,

  presence of genes which confer resistance;

• host range;

• other potentially significant physiological traits;

• stability of these traits;

• natural habitat and geographic distribution. Climatic characteristics of original habitats;

• significant involvement in environmental processes (such as nitrogen fixation or pH regulation);

• interaction with, and effects on, other organisms in the environment (including likely competitive or symbiotic properties);

• ability to form survival structures (such as spores or sclerotia).

B. Characteristics of the modified micro-organism

• the description of the modification including the method for introducing the vector-insert into the recipient organism or the method used for achieving the genetic modification involved;

• the function of the genetic manipulation and/or of the new nucleic acid;

• nature and source of the vector;

• structure and amount of any vector and/or donor nucleic acid remaining in the final construction of the modified micro-organism;

• stability of the micro-organism in terms of genetic traits;

• frequency of mobilization of inserted vector and/or genetic transfer capability;

• rate and level of expression of the new genetic material. Method and sensitivity of measurement;

• activity of the expressed protein.

C. Health considerations

• toxic or allergenic effects of non-viable organisms and/or their metabolic products;

• product hazards;

• comparison of the modified micro-organism to the donor, recipient or (where appropriate) parental organism regarding pathogenicity;

• capacity for colonization;

• if the micro-organism is pathogenic to humans who are immunocompetent:

  (a) diseases caused and mechanism of pathogenicity including invasiveness and virulence;

  (b) communicability;

  (c) infective dose;

  (d) host range, possibility of alteration;

  (e) possibility of survival outside of human host;

  (f) presence of vectors or means of dissemination;

  (g) biological stability;

  (h) antibiotic-resistance patterns;

  (i) allergenicity;

  (j) availability of appropriate therapies.

D. Environmental considerations

• factors affecting survival, multiplication and dissemination of the modified micro-organism in the environment;

• available techniques for detection, identification and monitoring of the modified micro-organism;

• available techniques for detecting transfer of the new genetic material to other organisms;

• know and predicted habitats of the modified micro-organism;

• description of ecosystems to which the micro-organism could be accidentally disseminated;

• anticipated mechanism and result of interaction between the modified micro-organism and the organisms or micro-organisms which might be exposed in case of release into the environment;

• known or predicted effects on plants and animals such as pathogenicity, infectivity, toxicity, virulence, vector of pathogen, allergenicity, colonization;

• known or predicted involvement in biogeochemical processes;

• availability of methods for decontamination of the area in case of release to the environment.