The Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 No. 541

SCHEDULE 3 INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO RELEASE OR MARKET ORGANISMS OTHER THAN GENETICALLY MODIFIED HIGHER PLANTS

PART II INFORMATION RELATING TO THE ORGANISMS

Characteristics of the genetically modified organisms in their final form

33.  In relation to human health, animal health and plant health–

(a) the toxic or allergenic effects of the organisms and/or their metabolic products;

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

(c) the capacity of the organisms for colonisation;

(d) if the organism is pathogenic to humans who are immunocompetent–

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

(ii) communicability;

(iii) infective dose;

(iv) host range and possibility of alteration;

(v) possibility of survival outside of human host;

(vi) presence of vectors or means of dissemination;

(vii) biological stability;

(viii) antibiotic resistance patterns;

(ix) allergenicity; and

(x) availability of appropriate therapies; and

(e) the other product hazards.