The Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002 No. 3188 (W. 304)

SCHEDULE 2 INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO RELEASE OR MARKET GENETICALLY MODIFIED ORGANISMS OTHER THAN GENETICALLY MODIFIED HIGHER PLANTS

Part II INFORMATION RELATING TO THE GENETICALLY MODIFIED ORGANISMS

Characteristics of the genetically modified organisms

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 organisms to the donor, recipient or (where appropriate) parental organisms regarding pathogenicity,

(c) the capacity of the organisms for colonisation,

(d) if the organisms are 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.