(iii) Consider whether the inserted gene encodes a product that might act alongside the existing characteristics of the recipient micro-organism, so as to endow the GMM with altered pathogenic properties towards humans, or other organisms in the wider environment. For example Does the inserted gene encode a pathogenicity determinant, such as an adhesion, a penetration factor or a surface component providing resistance to host defence mechanisms? Is it possible that expression of the inserted gene could alter the tissue tropism, host range or infectivity as compared to the recipient micro-organism? Does the inserted DNA encode resistance to an antibiotic, other than the commonly used selection antibiotics, that might be used for the treatment of infections acquired either in the laboratory or outside? (iv) Consider whether an inserted sequence, that does not give rise to a harmful phenotype in the recipient could give rise to harm as a result of natural gene transfer to another, possibly related, organism. For example In the event of a breach of laboratory containment, could the recipient organism survive in the environment, either as a organism (e.g. in soil or sewage), or by infection of some other host? “free living” Is the vector mobilisible? Is the nature of the inserted gene such that its widespread dissemination in the environment would present environmental concerns e.g. a drug resistance or antibiotic resistance gene, or an intact provirus?
(iii) Consider whether the inserted gene encodes a product that might act alongside the existing characteristics of the recipient micro-organism, so as to endow the GMM with altered pathogenic properties towards humans, or other organisms in the wider environment. For example Does the inserted gene encode a pathogenicity determinant, such as an adhesion, a penetration factor or a surface component providing resistance to host defence mechanisms? Is it possible that expression of the inserted gene could alter the tissue tropism, host range or infectivity as compared to the recipient micro-organism? Does the inserted DNA encode resistance to an antibiotic, other than the commonly used selection antibiotics, that might be used for the treatment of infections acquired either in the laboratory or outside? (iv) Consider whether an inserted sequence, that does not give rise to a harmful phenotype in the recipient could give rise to harm as a result of natural gene transfer to another, possibly related, organism. For example In the event of a breach of laboratory containment, could the recipient organism survive in the environment, either as a “free living” organism (e.g. in soil or sewage), or by infection of some other host? Is the vector mobilisible? Is the nature of the inserted gene such that its widespread dissemination in the environment would present environmental concerns e.g. a drug resistance or antibiotic resistance gene, or an intact provirus?
F-IBC%20Form_final%2006.12.2017.docx