If the modification has resulted in a form of attenuation, how extensively has this strain been utilized without incident and/or has the attenuation been proven in animal models? (if applicable) rDNA/GMMO/transgenic animal research to be conducted with Human Animal Other: ________________ (select applicable type): Plant Cell lines Will the research involve the expression of cloned DNA? Yes No Will research involve the purification of cloned DNA product? Yes No Will the recombinant used for genome editing by CRISPR/cas9? Yes No If genome editing will be done, will it be performed on germ line Yes No n/a cells? Does the inserted genetic material increase, decrease or cause no change in pathogenicity of the biological material (once Increase Decrease No change inserted)? Will the rDNA, when inserted to a cell, animal, and/or plant, produce substances that are biohazardous to individuals Yes No handling the cells, animals, and/or plants? Does the inserted gene encode a known toxin or relatively Yes No uncharacterized toxin? Does the modification have the potential to the host range, Yes No or cell tropism of the recipient virus or bacterium? Does the modification have the potential to increase the Yes No replication capacity of the virus or bacterium? Does the inserted gene encode a known oncogene? Yes No n/a Does the inserted gene have the potential for altering the host Yes No n/a cell cycle? Does the viral or bacterial DNA integrate into the host genome? Yes No n/a What is the probability of generating replication-competent virus, Low Intermediate n/a or bacteria? High Does the modification have an effect of increasing or decreasing Increase Decrease n/a the efficacy of available treatment or prophylaxis?
If the modification has resulted in a form of attenuation, how extensively has this strain been utilized without incident and/or has the attenuation been proven in animal models? (if applicable) rDNA/GMMO/transgenic animal research to be conducted with (select applicable type): Human Animal Other: ________________ Plant Cell lines Will the research involve the expression of cloned DNA? Yes No Will research involve the purification of cloned DNA product? Yes No Will the recombinant used for genome editing by CRISPR/cas9? Yes No If genome editing will be done, will it be performed on germ line cells? Yes No n/a Does the inserted genetic material increase, decrease or cause no change in pathogenicity of the biological material (once inserted)? Increase Decrease No change Will the rDNA, when inserted to a cell, animal, and/or plant, produce substances that are biohazardous to individuals handling the cells, animals, and/or plants? Yes No Does the inserted gene encode a known toxin or relatively uncharacterized toxin? Yes No Does the modification have the potential to the host range, or cell tropism of the recipient virus or bacterium? Yes No Does the modification have the potential to increase the replication capacity of the virus or bacterium? Yes No Does the inserted gene encode a known oncogene? Yes No n/a Does the inserted gene have the potential for altering the host cell cycle? Yes No n/a Does the viral or bacterial DNA integrate into the host genome? Yes No n/a What is the probability of generating replication-competent virus, or bacteria? Low Intermediate n/a High Does the modification have an effect of increasing or decreasing the efficacy of available treatment or prophylaxis? Increase Decrease n/a
Risk%20Assessment%20for%20rDNA-GMMO-transgenics%20form.docx