Molecular Biology
It’s a Matter of Perspective
The investigators who submit IBC protocols
want to perform their experiments safely.
However, their perception of the risks
involved will not necessarily be the same as
that of a biosafety professional.
Risk Assessment
The following risk assessment will identify the
biological containment system to be used:
Properties of the donor organism
Nature of the DNA sequences that will be
transferred
Properties of the recipient organism
Properties of the environment
Biological Expression System
Most routine genetic engineering experiments
can be performed safely in E. coli
K12/pUC18 at BSL 1 provided the inserted
foreign DNA sequences do not require a
higher BSL.
Donor Organism and Cloned DNA
Insertion of well-characterized DNA sequences that
are unlikely to be involved in pathogenicity may
not require additional safety measures.
In cases where these sequences are not characterized,
a situation that is typically encountered when a
library of genomic DNA of an organism is being
established, a higher BSL will be required.
Cloning of genes coding for proteins that have
potential pharmacological activity such as toxins
may therefore require higher BSL.
Viral Vectors for Gene Transfer
Although viral vectors used in gene therapy or
gene transfer are replication-defective, they
should be handled at the same BSL as the
parent viral vector from which they are
derived since the virus stocks may be
contaminated with replication-competent
viruses, which are generated by rare
spontaneous recombination events in the
complementing cell line.
Transgenic and “Knock-Out”
Animals
Animals carrying foreign genetic information
(transgenic animals) should be handled in the
containment level appropriate to the
characteristics of the products of the foreign
genes. For each new line of transgenic animal, the
routes by which the animals can be infected, the
inoculum size required for infection, and the
extent of the virus shedding by the infected animal
must be determined.
Animals with targeted deletions of specific genes
(“knock-out” animals) do not generally present
particular biological hazards.
