Last modified December 16, 2009
"Containment" means that physical, chemical or biological barriers are used to protect humans and the environment from genetically-modified organisms (GMOs) or genetically-modified microorganisms (GMMs). The Health and Safety Executive (HSE) and DEFRA are responsible for enforcing the regulations, and they do so (in the case of lab animals) in concert with the Scientific Advisory Committee on Genetically Modified Organisms (Contained Use), or SACGM(CU). This committee produces an annual report. DEFRA (or the Scottish Government or the Wales Assembly Government) is responsible for GMOs in the area of farm animals, veterinary medicines, animal feed, plants, fertilizer, food and forestry, and marine environments. SACGM(CU) produce a Guidance document and update it as needed. HSE covers most everything and is responsible for permissioning.
The definition of a GMO is "an organism (with the exception of humans) in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination using recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules, produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation."
A GMO is one that has had its genes manipulated "directly." If the organism is still capable of reproducing outside the lab, as most mice are, a risk assessment must be submitted to the competent authority (HSE or DEFRA). The majority of work is with viruse vectors such as retroviruses and adenoviruses for expression of genes in mammalian cells. With the advent of retroviral and lentiviral vectors, new concerns for safety have arisen, especially with lentiviruses, which can promote insertional mutagenesis. The SACGM(CU) commissioned a research study in 2008 to address this issue.
In order to determine what regulatory measures apply, the sequence is:
risk assessment--> containment requirements--> classification (i.e. hazard groups 1-4)--> notification
1. Appoint a Biological Safety Officer to assist in complying with health and safety legislation. Note that the responsibility to provide a safe working environment cannot be delegated to the BSO by management. Some of the BSO's duties include advising on containment, training, risk assessment and coordination of notification activities. They have a number of duties which are listed in the Guidance.
2. Appoint a Genetic Modification Safety Committee and follow its advice. SACGM(CU) and HSE think this committee is extremely important; its activities will be carefully reviewed and monitored. The GMSC advises management on the adequacy of any risk assessment
3. Keep all safety policies under review, implement controls, and monitor efficacy. Management is required to ensure progressive improvement in safety and health by reviewing goals and comparing against the plans that were implemented. Locally organised inspections are recommended to prevent "creep" in compliance.
4. Remind employees that they also have a duty to take reasonable care for their own health and safety and that of others who may be affected by their acts or omissions.
©1999, Janet Becker Rodgers, DVM, MS, DipACLAM, MRCVS
All rights reserved.
Comments? Send an email to janet.rodgers@vet.ox.ac.uk