BioSafety

This is a collection of the resources that we have been using as guidance for making lab safety decisions. As far as a I know these are publicly available documents;

Genetic modification (contained work)

"The terms containment and contained use refer to activities with GMOs that employ control measures such as physical, chemical or biological barriers to limit their contact with humans and environment."

These activities are regulated under the Genetically Modified Organisms (Contained Use) Regulations 2000.
The Genetically Modified Organisms(Contained Use) Regulations 2000
The Genetically Modified Organisms (Contained Use) (Amendment) Regulations 2002
The Genetically Modified Organisms (Contained Use) (Amendment) Regulations 2005
The Genetically Modified Organisms (Contained Use) (Amendment) Regulations 2010
HSE: What is contained use of GMO?

"If you follow this guidance you will normally be doing enough to comply with the law." (HSE: SACGM Compendium of guidance)
http://www.hse.gov.uk/biosafety/gmo/index.htm

The HSE provide a compendium of guidance on the regulations; SACGM guidance provides technical and scientific advice to the UK Competent Authorities on all aspects of the risks posed to human health and the environment regarding contained use activities with genetically modified organisms (GMOs).
The SACGM Compendium of guidance: Contents page

"The guidance covers what is required by law for contained use activities with GMOs and represents what is considered to be good practice by the committee. By following it, users will be doing enough to comply with the Contained Use Regulations, and other legislation that impinges upon work with GMOs. "

and

"Following this guidance is not compulsory and you are free to take other action. But .... if you do follow this guidance you will normally be doing enough to comply with the law. Health and safety inspectors seek to secure compliance with the law and may refer to this guidance as illustrating good practice."
http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/part1.pdf

Notification fees

Revised GMO notification fees with effect from 1 March 2013

£472
First use of premises:class 1, non-harmful GMMs. The notifier may begin work as soon as HSE acknowledges receipt of the notification AND any requirements relating to activity notification have been met. Consent required: No

£943
First use of premises where CU1 is accompanied by a class 2 activity. Notification period is 45 days from date of acknowledgement. Consent required: No

£1022
First class 3 activity, The CA must issue a Consent (or a reason for refusal) within 90 days of acknowledgement. A consent cannot be issued in less than 30 days, as the public has a right to make representation up to 30 day. Consent required: Yes

Hazardous chemicals and substances

Control of substances hazardous to health

File:L5.pdf

(Fifth edition) The Control of Substances Hazardous to Health Regulations 2002 (as amended) Approved Code of Practice and guidance

Terminology

Competent Authorities - ???

dutyholders - ?? referenced in the ammendments doc, no idea what the definition is... @todo

GMO - defined as 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 6 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’

REACH - (Registration, Evaluation, Authorisation and restriction of Chemicals) is the system for controllingchemicals in Europe. It became law in the UK on the 1st June 2007. http://www.hse.gov.uk/reach/resources/reachsds.pdf

SACGM - Scientific Advisory Committee on Genetic Modification

Other countries

CDC - Biosafety in microbiological labs

http://www.cdc.gov/biosafety/publications/bmbl5/bmbl.pdf

"Over the past two decades, Biosafety in Microbiological and Biomedical Laboratories (BMBL) has become the code of practice for biosafety—the discipline addressing the safe handling and containment of infectious microorganisms and hazardous biological materials. T"

"We wish to emphasize that the 5th edition of the BMBL remains an advisory document recommending best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety perspective, and is not intended as a regulatory document though we recognize that it will be used that way by some."

WHO - Laboratory biosafety manual

File:Biosafety7.pdf

which introduces a bunch of concepts which come up in more recent guidelines and regulations;

Throughout this manual, references are made to the relative hazards of infective microorganisms by risk group (WHO Risk Groups 1, 2, 3 and 4). This risk group classification is to be used for laboratory work only. Table 1 describes the risk groups. Table 1. Classification of infective microorganisms by risk group

• Risk Group 1 (no or low individual and community risk)

A microorganism that is unlikely to cause human or animal disease.

• Risk Group 2 (moderate individual risk, low community risk)

A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited.

• Risk Group 3 (high individual risk, low community risk)

A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available.

• Risk Group 4 (high individual and community risk)

A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly. Effective treatment and preventive measures are not usually available.

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