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BioSafety: Difference between revisions
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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; | 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 = | = Genetic modification (contained work) = | ||
The | "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.'' <br/>[http://www.legislation.gov.uk/uksi/2000/2831/contents/made The Genetically Modified Organisms(Contained Use) Regulations 2000]<br/>[http://www.hse.gov.uk/pubns/indg357.pdf The Genetically Modified Organisms (Contained Use) (Amendment) Regulations 2002]<br/>[http://www.hse.gov.uk/biosafety/GMO/guidance/amendingregs.pdf The Genetically Modified Organisms (Contained Use) (Amendment) Regulations 2005]<br/>[http://www.legislation.gov.uk/uksi/2010/2840/contents/made The Genetically Modified Organisms (Contained Use) (Amendment) Regulations 2010]<br/>[http://www.hse.gov.uk/pubns/indg86.pdf HSE: What is contained use of GMO?]<br/> | |||
"'''If you follow this guidance you will normally be doing enough to comply with the law.'''" (HSE: SACGM Compendium of guidance) <br/> | |||
http://www.hse.gov.uk/biosafety/gmo/index.htm | 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). <br/> | |||
[http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/ 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 | 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." <br/> | "'''''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." <br/> | ||
http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/part1.pdf | http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/part1.pdf | ||
== Notification fees == | |||
[http://www.hse.gov.uk/biosafety/gmo/acgm/acgmwarn.htm Revised GMO notification fees with effect from 1 March 2013] | |||
£472<br/> | |||
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<br/> | |||
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<br/> | |||
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 | |||
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= Terminology = | = 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 | 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 | |||
