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BioSafety

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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;

The main issue of GMO work in the UK, is the need to register the premises in which GMO work takes place. The HSE maintain a public list of premises registered for GMO work here; http://www.hse.gov.uk/biosafety/gmo/publicregister.pdf



Genetic modification (contained work)

Activity Classes

Schedule 1 Classes of activity involving genetic modification

Regulation 2(1) Class Description

1 Activities of no or negligible risk, for which containment level 1 is 
appropriate to protect human health and the environment.
2 Activities of low risk, for which containment level 2 is appropriate to protect 
human health and the environment.
3 Activities of moderate risk, for which containment level 3 is appropriate to 
protect human health and the environment.
4 Activities of high risk, for which containment level 4 is appropriate to 
protect human health and the environment.

http://www.tradeunionstudiesleeds.org.uk/Resources/HandSPub/Legal/l29.pdf

Short version

The containment measures for GMO in force in the UK, are set out in Part 2 of Schedule 8 of the GMO(contained use) regulations 2000;

http://www.legislation.gov.uk/uksi/2000/2831/schedule/8/made

The containment measures for working with contained microbes in laboratory conditions for CL1 and CL2 activities are given in the following table;


Containment Measures Containment Levels
1 2
1 Laboratory suite: isolation (Note 1) not required not required
2 Laboratory: sealable for fumigation not required not required
Equipment
3 Surfaces impervious to water, resistant to acids, alkalis, solvents, disinfectants and decontamination agents and easy to clean required for bench required for bench
4 Entry to lab via airlock (Note 2) not required not required
5 Negative pressure relative to the pressure of the immediate surroundings not required required where and to extent the risk assessment shows it is required
6 Extract and input air from the laboratory shall be HEPA filtered not required not required
7 Microbiological safety cabinet/enclosure not required required where and to extent the risk assessment shows it is required
8 Autoclave required on site required in building
System of work
9 Access restricted to authorised personnel only not required required
10 Specific measures to control aerosol dissemination not required required so as to minimise
11 Shower not required not required
12 Protective clothing suitable protective clothing required suitable protective clothing required
13 Gloves not required required where and to extent the risk assessment shows they are required
14 Efficient control of disease vectors (eg rodents and insects) which could disseminate GMMs required where and to extent the risk assessment shows it is required required
15 Specified disinfection procedures in place required where and to extent the risk assessment shows they are required required
Waste
16 Inactivation of GMMs in effluent from handwashing sinks and showers and similar effluents not required not required
17 Inactivation of GMMs in contaminated material and waste required by validated means required by validated means
Other measures
18 Laboratory to contain its own equipment not required not required
19 An observation window or alternative is to be present so that occupants can be seen required where and to extent the risk assessment shows it is required required where and to extent the risk assessment shows it is required
20 Safe storage of GMMs required where and to extent the risk assessment shows it is required required
21 Written records of staff training not required required where and to extent the risk assessment shows they are required

Long Version

"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

Regulations

  • Require risk assessment
  • classify the activities
  • require notification of premises
  • require notification of activities of class 2, class 3 and class 4 to the competent authority
  • require fees for notification of premises
  • require a public register of premises


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

required notification Information

INFORMATION REQUIRED FOR A NOTIFICATION UNDER REGULATION 9(1)

Where the regulations do not apply

PART III TECHNIQUES TO WHICH THESE REGULATIONS DO NOT APPLY

self-cloning

3. These Regulations (except regulation 17) shall not apply to the following techniques of genetic modification, provided that they do not involve the use of recombinant nucleic acid molecules or of genetically modified organisms other than those recombinant nucleic acid molecules or genetically modified organisms produced by one or more of the following techniques of genetic modification—

(d)self-cloning, where the resulting organism is unlikely to cause disease or harm to humans, animals or plants.

4. In paragraph 3—

(a)“self-cloning” means the removal of nucleic acid sequences from a cell of an organism which may or may not be followed by reinsertion of all or part of that nucleic acid (or a synthetic equivalent), whether or not altered by enzymic or mechanical processes, into cells of the same species or into cells of phylogenetically closely related species which can exchange genetic material by homologous recombination; and

(b)self-cloning may include the use of recombinant vectors, with an extended history of safe use in the particular organism, to manipulate and reinsert the nucleic acid sequences, but the vectors shall not consist of any genetic elements other than those designed for vector structure, vector replication, vector maintenance or marker genes.

General Principles of good microbiological practice and of good occupational safety and hygiene

Regulation 17(2) and (3) SCHEDULE 7


The general principles of good microbiological practice and of good occupational safety and hygiene are as follows—

(a) Keeping workplace and environmental exposure to any genetically modified micro-organism to the lowest reasonably practicable level;

(b) Exercising engineering control measures at source and supplementing these with appropriate personal protective clothing and equipment where necessary;

(c) Testing adequately and maintaining control measures and equipment;

(d) Testing, where necessary, for the presence of viable process organisms outside the primary physical containment;

(e) Providing appropriate training of personnel;

(f) Formulating and implementing local codes of practice for the safety of personnel, as required;

(g) Displaying biohazard signs where appropriate;

(h) Providing washing and decontamination facilities for personnel;

(i) Keeping adequate records;

(j) Prohibiting in the work area eating, drinking, smoking, applying cosmetics or the storing of food for human consumption;

(k) Prohibiting mouth pipetting;

(l) Providing written standard operating procedures where appropriate to ensure safety;

(m) Having effective disinfectants and specified disinfection procedures available in case of spillage of genetically modified micro-organisms; and

(n) Providing safe storage for contaminated laboratory equipment and materials where appropriate.

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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