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BioSafety: Difference between revisions
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http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/part1.pdf | http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/part1.pdf | ||
== Regulations == | |||
== Notification fees == | * 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 === | |||
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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 | 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 === | |||
[http://www.legislation.gov.uk/uksi/2000/2831/schedule/5/made INFORMATION REQUIRED FOR A NOTIFICATION UNDER REGULATION 9(1)] | |||
=== Where the regulations do not apply === | |||
[http://www.legislation.gov.uk/uksi/2000/2831/schedule/2/part/III/made 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 = | = Hazardous chemicals and substances = | ||
