Biological agents
ACOP
Notification of the use or storage of biological agents (Schedule 3,
paragraph 12)
28 Schedule 3, paragraph 12 requires that certain activities involving
biological agents should be notified to HSE, unless notification has already
been made under the Genetically Modified Organisms (Contained Use)
Regulations. Notice must be given:
(a) of an intention to use or store an agent or agents from a particular group,
other than Group 1, for the first time. Only the group need normally
be notified, but the actual agents to be used or stored at the time of this
first involvement with a group should also be identified:
(i) if they are among those specified in Part V of Schedule 3. It should
be noted that this includes all Group 4 agents whether or not they
appear in an approved classification;
(ii) if they are Group 3 agents which do not appear in an approved
classification;
(b) subsequently, of the use or storage for the first time of:
(i) any particular Part V agent not already notified, whether or not it
appears in an approved classification; and
(ii) any Group 3 agent that does not appear in an approved
classification.
If a notification under (a) has specified all Part V or Group 4 agents in the
approved classification, then the requirement to notify in respect of those
agents under (b)(i) will vanish.
29 The term ‘use’ in Schedule 3, paragraph 12 should be taken to exclude
activities in which agents are incidentally present (see paragraph 10 of this
ACOP), but to include the provision of a diagnostic service.
30 However there are derogations from the duty to notify where the activity
is the provision of a diagnostic service:
(a) the duty described in paragraph 28(a) of this ACOP does not apply to
the provision of a diagnostic service for Group 2 agents, or for Group 3
agents except for those that are included in Part V, unless a process likely
to propagate or concentrate an agent is involved. In general this will
relieve, for example, haematology, clinical chemistry or histopathology
laboratories providing diagnostic support in the care of Group 2 or 3
infected patients from the duty to notify in respect of those activities.
Laboratories providing any kind of diagnostic service in relation to Part V
agents are subject to the duty in full;
(b) the duty described in paragraph 28(b) of this ACOP does not apply to
the provision of a diagnostic service unless a process likely to propagate
or concentrate an agent is involved, and the agent does not appear in an
approved classification.
Notification of the consignment of biological agents (Schedule 3,
paragraph 13)
31 Schedule 3, paragraph 13 requires that notification is given to HSE when
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