Memorandum 37
Supplementary memorandum from the Health
and Safety Executive
You requested further clarification on my letter
dated 10 March 2008.
PARAGRAPH 1.2: NOTIFICATIONS
MADE UNDER
COSHH
Legal position: Schedule 3, Part I of COSHH
Para 5(1): "an employer shall not use for the first time
one or more biological agents in Group 2, 3 or 4 at particular
premises ... unless he has notified the Executive of his intention
... at least 20 working days in advance for any of the activities".
Para 5(4): "upon receipt of notification
... HSE shall, within 20 working days ... send acknowledgement
of receipt or request further information; within 10 working days
of receipt of further information send acknowledgement of receipt".
PROCESS IN
PRACTICE
There is no explicit clearance/consent required
by law. In practice HSE send an acknowledgement of receipt with
statement that they "will receive a further letter in due
course to confirm that you may begin work with the agent(s)"
(Annex 1). Once HSE are satisfied they will send a second letter
(Annex 2) to approve the work.
PARAGRAPH 2.2: MOVEMENT
BETWEEN CL4 SITES
Legal position: Schedule 3, Part I of COSHH
Para 6(1): "an employer shall not consign a Group 4 biological
agent or anything containing, or suspected of containing, such
an agent to any other premises, whether or not those premises
are under his ownership or control unless he has notified HSE
of his intention to do so at least 30 days in advance".
Depending on how the employer chooses to notify
their premises (under both COSHH and GMO(CU) there may be the
potential for work at CL4 to be moved between different sites
without being legally required to notify HSE.
PROCESS IN
PRACTICE
All CL4 sites and laboratories have been established
for some time and are well known to the HSE with a long history
of interaction at the organisation, site and laboratory level.
The size of a CL4 site tends to be restricted to a small number
of laboratories/animal house facilities.
If new agents are worked with they tend to be
in these facilities which are well known to HSE with a regular
inspection history. In the (very rare) event of Group 4 agents
moving between different sites of the same organisation, the custom
and practice is that the safety officer lead for that site will
contact their lead HSE inspector to make them aware and seek assurance
that this is acceptable.
March 2008
Annex 1
CONTROL OF SUBSTANCES HAZARDOUS TO HEALTH
REGULATIONS 2002
(AS AMENDED)
On behalf of the Executive, I acknowledge receipt
of your notification for the subsequent use of biological agents
in Hazard Group 3.
You will receive a further letter in due course
to confirm that you may begin work with the agent(s).
Yours sincerely
Annex 2
CONTROL OF SUBSTANCES HAZARDOUS TO HEALTH
REGULATIONS 2002
(AS AMENDED)
On behalf of the Executive, I have no objections
to you undertaking work with the Hazard Group 3 agent.
On receipt of this letter you may begin work
with the agent, namely Mycobacterium tuberculosis.
There are no specific conditions attached to
this letter. However, should any of the details given in your
notification change substantially, you should notify us in writing
of the changes. You should also keep us informed of any administrative
changes eg change of named contact, e-mail address.
This letter does not imply HSE's endorsement
of the containment and control measures taken at your premises
or that these measures comply with COSHH or other health and safety
legislation. HSE Inspectors may make additional observations and
requirements when carrying out site inspections.
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