Health and safety : control of biological agents: proposals for amendments to the Control of Substances Hazardous to Health Regulations 1988

58 Pages·1993·3.1 MB·English

by  Great Britain. Health and Safety Executive

THE CONTROL OF BIOLOGICAL AGENTS: PROPOSALS FOR AMENDMENTS TO THE
CONTROL OF SUBSTANCES HAZARDOUS TO HEALTH REGULATIONS 1988
CONTENTS
Page
Introduction 1
Background 2
The Biological Agents Directive 3
The Classification Directive 5
Classification nomenclature 5
Biological agents, genetic modification 6
and COSHH
Notification of activities involving
biological agents 6
Outline of proposals 7
Supplementary ACoP on biological agents 10
Amendments to general ACoP 10
Implications for industry 10
Table 1: comparison of containment measures 11
specified by directive 90/679/EEC
and ACDP guidance
Appendix 1: proposals for amending the COSHH 12
Regulations in relation to
biological agents
Appendix 2: draft approved code of practice 34
Appendix 3: draft amendments to general ACoP 45
Appendix 4: the Biological Agents Directive 46
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Introduction
1* This is one of two Consultative Documents containing the
Health and Safety Commission1s proposals for amendments to the
Control of Substances Hazardous to Health Regulations 1988
(COSHH) The other deals with the application of the Regulations
.
to some chemical agents. This one sets out draft amendments that
alter the way in which the Regulations apply to risks arising from
exposure to micro-organisms, and extend their application to some
other biological risks (Appendix 1) . A draft Approved Code of
Practice (ACoP) supplementing the general COSHH ACoP, accompanies
,
the proposed biological agents amendments (Appendix 2) . Some minor
amendments to the general ACoP are proposed also (Appendix 3)
2. The proposals in this document are to implement the EC
Biological Agents Directive (90/679/EEC) (Appendix 4) , together
with a proposed directive on the classification of biological
agents which is to be linked to it. At the same time they absorb
and replace the notification requirements at present contained in
the Health and Safety (Dangerous Pathogens) Regulations 1981.
3. The amendments resulting from both consultative exercises are
to be incorporated into a consolidated version of COSHH, bringing
together all the amendments made so far. Consolidation in itself
will not alter the substance of the regulations but will merely
gather their several separate parts into a single text.
4. After considering the comments made in response to both
documents the Health and Safety Commission will submit its revised
proposals to the Secretary of State. It is intended that the
amended COSHH Regulations should come into force on 1 January
1994. As in the case of the three earlier sets of COSHH amendment
Regulations (which came into force on 1 January 1991, 1992 and
1993) there will be at the same time a new edition of the HMSO
publication combining the amended COSHH Regulations, the general
ACoP and the supplementary ACoPs.
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. .
5 The Health and Safety Commission would welcome comments on the
proposals that follow.
6.
Background
Council Directive 90/679/EEC on the Protection of Workers from
Risks Related to Exposure to Biological Agents at Work - referred
to in this document as the "Biological Agents Directive" - is one
of the individual Directives adopted under Article 16(1) of the
Framework Directive on Health and Safety (89/391/EEC) The
.
Framework Directive itself has been implemented in the UK mainly
by the Management of Health and Safety at Work Regulations 1992.
Individual directives already implemented cover the workplace, the
use of work equipment, the use of personal protective equipment,
manual handling of loads, work with display screen equipment and
work with carcinogens. All are based on Article 118A of the Treaty
of Rome. Implementation in Great Britain is mainly by means of
regulations made under Section 15 of the Health and Safety at Work
Etc Act 1974 (HSWA)
7. The Health and Safety Commission’s policy on the negotiation of
the EC's programme of health and safety directives has been set
out in its Plans of Work for 1990-1 and 1991-2. Good progress has
been made with the modernisation of British health and safety law
by means of regulations made under HSWA and that has stood us in
good stead in advancing British models as a basis for EC
provisions. But we have had to recognise that the outcome of
Community negotiations, especially under the system of qualified
majority voting introduced by the Single European Act, requires
compromises that entail changes and additions to UK regulations to
meet the objectives of the directives.
8. The strategy of the Health and Safety Commission in putting
forward proposals for implementing the Framework and associated
directives is:
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(a) to avoid disrupting the basic framework established by HSWA,
and to minimise change to the most recent regulations;
(b) to continue where appropriate the modernisation of health and
safety law made before 1974 and to take the opportunity to repeal
outdated legislation;
(c) to further the Health and Safety Commission’s philosophy of
introducing control measures proportionate to the risk;
(d) to propose regulations that meet the requirements of the
directives, but do not go beyond them, so as to minimise the
impact of alterations in the law at a time when the requirements
of the EC necessarily mean considerable changes in it.
Nevertheless, in implementing directives the Commission proposes
where appropriate to extend the necessary controls to the self
employed and to public safety in conformity with the provisions of
HSWA.
Precisely how this is done depends on the terms of each directive
and its relation to UK law.
The Biological Agents Directive (90/679/EEC)
9. The Biological Agents Directive was adopted on
26 November 1990. During EC negotiations the UK was successful in
aligning most of it with UK law and practice. But because the
Directive s requirements are mandatory some of what is now
*
established practice, but laid down in guidance rather than
statutorily required, has to be embodied in the law.
10. The Directive defines biological agents (but see paragraph 21
below) and sets out criteria for placing each agent in one of
,
four categories according to the risk of human infection
associated with it. The defining characteristics of a biological
agent also include toxic and allergenic properties, but the
infection criterion is the only one used for the classification
scheme. The group into which an agent falls is to be taken into
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account in preparing a risk assessment and in selecting
containment or control measures The classification scheme is
*
based closely on the one developed in the UK by the Advisory
Committee on Dangerous Pathogens (ACDP) and published in
Categorisation of Pathogens According to Hazard and Categories of
Containment (HMSO 1990) .
11. The Directive requires that employers carry out an assessment
of the risks, and base on it the precautionary measures they take.
A distinction is drawn between activities in which there is a
deliberate intention to work with or use biological agents and
activities where exposure is incidental (for example, agriculture
or health care) An indicative list of activities of the second
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sort is given, but the risk assessment remains the primary
determinant of the action required.
12 The Directive requires that as far as the nature of the
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activity permits, that is to say where a choice of agent is
possible, the least harmful one with which it is still possible to
carry out the activity should be used. A range of specified
control measures must then be considered and applied in the light
of the assessment of risk. Some special measures, including rules
for matching containment measures to the classification of the
agent, are set out for certain types of health and veterinary care
facility, laboratories, animal rooms and industrial processes. For
activities other than industrial processes the containment
measures that appear in annexes to the Directive are modelled on
the ACDP scheme, and for industrial processes on the principles
published by the OECD as recommendations for large scale work with
genetically modified organisms (see paragraph 17 below)
13 The remaining provisions of the directive broadly follow the
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pattern of COSHH, except for the requirements for a list to be
kept of exposed workers where there is deliberate use of agents in
the two most hazardous categories, or significant risk from them,
and for notification to be given to the competent authority of
certain activities involving biological agents. Notification
requirements do however already exist in the UK under the Health
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and Safety (Dangerous Pathogens) Regulations 1981 (see paragraph
19 below)
The classification directive
14. Article 18 of the Biological Agents Directive requires the
Council of Ministers to adopt a first list of agents classified in
the three most hazardous groups. Article 19 provides for the list
to be updated.
15. A proposal for a directive containing this first list and
amending the as yet empty Annex III of the Biological Agents
Directive, together with notes on the application of the
classification scheme, is under negotiation. The current draft
parallels closely the current ACDP categorisation. Although
expected to omit little the list will not be exhaustive and agents
that do not appear in it will not implicitly be in group 1 (the
least hazardous category) the correct group for them must be
;
identified by applying the classification criteria. There is an
indication in the draft list of which agents are likely to cause
toxic or allergic reactions (bearing in mind that classification
is on the basis of infection risk only) When the list has been
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adopted by the Council of Ministers we propose that it should
b1e6.come an "Approved Classification" under COSHH, and be issued as
a new edition of the ACDP categorisation document. The list is
expected to be adopted in 1993, but if it is delayed then we
propose that the existing ACDP categorisation should be used
meanwhile.
Classification nomenclature
The Directive refers to the groups that result from the
classification scheme as "risk" groups. Established practice in
the UK, following the ACDP scheme, is to call them "hazard"
groups, and it is proposed that this familiar nomenclature should
be retained in the implementing legislation to avoid confusion.
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Biological agents genetic Modification and COSHH
f
17.
Separate sets of regulations already place some requirements
on activities involving genetically modified organisms (GMOs)
They are the Genetically Modified Organisms (Contained Use)
Regulations 1992, and the Genetically Modified Organisms
(Deliberate Release) Regulations 1992, which implement directives
90/219/EEC and 90/220/EEC respectively. Some biological agents
will also be GMOs, and there will therefore be an overlap between
COSHH and the GMO legislation. Where a duty is performed to comply
with the more specific GMO regulations it will count as compliance
with any overlapping requirements of COSHH. In particular, an
assessment of risk carried out for the purpose of a notification
m1a8d.e under the GMO regulations will constitute a major part of the
assessment required by COSHH Regulation 6, and the draft
amendments explicitly provide that dual notification under the GMO
regulations and the amended COSHH regulations is unnecessary.
It should be noted, however, that the classification schemes
used in COSHH and the GMO Contained Use Regulations are very
different from one another. A biological agent that falls or is
treated as falling into hazard group 1 may be a Group II GMO,
because of the environmental risks associated with it or because,
even though now unlikely to cause human disease, it is derived by
genetic modification from a pathogenic parent organism. In the
latter case the GMO Regulations permit the selection of
19.
containment measures appropriate to the agent’s reduced virulence
and its corresponding COSHH hazard group. Where there is a
mismatch, as in the case of a GMO/biological agent which is non-
hazardous to humans but environmentally harmful, the more
stringent set of requirements must be followed.
Notification of activities involving biological agents
Article 13 of the Biological Agents Directive contains
requirements for the notification to the competent authority of
certain activities involving biological agents. They overlap with
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those already in existence in the UK under the Health and Safety
(Dangerous Pathogens) Regulations 1981 (DPR) The proposed
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amendments add new notification requirements to COSHH which merge
the provisions of the Directive and the requirements currently set
out in DPR. DPR themselves are repealed.
20.
Outline of proposals
We propose that the principal amending provisions concerning
biological agents should be concentrated in a schedule to COSHH (a
new Schedule 11) rather than distributed throughout the existing
,
text in the form of regulation by regulation amendments. Although
the main regulations and the schedule will need to be taken
together, this arrangement has the advantage that most of the new
and specific biological agents provisions can be read as a whole.
A2m1e.ndments to Regulations 2 and 5 of the principal Regulations are
needed however to introduce new definitions associated with
biological agents and to activate the new schedule.
Definitions
A new definition of "micro-organism" is introduced into COSHH
Regulation 2, and a definition of "biological agent" given in
S2c2.hedule 11 paragraph 1. The definition of "biological agent" is a
little wider than that given by the Directive, to take account of
the possibility that there may be important harmful effects other
than infection, toxic effects or allergy; for example, the
possible colonisation of a worker by cells derived from tumours or
immortalised cell cultures.
Classification and risk assessment
Schedule 11 paragraphs 1 and 3 introduce the classification
criteria referred to above, and the Approved Classification which
is to be based on the Classification Directive. A link is made in
Schedule 11 paragraph 4 between classification and the risk
assessment required by Regulation 6
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Prevention and control of exposure
23. Schedule 11 paragraphs 5 and 6 enlarge upon the existing
COSHH Regulation 7, in its application to biological agents. They
require first that substitution of an agent by a less harmful one
should always be used where the nature of the activity permits,
and then other means of preventing exposure where reasonably
practicable. A list of measures for the control of any remaining
exposure is then given, all of which must be considered and
applied as appropriate in the light of the assessment of risk.
This means that not all the measures will need to be applied, or
applied in full, in every case. There will be situations where a
particular measure has little effect on the risk. Some are likely
to have little bearing except in activities where there is a
deliberate intention to use or work with a particular agent. It
should be noted that the provision of vaccines in appropriate
cases, which appears in Article 14(3) of the Directive under the
heading of Health Surveillance has been included as Schedule 11
paragraph 6(i).
24. Schedule 11 paragraphs 7 and 8 set out some additional
measures for health and veterinary care facilities, laboratories,
animal rooms and industrial processes, and give rules for the
selection of containment measures on the basis of the
classification of the agent. The table of containment measures for
health and veterinary care facilities, laboratories and animal
rooms set out in the draft Schedule 11 Part II is taken from the
Biological Agents directive. It departs in some respects from the
corresponding but more precisely formulated set of measures
contained in the UK guidance referred to at paragraph 10 above.
Table 1 of this document compares the two tables for those items
where there are differences. We propose that the regulations as
amended should follow the current established UK system rather
than the directive in this respect, which would mean incorporating
the measures shown on the left hand side of the levels section of
Table 1.
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Maintenance, examination and test of protective clothing and
equipment
25. Schedule 11 paragraph 9 adds some additional requirements to
COSHH Regulation 9 in order fully to implement the Directive, and
to prevent protective equipment from acting as the means by which
biological agents are transmitted.
Information for persons who may be exposed to biological agents
26. Schedule 11 paragraph 10 enhances COSHH Regulation 12 to
ensure that employees have written information about serious
accident procedures and the handling of the most hazardous agents,
and that they report accidents and incidents.
List of employees exposed to certain biological agents
27. Schedule 11 paragraph 11 sets out a new requirement for the
keeping of a list of employees exposed to agents in the two most
hazardous categories, limited (by Schedule 11 paragraph 2) to
activities where there is a deliberate intention to use or work
with the agents in question, or there is significant risk. The
requirement for the list is separate from the requirement for
health surveillance contained in COSHH Regulation 11.
Notification of activities involving biological agents
28. Schedule 11 paragraphs 12 to 14 set up the notification
scheme referred to at paragraph 19 above. To implement the
directive it extends to some agents other than those covered by
DPR. Incorporation of the DPR provisions means that the new
requirements go beyond the directive in some respects,
particularly in the requirement to notify consignment, and this
effect has been increased slightly by referring to group 4 instead
of the more limited DPR category of "listed pathogen", in order to
align the requirements from the two separate sources.
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