Memorandum submitted by the Health and
Safety Executive
INTRODUCTION
1. On 20 December 1999 the Government announced
its response to the advice from the Veterinary Products Committee
(VPC), the Advisory Committee on Pesticides (ACP) and the Committee
on Safety of Medicines (CSM) on the regulatory implications of
the report on organophosphates (OPs) by the Committee on Toxicity
of Chemicals in Food, Consumer Products and the Environment (COT).
2. The action proposed by Ministers in their
response takes the form of a four-point plan. This memorandum
sets out for the Committee HSE's role in implementing the four-point
plan; and provides general background information on HSE's role
in relation to organophosphorus (OP) pesticides and veterinary
medicines.
HSE'S ROLE
IN RELATION
TO ORGANOPHOSPHORUS
(OP) PESTICIDES AND
VETERINARY MEDICINES
3. The Health and Safety Commission (HSC)
and the Health and Safety Executive (HSE) regulate virtually all
risks arising from work activity in Great Britain. The HSC and
HSE were established by the Health and Safety at Work etc. Act
1974 (HSWA), which lays general health and safety duties upon
all who own, manage and work in economic undertakings. The HSC's
main role is to propose health and safety law and standards to
Ministers. HSE advises the Commission and enforces the legislation
through health and safety inspectors. In certain premises, local
authorities are allocated this enforcement role.
4. In general terms, HSE is responsible
for ensuring that the risks to people arising from the use of
chemicals at work—including OP sheep dips and pesticides—are
properly controlled.
5. All pesticides and veterinary medicines
must be approved by Ministers before they can be marketed in the
UK. Applicants are required to submit substantial data dossiers
for scrutiny to satisfy criteria of safety, quality, and efficacy.
Dossiers are examined by scientists of the Pesticides Safety Directorate
(PSD) and the Veterinary Medicines Directorate (VMD) and the advice
of the independent ACP and VPC is sought. The Committees make
recommendations as to whether the chemicals can be approved as
a pesticide (ACP) or veterinary medicine (VPC) and, if so, under
what conditions. Primary responsibility for the authorisation
scheme for veterinary medicines (including OP sheep dips) rests
with the VMD, an Executive Agency of MAFF. Once products are authorised
for marketing and use, safe use at work is subject to the requirements
of the Control of Substances Hazardous to Health Regulations (COSHH)
1999, made under HSWA. HSE and local authorities are responsible
for enforcement of these requirements.
6. For pesticides, the Control of Pesticides
Regulations, 1986 (COPR) require a thorough assessment of the
risks such chemicals pose to both people and the environment.
The PSD Executive Agency of MAFF administers approvals for agricultural
pesticides; and HSE's Pesticides Registration Section deals with
non-agricultural pesticides. HSE is responsible for enforcing
controls on both agricultural and non-agricultural pesticides
under the terms of an Agency Agreement made between MAFF Ministers
and the HSC. This Agreement will shortly be replaced by new Agreements
covering England, Scotland and Wales, following the introduction
of Scottish pesticides legislation, but these are administrative
changes and, in practice, HSE's role will remain essentially unchanged.
7. HSE liaises closely with MAFF (including
its Executive Agencies, VMD and PSD), DH and other interested
Government bodies in the formulation of policy and production
of guidance relating to pesticides and veterinary medicines. For
example, HSE is working with MAFF to revise the Code of Practice
on Safe use of Pesticides on Farms and Holdings (the Green Code).
One of the aspects of the code that will be looked at is the advice
on OPs, in light of the COT findings. Advice and enforcement is
based on COSHH, which place duties on employers to assess and
adequately control risks to health and to train, instruct and
ensure the competence of their employees.
8. HSE co-ordinates the Pesticide Incidents
Appraisal Panel (PIAP) which reviews investigation reports concerning
alleged ill health linked to pesticide exposure. HSE also co-operates
with the VMD in the Suspected Adverse Reactions Surveillance Scheme
(SARSS) which has a similar role for veterinary medicines. Both
PIAP and the SARSS Appraisal Panel serve to inform the respective
advisory committees about adverse reactions.
9. HSE is also represented on the interdepartmental
Office Group on OPs (OGOP), which was established in 1997 to ensure
effective co-ordination of policy and action on OPs by Government
Departments and Agencies. OGOP is chaired by a senior official
in MAFF.
THE COT WORKING
GROUP ON
OPS
10. The COT Working Group on OPs was set
up in early 1998 in response to concerns about the human health
implications of OPs. It was intended to be a fresh, thoroughgoing
review of all the available scientific evidence. The Group's terms
of reference were: "To advise on whether prolonged or repeated
low-level exposure to OPs, or acute exposure to OPs at a lower
dose than causing frank intoxication, can cause chronic ill health
effects." For practical reasons, the Group concentrated upon
class effects of OPs (ie they did not consider compound specific
effects) and specifically neurotoxic effects. Although they were
aware of concerns about other possible class effects of OPs (eg
effects on the cardiovascular system, respiratory system and on
bone density) they focused on neurotoxic effects because they
were the types of illness most frequently attributed to OP exposure.
11. The COT report was published on 26 November
1999. Its central finding was that the available evidence did
not support the hypothesis that prolonged, low-level exposure
to OPs caused neurophysiological or psychiatric illness or significant
harm to the peripheral nervous system, but the possibility that
a small subgroup of exposed persons may be affected could not
be excluded.
THE REGULATORY
COMMITTEES' ADVICE
12. The regulatory committees unanimously
agreed with the COT's conclusions that the conjectured ill-health
effects resulting from prolonged low-level exposure to OPs remain
unproven. They broadly endorse the report's recommendations for
further research, especially to answer the question whether there
is a small group of individuals particularly susceptible to OPs.
13. The regulatory committees advised against
any general withdrawal of OPs from the market. However, in the
light of the report published on 1 July 1999 by the Institute
of Occupational Medicine on its epidemiological study into the
effects of exposure to OP sheep dips, which confirmed that the
main risk of exposure arose from handling the concentrate and
highlighted deficient container designs, the VPC advised that
all OP sheep dips should be withdrawn from the market pending
the introduction of improved containers. This action was recommended
after the manufacturers had been given the opportunity of a three
month period to bring forward satisfactory plans for improved
containers and delivery systems.
THE FOUR-POINT
PLAN
14. The four-point plan involves a number
of Government Departments and Agencies and is being overseen by
OGOP. HSE's main areas of involvement are highlighted in bold
type below:
— Withdrawal of OP sheep dip products
from the market until containers are introduced which will minimise
operator exposure to the concentrate. The Veterinary Medicines
Directorate (VMD) wrote on 20 December to all holders of marketing
authorisations for OP dips requiring that sales be suspended,
and recall by 31 January of product from distributors and farms.
In line with the ACP advice, the Pesticides Safety Directorate
(PSD) has taken urgent action to confirm that all containers of
OP pesticide concentrates comply with modern standards, and has
established that this is the case. Although it has no direct responsibility
for these actions, HSE has an input to them through its officials'
attendance at, and advice to, the advisory committees;
— An ongoing review of OP and carbamate
anticholinesterase compounds (OPs and compounds with similar modes
of action). HSE's Pesticides Registration Section is responsible
for the review of non-agricultural pesticides, and PSD is
carrying out a similar review of agricultural pesticides. As of
20 December 1999, approvals for 14 OP compounds had been revoked
as a result of the review, in each case because the manufacturer
had chosen not to submit the data packages required. The VPC is
reviewing OP veterinary medicines other than sheep dips;
— implementation of a range of measures
aimed at continuing to promote best practice in use of sheep dips,
including:
(a) further improvements to labelling;
(b) a continuing programme of targeted
inspections of sheep dipping operations by HSE inspectors. Part
of HSE's Field Operations Directorate's preventive inspection
programme, the visits target the use of OP and synthetic pyrethroid
(SP) based sheep dips. The aim of the visits is to ensure compliance
with COSHH including physical control measures; and that operators
are properly trained and competent. Associated publicity is being
used to maximise the impact of the inspection campaign in promoting
compliance. Enforcement action (such as the use of notices and
prosecution) is taken where appropriate. The targeted inspection
programme is expected to run until the end of 2000;
(c) a review of HSE guidance leaflets
AS29 (rev2) "Sheep dipping", AS31 "Veterinary medicines—Safe
use by farmers and other animal handlers", and AS27 (rev)
"Agricultural pesticides", in the light of the latest
scientific advice, including the COT report. Where necessary,
revised guidance will be published by March 2001;
(d) supply of protective gloves with sheep
dip by the manufacturers;
(e) for sheep dip, licensing Ministers have
accepted the HSC advice that users of OP sheep dips should not
be compelled to hold certificates of competence. In 1999 the Commission
twice reaffirmed its earlier view that while certification schemes
had a place in the range of methods by which employers could satisfy
their duties to train and ensure competence, there were major
drawbacks to mandatory certification. Ministers have also decided
not to extend mandatory certification for agricultural pesticide
users, following a consultation exercise conducted earlier in
1999.
— A targeted research programme to
take forward the research recommendations from COT and the regulatory
committees. Ministers have now approved plans for a one day Workshop
in March, involving scientists researching into the effects of
OPs, in order to develop a research requirements document for
topics recommended by COT. HSE will consider (part) funding
such research in due course with MAFF and DH. The Workshop
is intended to allow all participants to play a role in refining
the questions to be addressed by the research programme. In addition,
the Interdepartmental Network on OP Research (INOR—the research
arm of OGOP) is currently discussing a proposal to investigate
databases of people who believe they are suffering from the effects
of OPs. INOR hopes that this latter project will start early this
year. HSE has been involved in the discussions, and may contribute
towards the project costs.
|
