Response to the Committee's conclusions
and recommendations
CONSULTATION BEFORE THE RECALL
Recommendation (a):
"We agree with Professor Aitken that there is a need for
dialogue between the Environment Agency and the Veterinary Medicines
Directorate about the review process, and believe the discussions
should also examine how the Environment Agency can be directly
involved in VPC processes rather than through the officials of
the DETR."
Recommendation (b): "We agree that, whilst
Parliament has the right to know the outcome of ministerial decisions
prior to their wider dissemination, representative organisations
could have been consulted on the Government's proposals prior
to a final announcement; nor do we see any issues of commercial
confidentiality arising since the products were to be withdrawn
completely at the cost of the companies involved (hence early
warning would not affect sales) or potential stockpiling difficulties
for the same reason that the concentrate was to be collected from
all farms. Consultation with manufacturers and farmers' organisations
would have prevented the announcement from appearing to be a panic
measure and would have greatly facilitated the provision of advice
and the smooth handling of the withdrawal process in its immediate
aftermath. In these circumstances, the culture of secrecy proved
most unhelpful. We recommend that, in future similar cases, consultation
be undertaken with interested parties on potential courses of
action prior to the official announcement to Parliament."
Response
5. The Government agrees that there would be advantages
in ensuring that the VPC has direct access to advice from the
Environment Agency on subjects where this would be relevant. Such
arrangements are being put in place.
6. The issue of deciding not to consult in advance
of a formal announcement is not a question of commercial confidentiality
or of a culture of secrecy but of acting properly within the legal
framework. The withdrawal of marketing authorisations is one step
in a formal, statutory process, responsibility for which rests
with the Agriculture and Health Ministers acting as the Licensing
Authority. It would not have been appropriate to discuss the action
proposed with the authorisation holders before the Licensing Authority
Ministers and Departments had agreed to take that action. The
action taken by the Licensing Authority gave marketing authorisation
holders a statutory right to make representations (appeal) against
the action taken. It was, in any case, made fully clear to the
marketing authorisation holders in July that in the event that
their plans for modifications to containers were not found acceptable,
the VPC was minded to advise regulatory action in relation to
marketing authorisations.
Consultation on packaging improvements
Recommendation (c): "We believe that a more
constructive dialogue between VPC/VMD and the manufacturers in
the period after July was possible and could have led to the development
of workable proposals for container improvements."
Response
7. The letter of 29 July to marketing authorisation
holders set out the VPC's parameters for improved concentrate
containers. It was not for the VPC to dictate how each company
might wish to modify containers in order to minimise the risk
to the operators. Thus it was open to each company to make commercial
judgements in each case as to the best and most cost effective
way to meet the requirements. Officials met with representatives
of the companies, separately and together, as early as August
1999 to listen to their plans and to answer questions. However,
officials rightly could not prejudge the advice of the Committee
to Ministers.
Information for farmers
Recommendation (d): "We
recommend that before such important announcements in the future
MAFF prepare an information sheet (embargoed if necessary) that
summarises the announcement and its implications for regional
service centres, helpline staff and advisers within farmers' representative
organisations. This information should also be made available
to farmers and other organisations via the Internet."
Response
8. The Government accepts that information for farmers
about the announcement could have been better handled. In particular,
Regional Service Centres and helpline staff should have been provided
with detailed advice on the practicalities of the recall once
the Licensing Authority Ministers had taken their decision. Such
information can, in future, be made available on the MAFF and
VMD websites. It might also have been helpful to facilitate an
early meeting at which marketing authorisation holders could have
discussed their plans for recalling products with VMD and other
officials.
Animal Welfare and Health
Recommendation (e): "We believe that there
should be a 'Plan B' in case of a major outbreak of sheep scab
during the period of time farmers are without OPs. We recommend
that MAFF consult on and publish such a plan as a matter of urgency."
Response
9. The Government recognises the real concern of
sheep farmers to have the full armoury of controls, including
OP dips, available and the VPC are providing every assistance
to the companies to enable OP dips to return to the market once
the concerns of the VPC have been addressed. It is hoped that
OPs may again be available to the industry within 12 months.
10. The Government does not believe that any contingency
plan for the period in which OPs are not available is necessary.
Even though OP dips have been withdrawn from the market, there
are other dip and injectable products available. These, if used
according to the manufacturers' instructions, are effective and
we anticipate will be sufficient to deal with the disease situation
in the Autumn. It would not be possible, having withdrawn OP dips
from the market on safety grounds, to return them to the market
unless the concerns of the VPC had been satisfactorily addressed.
11. The Sheep Scab Order 1997 was introduced at the
industry's request for legislation so that the industry could
deal with those less responsible individuals who did not treat
their sheep against scab. It is an offence for sheep farmers to
have scabby sheep and not treat the whole flock. Any sheep farmers
aware of scabby flocks can report the matter to the local authority
who are responsible for enforcement. Therefore the industry has
the legislative means and alternative products to deal with any
significant increase in the incidence of sheep scab.
Economic issues
Recommendation (f): "We
recommend that the Government assess the level of scab and evaluate
the economic impact upon farmers of alternative approaches to
eradicating scab from the UK. We further recommend that the likely
economic cost to farmers of the cost of withdrawal of OP sheep
dips be assessed and published."
Response
12. Sheep scab is not a notifiable disease and no
precise information on its occurrence is held centrally. The Sheep
Scab Order 1997 gives powers to Local Authorities to investigate
cases of scab and to require control measures under the supervision
of a private veterinary surgeon. In such cases, samples taken
by Local Veterinary Inspectors for diagnosis are examined by the
Veterinary Laboratories Agency (VLA). This information provides
some evidence of the occurrence of scab. The VLA report that the
number of cases referred to them for diagnosis has declined recently.
It is not clear whether this is due to a reduction in scab or
a reduction in the reporting of possible scab to Local Authorities.
Surveillance for sheep scab will be considered as part of on-going
work to develop a coherent strategy for veterinary surveillance.
13. The Government has funded work since 1996 to
explore non-chemical methods as alternative approaches to sheep
scab control. One avenue of approach is based on earlier published
work funded by MAFF at the Royal Veterinary College. The earlier
results showed evidence of an immune response in the blood of
sheep affected by sheep scab mites. A four-year programme, costing
£1.6m, investigated the significance of this. The results
in 1999 showed that the approach to the immunological control
of sheep scab is complex and requires an understanding of a number
of key elements if a vaccine is to be developed. A further, three-year
study focussing on these elements is in hand.
14. A major effort to eradicate sheep scab was undertaken
between 1976 and 1992. This included supervised national dipping
during specified periods, movement controls, and segregating dipped
and non-dipped sheep in markets. Fleece samples were checked for
evidence of dipping. Where outbreaks occurred, there was full
tracing of contact sheep by the State Veterinary Service. Eradication
was not achieved despite this intensive effort. The reasons were
attributed to a major increase in the size of the national flock,
from 27 million in 1976 to 45 million in 1992, greater movement
of sheep around the country, and a lack of commitment by some
sheep farmers. A contributory factor was the difficulty of ensuring
a complete gather on common or open grazing land and the impossibility
of gathering feral sheep. None of these factors has changed and
the reintroduction of a national eradication plan is not considered
feasible.
15. The economic cost to farmers of the
withdrawal of OP sheep dips is marginal. Alternative products
are more expensive - the cost of OP dip per sheep treated is around
30p, whereas the cost per sheep of an injectable and a pour-on
product is around 80p. However, the labour costs of dipping sheep
are considerably higher since more people are needed.
Re-introduction of OP sheep dips
Recommendation (g): "We recommend that the
VPC and MAFF prepare and publish a timetable for the re-introduction
of OP dips, in both interim and permanent container designs, subject
to the achievement of necessary safety measures, in order to reduce
uncertainty in the industry."
Response
16. The timing of the reintroduction of OP sheep
dips has been largely in the hands of the marketing authorisation
holders. However, as already indicated, officials and the VPC
will co-operate fully to assist their return at the earliest opportunity.
17. Unfortunately, plans developed by one company
for a change to containers in the short term and closed transfer
systems as long term solutions, which were found acceptable by
the VPC at its meeting in November 1999, were not taken forward
because of the merger of the company with another. Marketing authorisations
for the products in question were terminated at the request of
the company which held them after the merger. Had these plans
gone forward, then improved containers for OP dips would probably
have been available in the Summer of 2000 and closed transfer
systems might have been developed by the end of the year.
18. The Ministers who jointly form the Licensing
Authority are currently considering advice from the Veterinary
Products Committee (VPC) on the return of OP sheep dips onto the
market.
Protection of dippers
Recommendation (h): "We find some merit in
the idea of making laminated sheets part of the required labelling
of each dip container and recommend that the Government consider
making it a legal requirement that laminated sheets be given out
to purchasers of OP sheep dip at the point of sale."
Recommendation (i): "We
recommend that the new labels for OP sheep dip concentrate be
agreed as soon as possible, giving due regard in their wording
and positioning to the practical circumstances in which the product
is used."
Recommendation (j): "We recommend that the
Government reconsider the scope of the Certificate of Competence
for the use of sheep dips."
19. New labels for sheep dips are well advanced and
marketing authorisation holders will be expected to adopt the
new labels as part of the process of an eventual return of their
products to the market. We agree that the provision of a laminated
sheet at the point of sale has attractions and we will shortly
consult on ways to bring such a requirement into effect.
20. The Government received advice from the Health
and Safety Commission in November 1999 against a statutory requirement
for users of sheep dips to hold Certificates of Competence. The
HSC, which has the responsibility for advising the Government
on such matters, advised that there is already extensive legislation,
including the COSSH Regulations, requiring dippers to be fully
trained and competent and that requiring mandatory certification
would not necessarily improve practice. On the contrary, mandatory
certification may lead dippers to consider that certificates discharge
them from their responsibility to work safely every time they
dip and would not assist enforcement. The Government accepts the
Committee's recommendation that the scope of the Certificate of
Competence Scheme should be reconsidered. The Government is currently
considering whether to consult interested parties on making it
an offence if the person supervising the dipping operation and/or
the principal concentrate handler do not hold a Certificate of
Competence.
Ministry of Agriculture, Fisheries and Food
July 2000
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