MEMORANDUM 38
Submitted by The Soil Association
SUMMARY
The Soil Association has not responded in detail
to the draft legislation on the Food Standards Agency. This is
partly a question of time and resources, and partly because we
are aware that other organisations have more detailed expertise
on the regulatory aspects.
Our overview and critique of the Agency is that
the rationale for its creation is flawed in that it has been designed
to treat symptoms not causes. As such it will have only limited
ability to prevent the development of new food safety problems
which generally arise through weaknesses in agricultural policy,
over which the Agency will have no control.
We believe that the largely regulatory approach
of the Food Standards Agency will unfairly and unjustifiably burden
many small and medium scale food producers with costs and red
tape which will not recognise the greatly reduced risks associated
with small scale and less intensive production methods and as
a result will make these businesses unviable.
Our primary concerns with the proposed legislation
relate to the Government's refusal to bring the regulation of
veterinary medicines and pesticides under the Food Standards Agency.
If Ministers are still not prepared to do this we feel they must
at the very least give the Food Standards Agency the over-arching
role of co-ordinating action across all relevant departments and
non-government organisations against the growing problem of resistance
to therapeutic agents used in food production.
We are happy to be involved with and represented
on the various agency committees, since we recognise that even
if our perceptions about the structural flaws of the design of
the Agency are accurate, its development is now a reality and
it will be important to make it work as well as possible.
Inherent problems with the concept of the Food
Standards Agency.
Our presumption is that the Agency has been
established in direct response to growing public concerns arising
from a wide range of food safety scares which have occurred over
the last few years.
The Government's response to these events has
been to presume that they have been caused by a combination of
a failure to separate vested interest groups from consumer interests
and poor policing of food hygiene, safety and quality.
Consistent with this analysis, the design of
the Agency therefore reflects:
separation of those responsible for agricultural
practice and policy from those with a consumer interest in food
and farming; and
an increase in pre- and post-farmgate food quality
and safety scrutiny, with particular emphasis given to hygiene.
The problem with this approach is that:
the Agency will have to deal with the consequences
of flawed and inherently unsustainable production practices which
have, we believe, been responsible for every one of the recent
food quality and safety scares;
as a direct consequence of the structure of the
Agency excluding those with an agricultural interest and excluding
the Agency from any significant role in the development of broader
agricultural policy, those involved with the Agency will be either
unqualified or unable to correct the current deficiencies in agricultural
practice and so will be straddled with the increasingly onerous
and demanding task of undertaking a quality control function for
an industry which is designed to deliver defective products;
nothing within the remit of the Food Standards
Agency will be able to bring about a overall reduction in the
use of pesticides, ammonium-based fertilisers, antimicrobial feed
additives, or any of the vast number of other agricultural inputs
which contribute both to food safety problems directly through
environmental pollution, food contamination and the development
of resistance to therapeutic agents and indirectly by making possible
the most intensive and often dangerous aspects of modern food
production.
The Soil Association would therefore have preferred
to see the substantial effort currently going into the establishment
of the Food Standards Agency used to restructure and OEgreen1
the Ministry of Agriculture, Fisheries and Food, so that food
safety problems could have been addressed in an integrated and
fundamental way through changes in agricultural policy which encouraged
a move away from damaging chemical inputs and towards a more systems-oriented
approach. Had this happened we believed it would then not have
been necessary to bring about the artificial, inappropriate and
in the long term unworkable separation of food and agricultural
policy which is enshrined in the draft Food Standards Agency legislation.
As this has not happened we believe there is
a real risk that the Agency will have a higher workload than anticipated,
since current agricultural practice is likely to continue generating
new food safety problems. If this happens the Agency will appear
to have justified its existence, however, the reality will be
that it has been constructed in such a way that it can only react
to food safety problems. If it is well run it may be able to react
more promptly and effectively once problems arise, but it will
have very little ability to prevent them from occurring.
The only major exception to this relates to
the proposal to bring the new committee on animal feedingstuffs
under the umbrella of the Agency. Compared with the rest of the
Agency's role this appears something of an anachronism and has
come about only because of the BSE crisis and the fact that leaving
such a committee within MAFF would be politically unacceptable.
COSTS
A higher level of activity than planned and
any major new food safety crisis could lead to substantial increase
in running costs. Were these to be recouped through an increase
in the proposed flat rate levy this could have a devastating effect
on small and even medium-sized producers. This is one reason why
we oppose the flat rate levy. We also oppose it because if and
when something goes wrong the risks associated with a small business
are proportionately lower than those associated with a large one.
Consequences of the regulatory approach on small
businesses
Tackling food safety through increased regulation
rather than through agricultural policy has the potential to undermine
the financial viability of the very systems of agriculture which
could and should be promoted and developed as an alternative to
those which are currently causing most food safety problems. A
good example of this would be the proposed new charges for the
enforcement of hygiene standards on small abattoirs and meat processors.
The requirements are in themselves so draconian that many small
operators will find them impossible to meet. They are also already
forcing the closure of small abattoirs with exemplary hygiene
records. Those that can afford to make the structural changes
will then face a level of charges per tonne so much greater than
the higher throughput operators that the majority of them could
be put out of business. It has, for example, been estimated that
inspection charges will be about £1 per tonne in large abattoirs,
but for small abattoirs this could be as high as £186 per
tonne. Virtually all organic meat businesses are currently operating
through decentralised small abattoir and processing units. Not
only will such increased charges threaten the viability of many
organic producer-retailers, but they will also force the closure
of yet more small abattoirs and kill off the burgeoning development
of local food initiatives which, in the case of meat, require
local slaughtering for welfare and environmental reasons.
Specific concerns with the proposed legislation
on Veterinary Medicines
While we would have been happy to see all safety
evaluation and regulation of agricultural inputs stay with a reformed
MAFF we are deeply concerned that the regulation of veterinary
medicines and pesticides are to stay within MAFF under the proposed
arrangements.
The regulation of veterinary medicines on farms
is a more complex matter than most people might suppose with at
least eight separate bodies having a statutory involvement and
several other having an important role. Failures here have so
far not led to a major food safety crisis, but there are a number
of problems just beneath the surface any one of which could suddenly
develop as a full blown crisis with which the Agency would have
to deal. Professor James originally proposed that responsibility
for evaluating the safety of veterinary medicines should pass
to the Food Standards Agency, but government rejected this as
a result of the many representations it received from the pharmaceuticals
and intensive livestock farming industries.
The basic argument was that this should stay
with MAFF because of its knowledge of production systems and expertise
in assessing the efficacy of products. The clear concern from
the industry being that a Food Standards Agency, driven by consumer
concerns about food safety would move rapidly to ban a large number
of products suspected, but not proved to be dangerous, on which
the intensive farming industry depends. This issue more than any
other symbolises the conflict that exists between OEefficacy1
and OEsafety1 on a wide range of input-related issues
and is an example of where government Ministers may have to arbitrate
in the future between conflicting advice from MAFF and the Food
Standards Agency.
On animal feed government has given the advantage
to the Agency, with veterinary medicines and pesticides it has
left this with MAFF and given the Agency only a seat on the relevant
committees and the right to be consulted on policy aspects. In
practice this will give the Agency no ability to set the agenda
and in order to be in a position to use the veto it has been given
it would need access to the same information as MAFF and would
also need to duplicate its evaluation work. This is both impractical
and extravagant. It is also not clear that the Food Standards
Agency will have access to all relevant information or even that
the Food Standards Agency representative on the Veterinary Products
Committee will be free to circulate normally confidential committee
papers within the Agency.
Critical need for an Agency with over-arching
responsibility
However, there is a more fundamental reason
still why we believe the Agency should have an increased role
in regulating veterinary medicines. The example of the problem
of antibiotic resistance passing from animals to the human population
in zoonotic infections shows why there is a desperate need for
a single body with a food safety remit to take overall responsibility
for co-ordinating action throughout all government departments,
agencies and non-governmental organisations with a responsibility
in this area. Since 1968 setting policy on farm antibiotics has
been the joint responsibility of Agriculture and Health Ministers
and both MAFF and the DoH have departments dedicated to this issue.
Increasingly policy is, however, being set at a European level
and Britain is being dragged reluctantly to adopt a more precautionary
approach. However, there is a bewildering array of other bodies
with a responsibility in this area too and no effective co-ordination
of their work. This is both inefficient and means that issues
such as antibiotic resistance are being tackled in a haphazard
and ineffective way.
Licensing of veterinary medicines and residue
testing is undertaken by the Veterinary Medicines Directorate
(VMD), but controlling the problem of antibiotic resistance is
not in the VMD's mission statement. Resistance in farm pathogens
is not routinely monitored, but some work carried out by the Veterinary
Laboratories Agency (VLA) resistance in gram negative human pathogens
of farm animal origin is monitored by the Public Health Laboratory
Service, but there is no routine monitoring of the more dangerous
gram positive pathogens and the use of medicated feed is prescribed
by veterinary surgeons and monitored, along with the unprescribed
of antibiotic zootechnical feed additives, by the Royal Pharmaceutical
Society of Great Britain.
Use of other therapeutic antibiotics on farms
is also prescribed by veterinary surgeons, but monitored by the
State Veterinary Service, Trading Standards Officers and practising
veterinary surgeons, safety of veterinary medicines on farms is
policed by the Health and Safety Executive.
Education of vets over prescribing practice
and changes in veterinary medicines legislation is the responsibility
of the Veterinary Colleges and the British Veterinary Association
disciplining of vets caught breaking prescribing guidelines is
carried out by the Royal College of Veterinary Surgeons.
While formal statistics do not exist there is
little doubt that a significant number of people are dying in
the UK each year from drug resistant infections of farm animal
origin. The rise in deaths from multi-drug resistant gram positive
infections being most alarming. The problem of antibiotic resistance
is widely recognised as one of the greatest threats to face mankind,
yet we have no co-ordinated action to deal with it and we have
no agreement between the different bodies with statutory responsibility
on how serious the problem is or how it should be addressed. The
UK Government, for example has been forced to agree to a ban on
a number of growth promoting antibiotics due to pressure within
Europe from Sweden, Finland and Denmark. Without this pressure
no action would have been taken. However, since farmers are free
to change to alternative antibiotics the problem has not yet been
resolved in any long term way.
Lack of co-ordinated action
An example of the critical need for a co-ordinating
agency on veterinary medicines is the total lack of dialogue between
the Veterinary Medicines Directorate and the Public Health Laboratory
Service. The VMD is a quasi-commercial executive agency of MAFF.
Since 1990 it has been entirely responsible for its own funding
most of which comes from the business of licensing veterinary
medicines, a business for which it will increasingly have to compete
at a European level. The PHLS is an agency of the Department of
Health funded by a direct annual government grant of about £50
million. The PHLS monitors the level of drug resistant infections
in the human population and therefore sees the consequences of
veterinary medicines licensing and prescribing policy. It also
undertakes detailed research in this area and publishes figures
on trends. However, despite this it has no input into veterinary
medicines policy and no formal liaison with the VMD to discuss
these issues. This is in marked contrast to the routine liaison
between the VMD and the pharmaceuticals industry.
The Veterinary Products Committee
Special mention must be made of the Veterinary
Products Committee (VPC). The VPC is an independent advisory committee
which takes decisions about the licensing of veterinary medicines
and gives advice to Ministers on veterinary medicines policy.
It comes under the secretariat provided by the VMD and has long
been perceived as being too heavily stacked with industry representatives
and of putting the commercial interests of both industry and the
VMD before its requirements in relation to public safety. For
example, for over 20 years, and despite the efforts of a few individual
committee members, the VPC has done everything in its power to
prevent the banning of antibiotic growth promoters used in the
feed of all classes of farm animals.
In 1976 the VPC extended the use of the growth
promoting antibiotic avoparcin to adult and breeding cattle, against
the recommendations of the Swann Committee and without any published
work on the theoretically probable effect this would have of increasing
levels of salmonella and E. coli in cattle.
In 1981 the VPC would not agree to allow an
independent committee of microbiologists which advised it to review
the use of existing growth promoting antibiotics. Enraged the
committee, chaired by former head of the PHLS, Sir James Howie
went direct to Ministers who refused to discuss the issue and
sacked the advisory committee.
In 1986 the VPC sidestepped moves to ban antibiotic
growth promoters along with hormone growth promoters as happened
in Sweden.
In 1993 the VPC against advice, licensed several
fluroquinlone antibiotics including enrofloxacin for animal usage
(effectively the same antibiotic as ciprofloxacin used in human
medicine) and did nothing to prevent its widespread prophylactic
and therefore additionally, growth promoting use, by pig and poultry
producers. By 1994 the PHLS found ciprofloxacin resistant strains
in six per cent of some types of food poisoning bacteria isolated
from human sufferers. Levels have increased annually since that
time.
In 1996 the VPC advised British government representatives
to vote against an EU initiative to ban avoparcin the most widely
used growth promoting antibiotic, closely related to vancomycin
the most important drug of last resort in human medicine. Britain
was the only Member State to oppose the ban and avoparcin now
banned worldwide since evidence that it was causing cross-resistance
with vancomycin has become too strong to ignore.
In 1997 the VPC decided there was no need to
act on Finnish evidence which showed that the use of the growth
promoting antibiotic tylosin phosphate (the most widely used growth
promoter in pig production) was causing resistance to the related
antibiotic erythromycin. Tylosin phosphate is now to be banned
throughout EU from July 1999.
The VPC has recently endorsed the fait accompli
European decision to ban six growth promoting antibiotic feed
additives, but failed to recommend a ban on four others including
avilamycin which is now seeing increased usage, despite being
aware of the build up of avilamycin resistant enterococci in the
human population which will be resistant to a new related life-saving
antibiotic currently under development.
The fundamental problem here is not with the
individual members of the VPC, but with Ministers and civil servants
who maintain the OEbalance1 of the committee and with
the VMD which is itself far too heavily influenced by industry.
If Ministers are not prepared to bring the VMD
under the control of the Food Standards Agency we feel they must
firstly give the Agency the over-arching role of co-ordinating
action against resistance to all therapeutic agents used in food
production and processing and separately act to change the culture
within the VMD and the VPC, by redefining their terms of reference
and removing the commercial necessity from the VMD.
March 1999
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