Memorandum submitted by Carmarthenshire
County Council (M9)
EXECUTIVE SUMMARY
1. In order to fulfil food safety and public
health standards, Carmarthenshire County Council submits Shellfish
samples for Diarrhetic Shellfish Poisoning (DSP) as directed by
the protocol drawn up by the Food Standards Authority ( FSA ),
being the Central Competent Authority. The cost of sampling is
borne by FSA and it is FSA that directs to which laboratory the
samples are submitted for testing.
2. The Authority has at all times issued
Temporary Prohibition Orders (TPO) in accordance with the advice
and knowledge of FSA. In fact, after the issuing of the initial
TPO, permission has to be sought from FSA to issue further TPO's.
Local Authorities have been given clear advice from the FSA that
"atypical" DSP should be considered as a potential threat
to public health. In line with this advice Carmarthenshire County
Council has continued to issue TPO's on receipt of positive results.
Not to have done so would have been a failure in protection of
the public.
3. In collaboration with its neighbouring
Authority, the City and County of Swansea, Carmarthenshire County
Council has taken such steps as it can in to assist the Industry—by
offering a sum of £10,000 towards research into DSP in the
Inlet and in putting the case forward for zoning the Inlet, thus,
hopefully, allowing areas of the Inlet to be open at any one time.
4. At the very start of the problems with
DSP, local authorities were not allowed direct access to the testing
laboratory. On occasions delays in receiving results were experienced
as results had to be transferred from London to Cardiff and then
to the Welsh Local Authorities. This problem was then resolved.
5. Although FSA have sponsored research
into the cause(s) of "atypical" DSP, to date, there
has been no definitive answer as to the cause of the positive
results to the mouse bio-assay. It is important that the research
continues in order to determine if the "causative agent"
has a deleterious effect on public health.
1. INTRODUCTION
1.1 Carmarthenshire County Council is the
"food authority" for the implementation of the requirements
of EC Directives 91/492/EEC and 91/493/EEC which have been converted
into the Food Safety (Fishery Products and Live Bivalve Molluscs)
(Hygiene) Regulations 1998 (as amended).
1.2 The Council and its predecessor Authorities
have been responsible for the enforcement of the original regulations
since their coming into force in 1992.
1.3 The Council is responsible for the monitoring
of classified harvesting areas in its area and is also involved
in the DSP/PSP/ASP monitoring programme. There are two main areas
for the commercial harvesting of shellfish on Carmarthenshire's
area—The Three Rivers Area, which is only occasionally harvested,
and the Burry Inlet. Carmarthenshire County Council is responsible
for the northern side of the Inlet. The natural boundary between
Carmarthenshire and the City and County of Swansea it the main
channel of the River Loughor.
1.4 The Burry Inlet has historically been
a harvesting area for bivalve molluscs and in particular has been
famous for the harvesting of cockles (there is evidence that shellfish
were harvested in Roman times). The Inlet, particularly on its
southern shores, was the site of numerous small processing plants.
Those smaller units have disappeared and given way to larger,
more sophisticated shellfish processing plants. The Burry Inlet
shellfish industry is worth millions of pounds annually and unlike
its counterparts in other regions of the United Kingdom harvesting
is undertaken on a year round basis ie there is no closed season.
2. CARMARTHENSHIRE
COUNTY COUNCIL
EXPERIENCE
2.1 In line with other Local Authorities
with classified shellfish harvesting areas, Carmarthenshire County
Council submitted samples of live shellfish and seawater in order
to comply with the agreed DSP/ASP/PSP sampling protocol issued
by D.O.H. (subsequently FSA). The Authority is responsible for
complying with the sampling protocol and must submit samples to
the accredited laboratory designated by FSA, (since June 2001
this has been the CEFAS laboratory at Weymouth). Over a number
of years the sampling regime had thrown up an occasional isolated
positive result for diarrhetic shellfish poisoning (DSP), but
positive results were rarely reported on re-sampling.
2.2 The 2001 sampling protocol required
Carmarthenshire County Council to submit three samples of shellfish
from Burry Inlet (North) and the City and County of Swansea to
submit four samples.
2.3 On 11 July 2001 Carmarthenshire County
Council were notified that a sample of cockles submitted that
week had proved positive for the presence of DSP. The Authority
immediately issued a Temporary Prohibition Order for that area
of the Burry Inlet which fell within the jurisdiction of Carmarthenshire
County Council as the food authority empowered under the directive
(91/492/EEC). The City and County of Swansea and Carmarthenshire
County Council worked together on this issue and it was agreed
that one positive result (either from the three samples submitted
from Carmarthenshire or the four samples submitted from Swansea)
would require the closure of the whole Inlet.
2.4 The Temporary Prohibition Order (TPO)
ceases 28 days after the date of service, unless revoked previously.
Authority to serve further TPO's requires consent from the Minister
(in the Welsh context, FSA Wales).
2.5 Following more positive results on both
sides of the Inlet further TPO's were issued by Carmarthenshire
county Council (with the consent of FSA Wales) on 8 August 2001,
5 September 2001, 3 October 2001 and 31 October 2001.
2.6 Industry, in turn, blamed a stored "reservoir"
of water being discharged on occasions into the Inlet, the increased
"cleanliness" of the water following the commissioning
of the new sewage treatment works and also various discharges
into the Inlet.
2.7 Having received a series of negative
results on the North Side (5 November 2001, 12 November 2001 and
18 November 2001) enquiries were made as to whether that area
of the Inlet could be opened. After first having some positive
comments and implied agreement, Carmarthenshire Council took the
decision to revoke the order in order for harvesting to recommence.
Support for this move was unfortunately withdrawn due to a misunderstanding
over the nature of the situation. A further TPO was issued on
30 November 2001.
2.8 Obviously by this time the shellfish
industry within the Burry Inlet was in uproar and could not accept
that the positive results were purely as a result of an algal
bio-toxin giving a positive result for DSP using the mouse bioassay
(MBA).
2.9 Increasingly, however, Industry were
questioning the validity of the DSP test, which is a mouse bioassay
test, being undertaken by the CEFAS Laboratory at Weymouth in
Dorset, Industry's concerns centred around the increased number
of "positives" since the contract for DSP testing had
been won by the laboratory at Weymouth at the expense of the Fishery
Research Service at Aberdeen (FRS).
2.10 The Local Authorities involved and
Industry were also concerned about the length of time following
sampling and receiving results. Local Authorities were not allowed
to have direct contact with the testing laboratory and results
were first reported to FSA before cascading to Local Authorities.
This could mean a period of 4 days from sampling to result and
the consequential problems that could ensure of recall of product
was required.
2.11 In February 2002 Carmarthenshire County
Council convened a meeting of interested parties in order to fully
discuss the implications of the problems within the Burry Inlet.
The meeting included representatives of local government, FSA,
National Assembly for Wales, Sea Fisheries and Industry. The purpose
of the meeting was to find a way forward and to receive information
as to the current state of knowledge.
2.12 In this meeting Carmarthenshire County
Council offered a sum of £10,000 in order to assist with
a possible research project centred around University of Wales,
Swansea—which would hopefully receive a grant from Objective
1 funding. Unfortunately, there has been no further development
on that front and it would appear that the project is not going
ahead.
3. "ATYPICAL"
DSP
3.1 New information was also being received
to the effect that the positive results for DSP were due to a
novel toxin, which was causing, on numerous occasions, rapid death
in the mice with severe neurological symptoms. These symptoms
were not typical of the normal DSP syndrome caused by known algal
bio-toxins. Results were therefore reported as "atypical"
DSP.
3.2 Guidance from FSA was to continue to
treat the "atypical" DSP response as a possible risk
to public health as the "toxin" was causing symptoms
in the laboratory mice. Local Authorities were advised to issue
TPO's on the basis of an atypical response, as this novel toxin,
could at a future date, present itself as a human infection. It
was wise to err on the side of caution and protect any possible
effects on public health. Such action was consistent with other
novel agents and the actions to control BSE, for example.
3.3 The Industry, through the Shellfish
Association of Great Britain, was becoming increasingly angry
at the perceived lack of progress in identifying the novel toxin
and were convinced that there was a fundamental flaw in the sampling
technique at CEFAS, Weymouth. The Association's contention was
that the positive results were in fact "false" positives
due to the carry over of diethyl ether (DEE) into the mouse inoculant
and it was this that provided the results for "atypical"
DSP. Local Authorities were also becoming increasingly concerned
with the lack of progress in identifying this novel toxin and
were becoming under greater pressure to discount all positive
results from CEFAS.
3.4 Local Authorities were continually being
lobbied by Industry as to their concerns in respect of the "flawed"
testing methods.
4. ZONING
4.1 A total of seven samples for a relatively
small area (when compared to the Thames Estuary and the Wash)
appeared to be excessive, especially when one positive sample
on either side triggered off a new or continuing TPO. Because
of the high number of positive results being found in the Inlet,
the area was utilised as an ideal source of positive material
for further research by FSA into the atypical DSP and we were
advised to maintain the level of samples submitted.
4.2 However, in August 2002, both the City
and County of Swansea and Carmarthenshire County Council were
in negotiations with FSA as to the zoning of the Burry Inlet into
distinct, easily identifiable and easily controlled zones.
4.3 Agreement was reached with FSA that
the Burry Inlet could be zoned into three zones—the zones
would reflect, to a large extent, the main harvesting areas. The
zones were (and still are):
— Burry Inlet North (West)—north
of the main river channel (Carmarthenshire County Council)
— Burry Inlet South West—to the
western end of the harvesting area, south of the main river channel
(City and County of Swansea)
— Burry Inlet South East—to the
eastern end of the harvesting area, south of the main river channel
(City and County of Swansea)
A buffer zone would be provided between the
two south zones.
4.4 One sample from each of the zones would
be submitted for analysis. A positive result in one zone would
only require the closure of that zone. In this way it was hoped
that the gatherers would at least be able to harvest one or more
zones of the Inlet at any particular time (dependant on results).
5. FURTHER RESEARCH
5.1 As part of its research effort as to
the actual cause of the atypical DSP found in the mouse bio-assay
FSA invited Professor Yasumoto (one of the world's experts on
marine bio-toxins) to the United Kingdom from Japan in order that
he could observe the response in the mice during the mouse bio-assay.
The Professor observed the test being carried out and was of the
opinion that it could well be a novel toxin causing the observed
response. He offered to undertake further tests on positive sample
at his laboratory in Japan, provided that sufficient sample material
could be transported to him. Unfortunately, to date, because of
various circumstances no samples have yet been forwarded to Professor
Yasumoto for analysis.
5.2 Increasingly the shellfish industry
was being advised by organisations such as INTEGRIN Advanced Bio-systems
and others whose advice to the Industry was in direct contrast
to the advice being offered by FSA through its contracted laboratory;
CEFAS at Weymouth
5.3 Again, Local Authorities were under
increasing pressure to question results received via the FSA and
the laboratory in Weymouth.
5.4 Such were the concerns of the FSA that
they commissioned an independent audit of all three laboratories
testing for DSP in the United Kingdom in order to establish if
there were any "significant" differences in the way
the mouse bio-assay was being undertaken in the three testing
laboratories :-
— DARD, Northern Ireland.
5.5 Professor Makin who undertook the audit,
did not severely criticise any of the laboratories, but did indicate
weakness in each. In particular, a standard operating procedure
(SOP) should be adopted in all three laboratories and the SOP
should be instituted in all three centres without delay.
5.6 The Industry perceives that Local Authorities,
having received the advice and information from the Industry's
own scientific advisors, consider it now untenable for those Authorities
to continue to support the results of the FSA's contracted laboratories.
In the opinion of the Industry those Authorities who do so are
acting in contravention of their legally defined duties—in
effect are acting ultra vires.
5.7 Representatives of Industry are adamant
that their argument lies firstly and foremostly with the FSA,
but can only take action against the "Food Authority"
ie the Local Authority.
5.8 Six Local Authorities in England and
Wales have been threatened with a Judicial Review of their enforcement
functions under the Directive, particularly in the light of the
"scientific evidence" presented to those Authorities
by the Industry's scientific advisors at a meeting in London on
15 October 2003.
5.9 Local Authorities are receiving advice
from both the FSA and Industry, and that advice appears to be
contradictory. In considering the situation the Local Authorities
found themselves in, it was agreed to obtain the advice of an
independent expert who could hopefully advise the Local Authorities.
The Marine Institute in Ireland has been identified and all relevant
papers, both from FSA and Industry have been forwarded for advice.
Obviously, Local Authorities find themselves in an increasing
dilemma—FSA is the "central competent authority"
for food related matters in the United Kingdom and the mouse bio-assay
it still the standard reference test under the directive—on
the other hand Local Authorities are being threatened with Judicial
Review for relying on, as the Industry perceives it, a flawed
and discredited test.
5.10 To its credit the FSA is undertaking
a series of research programmes in order to look at particular
areas of concern eg does the carry over of diethyl ether (DEE)
have an effect on positive results for atypical DSP?
5.11 In the light of concerns raised about
testing, the laboratories met to discuss any possible differences
in operating procedures. As a result, in June 2003 a new procedure
was implemented in the laboratories. There followed a spate of
positive results and the Burry Inlet (North) was closed for eight
weeks during the summer time. This period coincided with a period
of very hot weather which killed off a high proportion of cockles
exposed to the heat during times of low water. Following an audit
of procedures further discussions were held and a standard operating
procedure, based mainly on the DARD procedure was implemented
in September 2003. During the period 8 September 2003 to 1 December
2003 only one positive result was recorded for the north of the
Inlet (6 0ctober 2003). In fact recently there have been some
weeks where no positive results for DSP have been recorded in
the United Kingdom.
6. COMMUNICATION
6.1 Communication between the FSA, the Shellfish
Industry and local authorities has been less than satisfactory.
6.2 Initially when the first traunch of
positive results were received, Local Authorities were not allowed
direct communication with the testing laboratory. On occasions
this meant an increased delay in reporting results and arranging
for the issuing of TPO's (on positive results). Local authorities
were increasingly receiving complaints that this was an increased
pressure on gatherers due then need to recall product gathered
between the time of sampling and receiving the results (anything
up to four days).
6.3 This matter was resolved, to some extent,
in 2002, and Authorities received results directly from the laboratory.
6.4 A major cause for concern was the exchange
of information between all three parties. There has been little
openness or transparency. The Shellfish Industry received information
which would have benefited local authorities, yet it was not shared
and on some occasions, the FSA communicated with the Industry
and failed to share the information with the local authorities.
6.5 FSA have also stated in a recent Welsh
stakeholders meeting that it is unfortunate that the Agency had
been a little remiss during the first two years of the DSP problem
before taking the steps to ensure that necessary action was implemented.
7. CONCLUSION
7.1 Carmarthenshire County Council has undertaken
its responsibilities under the regulations diligently and always
with reference to its neighbouring Authority, the City and County
of Swansea. The Council continues to be advised by the Food Standards
Agency on the matter of DSP (the Agency being the central competent
authority) and until it is advised differently cannot envisage
that advice being ignored.
7.2 The Authority is aware of the controversy
raised by the mouse bio-assay test and the increased pressures
to opt for chemical testing. However, the mouse bio-assay (MBA)
continues to be the base reference test for countries within the
European Union and must therefore accept the results of MBA testing,
unless otherwise advised by a change in the directive.(Even though
the mouse bio-assay is apparently not universally utilised within
all member states of the Community).
7.3 Carmarthenshire County Council has attempted
to assist the Industry during this particularly difficult period
and did offer a sum of £10,000 for research into the causes
of DSP in the Inlet in February 2002. To date this offer has not
been taken up and unfortunately, there does appear to be little
commitment and urgency by other partner organisations to achieve
a resolution of the problem. The Council would welcome an intervention
at the highest possible level, to ultimately determine the implications
for public health.
January 2004
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