Memorandum submitted by Kershaws Frozen
Food Ltd (M10)
SUMMARY
— Kershaws, along with the rest of
the cockle industry, has been adversely affected by FSAs actions.
In our case this has resulted in a direct loss of 75 jobs.
— FSA cite the "precautionary
principle" to justify their actions. However, this has not
been applied within the recommended guidelines of the Commission
of the European Guidelines COMM (2000) issue 1. FSA has failed
to demonstrate proportionality, non-discrimination, consistency
and the requisite cost/benefit analysis; as well as failing to
take account of scientific developments and addressing the issue
of burden of proof.
— If there was a true risk from cockles,
FSA should have stopped all imports from the Netherlands harvested
some 60 miles from the Thames estuary and which would have certainly
failed the tests applied by FSA to UK cockles.
— FSA ignored the advice of the experienced
FRS and, despite public statements in favour of transparent openness,
Industry partnerships and collaborative approaches, they have
been combative, dismissive and adversarial to Industry's initiatives
for resolving this issue. Their public statements on the affair
have not matched the scientific results.
— FSA have failed to make a genuine
attempt to get to the truth of the atypical response. They have
instead applied unlimited resources in an increasingly desperate
and unfruitful search for evidence to support their assertion
that there is a toxin present in cockles.
— FSA have used poor scientific methodology
and misused animals. Animal welfare has not been properly considered
as required by the Animals (Scientific Procedures) Act 1986 and
they did not inform The Home Office of solvent carry-over until
October 2003.
— We consider that the Industry position
that the alleged toxin is nothing more than a spurious artefact
caused by negligent application of the mouse bioassay has been
fully vindicated by the lack of any atypical results since solvent
carry-over was eliminated in November 2003. FSA only acknowledged
solvent carry-over after considerable pressure from industry and
still continue to deny this is the cause of the atypical response.
This proves bias on the part of FSA or at least incompetence in
scientific interpretation.
— Had the FSA followed the advice from
industry and FRS, this problem would have been resolved within
at most a few months rather than the two and a half years it has
taken.
— We believe that Industry should receive
appropriate compensation from the FSA for the unnecessary damage
they have caused the industry. We also believe that scientific
procedures within the FSA need to be radically overhauled to prevent
this happening again.
1. Mr David Kershaw is a director of 3 companies.
He has spent 32 years working in the shellfish industry, ensuring
we place a safe product on the international market.
Mr Andrew Rattley is operations manager of Kershaws,
he has spent 31 years working in the food industry, and was trained
under the guidance of the Royal Society of Hygiene, the Institute
of Meat and the Institute of Environmental Health Officers.
We are both highly trained and qualified in
our field of food safety.
2. We attach to this submission appendices
of documents marked "AR" [Not printed]. Numbers in brackets
in this letter refer to the appendices numbers marked in the bottom
right corner of the documents. We confirm that we wish to attend
to give oral evidence to the select committee to expand on the
points we make in this letter.
3. Margaret and Edwin Kershaw formed Kershaws
Quality Foods in 1946. We are now market leaders in our Industry
ensuring a high quality product in the United Kingdom as well
as the international market. We have gained International respect
and awards through our determination to be at the forefront of
food safety. We are proud to be able to export 95% of our products
in an industry worth more than £20 million year in export
sales. However, our industry's credibility in the international
market is now seriously undermined by the actions of the FSA.
June 2001—CEFAS take over the cockle tests
History of the cockle bed closures
4. The cockle industry was one of the success
stories of modern Britain. Approximately 3,000 people participate
in the cockle industry, mainly small businesses and self employed
individuals in rural coastal areas, generating a turnover in excess
of £20 million a year. The major fisheries are in the Burry
Inlet, the Thames and The Wash. Our company, Kershaws Quality
Foods, employs 200 people on the Thames Estuary; Rory Parsons
runs a processing plant which employs 200 people in the Burry
Inlet and John Lake is part of an industry in The Wash that supports
another 1,600 people. These fisheries have been closed for long
periods during the previous two and half years causing significant
hardship and bankruptcies to those in the industry. Kershaws have
made 75 people redundant and along with other companies has been
forced to import Dutch cockles at a grossly inflated price in
order to remain in business in the UK markets. Total losses, across
the industry are estimated at £250,000 a week.
5. The crisis for the cockle industry began
when the FSA transferred its testing for Shellfish toxins from
the Fisheries Research Services ("FRS") Aberdeen for
England and Wales to the Centre for Environment, Fisheries and
Aquaculture Science ("CEFAS") in Weymouth. The algal
toxin monitoring and surveillance programme for England and Wales
which FRS had undertaken on behalf of MAFF since 1996 had been
put out to tender by the FSA. The new programme in England and
Wales started in June 2001 and CEFAS assumed responsibility for
it at that time (page 1)[Not printed]. The FRS continued with
the monitoring programme in Scotland. Immediately after the programme
had been transferred to CEFAS, we became aware that they were
obtaining an abnormally high number of positive results for DSP
which led to the issue of temporary prohibition orders by the
local authorities and the closure of various cockle beds. Shellfish
collection bans have been in place frequently and for various
periods of time since then.
6. At this stage the results were not described
as being atypical. It was widely reported in the press that shellfish
beds along the Thames Estuary had become contaminated with dangerous
poisons (pages 2 and 3) [Not printed].
7. During the first season of cockle closures
between June and December 2001, there was no question that those
in the industry believed that a new toxin had been discovered.
This was based on the information we were receiving from the FSA.
It was only as the closures continued and further investigations
were carried out by Kershaws that we began to have concerns that
the results were not necessarily indicative of the presence of
a new toxin, but could be due to procedural problems in the testing
carried out by CEFAS. Kershaws repeatedly informed the FSA of
these concerns throughout the latter part of 2001.
8. The method of testing for cockle toxins
involves injecting live mice with large doses of solvent extracted
cockle flesh. At CEFAS if more than two out of three mice die
within a certain period then a "positive" result is
reported (often this was only one out of two as CEFAS incorrectly
applied the assay to only two mice if there was insufficient extract
obtained). Mice were going into a fit immediately with death soon
after. The evidence from abroad was that the mouse test was far
from precise and was associated with false positives. Various
other EU member states had refined the mouse test, as had the
FRS over the years, and other countries had switched to alternate
methods of testing. There was no evidence of human illness caused
by the cockles.
Despite the number of atypical results,Dr Jonathan
Back, Head of Food and Microbiology at the FSA, told the Shellfish
Association's annual conference in May 2002 that: "The mouse
bioassay is not a perfect test. But it's the only one we've got.
We cannot change to a different test merely in order to get negative
results. We know that there is a toxin in these shellfish which
is killing mice within 5 minutes, with neurological symptoms."
(page 3A) [Not printed]. Dr Back informed the conference that
work was being done by CEFAS to identify the toxin but the results
were some way off. The FSA have found no evidence of a toxin.
9. We do not believe that the FSA adopted
a reasonable or responsible approach when the atypical results
occurred. The immediate reaction of the FSA can be criticised
since they were aware, or should have been aware, of the fact
that the mouse bioassay test is known for producing false positives.
The initial assumption of the FSA was that a normal DSP toxin
episode had occurred and they proceeded with investigations to
determine which toxin it was. Having ruled out known toxins they
concluded that the atypical results were being caused by a new
toxin. There was no review of the methodology employed at the
CEFAS laboratory to check whether this was the cause. The FSA
appeared to accept that it was possible that the transfer of testing
to CEFAS had coincided with areas as far apart as South Wales,
the Thames and The Wash becoming simultaneously contaminated.
This was despite the fact that there was no evidence linking the
atypical reaction of the mice with the known reaction to DSP toxins
and there was no evidence of the presence of algae which are known
to produce DSP toxins. Water samples, as well as cockle samples,
are taken by the local councils. Throughout the last two and a
half years these have not produced any evidence of poisonous algae
being present in the water.
10. We have also seen no evidence of any
inter-laboratory collaboration prior to the transfer of the contract
to CEFAS. It appears that the introduction of the methodology
at CEFAS was carried out without any reference to the previous
methodology undertaken by the FRS at Aberdeen. Once the atypical
results had appeared, there was no consultation with the Aberdeen
laboratory.
11. By the summer of 2002, it had become
Kershaws' view that the atypical results were being caused by
a variation in the methodology between the CEFAS laboratory and
the FRS laboratory. The FRS laboratory continued to have only
negative results and the Scottish cockle beds had remained open
continuously since 2001. At Kershaws' request local authorities
agreed to carry out duplicate testing of the cockle samples and
therefore those samples which produced atypical results at CEFAS
were subject to tests at other laboratories. Independent tests
of duplicate samples have also been carried out in other countries
and negative results have ALWAYS been produced. None of
the duplicate tests indicate the presence of any toxin in the
cockles. All the tests were carried out in accordance with the
European Directive and the FSA accepts that the methods are valid
for detecting known toxins. The FSA gave instruction to the Local
Authorities to ignore all results obtained by Industry.
12. In October 2002, further pressure from
industry resulted in the FSA asking FRS to undertake a detailed
paper comparison of the methodology used by the statutory testing
laboratories in the UK, to ascertain what could be causing the
conflicting results. In addition, the FSA asked CEFAS to organise
a trial to compare the testing procedures at CEFAS, the FRS and
DARDNI (the Department of Agriculture and Rural Development Veterinary
Sciences Division), the statutory testing laboratory in Northern
Ireland. Cockle samples were obtained from areas in the Burry
Inlet and the Thames which were expected to produce atypical results.
These were sent to Weymouth, split and sub-samples sent on to
Aberdeen and Northern Ireland. All three laboratories undertook
testing using their standard methodology and a member of the CEFAS
staff travelled to Aberdeen to use the CEFAS methodology, but
with the FRS laboratory equipment and mice.
October 2002 Comparative Trial between the 3 UK
Laboratories
13. As one would expect there were significant
similarities between the methods used by the different laboratories
because they all based their mouse test on the method of Professor
Yasumoto. However, there were significant differences between
CEFAS, DARDNI and FRS in the procedures. The results of the trial
were that FRS obtained negative results, while, CEFAS, DARDNI
and the CEFAS method used at Aberdeen gave atypical results.
14. Rather than carrying out further investigations
into the methodology, the conclusion of the FSA was that the method
used at Aberdeen did not detect the alleged new toxin which was
picked up by the CEFAS test. Most impartial observers would have
thought that the FRS test should have been given greater consideration,
as they were responsible for regulation many years prior to June
2001. However, the FSA stated that the FRS test methodology was
wrong, as it did not detect the alleged toxin that CEFAS and DARDNI
did. Despite this the FRS continued to use their methodology in
Scotland on Scottish cockles and have continued to obtain no atypical
results. These cockles are freely available for consumption throughout
the UK. There has been no incidence of human toxicity reported.
December 2002—The FSA's "updating report"
15. On 12 December 2002 the FSA published
its "updating report" in relation to the cockle bed
closures. Following their analysis of the methodology used by
CEFAS, FRS and DARDNI, the FSA decided that it should continue
its precautionary approach in protecting consumers from the potential
risk of what they believed was a new toxin. The report highlighted
the studies which had been carried out and indicated at paragraph
9 that "There was no evidence to suggest that the tests giving
the positive results are in any way flawed. The possibility that
the positive results are due to chemicals used in the extraction
process has been ruled out". Their conclusion was that "Our
investigations have eliminated a number of possible causes of
the atypical DSP positives observed from cockles", i.e. there
was no doubt in the FSA's mind that the criticisms from Industry
were unfounded (a) there was nothing wrong with the methodology
at any of the laboratories (other than FRS) and (b) there was
no solvent carryover. Further, when announcing the report, the
newly appointed interim Deputy Chair of the FSA and the chair
of the Agency's Advisory Committee for Wales said "The Agency
must protect public health. This toxin could be harmful to people
and that may not be apparent for many years. We have carefully
considered the tests and have no doubts about the methodology
used by our laboratories." (pages 4 and 5) [Not printed].
Following the points raised by the industry, this was not the
response which we were expecting.
16. Having seen some of the background material
which resulted in the December report being published, it appears
to us that the final report does not reflect the findings of the
FRS laboratory.
17. We refer to pages 6 and 7 [Not printed]
which refer to the comparison of the extraction methods between
CEFAS and FRS. This illustrates the differences in methodology
between FRS and Weymouth. In particular there is overnight holding
to ensure no solvent carryover; there is a different application
of Tween 60 to put the extract into suspension and there are differences
in the acetone extraction methods.
18. An initial report was compiled by CEFAS
in Oct 2002 which was then commented upon by FRS (pages 8 to 12)
[Not printed]. We have not seen a copy of CEFAS' initial report.
Points 1 to 10 of the FRS document emphasise that the test, originally
designed to detect shellfish biotoxins has not been validated
and the design of the test together with the high number of variables
in the methodology between laboratories means that if an atypical
response is encountered, interpretation can only be speculative.
The absence of a procedural control (a mouse injected with extract
from a toxin-free matrix put through the extract procedure) means
that it is impossible to reach a meaningful conclusion. Point
11 makes it clear that FRS did not believe that the centrifugation
used by the CEFAS member of staff was adequate to remove all particulate
matter.
19. It is clear from paragraphs 12 to 14
that solvent carryover is a critical issue. In layman's terms
if there is even a trace amount of solvent in the injectable it
may cause death. Certainly the level would be difficult to detect
by smell, so if you do smell it, there is too much solvent. FRS,
the Home Office, the Department of Health and the observer from
CEFAS all reported smelling solvent in the extracts produced by
the CEFAS method. It was also reported at this time that a member
of staff from CEFAS observing the procedure at FRS confirmed that
the same solvent smell in the extract was encountered at CEFAS.
20. A competent laboratory would go to exhaustive
lengths to eliminate any possibility of solvent carryover and
perform a simple analysis for DEE and acetone. Solvent carryover
can be detected in a matter of minutes by the simplest of methods
but CEFAS did not do this. Even now the FSA are not directly investigating
whether solvent carryover is responsible for the atypical results.
21. Despite the references to solvent carryover,
both in the FRS report and the "discussion issues" document
(page 13) [Not printed], the FSA formal statement issued in November
2002 states that whilst "solvent contamination has been suggested
by the industry as a potential cause of the differing results,
the agency believes this is `highly unlikely' to be the case"
(page 14) [Not printed].
22. This view is further reported by the
FSA in correspondence (pages 15 and 16) [Not printed]. In a letter
of 13 November 2002, Joy Whinney of the FSA states that "all
were agreed that solvent carryover was highly unlikely to be the
cause of the atypical mouse deaths and it is concluded that "the
methods used at CEFAS and DARDNI may just be better at extracting
the toxic substance" (pages 17 and 18) [Not printed].
23. The information coming out of FRS Aberdeen
through conversations with Godfrey Howard MBE who has served 36
years as a shellfish biologist and held the post senior shellfish
hygiene manager for the past 14 years at the laboratory was different
to the information being reported by the FSA. Godfrey Howard stated
in a telephone conversation with Dr Clive Askew of the Shellfish
Association of Great Britain towards the end of October 2002 that
he believed that the way the mice were dying was consistent with
solvent carryover.
24. On 31 October 2002 Godfrey Howard confirmed
to Dr Peter Hunt of the Shellfish Association of Great Britain
that there appeared to be solvent carryover in the Weymouth testing
which pre-empted any conclusion to the DSP toxin testing (page
19) [Not printed]. A further conversation was had with Godfrey
Howard on 27 November 2002 (pages 20 to 22) [Not printed] after
the relevant parties had seen Joy Whinney's letter to Mr Parsons.
Dr Hunt asked Godfrey Howard whether he agreed that solvent carryover
was highly unlikely to be the cause of the atypical mouse deaths.
Godfrey Howard replied that in his opinion the Aberdeen laboratory
did not agree with this conclusion and he had not written the
response to the FSA which was submitted by his colleague Dr Liz
Smith. Godfrey Howard said that the Aberdeen laboratory had asked
for another series of tests to eliminate the differences in methodology
between the two laboratories as he believed it was the differences
in extraction techniques that were causing the conflicting results.
Such investigations were not carried out by the FSA until July
2003 and only then once additional pressure had been brought to
bear by the industry.
25. There is no reason why comparative testing
and the investigation of solvent carryover as a possible reason
for the death of the mice could not have been carried out in the
autumn of 2001.
26. It is clear that despite the fact that
the FRS had carried out tests for over 15 years before the testing
switched to CEFAS in June 2001, the FSA were more prepared to
stand by the methodology at the Weymouth laboratory. They had
become blinkered with the idea that it was a new toxin and were
not prepared to consider the fact that it could be something else.
27. Throughout the period from January 2003
to June 2003 there were ongoing discussions between industry and
the FSA with regard to issues arising from the atypical results
and we believed that some progress was being made. However, none
of the tests which we suggested should be put in place were accepted
by the FSA.
In January 2003, following a meeting with the
FSA, we arranged for a presentation to be given by Jim Cockrill
(Toxicologist JRF International) at the SAGB office Fishmongers
Hall London, which detailed various alternative (and more probable)
explanations for the atypical response. These comprised artefactual
and procedural effects (associated with the variables of the method)
or possibly a non-toxic component of cockle origin to which mice
reacted during the test but which had no adverse health implications
to consumers. We were led to believe, from this meeting that the
FSA accepted the validity of these alternative hypotheses and
that they would devote (at least) equal efforts to investigating
these as probable causative agents. Sadly the evidence of the
last year has proved this not to be the case. Solvent carry-over
(DEE and acetone), water-soluble cockle components (which must
be excluded from the test extracts) and the provision for the
correct cockle sampling (shipped to the Labs in good condition
without deterioration) are only some of the procedural issues,
which required priority investigation. These matters remain uninvestigated
in whole or in part while every effort appears to have been applied
to pursue the justification of the "novel toxin" concept
proposed by CEFAS and the FSA.
We observe that the other competent authorities
who have addressed this and the wider issue of false positives
in shellfish toxin testing programmes have all made significant
progress in method adaptation and animal test replacement by addressing
such procedural test issues, sample collection and the quality
of sample processing.
June 2003—Introduction of the new standardised
test
28. In the early summer of 2003 we learned
that the FSA had proposed that all UK monitoring laboratories
would use the same operating procedure as from 3 June 2003. This
new SOP was to be based predominantly on the CEFAS method. The
position at this time is set out in an email from Ms Clare Boville
of the FSA to Dr Peter Hunt of the Shellfish Association of Great
Britain (pages 23 to 27) [Not printed]. Ms Boville also confirmed
that the new procedure will not include any controls because the
same methodology as used on other shellfish species acts as an
adequate control of the methodology and she claimed that the Home
Office will not allow additional tests on mice. (The Home Office
deny ever making this statement).
29. As the cockle season began again in
June, there were immediate closures and it became apparent that
despite the ongoing discussions with the FSA, no progress had
been made at all. Nothing had been done by the FSA to resolve
the questions of the atypical results since the publication of
the December 2002 report. By this time Kershaws and its scientists
were certain that there was no known or new toxin present, but
that the atypical results were being produced by the methodology
carried out by CEFAS.
30. There was further support for this view
when the standardised (new CEFAS) method was introduced by FRS
in Scotland. It immediately produced a reaction similar to that
experienced by CEFAS: the mice died very quickly.
31. Acting on instruction from the FSA Scotland
and the Home Office, FRS immediately abandoned the test and reverted
to their previous methodology. (Because the whole of the Scottish
shellfish industry would have closed overnight) There have been
no atypical results in Scotland since that time.
32. Again, there have been telephone conversations
between members of the Shellfish Association of Great Britain
and Godfrey Howard in June 2003 concerning the discontinuance
of the new standardised protocol by FRS Aberdeen (page 28 and
29) [Not printed]. In conversations Godfrey Howard said that FRS
Aberdeen was conducting an independent analysis of the methodology
and hoped to have the results within one month. Godfrey Howard
made it clear that the FSA had previously blocked any analysis
of the methodology which was why the tests were now being carried
out by the FRS. We understand from a conversation we had with
him that the decision to revert to the previous testing method
had been taken on advice from the Home Office advisor, the supervising
vet and the Scottish FSA who had informed FRS that they should
revert back to the previous method for all tests.
33. Three weeks later in July 2003 Godfrey
Howard informed Dr Hunt that the formal tests which had been conducted
by the Mcauley Institute to ascertain the presence or absence
of solvent in the extract had demonstrated clear solvent carry-over
(page 30) [Not printed].
34. For a period of over two months Industry
sought a copy of the Macaulay Institute report from the FRS, the
Macaulay Institute and the FSA. The position of the FSA was that
the Macaulay Institute report was a small pilot study and that
investigations to assess whether the methods in use at CEFAS,
DARDNI and FRS resulted in ether carry-over were continuing. Only
once the whole programme of work to investigate the ether carry-over
issue had been completed would the results be made available.
We were therefore refused access to this report for a number of
weeks.
35. Despite these developments the FSA maintained
a different position in their correspondence with the outside
world. A good example of this is a letter from Sir John Krebs
of the FSA to Chris Leftwich, the Chief Fisheries Inspector dated
6 November 2003. This states that "the agency always aims
to operate in an open and transparent manner" and their general
practice has been "in keeping with the Agency's policy of
releasing information at the earliest possible opportunity"
(pages 33 and 34) [Not printed]. The letter refers to the audit
of the laboratories by Professor Makin and other recent developments.
Summer 2002—Independent audit of the laboratories
36. In July 2003, under pressure from industry
the FSA finally commissioned two reports to investigate the methodology
being used at the laboratories and to determine whether or not
the atypical results were being caused by solvent carryover.
1 October 2003—Meeting with the FSA
37. On 1 October 2003 representatives from
industry and local councils attended a meeting at the FSA in London.
A presentation was given by Professor Makin who had carried out
the independent audit of the CEFAS laboratory, FRS and DARDNI
on behalf of the FSA. A presentation was also given by Ms Claire
Boville on behalf of the FSA. Both reports, together with a schedule
setting out the FSA's response to the findings of Professor Makin's
report were distributed at the end of the meeting and were made
generally available on the FSA website.
FSA Change in policy following the publication
of the reports
38. The reports indicated that the FSA now
accepted that there was, in fact, solvent carryover but not that
the solvent carryover was the cause of the atypical response.
This was a major volte face as the FSA had previously denied that
there was any solvent carryover. The FSA also finally accepted
that the three laboratories were not operating the same testing
procedures and that they needed to address the quality and consistency
of their performance and procedures. This is clearly something
which the FSA could have investigated and dealt with two and half
years ago. It became clear from the report that steps were finally
being taken to minimise solvent levels (conclusion 1) and operating
procedures were being tightened up (conclusion 2). Further, the
operating procedure currently being used by DARD was to be implemented
in all three laboratories from the end of October 2003.
39. This contrasts with the view of the
FSA in December 2002 when they stated that they had "no doubts
about the methodology used by our laboratories". This stark
change in policy, which continues to be denied by the FSA, is
clearly due to the criticisms of CEFAS in Professor Makin's report:
Criticisms of CEFAS in Professor Makin's Report
[Not printed]
40. At page 15 Professor Makin states—The
SOPs specifically relating to DSP analyses at CEFAS leave a great
deal to be desired. They must be re-written so as to present the
procedures in a clear unambiguous way, removing extraneous matters
which are not immediately relevant.
41. At page 16—He is surprised "that
the deviations from the SOPs have not already been spotted by
the CEFAS quality manager but also by UKAS". These deviations
are not listed anywhere in the report.
42. At page 26—Crucially "the
extracts prepared during the visits, which were obtained after
the ether had been evaporated were significantly different between
CEFAS and the other laboratories for all the samples. The CEFAS
extracts were often very dirty and contained liquid whereas the
FRS and DARD residues (that I saw) were usually dry with little
or no liquid (ie, no water present). This suggests the possibility
that CEFAS are getting water carry-over, perhaps because of the
way that CEFAS carries out the extraction (slightly more vigorously
shaken than FRS and DARD who use a gentle swirling action)".
43. The FSA had come to the conclusion that
the DARD method was preferable and also that there needed to be
one body overseeing the methodology at the three laboratories;
This role was given to the National Reference Laboratory. They
had been previously excluded.
44. Despite the FSA's conclusions in the
reports (1) that solvent carry-over was not the cause of the atypical
response and (2) that no evidence has emerged from the audit that
supported an argument that the cause of the atypical response
is due to methodology, efforts were immediately made to ensure
that (1) there was no solvent carry-over in the future and (2)
that the methodologies at the three laboratories were the same
and that (3) CEFAS used a different procedure as from the end
of October 2003.
Expert conclusions on the two FSA reports and
Professor Makin's audit
45. Following receipt of the reports, Kershaws
instructed Dr Doug McKenzie of Integrin Advanced Biosystems Limited
prepare an independent review of Professor Makin's audit and the
FSA report. Amongst other things his report addresses the question
of whether the cause of the atypical results is more likely to
be a new toxin or a methodological problem. His views are:
— It is a central part of the FSA case
that there is a toxin present in the cockles and it follows that
it should always be found in positive samples and never in negative
samples. [As] the same sample [of cockles] produces a mix of positive
and negative results then this strongly indicates that a methodology
problem is occurring.
— There is carry-over of solvents into
the final extract and at CEFAS this [is] often at very high levels.
— The level of DEE in some CEFAS samples
[is] sufficient to kill mice.
— Neither water or any of the solvents
should be carried over into the injected extracts. The presence
of either solvents or water has been previously associated with
false positives in the MBA, including symptoms similar to the
atypical response. The observation that the MBA is not being undertaken
in an appropriate fashion means that the simplest hypothesis regarding
the cause of the atypical response is that poor methodology rather
than the presence of an unknown toxin is the cause.
— The conclusion that solvent carry-over
is not implicated in the atypical response is not justified by
the data given.
— There clearly is something about
cockles that is affecting the assay but there is absolutely no
supporting evidence of any kind for there being a lipophilic toxin
present whereas there is considerable evidence that the DSP MBA
is not being conducted properly, both in the FSA and Professor
Makin's report.
— Dr Doug McKenzie's conclusion is
that "I think both the FSA and Professor Makin's report
go a considerable way in vindicating industry position. The DSP
MBA is clearly not being properly applied, particularly at CEFAS".
"The burden of proof is pointing towards a methodological
problem and it is only a question of for how long the FSA wish
to maintain their current position".
46. Reports were also submitted from Jim
Cockrill and Allan Parsons of EC Laboratories Limited.
47. The local authorities and the FSA were
provided with a copy of Doug McKenzie's report in draft form on
13 October 2003 and Industry is still waiting for a response.
I understand that the local authorities have commissioned their
own independent experts to assess the evidence. For some reason
this procedure seems to have already taken three months when Industry
was able to produce its' reports within two weeks. In the meantime,
despite the findings in the reports the local authorities and
the FSA continue to rely on the mouse bioassay test and the results
from CEFAS.
17 November 2003—Implementation of the new
NRL SOP
48. The FSA have now overseen the introduction
of the new UK NRL SOP at the three statutory laboratories and
we understood that this was fully implemented on Monday 17 November
2003.
There have been no atypical results at any of
the laboratories since the new SOP was introduced.
49. At a meeting with the FSA on 13 November,
Industry requested confirmation from the FSA that the carryover
of solvent has been eliminated and have asked to be provided with
the test results for solvent carryover in respect of each and
every sample of cockles. Additional information has also been
requested by Kershaws from CEFAS and DARD. To date this information
has not been provided by the FSA.
The CIVIT proposal
50. Kershaws in the meantime, have taken
the initiative, and on 10 November 2003 have provided the FSA,
local authorities and other interested parties with the CIVIT
proposal. CIVIT stands for Cockle Industry Voluntary Initiative
on Toxin Testing. The proposal commissioned by Kershaws and devised
by Dr Doug McKenzie sets out a programme of alternative test methods
which will produce better public health protection than that currently
given by the mouse bioassay. Notwithstanding the local authorities
continued reluctance to rely on such alternative tests, Kershaws
have asked the local authorities to arrange for additional samples
of cockles to be provided to those laboratories involved in the
CIVIT scheme. It is proposed that testing of these samples be
carried out both under the CIVIT scheme and in accordance with
the new mouse bioassay test. Again, despite recent meetings with
the local authorities and the FSA they have refused to take this
proposal forward.
CONCLUSIONS
The FSA has failed to carry out proper investigations
51. Atypical results only began to occur
in the summer of 2001 following the transfer of testing to CEFAS.
Since then there have been a variety of suggestions as to the
cause but not all of these have been investigated. The FSA has
persisted with the belief that there is a new toxin and has refused
to carry out tests which could have eliminated other causes. Only
recently have the FSA carried out a more detailed examination
of the differences in the methodologies used at the various laboratories
and the possibility of solvent carry-over. Despite this being
raised as an issue by the cockle industry in January 2002 and
considered by some at the FRS laboratory to be a major problem
as long ago as October 2002, the December 2002 FSA report clearly
excluded solvent toxicity as an explanation for the results, when
the FRS laboratory clearly had a different view. At the very least
further tests should have been carried out at that time.
52. The December 2002 report concluded that
the FSA is "pursuing analytical work" and "continuing
international collaboration". It is indicated that the FSA
will investigate "as a priority the effects the toxic substance
has" to try "to determine any possible human health
implications". None of this work has been carried out. No
standard toxicity study or post mortem analysis has been performed.
Contradictions in the FSA policy
53. If it were truly the case that the FSA
believed that an unknown toxin were killing the mice they could
not have accepted the rejection of the new standardised test in
Scotland when it produced the same atypical results in June 2003.
Those particular atypical results were never acted upon. Neither
could they have accepted the continual import of Dutch cockles
into England and Wales when these are harvested from areas only
a relative short distance from supposedly Toxic cockles.
54. The logic of allowing beds to be open
if two negative results are found in successive weeks, and the
zoning of areas of the Wash, Thames and Barry Inlet, introduced
in 2002, is also open to question. The precautionary principle
adopted by the FSA does not appear to extend to such issues. Surely
if there was a real risk of a health scare there should have been
an immediate ban of cockle harvesting and a suspension of the
mouse test until the toxin could be evaluated. The FSA's approach
is therefore totally inconsistent. Either there is a real risk
and urgent action is required or there is no risk at all. The
FSA's position has been muddled and contradictory throughout.
No evidence of harm to public health
55. There is no evidence of public health
incidents arising from the eating of cockles. No human response
has been observed among those consuming cockles placed on the
market in the days immediately preceding the atypical results.
The usual procedure is for samples to be taken on a Monday with
the results being declared on a Thursday or Friday. None of the
councils have ever taken any action to recall cockles which have
been harvested during that period when the tests showed an atypical
result from the Monday samples. The local councils did not recall
these allegedly contaminated cockles. These cockles would then
have been consumed by the public. There have been no public health
problems reported. It is therefore difficult to see how the
FSA can say that this course of action is consistent with their
precautionary approach.
No evidence of a toxin
56. The FSA have no evidence that the unknown
agent which is killing the mice is a toxin. On the other hand,
despite maintaining for two and half years that there was no solvent
carry-over, this has now been shown to exist. This is a major
departure from good practice in the mouse bioassay, and is a known
source of artefact. The correct scientific response all along
was for artefact to become the main hypothesis for explaining
the atypical response until it could be shown that the methodology
used by the laboratories was 100% correct. This is how other countries
have treated such atypical responses. They have not presumed the
problem to be due to a new unknown toxin.
Summary
57. In placing the DSP screening contract
with CEFAS the FSA failed to exercise proper management, failed
to monitor the proper implementation of the testing programme
and failed to ensure effective quality management of the screening
tests.
58. The FSA have ignored (or failed to act
on) scientific advice from multiple sources (UK and international)
indicating a probable artefactual/procedural cause for the atypical
response. They have therefore failed to apply scientific objectivity
and have misused public resources, not to further scientific knowledge
or to protect public health but to protect there own untenable
position.
We would now ask that the Government insist
that the FSA discontinue the mouse test and move towards alternative
methods of testing (CIVIT) as a matter of urgency.
January 2004
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