Supplementary memorandum submitted by
the Shellfish Association of Great Britain (M5a)
Thank you for the opportunity to submit additional
comments following the verbal hearing on Monday. There were certain
parts of Dr Bell's statement with which we disagree and other
matters in the discussion which need clarification.
1. The FSA Board and Management has repeatedly
declared that "there is a toxin which could be harmful to
people and that may not be apparent for many years" and that
"the FSA has no doubts about the methodology used by their
laboratories". These statements had never been retracted
prior to the EFRAC verbal hearing when we understood Dr Bell to
say that there was no evidence of a toxin and that he has never
been convinced that there was one. This now needs to be formally
rectified in public statements.
2. Dr Bell stated, and paragraph 26 of the
FSA written submission reported, that Professor Makin's report
provides evidence that atypical response was not caused by solvent
carryover. Professor Makin agreed on 13 November 2003 that on
the evidence, he could equally have made the opposite statement
that " there was no evidence that the atypical response was
not caused by solvent and there was no evidence that it was caused
by a novel toxin". The point is that following the admission
by Professor Makin, it is now knowingly misleading for the FSA
to continue to use his original statement "No evidence emerged
from this audit to support the view that the atypical response
is due to the presence of ether in the Tween extract . . .".
This is referred to in paragraphs 26 and 37 of the FSA written
submission. However, page 42 of the Macauley Report shows the
association of solvents with water carryover. The evidence to
date does not eliminate either direct or indirect association
with solvents and to infer that it does is misleading. Continued
use of such unfounded claims by the FSA will initiate a formal
complaint of misconduct by the Association to the Office of Science
and Technology.
3. The implication by FSA of minimal impact
on industry was misleading. Most cockle products are exported
with remaining domestic sales supplied to retail, both on contracts
to continually supply. These contracts could not be honoured and
the business was lost. Size restrictions were relaxed to facilitate
some continuity but juvenile cockles achieve 25 to 50% of mature
cockle prices, dependent on quality, and there are also significant
implications to future quotas and catches. I understand that the
details of the impact were supplied to DEFRA and the FSA but have
been selectively quoted.
4. There was reference to the Irish situation
and I attach a communication from the Irish Shellfish Association
(Appendix I) [Not Printed] which describes what actually happened.
It illustrates that despite acrimonious beginnings, close, risk
based, industry/regulatory cooperation can achieve sensible consumer
protection with minimal disruption to industry. A similar approach
applies in New Zealand, Canada and most other EU Member States.
5. The restrictions placed by the Home Office
on the FSA and its contracted laboratories were only briefly mentioned.
It is understood that the Home Office was not advised of the flawed
methodology and multiple solvent/cockle matrix carryover until
October 2003 after which the attached letter (Appendix II) [Not
Printed] was sent to the respective parties.
6. Dr Bell stated that the results of the
LGC project to detect and possibly identify unknown toxin/s in
the cockle extracts was ongoing. The project was completed at
the end of October 2003 and report received by the FSA on 6 November
2003, since when industry has been trying to secure a copy. The
FSA website confirms that the project has not been able to identify
the compound causing the atypical response but FSA editorial changes
were being sought.
7. Most cockles are cooked immediately on
landing and insufficient reference in the EFRAC Inquiry has been
made to end product testing which Industry supports in order to
demonstrate the integrity of its products. Such end product testing
is required under Directive 91/492 but at the meeting with Industry
on 1 October 2003, the FSA stated that end product testing does
not have a role in ensuring safety.
8. Finally, with reference to the comments
made by Alan Simpson, MP on the robustness of comments made in
my written submission, many things are easier left unsaid, but
need to be said, and I confirm my belief that the modus operandi
of the FSA needs urgent investigation. Industry has very actively
sought compromise and offered willingness to work with the FSA
but this has been repeatedly rejected outright with contempt.
The FSA publicity machine professes to science-based integrity,
transparency, open consultation and participative investigation,
all honourable and very desirable, but apparently not applied
in reality. Environmental Health Authorities, contracted laboratories
and Consultants and even related "subsidiaries" such
as the FSA Scotland appear in fear of the Agency "power"
and control on available funds; scientific challenge is ignored
or worse. The final paragraph of my written submission was not
said lightly, such control has enabled the paymaster to undermine
the integrity of the science with impunity. The acceptance of
flawed methodology threatens wider animal testing programmes.
Industry and Enforcement Authorities have all noted repeated major
deviations and omissions in Minutes of meetings prepared by FSA
Officers. I fear the issue is much deeper than the EFRAC Chairman's
concluding remarks on the need for counselling between warring
partners.
22 January 2004
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