Memorandum submitted by Canterbury City
Council (M11)
EXECUTIVE SUMMARY
Canterbury City Council members and officers
have a great commitment to maintaining a thriving shellfish industry
which contributes a safe and high quality product to our local
economy. In light of the hardship which has resulted from the
atypical DSP closures we would like to make the following recommendations:
Recommendation 1
Roles must be clarified and Food Standards Agency
must be made accountable for their choices with regard to sampling
programme and testing rather than food authorities. Communication
must be improved between FSA, FAs and the Shellfish Industry.
All must be represented and play equal parts to ensure a system,
which can effectively control potential public health problems.
Recommendation 2
All laboratories in Europe should agree to use
the same testing methods. There should also be agreed EU operating
procedures. The FSA has already commissioned some work on alternative
testing methods, we would like to see the UK leading the way for
a replacement of routine mouse bioassay tests with accredited
analytical techniques.
Recommendation 3
The UK must have an active effective NRL which
co-ordinates sampling in UK and also keeps it in line with the
rest of Europe.
The FSA is the competent authority in the UK
and must ensure they have the necessary resources to carry out
the functions outlined in article 2 of the council decision 93/383/EEC.
This includes aspects of consistency, communication and quality
assurance and control. It is recognised that some improvements
have been made recently.
Recommendation 4
The FSA should lead a review of how the sampling
programme and result communication works with all interested parties,
before the main harvesting season in summer 2004.
In conclusion CCC has conscientiously undertaken
its food enforcement responsibilities during a troubled period
for the shellfish industry and has continued to follow the advice
of the FSA. We have also listened to the concerns of the local
shellfish industry and tried to prevent controls and restrictions
placing unnecessary burdens on struggling local businesses.
This commitment to following FSA guidance has
been challenged by the shellfish industry and to retain an impartial
view of conflicting reports it has been necessary to employ expert
advice on legal and scientific issues.
We accept that as competent authority the FSA
is now taking steps to identify and assess the implications of
this possible new toxin which initially became apparent in 2001.
After reports in 2003 the FSA is also implementing better controls
of testing procedures.
As stated in our report it is hoped that in
future communications between the appropriate authorities and
the industry will be improved to ensure more effective control
of this issue and any new public health concerns.
1. INTRODUCTION
1.1 This submission is on behalf of Canterbury
City Council. Canterbury is a food authority with responsibility
for enforcing food safety legislation within its food premises
and shellfish harvesting areas—Whitstable Port Health Area.
This is a well-known shellfish producing area on the North Kent
coast. Three shellfish companies and various harvesters farm private
and public shellfish beds. Oysters, clams and cockles are commercially
harvested and processed and the waters are a good source of seed
mussels, which are grown on elsewhere.
1.2 Since 2001 repeated positive results
for the DSP test have lead to 12 closures on the advice of the
Food Standards Agency this has meant approximately 270 lost harvesting
days for cockle harvesters. In July 2003 representatives of the
cockle industry threatened six food authorities, including Canterbury
City Council with judicial review on the grounds that these closures
were outside the scope of the legislation. The five other affected
food authorities are:
Boston Borough Council
Carmarthenshire County Council
City and County of Swansea
Corporation of London
Kings Lynn and West Norfolk Borough Council.
2. BACKGROUND
Since the Shellfish Hygiene Directive (91/492/EEC)
was adopted by the UK in 1992 there has been a legal requirement
for the council to carry out sampling for naturally occurring
bio-toxins in shellfish. The directive is currently translated
into UK legislation by the Food Safety (Fishery Products and Live
Shellfish) (Hygiene) Regulations 1998 (as amended). Under these
regulations the responsibility for controlling shellfish bio-toxins,
such as Diarrhetic Shellfish Poisoning (DSP), is shared between
the government, Food Standards Agency (FSA) since 1999, and food
authorities (FAs). The sampling programme and testing arrangements
are the responsibility of the FSA and the sampling and any necessary
closures are the responsibility of the Food Authority. This division
means FAs have no choice or direct control over the sampling programme
or testing laboratory.
2.1 Since 2000-01 shellfish, specifically
cockles, within the Thames, Wash and Wales have tested positive
for Diarrhetic Shellfish Poisoning (DSP). Bivalve shellfish such
as cockles and oysters filter seawater to feed on microscopic
algae, which grow naturally. Some types of algae when concentrated
can make the shellfish poisonous to people when eaten. In the
case of DSP the symptoms are stomach ache and diarrhoea shortly
after consumption of affected shellfish. No cases of illness have
been linked to closures or shellfish consumed during the time
closures have been in place. It seems the problem identified since
2001 is a new toxin which triggers a positive DSP result, the
source and identity of this "a typical" DSP toxin are
not yet known. Research funded by the FSA to identify the toxin
and assess risk to consumers is ongoing.
2.2 Prior to 2001 all samples for the UK
were analysed in Aberdeen, at the Fishery Research Laboratory.
Only occasional positive results were detected. The programme
included water samples to identify algae known to be toxic and
a rolling programme of shellfish meat samples to analyse for the
toxins. In 2000 some positive results for DSP were received in
the Thames and Canterbury district. As the programme intensified
testing work was divided between other UK accredited laboratory.
CEFAS in Weymouth took over the programme for England and Wales
in summer 2001.
2.3 There are several testing methods allowed
by EU law to detect DSP. Classic DSP is usually caused by one
of a group of 5 recognised toxins and these can be recognised
by chemical methods. The reference method under Commission Decision
2002/225/EC remains the use of mice, which are injected with an
extract from the shellfish. DSP toxins are found in the fatty
tissue of the shellfish and therefore the toxins will be removed
from the flesh by using solvents such as ether and acetone. The
extract should then be cleaned of solvents before injecting into
mice. If the mice die this indicates DSP is present.
2.4 A large increase of atypical positives
since summer 2001 coincided with the testing work for England
and Wales being moved to CEFAS. This lead to concerns from the
industry and some Food Authorities that increased number of positives
were due to a problem with the testing method in the new laboratory.
These worries were voiced to the FSA who agreed that the following
work would be carried out; 1. Work to audit the testing
protocols used in the three different laboratories 2. Commission
a standard test protocol for all UK (and possibly European laboratories) 3. Consider
if there was ether carry over which could be causing positive
results 4. Also carry out work to identify the toxin and
establish if it posed a risk to human health.
2.5 The FSA have, in October 2003, produced
two reports which they consider show there are no reasons why
testing methods 1 above or ether carry over 2 above, are responsible
for the atypical positives. Enforcers facing possible judicial
review and the industry are still concerned. The audits show that
there is significant ether carry over produced by testing methods—although
the FSA conclude the amount is insufficient to cause mouse deaths.
2.6 The audits of all three laboratories
also show major problems with quality assurance and practises
including reports of dirty extract containing water and ether
being injected into mice at CEFAS. Again the FSA consider the
reports do not show the atypical results are due to testing problems.
Many of the issues surrounding the testing are very technical.
2.7 The Shellfish industry has commissioned
their own review of these reports by Dr McKenzie at Integrin and
certainly draw different conclusions to the FSA. Food authorities
have been in the centre of these arguments and have felt it necessary
to commission their own scientific advisor to obtain an impartial
interpretation of these detailed technical discussions and papers.
These are included as an appendix to this submission.
3. IMPACT OF
CLOSURES DUE
TO ATYPICAL
DSP ON CANTERBURY
CITY COUNCIL
AND LOCAL
SHELLFISH INDUSTRY
3.1 Canterbury City Council covers Whitstable
Port Health Area. This well known shellfish producing area contains
important cockle harvesters and processors operating from the
harbour. Since 2001 repeated positive results for the DSP test
have lead to 12 closures on the advice of the Food Standards Agency.
Cockle harvesters have lost approximately 270 harvesting days.
Clam, oyster and whelk harvesters have also been affected although
they have still been able to operate. The media and public often
overlook the fact these species are unaffected.
3.2 Within the Canterbury district Shellfish
growers had to decommission one harvesting vessel making two fishermen
redundant. There were also two small processors dependant on cockles
from the privately owned A class cockle harvesting area who have
not processed cockles since 2001. In addition to DSP the grounds
have been reclassified as B and can only be processed by an approved
fishery establishment. For the remaining shellfish industry press
interest in the closures have too frequently raised a negative
profile of Whitstable, making the shellfish appear blighted. Also
DSP is often associated with dirty, polluted waters, which discourages
families and water sports users as much as "gastro tourists".
Shellfish are an important incentive for visitors to come to the
Canterbury district particularly for the coastal areas.
3.3 Remaining shellfish harvesters are affected
too—cockle harvesters and processors are continually worried
those closures may lead to product recall and that they cannot
plan harvesting or supply customers with a product reliably available.
3.4 Long-term closures can also damage the
future viability of harvesting areas by overcrowding and killing
cockle stock. This is particularly true in the Burry Inlet, Wales
where hand raking is an important part of the environmental management
of the Inlet ecology.
3.5 For food authorities since 2001 the
atypical DSP issue has become a major drain on resources. Sampling
is expensive, time consuming and often difficult where boat hire
is needed. When closures are in place this is a weekly process.
There is also the enforcement of closures and advertising of the
problem locally. Enforcement is not easy particularly in a large
sea area when most food authorities do not maintain their own
sampling vessels or crew. In addition the dispute over the cause
of the atypical problem has meant repeated meetings—particularly
In London and appointment of various experts for impartial advice.
3.6 Food Authorities have a legal duty to
sample and enforce the legislation but no additional funding is
available for this particularly expensive area of food enforcement.
4. THE FOLLOWING
ISSUES HAVE
BEEN RAISED
AS MAJOR
CONCERNS BY
FOOD AUTHORITIES
4.1 Arrangements for enforcement of legislation
are divided between the Food Standards Agency and food authorities
legislation dealing with shellfish is split between Food Standards
Agency and Food Authorities. The FSA is the competent authority
for programme and testing and the food authorities sample and
enforce closures on FSAs advice. There are also concerns over
the wording and possible interpretation of some of the legislation
and commission decisions.
4.2 There are complexities in the way the
legislation is enacted, which cause difficulties for authorities
and FSA although food authorities have no influence on testing
scheme because they implement closures they are legally accountable
for the choices made. This is highlighted by the fact the industries
proposed judicial review targets food authorities.
4.3 FSA have access to the funds and scientific
expertise. They are responsible for arranging the sampling programme,
appointing testing laboratories, choosing the testing methods
and issuing guidance to FAs. These FAs have been made responsible
for carrying out sampling although they receive no additional
funding. Also for implementing temporary closures if they are
satisfied there is a risk to public health.
4.4 Under the Food Safety Act 1990, the
FSA may issue codes of recommended practise as regards the execution
and enforcement of the Act and regulations and orders made under
it. The FSA may also under the Act give a food authority, such
as ourselves, a direction requiring them to take any specified
steps in order to comply with the code. Under the Act we have
to have regard to any relevant provision of any such code and
comply with any direction. If we don't have regard or comply the
FSA can take action through the courts to make us comply. The
FSA also has default powers where it or another authority (if
we have failed to discharge any duty imposed by or under the Act
and the failure affects the general interests of consumers of
food), discharge that duty in place of the authority and to determine
this, a public inquiry may be held.
4.5 FAs are required by the FSA, to regularly
collect and send shellfish for testing. If the test results are
DSP positive than we must issue a Temporary Prohibition Order
(TPO) to close the harvesting area. FSA guidance is to treat positive
results for atypical DSP positive results the same. Recently new
advice was issued by the FSA including standard wording for the
TPO.
4.6 There are concerns in some districts,
such as Canterbury, where shellfish are farmed that the new guidance
issued by the FSA on the drafting of TPOs causes unnecessary burdens
for our local shellfish industry. Previously Canterbury chose
wording, which focussed on restricting gathering for sale for
human consumption. The wording in the guidance prevents collection
for any reason. Canterbury has three shellfish companies who farm
private shellfish beds. If they are prevented from selling for
food they can still grade and relay shellfish on their grounds.
In the past they have also gathered and sold on genuine seed shellfish.
The wording now laid down in the FSA guidance prevents any collection
for whatever reason. FAs are concerned that individual circumstances
are not taken into account when considering guidance and the wording
of TPOs.
4.7 This division of responsibilities and
funding are complex. Enforcement is at a local level but decisions
are made on the FSAs advice. Any dispute over closures is therefore
directed through the FAS. This is made slow and cumbersome by
slow and unwieldy communication between FSA, laboratories, FAs
and shellfish industry. It is not easy to find a mechanism for
making the FSA accountable for actions.
Recommendation 1
Roles must be clarified and FSA must be made
accountable for their choices with regard to sampling programme
and testing rather than FAs. FAs must not be placed in this "piggy
in the middle" role.
Communication must be improved between FSA,
FAs and the shellfish industry. All must be represented and play
equal parts to ensure a system, which can effectively control
potential public health problems. Major shellfish producing countries
such as New Zealand have already made this commitment.
5. Food Authorities are concerned about
the use of the mouse bioassay (MBA) test for DSP and some other
toxins—some EU states and other shellfish producing countries
do not use this method.
5.1 At present all EU countries should follow
the EU commission decision dated 15 March 2002. This has set down
testing methods for DSP. These include chemical methods, High
Pressure Liquid Chromatography, Liquid Chromatography—Mass
Spectrometry(LC-MS) and phosphatase inhibition assay but if when
the results of the analyses performed demonstrate discrepancies
between the different methods, the mouse bioassay (MBA) should
be considered as the reference method. Food authorities accept
that currently MBA must have a role in toxin testing.
5.2 The FSA is the competent authority to
decide on testing and the sampling programme for bio-toxins. They
have chosen the MBA for all UK testing. Many other EU countries
do not apparently routinely test all DSP samples in this way.
Holland use a rat bioassay and Germany only chemical testing methods.
Even where countries used the MBA standard operating procedures
appeared to differ. Countries such as New Zealand and Canada are
moving towards replacement of mouse testing with a LC-MS test.
A presentation by Prof Yasumoto, the scientist who developed the
MBA, in May 2003 indicated he is working on alternative testing
methods for known toxins and that he anticipated MBA would only
remain important for detecting unknown or new toxins in the future.
Recommendation 2
All laboratories in Europe should agree to use
the same testing methods. There should also be agreed EU operating
procedures. The FSA has already commissioned some work on alternative
testing methods, we would like to see the UK leading the way for
a replacement of routine mouse bioassay tests with accredited
analytical techniques.
6. Food Authorities are concerned that differences
in testing existed in the three UK laboratories as highlighted
in the FSA reports issued on 2 October. The hierarchy of laboratories
and communication between them was also confused; the National
reference Laboratory status was unclear. Also EU SOP for any procedures.
6.1 In 2001 two new laboratories were appointed
by the FSA to carry out the toxin testing as the programme expanded.
FRS Aberdeen had previously done the testing for all UK. DARD
Belfast and CEFAS Weymouth were appointed to cover Northern Ireland
and England and Wales respectively. It became clear after the
visit of EC auditors in July 2002 that the role of the national
reference laboratory was not being carried out and that quality
assurance and control procedures in the two laboratories visited
then (not CEFAS) were inadequate. It later became clear that the
testing procedures differed significantly between the three laboratories
and rather than the NRL co-ordinating methods and procedures the
two new laboratories were responsible for changing established
testing methods.
6.2 FSA reports published in October 2003
indicated improvements requested by the State Veterinary Officers
had still not been implemented. The NRL still seemed to lack its
lead role to ensure consistency in UK laboratories—in fact
the process seemed to be that the DARD and CEFAS laboratories
were dictating changes. The three laboratories were still testing
for DSP using different protocols. Also there also seemed to be
little quality control or assurance procedures in place in the
3 testing laboratories again a role the NRL should lead on.
6.3 Article 2 of Commission Decision 93/383/EEC
on the National Reference Laboratories sets tasks of each member
states NRL which include co-ordinating activities of other UK
biotoxin testing laboratories and assisting the competent authority
(FSA) in each member state to organise sampling programmes.
Recommendation 3
The FSA is the competent authority in the UK
and must ensure they have the necessary resources to carry out
the functions outlined in article 2 of the council decision 93/383/EEC.
This includes aspects of consistency, communication and quality
assurance and control. It is recognised that some Improvements
have been made recently.
The UK must have an active effective NRL which
co-ordinates sampling in UK and also keeps it in line with the
rest of Europe.
7. WEAKNESS OF
OPERATION OF
TESTING AND
SAMPLING PROGRAMME.
7.1 There is scope to make improvements
to the sampling and testing programmes at all levels. Good communication
is a key factor and to be effective industry, food authorities,
laboratories and the FSA must be involved and have equal access
to data about results, closures and sampling programmes. At present
testing is slow and communication of results unwieldy. To have
good product recall system during closures this is vital. The
industry has made proposals (CIVIT) for an alternative testing
and communication system and although it is unclear how this proposal
will fit with the statutory sampling programme it is important
all parties work together at how this can be incorporated. Ireland
and New Zealand have already adapted sampling programmes in this
way.
Recommendation 4
The FSA should lead a review of how the sampling
programme and result communication works with all interested parties,
before the main harvesting season in summer 2004.
8. Conclusions
CCC has conscientiously undertaken its food
enforcement responsibilities during a troubled period for the
shellfish industry and has continued to follow the advice of the
FSA. We have also listened to the concerns of the local shellfish
industry and tried to prevent controls and restrictions placing
unnecessary burdens on struggling local businesses.
This commitment to following FSA guidance has
been challenged by the shellfish industry and to retain an impartial
view of conflicting reports it has been necessary to employ expert
advice on legal and scientific issues.
We accept that as competent authority the FSA
is now taking steps to identify and assess the implications of
this possible new toxin which initially became apparent in 2001.
After reports in 2003 the FSA is also implementing better controls
of testing procedures.
As stated in our report it is hoped that in
future communications between the appropriate authorities and
the industry will be improved to ensure more effective control
of this issue and any new public health concerns.
January 2004
APPENDIX 1
REFERENCES
Agency's response to the findings of Professor
Makins report.
Also Shellfish industries critical reviews of
the 2 FSA papers dated 1 October 2003 by independent scientific
advisors.
Commission Decision 93/383/EEC on the National
Reference Laboratories.
Commission decision of the 15 March 2002 laying
down detailed rules for the implementation of the CD91/492/EEC
as regards the maximum level and the methods of analysis of certain
marine biotoxins in the bivalve molluscs, echinoderms, tunicates
and marine gastropods 2002/225/EC.
Council Directive of the 15 July 1991 laying
down the health conditions for the production and the placing
on the market of live bivalve molluscs (91/492/EEC).
DG (SANCO) /8614/2002-MR final report of a mission
carried out in the UK from 8-17 July 2002 regarding the implementation
of Council Directive 91/492/EEC (Live Bivalve Molluscs) and Council
Directive.
Food Safety (Fishery Products and Live Shellfish)(Hygiene)
Regulations 1998 (as amended) Guidance to Food Authorities that
have designated Bivalve Mollusc production areas in their district
29/08/2002 amended 3 September 2003 with additional guidance in
the light of atypical DSP problem (Service of TPOs)
Food Safety Act 1990.
Food Safety (Fishery Products and Live Shellfish)(Hygiene)
Regulations 1998 (as amended).
FSA report 1 October 2003 "Investigations
to assess whether diethyl ether or acetone carry-over during the
DSP standard operating procedure is responsible for the atypical
response in mice".
Professor H Makin 1Oct 2003 "An audit of
methods and procedures for lipophilic toxin analysis used by Laboratories
at CEFAS, FRS and DARD, which undertake the statutory monitoring
of shellfish toxins in the UK".
| 
