Select Committee on Environment, Food and Rural Affairs Minutes of Evidence

Supplementary memorandum submitted by the Food Standards Agency (M15a)

  1.  During the Food Standards Agency's oral evidence to the Committee on 19 January 2004 I undertook to provide the Committee with some further information on:

—  Insufficient sample, and occasional operator error in DSP testing, at CEFAS (Qs 82 and 83)

—  Replication of the results in the Netherlands (Q86)

—  Spending on shellfish work (Q117)

  2.  I am also taking this opportunity, further to the Chairman's offer, to provide additional information which may assist the Committee in its Inquiry.

INSUFFICIENT SAMPLE, AND OCCASIONAL OPERATOR ERROR IN DSP TESTING, AT CEFAS

  3.  Guidance on the size of in-shell sample to be collected was provided to Local Authorities at the time CEFAS assumed responsibility for statutory testing. On occasions, insufficient shellfish flesh is received at CEFAS to allow them to undertake the biotoxin tests. This can be because not enough individual animals are sent, dead material is inadvertently included, or the sampled animals are too small to provide the necessary weight of meat. In such cases CEFAS requests a further sample, but if this is not provided, and bearing in mind testing is in the interests of protecting public health, tests for the regulated toxin groups are prioritised according to the status of the fishery. Thus, for example, where an area is closed for DSP, the DSP test would have priority.

  4.  As part of the CEFAS accredited system a log of departures from protocols (including operator error) and the associated corrective actions is maintained. Following the Committee's interest, CEFAS has reviewed the log, and for the 3,464 samples processed for the DSP test since June 2001 there were logged departures in respect of less than 1% of samples. Examples of logged departures include glass funnels shattering through wear and tear, difficulty in sample homogenisation and partial sample spillage because of equipment problems.

  5.  Since June 2001, only six logged departures have been recorded as operator error. Five of these were due to sample spillage. On 12 November 2003, however, a technician mistakenly used ether instead of acetone at the first stage of the procedure. The error was immediately picked up, appropriately logged, and the affected samples were not processed further. No result was given for those samples, and the Local Authority was asked to resample the area.

REPLICATION OF THE RESULTS IN THE NETHERLANDS

  6.  The Agency is aware that some Food Authorities have been approached by the industry to collect extra samples for "duplicate testing", however, we are not in receipt of any data to back up the assertion that replication of the results has not been possible in the Netherlands.

  7.  Statutory testing is the responsibility of Member States, and the results are not interchangeable with those from the industry's own testing. Public health protection decisions are made on the basis of the statutory results. Any industry testing does not form part of the UK or Dutch statutory monitoring programmes, and will have been undertaken on a commercial basis, using non statutory samples.

  8.  In 2001 the EU Food and Veterinary Office (FVO) visited the Netherlands to inspect the official monitoring and testing arrangements for shellfish. It noted that the routine testing is carried out by a private laboratory (RIVO), using a rat bioassay, and that verification or confirmatory testing in cases of positive or unusual results is carried out by the Dutch National Reference Laboratory (RIVM) using the mouse bioassay as the reference method.

  9.  The FVO report criticised the biotoxin analytical methods used in the Netherlands for not complying with EU legislation. It also criticised the Dutch NRL for not adequately co-ordinating the analytical activities at the laboratory. The FVO indicated that the number of sampling points for routine biotoxin monitoring in the Netherlands should be increased. In responding to those criticisms, the Dutch Competent Authority pointed out that the rat bioassay cannot detect the full range of DSP toxin groups regulated by Commission Decision 2002/225/EC (ie it is unable to detect yessotoxins and pectenotoxins).

  10.  The Agency takes the view that, until we have assessed the human health implications, any test method used for comparative purposes must be capable of detecting the atypical response seen in the UK.

SPENDING ON SHELLFISH WORK

  11.  The Tables at Annex 1 outline Government expenditure on shellfish matters. A list of programme research projects on shellfish issues is provided. This includes the work undertaken to develop alternatives to the mouse bioassay: work in this area has been undertaken since the mid 1990s, and has been stepped up since the Agency took over responsibility for this area of work in 2000.

INTERACTIONS WITH STAKEHOLDERS ON THE ATYPICAL ISSUE

  12.  The FSA has written to, and talked regularly with, industry, the enforcement authorities, laboratories, and other Government Departments in its endeavours to resolve the complex problem of the atypical MBA results. The list of the meetings held (Annex 2) indicates the extent of stakeholder engagement. This does not take account of extensive written, e-mail, and telephone contacts, as well as responding to industry questions at FSA open Board meetings. In all these interactions the FSA has carefully considered the points made by industry, and has taken them into account wherever possible when planning research and other investigations, which so far have been undertaken at public expense.

THE BIOLOGICAL SYSTEM USED TO TEST FOR DSP AT DARD

  13.  DARD has been testing for marine biotoxins in shellfish for a long time. They have been responsible for the statutory programme in NI since it was first required under EU law (1992). The rat bioassay was originally used to test for DSP in Northern Ireland, but since January 2001 the mouse bioassay has been used. The first atypical response was detected from cockle samples collected on 22 August 2001 from Dundrum Bay, and the laboratory has continued to detect atypical responses since then. In both 2001 and 2002, 45% of cockle samples tested at DARD gave atypical results; in 2003, the figure was 10%. The number of cockle samples tested in each of those years was 20, 83 and 59 respectively.

INDEPENDENT REVIEW OF AGENCY WORK BY THE IRISH MARINE INSTITUTE

  14.  Local Authorities in England and Wales recently commissioned an independent review by the IMI (the Irish National Reference Laboratory for biotoxins) of the Makin report, the Agency's solvent carry over report, and the industry critiques of those reports. A copy of the report is at Annex 3 [Not Printed]. Dr Terry McMahon, who carried out the review, concludes that "the fundamental issue of the unambiguous identification of the cause, or causes, of the atypical response still remains unresolved . . . Based on the documentation provided to me there is no clear and unambiguous evidence available which explains the atypical response seen."

  15.  Dr McMahon disagrees with the suggestion from Dr McKenzie, a consultant for the SAGB who reviewed the FSA report on solvent carry over, that the lack of a known toxin, or known toxic algae, is evidence against a toxin being the cause. Dr McMahon draws attention to the situation in Ireland in 1995 when atypical responses to the DSP test were detected. These subsequently led to the identification of azaspiracid, a novel toxin, which is now regulated by EU legislation. He also points out that the concentration of lipophilic toxins in shellfish can vary considerably over very small distances and states "it would be very surprising if every sample from a production area gave a positive response in a mouse bioassay".

QUOTA FIGURES

  16.  The quota uptake tonnages provided in the FSA's Written Evidence were provided by the Sea Fisheries Committees and Local Authorities. These figures do not seem to be in dispute. The FSA is not aware of any evidence that the overall quality of cockles harvested since the occurrence of the atypical problem has been different to that previously.

CONDITION OF SAMPLES SENT TO THE LABORATORIES FOR TESTING

  17.  Protocols for sample collection, packaging and transportation have been in place in all parts of the UK since 2001. These protocols were developed by the laboratories (CEFAS, DARD and FRS) and are issued to Local Authorities which collect the statutory monitoring samples. The UK NRL has been commissioned by the Agency to produce best practice guidance, which can be used throughout the UK. This document is expected to become available in April 2004.

  18.  It would seem unlikely that sample collection and transportation has any significant bearing on the atypical results because practices in England and Wales and Scotland are similar, yet Scotland has not experienced the atypical DSP response. Additionally, cockle samples from the Burry Inlet have always been transported under chilled conditions but have shown no difference to other cockle areas in terms of the atypical DSP response. The most stringent sample collection and transportation arrangements apply in Northern Ireland, and the DARD laboratory has detected atypical responses throughout 2001, 2002 and 2003. The industry's assertion that the atypical findings might arise from "stressing" is therefore very questionable. Certainly no scientific evidence has so far been produced to support this.

Dr J R Bell, Chief Executive

29 January 2004

Annex 1

ESTIMATED GOVERNMENT EXPENDITURE FOR FINANCIAL YEAR 2003-04 (£K)

	England	Scotland	NorthernIreland	Wales	Total
Biotoxin Monitoring Programme	355 (EW)	500	173	—	1,028
Atypical Research	193	7	0	0	200
Staff costs on Biotoxins/Atypical	202	14	12	6	234
Staff costs on all shellfish matters	267	138	23	6	434
Research costs—Alternative methods and standards	159	0	0	0	159
Other Atypical costs—training visits, equipment etc	2	32	1	1	36
Phytoplankton Monitoring	60	100	20	0	180
Inspection and Approval of Depuration Plants	218	48	5	0	271
Shellfish Bacteria and Virology Research	281	0	0	0	281
Shellfish Classification	330	170	106	0	606
Other Shellfish Research	73	50	0	0	123
Other shellfish costs	27	70	10	0	107
Compensation	0	0	0	300 *	300 *
Total	2,147	1,129	350	313	3,959

* = 50% EU funded

Value of cockle market quoted by SAGB in evidence to EFRACOM—£20 million

Research: programme projects on shellfish biotoxins commissioned by MAFF and FSA since 1988

Title	Cost £
Further work on scombrotoxin (FC0707)	118,204
Development of improved sensory methods for detecting and measuring taints in seafoods (FC0708)	63,350
A preliminary study investigation of distribution of Dino-flagellate cysts in sediments in Ardtoe region of Western Isles. (FC0710)	2,000
A study of Alexandrium cysts off the East coast of Britain (FC0711)	111,499
The Isolation and Culture of Dinoflagellates potentially associated with Diarrhetic Shellfish Poisoning (DSP) (FC0712)	15,000
Detection of sodium channel blocking toxins in British coastal waters (FC0713)	54,786
Immunodetection of toxin dinoflagellates (FC0715)107,975Large volume culture of toxic dinoflagellates (FC0720)	50,000
Toxic algae and their effects on coastal zone fisheries (FC0722)	66,522
Cultivation of toxic dinoflagellates (FC0725)40,053Coastal zone colour zone scanner archive in relation to toxic phytoplankton blooms (FC0726)	23,365
Cultivation of toxic dinoflagellates (FC0730)31,882Reviews of current research into phycotoxins (FC0731)10,320PSP bioassay studies (FC0734)	10,325
The significance to human health of the chemical contamination of commercial shellfish (FC0735)	40,239
Development of reliable and specific analytical methods and rapid assay procedures for phycotoxins (FC0736)	26,250
Development of reliable and specific analytical methods and rapid assay procedures for phycotoxins-PSP (FC0737)	26,250
Development of in-vitro bioassays for detection of PSP and related toxins (FC0739)	87,095
Development of reliable and specific analytical methods and rapid assay procedures for phycotoxins (FC0741)	40,062
Development of reliable and specific analytical methods and rapid assay procedures for phycotoxins (FC0742)	33,993
Development and assessment of reliable specific assay procedures for detection of marine biotoxins in shellfish (FC0745) (B09012)	322,388
Development of methods for and Survey of Recently Discovered Toxins in UK Shellfish (B04004)	376,024
Assessment and Validation of a Commercial Rapid Qualitative Assay (MIST Alert) for the Detection of ASP and PSP in the UL Monitoring Programme and as an End Product Test (B04006)	231,779
Assessment, Development and Validation of Alternative Methods for the Determination of PSP, DSP and ASP Toxins Using HPLC-MC-MC (B04007 and B04010)	385,047
Development and Assessment of Reliable, Specific Assay Procedures for Detection of Marine Biotoxins in Shellfish	322,388
Validation of the Extraction Procedures Applied in the Yasumoto Method for the Detection of Toxins in Shellfish Associated with DSP (B16002)	31,567
A Study to identify the causal agent(s) responsible for the atypical DSP symptoms from cockles and mussels using LC-MS (B16001)	39,993
Evaluation of the acute toxicity of cockle extract following IP and oral administration in the mouse	19,600
Total	2,687,956

  Research projects on shellfish bacteriology/virology commissioned by MAFF and FSA since 1990

Title	Cost £
Shellfish Microbiology (advice and inspection) (Replaced by FC0724 and FC0718) (FC0701)	74,909
Development of molecular biological methods for fisheries research (FC0702)	90,608
Studies of viruses in shellfish in relation to Public Health (FC0703)	1,133,792
Naturally occurring biological contaminants (FC0704)	186,517
Microbiological quality of shell fish waters (FC0705)	99,600
Investigation into use of coliphage to assess influence of re-laying and depuration on contamination of m. (FC0706)	33,600
Handling Live Molluscs (FC0709)	30,000
Depuration techniques for Oysters and Clams (FC0714)	31,400
A study to evaluate the feasibility of using coliphage as hygienic indicators in molluscan shellfish (FC0717)	52,789
Duties relating to EC directive 91/492 EEC on Shellfish Hygiene (FC0718)	1,086,135
Development of gene probe techniques for the detection of viral pathogens relevant to fisheries research (FC0719)	220,909
Monitoring for food quality assurance purposes (FC0712)	461,428
Shellfish Microbiology (advice) (FC0724)168,407
Role and fate of micro-organisms in bivalve molluscs with reference to bacteria and viruses (FC0727)	159,700
Technological developments to improve the hygienic standards in the inshore shrimp fishery (FC0728)	32,600
Studies on application of enterovirus RT-PCR to environmentally contaminated shellfish (FC0729)	18,650
Re-appraisal of existing operating criteria for purification of bivalve molluscs in the UK (FC0732)	46,312
Studies on the removal of human pathogenic viruses from molluscan shellfish during depuration (FC0733)	113,583
Detection and removal of human viral pathogens in bivalve shellfish (FC0738)	974,933
Monitoring for food quality assurance purposes Phase II (FC0740)	67,100
An assessment of the impact of different types of sewage treatment on the contamination of shellfish (FC0748)	24,817
The development of improved, simplified and standardised PCR based techniques for the detection of Noroviruses and Hepatitis A Virus in Molluscan Shellfish (B04001)	319,906
Development of procedures for improved viral reduction in oysters during commercial depuration (B04002)	296,467
Developing methods for the isolation and detection of viruses in shellfish, particularly Noroviruses (B04003)	150,185
Application and validation of techniques for the detection of pathogens in shellfish (B04008)	211,682
Evaluation and validation of alternative indicators of viral contamination in bivalve molluscan shellfish (B04009)	232,209
Survival of small round structures viruses and potential viral indicators in sewage treatment processes and in marine environments (B05001)	354,930
Evaluation of methods for the assessment of sewage discharge consent applications with respect to shell fisheries (B05002)	163,268
Development of procedures to distinguish between human and animal faecal contamination in shellfisheries (B05005)	272,714
Evaluation of the impact on shellfisheries production of runoff from land receiving organic wastes (B05006 and B05007)	315,800
Total	7,424,950

Annex 2

MEETINGS WITH TRADE, INDUSTRY AND LOCAL AUTHORITIES

Date	Meeting
12 February 2002	FSA meet with Carmarthen and Swansea Council, local gatherers, processors, representatives from National Assembly of Wales, Environment Agency and Sea Fisheries to discuss the problem of DSP in Burry Inlet.
10 June 2002	Food Legislative Advisory Committee of Seafish attended in York by FSA, SAGB and other Members of the fish and shellfish Industry to discuss various issues including atypical update and discussion.
24 June 2002	FSA attend open forum meeting at Whitstable with local authorities, industry and other stakeholders to discuss atypical issue.
12 August 2002	Food Legislative Advisory Committee of Seafish attended in York by FSA, SAGB and other Members of the fish and shellfish Industry to discuss various issues including atypical update and discussion.
19 September 2002	Meeting in Swansea to discuss DSP issues. Open forum meeting attended by members of the industry, local authorities and other stakeholders to discuss the atypical issue and particularly the Burry Inlet.
14 October 2002	Food Legislative Advisory Committee of Seafish attended in York by FSA, SAGB and other Members of the fish and shellfish industry to discuss various issues including atypical update and discussion.
9 December 2002	Food Legislative Advisory Committee of Seafish attended in York by FSA, SAGB and other Members of the fish and shellfish industry to discuss various issues including atypical update and discussion.
14 January 2003	FSA attended SAGB Mollusc Committee meeting in London at Fishmonger's Hall to discuss various issues including an update and discussion on atypical issue.
15 January 2003	FSA meeting with Chairman, FSA officials and SAGB delegation to discuss atypical issue and way forward.
5 March 2003	FSA attend meeting with SAGB at Fishmonger Hall, London to discuss way forward on atypical issue.
14 April 2003	Food Legislative Advisory Committee of Seafish attended in York by the FSA, SAGB and other members of the fish and shellfish Industry to discuss various issues including atypical update and discussion.
2 May 2003	At Agency request Professor Yasumoto attends a meeting with stakeholders in London to give his view of UK atypical problem and report on his findings while at CEFAS.
7 May 2003	Meeting of Thames Shellfish Advisory Committee attended by Local Authorities, FSA, Thames and North Kent Coast shell fishermen to discuss various issues including atypical update and discussion.
9 June 2003	Food Legislative Advisory Committee of Seafish attended in York by the FSA, SAGB and other members of the fish and shellfish Industry to discuss various issues including atypical update and discussion.
23 July 2003	FSA meeting with stakeholders in Wales on atypical DSP matters.
1 October 2003	FSA meeting with industry, SAGB, Food Authorities and Prof. Makin to outline findings of independent audit, solvent carry-over investigations and agreed action plan.
13 October 2003	Food Legislative Advisory Committee of Seafish attended in York by the FSA, SAGB and other members of the fish and shellfish Industry to discuss various issues including atypical update and discussion.
13 November 2003	FSA meeting held with stakeholders, scientific advisors to the industry and representatives from the 3 statutory monitoring labs, CSL and Professor Makin to discuss detail of the audit and solvent carry over reports.
8 December 2003	Food Legislative Advisory Committee of Seafish attended in York by the FSA, SAGB and other members of the fish and shellfish Industry to discuss various issues including atypical update and discussion.
29 January 2004

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Prepared 20 February 2004