Minutes of the Molluscan Shellfish Committee - 13th June 2017

• FSAI: David Lyons (Chair), Maria Meghen, 
• SFPA: Micheal O’Mahony, Brian Nolan, Bernard O’Donovan, Aileen O’Sullivan,
• MI: Jeffrey Fisher, Dave Clarke, Conor Duffy, Joe Silke
• Irish Water: Kate Harrington, Claire Cremin
• Industry: Ray Harty, Oyster Packers, 
• Patrick Murphy ISWFPO & shellfish farming
• Apologies: Richie Flynn (ISA), Paul Hickey (HSE), Andy Mulloy (Processing), Pat Mulloy (Processing), Sinead Keaveney, Vicky Lyons (BIM), Terence O’Carroll (BIM), Lorcán O’Cinnéide (IFPEA), Liam O’Suilleabhán (EPA) and Finian O’Sullivan (ISA).

DL welcomed the attendees and thanked the SFPA for hosting the meeting. There was a roundtable of introductions.

1. Minutes and matters arising from the last meeting (14th February 2017)

The Committee congratulated JS & the MI on the very successful ICMSS in Galway May 2017. More than two hundred delegates attended the conference which is the only international conference that focuses specifically on molluscan shellfish safety. Conference Abstracts are available.

It was noted that there is no plan to amend the definition of production period in the Biotoxin COP at present.

The minutes were agreed with no changes. Update: The 14th February minutes are now available on the FSAI MSSC webpage 

2. Standing Items

2a. Update on Microbiology and Biotoxin Sample Co-ordination (SFPA) 

BN reviewed the sampling and microbiology results to date in 2017. He noted recent biotoxin warnings, frequency changes and closures. The current sampling frequencies are weekly for all mussels and for all species in Bantry Bay, fortnightly for scallops and monthly for all other species. JS noted that areas that continue to be monthly may need some extra sampling if the risk increases. 

2b. Toxicity Summary Report including Production Area Closures, Management Cell Decisions and Sample Turnaround Time (MI) 

DC provided details on toxicity from January to May 2017. A number of species south of Galway Bay showed that a DSP event was creeping in very slowly. At present there are some closures in Bantry Bay and levels are increasing in Kenmare Bay. AZP is quiet at present. DC noted that phytoplankton sampling coverage is good. There was only 1 closure due to missed phytoplankton samples. This was in Kinvarra and was opened on a Management Cell Decision. JS noted we are now in high risk period of areas going over the regulatory limit. He encouraged industry not to harvest without a result for the current production period. DC suggested that industry should check results from adjoining areas as this will give additional information. BN noted that industry is paying attention to the available information and the warnings issued to date.

3. Biotoxin Programme

3a. ASP Event 

MOM noted a concern about the timing of the return to pre-toxicity sampling frequencies after the last ASP toxin episode. He noted that the toxic episode came with little warning and showed high levels of toxicity. JS noted that there are lots of safeguards to pick up increasing toxicity but agreed that the timing of a return to pre-toxicity sampling frequencies can be reviewed. CD stated that the ASP episode was complicated by the delayed arrival of a sample and an MI laboratory issue. The MI sends informal feedback to industry where there is a concern about toxicity. JS noted that in addition to the specific ASP method, the LC-MS produces a trace for ASP. BN queried if it was unusual for oysters and clams to show higher toxicity than mussels. DC noted that unusual toxicity patterns are seen at times.
Action: MI/SFPA/FSAI to consider amending the COP for Biotoxins to outline the change of frequency process and also the addition of information on risk assessment. 

3b. HABS Update 

DC explained the improved HABS system. The current HABS will be closed at the end of the year and HABS II will then be available. JS noted that the MI wants to ensure that users are supported in the change to the new system and will provide training.

3c. Tetrodotoxin

CD gave an overview of Tetrodotoxin (TTX) to date. The first report of the toxin in Europe involved a man who became ill in Malaga after eating a gastropod. The UK has reported on a screening study and a follow-up study where it found TTX in shellfish from the South East of England but not in Wales or Northern Ireland. The Dutch commenced sampling in 2015 and following a risk assessment they set a limit of 20µg/kg which was their LOQ, due to uncertainty in the toxicology data. TTX was then included in the Dutch national monitoring programme. Peaks in toxicity were found in summer and in 2016 two areas were closed. An EFSA Scientific Opinion on TTX was published in April 2017 and it calculated that a limit of 44µg/kg of TTX would be safe to consume. This is considered conservative as PSP has a similar toxicity and it has a legal limit of 800µg/kg. BOD queried the process of setting the level. CD said that the low EFSA level of 44 is an issue as its difficult to go up from there. DL noted the 400g portion is also large but AOS noted that EFSA is happy with that. 

The MI is developing a TTX method and CD has been in contact with international experts. Progress is slow and resources cannot be diverted from the regulatory programme. CD noted that the EFSA limit will be hard to meet with the method that is in development. He noted that the Dutch have found TTX in Irish mussels that had been relayed in Dutch waters. At a recent meeting between the Commission (CION), the EU Reference Laboratory (EURL) and Member State (MS) National Laboratories it was noted that few MS have a method set up. There are a variety of different methods and different machines in use. The EURL plans to commence a proficiency testing scheme by end of year and training. One positive that CD noted is that TTX reference material is available to use for spiking experiments.

AOS reported on the TTX discussion at the EU LBM Expert Working Group meeting on the 9th June. The CION representative noted gaps in the TTX data and the need for more work on the method, with inter-comparisons needed. CION does not plan to take action until there is more data available and the method is established. AOS noted the Dutch are now using the EFSA TTX limit of 44ug/kg.
MOM said that action must be taken on TTX but that data on the prevalence is needed. Following the establishement of a robust method he suggested that there is a need for a national survey to inform a regulatory impact assessment. 

4. Microbiology and Virology 

4a. Norovirus Testing and Regulation in other Jurisdictions

RH explained the Asian Oyster Group’s experience of exporting to Asian countries in the last 18 months. He noted that there is no EU limit in legislation for norovirus and that the countries they export to have different approaches. The members of the group have included norovirus in their Food Safety Management Systems (FSMS) and are taking a cautious approach to ensuring the long- term viability of the market opportunity. RH thanked the MI for support in analysis. He asked for assistance in setting a plan of action in place to ensure the safety of product, including action at set levels.

JS said the MI is happy to support industry but noted that it is unable to provide routine large scale commercial testing for viruses. The MI and BIM are in communication on a solution for commercial testing and BIM are looking at the business model to establish a norovirus commercial laboratory. AOS noted that the EU RL is developing guidance for norovirus commercial labs. 

BOD agreed with the importance of industry working together to avoid export risks. He would like to see industry set one limit, until an EU limit is set. MOM suggested that companies avoid exporting during high risk period and that they keep library samples. He noted that norovirus must be included in companies FSMS. He said that the agencies would support the group although he noted that the SFPA is not in a position to set a limit. MOM noted the FSAI Norovirus Opinion. 

Action: FSAI to contact BIM on management advice for the Asian Oyster Group after consultation with SFPA and MI

4b. 2017 Annual Classification review 

BN noted that the MI/SFPA classification recommendations were circulated on the 6th June to the ISA, SFPA ports and the Implementation Team and the Implementation team meeting will be held on the 28th June. The classification is based on a 3 year data set. He noted that the classification system was highlighted at all 7 SFPA Breakfast Events around the country. He noted that this is the first classification since the amendment to Regulation 854/2004 came into effect on the 1st January 2017 and brought changes to the margin of tolerance for A class waters. He noted that while 700 MPN is the upper limit for A Class results, 790 MPN is a more frequent result. He noted the amendment to the legislation has had a small effect overall to date. 

Action: Industry to forward comments via port offices to SFPA. Update: The 2017/2018 Classification is now available

4c. Review of SFPA Microbiology COP on the microbiological monitoring of Classified LBM production areas in Ireland 

SFPA has produced a draft update to the Microbiological COP following the introduction of Regulation 2285/2015 and the subsequent update to the EU RL guidance. BN reviewed the changes and noted changes, including: the definition of a dormant fishery, the minimum total number of samples for a seasonal classification , alert status and sample result discarding. PM queried the limits for a seasonal classification. BN noted sampling issues for seasonal fisheries as it may be difficult to get samples year round. MOM noted CION is not in favour of seasonal classifications and so there is a need for robust data. AOS noted that EU WG discussed seasonal classification and the EU RL plans to include a harmonised approach in its guidance.

Action: Comments on the draft Microbiology COP to be submitted by the 23rd of June. Update: Version 5 of the Microbiology COP is now available

4d. Resolutions of the workshop of NRLS for Monitoring Bacteriological and viral contamination of bivalve molluscs, May 2017

JS noted that CEFAS will no longer be EU RL for microbiological and viral contamination after the end of 2018. It is expected that a new laboratory in Sweden to take over all viruses but there are concerns as LBM are unique. CION promised that cognisance would be taken of the public health challenges of LBM. The workshop expressed significant concerns with respect to future plans for the NRL network. AOS provided an update from the EU LBM Expert WG explaining that the plan is for responsibility for E. coli to move to the EU RL in Rome and for salmonella to move to the EU RL in the Netherlands. JS noted the concern that they are not expert shellfish laboratories and there are concerns over matrix effects.

JS noted that the USA’s FDA has accepted EU data showing continued the equivalency of the US approved and EU A Class areas following the introduction of Regulation 2285/2015. He noted the publication of ISO 15216-1:2017, a validated standard for the quantification of viruses in food including LBM. He noted emerging risks in relation to Vibrio parahaemolyticus & Vibrio vulnificus linked to sea temperature and salinity changes.

4e. EU Baseline Survey on Norovirus – update

BN noted that sampling for the EU Baseline Survey on Norovirus has now commenced. Updated sampling guidance has been issued as the oysters must be within market size and samples over market size will be rejected. There have been a few rejections due to high temperatures on arrival in the laboratory but these were resampled so no samples were missed. It was noted that there will be an EFSA network web conference on the 22nd June for survey managers from the MS. The meeting will discuss reporting issues, data quality issues and preliminary results.

5. AOB

5a. FSAI MOUs with the Loughs Agency and BIM

DL noted that the FSAI has recently renewed it MOUs with the Loughs Agency and BIM.

5b. EU COP for Biotoxins

CD noted that CION has asked for EU RLs to produce a COP for Biotoxin monitoring, but he noted that laboratories don’t have expertise in this area and so he hopes other agencies will collaborate on the document. MOM agreed with this concern. DL noted that there isn’t an equivalent network of risk managers or regulators, but maybe there will be an option to nominate another agency

5c. Shellfish Regional Information Events

DL noted that Shellfish Regional Information Events will be held in the autumn to provide an opportunity for those involved in the sampling, production, handling and sale of LBMs to learn about the latest developments in the area. 

5d. 2017 Schedule of remaining MSSC Meetings 

*note changes

Last reviewed: 18/10/2017