EHJ March 2005, pages 16-18

A recent dispute between the shellfish industry and the Food Standards Agency over the accuracy of tests to detect toxins in shellfish almost ended in the courts. David Lyons explains how the Irish resolved a similar dispute and suggests that the UK could learn from Ireland's experience

Reading the House of Commons Environment, Food and Rural Affairs Committee's report - the Food Standards Agency and Shellfish - may provide a startling sense of deja-vu for anyone involved in the monitoring and management of biotoxins in shellfish in Ireland over the last six years.

Phrases such as "poor communication", "absence of openness, transparency, and accessibility" and "poor co-operation" were equally applicable on the other side of the Irish Sea in the late 1990s as they were on the Westminster side in more recent times.

Biotoxin monitoring and management in Ireland has progressed, though, from the nadir of 1999 when prolonged closures, a novel toxin and bitter disputes characterised the environment within which this rapidly expanding food sector was expected to operate. So much so, that the very viability of the sector was in jeopardy.

How the situation in Ireland changed to one where the management and monitoring programme has been recognised as world-leading and a source of competitive advantage for the industry can perhaps serve as a template for other sectors.

However, this would not be to suggest that the Irish programme is perfect. Far from it, many challenges remain, including the application of new methodologies, developing provisions for dealing with emerging toxins and new derivatives of existing ones.

Like the United Kingdom, the toxins of major significance to Irish shellfish production are those that cause diarrhetic shellfish poisoning (DSP), paralytic shellfish poisoning (PSP) and amnesic shellfish poisoning (ASP).

One toxin particular to Ireland emerged in 1995 when consumers in the Netherlands fell ill following the consumption of Irish mussels. It was quickly realised that this new toxin was unlike any detected previously, but it took a further three years of intense investigation to elucidate its structure. This toxin would eventually be christened azaspiracid (AZA). As with some of the other toxins AZA has since been shown to be a wider problem for the European shellfish industry.

For the industry, this was another hammer-blow coming at time when it was experiencing its worst series of closures and losing upwards of Û4m per annum (£2.6m), and things seemed destined to get worse.

In the middle of this crisis, the Food Safety Authority of Ireland (FSAI) was established, with a remit extending into the already troubled world of shellfish production. For the industry it looked as if an agency whose declared primary aim was the protection of the consumer, would have little to offer by way of solutions to their problems.

One of the first acts of the new authority was to arrange a series of meetings around the coast where regulators, scientists and industry engaged in the traditional free and frank exchange of views.

From these meetings it quickly became apparent that adversarial positions were being fostered by mutual misunderstandings. Subsequently, a visit to examine the regulation of the shellfish industry in New Zealand led to the development of a partnership approach and the formation of the Molluscan Shellfish Safety Committee (MSSC).

This committee was to scrutinise, and where necessary, change the monitoring programme. While its primary aim was to protect the consumer, it was also charged with ensuring consumer confidence in the safety of shellfish and with supporting the long-term sustainability of the shellfish industry."

The problem was attacked from two angles: there would be rigorous scientific monitoring and an active programme of communications, along with research into harmful algal events to help improve the science on which the risk management was based.

As conceived, the MSSC was to be chaired by the FSAI with representation from the relevant public bodies and crucially industry, who were given full representation to allow them to influence the transformation process.

As the MSSC set about its work, changes were introduced in all aspects of the programme. The mouse bioassay was modified (see box), and inter-laboratory calibration exercises were introduced and continue to be carried out on a regular basis.

Chemical testing (using liquid chromatography - mass spectrometry) was developed and an extensive programme of test accreditation was pursued. Phytoplankton sampling, intended to provide some degree of early warning was also extended.

Sample turnaround was improved to two days in most cases, with results being published on the websites of the FSAI and the Marine Institute and sent electronically and via SMS to producers and regulators.

All parties contribute to the programme. So while there has been significant investment on the part of the government agencies in terms of equipment and expertise, industry too has played its part by contributing services-in-kind, for example equipment and boats, when they were required.

One key element of the whole initiative, however, was not introduced until 2002. A persistent problem for both industry and regulators was dealing with conflicting results, for example a negative mouse bioassay combined with a positive chemistry result.

This led to a "management cell" being created to provide proactive risk management in such "non-routine" situations. The cell includes a representative from the FSAI, the Marine Institute and the Department of the Marine as well as from industry.

Any member of the management cell can initiate it and ask for a result or a site's production status to be reviewed. Discussions usually take place over the telephone or electronically and decisions are arrived at on a consensus basis. Ninety per cent of decisions are made on the same day they are raised.

On those rare occasions where consensus is not possible, then the view of the FSAI representative, as chair of the cell, is adopted. This is consistent with the idea that the management cell is first and foremost an instrument of consumer protection.

Despite initial concerns that industry might use the management cell to challenge every regulatory decision, this has not been the case. In a typical year, the Marine Institute will process over 2,500 shellfish samples. In 2004, the management cell was initiated 49 times and of those occasions it was the Marine Institute, which was the initiator on 36 occasions.

From the research angle, the institute has been involved, with other international and industry partners, in studying the toxicology of AZA, developing new analytical methods and investigating the oceanography of the harmful algal events that lead to the production of these biotoxins in the first place.

Moreover, the FSAI and the institute are both partners in the recently launched EU Biotox project, which is intended to develop cost-effective tools for risk management and traceability systems for lipophilic marine biotoxins in seafood.

This research work will inform future developments in the monitoring system and ensure that the risk management element of it operates from a sound scientific base.

The Irish Marine Biotoxin programme remains very much a work in progress. For change to have occurred though, a paradigm shift was initially needed. All parties needed to realise that while there was no market for unsafe food, neither was there scope for providing consumer safety through regulation-by-diktat.

Essentially, there needed to be a shared realisation that the goal was the same for everyone - the provision of safe food. The introduction of greater co-operation, improved communication and much more transparency helped in the development of areas of commonality and co-operation, making it then possible to cultivate the practical solutions that now characterise the monitoring programme in Ireland

David Lyons MCIEH is a contracts manager with the Food Safety Authority of Ireland, a work package leader in the EU Biotox project and member of the joint FAO/IOC/WHO ad hoc expert consultation on biotoxins in molluscan bivalves. Tel: 00357 1 8171320, e-mail: dlyons@fsai.ie

The views expressed in this article are those of the author and do not necessarily reflect those of his employer

Further information

• Coakley, T. "Should food producers fear food safety", Inshore Ireland, January 2005.
• Food & Agriculture Organisation's Food and nutrition paper, number 80 - marine Biotoxins, Rome 2004.
• James, KJ, Fidalgo Sa«ez, MJ, Furey, A, & Lehane, M. "Azaspiracid poisoning, the foodborne illness associated with shellfish consumption", Food additives and contaminants, volume 21, number 9 (September 2004), pages 879-892.

National Oceanographic and Atmospheric Administration's Center for Coastal Environmental Health and Biomolecular Research. Visit: www.chbr.noaa.gov/Index.htm.