Proposal to amend Regulation (EC) No. 2074/2005 with regard to recognised testing methods for detecting marine biotoxins in live bivalve molluscs (Scotland)

In the UK, the Food Standards Agency (FSA) is the designated Competent Authority responsible for ensuring that the statutory monitoring programme for biotoxins in live bivalve molluscs (LBM) and other shellfish is in place using the methods of detection set out in Regulation (EC) No.2074/2005¹. Regulation (EC) 854/2004² stipulates that shellfish flesh is to be monitored routinely for three groups of marine biotoxins: paralytic shellfish poisoning, amnesic shellfish poisoning and lipophilic toxins. Mouse bioassay (MBA) is currently used in the UK as the reference method for detecting lipophilic toxins, including those belonging to the diarrhetic shellfish poisoning (DSP) group. However, while the MBA is currently prescribed in the EU Regulation as the reference method for detecting lipophilic toxins, it is recognised that it has scientific shortcomings and an alternative method for detecting these toxins is required. Furthermore, the use of animals in testing for scientific purposes is regulated under EU³ and national law⁴. These rules prohibit unnecessary animal testing, and in particular require replacement of animal tests where a scientific alternative is available.

For the past few years, the FSA has commissioned research to develop an alternative, more effective method for the quantification of lipophilic toxins. Results from FSA-funded research and similar initiatives at national and international level have shown that liquid chromatography-mass spectrometry (LC-MS), a chemical-based method, has an improved detection capability and is a highly specific method for the quantification of lipophilic toxins. As the LC-MS addresses the ethical and scientific concerns identified with the MBA, the method is now being proposed to replace the bioassay.

Following EFSA’s review⁵ of the available data and recent advances in LC-MS methodology, the Commission has proposed an amendment to the legislation to adopt LCMS as the reference method for detecting lipophilic toxins. In order to allow member states time to adapt their monitoring programme and apply the validated LC-MS method, the proposed amendment to the legislation includes a transitional period of three years after which the MBA can only be used to detect new or unknown marine biotoxins. The Commission’s proposal was accepted by the Standing Committee on the Food Chain and Animal Health (SCoFCAH) in November 2009 and is expected to be adopted before the end of 2010. FSA research on the LC-MS will soon provide a validated LC-MS method that would allow early implementation of the requirements of the Commission's proposal, and the method could be applied in the UK statutory monitoring programme early in 2011.

The replacement of the MBA with the more robust LC-MS method as the recognised testing method for lipophilic toxins will increase confidence in the results of the statutory monitoring programme. In addition, the implementation of the LC-MS will reduce the reliance on animal testing in the statutory biotoxin monitoring programme.

Endnotes
¹ Regulation (EC) No. 2074/2005 laying down implementing measures for certain products under the EU Food Hygiene Regulations and the Official Control Regulation (EC) No. 882/2004.
² Regulation (EC) No. 854/2004 laying down rules for the organisation of official controls on products of animal origin intended for human consumption
³ EU Council Directive 86/609/EEC
⁴ Animals (Scientific Procedures) Act 1986
⁵ Scientific Opinions of the Panel on Contaminants in the food chain - Marine biotoxins in shellfish: Okadaic acid and analogues (adopted on 27 November 2007); Azaspiracid group (adopted on 9 June 2008); Yessotoxin Group (adopted 2 December 2008); Pectenotoxin group (adopted 27 May 2009); Summary on regulated marine biotoxins (adopted on 13 August 2009)

Options being considered are:

1. Do nothing and continue to use the MBA for the testing of lipophilic toxins in the UK‘s statutory monitoring programme
2. Replace the MBA with LC-MS for the testing of lipophilic toxins in the statutory monitoring programme at the end of the Commission’s transitional period
3. Replace the MBA with LC-MS for the testing of lipophilic toxins in the statutory monitoring programme as soon as the chemical method has been validated, i.e. before the end of the transitional period.

Preferred option
Option 3 is the preferred option. Doing nothing (option 1) or delaying the introduction of the LC-MS to the end of the transitional period (option 2) will mean that the best available method is not being used. As the MBA is known to provide variable results and does not quantify levels of lipophilic toxins, its continued use when a better alternative is available will have negative implications for food businesses due to unnecessary closures from compounds that may interfere with the MBA, such as free fatty acids in the shellfish samples. The continued use of the MBA will also affect public health negatively due to the potential inability to detect lipophilic toxins at the required levels. In addition, continuing to use an animal assay when a scientific alternative is available is in contravention of EU and national legislation, as well as contrary to the Agency’s commitment to minimise use of tests involving animals.

The introduction of the LC-MS in the monitoring programme will, however, increase the unit cost of tests for lipophilic toxins in the Agency’s funded monitoring programme, as the LC-MS is a more resource intensive method and involves more specialist analysis than the MBA. This may be a short term effect if, over time, more testing laboratories enter the market, as LC-MS does not require a special operating licence and more laboratories may be able to offer tests at competitive prices. The format in which results are reported within the monitoring programme will also change as the MBA and LC-MS are quite different methods and determine toxicity on a different basis. The costs and benefits are described further in the Impact Assessment in Annexe B.

In addition, the changes in the testing regime may also have implications in terms of the reporting of test results to the Agency as it is expected that the new procedures may in some cases add up to a further 24 hours before results of the monitoring programme are available. The LC-MS turn-around of results is similar to that of the MBA carried out with a 24-hour observation period.

Key proposals:

• To replace the mouse bioassay (MBA) with liquid chromatography-mass spectrometry (LC-MS) for the detection and quantification of lipophilic toxins, including DSP toxins, in live bivalve molluscs.
• To introduce the LC-MS in the Agency’s statutory monitoring programme for marine biotoxins in shellfish as soon as a validated method is available (likely to be early 2011).

The current consultation is part of the FSA commitment to replace animal testing in the statutory monitoring programme for marine biotoxins in shellfish and ensure fit-for-purpose methodology is used in all statutory testing. Informal consultation in meetings and correspondence with the shellfish industry and their representatives and with animal protection organisations has taken place regarding the limitations of the MBA and the intention to introduce the LC-MS in the UK statutory monitoring programme. The introduction of LC-MS is welcomed by industry and animal protection organisations. The FSA now welcomes comments from all interested parties on the proposals set out above. Interested parties are particularly invited to respond to the following questions:

1. Do you agree with the replacement of the MBA by LC-MS for the testing of lipophilic marine biotoxins?
2. Do you agree that use of the LC-MS method should be introduced as soon as a validated method is available to the UK, rather than wait until the end of the transition period (likely to be early 2011)?
3. Do you agree with the approximate cost per sample used for MBA and LC-MS tests across all countries?
4. Can you provide any further evidence on the costs and benefits to the industry that would arise from the implementation of the LC-MS to input at the Impact Assessment in Annexe B? Specific information on the likely impact on smaller businesses would be very helpful.

We welcome comments from all interested parties. Please send your response by email or post using the contact details given above. All responses received will be given careful consideration. We would particularly encourage responses from consumers and encourage shellfish harvesters and their representatives to send comments regarding the impact of using the new methodology on their business. A summary of all comments received and the FSA response to each will be published on the Agency’s website within three months.

Responses are required by close 24 November 2010. Please state, in your response, whether you are responding as a private individual or on behalf of an organisation/company (including details of any interested parties your organisation represents).

This consultation has been prepared in accordance with the HM Government Code of Practice on Consultation, which states that a consultation must follow better regulation best practice, including carrying out an Impact Assessment (Regulatory Impact Assessment in Scotland). The assessment is included in the consultation documents.

We are interested in what you thought of this consultation and would therefore welcome your general feedback on both the consultation package and overall consultation process. If you would like to assist us to improve the quality of future consultations, please feel free to share your thoughts with us by using the consultation feedback questionnaire.

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In accordance with the FSA principle of openness our Information Centre at Aviation House will hold a copy of the completed consultation. Responses will be open to public access upon request. The FSA will also publish a summary of responses, which may include personal data, such as your full name and contact address details. If you do not want this information to be released, please complete and return the Publication of Personal Data Form. Return of this form does not mean that we will treat your response to the consultation as confidential, just your personal data.

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Within three months of a consultation ending we aim to publish a summary of responses received and provide a link to it from this page.

If, after three months, the summary is still not showing, please contact the person who was responsible for the original consultation. Alternatively, you can contact the FSA Consultation Co-ordinator by email: consultationcoordinator@foodstandards.gsi.gov.uk