Testing for Oxytetracycline residues in honey following treatment of bees for a European Foulbrood outbreak in Scotland

Who will this consultation be of most interest to?
Consumers of honey and honey products, bee farmers in areas affected by the EFB outbreak in Eastern Scotland and, more generally, the honey industry. Competent authorities involved in veterinary residue testing and enforcement will also need to be aware.

What is the subject of this consultation?
Last autumn, the Scottish Government arranged treatment of an EFB outbreak in eastern Scotland with OTC and there is a possibility of OTC residues in honey when production starts in spring 2010. Consequently, following liaison with SG and having sought opinion from the European Commission and other competent authorities, this consultation sets out options for OTC levels in honey to protect consumer choice and inform the honey industry concerning testing requirements.

What is the purpose of this consultation?
To inform key stakeholders about a proposed testing strategy to protect consumer confidence in honey.

To seek comment on options regarding an action level for OTC residues in honey following treatment of an EFB outbreak in eastern Scotland.

European Foulbrood is a notifiable and devastating bacterial disease of bees and Oxytetracycline is the only registered treatment for its control. In response to an outbreak of EFB in honeybees in eastern Scotland during 2009, the Scottish Government initiated a voluntary programme of OTC treatment of affected hives in September 2009. Following confirmation from the Veterinary Medicines Directorate (VMD) that use of the cascade was permitted, SG used a pure OTC product, 'Aquatet' for the treatment of bees under the provisions of the Veterinary Medicines Regulations 2008. The OTC was formulated in icing sugar to the correct dose for application to beehives.

Approximately 4,660 hives were treated following honey collection and prior to overwintering. Dilution caused by honey flow is an important factor in the depletion of residues in honey and external temperature is another factor. Owing to the fact that no honey is produced during overwintering, and the severity of last winter, it is possible that residues of OTC will be present in honey from treated hives once production commences this spring.

EU legislation on Veterinary Medicines Residues (Council Regulation 470/2009 and Commission Regulation 37/2010) sets maximum residue limits (MRLs) for pharmacologically active substances in foodstuffs of animal origin; however, no MRL exists for OTC in honey. Under these regulations, if no MRL is set then the substance must be absent from the foodstuff. Furthermore, Council Directive 2001/110/EC specifies that honey must be 'as far as possible free from organic or inorganic matters foreign to its composition' - this is implemented in Scottish law by 'The Honey (Scotland) Regulations 2003' (equivalent legislation exists in England, Northern Ireland and Wales).

Aside from the legislative position, OTC residues in honey should be minimised and must not pose a risk to consumers. At parts per million levels, OTC can pose a risk by disturbing the balance of intestinal bacteria, so allowing pathogenic species to flourish.

Following liaison between FSA, SG, bee farmers and VMD, honey produced from OTC treated hives in spring 2010 will be tested for OTC residues. Results sent to the food business operators (FBOs) will be copied to FSA, SG and VMD for further action as necessary. FSA has sought clarification on the EC position re OTC residues in honey and consequently options are presented for comment concerning suitable residue levels for testing.

Testing
Honey produced from treated hives in spring 2010 will be tested for OTC residues. Under advice from SG Bee Inspectors, FBOs will provide samples and arrange for analysis to be carried out by laboratories accredited to ISO17025 and using a method that is validated to EU standards for veterinary medicine residues i.e. to Commission Decision 2002/657/EC concerning the performance of analytical methods and the interpretation of results.

Samples will be taken after initial bulking from the apiaries and prior to subsequent processing or blending. Bulked honey will be held at the FBO's premises while testing is completed.

Results will be sent to the FBOs and copied to FSA, SG and VMD for further action as necessary. If results are below the levels agreed after consultation, honey will be released onto the market. If results are at or above the levels, the honey will be regarded as non-compliant and must not enter the food chain.

The FSA will advise the relevant Local Authority (LA) for both the bulking premises location and location of the FBO (if different) of the results. For levels at or above the action level, the FBO must provide the LA with confirmation that the honey has been destroyed or otherwise removed from the food chain. In the absence of confirmation, further enforcement action may be required.

Action level

FSA has sought opinion from the European Commission and other competent authorities in the UK regarding setting a suitable Action level for OTC residues in honey. Consequently, three options and the basis of each are presented here for comment.

It should be noted that although OTC can pose a risk by disturbing the balance of intestinal bacteria at parts per million levels, an FSA risk assessment indicates that residues at the levels presented here would not represent a food safety risk.

• Option 1: 25 µg/kg¹

The Committee for Medicinal Products for Veterinary Use (CVMP – a committee of the European Medicines Agency) considered the specific use of OTC for bees in 2006 and 2008. On each occasion its summary opinion was to recommend a provisional MRL of 25 µg/kg for OTC in honey.

• Option 2: 20 µg/kg

The Community Reference Laboratory (CRL) recommends a level of 20 µg/kg for screening for tetracycline residues in honey. This level is also used by the Food and Environment Research Agency (FERA) for the VMD National Statutory Scheme.

• Option 3: not detectable (i.e. below limit of detection)

Although the CVMP has recommended a provisional maximum residue limit (MRL) of 25 µg/kg for OTC in honey, this level has not yet been adopted as an EU MRL.

In the absence of an EU MRL for tetracycline in honey (Commission Regulation 37/2010), honey containing residues of OTC at any level can legally be rejected by another Member State.

Although the CRL screening level is 20 µg/kg, laboratories can detect to lower levels depending on the methodology used. FERA use a confirmatory method on suspect positive samples of 10 µg/kg and any sample equal to or greater than this level is considered non-compliant.

The FSA is seeking the views of the Commission and other competent authorities on what would constitute an acceptable limit of detection if it is decided that OTC should not be present at detectable levels.

Key proposals:

• test honey from OTC treated hives for residues and take action as necessary
• set an Action level for OTC residues in honey from treated hives

¹ µg/kg = parts per billion (ppb)

Prior to this consultation, SG initially notified FSA of its planned OTC treatment programme in September 2009 and has liaised closely since. FSA has liaised with SG, VMD, FERA and UKRep and has informed local authorities in Scotland of the issue. FSA also intends to participate in a meeting SG has organised with bee farmers on 25 March 2010.

Responses to this consultation will help to inform the FSA about the acceptability of this proposed action to protect consumer confidence and avoid detriment to the honey industry.

Questions asked in this consultation:

1. Is the proposed testing regime satisfactory?
2. Which suggested Action level is preferred?

The FSA welcomes comments particularly from bee farmers affected by the EFB outbreak and consumer groups. If you are aware of other individuals or organisations for whom this consultation would be relevant, please pass it on and ask them to inform the FSA of their interest.

Responses are required by close 15 April 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 stakeholders 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.

In accordance with the FSA principle of openness we shall keep a copy of the completed consultation and responses, to be made available to the public on request. The FSA will publish a summary of responses, which may include personal data, such as your full name. Disclosure of any other personal data would be made only upon request for the full consultation responses. 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.

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