Annex 4 - The Food Standards Agency's Approach to the Control of Coccidiostats

Outcome of the Stakeholder Consultation on Coccidiostat Residues in Poultry.

Introduction

1. The Food Standards Agency hosted a meeting to discuss Residues of Feed Additives used as Coccidiostats in Poultry at its Aviation House headquarters on the 16 January 2002. The main aim of the Stakeholder Meeting was to create a better understanding of the range of stakeholder opinions and determine a way forward to reduce avoidable residues in food.

2. This paper has been prepared to develop the ideas and issues which arose from that meeting. The paper takes into account the talks given by the many speakers and the questions and comments by the audience. It also takes into account written comments received after the meeting and responses to a subsequent consultation document. The paper sets out the issues and presents a preliminary view on how coccidiostats should be controlled. It includes the views of Stakeholders. A list of coccidiostats is attached to this paper (at the end of this annex).

The Problem

3. In June 2001, The Soil Association published a report (Too hard to swallow - the truth about drugs and poultry). The report claimed that pressure on the poultry industry to rear poultry intensively had led to the widespread use of large quantities of drugs which in turn may have a harmful effect on human health. One particular problem that was highlighted was nicarbazin residues in poultry products.

4. The presence of residues of nicarbazin in poultry is an issue of longstanding concern. Residues in eggs were dealt with effectively by the industry in liaison with the Veterinary Medicines Directorate (VMD). However, the issue of nicarbazin residues in liver has not been resolved. Although this is not considered to be a food safety issue, the continuing contamination is unacceptable and is indicative of poor practice.

5. This paper addresses the following issues:

• Is the precautionary principle applied effectively to the regulation of veterinary medicines and feed additives?
• Do the EC feed additive controls provide an adequate way forward to prevent or minimise residues in food?
• Do the current reporting arrangements for the VMD surveillance programmes serve the best interests of consumers and aid the effective resolution of residue problems?
• How the consumer can be kept better informed of what is happening in the processes that control residues in food.
• How best practices in the industry can be identified and spread.
• What further action should be taken?

Is the precautionary principle applied effectively to the regulation of veterinary medicines and zootechnical feed additives?

6. Progress is being made in that:

• The setting of Acceptable Daily Intakes (ADIs) by bodies such as European Commission's Scientific Committee on Animal Nutrition (SCAN) and Joint FAO/WHO Expert Committee on Food Additives (JECFA), is by definition a precautionary approach where safety factors are applied. The Agency welcomes the Commission Paper on the Precautionary Approach to risk assessment. The Agency believes that it is right to take action on the basis of the risk, and not the hazard.
• The Committee on Toxicity (COT) is considering the potential for interactions that might cause safety concerns in both pesticides and veterinary medicines. The draft report was circulated for consultation and there was an open meeting of the COT on 28 February 2002 to consider the draft report. Once the report is finalised, the Veterinary Products Committee (VPC) will be asked to consider any implications for the current regulatory system for veterinary medicines. If the VPC recommends changes, the Agency could draw these to the attention of SCAN.
• The Soil Association remains concerned that the potential for interactions undermines the assertion that the regulatory risk assessment process is founded on a precautionary approach. In contrast M J Carter Associates is concerned that the Agency should not the precautionary principle by default as an alternative to a robust risk assessment which takes into account uncertainties in the data.
• The Soil Association has questioned in particular the safety-in-use of lasalocid. We received further written information on this coccidiostat and have obtained copies of the articles brought to our attention. We are considering the particular issues raised by this information and we believe it raises no immediate concerns. The Soil Association has restated its concerns about the safety of nicarbazin residues. The Agency considers this to be a food contamination issue rather than a safety issue, but expects industry to take appropriate action to resolve the issue without further delay.

The effectiveness of the current regulatory system for coccidiostats:

7. Progress is being made in that:

• Coccidiostats are undergoing review at the European level to ensure that all those substances authorised are supported by adequate data packages. Already, nicarbazin and dimetridazole have been withdrawn as feed additives and discussions are taking place about the possible of withdrawal of or submission of further safety data for others. It should be noted that nicarbazin will continue to be used, albeit at a lower level in combination with another active product.
• The Veterinary Products Committee (VPC) Sub Group on Antimicrobial Resistance recommended in their draft report that coccidiostats with antibacterial activity should not be licensed for growth enhancing purposes where they are used in human or veterinary medicine. It also recommended that medicinal feed additives should be evaluated and regulated in the same way as veterinary medicines: “Given the concerns raised by expert groups on the therapeutic and prophylactic use of antimicrobials in livestock it is recommended that all such use should be restricted under veterinary control. Consequently, all antimicrobials licensed for therapeutic and prophylactic use in livestock should be prescription only medicines (POMs). It is noted that antimicrobials used as coccidiostats or for growth-enhancing purposes are authorised under European Regulations (70/524 EEC) and are classified as feed additives. The Working Group is of the opinion that coccidiostats are used solely for the treatment or prevention of disease in animals and should therefore be authorised as veterinary medicinal products under EU Legislation 81/851/EEC. Coccidiostats with antibacterial activity should not be licensed for growth-enhancing purposes where they are used in human or veterinary medicine or where they select for organisms resistant to antimicrobials used in human or veterinary medicine. It is recommended that an assessment of the risk of such products selecting for organisms resistant to antimicrobials used in human medicine should be undertaken as part of the authorisation process.”
• The intention has been announced by the Commission that the four remaining antibiotic products used as animal growth promoters in animal feed will be phased out by 2006. The Agency supports this action and the above recommendations by the VPC Subgroup.

The effectiveness of the current surveillance system

8. Action is being taken as follows:

• The independent Veterinary Residues Committee (VRC) as one of its tasks, advises on how improvements can be made to the Non-Statutory Surveillance system and the way results are reported.
• The VRC will be reviewing the sampling programme and will address the issues of a better statistical basis and the increase in testing of imports. It has already recommended that sampling should be carried out throughout the year as opposed to the current April-December arrangements.
• In 2002 there will be an increased number of 300 liver samples taken for analysis in the Statutory Programme.
• For the fast track pilot study for nicarbazin residues.
• There will be a new questionnaire at the time of sampling so that practices can be compared in relation to the different residue results.
• Analyses will be speeded up and there will be prompt investigation of positives.
• Information must be given to the industry to enable them to know which or whose poultry has elevated residues.
• Audited Feed Assurance schemes and Good Operational Practices looking at critical control points have already been developed by the industry for feed mills and producers and these are to be more widely applied throughout the industry.
• The industry is to set maximum feed contamination targets.
• Producers have agreed to be open and transparent about corrective action being taken.
• Since the use of nicarbazin continues in a mixed product; and there is the possibility of it returning to the market as a single product, it is important to resolve the fundamental contamination problems identified by the stakeholder meeting.
• Some concern has been expressed that surveillance for nicarbazin residues will unfairly penalise UK producers since chicken livers on sale in the UK only come from home production. Specific requests were made for surveillance to include more imported foods.
• The industry has undertaken to eliminate the high level occurrences of residues by July 2002.

How the consumer can be kept better informed of what is happening in the processes that control residues in food:

9. Progress is being made by the VRC and VMD in these areas:

• The VRC has recommended increased openness and transparency in the veterinary surveillance programmes. It has begun by publishing the committee papers in advance of its meetings and provides a full record of its discussions through the minutes and its website.
• The VRC has agreed to recommend the principle of providing brand name information with survey results and its specific application to some surveys from June 2002. The Agency and PSD support the implementation of this policy to put the reporting of veterinary medicine residues surveillance in line with that for pesticides and residues of food additives and contaminants. The Agency is recommending that the results of the monitoring for nicarbazin residues are published with brand names of samples bought at retail level.
• The way that the VMD reports the results of surveillance in terms of presentation of the numerical information is being improved to provide more meaningful explanations for consumers.

How best practices in the industry can be identified and spread:

10. Progress is being made in that:

• Action is being taken by industry to investigate ways in which residues occur and to spread best practice to minimise residues across the whole industry.
• The Agency has been asked to consider carefully the case for vaccination as an alternative to the use of coccidiostats. In contrast the main body of UK poultry producers argue that the current uses of coccidiostats are vital to the control of the disease and to minimise suffering. The institute for Animal Health argues that more work needs to be done on the development of vaccines if it is considered necessary to replace cocidiostats totally.

The Way Forward

• The Agency is committed to improvements in the surveillance of veterinary residues and will be working closely with the VRC and VMD to take forward the work identified by the recent Stakeholder meeting.
• Building on the Board meeting, the Agency will develop a strategy to address the issues set out above and resolve the problem of nicarbazin residues, a key part of which will be support for the VRC's advice to provide brand name information with survey results. Publication of brand name information will help to minimise residues.

Chemical Safety and Toxicology Division

Food Standards Agency

May 2002

Glossary

DEFRA - Department of the Environment, Food and Rural Affairs

DH - Department of Health

EU - European Union

VMD - Veterinary Medicines Directorate (DEFRA Agency)

VPC - Veterinary Products Committee

VRC - Veterinary Residues Committee

COT - Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment

WiGRAMP - Working Group on the Risk Assessment of Mixtures of Pesticides and Veterinary Medicine

ADI - Acceptable Daily Intake

MRL - Maximum Residue Limit or Level

SCAN- EU Scientific Committee on Animal Nutrition

DARDNI - Department of Agriculture and Rural Development Northern Ireland

RPSGB - Royal Pharmaceutical Society of Great Britain

ZTA - Zootechnical Feed Additive

POM - Prescription Only Medicine

MFS - Medicated Feedingstuff

PML - Pharmacy and Merchants List

* Ionophores (specific type of coccidiostat) - 5 ionophores are permitted in the UK

Key: GSL = A medicine from within the General Sale List

POM = A Prescription Only Medicine

MFS = A medicated pre-mix requiring a MFS prescription

ZFA = Zootechnical Feed Additive

Data sources: National Office of Animal Health (NOAH) veterinary compendium 2001-2002 and the Handbook of Feed Additives 2002