Residue control policies and capacity building

Gijs T.J.M. Theunissen, The Hague, The Netherlands

Introduction

Requirements for the quality and safety of products of animal origin vary widely from one region to another the world over. In the western world were food safety is increasingly becoming a public issue, food safety standards have thus been tightened over recent years. Until the mid-1960s the general idea of food safety meant that food should not contain any potentially harmful residues of veterinary medicinal products. This was a realistic goal because at that time residues could only be determined in concentrations of around 1 mg/kg. Since then the availability and sensitivity of methods of analysis has continuously improved and the detection of concentrations as low as 1 ng/kg are frequently state of the art today. These improvements mean that continuously lower amounts of residues are detected, which would previously have gone undetected.

The use of increasingly sensitive detection methods has led to more products being denied market access, which in turn has led to trade conflicts with third countries. A number of European Member States and exporting countries have been affected by these trade conflicts. Some producers and producing countries were temporarily withdrawn from the list of approved exporters following the detection of trace amounts of chloramphenicol (in shrimps) and nitrofurans and malachite green, others were forced to implement rapidly drastic measures.

It is important therefore that we should find ways to resolve the problems resulting from the zero-tolerance policy adopted by the EU. The industry, being responsible for the products they buy abroad, is expected to make a considerable contribution to help resolve these problems. The government will, where necessary, support the industry in this.

All products entering the European market, whether produced internally or abroad, are to meet European requirements. These requirements do not allow the use of in the EU prohibited or unauthorized substances.

I believe that in order to resolve current or potential trade conflicts efforts are to be made in two areas:

1. Countries wishing to export their products to EU countries should improve their production processes and methods of inspection to allow them to meet EU requirements. This implies banning the use of prohibited substances.
   
   
2. The EU and other western countries should work toward a more uniform policy both in terms of legislation and enforcement where these prohibited substances are concerned. I would argue for an adaptation of the current zero-tolerance policy.

I. Improving production processes and methods of inspection in countries wishing to export to the EU.

Countries wishing to export their products to EU countries should have their production processes and methods of inspection on a level which will give them the assurance that their products meet the EU requirements. If there are problems, they should know where in the production chain these problems occur and how they can be prevented. The industry itself is responsible for improving its production processes. To help countries do this, tripartite partnership projects were set up in cooperation with the government.

The WSSD^[90] (in Johannesburg, August/September 2002) identified market forces and improved access of farm products to western markets among the most important conditions for sustainable development. One way of improving market access of developing countries is through partnerships between governments, business and civil society. Each party would have to make its contribution from its own specific field. Civil society would have to identify the priorities for sustainable development, business would have to provide investment and earn a profit from the economic growth that would occur and governments would have to make the rules to ensure that the expected environmental, social and economic benefits were delivered. Apart from the economic dimension (profit) the social (people) and ecologic dimension (planet) are becoming increasingly important.

The Netherlands have committed themselves to set up tripartite partnerships with developing countries with the aim to improve market access of food and agricultural products with respect to food safety, environment and veterinary/phytosanitary matters. These commitments are laid down in the Netherlands' action program "Sustainable Action" and the "Memorandum on Policy Coherence between Agriculture and Development Policy".

An example of these tripartite partnerships is that between the Netherlands, Malaysia and Indonesia. This partnership aims at improving market access of shrimps. It not only focuses on improving the quality of the product, but also on improving working conditions and maintaining the marine ecosystems. The Dutch parties involved include the Ministry of Agriculture, Nature and Food Quality and the Ministry of Foreign Affairs/Development Cooperation. The Netherlands hopes this initiative will encourage other Member States to launch similar projects.

The Shrimp Product Safeguarding partnership: Indonesia - Malaysia - The Netherlands

As mentioned before the idea of tripartite partnerships stems from the World Summit on Sustainable Development (WSSD) in Johannesburg. Such partnerships would offer a platform for dialogue and cooperation between government agencies, business and non-governmental organisations of the countries involved and is based on mutual respect and shared responsibility. The partners/stakeholders would share the common objectives of the partnership, which could not be achieved by partners individually. After the WSSD a number of partnership initiatives were launched. The Netherlands launched a partnership to improve market access. The focus was on improving food quality standards, and a number of countries showed interest, among them Indonesia, Malaysia, Vietnam, Uganda, Tanzania and Zambia. As a first step, the Netherlands asked these countries to identify a few products or product groups that they thought would benefit from such a project. It was no surprise that shrimps were mentioned by both Indonesia and Malaysia.

The initiative for a Partnership on Market Access with Indonesia and Malaysia was officially launched at the Partnership Workshop for Shrimp Safeguarding, held from 6 to 8 October 2003 in Surabaya, Indonesia. A Partnership project on shrimp and fish production in Vietnam was launched this summer.

The Surabaya Workshop concluded with a targeted Action Plan to enhance food safety, sustainability and environment standards in the production and export of shrimp products. Participants underlined the vital importance of market access for developing countries. A similar Workshop was held in Vietnam, in Ho Chi Minh City, in July 2004.

The Partnership for Shrimp Product Safeguarding

The tripartite Partnerships aim to reach common objectives in a particular field of interest. In the Partnership for Shrimp Production Safeguarding the governments, private partners and civil society organisations of the Netherlands, Indonesia and Malaysia work together to improve market access for shrimps from Indonesia and Malaysia to the Netherlands/EU and to contribute to sustainable development and poverty alleviation. Market access is enhanced by capacity building in the field of quality and safety. The products should meet quality standards related to health, the environment and sanitary and phytosanitary matters. Meeting quality and safety standards implies an approach that addresses the whole food chain or sector, from cultivation, production, transport, storage and processing of shrimps, to exporting them.

Implementation of the project

Most partnership projects run over a three-year period. The shrimp partnership projects in Malaysia and Indonesia were launched in 2003 and will reach the end in 2006. The Partnership with Vietnam started only recently. The project's activities are aimed at policy development, strengthening quality control systems and production/marketing development. By now the public and private partners involved and their wishes and obligations have been established. Once this is done, the problems can be identified, possible solutions developed and technical assistance organised. If production methods are to be improved possible sources of contamination must be identified and eliminated. HACCP is introduced to prevent food safety risks and government inspection methods improved. The use of banned disinfection agents, antibiotics and pesticides should be looked into and the practice prohibited. Attention is paid to possible background contamination of prohibited substances in the environment and the legislation in place. Much is done in the field of education, training and extension to help companies find alternative, clean production methods. The need for sustainable production is stressed and small holders are given advice on ways to improve their methods of production.

Exporting countries should introduce pre-shipment controls to assess the quality of consignments leaving the country. Although pre-shipment controls cannot completely take away the risk of consignments being refused entry (inhomogeneity of consignment, sampling and testing methods used) they considerably reduce the risk of refusal. All consignments will be inspected on entering the EU.

On-going activities

In the partnership projects the following activities have been implemented or scheduled:

• Multi-stakeholder meetings with the identified partners: these are partners from Government, NGOs and private sector. This is very important to identify the problems and to find commitment for possible solutions. These meetings are complex and challenging as the interests of stakeholders are sometimes not easy to combine.

• Identification of problems and possible solutions in the framework of the project: in the projects there are financial constraints. It is important that stakeholders invest in the solutions also beyond the project budget

• Planning of activities

• Training courses on legislation and control: is residue legislation adequate and can this legislation be enforced. Are forbidden substances included in national legislation

• Training course on MRL problems and solutions

• Identification of laboratory capacity building needs (in preparation): this could be public laboratories or private accredited labs. Should cover both training and equipment needs

• Research of back ground values of forbidden substances (antibiotics) in the shrimp habitat (in preparation): are there enough data available, is field research necessary

• Research to alternative drugs to replace forbidden substances (in preparation): each country should look into the possibilities regarding alternative drugs. Some field tests should be included.

• Pilot region (in preparation): several tests, capacity building activities and experiments will be done in a specific region. This will include food safety improvements and activities in the field of environmental protection, water quality, small holder development.

II. What the EU can do to resolve the problems resulting from the zero-tolerance policy

In spite of the best efforts made by third countries it will probably be some time before third country products meet all EU requirements. To resolve current trade conflicts quickly a review of the EU food safety policy in place might be necessary. Obviously, food safety policy should guarantee the protection of consumer health but the policy must not lead to disproportionate trade barriers. EU food safety regulations might be to strict particularly those covering substances without a European authorization but which are allowed to be used as veterinary medicinal products in other parts of the world.

By the end of 2003 the European Commission published its Reflection Paper on Residues in foodstuffs of animal origin and asked Member States to come up with suggestions to determine new means to balance consumer protection, animal health, welfare and trade requirements through a more consistent approach to risk analysis and control.

The Commission stated the following goals:

• Trade problems need to be resolved (between Member States and between the EU and third countries).

• Risk management needs to be well balanced (not just risk assessment but also consideration of the ALARA principle).

• A more flexible strategy needs to be developed for the residue control at companies (farms), slaughterhouses and imports.

Suggestions from the Netherlands to this paper include the following:

Suggestions for a short-term resolution of problems

At present the way a Member State checks for the presence of substances and imposes sanctions varies from one Member State to another. In view of the free movement of goods within the European Union it is important that these checks and the measures taken when the rules are breached should all be similar. The current variation in practice is confusing for third countries' exporters. The Netherlands therefore suggests that European policy on prohibited substances should be harmonised including the sanctions taken when countries are in breach.

A. Harmonised controls on residues of prohibited or unauthorised substances

In May 2004 the Netherlands put forward proposals, which are reflected in the Commission's plan on Required Performance Levels submitted recently. The Commission proposes that all Member States use the same required performance limits (RPL) when sampling for the presence of certain prohibited or unauthorised substances. RPL's correspond to the average limits above which the detection of a substance or its residues can be construed as methodologically meaningful.

· In my opinion in the establishment of RPLs a distinction should be made between:

o A. Substances expressly prohibited

o B. Other substances (in particular substances not authorized in the European Community but which are allowed to be used as veterinary medicinal products in other parts of the world.

· I think that the RPLs for group A should be lower than for the second group B.

· I believe that we should continue to strive for the establishment of internationally recognised ADI/MRLs for these other substances. It is the only way to properly assess the possible risk they pose to public health.

B. I would like a harmonised system for sanctions on finding residues of prohibited or unauthorised substances

· When residues of these substances exceed RPLs EU Member States can either destroy the consignment or, under certain conditions, return it to the country of origin.

· When from one country residues of these substances are repeatedly found below the RPL this country will receive an official warning and the request to improve the control of its production and marketing chain. The EU might also step up inspection frequency of products coming from the country in question. If the country does not improve the EU may refuse entry of products from this country till they have improved their production and control system.

I would like to stress that the use of prohibited substances should be forbidden as this poses a risk to public health. I believe the EU should strongly discourage the use of such substances in third countries by encouraging proper legislation, watertight controls and sound communication.

Suggestions for a long-term resolution of current trade problems:

An effort should be made to establish globally recognised ADI/MRLs for as many veterinary medicinal products as possible.

· Worldwide harmonisation of ADI/MRLs

o To reduce the number of substances without globally recognised ADI/MRLs, globally accepted (Codex) MRLs should be established.

o The EU Commission could try to find out how to transpose current MRLs established by the EU into CODEX MRLs. The EU could also try to find a way to establish new EU MRLs on the basis of Codex standards.