6. Regulatory framework at the national and regional level

Introduction

The workshop noted that one responsibility of a national government is to provide for appropriate public and animal health protection by approving safe and effective veterinary drugs for use in food producing animals and enforcing other provisions regarding food safety. Incumbent in this regulatory framework is the responsibility of managing veterinary drugs without an ADI or MRLs to protect consumers and minimise disruption of international trade.

The workshop identified seven elements that were appropriate for either developed or developing country regulatory frameworks. Overlying the development of a regulatory system should begin with an appropriate definition of a government's policy regarding its public health objectives (e.g., its appropriate level of protection) applying appropriate science-based measures. Secondly, legislation, regulations and guidance documents should be provided on how to put the regulatory framework in place. The third essential element is to establish and maintain adequate technical resources for conducting food safety assessments and developing national regulatory standards for residues of veterinary drugs in food. To determine compliance with MRLs and provide assurance to consumers of the safety of food animal products, risk based residue control programmes are required. In addition, regulatory authorities need to have effective surveillance and compliance programs for pharmacovigilance and enforcement of national and/or international residue limits. To facilitate residue control programmes for food of animal origin, effective analytical methods are required. Finally, adequate data and information systems are critical for the assimilation and dissemination of information regarding national and international standards for residues of veterinary drugs.

Status quo

The workshop noted that the regulatory framework differs significantly between countries. Whilst some countries have a fully developed system, in others the use of veterinary drugs without an ADI/MRL is not adequately controlled and there is a very poorly developed food safety infrastructure with little experience in the effective control of veterinary drugs throughout the food production chain. Some countries may lack effective legislation (on the registration, distribution, use, etc, of veterinary medicines) and/or the means of implementing their legislation as a result of insufficient resources, knowledge & technical expertise. Other countries have a rapidly developing infrastructure and have most of the basic systems identified above, but lack specific technical expertise, for example, on analytical method validation.

Generally, developing countries seek assistance for their regulatory frameworks by looking to Codex to incorporate food safety standards into their regulatory frame work, including national legislation

Regulatory framework weaknesses

The workshop was aware that several factors may exist that could result in some deficiencies among member countries contributing to the absence of one or more elements of a comprehensive regulatory framework, particularly in developing countries. Contributory factors include:

• Lack of priority for a government commitment to national policy

• Some countries give a low priority to implementation of their food safety measures

• Inadequate resources to formulate and implement national food safety programs

• Lack of co-ordination amongst relevant stakeholders

• Stakeholders are not always involved in the formulation and implementation of food safety programs

• Insufficient numbers of veterinary drugs have Codex MRLs that could be adopted by governments as national MRLs

• There is inadequate enforcement of measures to ensure the prudent use of veterinary drugs, especially at farm level.

The workshop was able to identify measures and actions to facilitate improvements in national regulatory programmes. These include:

• Increasing awareness and commitment of policy makers at national level to improve public health protection and promote international trade.

• Designing capacity building to meet specific national needs.

• Encouraging stakeholder involvement in the formulation and implementation of the food safety programs by national governments.

• Improving co-ordination and communication amongst competent authorities with responsibilities on food safety programs.

• Implementation of mentoring programs with countries having comprehensive food safety programs.

• Improving control on the use of veterinary drugs especially at the farm level.

Factors for improvement in food safety programs, particularly in developing countries

The workshop considered that there are promising factors that may facilitate improvements in food safety programmes, particularly in developing countries. These include the following:

• Market access and economic factors

• Consumer demand for safer food

• Export market access has increased the demand/need to produce safer and higher quality food

• The need to end disruption in international trade/markets

• The willingness to pay attention to substances without an ADI or MRL

• Paying attention to their obligation to review and update their food safety regulations to be science-based to comply with the WTO/SPS Agreement. Measures indicated above will facilitate meeting their commitments to the WTO/SPS agreement.

• Developing countries are not receiving full benefit of the provisions of the SPS Agreement regarding technical assistance^[2].