Regulatory models

Introduction This paper provides an explanation of the food safety Regulatory Model (the Model) as it operates at the present time, a decade on from its introduction in the late 1990s. The paper outlines: ? the participants in the Model and their roles and responsibilities; ? the basis for the development of the Model; ? the benefits that the Model delivers; and ? the issues that impact on the Model, now that it has made the transition from being a theoretical concept to a structure that has been tested in operation. Many of these issues have arisen as a result of the realities of the structure and size of the New Zealand food industry. The paper addresses how the Model has needed to evolve to accommodate these issues. The paper amasses information about how the Model has been put into practice both in the past and currently. It aims to facilitate understanding of the Model and to provide a context for any discussion and consultation that may occur in the future about the roles and responsibilities of the participants in the Model. The Model emerged from the work of the Independent Scoping Review Team, which was established in 1996 to review the Quality Management division of the then Ministry of Agriculture and Forestry. The Model built on developments which had occurred in prior years, such as the adoption by the food industry of self-regulating quality control assurance measures, often based on HACCP methodologies; and a corresponding reduced reliance on prescriptive end-point inspections by government officials. In 2007, the New Zealand Food Safety Authority (NZFSA) initiated an internal qualitative review (the Review) of the Model. The Review was undertaken in the context of the work being undertaken to develop the proposed new domestic food regime and took into account the results of consultation with industry on the Domestic Food Review. The objective of the Review of the Model was to examine how, during its ten years in operation, the Model had translated from theory into practice. NZFSA was concerned to determine whether the Model remains an effective and appropriate tool, including for the new domestic food regime. The Regulatory Model: An Explanation NZFSA Public Information Paper April 2008 4 The Review concluded that the Model remains of central relevance to the overall food safety risk management framework. The principles of the Model are now incorporated into New Zealand’s food safety legislation, such as the Animal Products Act 1999 (APA) and the Wine Act 2003. However, the lessons learnt from putting the Model into practice have encouraged some refinements to be made to the roles of the participants in the Model. These refinements essentially represent alterations in approach and interpretation, rather than wholesale change, and are in accordance with both the needs of New Zealand industry and good regulatory practice. An example includes the Model now needing to accommodate more than one type of regulator (NZFSA and Territorial Authorities for instance). NZFSA concludes that the Model is a living structure which may continue to evolve. It is expected that, from time to time, there may be further debate and as appropriate consultation about the need for the roles and responsibilities of participants in the Model to adjust to reflect developments in the New Zealand food industry. The Regulatory Model: An Explanation NZFSA Public Information Paper April 2008 5 2 A description of the Regulatory Model 2.1 The Structure of the Model The New Zealand Food Safety Regulatory Model 2.2 The Participants in the Model The Regulatory Model consists of three participants: the regulator, the verifier and the industry operator. Each participant is represented by a tier in the Model. The three participants assume complementary roles and responsibilities which, when combined, enable the Regulatory Model to function as a robust and effective tool to protect and enhance New Zealand’s position as a trusted supplier of safe, “fit for purpose” and truthfully labelled food for domestic and international consumers. The Model will be consistently applied across all sectors of the food industry, regardless of whether products are sold domestically or exported. The Model is relevant to products which pose both lower and higher risks to public health. The key roles and responsibilities of the three participants in the Model, as it operates at the present time, can be defined as follows: The Regulatory Model: An Explanation NZFSA Public Information Paper April 2008 6 2.2.1 The Regulator ? Audits and monitors the overall food safety system for effectiveness and efficiency. ? Develops, negotiates and sets standards (including technical and operational standards for domestic requirements; generic export standards and specific standards relating to bilateral trade access agreements; and international standards, such as those set by the Codex Alimentarius Commission (Codex)). ? Provides official assurances, including export certificates, where these are required as a condition of overseas market access. ? Provides technical input and policy input to laws and regulations. ? Defines competency criteria for, and approves or recognises, the verifier. Also approves, recognises or appoints other essential components in the food safety system, such as laboratories. May work closely with accreditation bodies (the International Accreditation New Zealand (IANZ) and the Joint Accreditation System of Australia and New Zealand (JAS-ANZ))1 in assessing conformance with competency criteria. ? Monitors and audits the performance of the verifier. ? May provide advice, and promote or foster initiatives, related to increasing the capability of the verifier. (An example could be the regulator running calibration or information workshops for verifiers). ? Develops resources that may assist the industry operator to develop and to implement risk based management plans2 . (Resources can include off-the-peg plans, templates for plans, codes of practice and other guidance material). ? Approves and registers risk based management programmes adopted by the industry operator. 1 For further information, refer Appendix 1: Glossary of Terms. 2 The term risk based management programmes takes a wide meaning in this paper and includes all types of risk based management programmes falling under the various legislation which NZFSA administers. These include RMPs (Risk Management Programmes) under the Animal Products Act 1999, FSPs (Food Safety Programmes) under the Food Act 1981 and FCPs (Food Control Plans) which will be established under the proposed new Food Act. The Regulatory Model: An Explanation NZFSA Public Information Paper April 2008 7 ? Ensures compliance costs for industry are minimised, by setting standards and other requirements that are commensurate with the risk(s) and robust enough to deliver the appropriate level of control. ? Undertakes compliance, surveillance and enforcement roles to remedy non-compliance issues. ? Responds to food emergencies and recalls. 2.2.1.1 More than one type of regulator There can be more than one type of regulator. For example, whilst NZFSA is the central government agency with overall management responsibility for the food safety system, Territorial Authorities also undertake regulatory functions within the domestic food sector. 2.2.1.2 The relationship between the regulator and the verifier The three-tier Model recognises that regulation and verification are closely related. Following on from this, a regulator can act as a verifier. For example, the NZFSA Verification Agency (the VA) provides verification and related services to a number of New Zealand food sectors. Indeed in some cases, the VA is the only supplier of verification services, either due to the mandatory requirements of overseas markets or the absence of any other approved or recognised verifier. The VA operates under statutory authority to the NZFSA Chief Executive and is a business group within NZFSA (although there is a significant degree of organisational separation between the VA and the other groups with NZFSA). Likewise, under the proposed new Food Act (if agreed by Parliament), Territorial Authorities will act as both regulators and verifiers. However, where a single entity fulfils the role of both a regulator and verifier, it is essential that robust principles and procedures are in place to ensure adequate separation between the regulatory and verification roles.