EHJ August 2002, volume 110/08, pages 232-234 Does de-regulation really contribute to a steep increase in foodborne illness? Does the key to long-term food safety lie with education not legislation? Mike Orchard discusses the current mechanism in New Zealand for assuring food safety and debates whether this offers a better way forward for food hygiene than the current European approach

Over the years, the regulation of food safety in New Zealand has moved away from the traditional model, based on prescription and inspection, towards a risk management approach based on Hazard Analysis Critical Control Point (Haccp). New Zealand is not unique in this regard - Haccp is internationally acknowledged as the leading system for controlling food safety - but the country is pioneering a new path in its application of Haccp. Rather than following the route taken in Europe of incorporating Haccp principles within a modified set of hygiene regulations, New Zealand has implemented a system that is entirely focused on outcome, without reference to method, dispensing with the need for hygiene regulations altogether.¹

The risk-based regulatory model (see figure 1) in New Zealand is based on the Government acting as the regulator, the industry producing food that is "fit for purpose", using Haccp-based plans, and independent verification that the industry has abided by its plans. Instead of prescribing how, or even what, must be done, the risk-based regulatory model is outcome based. This enables businesses to be flexible in determining how best to produce food that both meets commercial objectives and achieves the outcome of being "fit for purpose".

Haccp-based plans require businesses to integrate food safety into the core of their management systems, rather than just being an ancillary process. Corrective actions for non-conformances are set out in the Haccp plan, while the regulator is able to intervene and apply sanctions where there are issues of public health significance.

In New Zealand, the new risk-based regulatory model is being applied across the food industry from growers, primary processors and manufacturers to retailers. However, the legislative mechanism used to introduce it has varied across industry sectors (animal products, dairy, retail etc). The harmonisation of its application across all sectors is one of the challenges now facing the newly established New Zealand Food Safety Authority (NZFSA).

At present, the domestic retail and processed food sector in New Zealand is in a voluntary transition period. This means that they can either comply with the food hygiene regulations and continue to be inspected by local authority EHOs, or they can implement a Haccp-based food safety programme (FSP) that will be audited by an approved third-party auditor under the new risk-based regulatory model (such businesses are exempt from the regulations and EHO inspection).

This voluntary interim period has provided a window to pilot and establish auditor and programme approval processes. However, it is intended to phase in a mandatory requirement for all food businesses to implement an approved FSP and thereby come under the new regulatory model.

Historically, as in the UK, food safety in New Zealand has been based on a model of prescription and inspection. However, if food safety is to be assured the conventional approach of enforcing prescriptive regulations cannot continue to be propagated (see table 1 below). In the risk-based regulatory model, the Government's role as a regulator is to set outcome standards, ensure a robust audit and approval process and apply sanctions where necessary.

The assessment of Haccp-based plans and their ongoing audit does not need to be undertaken by the regulator. Instead, these functions can be carried out by other agencies that meet specified competency criteria set by the regulator. This model enables the regulator to focus its attention on those businesses that are not performing adequately, to ensure remedial action is taken, rather than expending limited resources monitoring both the good and the bad.

The present system in New Zealand requires FSPs to be assessed for approval by health protection officers (HPOs), who act as agents of the NZFSA - the "regulator". Once approved, FSPs are subject to audit by a third-part auditor approved by the NZFSA but contracted by the company. Audit frequency is determined by risk. Auditors - who are not regulatory officers and hold no legislative powers - submit completed audit reports to HPOs within the district health boards (DHBs). If an auditor becomes aware that a critical control point is either absent or ineffective, thus causing a potential risk to public health, they must immediately inform the DHB.

The audit process has a number of distinct advantages over the old inspection regime (see table 2 above) and the New Zealand approach differs quite radically to that taken by European Directive 93/43/EEC. Despite the inclusion of a "hazard analysis" requirement in the directive, it seems that the principles of risk management have not been integrated into the core of all food businesses.² Rather, "hazard analysis" is viewed by many food businesses in the UK as a somewhat unnecessary peripheral issue; so they continue to focus on the "tangible" prescriptive requirements contained in the schedules. Enforcement officers are told to focus on risk, yet are unable to audit or effectively enforce "hazard analysis" due to the absence of a requirement that this crucial management system be documented.

The Pennington Report has since highlighted the importance of incorporating all seven principles into both the directive and regulation 4(3). But the question arises: If full Haccp is mandated what need is there for the prescription contained in the schedules and accompanying regulations? What value will they continue to add? Would it not be better to remove the prescription and focus both businesses and regulators on risk?

Arguably, the most complex challenges that face both countries involve moving small and less developed businesses (SLDBs) into a Haccp-based framework. Issues surrounding language, knowledge, educational ability, resources (time and money) etc all present potential hurdles that must be overcome.

In New Zealand, the businesses that are opting for FSPs are those that are well resourced and/or dedicated to the improvement of food safety. This is demonstrated by the fact that 78 per cent of approvals during the voluntary transition period have been made under a general agreement (generic multi-site company FSP) with 22 per cent being novel (one-off programmes).

• The NZFSA is working with the industry to develop "acceptable solutions" to provide SLDBs with the tools to assist with Haccp and options for controlling food safety hazards. Examples of resources include:
• template-based codes of practice;
• process specific (eg pie making) and process wide (eg sickness policy) "plug-in" modules that can be used to create a programme;
• providing guidance for the science behind CCP/CLs (eg cooking time/temp); and
• educational resources (videos, booklets etc).

The focus is on the outcome (ie food that is "fit for purpose") rather than the method. The templates must not be viewed as the only way of controlling hazards or they too will just become another set of prescriptive rules. There is a measure of similarity with the approach taken with the guidance provided in the UK's Industry Guides, however the Industry Guides fall short of providing template solutions for Haccp. However, even with template solutions many SLDBs still need hands-on help to make the transition to a Haccp mindset.

In New Zealand, that support comes at the cost of a consultant. EHO involvement is at best marginal, due in part to the uncertainty of their future role in food regulation. This is in contrast to the UK, where EHOs have increased their profile within the regulatory system.

The educative approach taken by EHOs to increase compliance with regulation 4(3) has been identified as a significant factor in the implementation of "hazard analysis."³ Indeed in the UK, the Food Standards Agency has identified "maximising the role of local authorities" as a key element of its strategy for the implementation of Haccp.⁴

Although the future role of EHOs in New Zealand's new regulatory model is under review, it is clear that there is considerable scope for their involvement and some have already taken the step of becoming approved as auditors. Those that make the transition will be ideally placed to assist SLDBs apply the template solutions being produced ("acceptable solutions").

The level of support that SLDBs need to implement Haccp will be a decisive factor in deciding whether a system without the "do's and don'ts" of prescriptive regulations is too idealistic. Experience so far has proven that Haccp-based FSPs can work in a variety of businesses. But the question remains: "Can such an approach work for all businesses, taking into account the hurdles faced?"

Traditionally the regulation of food safety in both the UK and New Zealand has for too long centred on facilitating the regulator to enforce food hygiene, rather than the outcome of businesses producing food that is "fit for purpose". Future food regulatory systems must enable and empower industry to take full-responsibility for producing food that is "fit for purpose". A true Haccp-based regulatory system will provide the framework to enable businesses to assure food safety. Such a system does not allow the regulator to hide behind the "thou shalt" of a regulation, but rather face the question "what is the risk?"

Mike Orchard trained in environmental health at Middlesex University and has worked as an EHO in both the UK and New Zealand. He presently works as an advisor (risk management) with the NZFSA. He is also on the Executive of the New Zealand Institute of Environmental Health. Contact: mike.orchard@nzfsa.govt.nz or mike.orchard@nzieh.org.nz

The views expressed in this article are those of the author and do not necessarily reflect those of his employer, or the New Zealand Institute of Environmental Health.

References

1. Note: the directive omitted two of the seven principles - documentation and verification.
2. Joint Lacots, REHIS, CIEH. Undated. Position on the implementation of Haccp in small and less developed businesses. London, CIEH.
3. Orchard, M.B. Hazard analysis: Are we getting the message across? Dissertation in part fulfilment of BSc(Hons). London: Middlesex University
4. FSA, 2002. Strategy for the wider implementation of Haccp. Agenda Item 4, 14 November 2001. London: Food Standards Agency.