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Domestic Food Review Summary of submissions: Papers 6 & 7

Submission Summary: Criteria and processes for various approvals (Paper 7)

Introduction

The purpose of Paper 7 was to establish whether or not an approvals system was justified as part of New Zealand’s food safety system, and if it was, to:

• identify the criteria that would be used to ensure that any required approvals were justified; and

• establish a framework for the legislative and administrative processes for such a system.

The regulator (in this case, primarily NZFSA) currently issues approvals for various aspects of food production and processing in New Zealand, but these requirements were characterised by a lack of legislative coherence and consistency. The paper examined the need for legislation to enable the regulator to approve compounds, documents, equipment, persons, premises and systems used in connection with the production and processing of food in New Zealand.

Public comment was sought on the principles for other approvals; the criteria for approvals; legislative processes for approvals; and the publication of approvals. An ‘approval’ was described as recognition by the regulator that the relevant compound, document, equipment, person, premises or system had met all regulatory requirements at the time of the approval.

The paper was divided into the following sections:

A. Scope: considered the criteria and processes needed to administer the regulator's approvals. The process for registering Food Control Plans and the recognition of persons or agencies who might evaluate and/or verify Food Control Plans were excluded from this paper as they were covered in Paper 4: Implementation of Food Control Plans. Additionally requirements for export approvals and matters associated with government staff (i.e. appointments, statutory powers or delegations) were also excluded.

B. Background: dealt with the need to extend consideration of the ideas and concepts discussed in Paper 4 (which dealt primarily with proposals around Food Control Plans) to a broader range of 'approvals'.

C. Are Approvals Necessary? Described the primary objective of approvals on safety and/or suitability grounds as ensuring that substances did not contaminate or generate unacceptable residues in food. Many reasons were put forward for using approvals as the preferred regulatory intervention to achieve the above objective, such as unique methodologies; standard methodologies; and costs.

D. Criteria for Approvals: presented general criteria that were proposed to govern all approvals and the approval system of compounds, documents, equipment, people, premises and system. Additionally the appendix contained specific information on laboratories.

E. Legislative Processes for Approvals: outlined the basic framework for an approvals procedure with specific detail on what was expected to be included was outlined. It also looked at a generic appeal and review process that was intended to be used where an approval was declined and at the publication of approvals.

F. Appendix: Proposed Treatment of Laboratories: described various laboratory testing regimes across the food sector, differences among the regimes analysed and a more consistent and harmonised approach for the future, based on the principles and criteria discussed in this paper was proposed.

Overview of submissions

Businesses of all sizes, industry organisations and government agencies, TAs and PHUs/District Health Boards were the main submitters on Paper 7 Criteria and processes for various approvals.

Forty-five written submissions commented on various sections of the various approvals paper. These comprised:

• 17 government bodies (including TAs and PHUs/District Health Boards)

• 13 academic/professional institutions

• 9 industry organisations

• 4 businesses

• 2 community groups, clubs, associations, not-for-profit organisations and schools.

Summary

Comment on the paper itself

Submitters generally supported the principles and criteria outlined in Paper 7 with some commenting that their comments on this paper should be considered alongside their submission on papers 1-5 of the Domestic Food Review. Submitter comments focused on the four principles that had been proposed in the paper to support the various approvals that would be required to ensure safe and suitable food was delivered to consumers.

A. Scope

Under the current regulatory systems administered primarily by NZFSA (including the associated Acts, regulations and standards) approvals had been required for compounds, documents, equipment, persons, premises and systems. Submitters were supportive of the scope of the paper.

B. Background

The background highlighted that there was currently no consistent approach to approvals and that the types of approvals and the justification of them were inconsistent. It also noted that there was a measure of unnecessary and inefficient duplication in databases and administrative systems. Submitter comment supported a nationally consistent approach to approvals and the avoidance of duplication of approval systems.

A submitter commented that it would have been useful to have specific examples of approvals for various stages of a food production to aid in determining if an approval system was justified.

Clutha District Council stated that in as much as the approvals discussed within this paper were for issues which were national in scale and outside the scope of current local government jurisdiction that the Council had no comments to make on the paper other than to recognise the need for such a system of approval with regard to goods and services that had a direct bearing on food hygiene.

Waikato District Health Board supported an approval system, which enhanced the safety and suitability of food in New Zealand while encouraging innovation, diversity and competition.

C. Are Approvals Necessary?

The primary objective of approvals on safety and/or suitability grounds was to ensure that substances did not contaminate or generate unacceptable residues in food. Two principles were discussed in paper 7:

Principle 1: The regulator should have the legal authority to require approvals of certain compounds, documents, equipment, persons, premises and systems:

• when justified according to specified criteria, including that the approval addresses an identified food safety or suitability risk and builds credibility and confidence in the food supply

• using administrative tools that ensure the approvals system is efficient and can be clearly understood.

Principle 2: The regulator should avoid unnecessary duplication of approval systems.

Submitters were supportive of the two principles and considered that a formal approval system was necessary, duplication of systems should be avoided, and compliance costs should be minimised. The criteria for approvals should be based on objective analysis of risk, taking into account sound science and the relevant costs and benefits.

Timaru District Council stated that given the scope of matters covered by the Domestic Food Review, the Council was of the view that a formalised approval system was appropriate. There needed to be a set process in place to cover the use of any thing in the food programme from a food safety programme itself to a certain type of dishwasher or auditor to audit the programme.

D. Criteria for Approvals

Three proposed criteria for approvals were discussed in Paper 7.

Criterion 1: The approval provides or improves credibility of and confidence in the food supply because one or more of the following apply:

• matters that relate directly to food safety and suitability

• standards can be more easily met because of the approval

• process checks (such as testing) are more comparable, reliable and defensible

• competence of persons performing critical activities clear

• industry standardisation results that relates directly to food safety or suitability

• consistency with international standards

• fosters continuous improvement.

Criterion 2: The approval improves efficiency because the relevant approval will be applied widely and/or consistency or standardisation will be increased.

Criterion 3: The approval is clear and delivers transparency because it ensures system accountability and/or improves industry understanding.

Submitters who commented on the criterion supported them.

E. Legislative Processes for Approvals

This section considered processes for approvals and the publication of approvals. It set out the basic framework for the approvals procedure, key elements for a generic appeal and review process, which would be available where an approval was declined and proposed that the regulator publicise approvals. The following two principles were proposed:

Principle 3: Approvals should be time-bound; may be subject to conditions; may be surrendered, suspended or withdrawn with proper cause; will be subject to cost-recovery; and decisions may be subject to review and appeal.

Principle 4: Regulator approval systems should be published (via a website) and enable the clear identification of what items have been approved by the regulator.

Submitters considered that the framework was appropriate, however, further discussion of cost recovery principles and mechanisms would need to be considered in more depth. Support for a web based approvals register was strong, but a few submitters felt that this would not provide universal coverage, such as in rural areas where the internet might be unavailable or difficult and costly to access.

New Zealand Pork Industry Board stated that at a general level the principles seemed an appropriate framework within which to consider the use of approvals. The Board pointed out that web-based publication of approvals would not generate universal coverage of food businesses.

F. Appendix: Proposed Treatment of Laboratories

The appendix described the various laboratory testing regimes across the food sector, analysed the differences among the regimes, and proposed a more consistent and harmonised approach for the future, based on the principles and criteria that were previously set out in the paper.

The few submitters who specifically commented on the appendix were generally supportive of the process outlined in the document. A submitter who commented on the six key elements noted that export activities would be managed differently to domestic requirements because of overseas market access requirements. The submitter agreed that ISO17025 was the best standard but did not support other elements such as a public register of approved laboratories as this was a duplication of what would be on the IANZ website.

Waikato District Health Board stated that currently, laboratory accreditation had been limited to those who wished to be accredited. It was a good idea to require approval of laboratories. However the Board advised of the need for care in relation to standards that would be accepted. It also needed to be determined which laboratories would need to be approved.

One submitter gave detailed comment on experiences conducting laboratory tests, stating that laboratory approval should only be applicable for routine test procedures where there was an appropriate and technically valid laboratory accreditation and individual competent analysts should not be excluded from approval of the above routine test procedures. The comments were based on specific incidents that had been seen during the last 12 years.