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Domestic Food Review - Policy and Related Implementation Position Paper

4 Overview of New Food Regulatory Regime

All food businesses will be required to comply with provisions of the new food regulatory regime. This section provides a description of the key elements of the new food regulatory regime that will be administered by NZFSA and Territorial Authorities.

4.1 The new food regulatory regime

The new system of food regulation comprises three key players (as it does now):

• the regulator, across three levels of government – NZFSA, the Public Health Units of District Health Boards operating under contract to NZFSA, and Territorial Authorities;

• the verifier – any agency recognised to undertake external verification (currently audit or inspection) activities, including the NZFSA’s Verification Agency and Territorial Authorities; and

• food businesses – all food producers, processors and handlers, transporters, sellers and importers.

NZFSA is the principal regulator responsible for food control in New Zealand and for ensuring that the overall food regulatory regime is effective.

4.2 Which food businesses are affected by the new food regulatory regime?

Under the new regime, food businesses will be required to register a Food Control Plan, and/or will be subject to a National Programme, or are to operate under Food Handler Guidance; unless they are operating under the Animal Products Act or the Wine Act. The current exemptions from registration provided by regulation 4(4) of the Food Hygiene Regulations 1974 will cease and some other food businesses will become covered by the definition of a food business in the proposed Food Act (for example food transporters and distributors). This means those food businesses will come under the new food regulatory regime when their sector(s) transition.

Food exporters

Food that is produced or processed and handled in New Zealand for export will be required to meet the safety and suitability requirements of the domestic food regulatory regime. Exporters may receive exemption from certain requirements of New Zealand Food Standards and/or the Joint Food Standards Code, as determined on a class or classes basis by NZFSA. All such food must be exported. Any that is not exported will be required to comply with the new food regulatory regime. The setting of export requirements and the issuance of official assurances were excluded from the Domestic Food Review, except that the proposed Food Act will make provision for the Chief Executive of NZFSA to issue statements as to compliance with New Zealand standards of food that is produced or processed and handled in New Zealand for export.

Food importers

All food imports will be subject to the clearance requirements of the proposed Food Act. In addition, all food businesses that import food or food products (which include import agents) for commercial purposes must meet regulatory requirements specific to their import activities. Within six months of commencement of the proposed Food Act each commercial food importer will be required to register as an authorised importer.

NZFSA will specify categories of imported foods and the requirements that apply to those categories for the purposes of determining which food importers require a Food Control Plan, which are to operate under a National Programme, and for the administration of food clearances.

Importers of only low regulatory interest foods, which will be specified by NZFSA, will not be required to prepare a Food Control Plan for their food imports. Instead, a National Programme (Imported Food) encompassing generic standards for imported food will be developed by NZFSA and applied to these foods.

Within 12 months of commencement of the proposed Food Act, importers of medium or high regulatory interest foods will be required to register a Food Control Plan (Imported Food). NZFSA will develop a model that food businesses may use to complete their Food Control Plan (Imported Food). The model can be tailored to the activities of the business and the types of food imported.

To facilitate a smooth transition from the existing to the new imported food regime, relevant existing food import standards will be carried forward during the transition period, and some will be reviewed.

Food importers who have domestic food operations will be required to also comply with the regulatory requirements for their domestic food sector(s). Progressively, and well in advance of the end of the transition period, NZFSA intends to have developed rationalised processes that offer those food businesses the choice of registering one Food Control Plan covering all of their operations generally (except for those covered by a National Programme).

4.3 What will food businesses be required to do?

Sectors are intended to migrate to the new food regime in stages over a five-year transition period, which will start six months after the proposed Food Act’s commencement date. Higher-risk sectors will generally adopt the new regime first (see Tables 3.1 to 3.5).

The Government has decided that under the new Food Act each food business will be required to use one or more tools to ensure the safety and suitability of food. The tools are:

• Off-the-peg Food Control Plans: NZFSA will develop and make freely available off-the-peg Food Control Plans where this is the most efficient option because of commonality among products and processes across a significant number of food producers. Off-the-peg Plans will be developed according to the timetable set out in Tables 3.1 to 3.5 in this Paper. NZFSA is endeavouring to develop off-the-peg Plans that will be easily understood, simple and quick to complete.

• Custom-made Food Control Plans: A custom-made Food Control Plan is created by a food business for its operations. It may be developed from scratch, or may be adapted from one or more off-the-peg Food Control Plan models. An example of a custom-made Food Control Plan is one that includes unique or private practices, which will remain confidential to the food business, but will be seen by the regulator and external verifier. A custom-made Food Control Plan is one that is significantly different from of NZFSA’s freely available, sector specific off-the-peg Food Control Plans. NZFSA is currently developing what ‘significantly different’ in this context means. In any case a custom-made Food Control Plan must contain all the necessary Food Control Plan components. Food businesses will incur the cost of the preparation and, if required, of evaluation of the custom-made components of their Food Control Plan.

• National Programmes: These will be developed by NZFSA in conjunction with an organisation representing the sector (where applicable) to control some or all food safety and/or suitability issues across all or part of a particular sector, or in a particular part of the food chain (food businesses could still be required to have a Food Control Plan to address any food safety and suitability issues in their food operation that are not dealt with by the National Programme).

Further detail of what food businesses will be required to do is contained in section 3, ‘Transition Implementation’.

Food businesses that fall within the listings provided in Appendix 2 (other than those that already operate under a Food Safety Programme or the Food Hygiene Regulations) generally will not need to operate under a Food Control Plan, a National Programme or Food Handler Guidance because they are covered by other food legislation. These businesses, depending on their activities, will still be subject to the general provisions of the proposed Food Act, which will require compliance with the joint Food Standards Code and New Zealand-only standards.

Food activities that meet criteria specified in Appendix 3 do not need to operate under a Food Control Plan or a National Programme. Those undertaking such activities are still required to meet food standards because operators are still responsible for providing safe and suitable food under the proposed Food Act. To assist them to achieve this, Food Handler Guidance (an educational tool) will be available from Territorial Authorities.

4.4 Evaluation of Food Control Plans

Evaluation is the initial assessment of whether a custom-made Food Control Plan:

• meets the regulatory requirements

• is appropriate to the business

• covers the scope of the business

• is technically sound

• will deliver food that is safe and suitable.

The evaluation principles are as follows:

• off-the-peg Food Control Plans will be NZFSA-approved prior to issue, so Plans fully based on these will not require evaluation

• a custom-made Food Control Plan (whether derived from an off-the-peg Food Control Plan or not) must be evaluated prior to registration unless the regulator approves alternative arrangements

• ‘significant variations’ to an off-the-peg Food Control Plan, which include assessment of the impact of the variations on the overall Food Control Plan, are likely to require evaluation. Variations that are not ‘significant’ would not require evaluation. The details of ‘significant variations’ are being developed and will be advised when complete.

In developing the evaluation process and procedures NZFSA is drawing on experience with evaluation of risk-based management plans which fall under other legislation that it administers and is seeking to minimise the compliance costs faced by food businesses. Where evaluation is required, the evaluator will issue an evaluation report based on guidance provided by NZFSA. This report is to be submitted with the application for registration to assist assessment of the application. NZFSA may request a copy of some or all of the custom-made Food Control Plan. The food business pays for evaluation.

NZFSA intends that appropriately skilled evaluators be recognised by NZFSA at least nine months before the registration deadline of the relevant food sector. The competencies required for Food Control Plan evaluators will be the same as Food Control Plan external verifiers. NZFSA is developing a new standard for external verification and evaluation consisting of the key elements of ISO 17020 plus additional criteria required by NZFSA. Recognition by NZFSA will be dependent on evaluators achieving accreditation to this standard or meeting transitional requirements.

Recognised evaluators will include some staff of the NZFSA Verification Agency, and may include staff from Public Health Units or Territorial Authorities, auditors of Food Safety Programmes and private agencies or persons (third party agencies).

In recognising evaluators, NZFSA will:

• list the specific activities and functions or food sectors for which each evaluator is recognised

• include a renewal or expiry date

• have procedures for suspension, surrender or revocation of recognition (along with appropriate appeal processes)

• require evaluators to demonstrate that they meet requirements for ongoing recognition (including maintaining competence).

4.5 Food Control Plan registration process – off-the-peg and custom-made

Off-the-peg Food Control Plan

Off-the-peg Food Control Plans and guidance material will be freely available to food businesses directly from Territorial Authorities and through NZFSA. These documents will be available at least nine months prior to the registration deadline for each food sector. The local Territorial Authority will be the ‘shop front’ for most food businesses particularly those using off-the-peg Food Control Plans. Those businesses with an existing Risk Management Programme, Wine Standards Management Plan or Food Safety Programme registered with NZFSA or operating under a Regulated Control Scheme can continue to communicate directly with NZFSA.

It is the responsibility of each food business to approach the Territorial Authority to obtain the necessary Food Control Plan material and guidance. All applicable parts of an off-the-peg Food Control Plan are to be completed in full by each food business. The Plans and guidance material will include an application for Food Control Plan registration. The properly completed application form of the off-the-peg Food Control Plan, together with the registration fee set by the Territorial Authority must be submitted to the Territorial Authority for registration by the notified date - at least three months before the notified registration deadline.

An off-the-peg Food Control Plan covering premises located beyond the jurisdiction boundary of a single Territorial Authority (that is, operating in two or more Territorial Authorities) will be registered by NZFSA. There are exceptions however.

Mobile operators, must choose their ‘home base’ Territorial Authority in which to register. As well, food businesses that operate a number of premises will have the choice of registering separate off-the-peg Food Control Plans either for all premises within each Territorial Authority or for each individual premise. In these two circumstances the Territorial Authority may register the Food Control Plan(s).

For existing businesses that register an off-the-peg Food Control Plan the Territorial Authority (or other verifier) may perform the initial verification at any time during the first six months after the registration date of that Plan.

Diagram 2.1: Off-the-peg Food Control Plan Registration Process during Transition

Custom-made Food Control Plans

This section describes aspects of the custom-made Food Control Plan registration process that differ from those for an off-the-peg Plan. In general, NZFSA will register custom-made Food Control Plans although some Territorial Authorities, if fully accredited and competent, may be eligible to do so. For the purposes of this section, only NZFSA is referred to for registration.

Guidance material for preparing a custom-made Food Control Plan will be freely available from NZFSA and Territorial Authorities.

If NZFSA advises that a custom-made Food Control Plan does not need to be evaluated before the food business applies for registration of that plan, some or all of that custom-made Food Control Plan may need to be submitted to NZFSA with the application form.

Custom-made Food Control Plans will be assessed and registered by NZFSA. When an application for registration of a custom-made Food control Plan is lodged with a Territorial Authority, the Territorial Authority will check to ensure the required documents have been supplied and the registration fee is included before sending the application on to NZFSA.

For existing businesses that register a custom-made Food Control Plan, the external verifier may perform the initial verification at any time during the first 12 months after the registration date of that Plan. For example, a custom-made Food Control Plan that has undergone an on-site evaluation before registration with no issues of concern raised, may not require verification for another 12 months.

NZFSA would expect nearly all new food businesses with a custom-made Food Control Plan to receive an on-site evaluation before commencing operations. The timing of the initial verification would depend on the risks associated with the operations, including the assessment of the evaluator, when applicable.

Diagram 2.2: Custom-made Food Control Plan Registration Process during Transition

General

Territorial Authorities and NZFSA (as the case may be) will have a period of three months between the application lodgement deadline and the registration deadline to assess applications and register Food Control Plans. The registering authority may request additional information from the operator. The registration assessment process is needed to check that the:

• application form for registration of the Food Control Plan contains all of the information needed

• Food Control Plan is appropriate to the operations of the food business

• Food Control Plan (custom-made only) contains all the components and information needed

• holder of the Food Control Plan (known as the ‘’operator’‘ and usually the business owner) is a ‘fit and proper person’ (such as, having no relevant criminal convictions).

In most cases a Territorial Authority will assess applications for off-the-peg Food Control Plans while NZFSA will assess applications for custom-made Food Control Plans.

Food Control Plan registrations will be time-limited and non-transferable. A Food Control Plan will, in most cases, require annual renewal of registration, as is generally the case under the Food Hygiene Regulations 1974. Renewal of the registration or re-registration is expected to be a straight forward administrative process but this will depend on the most recent verification report determining that the food business is continuing to provide food that is safe and suitable.

An operator may apply for registration of their Food Control Plan at any time after the Food Control Plan material is published up to the application lodgement deadline (six months).

Food businesses will be encouraged to lodge applications for registration of Food Control Plans with their Territorial Authority, which will determine the appropriate party to assess the application.

After the registration deadline for a food sector has passed, food businesses in that sector without Food Control Plans cannot operate without first registering a Food Control Plan. Selling food from a food business that should have a registered Food Control Plan but is operating without one will carry significant penalties under the proposed Food Act.

The proposed Food Act provides flexibility for the management of the transition of sectors and will enable NZFSA to issue notices to:

• specify the registration cycle to apply to a food sector or classes of food businesses within a sector

• inform food sectors or classes of food businesses of their process, timeline and deadline for registration of a Food Control Plan or for complying with a National Programme.

Throughout the transition and thereafter the regulator – NZFSA and Territorial Authorities – will be required to maintain registration databases of food businesses registered under the ‘old’ and ‘new’ regulatory regimes. This could be done as simply as adding a ‘flag’ to entries in the existing registration database to denote whether a food business is under the ‘old’ or the ‘new’ regime. Alternatively, the regulator might choose to invest in a new system. In developing information technology requirements, NZFSA will work closely with representatives from Territorial Authorities.

NZFSA, Public Health Units and Territorial Authorities recognise the importance of information capture and access to such information across all regulators. NZFSA will be working with Public Health Units and Territorial Authorities to ensure there are public registers of commercial importers, food businesses with registered Food Control Plans, and recognised agencies and persons.

4.6 Food Control Plans require external verification

External verification will involve a physical inspection of the premises, a review of all components of the Food Control Plan, scrutiny of records and enquiry of staff as necessary. It will check that the Food Control Plan continues to meet regulatory requirements, is being followed, is appropriate to what the food business does, and the food business is managing and minimising food hazards adequately. The external verifier will complete a simple report to the food business and update the registration authority following each verification visit and, when appropriate, will initiate action to remedy non-compliance based on guidance material issued by NZFSA.

Verifications will be performed by persons recognised by NZFSA as competent to undertake the verification, and employed by a recognised third-party agency or Territorial Authority. They also could be performed by NZFSA’s Verification Agency but generally this would be as provider of last resort. Transitional arrangements are required to enable verification to be performed at the outset of implementing the new regime while giving verifiers/verification agencies adequate time to achieve the standard required. Such transitional arrangements are likely to apply to most, if not all, existing Environmental Health Officers currently undertaking food-related activities and Food Safety Auditors.

Territorial Authorities will primarily perform verification of registered off-the-peg Food Control Plans for food retail and food service businesses whose premises are located exclusively within one Territorial Authority. Territorial Authorities will have exclusive external verification of such off-the-peg Food Control Plans, except for those businesses with an existing external verifier or auditor of food safety, for example, rest homes. To do this level of verification Territorial Authorities will have a graduated programme for meeting the new verification agency standard in full by the end of the transition period. Some Territorial Authorities contract out their current inspection of premises. Inspection is to be replaced by verification (of a limited kind) from the start of transition. Territorial Authorities may contract out verification of food businesses from the outset. All such contracted out roles must be to an agency (or agencies) or person(s) recognised by NZFSA.

Food businesses with Food Control Plans that do not meet the criteria for exclusive verification by the local Territorial Authority must nominate an NZFSA recognised third-party verifier. In these circumstances, they may only nominate a Territorial Authority if it is an agency recognised by NZFSA as meeting the new accreditation standard in full. Where such a registered Food Control Plan covers more than one premise, the food business may, if it wishes, choose a separate recognised verifier for each premise.

Generally, Food Control Plans will be required to be verified annually. However, this frequency and intensity may increase or decrease depending on the risk and complexity of the specific activities, and the history of compliance of the business with that Food Control Plan. Verification costs will be paid for by the food business just as inspection costs are now. While NZFSA will give guidance on fees to Territorial Authorities and industry, the verifier can set their fees to cover actual and reasonable costs (and for private sector verifiers, to earn a profit).

NZFSA will recognise external verifiers for each sector by the time food businesses in that sector might start to register Food Control Plans (as outlined in Diagrams 2.1 and 2.2 and in Tables 3.1 to 3.5).

Organisations and individuals wishing to be recognised by NZFSA as third-party verifiers will be subject to the following accreditation and recognition requirements from commencement of the transition of each applicable food sector:

• meeting a standard under development by NZFSA that incorporates all the key elements of ISO 17020 and specific criteria set by NZFSA (a consultation document will be issued), and assessed by an accreditation agency

• demonstrating that the personnel in an organisation have relevant technical competency

• meet requirements for independence, confidentiality, and management of potential conflicts of interest

• passing a ‘fit and proper person’ test (such as having no relevant criminal convictions).

In recognising verifiers, NZFSA will:

• list the specific activities and functions or food sectors for which a verifier is recognised

• include a renewal or expiry date

• require verifiers to demonstrate that they meet requirements for ongoing recognition (including maintaining competence)

• have procedures for suspension, surrender or revocation of recognition.

NZFSA will also provide guidance material and workshops for verifiers to ensure they are aware of their role and responsibilities and with a view to enhancing national consistency of application.

4.7 National Programme Implementation Process

The process for each National Programme will be tailored to each sector or group of businesses to which it applies. As for a Food Control Plan, after the implementation deadline for a National Programme has passed food businesses with related operations must have adopted the requirements of the National Programme.

4.8 Education and competency requirements

NZFSA has identified the need for a coordinated approach to achieving competencies during the implementation process. Competency requirements will be identified and developed with training providers, the food industry and in parallel with the development of the sector specific tools, if appropriate.

The new food regulatory regime will provide for competency requirements for:

• some individuals subject to Food Control Plans and National Programmes

• those food businesses performing certain activities

• verifiers, evaluators and Food Act officers.

The focus will be on establishing competency requirements that must be met or demonstrated, not the prescription of training.

Training to meet the requirements of Food Control Plans and National Programmes will be the responsibility of individual businesses, likely with the support of an industry training organisation.

4.9 Review of the Food Regulations

The Food Hygiene Regulations 1974 and the Food (Safety) Regulations 2002 are to be revoked. These regulations will be replaced by new regulations made solely under the proposed Food Act. The new regulations will include outcome standards representing good operating practice. The outcome standards and associated requirements will apply to all food businesses and will relate to ensuring that food is safe and suitable for its intended purpose.

A transitional registration process for premises operating under the current food regulatory regime will be provided for along with any associated implementation requirements until these food businesses are required to move into the new regime. It is intended that the bulk of Schedule 1 of the Food Hygiene Regulations be carried over for the transition period to ease transition. Provisions for food businesses currently exempt, partially exempt or omitted from the Food Hygiene Regulations 1974 will also be carried over. These current exemptions or omissions will cease to apply when food businesses are required to come under the new regulatory regime.

4.10 Roles and responsibilities

The principal parties described in this section to be involved in ensuring the safety and suitability of food are NZFSA (including roles carried out on its behalf by Public Health Units under contract), Territorial Authorities and food businesses.

Tables 2.1 and 2.2 summarise elements of the new regulatory regime that will be put in place by NZFSA and Territorial Authorities respectively to facilitate the transition policy. Territorial Authorities may choose whether to meet their responsibilities with their own staff or with the contracted services of other agencies or individuals recognised by NZFSA.

Table 2.1: NZFSA – Roles and Responsibilities (includes contracted roles of Public Health Units)

Regulations, standards and systems	Pre-requisites to commence Food Control Plan Registration in Year 1	Ongoing roles during five-year transition and thereafter
• Administer proposed Food Act • New Food Regulations and related standards and notices for domestic and imported food • Food Control Plan guidance material • Approvals and accreditation system • Compliance (systems audit): tools, procedures, incentives • Cost-Recovery standards and delivery mechanisms • Performance and monitoring system • Investigations policy and system • Enforcement policy • Incident-response system • Contracted roles of Public Health Units • Operational protocols with Territorial Authorities	• Food Control Plans: off-the-peg Food Control Plans, Food Control Plan guidance material, ‘fit and proper person’ test • Approvals and recognitions needed • A registration system • Operate registration system – existing and new in parallel • Evaluation (for sectors at start date): tools, training material; approved trainers of evaluators; recognise evaluators • Verification (for sectors at start date): tools; training material; approved trainers; recognise verifiers • Review and develop procedures and systems for investigations and enforcement • Revise systems for operational response and recalls • Preparation of generic Food Handler Guidance for sausage sizzles, bed & breakfast, school galas	• Food Control Plans (remaining sectors) • National Programmes; standards, notices and implementation tools • Approvals and recognitions • Operate registration system – existing and new in parallel • Evaluation (remaining sectors): tools, training material; approve trainers of evaluators; recognise evaluators • Verification (remaining sectors): tools; training material; approve trainers; recognise verifiers • Investigations: review and refine systems • Enforcement: standardise and refine sanction mechanisms • Operational response and recalls – review and refine systems • Food Handler Guidance (remaining categories)

Note: ‘Operational response’ relates to emergencies and cases of foodborne illnesses.

Table 2.2: Territorial Authority – Roles and Responsibilities

Regulations, standards and systems	Pre-requisites to commence Food Control Plan registration in Year 1	Ongoing roles during five-year transition and thereafter
• Ensure bylaws are aligned with the proposed Food Act and notices • System to meet pre-requisite and ongoing roles especially Food Control Plan registration and verification	• Preparation to be the ‘shop front’ for food businesses • Implement new registration system, if necessary • Operate registration system – existing and new in parallel • Education of food businesses and the public as necessary • Training of staff to carry out functions and activities under the new regime • Verification: of businesses both with and without off-the-peg Food Control Plans • Investigations: implement revised policy and system • Enforcement: implement new policy and system to enhance national consistency • Implement new system to deliver response and recalls • System to deliver Food Handler Guidance to relevant persons • Provision of advice and dissemination of information on food safety and suitability	• Involvement with National Programmes if appropriate • Operate registration system – existing and new in parallel • Education of food businesses and the public as necessary • Training of staff • Verification: continue verification of off –the-peg Food Control Plans as appropriate • Verifier of non-exclusive Food Control Plans an option • Perform investigations • Enforcement: standardise and refine sanction mechanisms and liaison with NZFSA • Apply new enforcement mechanisms • Perform operational response and recalls.

4.11 Responsibilities of food businesses

The principal role and responsibility of food businesses is to produce safe and suitable food. To demonstrate Good Operating Practice and fulfil this responsibility many food businesses will be required to register and implement a Food Control Plan.