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Dairy Risk Management Programmes

April 2007

Animal Products Act 1999
Information Pamphlet

Background

The Animal Products Act 1999 (APA) requires all animal products that are traded to be “fit for intended purpose”. The main way of achieving this is through a Risk Management Programme (RMP). An RMP is a documented programme that identifies and manages hazards and other risk factors.

RMPs may be developed from scratch by businesses, or may be based on NZFSA-approved codes of practice, templates or models (where available). The RMP must address the animal materials and products used, the processes performed, and the product range produced.

This pamphlet covers RMPs for the processing of dairy materials and dairy products. For further information on RMPs involving the processing of other animal products, please refer to the NZFSA website Other Animal Products and the information pamphlet entitled Risk Management Programmes (Other than Dairy).

The legal framework for dairy RMPs

The key pieces of legislation relating to dairy RMPs are listed below. Refer to the NZFSA website for full details of any amendments to this legislation.

Acts

Animal Products Act 1999

Animal Products (Ancillary and Transitional Provisions) Amendment Act 1999

Regulations and Orders

Animal Products (Dairy) Regulations 2005

Animal Products (Dairy Industry Fees and Charges) Regulations 2005

Dairy Industry (IMA Certification) Regulations 2000

Dairy Industry (National Residue Monitoring Programme) Regulations 2002

Animal Products (Exemptions and Inclusions) Order 2000

New Zealand (Milk and Milk Products Processing) Food Standards 2002

Notices

Animal Products (Dairy Processing Specifications) Notice 2006

Animal Products (Dairy Recognised Agency and Recognised Persons Specifications) Notice 2005

Animal Products (Dairy Recognised Agency and Recognised Persons Specifications) Notice 2006

Animal Products (Dairy Risk Management Programme Specifications) Notice 2005

D203.1 Dairy IMA Certification (deemed specification)

D204.1 Quota Compliance Programmes (deemed specification)

Approved Criteria

DPC1: Approved Criteria for General Dairy Processing

DPC2: Approved Criteria for Farm Dairies

DPC3: Approved Criteria for the Manufacturing of Dairy Material and Products

DPC4: Approved Criteria for Storage and Transportation of Dairy Material and Products

Food Standards Code

The Food Standards Code applies to all foods produced or imported for sale in Australia and New Zealand. RMP operators must comply with the provisions of this Code. It contains standards for composition, labelling, substances added to food (e.g. additives and processing aids) and contaminants.

It should be noted that product for export (other than to Australia) is exempt from certain requirements of the Code under section 60B of the APA.

People/operations that need a dairy RMP:

• all farm dairy operators

• all operators in the chain from the farm to the point of export, including dairy manufacturers, stores and transporters unless exempt under section 9 of the APA, or if operating under a Food Safety Programme (New Zealand and Australian markets only)

• processors of dairy material or product intended for animal consumption that will be exported

• processors of technical grade products (E.G: pharmaceuticals) if they make dairy material or product for human or animal consumption that requires an RMP, or if the product is for export.

All new dairy processors who are required to operate under a registered RMP must have it registered before they begin any operations.

People/operations that do NOT need a dairy RMP:

• processors of dairy material or product for the domestic market or Australia only, and who are operating under an approved Food Safety Programme (FSP)

• processors of dairy products for animal consumption for the domestic market, if no other operations at the same premises require an RMP

• processors of technical grade dairy material or product, if no other operations at the same premises require an RMP.

NOTE: Processors of mixed food products that are intended for export and contain dairy material (but are not principally dairy, e.g. pizzas) may be given official assurances for the dairy component (where it is possible to trace the dairy component to APA compliance), but may operate under an FSP, the Food Hygiene Regulations, or an RMP.

Dairy Transition to RMPs

Deemed RMPs

Approved product safety programmes that were in existence before the APA was extended to include coverage of dairy products have been deemed as RMPs under the Act. In these cases the operator has until 31 May 2007 to amend the programme to be fully compliant with all RMP requirements. This includes evaluation and registration with NZFSA. After 31 May 2007, a deemed RMP has no legal status.

If an operator makes a significant amendment to a deemed RMP at any stage before 31 May 2007, the RMP must be amended to comply with all of the RMP requirements, and evaluation and registration is required at that time.

RMP Processes

The following table depicts the steps involved in developing and registering an RMP, and identifies the person responsible for the various tasks.

RMP configurations

An RMP may be configured in various ways for the number and types of products, processes, sites and businesses that it covers. It may be developed as a stand-alone programme for each type of dairy material or dairy product, process or operation, or premises; or it may cover many materials, products, processes, operations or premises. It may also be developed for a single business or for multiple businesses. Whichever arrangement is chosen, the operator must ensure that every aspect of the operation that requires an RMP is addressed.

Single-business RMPs can be:

• single-site, with one RMP (the simplest form of an RMP)

• single-site, with more than one RMP (may be useful if the operations are split in a logical way, but the cost of registration, evaluation and external verification would be higher)

• multi-site, with one RMP (useful if all sites operate in a similar manner; it may be necessary to add site-specific details to parts of the RMP)

• multi-site, each with more than one RMP (a complex arrangement; has added costs for registration, evaluation and external verification of the RMPs).

Multi-business RMPs

An RMP apply to more than one business if the Director-General so approves. Multi-business RMPs are only appropriate for businesses that have similar operations, and when all operators have agreed to operate under the RMP. This is usually done to share resources in RMP development and to minimise costs. The configurations for multi-business RMPs are the same as for single business RMPs (as listed above) but would apply to more than one business.

Main Components of an RMP

The following summarises the main components of an RMP. For further details please refer to the Animal Products (Dairy Risk Management Programme Specifications) Notice.

Use of Approved Codes of Practice, Templates and Models

NZFSA may approve codes of practice (COPs), templates and models under the APA if they meet the requirements for approval. COPs, templates and models provide industry-agreed information on how to meet regulatory requirements and cover Good Manufacturing Practice (GMP), HACCP application and other RMP requirements.

Using approved COPs, templates and models as a basis for the RMP will:

• ensure that the operator complies with current best practice or acceptable industry practices and procedures

• ensure that the operator meets the relevant regulatory requirements

• simplify the evaluation and external verification of RMPs.

Tailoring is still needed, the extent of which will depend on how the approved document applies to the business, but use of an approved COP, template or model will greatly simplify the development process and, in some cases, will remove the need for an evaluation.

An example of an approved COP and template is the Code of Practice for Cold and Dry Stores.

RMP Registration

Before operating, an RMP must be registered with NZFSA.

Validation

Validation is the initial demonstration that the RMP meets all necessary requirements and that it is effective in consistently providing products that are fit for intended purpose. If there is insufficient evidence to validate the effectiveness of the RMP at the time of application for registration (e.g. for new businesses or new processes), the operator will need to document a protocol for collecting evidence in a scientifically sound and statistically valid manner. The protocol is evaluated as part of the independent evaluation. NZFSA may apply conditions on the registration of an RMP that contains a protocol. After registration of an RMP that is incompletely validated, the next steps are completion of validation and independent evaluation.

Evaluation

Unless the requirement is waived, an application to register an RMP must be accompanied by an evaluation report by an independent, recognised evaluator.

The operator must engage the services of an evaluator who has been recognised for the product groups covered by the RMP to be evaluated.

Application for unique location identifier

Before applying for RMP registration, the operator must apply to NZFSA for a unique location identifier for each location specified within the programme. The operator nominates the unique identifier, which must be approved by NZFSA.

Application for registration

When applying for registration, the operator must include:

• the evaluation report (including premises and heat treatment evaluation reports)

• the endorsed RMP or an outline (as defined below)

• an application form (DPF-4) including a personal declaration and the relevant fee (inc GST).

NZFSA will undertake an assessment of the RMP and, if satisfied, will register the RMP and put key information onto a public register.

RMP Outline

A RMP outline for a single business must include:

• unique location identifier(s)

• name of operator

• the dairy material or dairy product business/businesses covered by the programme

• the animal material or animal product being produced or processed

• any other businesses to which the programme applies (if it does not apply only to the business of the person applying for registration)

• name, position or designation of the person responsible for the day-to-day management of the RMP, as nominated by the operator of the business

• principal categories of processing and dairy material

• location and type of premises or place, and the physical boundaries of the programme

• the name of the recognised verifying agency that has indicated responsibility for the verification of the programme

• range of risk factors addressed

• the outcomes relating to dairy material or dairy product

• description of each process covered by the programme

• corrective actions and procedures for non-compliance and non-conforming dairy material and dairy product

• verifiers’ rights and provisions to enable verification activities to be completed

• the list of all the documents that make up the RMP, their status at the time of registration, including the version and date of issue or other means of identifying their status.

NB: For guidance on the contents of a multiple business RMP outline, please refer to the Animal Products (Risk Management Programme Specifications) Notice, the Risk Management Programme Manual and the guidance material, which are available on the NZFSA website.

Duties

Once registered, an operator must comply with the duties laid out under the APA. These include:

• ensuring their RMP and operations comply with the APA

• adequately implementing and resourcing all operations

• ensuring all operations under the RMP are operated within the capability and capacity of the premises, facilities, equipment and staff, and deliver animal product that is fit for intended purpose

• giving verifiers freedom and access, as needed, to carry out their functions and activities

• notifying NZFSA of any change in the operator's recognised verifying agency.

Where to get further information about an RMP

For more information on the processing of dairy products refer to the NZFSA website: http://www.nzfsa.govt.nz/dairy/index.htm

Also refer to the RMP Manual for Animal Product Processing Excluding Dairy for further background information.

This publication is not a legal interpretation of the Animal Products Act or the Animal Products (Ancillary and Transitional Provisions) Act and is intended only as a guide.