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Risk Management Programmes (Other Than Dairy)

June 2006

Animal Products Act 1999
Information Pamphlet

Background

The Animal Products Act 1999 (APA) requires all animal products traded and used to be “fit for intended purpose”. The main way of achieving this is through risk management programmes. A risk management programme is a documented programme to identify and manage hazards and other risk factors.

Risk management programmes must either be individually developed by businesses, or may be based on NZFSA approved Codes of Practice, templates or models (where available) and must address the animal materials and products used, the processes performed and the product range produced.

An amendment to the APA came into effect on 1 June 2005 and brought dairy processing under its ambit. The coverage of this information pamphlet is limited to risk management programmes for the processing of animal materials and animal products other than dairy products. For further information on risk management programmes involving the processing of dairy products, please refer to the NZFSA website Dairy Products.

The legal framework for Risk Management Programmes

The key pieces of legislation relating to risk management programmes 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) Act 1999

Regulations

Animal Products Regulations 2000

Animal Products (Ancillary and Transitional Provisions) Regulations 2000

Animal Products (Fees, Charges, and Levies) Regulations 2002

Orders in Council

Animal Products (Exemptions and Inclusions) Order 2000

Notices

Animal Products (Definition of Primary Processor) Notice 2000

Animal Products (Risk Management Programme Specifications) Notice 2003

Animal Products (Specifications for Products Intended for Human Consumption) Notice 2004

Animal Products (Specifications for Products Intended for Animal Consumption) Notice 2006 (in preparation)

Animal Products (National Microbiological Database Specifications) Notice 2005

Animal Products (Specifications for the Ante-mortem and Post-mortem Examination of Poultry Intended for Human or Animal Consumption) Notice 2005

Animal Products (Specifications for the Ante-mortem and Post-mortem Examination of Mammals, Ostriches and Emus Intended for Human Consumption) Notice 2006 (in preparation)

Animal Products (Branding and Associated Requirements) Notice 2006 (in preparation)

Animal Products (Accredited Evaluator Specifications) Notice 2003

Animal Products (Accredited Persons Specifications) Notice 2001

Food Standards Code

The Food Standards Code contains standards for composition, labelling, substances added to food (e.g. additives and processing aids) and contaminants and applies to all foods produced or imported for sale in Australia and New Zealand. Risk management programme operators must comply with the provisions of this Code (unless an exemption has been granted for specific export products).

Risk Management Programme Coverage

All primary processors of animal material (except those with exemptions) must have a risk management programme, including:

• mammal and bird (including ostrich and emu) primary processors;

• avian egg producers and packers, deer velvet and fish primary processors (as defined in the Animal Products (Definition of Primary Processor) Notice 2000).

Certain secondary processors of animal product must have a risk management programme, including

• secondary processors of animal products intended for human or animal consumption, except to the extent that they are subject to the Food Act regime;

• secondary processors of animal products intended for human or animal consumption requiring official assurances;

• renderers and blood-drying operations for mammals and birds;

• dual operator butchers (butchers dealing in both homekill and regulated meat).

People and/or operations NOT needing risk management programmes:

• Primary producers of animal products;

• Certain fish caught in the New Zealand Exclusive Economic Zone;

• Processing of fish on a vessel that is registered as a limited processing fishing vessel under the regulated control scheme;

• Processors of fish bait, berley or chum and those who catch, process and sell whitebait;

• Tourist or charter fishing vessel operators and fishing guides;

• Fish on retail premises where the trader is operating under the Food Act (Food Hygiene Regulations or food safety programme) and fish sold by a combination of retail and wholesale where the trader has a food safety programme under the Food Act;

• Temporary holding and storage places for fish or wild mammal carcasses (animal material depots);

• Primary processors of muttonbirds;

• Egg producers who sell eggs direct to the consumer or end user from 100 birds or less, and do not sell any eggs to any person for further sale;

• Products covered by the Medicines Act 1981 and Agricultural Compounds and Veterinary Medicines Act 1997;

• Animal product processed in accordance with the Food Act regime and voluntarily bought as petfood e.g. meat pieces bought from a supermarket as petfood;

• Airline holding facility operators if the facility is within the confines of the airport and adjacent to the tarmac;

• Harvesting, collecting, grading, storage and transport of deer velvet;

• Apiarists;

• Taxidermy operations;

• Primary processing of animal material for purposes other than human or animal consumption e.g. skinning and shearing.

Risk Management Programme Processes

The following table depicts the steps involved in developing and registering a risk management programme, including the responsibilities for the various tasks.

Information	Responsibility	Main Source of Information
Design and development of the RMP	Operator	RMP specifications Specifications for products intended for human consumption Specifications for products intended for animal consumption (pending) National Microbiological Database Specifications Ante-mortem and Post-mortem Examination of Poultry Intended for Human or Animal Consumption Specifications Ante-mortem and Post-mortem Examination of Mammals, Ostriches and Emus Intended for Human Consumption Specifications (pending) Branding and Associated Requirements Specifications (pending) Sections 2 to 4 of RMP Manual
Confirmation of validity of the RMP Contracting verification services	Operator	RMP Specifications Section 5 of RMP Manual Sections 4 and 8 of RMP Manual
Independent evaluation of the RMP (unless exemption given)	The operator must contract a NZFSA recognised evaluator	RMP Specifications Evaluator Specifications Section 6 of RMP Manual Evaluator’s Manual
Application for registration of the RMP	Operator	RMP Specifications Section 7 of RMP Manual
Registration approval and notification	NZFSA	Animal Products Act, Part 2
Operation of RMP Specific operational duties Application for significant amendments to registered RMP Operator verification	Operator Operator Operator	Section 7 and 8 of RMP Manual
Independent verification	Recognised verifier	Recognised Agency and Person Specifications
Cessation Surrender of the registration of the RMP Suspension of registration Deregistration	Operator NZFSA NZFSA	Animal Products Act, Part 2 Section 9 of RMP Manual

Risk Management Programme Configurations

A risk management programme may be configured in various ways for the range and types of products, processes, sites and businesses that it covers. It may be developed as a stand-alone programme for each type of animal material or 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. Whatever arrangement is chosen, the operator must ensure that no aspect of the operation requiring a risk management programme is missed.

Single-business risk management programmes can be:

• Single-site, with one RMP. (This is the simplest form of a RMP and its use is encouraged whenever applicable);

• Single-site, with more than one RMP. (This may be useful if the operations are split in a logical way e.g. product or process, but the cost of registration, evaluation and external verification of the RMPs would be higher);

• Multi-site, with one RMP. (This is useful if all sites operate in a similar manner. It may be necessary to add site-specific details to parts of the RMP. The operator must be aware that changes to the RMP will impact on all of the sites that have been included);

• Multi-site, each with more than one RMP. (This is a complex arrangement which should be avoided unless there are logical reasons for such an arrangement. It would add to the cost of registration, evaluation and external verification of the RMPs).

Multi-business risk management programmes

A risk management programme may apply to more than one business, if the Director-General so approves. Such a multi-business risk management programme is more appropriate for businesses that have similar operations and where all operators have agreed to operate under one risk management programme. This is usually done by small businesses to share resources in risk management programme development and to minimise costs. The configurations for multi-business risk management programme are the same as for single business risk management programmes (as listed above) but would apply to more than one business.

Implications for market access

Where a single RMP covers more than one site or more than one business this may raise problems if the operator is intending to export product and country listings are required. Where an operator intends to export they should contact the NZFSA to discuss the implications of multi-site/multi-business risk management programmes.

Main Components of a Risk Management Programme

The following summarises the main components of a risk management programme. For further details please refer to the Animal Products (Risk Management Programme Specifications) Notice and the Risk Management Programme Manual, both of which are available on the NZFSA website.

Scope		• The boundaries of the physical area covered by the RMP • Description of animal material, animal product name or type and its intended purpose
Authorities		• The identity (either by position, designation or name) and responsibilities of every person responsible for monitoring, corrective action, and operator verification activities. • The identity of the day-to-day manager of the RMP
Regulatory Limits, Important Product Characteristics		Regulator and operator defined measurable characteristics respectively that define suitability for processing or fitness for intended purpose for each animal product or group of similar animal products
Processes		Every process or operation carried out, including all inputs, outputs and rework, where applicable.
GMP/ Supporting Systems		Systems to ensure that GMP is applied and that managers and staff know what to do
Hazard Analysis and Control		• Hazard analysis — human health, animal health • Control measures applied (and description of any uncontrolled hazards) • Monitoring, corrective action and verification
Control of Other Risk Factors		Identification and control of any risks to wholesomeness or from false or misleading labelling
Documentation and Record Keeping		• Record keeping systems, including process for tracking RMP amendments • Archive procedures
Verification		• Operator verification procedures • Rights for independent third party verifiers

Use of Approved Codes of Practice, Templates and Models

The 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. Several approved documents are available on the NZFSA website.

Using approved COPs, templates and models as a basis for the risk management programme 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; and

• simplify the evaluation and external verification of RMPs.

Tailoring is still needed, the extent of which will depend on the applicability of the approved document 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.

The COPs, templates and models that are currently approved are:

• Code of Practice: Processing of Bee Products;

• Risk Management Programme Template for Dual Operator Butchers;

• Egg Risk Management Programme Template.

Risk Management Programme Registration

Before operating, a risk management programme must be registered with NZFSA.

Confirmation of validity

Confirmation of validity is the initial demonstration that the risk management programme meets all necessary requirements and that it is effective in consistently producing products that are fit for intended purpose. The operator must confirm that all documentation is present and correct, and that the RMP is ready to operate before registration. But when there is insufficient evidence to confirm the effectiveness of the risk management programme at the time of application for registration (e.g. for new businesses or new process), the operator may need to document a protocol for collection of evidence in a scientifically sound and statistically valid manner. The protocol is evaluated as part of the independent evaluation. After registration, confirmation of validity is completed, and the independent evaluation is finalised.

Evaluation

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

It is preferable to engage the services of an evaluator who has activity endorsements related to the risk management programme to be evaluated. A list of NZFSA recognised evaluators is on the NZFSA website: Recognised evaluators

Application

When applying for registration, the operator must include:

• the evaluation report;

• the endorsed risk management programme, risk management programme outline (as defined below) or risk management programme amendment;

• a completed application form including a personal declaration and the application fee.

The NZFSA undertakes an assessment of the risk management programme and if satisfied with the contents the programme is registered and key information is put onto a public register. The NZFSA assessment is charged out at an hourly rate.

Risk Management programme outline

A risk management programme outline for a single business must include:

• Name and address of the operator;

• Business identifier and RMP number;

• Name, position or designation of person who is responsible for the day-to-day management of the RMP, as nominated by the operator;

• Physical address of the premises;

• Physical boundaries of the RMP and a description of any shared facilities;

• All animal materials and products entering and leaving the RMP, and their intended use;

• Any important characteristics, including operator-defined parameters relating to suitability for processing or fitness for intended purpose;

• Description of each process;

• A statement from the recognised verifying agency, or (and if appropriate in the case of a food safety programme registered as risk management programme under section 34 of the Act, the approved auditor under the Food Act 1981) indicating that it is prepared to be responsible for the verification function of the programme.

A list of all the documents that make up the risk management programme and their status at the time of registration, including the version and date of issue must also be provided.

NB: For the contents of a risk management programme outline for a multi-business RMP, please refer to the Animal Products (Risk Management Programme Specifications) Notice and the Risk Management Programme Manual, which are both available on the NZFSA website.

Risk Management programme review

All risk management programmes must be reviewed every 3 years from the date of registration.

Duties

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

• ensuring that their risk management programme and operations comply with the APA;

• adequately implementing and resourcing all operations;

• ensuring that all operations under the risk management programme are within the capability and capacity of the premises or place, facilities, equipment, and staff to deliver animal product that is fit for purpose;

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

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

Export Requirements

Export requirements are additional to the requirements for risk management programmes. For further information on export requirements, please refer to the NZFSA website Overseas Market Access Requirements

Further Information on Risk Management Programmes

The Risk Management Programme Manual contains further information about the development, implementation and operation of a risk management programme.

Risk Management Programme Manual

For further information on risk management programmes also see the following website:

General RMP 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.