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Risk Management Programme Manual for Animal Product Processing
7 Operating the Registered RMP
Amendment 3
October 2009
7.1 Introduction
This section summarises your key responsibilities once your RMP has been registered.
You may only commence processing for trade from the date of notification of registration of your RMP. Prior to this, you can only process on a trial basis and no animal material or animal product can be traded. This means that the resulting animal material or animal product must be disposed of. (e.g. burnt or buried and in accordance with any other applicable legislation).
You must comply with any conditions specified by NZFSA on your RMP. You are required to operate in accordance with your RMP. It is illegal to operate outside the scope of your RMP.
When implementing the registered RMP, you must achieve ongoing effective control of hazards and other risk factors associated with the product and the process.
You must have your RMP verified by a recognised verifying agency.
7.2 Operator’s Duties
(Section 16 of the Animal Products Act)
You have the following duties:
• to ensure that the operations of your business do not contravene the relevant requirements of and under the Act, including the requirements set out in your RMP
• to ensure that your RMP, is consistent with the requirements of regulations and specifications under the Act
• to adequately implement and resource all operations under the programme, including provision for the instruction, competency, and supervision of staff to ensure the delivery of product that is fit for intended purpose
• to ensure that the capability and capacity of your premises, facilities, equipment and staff are adequate to deliver product that is fit for intended purpose
• to give the recognised verifying agency such freedom and access to carry out their functions and activities under the Act.
The resources required to ensure that your registered RMP continues to be effective should include, as appropriate:
• trained and competent personnel (see section 3.12)
• calibrated measuring equipment; and
• competent laboratory services (this work may be contracted out).
(Section 16(2) of the Animal Products Act)
Where you fail to undertake your duties you will be in breach of APA requirements. This may result in:
• interruption of operations
• prohibition on use of process or equipment
• increased external verification of the RMP
• product disposal
• recalls
• suspension or deregistration of the RMP
• prosecution where appropriate.
7.3 Conflict between RMP and Regulations or Specifications
(Section 30 of the Animal Products Act)
Where there is any conflict between documented requirements of a registered RMP and requirements of regulations or specifications made under the APA, the requirements of the regulations or specifications will prevail.
7.4 External Verification
(Sections 101 and 107 of the Animal Products Act)
The verification requirements carried out by the recognised verifier for non-dairy RMPs that do not require official assurances for export is prescribed by the Verification Statement of Policy. This is available at the following website address:
http://www.nzfsa.govt.nz/animalproducts/publications/policystatements/verification/index.htm
For dairy RMPs that do not require official assurances for export, the verification system is described in the Approved Criteria for the Manufacturing of Dairy Material and Product (DPC3), available at the following website address:
For all export animal products (including dairy) that require an official assurance the verification requirements are prescribed by the Animal Products (Export Verification Requirements) Notice 2009 and the Animal Products Export Verification Programme, available at the following website address:
The verification frequency will depend on your level of compliance with the registered RMP and any applicable export requirements (i.e. is performance based). If the operation complies with the documented programme and can consistently demonstrate its effectiveness, the verifier may be able to apply a lower frequency. A higher frequency will be applied if the programme is not implemented correctly. More frequent verification may be required if the business is exporting.
7.5 Amendments to the RMP
If you amend your RMP for any reason the amendment will either be classified as significant or minor. Information on significant amendments and the requirements of clause 22 of the Animal Products (RMP Specifications) Notice 2008 is given in Appendix G. The tables provide examples of significant and minor amendments.
22. Significant amendments to the risk management programme
22(1) The following activities that result in changes to the risk management programme require registration as an amendment in accordance with section 25 of the Act (except where they are done on a trial basis and the affected animal material or animal product is not traded)—
(a) making major alterations to the processing facilities or equipment which may impact on fitness for intended purpose of the animal material or animal product.
(b) relocating processing operations to a new physical address (except where this is already permitted for mobile premises and vessels):
(c) processing animal material or animal product that is not covered by the risk management programme, except —
(i) where the product and process are similar, and
(ii) a documented risk factor identification and hazard analysis has shown that all risk factors associated with that animal material or animal product are already adequately addressed by the risk management programme:
(d) setting up a new process or process modification that is not covered by the risk management programme, except —
(i) where the process or process modification is similar to existing processes, and
(ii) a documented risk factor identification and hazard analysis has shown that all risk factors associated with that process are already adequately addressed by the risk management programme:
(e) making any other changes that introduce new risk factors, or adversely impact on existing risk factors:
(f) merging two or more registered risk management programmes:
(g) splitting a registered risk management programme into two or more risk management programmes:
(h) adding a business to a multi-business risk management programme except where the Director-General’s approval under section 17A of the Act applies to a type of business, premises or place rather than to specific businesses.
Significant amendments require evaluation by a recognised evaluator and registration with NZFSA. Minor amendments can be made without evaluator or NZFSA involvement. The key consideration when deciding this is whether or not the amendment meets criteria set in Section 25 of the Act and Part 4 of the Animal Products (RMP Specifications) Notice 2008.
You may consult a recognised evaluator or a technical expert to assist in making this decision. In addition, if your product is intended for export NZFSA strongly recommends that you discuss proposed amendments with your verifier to identify any potential market access implications.
You must identify any amendments made to your RMP as described in the document control section of your RMP. Validation must be conducted where necessary for every amendment.
7.5.1 Significant Amendments to the RMP
Significant amendments to the RMP must be registered in accordance with the APA and validated as described in section 4.
(Section 25 of the Animal Products Act)
You must apply for registration of the amendment, where any change, event or other matter means that the programme:
• is no longer appropriate, or will no longer be appropriate to the animal material or product, processes, or premises or place covered by the programme; or
• otherwise impacts, or will impact, on the fitness for intended purpose of the animal product concerned or the content of the RMP as required under section 17 (1) of the APA.
You must apply for registration of the amendment in advance of any known change, event, or other matter. In all other cases you must apply for registration of the amendment as soon as practicable. Refer to sections 5 and 6 for the evaluation and registration requirements.
If you do not comply with registration requirements for a significant amendment to your RMP, you will be in breach of the APA. Depending on the circumstances, this could result in suspension or de-registration of the RMP, or prosecution.
7.5.2 Minor Amendments to RMPs
(Section 26 of the APA)
If you decide an amendment is minor, you must ensure sufficient written evidence is available to support this decision, e.g.:
• a full description of the amendment (including details of any planned construction or alterations); and
• evidence that clause 22 of the Animal Products (RMP Specifications) Notice 2008 has been considered.
If the changes are editorial, no evidence is required.
All minor amendments must be checked by the recognised verifier as part of their verification activities.
7.5.2.1 Notifications to NZFSA
To ensure the registration details shown on the public register of RMPs are current and accurate, some changes require notification to NZFSA. The AP50 form (available on NZFSA website) specifically details which changes are to be notified to NZFSA, for instance changes in trading name, or the addition of products where this is not considered a significant amendment.
This change to the RMP will undergo an assessment process at NZFSA. In situations where NZFSA then deems the change to in fact be significant, the operator will be notified and will be required to complete a significant amendment application.
New Zealand Food Safety Authority
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NEW ZEALAND
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