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Risk Management Programme Manual for Animal Product Processing
6 Registration
Amendment 3
October 2009
6.1 Introduction
This section describes how you should apply for registration of your RMP and how NZFSA processes your application.
6.2 Application for Registration
(Section 20 of the Animal Products Act)
You must apply to NZFSA for registration of the RMP, using the correct application form for your situation. Your RMP must be registered before you commence operations for trade. The application forms are:
AP3 – Dual Operator Butcher RMP Registration
AP4 – Risk Management Programme Registration
AP5 – Risk Management Programme under New Operator Registration
AP6 – Risk Management Programme Amendment Registration
These forms are available on the NZFSA web site at: http://www.nzfsa.govt.nz/animalproducts/publications/forms/index.htm.
http://www.nzfsa.govt.nz/dairy/publications/forms/index.htm.
The AP3, AP4 and AP6 application forms prompt you to include all other information that will be required for registration of the RMP including:
• the document list (see section 3.3)
• the endorsed RMP or RMP outline
• the independent evaluation report (no more than 6 months old) if required (see section 5.4). For dairy processors the evaluation report will include heat treatment and/or premises evaluation reports
• confirmation that the recognised RMP verifying agency has agreed to verify the RMP (see section 3.18)
• the application fee; and
• AP49 Principle Categories of Processing tables as applicable.
The person who signs the declaration on the application form must have the appropriate authority to act on your behalf.
6.2.1 RMP Documents to be Submitted for Registration
The entire endorsed RMP may be submitted, or an outline as defined below.
4. Documentation to be submitted as an outline of the contents of a risk management programme
(1) For all outlines:
If an operator chooses to submit an outline under section 20(2)(a)(ii) of the Act for a risk management programme, the documentation to be submitted must include all of the following—
(a) the name and address (including the electronic address, if available) of the operator of the risk management programme;
(b) the business identifier;
(c) A unique location identifier or identifiers required by clause 5(3) of the Animal Products (Risk Management Programme Specifications) Notice 2008;
(d) the name, position or designation of the person responsible for the day-to-day management of the risk management programme, as nominated by the operator;
(e) one of —
(i) the physical address of the premises; or
(ii) for a mobile premises - any vehicle registration numbers, and the location at which the mobile premises is principally based; or
(iii) for a fishing vessel - the physical address of the operator, the name of the fishing vessel, and the fisheries registration number;
(f) the physical boundaries of the risk management programme and a description of any shared facilities as required by clauses 5(5) and 5(6) of the Animal Products (Risk Management Programme Specifications) Notice 2008;
(g) the information required under clauses 6 and 7 of the Animal Products (Risk Management Programme Specifications) Notice 2008;
(h) a step-by-step description of each process covered by the risk management programme, including all inputs and outputs in accordance with clause 9 of the Animal Products (Risk Management Programme Specifications) Notice 2008;
(i) where appropriate, the protocol in accordance with clause 18(1)(b) of the Animal Products (Risk Management Programme Specifications) Notice 2008;
(j) the document list required under clause 12 of the Animal Products (Risk Management Programme Specifications) Notice 2008;
(k) a statement in writing from the recognised risk management programme verifying agency, (or if appropriate in the case of a food safety programme to be registered as a risk management programme under section 34 of the Act, the approved auditor under the Food Act 1981) indicating that the agency has accepted the responsibility for the verification of the risk management programme.
(l) the operator must ensure that any outline of the risk management programme submitted to the Director-General accurately represents the programme at the time of application for registration.
(2) Additional requirements for outlines involving multi-business risk management programmes:
If an operator chooses to submit an outline under section 20(2)(a)(ii) of the Act for a multi-business risk management programme, the documentation to be submitted must include all of the following —
(a) the documents required under clause 4(1) with business-specific details where appropriate; and
(b) either —
(i) the name, position or designation of the person(s) responsible for the day-to-day management of the multi-business risk management programme at each premises or place; or
(ii) where the multi-business risk management programme will apply to a general type of business, premises or place, alternative details as approved by the Director-General;
(c) evidence in writing that the operator of the multi-business risk management programme will have sufficient control, authority, and accountability for all matters covered by that programme in relation to the businesses subject to its coverage;
(d) evidence in writing that the operator of the multi-business risk management programme has obtained the consent or otherwise taken into account the views of any person whose business is to be covered by the risk management programme.
6.2.2 Electronic Applications
If you submit documents electronically they must be in Microsoft Word, PDF or a format agreed with NZFSA prior to submission.
NZFSA recommends that hard copies are submitted as electronic applications may take longer to process and be more costly as a result.
6.3 Assessment and Registration
(Sections 19 and 22 of the Animal Products Act)
The standard timeframe for processing RMP applications is 10 working days from receipt.
An RMP cannot be registered until the documentation is complete, the premises and equipment are ready to operate and this has been signed off by the evaluator (where required). As a result, you should plan for the time taken to finalise the evaluation (including reporting) and NZFSA assessment time when determining when operations may be able to commence. You may elect to use an NZFSA policy that allows for pre-assessment of RMP documentation before the premises is complete. This could minimise the NZFSA assessment time after the premises construction has been completes for a new operation. See section 6.3.1.
NZFSA may request further information from you before determining whether to register an RMP. The application for registration will lapse if the information has not been supplied within 6 months from the date of request, or within an extended date as agreed with NZFSA.
NZFSA will register an RMP if satisfied that it meets all the requirements under the Act. If not, the registration may be refused (see section 6.5).
NZFSA will notify you when the RMP is ready for registration and will request payment of an assessment fee. This relates to the time involved in assessing your application and is calculated on an hourly basis. You must pay this fee prior to RMP registration.
After registering your RMP, NZFSA, will supply you with:
• a letter confirming registration
• a notice of registration
• a notice of conditions if applicable (legal requirements that you must comply with); and
• an authorised copy of the registered RMP or outline.
Your RMP verifying agency will be provided with copies of these documents. The original authorised documents will be held by NZFSA.
Once a programme is registered NZFSA enters details about the RMP onto the public register. The current RMP registers are located at:
http://www.nzfsa.govt.nz/animalproducts/registers-lists/risk-management-programmes/index.htm; (non dairy)
http://www.nzfsa.govt.nz/dairy/registers-lists/index.htm (dairy)
6.3.1 Pre-registration Assessment
NZFSA has developed an option for pre-assessment of the RMP documentation before premises construction is complete. This is intended to assist in the registration process and may reduce the time taken.
The use of this policy is limited to situations where:
• an evaluation is required
• the RMP documentation is complete and has been evaluated by the evaluator
• the documentation is unlikely to change prior to registration; and
• the premises construction is at a stage of ‘practical completion’.
In pre-assessment, the evaluator prepares an interim report. You must submit this report together with the application documentation to NZFSA for assessment. Any changes that are required prior to registration of the RMP can then be made and the application put on hold until the on-site assessment of the completed premises has occurred. NZFSA cannot register the RMP until evaluation has been completed, including on-site assessment, and any critical non-compliances have been closed out.
NZFSA will complete the registration process once construction is complete, the on-site assessment has occurred and the evaluation report is updated and submitted. Provided there are no changes, or only a few minor changes to the pre-assessed programme, registration should proceed without delay.
See: http://www.nzfsa.govt.nz/animalproducts/publications/policystatements/rmp/pre-reg-assess.pdf for more information.
6.4 Compliance with RMP Registration Conditions
It is your responsibility to ensure you comply with any RMP conditions. You must comply with any conditions within specified timeframes. If the timeframe is exceeded, NZFSA may apply additional conditions, or the registration may be revoked.
6.5 Refusal to Register
(Section 23 of the Animal Products Act)
If NZFSA declines to register your RMP, you will be notified in writing, clearly stipulating the reasons. You will be given a reasonable opportunity to make written submissions or be heard in respect of the notification to decline registration (i.e. within 30 days or as agreed).
Under Section 162 of the Animal Products Act, you may apply for a review of the decision if a person other than the Director-General makes the original decision to decline registration of your RMP. However, if the Director-General makes the original decision, there is no right of review.
Your application for review must be in writing and state the reasons why you consider that the original decision was inappropriate. Your application must be provided to the Director-General within 30 days of the original decision being notified.
The review will be carried out by the Director-General or a designated person not involved in the original decision.
The Director-General’s decision is final and subject to judicial review.
6.6 Completion of Validation
Where you have not been able to complete validation before the RMP is registered you must implement the protocol once the process is operating (see section 4.4). Once you have received an evaluation report confirming that validation has been completed, you must forward this report to NZFSA along with any other required documents (see section 6.2.1).
NZFSA will carry out an assessment of the documents and will notify you in writing of the outcome of the assessment and any changes to the RMP conditions.
6.7 Registration of Significant Amendments
Where a significant amendment to your RMP is made under section 25 of the Act, you must submit an application to NZFSA for registration of the amendment using form AP6. This must be accompanied by an evaluation report and the documentation listed below.
21. Documentation to be submitted for registration of a significant amendment of a risk management programme.
An application for registration of a significant amendment of a risk management programme must be accompanied by the following—
(a) the risk management programme pages affected by the amendment with the changes clearly identified; and
(b) where appropriate, the protocol in accordance with clause 18 (1)(b)
The process for registration of a significant amendment is the same as for initial registration of the RMP. You must develop your amendment and where appropriate validate it prior to having the amendment evaluated and then registered (see section 7.5).
6.8 Change of Registration Details
(Section 24 and 25 of the Animal Products Act)
You must notify NZFSA of any of the following changes to your RMP:
6.8.1 Change in Operator Only
Where a change in “operator” or “operator name” is the only change to your entire registered RMP, you must complete application form AP5.
The following circumstances involve a change in operator of a registered RMP, and so require completion of AP5:
• a change of company name
• a change to the (number of) members of a partnership
• a change in the names of the directors
• the operator’s death, bankruptcy, receivership, or liquidation.
6.8.2 Change in Day-to-day Manager of a Risk Management Programme
13. Notifications
(1) A risk management programme must contain a procedure for notification of the Director-General in writing , without unnecessary delay, of any change to the name or position or designation of the person(s) responsible for the day-to-day management of the risk management programme.
You must notify NZFSA of this change using an AP50 form. This is not a significant amendment to your RMP.
6.8.3 Change in Recognised Agency
(Section 16(2) of the Animal Products Act)
You must notify NZFSA as soon as possible of a change in the recognised verifying agency using form AP60.
This is not a significant amendment of your RMP.
6.9 Multi-Business RMP Registration
(Section 17A of the Animal Products Act)
If you are registering a multi-business RMP, the process is essentially the same as for a single business RMP. This includes the need for an evaluation where required. The documents submitted differ slightly (see section 6.2.1). NZFSA must be satisfied that the requirements in Section 17A of the Act have been met before the RMP is registered.
New Zealand Food Safety Authority
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