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May 2003

Streamlined RMPs and Significant Amendments

Uncertainty towards the end of 2002 as to whether the Animal Products Amendment Act was to be passed into law prior to 1 November 2002 and so bring about an extension to the transition period led to the development of a contingency option. This option, referred to as the "streamlined approach", allowed certain businesses that were licensed under the Meat Act to transit their existing recognised programmes to the Animal Products Act (APA) using an enhanced transitional arrangement.

The deadline for the use of the "streamlined approach" was 31 December 2002.

It appears that there may be some confusion about what can and cannot be done once a streamlined RMP has been registered. Simultaneous with streamlined RMP registration, the Meat Act licence was cancelled. The operator no longer operates under the Meat Act, but is subject to the APA. Meat Act licence capabilities no longer apply, the scope of operations is constrained by the scope of the registered RMP.

 The responsibilities that had applied under the Meat Act have altered. In terms of the RMP, MAFVA is no longer responsible for approving programmes or amendments. If an amendment is minor, the responsibility lies with the operator to ensure the amendment is valid and appropriately documented and implemented. If the amendment is significant, the evaluator is involved and the amendment must be registered with the DG. Regardless of whether the amendment is minor or significant, records of the analysis and decisions making process must be kept and made available for review. (Refer to clarification text below).

 Operators have agreed under sections 28 and/or 29 of the streamlined approach (as appropriate) to operate in accordance with the Meat Act regime documents listed. Verification activity will need to encompass checks of compliance with these standards.

 At the completion of the 3 year registration period, all RMPs, must be evaluated and re-registered. These must meet all the relevant requirements of the APA at that time.

 Significant Amendments

The Animal Products (Risk Management Programme Specifications) Notice 2000, provides:

 "28. Amendments to the risk management programme

1. The following amendments require registration in accordance with section 25 [significant amendments] of the Act-

1. major alterations to the processing facilities; and
2. relocating processing operations to a new physical address (except where this is already permitted under the risk management programme); and
3. processing animal material or animal product that is not covered by the risk management programme; and
4. permanently ceasing to process a particular type of animal material or product; and
5. process modifications that impact on the outcomes for animal material or animal product; and
6. changes to outcomes or introduction of new outcomes for animal materials or animal products.

2. The operator must, when making an amendment, consider whether consequential amendments to other components of the risk management programme are necessary."

In some cases it will be very clear if a significant amendment is needed, but where it is less clear, the operator must analyse the proposal e.g. if it is a new product, is it manufactured under an existing HACCP plan? Are new hazards introduced in the raw materials or by the amended process? Are these hazards controlled and additional outcomes introduced? If the operator is in doubt they should contact their evaluator for clarification.

When making a significant amendment to a streamlined RMP, the entire risk management programme must be evaluated and registered. To enforce this requirement, a condition was added to every streamlined RMP as follows:

"If the operator makes a change to the risk management programme that constitutes a significant amendment under section 25 of the Animal Products Act, the entire risk management programme must be re-evaluated by an accredited evaluator in accordance with sections 17 to 20 of the Act and then submitted to the Director-General for registration." 

Registration of a significant amendment to a RMP must be made prior to the implementation of that amendment where the operator knows in advance that it is required. Where this is not possible, or there would be a risk to the fitness for intended purpose of the product if the amendment was not made, the amendment must be registered as soon as possible.

 The operator must be aware that developing and registering a significant amendment may take some time. The operator must take full responsibility for ensuring that they will not be operating in breach of the Act due to lack of foresight in preparing the full RMP if a significant amendment is required.

Disclaimer:

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.