Guidance Document

Risk Management
Programme Manual
For Animal Product Processing
December 2023

A guidance document issued by the Ministry for Primary Industries

Guidance Document: Risk Management Programme Manual
December 2023

Title
Guidance Document: Risk Management Programme Manual

About this document

The guide has been developed to assist animal product businesses to develop and operate their RMP

Related Requirements
(1) Animal Products Act 1999
(2) Animal Products Regulations 2021 (version dated November 2021)
(3) Animal Products Notice: Production, Supply and Processing (version dated June 2022)

Document history
Version Date Section Change(s) Description
Changed
October 2009 NA NA
September 2018 All New format and branding.
Additional information on validation.
Incorporated the following Statements of Policy:
• Operator Responsibilities during Registration of a Risk Management
Programme (Version 1); and
• Pre-registration Assessment of Risk Management Programme
Documentation.
August 2019 3.1.2 Removal of the guidance box in relation to the process of transitioning to
a revised RMP template.
February 2020 7.1, 7.5 Incorporated changes as per the RMP Regulations introduced as part of
the Food Safety Law Reform Act (Regulatory Redesign).
All Updated clause references to the amended Animal Products Notice:
Specifications for Products Intended for Human Consumption (issued
2019).
7.1 Removed references to revoked Animal Products (Requirements for
Risk Management Programme Outlines) Notice 2008
4.3.3.3, 7.1.1 Incorporated References to Animal Products Notice: Risk Management
Programme Specifications Amendment and Requirements for Risk
Management Programme Outlines Revocation (issued 2020)
Included links to guidance documents on validation.
3.2 Included information about inclusion of non-animal products in an RMP.
November 2022 Incorporated changes as per the Animal Product Regulations 2021 and
the Animal Products Notice: Production, Supply and Processing,
introduced as part of the Food Safety Law Reform Act 2018.
Removed references to expired APA instruments, introduced references
to the new instruments, updated definitions.
General structure of the guide has been updated to reflect other MPI
documents to enable ease of reading and consistency (e.g., definitions
moved to the start of the document).
Guidance has been amended and where possible, simplified and
consolidated. Some key changes include:

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Version Date Section Change(s) Description

Changed
• more detail about electronic signatures
• simplification of principally dairy determination information
• RMP physical boundary guidance expanded
• some appendices have been deleted, reordered, renamed and a
new appendix added
• guidance around minor and significant amendments has been
amended.
• validation guidance amended for more clarity, including validation of
shelf life
• guidance added around exemption from requirement from an on-site
assessment during evaluation
• updated guidance on changing from a single-business RMP to multi-
business RMP
• operator verification guidance amended
• added guidance on whom to contact/notify at MPI, when required
(Note that although every effort has been made to provide with the
specific contact information where possible, please contact MPI at
[email protected] if a specific email has not been provided)
• clarified the relationship between supporting systems/GOP and
HACCP
• added guidance on including non-animal products in an RMP
• RMP contents table has been updated
April 2023 3.2 Added link to a new guidance document ‘Own-source water checklist
and template water-use plan’
December 2023 3.2 Added link to a new guidance document ‘Dairy Processors Template
Water-use Plan’
4.11.9 Corrected reference details

Contact Details
Ministry for Primary Industries (MPI)
New Zealand Food Safety
PO Box 2526
Wellington 6140.

Email: [email protected]

Disclaimer
This guidance does not constitute, and should not be regarded as, legal advice. While every effort has been
made to ensure the information in this guidance is accurate, the Ministry for Primary Industries does not accept
any responsibility or liability whatsoever for any error of fact, omission, interpretation or opinion that may be
present, however it may have occurred.

Copyright
Crown copyright ©. This copyright work is licensed under the Creative Commons Attribution 3.0 New Zealand
licence. In essence, you are free to copy, distribute and adapt the work, as long as you attribute the work to the Ministry for Primary
Industries and abide by the other licence terms. To view a copy of this licence, visit http://creativecommons.org/licenses/by/3.0/nz/.
Please note that no governmental emblem, logo or Coat of Arms may be used in any way which infringes any provision of the Flags,

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Emblems, and Names Protection Act 1981 or would infringe such provision if the relevant use occurred within New Zealand.
Attribution to the Ministry for Primary Industries should be in written form and not by reproduction of any such emblem, logo or Coat of
Arms.

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Contents Page

1 Purpose 10
1.1 How to interpret the RMP manual 10
1.2 Definitions 10
1.3 Abbreviations 17

2 Background 18
2.1 The Animal Products Act framework 18
2.1.1 Risk Management Programmes (RMP) 19
2.1.2 Regulated Control Schemes (RCS) 19
2.1.3 Export requirements 19
2.1.4 Authorisations and duties 20
2.2 Businesses requiring an RMP 20
2.3 Businesses not requiring an RMP 20
2.4 RMP configurations 20
2.4.1 Single-business RMPs 21
2.4.2 Multi-business RMPs 21
2.5 Including non-animal products in an RMP 21
2.6 Relationship between the APA and other legislation 21
2.6.1 Food Standards Code (FSC) 21
2.6.2 Food Act 2014 22
2.6.3 Operating under an RMP 22
2.6.4 Operating under an FCP registered as an RMP 22
2.6.5 Agricultural Compounds and Veterinary Medicines Act 1997 22
2.6.6 Medicines Act 1981 22
2.6.7 Dietary supplements 23

3 Resources for developing an RMP 24

3.1 Codes and templates 24
3.1.1 Operational Codes and COPs 24
3.1.2 RMP Templates 24
3.2 MPI guidance documents 25
3.3 HACCP plans 25
3.4 Other procedures 25
3.5 Peer-reviewed scientific information 25
3.6 Predictive models 26
3.7 Food control plans 26
3.8 RMP consultants 26

4 RMP development 27
4.1 RMP responsibilities 27
4.2 RMP components 28
4.3 Operator, business and RMP identification 29
4.3.1 RMP operator 29
4.3.2 Businesses covered by the RMP 29
4.3.3 RMP identifier 29
4.3.3.1 Registration number 30
4.3.3.2 RMP suffix (relevant to Non-dairy only) 30

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4.3.3.3 Unique Location Identifier (Dairy only) 30

4.3.4 Operator, business and programme identification 30
4.4 List of RMP documents 31
4.5 Management authorities and responsibilities 32
4.5.1 Day-to-day manager of the RMP 32
4.5.2 Evidence of sufficient control and consent for a multi-business RMP 32
4.6 Scope of the RMP 33
4.6.1 Physical boundaries 33
4.6.2 Clarification of RMP scope 33
4.7 Animal material and animal product description 34
4.7.1 Animal material or product entering or leaving the physical boundaries of the
RMP 36
4.7.2 Intended purpose 36
4.8 Limits 36
4.8.1 Regulatory limits 37
4.8.2 Operator-defined limits 37
4.8.3 Actions to be taken when limits are not met 38
4.9 Other product details 38
4.10 Process description 38
4.11 Supporting systems/Good Operating Practices (GOP) 38
4.11.1 Areas covered by supporting systems 39
4.11.2 Recommended content of each supporting system 40
4.11.3 Procedures for process control 40
4.11.4 Procedures for monitoring 40
4.11.5 Procedures for corrective actions 41
4.11.6 Corrective action procedure for unforeseen circumstances 41
4.11.7 Procedures for operator verification 42
4.11.8 RMP documents and procedures for document control 42
4.11.8.1 Authorisation or “sign-off” of documents 43
4.11.8.2 Amendments 43
4.11.9 Record keeping 44
4.11.9.1 Electronic records 44
4.11.10 Competencies and skills 44
4.11.11 Persons responsible for key tasks 44
4.11.12 Mandatory competencies 45
4.11.13 Suitable skills 45
4.11.14 Operator verification of the RMP 47
4.11.15 Notification and reporting requirements 48
4.11.16 Traceability and recall procedures 48
4.11.17 Traceability 48
4.11.18 Recall Procedures 49
4.11.19 Simulated/mock recall 49
4.11.20 Validation of Supporting systems/GOP 49
4.12 Application of HACCP 49
4.12.1 Types and sources of hazards 50
4.12.2 Conduct a hazard analysis 50
4.12.3 Identification of control measures 53
4.12.4 Uncontrolled hazards 53
4.12.5 Determine the Critical Control Points (CCPs) 53
4.12.6 Other CCPs that may be identified 58

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4.12.7 Establishing validated critical limits for each CCP 58

4.12.8 Establish CCP monitoring 58
4.12.9 Establish corrective actions 59
4.12.10 Validation of the HACCP plan and Operator Verification (HACCP) Procedures 59
4.12.10.1 Validation of the HACCP plan 59
4.12.10.2 Operator verification (HACCP) procedures 60
4.12.11 Establish HACCP documentation and record keeping 60
4.12.12 Common HACCP mistakes 60
4.13 Identification and control of risks to wholesomeness 61
4.13.1 Identification of risks to wholesomeness 61
4.13.2 Controls for risks to wholesomeness 62
4.14 Identification and control of risks from false or misleading labelling 62
4.14.1 Identification of risks from false or misleading labelling 63
4.14.2 Control of risks from false or misleading labelling 64
4.15 Validation of RMP effectiveness 64
4.16 Provision for verification activities 64
4.17 Additional requirements for Dual Operator Butchers 64

5 Checks and validation 66

5.1 Checks 67
5.1.1 RMP documentation 67
5.1.2 Premises and equipment are ready to operate 67
5.2 Validation 67
5.2.1 Validation procedure 68
5.2.2 Desired outcomes of validation 68
5.2.3 Protocol for validation 69
5.2.4 Trial design 70
5.2.4.1 Validation trial design 70
5.2.4.2 Uncontrolled parameters 70
5.2.4.3 Microbiological challenge testing 70
5.2.5 Records of validation information 70
5.2.6 Amendments to the RMP 72
5.2.7 Common validation mistakes 72

6 Evaluation 74
6.1 Evaluation of RMPs 76
6.1.1 Selection of a recognised evaluator 76
6.1.2 Evaluations of RMPs that cover both dairy and non-dairy 76
6.1.3 Desk-top assessment 76
6.1.4 On-site assessment 76
6.1.5 Resolving RMP deficiencies 77
6.2 Evaluation report 77
6.3 Evaluation after completing validation 77
6.4 Evaluation of significant amendments 78

7 Registration 79
7.1 Application for registration 79
7.1.1 RMP “required parts” to be submitted for registration 80
7.1.2 Electronic applications vs hard copy applications 81
7.2 Pre-registration assessment of RMP documentation 81
7.2.1 Pre-registration assessment procedure 81

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7.3 Refusal to register 82

7.4 Condition close-out after completion of validation 82
7.5 Registration of significant amendments 83
7.6 Change of registration details 83
7.6.1 Change in operator or operator name only 83
7.6.2 Change in day-to-day manager of an RMP 83
7.6.3 Change in recognised agency 83
7.7 Multi-business RMP registration 83

8 Operating your RMP 84

8.1 RMP operators’ duties 84
8.2 Conflict between RMP and the Act, Regulations or Notices 84
8.3 Verification by recognised verifier 85
8.4 Amendments to the RMP 85
8.4.1 Significant amendments to your RMP 85
8.4.2 Minor amendments to RMPs 86
8.4.3 Notifications to MPI 86

9 Ceasing operations or registration of an RMP 87

9.1 Surrender of registration 87
9.2 Suspension of operations 87
9.2.1 Suspension by MPI (mandatory suspension) 87
9.2.2 Suspension by operator (voluntary suspension) 88
9.3 Deregistration of the RMP 88

10 Principally dairy determination for multi-ingredient food 89

Appendix A: Businesses requiring RMPs 90

Appendix B: Businesses not requiring RMPs 93

Appendix C: Examples of limits 95

Appendix D: Procedures and processes requiring validation 103

Appendix E: Validation examples 109

Appendix F: Example of an RMP site plan 111

Appendix G: Guidance on the difference between significant and minor amendments 112
G.1.1 Changing the physical boundaries of the RMP 115
G.1.2 Removal of buildings and/or facilities 115
G.1.3 Construction of new buildings and/or facilities 115
G.1.4 Alterations to existing buildings and/or facilities 115
G.1.5 Relocating process operations 116
G.1.6 Adding new processing equipment 117
G.2.1 Adding new animal material or animal product 117
G.2.2 Adding new animal material within primary processing (non-dairy only) 118
G.2.3 Adding new animal product within secondary processing (non-dairy only) 119
G.3.1 Processing for a different consumer 120
G.3.2 Changes to processing categories 121
G.3.3 Adding new process or process modifications 121

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G.3.4 Changes to supporting systems 122

G.4.1 Merging RMPs 123
G.4.2 Splitting an RMP 123
G.4.3 Changing from a single-business to a multi-business RMP 123
G.4.4 Adding a business to a multi-business RMP 123
G.4.5 Formatting changes to the RMP 123

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Table of Figures and Tables

Figure 1: Animal Products Act framework ........................................................................................................ 18
Figure 2: Example of RMP details ................................................................................................................... 31
Figure 3: Decision tree for hazard analysis and CCP determination ............................................................... 55
Figure 4: Evaluation and registration process .................................................................................................. 75
Figure 5: Example site plan ........................................................................................................................... 111
Figure 6: Guiding principles to determine between a significant or minor amendment to your RMP ............. 112
Figure 7: Breakdown of the types of amendments and the corresponding section of Appendix G ................ 114

Table 1: RMP tasks and responsibilities .......................................................................................................... 27

Table 2: Components of an RMP..................................................................................................................... 28
Table 3: Examples of identifiers ....................................................................................................................... 29
Table 4: Example of an RMP document list ..................................................................................................... 31
Table 5: Examples of product description ........................................................................................................ 34
Table 6: Skills of responsible persons ............................................................................................................. 46
Table 7: Hazard identification for inputs ........................................................................................................... 52
Table 8: Hazard analysis and CCP determination template (includes an example of receiving honey supers)56
Table 9: Further explanation of headings in Table 8 ........................................................................................ 57
Table 10: Common HACCP mistakes .............................................................................................................. 61
Table 11: Examples of risks to wholesomeness and their controls .................................................................. 62
Table 12: Examples of risks from false or misleading labelling and their controls ........................................... 63
Table 13: Summary of document checks and validation of the RMP ............................................................... 66
Table 14: Example of desired outcomes to be achieved and possible evidence ............................................. 68
Table 15: Expectations for validation information ............................................................................................ 71
Table 16: Common validation mistakes and corresponding remedial actions ................................................. 72
Table 17: Example of limits for products for human consumption ................................................................... 95
Table 18: Examples of limits for products for animal consumption ................................................................ 100
Table 19: Examples of limits for dairy material and dairy products for human consumption ......................... 101
Table 20: Supporting system ......................................................................................................................... 103
Table 21: Supply of Animal Material .............................................................................................................. 104
Table 22: Primary Processing of animal products.......................................................................................... 105
Table 23: Secondary processing ................................................................................................................... 106

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1 Purpose
The Risk Management Programme (RMP) Manual has been prepared by the New Zealand Food Safety
(NZFS) business unit of the Ministry for Primary Industries (MPI) as a step-by-step guide to help you as an
animal product business operator to develop and operate your RMP. The manual provides answers to the
following questions:
• What is an RMP?
• Who needs an RMP?
• What resources are available to help you develop an RMP?
• What do you need in an RMP?
• How do you get an RMP evaluated and registered?
• How do you operate and amend an RMP?

1.1 How to interpret the RMP manual

Regulatory requirements and guidance information are differentiated in this document.

A regulatory requirement is identified by having a citation at the end of the relevant sentence or clause in
[square brackets] and the specific legislation from which the requirement has been taken. The word “must” is
often used to indicate its mandatory status. For example: “The operator of a risk management programme
must ensure that animal material, animal product, and other inputs are processed and handled in a way that
manages and minimises their contamination and deterioration” [AP Reg 58(1)].

In some cases, the requirements have been paraphrased or reworded using animal material and product
examples for context. Operators should refer to the cited legislation for the actual wording of the legal
requirement. You should also check the current edition of the documents or references mentioned in this
manual as they are amended from time to time. This Guidance may not reflect the latest amendments.

Guidance information, indicated by “should”, provides explanatory information, examples or options for
achieving a particular outcome or requirement. Operators may use alternative methods or measures to those
set out in the manual, provided they do not compromise good operating practices and the achievement of the
requirements. It is your responsibility as an RMP operator to ensure that all animal material and product is fit
for its intended purpose.

1.2 Definitions
APA or the Act means the Animal Products Act 1999, unless otherwise stated
animal means any member of the animal kingdom, and includes:
a) any mammal, bird, finfish, shellfish, reptile, amphibian, insect or invertebrate:
b) any other creature or entity that is declared by the Minister by notice in the Gazette to be an
animal for the purposes of the APA;
but does not include a human being [APA 4(1)]
animal consumption (see human or animal consumption)
animal material means any live or dead animal, or any tissue or other material taken or derived from an
animal [APA 4(1)]
animal product, or product means any animal material that has been processed (other than simply
transported or stored in such a way as not to involve any alteration to its nature) for the purpose, or ultimate
purpose, of consumption or other use by humans or animals [APA 4(1)]

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animal product business means a business undertaking that, for reward or for the purposes of trade,-
a) produces or processes animal material or product; or
b) exports animal material or product [APA 4(1)]
animal product officer, or officer, means a person appointed as an animal product officer under section 78
of the APA and includes the Director-General [APA 4(1)]
contaminant means any substance or thing which-
a) is undesirable, potentially harmful, or unexpected in a particular product or process; and
b) is or may be present in, or in contact with, animal material or animal product [APA 4(1)]
control:
a) when used as a noun means the state wherein correct procedures are being followed and any
established criteria are being met;
b) when used as a verb means to take all necessary actions to ensure and maintain compliance
with established criteria and procedures (see Codex GPFH)
corrective action includes an action-
a) to restore control; or
b) to identify any affected animal material or animal product, and –
i) ensure its fitness for intended purpose; or
ii) manage its disposal; or
c) to prevent recurrence of a loss of control [AP Reg 3]
critical control point, in relation to a hazard of significance referred to in section 17(3)(b) of APA, means a
point at which it is essential to use processes or procedures to control the hazard (whether by preventing or
eliminating it, or reducing it to an acceptable level) [AP Reg 3]
critical limit means a criterion, observable or measurable, relating to a control measure at a critical control
point that separates acceptability from unacceptability of animal material or animal product [AP Reg 3]
critical non-compliance means, in relation to a breach of a regulatory requirement, a breach that makes it
reasonably likely that 1 or more of the following may occur:
a) animal or human health is adversely affected;
b) access to overseas markets is jeopardised;
c) the integrity of the official assurance system is threatened;
d) the integrity of test results is threatened [AP Reg 3]
Director-General (D-G) means the chief executive of the Ministry [APA 4(1)]
day-to-day manager means the person identified in a RMP either by name, or the position or designation as
being responsible for the day-to-day management of that RMP as nominated by the owner or operator of the
business
document (verb) means to include in writing in the risk management programme (RMP)
dual operator butcher, or dual operator (DOB), means a retail butcher who:
a) is listed by the Director-General as a homekill or recreational catch service provider under
section 76 of APA; and
b) processes homekill or recreational catch at the same premises or place as the retail butcher
processes or trades in regulated animal product [APA 4(1)]
evaluation means the process of independent assessment of the validity of an RMP for the purposes of
providing an independent evaluation report as required under section 20(2)(b) of the APA
evaluator means a person or agency who is recognised under APA to carry out independent evaluations of
the validity of RMPs and the validity of significant amendments to those programmes [AP Reg 3]

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export requirements means requirements specified by the Director-General by notice under section 167(1)
of APA, in relation to all or any class or description of animal material or animal product intended for export, if
the Director-General is satisfied that the setting of the requirements—
a) is necessary or desirable for the purpose of facilitating access to overseas markets; or
b) is in accordance with the requirements of the relevant authority of the importing country, or can
reasonably be expected to satisfy the requirements of the relevant authority of the importing
country; or
c) is necessary or desirable to safeguard assurances provided by New Zealand [APA 60]
exporter means a person who exports any animal material or product from New Zealand, whether or not for
reward or for purposes of trade; and, where an exporter registered under Part 5 of APA is based overseas,
includes the New Zealand agent or representative of that exporter [APA 4(1)]
farm dairy means a place where milking animals are milked on a permanent or temporary basis; and
(1) subject to paragraph (2), includes:
a) any stockyard, milking yard, feed yard, silo pad, or other construction associated with or involved
in the activity of extracting milk from milking animals; and
b) any place where milk from the milking animals is first collected, filtered, deposited, cooled,
stored, or treated for transport or for further processing; but
(2) does not include any place where any further processing takes place, or transport to that place [APA
4(1)]
farm dairy operator means the person in charge of operations at a farm dairy, including the extraction of milk
from milking animals [APA 4(1)]
finfish has the same meaning as in the Fisheries Act 1996 [APA 4(1)]
fish means finfish and shellfish [APA 4(1)]
fit for intended purpose, used in relation to animal product that has been processed in accordance
with Parts 2 to 4 of APA, means that, by reason of animal material or product having had the relevant risk
factors managed in accordance with Parts 2 and 3 of APA, and meeting any relevant animal product
standards and any supplementary notices, the product is suitable for the purpose for which the product is
specifically stated or could reasonably be presumed to be intended having regard to its nature, packaging,
and identification [APA 4(1)]
food in the Food Act, unless the context otherwise requires,
a) means anything that is used, capable of being used, or represented as being for use, for human
consumption (whether raw, prepared, or partly prepared); and
b) includes—
i) seeds, plants, or plant material intended for human consumption, including seeds that are
intended to be sprouted and consumed as sprouts, but not other seeds, plants, or plant
material intended for planting; and
ii) live animals intended for human consumption at the place of purchase; and
iii) live animals intended for human consumption that are sold in retail premises; and
iv) any ingredient or other constituent of any food or drink, whether that ingredient or other
constituent is consumed or represented for consumption on its own by humans, or is used
in the preparation of, or mixed with or added to, any food or drink; and
v) anything that is or is intended to be mixed with or added to any food or drink; and
vi) chewing gum, and any ingredient of chewing gum, and anything that is or is intended to be
mixed with or added to chewing gum; and
vii) anything that is declared by the Governor-General, by Order in Council made
under section 393, to be food for the purposes of this Food Act [Food Act 2014]

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food control plan (FCP) is a plan designed for a particular food business to identify, control, manage and
eliminate or minimise hazards or other relevant factors for the purpose of achieving safe and suitable food,
taking into account:
a) each type of food that the food business trades in;
b) each type of process or operation that is applied to the food; and
c) each place in which the food business trades in food [Food Act 2014]
game estate means a place within which animals are kept (whether all of the time or only some of the time),
as if in the wild, for the purpose of providing opportunities for persons to hunt or catch them as recreational
catch as if in the wild, being animals of a species, kind, or description specified for the purposes of section
65B of the APA by the Director-General by notice under section 167(1) of APA [APA 65B]
game estate animal means any of the following (see section 65B of APA):
a) any deer species (including, but not limited to, red deer, fallow deer, wapiti deer (elk), sika deer,
white tail deer and sambar deer);
b) tahr;
c) chamois;
d) goats;
e) pigs;
f) wallabies;
g) buffalo;
h) sheep;
i) cattle [PSP Notice A1.3].
good operating practice (GOP) (including good agricultural practice, good hygienic practice and good
manufacturing practice) means documented procedures relating to practices that:
a) are required to ensure animal material and animal product are fit for intended purpose; and
b) are appropriate to the operating circumstances to which they relate
HACCP means a system which identifies, evaluates and controls hazards that are significant for food safety
HACCP plan means documentation or set of documents, prepared in accordance with the principles of
HACCP to ensure control of significant hazards in the food business (see Codex GPFH)
hazard means a biological, chemical, or physical agent that:
a) is in or has the potential to be in animal material or animal product, or is or has the potential to be
a condition of animal material or animal product; and
b) leads or could lead to an adverse health effect on humans or animals [APA 4(1)]
hazard analysis means the process of collecting and evaluating information on hazards identified in raw
materials and other ingredients, the environment, in the process or in the food, and conditions leading to their
presence to decide whether or not these are significant hazards (see Codex GPFH).
homekill means an animal that is killed or processed by its owner, or by a person who is listed as a homekill
or recreational catch service provider under section 76 of the APA, for the use or consumption of the owner
[APA 4(1)]
homekill or recreational catch service provider means a person who is listed by the D-G, to kill or process
homekill or recreational catch for reward, for the owner, hunter or harvester of the animal without needing to
have, or to comply with a registered RMP [APA 4(1)]
human or animal consumption used in relation to any animal product, means that the product is intended to
be eaten, or taken orally, or administered parenterally, or applied topically [APA 4(1)]
input means any animal material, animal product, or anything (such as an additive, a processing aid,
ingredient, or packaging) that is intended to be contained within, attached to, enclosed with, or otherwise in
contact with, the animal material or animal product [AP Reg 3]

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in writing means printed, typewritten, or otherwise visibly represented, copied, or reproduced, including by
fax or email or other electronic means [APA 4(1)]
MPI means the Ministry for Primary Industries
monitor in the context of a HACCP Plan, means the act of conducting a planned sequence of observations or
measurements of control parameters to assess whether a critical control point is under control.
multi-business RMP means an RMP where approval is given under section 17A of the APA for that
programme to apply to more than one business
non-conforming, in relation to animal material or animal product, means any material or product that is
known—
a) not to meet regulatory requirements; or
b) not to have been processed in accordance with regulatory requirements [AP Reg 3]
official assurance means a general statement to a foreign government or an agent of a foreign government,
attesting that, as appropriate, any 1 or more of the following applies in respect of any animal material or
animal product:
a) any specified process has been completed under the APA with respect to the animal material or
product concerned;
b) the animal product concerned meets the applicable animal product standards and any
supplementary notices;
c) any export requirements that are stated in the assurance have been met;
d) the situation in New Zealand, in relation to any matter concerning animal material or animal
products, is as stated in the assurance [APA 61(2)]
operator in relation to an animal product business, means the owner or other person in control of the
business [APA 4(1)]
operator-defined limit means a measurable limit established by a risk management programme operator to
manage the fitness for intended purpose of animal material or animal product [AP Reg 3]
operator verification means verification carried out by an operator
output means animal material or animal product resulting from an operation undertaken under an RMP
overseas market access requirement (OMAR) means export requirements specific to an identified
overseas market or markets.
parenterally means administering a substance to a human or animal by a route other than orally or topically
[APA 4(1)]
place includes any building, conveyance, craft, fishing vessel, or structure; and includes any land, water, or
other area where animals or animal material are produced or may be present [APA 4(1)]
premises include:
a) all premises, places and facilities within the physical boundary of any relevant RMP; and
b) any vessel or other conveyance, and any mobile premises, used for harvesting or processing
animal material or animal product, other than a transportation unit or animal material depot; and
c) the fixtures and fittings that form part of any premises [PSP Notice A1.3]
process includes kill, slaughter, dress, cut, extract, manufacture, pack, preserve, transport and store [APA
4(1)]
readily accessible in relation to documentation means that no matter where documents are stored, they can
be transferred electronically, mailed, couriered, or transferred by other means within the time period stated
recognised agency means a person or group of persons recognised by the Director-General under section
101 or 102, and section 102 respectively of the APA for the purpose of performing specified functions or
activities [APA 4(1)]

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recreational catch means a wild animal that—

a) is killed, captured, taken, or harvested by a recreational hunter or fisher, or other person
undertaking similar recreational activities (including a client hunter killing or catching an animal
on a game estate, as if in the wild), for the use or consumption of the hunter, fisher, or other
person in terms of section 68 of APA; and
b) is processed either by its catcher or by another person under section 69 of APA, and not in
compliance with Parts 2 to 4 of APA [APA 4](1)]
registration number means a unique identification code, selected by the operator and confirmed by MPI for a
premises covered by an RMP [AP Reg 5]
regulated control scheme (RCS) means a programme which is imposed by the D-G to manage risks where:
a) RMPs would not be feasible or practicable for the relevant risk factors to be managed; or
b) where it is more efficient for the government to run the programme or it may require statutory
authority to manage the risk factors; or
c) the measures are additional to meet any export requirements [APA 4(1)]
regulatory limit means a measurable regulatory requirement that is critical to fitness for intended purpose of
animal material or animal product [AP Reg 3]
required parts means those part of the RMP that must be submitted for registration if the operator is not
submitting the entire RMP [see AP Reg 26 & 27]
rendering means the breaking down of animal tissues into constituent fat and protein elements, whether by
the application of heat and pressure or otherwise [APA 4(1)]
retail butcher includes any type of butcher engaged in retail trade in regulated animal products [APA 4(1)]
risk factors means:
a) risks from hazards to animal or human health;
b) risks from false or misleading labelling; and
c) risks to the wholesomeness of animal material or animal product [APA 4(1)]
risk management programme (RMP) is a programme designed to both identify, and control, manage, and
eliminate or minimise hazards and other risk factors in relation to the production and processing of animal
material and animal products, in order to ensure that the resulting animal product is fit for intended purpose
[APA 4(1)]
sanitise means to disinfect, or to otherwise reduce or maintain microbial contamination to or at a level that
avoids the creation of a hazard, by the application of maintenance compounds or other things (such as steam
or light) [PSP Notice A1.3(1)]
secondary processor (non-dairy only) means a person who, for reward (other than as an employee) or for
purposes of trade, processes animal product at any stage beyond its primary processing [APA 4(1)]
shellfish has the same meaning as in the Fisheries Act 1996 [APA 4(1)]
shelf life means the period nominated and validated by the operator during which a product maintains its
fitness for intended purpose under specified conditions
single-business risk management programme means an RMP covering a single business
step means a point, procedure, operation or stage in the food chain, including raw materials, from primary
production to final consumption (see Codex GPFH)
topically means applying a substance externally to a part of the body of a human or animal [APA 4(1)]
trade means sell for human or animal consumption or use; and includes:
a) selling for resale (including as a constituent part of another article) for human or animal
consumption or use; and

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b) offering or attempting to sell, or receiving for sale, or having in possession or exposing for sale,
or sending or delivering for sale, or causing or permitting to be sold, offered, or exposed for sale;
and
c) barter; and
d) supplying an article under a contract, together with other goods or services or both, in
consideration of an inclusive charge for the article and the other goods or services; and
e) supplying an article where there is a statutory responsibility to supply; and
f) offering as a public prize or reward, or giving away for the purpose of advertisement or in the
furtherance of any trade or business; and
g) every other method of disposition for valuable consideration [APA 4(1)]
uncontrolled hazard means a hazard that—
a) has been identified in a hazard analysis for the processing activity or animal material or animal
product; and
b) is one for which the operator of the risk management programme has no control measure
available; and
c) is not subject to any regulatory limit or operator-defined limit [AP Reg 16(2)]
unique location identifier (dairy only) means a unique identification code to indicate the location or premises
within a risk management programme
validate means the process by which evidence is obtained to demonstrate that the risk management
programme is effective and animal material or animal product will be fit for its intended purpose, through the
achievement of any regulatory or operator-defined limit
validation protocol is a document that sets out how the operator will demonstrate that the RMP or aspects of
the RMP are effective [AP Reg 34(2) & PSP Notice B1.3]
verification includes the application of methods, procedures, tests, and other checks conducted by a verifier
to confirm—
a) in relation to a risk management programme or regulated control scheme—
i) whether operations that are subject to the programme or scheme are being carried out in
compliance with it; and
ii) the applicability of the programme or scheme to the operations of the relevant animal
product business; and
iii) the effectiveness of the programme or scheme;
b) in relation to animal material or animal products for whose export an official assurance is
required, whether the animal material or animal products have been produced or processed in a
way that meets the requirements for the official assurance;
c) whether a regulated person has complied with a requirement imposed by or under APA [APA
4(1)]
verifier means a recognised person whose specified functions and activities include carrying out verification
functions and activities [APA 4(1)]
wholesomeness in relation to any regulated animal product, means that the product does not contain or have
attached to it, enclosed with it, or in contact with it anything that is offensive, or whose presence would be
unexpected or unusual in product of that description [APA 4(1)]
wild animal means an animal that:
a) is a kind that occurs in the wild or in the sea; and
b) is not, immediately before its taking or capture, owned by any person [APA 4(1)]
Note - Any term or expression that is defined in the Animal Products Act 1999, Regulations and Notices made
under those Acts and used, but not defined, has the same meaning as in those Acts, Regulations or Notices.

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1.3 Abbreviations
ACVM Act: Agricultural Compounds and Veterinary Medicines Act 1997
AP Reg: Animal Products Regulations 2021
AP Reg amendment Animal Products Amendment Regulations 2022
APA: Animal Products Act 1999
D-G: Director-General
CCP: Critical Control Point
COP: Code of Practice or Operational Code
Codex GPFH: Codex Alimentarius Commission, General Principles of Food Hygiene, CXC 1-1969
(amended 2020)
DOB: Dual Operator Butcher
FCP: Food Control Plan
Food Act: Food Act 2014
FSC: Food Standards Code
GOP: Good Operating Practice
HACCP: Hazard Analysis and Critical Control Point
ISO: International Organisation for Standardisation
MPI: Ministry for Primary Industries
NMD Notice: Animal Products Notice: National Microbiological Database Programme
NZFS: New Zealand Food Safety
NZQA: New Zealand Qualifications Authority
OMAR: Overseas Market Access Requirement
PSP Notice: Animal Products Notice: Production, Supply and Processing
RA: Recognised Agency
RCS: Regulated Control Scheme
RMP: Risk Management Programme
EU: European Union
US: United States of America

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2 Background
NZFS, a business unit within MPI, is accountable for food/animal product control in New Zealand and for the
implementation and overall performance of the regulatory framework. The regulatory framework has been
established to define MPI’s responsibilities as a regulator, the responsibilities of recognised agencies and
persons, and you as the animal product business operator.

You, as operators of animal product businesses, are responsible for producing suitable animal material and
products that are fit for their intended purpose. Animal product businesses must not rely on MPI or recognised
agencies and persons to ensure the delivery of such products.

2.1 The Animal Products Act framework

The Animal Products Act 1999 (APA) sets up New Zealand’s legal framework for processing animal material
and products that all RMP operators must comply with (as described in Figure 1: Animal Products Act
framework below). Check the New Zealand Legislation website for the latest version of the APA and the AP
Regs.

Figure 1: Animal Products Act framework

Animal Products Act 1999

Sources of Information:
• Codes
• RMP templates and models
Regulations and Notices • MPI guidance documents
• HACCP plans
• technical publications
Operator’s registered risk • predictive models
management programme • trials and experiments
(RMP) • registered food control plans (FCP)
assessed against RMP requirements

The APA and its subordinate legislation are administered by MPI. The risk management system under the
APA provides for:
• the management of identified risk factors to ensure that animal materials and animal products are fit for
their intended purpose (for human or animal consumption); and
• facilitating access to overseas markets.

The risk management system comprises four main types of controls:

• Risk Management Programmes (RMPs);
• Regulated Control Schemes (RCS);
• export requirements; and
• authorisations and duties on various persons.

Each of these is explained in sections 2.1.1 to 2.1.4 of this manual.

You can see the APA Notices here

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2.1.1 Risk Management Programmes (RMP)

(Part 2 of the APA)

An RMP is a documented programme designed to identify and control risk factors in relation to the production
and processing of animal materials and animal products. This is to ensure that the resulting animal product is
fit for its intended purpose. The RMP is based on the principles of Hazard Analysis and Critical Control Points
(HACCP).

There are four types of risk factors:

• risks from hazards to human health;
• risks from hazards to animal health;
• risks from false or misleading labelling; and
• risks to the wholesomeness of animal material or animal product.

The first two points are collectively known as “hazards”. The second two are known as “other risk factors”.

To find out what is legally required to be included in an RMP, section 17 of the APA (Contents of and
Requirements for Risk Management Programmes) must be read in conjunction with the:
• Animal Products Regulations 2021; and
• Animal Products Notice: Production, Supply and Processing

2.1.2 Regulated Control Schemes (RCS)

(Part 3 of the APA)

A regulated control scheme (RCS) is a scheme developed by MPI to manage risks, where:
• RMPs would not be feasible or practicable;
• it is more efficient for the government to run the programme; or
• it is needed to meet the market access requirements of foreign governments.

Examples of RCSs include:

• Animal Products (Regulated Control Scheme – Bivalve Molluscan Shellfish) Regulations 2006; and
• Animal Products Notice: Regulated Control Scheme – Bivalve Molluscan Shellfish for Human
Consumption.
• Animal Products Notice: Regulated Control Scheme – Transport and Handling of Products for Export
with an Official Assurance.

You should refer to the relevant RCS Regulation and/or Notice for the requirements you will need to meet.
There may also be templates that you can use e.g. Regulated Control Scheme (RCS) Template for Transport
of Animal Material and Product.

2.1.3 Export requirements

(Part 5 of the APA)

There are general export requirements that apply to all exporters of animal materials or animal products. The
exported products must meet New Zealand Standards and comply with any additional requirements issued by
Notice, either as general export requirements or market specific requirements (these are called Overseas
Market Access Requirements (OMARs)) [APA 60 (1)]. Refer to the relevant Animal Product Notices (e.g. the
Animal Products Notice: Official Assurances Specifications for Animal Material and Animal Products and the
Animal Products Notice: Official Assurances Specifications for Dairy Material and Dairy Products) for the
additional requirements you need to meet.

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It is your choice whether to include procedures that describe how export requirements are met (e.g. OMARs)
in your RMP unless the OMAR requires otherwise. Businesses that are geared for markets such as the EU or
the US may choose to incorporate OMARs into their RMP. If you include export requirements in your RMP,
these will be the procedures you must operate to, i.e. meet New Zealand Standards and export requirements
to be compliant with the RMP.

For more information about the requirements for exporting animal product click this link: Requirements for
exporting animal products

If you have any questions about exporting animal products, email [email protected] for assistance.

2.1.4 Authorisations and duties

(Part 8 of the APA)

MPI can recognise agencies and persons to carry out certain functions and activities (e.g. evaluation and
verification of RMPs). A public register for all recognised agencies and persons is on the MPI Registers and
lists webpage. You can find out who has been recognised for the different functions by searching for the
following links:
• Evaluators;
• Verifiers;
• Dairy Specialists and Farm Dairy Assessors
• Animal products recognised agencies - including dairy; and
• Animal Product Recognised Laboratories – Recognised laboratories under APA

The APA also imposes duties on key persons. These are:

• RMP operators (see 8.1 RMP Operator’s Duties of this manual and section 16 of the APA);
• exporters (see section 51 of the APA);
• recognised agencies (see section 112G of the APA); and
• recognised persons (see section 112H of the APA).

If duties are not complied with, the APA allows for a number of measures to be taken. This can include
increased verification of RMPs by verifiers, suspension or deregistration of RMPs, deregistration of exporters
and removal of recognition of agencies or persons. In addition, those who commit offences under the APA are
liable to be prosecuted, and if found guilty, could be fined and/or even imprisoned.

2.2 Businesses requiring an RMP

See Appendix A: Businesses Requiring RMPs for details of the types of businesses that require an RMP.

2.3 Businesses not requiring an RMP

See Appendix B: Businesses Not Requiring RMPs for details of the types of businesses that do not need an
RMP. Some of these businesses may instead be required to operate under a risk-based measure under the
Food Act.

2.4 RMP configurations

You can develop an RMP as a stand-alone programme for each [APA 12]:
• type of animal material or animal product that the business produces or processes; and
• type of process or operation that is applied to the animal material or product; and

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• set of premises or place in which the animal material or product is produced or processed.

An RMP may also cover one or more materials, products, processes, operations, places or premises (sites).

An RMP may be developed for a single business or cover multiple businesses.

2.4.1 Single-business RMPs

(Section 12 (3) and 12 (4) of the APA)

Single-business RMPs can be:

• single-site, with one RMP (this is the simplest form of RMP);
• single-site, with more than one RMP (this is useful if the operations are split in a logical way, but the
overall cost to the business of registration and evaluation 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. You must be aware that changes to the RMP may impact
on all of the sites that have been included); and
• multi-site, each with more than one RMP (this is complex and should be avoided unless there are
logical reasons for such an arrangement. It would add to the overall cost to the business of registration
and evaluation of the RMPs).

The number of RMPs you will need depends on the complexity of the operation and how practical it is to
maintain and manage each one. Multiple RMPs may give you flexibility if one area of operation is substantially
changed in the future, or one RMP is suspended or deregistered. Export requirements may limit the ability to
use multi-site options, e.g. EU-listed premises (apart from dairy) must have a separate RMP for each physical
location.

2.4.2 Multi-business RMPs

(Section 17A of the APA)

A single RMP may apply to more than one business, if approved under section 17A by the Director-General
(D-G). A multi-business RMP is only appropriate for businesses that have similar operations and where all
operators have agreed to operate under one RMP. The legal requirements for RMPs also apply to multi-
business RMPs.

• Approval may be given subject to conditions. Approval will normally relate to specific businesses, but
may relate to a type of business, premises or place if such a “general approval” provides negligible risk
to human or animal health. If you are interested in this option, contact MPI to discuss further.

2.5 Including non-animal products in an RMP

You may want to include non-animal products in your RMP. The guidance document - Can I include non-
animal product foods in a Risk Management Programme? has been prepared by MPI to explain the options if
you want to include other foods in your RMP.

2.6 Relationship between the APA and other legislation

2.6.1 Food Standards Code (FSC)

The Food Standards Code sets out the standards relating to labelling, composition and contaminants of food
sold, processed or handled for sale or imported into New Zealand and Australia. The Food Standards Code is
developed by Food Standards Australia New Zealand (FSANZ).

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The Food Standards Code will apply regardless of whether operations are managed under the Food Act or
the APA.

You can access the Food Standards Code here.

2.6.2 Food Act 2014

The Food Act is a risk-based approach to managing food safety of food intended for human consumption.
Food business operations that are higher risk from a food safety point of view operate under more stringent
food safety requirements and checks (i.e. an FCP) than lower-risk food businesses (i.e. national programme).

Businesses who are doing some types of animal product primary processing, and those carrying out
secondary processing of animal products with a domestic focus can operate under the Food Act.

2.6.3 Operating under an RMP

(Section 32 of the APA)

Some animal product businesses do not need to operate under an RMP but may still choose this over other
options, such as an FCP. Choosing to operate under an RMP can allow you to more easily take advantage of
future export opportunities for animal products. However, an RMP can only be used if the processing involves
animal materials or animal products.

2.6.4 Operating under an FCP registered as an RMP

(Section 34 of the APA)

If your business operates under an FCP, you may wish to register your FCP as an RMP so that it can be
operated as an RMP under an intermittent basis only. This may be an option if you only occasionally intend to
process animal product for export under the RMP and the rest of the time operate under the FCP. You must
meet any general export requirements, export notices and OMARs applicable to your business while
operating the RMP for export purposes.

Contact MPI Approvals at [email protected] if you intend to operate under an RMP on an intermittent
basis when applying for registration [APA 34(1)].

MPI will decide whether verification will be carried out under the APA or the Food Act or both. You can change
your mind at any time and surrender your RMP registration.

2.6.5 Agricultural Compounds and Veterinary Medicines Act 1997

All agricultural compounds imported, manufactured, sold or used in New Zealand must be authorised under
the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 and its regulations.

The production of petfood in New Zealand is regulated under both the APA and ACVM Act. For example:
• the primary processing of animal products for petfood (e.g. slaughter and dressing of mammals and
birds) is covered by the APA and an RMP is required for these operations; and
• the labelling of manufactured petfood is covered under the ACVM Act.

2.6.6 Medicines Act 1981

Regulation 258 of the AP Reg exempts secondary processors of animal products that are a medicine or a
related product under the Medicines Act 1981 from the requirement to have an RMP and to meet Parts 2 to 4
of the APA.

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If an official assurance under the APA is required for the medicine or related product then an RMP is required
[AP Reg 258(3)].

2.6.7 Dietary supplements

If an official assurance under the APA is required for dietary supplements containing animal products, you will
need an RMP and to comply with the Dietary Supplements Regulations 1985. It is the sponsor’s (the person
legally responsible for placing the product on the market) responsibility to ensure the product is made to an
acceptable quality, is safe to use and complies with the law.

Further information can be found on the Medsafe website.

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3 Resources for developing an RMP

MPI has developed various resources to help when developing your RMP. These can be found on the MPI
website:
• Sector specific Operational Codes and RMP templates;
• Sector specific HACCP plans;
• Sector or topic specific guidance documents.

Additionally the following documents may be useful:

• peer-reviewed scientific information; and
• valid predictive models.

You will need to refer to the APA and any subordinate legislation for the regulatory requirements you must
meet.

Writing your own RMP requires specialist skills, particularly in relation to HACCP application and the
identification and analysis of risk factors. You should seek external assistance (see 3.8 RMP Consultants) if
you need specialist or technical help.

3.1 Codes and templates

Operational Codes, COPs, and RMP templates have been developed to assist businesses to meet regulatory
requirements, and on which an RMP can be based. These documents usually cover good operating practice
(GOP), HACCP application and other RMP requirements. If you follow the Operational Codes, COPs or RMP
templates this will:
• assist you to use current best practice or acceptable industry practices and procedures;
• assist you to address the relevant regulatory requirements within your RMP; and
• simplify the evaluation (where an evaluation is required) and verification of RMPs by verifiers.

3.1.1 Operational Codes and COPs

An Operational Code is a document which reflects agreed industry practice and provides information on how
to meet regulatory requirements. In most cases, an Operational Code is an updated version of a COP.

Parts of an Operational Code that are directly applicable to your business may be incorporated into your RMP
by reference. If you follow the recommendations in an Operational Code you will only need to comply with the
requirements, rather than having to prove that the procedures are valid.

If you decided to incorporate the whole or part(s) of an Operational Code into your RMP, then the
incorporated part(s) becomes mandatory (i.e. it is no longer a guide)

3.1.2 RMP Templates

An RMP template is a document with prompts for each mandatory requirement and includes areas that need
to be filled in to describe your operation e.g. a “fill in the gaps” document. MPI have developed templates for
select sectors only.

In most cases, if your RMP is fully based on a RMP template, the requirement for evaluation will be waived.
Refer to the Waiver of the Requirement to Provide a Copy of an Independent Evaluation Report to check if a
waiver has been given. If evaluation has not been waived, evaluation will still be required.

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You can also use an RMP template as a basis for your own RMP, and make modifications. If any of the
modifications you make are considered to be significant amendments, the parts modified will need to be
evaluated.

3.2 MPI guidance documents

MPI has developed various guides that you may also find useful:
• What is Validation? provides information on validation;
• RMP Operator Resource Toolkit provides examples of RMP forms and procedures (you are free to
modify these to your operation);
• Own-source Water Checklist and Template Water-use Plan (Non-dairy) can be used by non-dairy RMP
operators to develop water-use criteria and a water-use plan when using own-source water;
• Dairy Processors Template Water-use Plan can be used by dairy processors to develop a water-use
plan;
• Listeria Factsheets and Guidance provide information on Listeria and key good operating practices for
managing of Listeria in your operation;
• How to Determine the Shelf Life of Food can help you determine shelf life and how to apply the date
marking;
• Guidance for Dairy Manufacturers provides information to help dairy operators to complete their RMPs
or FCPs.

3.3 HACCP plans

Hazard Analysis and Critical Control Point (HACCP) is an internationally recognised system used to identify
and manage food safety hazards. HACCP can be used throughout all stages of the food chain, from primary
production to final consumption. Applying HACCP principles when developing a RMP is mandatory [APA
section 17].

MPI has developed HACCP guidance and generic HACCP plans to assist RMP operators:
• Hazard Analysis and Critical Control Point web page;
• Standardisation of Hazard Analysis and Critical Control Point (HACCP) describes MPI’s approach to
HACCP and has information on how to apply HACCP Principles;
• MPI Hazard Database has searchable information on food safety hazards that is reasonably likely to
occur in New Zealand, including applicable regulatory limits and actions operators can take to control
the hazards; and
• Sector specific HACCP applications.

3.4 Other procedures

You may have access to documented food control or quality assurance systems that meet customer
requirements (e.g. ISO 9001, FSSC 22000, etc.). You can incorporate by reference the relevant parts of these
documents into your RMP, as long as they do not conflict with any regulatory requirements. You will need to
make sure that RMP components that are not covered by these systems are added to complete your RMP.

3.5 Peer-reviewed scientific information

You may use scientific literature published in reputable journals (i.e. peer reviewed and appropriately
referenced) as a basis for establishing or justifying certain procedures and criteria used in your RMP. The use
of this type of information is only appropriate if the conditions or variables considered in the scientific study are
applicable to the process(es) covered by the RMP.

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3.6 Predictive models

You can use predictive models to establish product and process parameters. A predictive model is a
computer-based software programme that considers the various factors affecting a particular reaction,
operation or activity (e.g. growth or decline of foodborne microorganisms in food, a chemical deterioration,
etc.).

These models are valuable tools to support hazard analyses, develop critical limits and to evaluate the effect
of process deviations. They may also be used to predict the effectiveness of corrective actions but should not
be used in isolation from other resources. Parameters used in predictive models should match process
parameters, otherwise estimates are likely to be misleading.

Examples of some models:

• Pathogen Modelling Programme;
• Food Spoilage & Safety Predictor;
• ComBase;
• E. coli inactivation in fermented meats model developed by Tom Ross; and
• Process Hygiene Index (PHI) - the approximation of the potential bacterial growth that can occur during
the cooling of meat products from slaughter until the meat has cooled to 7°C.

3.7 Food control plans

(Section 32 of the APA)

You may use a FCP as a basis for an RMP, but it will need to be evaluated by a recognised evaluator to
ensure requirements of the APA are met prior to RMP registration.

3.8 RMP consultants

Sometimes it is useful to seek specialist advice to help develop your RMP. If you choose to use a consultant,
it is best to choose one who has relevant industry experience or is otherwise experienced with the APA. You
should check their reputation online and ask for references from customers who got the same or similar work
done.

You should also be clear about the type of advice you are seeking e.g. do you need food safety information
on a specific animal product, or do you need advice on how to meet the food labelling requirements? You
should look for a consultant that will help you understand what to do, and why.

You can find the list of RMP consultants on the MPI website by searching for ‘Hiring a food consultant’.

However, you should note that the consultants on this list are not approved by MPI and MPI has not
carried out any investigation into the qualifications, experience or abilities of any persons listed. The inclusion
of a consultant on the MPI list does not constitute an endorsement or recommendation by the New Zealand
government or MPI and, before employing the services of a consultant, you need to do the normal due
diligence you would when contracting any service provider or tradesperson.

If a recognised person (e.g. evaluator or a verifier) is acting as a consultant to help with the development of
your RMP, they will not be able to evaluate or verify your RMP within certain timeframes [AP Reg 74 & 84]:
a) an evaluator who was involved in the design or development of an RMP or a significant
amendment to that programme must not evaluate the programme for a period of 2 years after the
date on which the programme or amendment is registered, unless the D-G agrees otherwise in
writing [AP Reg 74].

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b) an evaluator must not use a technical expert for the purposes of AP Regs 77(3) or 81(3) if the
technical expert was also involved in the design or development of that programme or the
amendment being evaluated, for a period of 2 years after the date on which the programme or
amendment is registered, unless the D-G agrees otherwise in writing.
c) a verifier must not verify an RMP that they previously evaluated, or for which they evaluated a
significant amendment, for a period of 2 years after the date of the evaluation, unless the D-G
agrees otherwise in writing [AP Reg 84].

4 RMP development
Often a team approach is useful when developing an RMP due to the range of expertise, perspectives and
experiences needed. Members of this team should be selected based on their responsibilities, knowledge and
experience of:
• products and processes;
• hazards relevant to the scope of the RMP; and
• animal product safety practices and principles.

An understanding of the application of HACCP principles is needed to be able to develop and implement an
RMP. If this expertise is not available in-house, MPI recommends staff undertake HACCP training or get
advice from a consultant.

You cannot produce animal material or product for traded before your RMP is registered, so you need to
make sure you allow sufficient time to develop and have your RMP evaluated before registration. This can
take many months.

4.1 RMP responsibilities

Table 1: RMP Tasks and Responsibilities explains the tasks that need to be completed during the
development and implementation of an RMP and who is responsible for each task.

Table 1: RMP tasks and responsibilities

Task Who is What the task involves References to sections of

responsible the RMP Manual
Development Operator Develop the RMP Section 4
Checks & Operator Perform checks and validates the RMP Section 5
Validation
Evaluation Operator Hire a recognised evaluator to evaluate Section 6
the RMP
Recognised Evaluate and report on the validity of the Separate guidance document:
Evaluator RMP Evaluation Manual
Registration Operator Contract a recognised RMP verifying Section 4.16
agency to confirm they will verify the
RMP
Operator Apply to MPI to register the RMP Section 7.1
MPI Registers the RMP
Operation Operator Implement and operate the registered Section 8
RMP

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Task Who is What the task involves References to sections of

responsible the RMP Manual
Operator Verification by operator of RMP Section 4.11.14
Section 4.12.10.2
Verification Recognised External verification by recognised Section 8.3
Verifier verifier
Amendment Operator Amendments to the RMP - Certain Section 8.4
and Notification changes are registered by MPI or
notified to MPI
Operator Application for registration of significant Section 7.5
amendments to existing RMP
Cessation Operator or MPI Surrender of the RMP registration Section 9
Suspension of RMP operations
De-registration of RMP registration

4.2 RMP components

The RMP must include the components that are appropriate to your products and operation shown in Table 2:
Components of an RMP.

Table 2: Components of an RMP

Component Section Reference

Operator, business and RMP identification 4.3
List of RMP documents 4.4
Management authorities and responsibilities 4.5
Scope of the RMP 4.6
Animal material and animal product description 4.7
Limits 4.8
Other product details 4.9
Process description 4.10
Supporting systems/Good Operating Practices 4.11
(including but not limited to procedures for corrective actions for foreseen as well
as unforeseen type loss of control, recall, operator verification, notification,
document control and records)
Application of HACCP 4.12
Identification and control of risks to wholesomeness 4.13
Identification and control of risks from false and misleading labelling 4.14
Validation of RMP effectiveness 4.15
Provision for verification activities 4.16
Additional requirements for homekill and recreational catch providers (Applicable 4.17
to Dual Operator Butchers only)

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Each of these components are discussed below.

4.3 Operator, business and RMP identification

4.3.1 RMP operator
(Section 17, 19(a), 22(1)(b) and 22(1)(c) of the APA)

Your RMP must specify the name and address (including the electronic address, if available) of the business
owner or operator whose programme it is. The operator may be a company, a partnership or a sole trader. If
the operator is a company, then the name must exactly match the details given at the Companies Office, and
you must provide your New Zealand Business Number (NZBN), which can be found on your registration from
the Companies Office. If the operator is a partnership or a sole trader then the name(s) of the business
owner(s) must be given.

You, the operator, have the ultimate responsibility for ensuring that the RMP is effective. You, or the business
itself must be resident in New Zealand as defined in section YD 1 or YD 2 (excluding section YD 2 (2)) of the
Income Tax Act 2007 and you, together with business directors and managers, must be fit and proper persons
to operate an animal product business.

Definition of ‘fit and proper’

A fit and proper person must not have any conviction for an offence, in relation to fraud or dishonesty,
whether in New Zealand or overseas, in regard to running a business of the type covered by the APA [APA
22(1)(b)].

4.3.2 Businesses covered by the RMP

The name(s) of the business(es) or part-businesses covered under the RMP must be given in their legally
correct form. Where there is only one business under the RMP and the business details have already been
given as part of the operator details (see 4.3.1 RMP Operator) then no further information is required. If the
business trades under another name, this must also be provided [AP Reg 5(a)].

4.3.3 RMP identifier

For non-dairy operators, the RMP identifier is a combination of the Registration number (see 4.3.3.1
Registration number) and RMP Suffix (see 4.3.3.2 RMP Suffix).

For dairy operators, the RMP identifier is the Registration number. Dairy operators must also nominate a
Unique Location Identifier (ULI). (See 4.3.3.3 Unique Location Identifier).

A RMP identifier is applied to each RMP (see Table 3: Examples of Identifiers). The RMP identifier will appear
on the registration documentation for the RMP.

Table 3: Examples of identifiers

Registration number RMP Suffix Unique Location Identifier (ULI)

BUS111 01 123
BUS111 02 1234
BUS111 03 567

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4.3.3.1 Registration number

The registration number is a number or number/letter combination of at least 3 and not more than 10
characters with at least one numeric character and no leading zeros. You can indicate in your application the
registration number you want to use, but will need to confirm the availability of the business registration
number with MPI. Alternatively, MPI will assign a registration number. The registration number is not to be the
same as any exporter’s registration number, or an ID used for any other approval under the APA.

Further information
For the purposes of carcass brands, inspection legends and carton seals, there is a physical limit of 6
characters.

You should also consider overseas market access requirements (OMARs) when selecting your registration
number, e.g. EU-listed premises must have individual registration numbers for each premises. Where
appropriate, the registration number will be used by MPI for country listing purposes and may be used by you
for animal product labelling and identification. Any change to a registration number must be reflected in
updated packaging and country listings. Certain country listings may take 6 - 12 weeks to update, therefore,
any product produced under the RMP with a new registration number may not be eligible for export to the
affected countries until country listings have been updated. Once your registration number has been
established, it will be used for any future RMP registration applications.

You can check availability of registration numbers on the MPI website by searching for ‘Registered Risk
Management Programmes’.

Registration numbers from RMPs that are no longer registered are not available.

4.3.3.2 RMP suffix (relevant to Non-dairy only)

Most RMPs have 01 as the default RMP suffix. In rare instances, you may decide to operate one or more
RMPs under a registration number. Non-dairy operators will be assigned a consecutive two digit RMP suffix
(01-99), to each new RMP. Any amendments to the RMP will need to be identified using the appropriate RMP
number to ensure traceability.

4.3.3.3 Unique Location Identifier (Dairy only)

Operators of premises used for dairy manufacture or storage of dairy material or product must be assigned a
unique location identifier (ULI) by MPI for each location specified in the RMP, and the ULI must be included
in the RMP [AP Reg 5(d), PSP Notice D3.2(1)]. The ULI will appear on the registration documentation for
each registered RMP. If the RMP only covers processing at one location the ULI should ideally be the same
as the RMP identifier. An operator may request a specific ULI, but MPI will determine the ULI assigned, and
may decline a request for various reasons, including potential confusion with other premises or RMP IDs, or
another request for the ULI has already been received.

You can check the availability of Dairy ULIs on the MPI website by searching for ‘Register of Dairy Unique
Location Identifiers’.

4.3.4 Operator, business and programme identification

MPI recommends that information covered in 4.3 Operator, Business and RMP Identification is located at the
start of your RMP.

Figure 2: Example of RMP details gives an example of the way the information can be presented.

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Figure 2: Example of RMP details

Registration number:

RMP No:

Unique Location Identifier/s (dairy only):

Name of Operator:

Postal Address of Operator:

Physical Address of Operator:

Electronic Address of Operator:

Name of Business (if different to operator):

Address of Business (if different to operator):

4.4 List of RMP documents

You must have a list of all the documents that make up your RMP and indicate the date or version of the
documents at the time of registration of the RMP or any significant amendment to the RMP [AP Reg 24(3) &
(4), & 27(c)]. You will also need a method of identifying the current version of all documents that make up the
RMP [AP Reg 24(3) & (4)]. These lists may be one and the same.

A contents page may be used to meet this requirement (if sufficient details are included). An example is given
in Table 4: Example of an RMP Document List.

Table 4: Example of an RMP document list

Only for
multi-
businesses
Document Title Section Section Title No of Version – Amendment Businesses
Number Pages Date on record it Applies to
registration version-date
Manual A 3 Cleaning and 10 1– 2– All
Supporting Sanitation 01/01/2022 01/07/22
Systems
Manual B E only
Manual C All but E

Where only parts of a document are included in the RMP, you should clearly show which parts are included or
excluded by referencing those parts of the document that are included or excluded (whichever is easiest).

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4.5 Management authorities and responsibilities

(Section 17 of the APA)

4.5.1 Day-to-day manager of the RMP

You must nominate a person who is responsible for the day-to-day management of the RMP (by position, or
name and position) [AP Reg 5(b)].

This is the person who:

• is the authorised management representative for all aspects of RMP;
• will deal with MPI over any RMP issues; and
• will be present at verification visits.

This person may be the operator, a senior operational manager, a quality/technical manager or person with
similar competencies, authorities and responsibilities.

The operator must ensure the day-to-day manager is familiar with the RMP and has:
• knowledge in food safety of relevant animal materials and products and hygienic procedures and
practices;
• knowledge of regulatory requirements, including responsibilities, related to the effective implementation
of the RMP;
• technical knowledge and experience in the particular product/process; and
• able to liaise and communicate effectively with personnel and MPI.

It is acceptable to have more than one day-to-day manager provided their areas of responsibility are clearly
documented in your RMP.

MPI recommends that you also identify a back-up person and document how this person is assigned to cover
during periods when the day-to-day manager is unavailable.

MPI will need to be notified when the day-to-day manager is changed (see 7.6.2 Change in Day-to-day
Manager of an RMP).

4.5.2 Evidence of sufficient control and consent for a multi-business RMP

(Section 17A of the APA, AP Reg 28)

A person applying to MPI for approval of a multi-business RMP to apply to another business must provide the
following information:
• written evidence that, once registered, the operator of the multi-business risk management programme
will have sufficient control, authority, and accountability for all matters covered by the programme in
relation to each business;
• written evidence that the person applying for approval has obtained the consent or otherwise taken into
account the views of any person whose business is to be covered by the programme.

Examples of possible evidence include a signed contract or written correspondence between the parties.

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4.6 Scope of the RMP

(Sections 12(3) and 12(4) of the APA, AP Reg 6 &7)

The scope describes what is included in, and where necessary what is excluded from an RMP. You should
consider the physical and operational aspects of the RMP when determining your RMP configuration. All
animal material or animal product and the processes or activities covered by the RMP are to be included in
the scope.

4.6.1 Physical boundaries

The physical boundaries are one of the main determinants of the scope of your RMP. You must include a
description of the physical boundaries to which the RMP applies [AP Reg 6]. This must include facilities,
equipment, personnel amenities, external environment, processing, storage, support areas used under the
RMP and must also include any areas not routinely used.

You can show the physical boundaries on a diagram or site plan of the premises, mobile premises or vessel.
An example of a RMP site plan is included in Appendix F: Example of an RMP Site Plan. Wherever possible,
this should be drawn to scale and have enough detail to be able to readily allow the identification of any
changes to the boundary. You should identify any shared premises (both sites and buildings) and any remote
buildings or people living on site. Property boundaries can be used for the physical boundaries rather than the
footprint of the buildings. This may allow for possible constructional changes to be made at a later date
without requiring a significant amendment to the RMP. However, what is included in the physical boundaries
of the RMP will be subject to verification.

Ideally, the boundary should be a continuous line, rather than multiple boundaries (or “bubbles”) under the
same RMP with no designated pathway between the boundaries. If isolated bubbles are used to signify
boundaries, product cannot be moved between these areas nor can any other item used under the RMP (i.e.
cleaning products). If product is moved between the spaces outside of an RMP boundary with no designated
path, it may lose its export eligibility.

For multi-business RMPs, you may provide alternative details instead of the physical boundaries for each
business, premises or place if agreed with MPI. For example, multiple farm dairies operating under a single
multi-business RMP may have their physical boundaries identified by the operator by assigning an identifier
that is specific to each farm dairy and recording its location or address on a register [PSP Notice D2.2(5)].

If you operate a mobile premises ensuring that all appropriate facilities are available at all sites where the
premises operates is your responsibility.

Transport operators can meet the requirement to provide the physical boundaries by maintaining an up-to-
date list of the vehicles covered by the RMP.

4.6.2 Clarification of RMP scope

(Section 17(1) & (2) of the APA)

An RMP must be developed taking into account all relevant sources of potential risk factors that may affect
the animal material, animal product, operations or directly associated things when a person uses areas within
the physical boundaries of the RMP for any activity that is not covered by the programme.

Exclusions from RMP

You must document:

a) any animal material, animal product or food that is within the physical boundaries, but is excluded
from your RMP;

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b) the alternative regime under which they are regulated, e.g. another RMP, an FCP or national
programme under Food Act, ACVM or Medicines Act;
c) how the interfaces between the regimes will be managed; and
d) the authorities and accountabilities for resolving issues associated with those activities (e.g. any
disputes between the operators) [AP Reg 7].

When explaining how the interfaces are managed, you should clarify:
• the names or positions of the people responsible for managing the interface;
• clear identification of the processing areas that are used for RMP and non-RMP activities;
• any hazards or wholesomeness risk factors that may be introduced by the non-RMP activities and
relevant control measures;
• the extent of the operation that is under each regime (e.g. by describing the point at which the process
changes regimes);
• how RMP and non-RMP activities are separated (e.g. occur at the same time, physically separate or
separate by time and/or distance) and how this is managed (including managing personnel); and
• any particular procedures that must occur in between RMP and non-RMP operations (e.g. cleaning
and sanitation).

Shared facilities

If your RMP includes shared facilities (e.g. facilities that are shared with another business) you must
document:
• the areas within the RMP that are shared;
• the activities taking place that are not covered by the RMP, and the times when these activities occur;
• any hazards or wholesomeness risk factors that may be introduced by the other activities and relevant
control measures;
• how the shared facilities are managed, e.g. by complete cleaning, physical separation etc.;
• the names or positions of people responsible for managing the interface; and
• the authorities and accountabilities for resolving issues associated with those activities (e.g. any
disputes between the operators) [AP Reg 7].

Example of records include:

A contract stating who is responsible for maintaining specific buildings or equipment and if problems occur,
how these issues are raised, with the time frames for satisfactory resolution of these issues.

4.7 Animal material and animal product description

(Section 17(1)(c) of the APA & AP Reg 8)

Your RMP must include a description of the animal material and product it covers. Table 5: Examples of
Product Description shows how this information can be presented.

Table 5: Examples of product description

Requirements Example 1 Example 2 Example 3

Product Raw sheep carcasses, Table Eggs Pasteurised Liquid Milk made
cuts, trimmings from raw cows milk
Intended General public General public General public
consumer

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Requirements Example 1 Example 2 Example 3

Intended use • Further processing • To be cooked before • Ready-to-eat
into manufactured consumption
products, retail
products, food service
items
• To be cooked before
consumption
Regulatory None None Maximum microbiological
limits1 limits2:
(additional • Salmonella spp. not
regulatory limits detected in n=5 x 25 g
may apply) • L. monocytogenes not
detected in n=5 x 25 g
• Coagulase Positive
Staphylococci (S. aureus)
1000 cfu/g
• B. cereus 1000 cfu/g
• E. coli 100 cfu/g
Chemical maximum limits:
• Inhibitory Substances 0.006
IU/ml benzyl penicillin
equivalent [PSP Notice]
• Codex Maximum Residue
Limits for Veterinary Drugs
• Codex Extraneous Residue
Limits
• Food Standards Code
Chapter 1.4.1
Processing related limit:
• 72°C for 15 sec3
Action Limits:
• Chlorate 0.1mg/kg
Operator-defined To be defined by the To be defined by the To be defined by the operator,
limits operator operator e.g. for including:
Salmonella Enteritidis • Wholesomeness and
physical hazards
Other product • Packaging and • Have been candled, • Food Standards Code
details labelling as per are visibly clean and Standard 2.5.1
company specification packed • Shelf life and storage
• To be stored at or conditions
below 15°C with best

1 If limits exist, then elsewhere in the RMP the operator must also document actions to be taken when limits are not met.
2 Limits obtained from Table 4 in the PSP Notice.
3 Limit obtained from PSP Notice. Other time/temperature combinations could be used.

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Requirements Example 1 Example 2 Example 3

(refer to document before date of 35 days
xx)4 from date of lay
• Frozen to -12°C • PSP Notice Chapter J

4.7.1 Animal material or product entering or leaving the physical boundaries of the RMP

All of the animal materials or products entering or leaving the physical boundaries of the RMP must be
documented by their name or type, including those intended for human consumption, animal consumption,
industrial or other use [AP Reg 8].

They may be described individually or in groups, providing the grouping does not compromise the
identification and analysis of hazards and other risk factors. Grouping is normally based on having similar
inputs, process steps and intended purpose.

The name or type of animal materials or products required under AP Reg 8 can be addressed by using a
descriptor of the product such as raw, cooked, fermented, dried, canned, smoked, frozen, chilled, etc.

4.7.2 Intended purpose

You must document the intended consumer of the animal material or product that leaves the RMP, including
whether it is intended for:
a) human consumption: e.g. general population, infants, elderly, pregnant women, immuno-
compromised individuals;
b) animal consumption: e.g. pets, zoo animals, farmed animals; or
c) some other purpose e.g. Industrial or technical use (e.g. laboratory media) [AP Reg 8(c)].

AP Reg 8(c) requires you to document the intended use of the animal material or product an whether it
requires further processing, additional preparation by the final consumer or is ready-to-eat. You should include
further details where known, e.g. further processing may be described as canning, pasteurisation, drying, etc.

4.8 Limits
You must document, in relation to each animal material or animal product described in 4.7.1 Animal Material
or Product Entering or Leaving the physical boundaries of the RMP, any relevant regulatory and any operator-
defined limits [AP Reg 11] in relation to:
• risks from hazards to animal or human health;
• risks from false or misleading labelling or representation; and
• risks to the wholesomeness of animal material or animal product.

Regulatory and operator-defined limits define the fitness for intended purpose of animal material or animal
product. Limits that are essential for food safety should be considered when determining critical control points
(CCPs) for your process and may result in a CCP or may be adequately covered by GOP.

Examples of regulatory and operator-defined limits can be found in Appendix C: Examples of Limits.

4 This could be a reference to a company document where the packaging specification is located.

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4.8.1 Regulatory limits

A regulatory limit is a measurable regulatory requirement that is critical to the fitness for intended purpose of
animal material or animal product, e.g. microbiological or chemical limits, pasteurisation parameters for milk,
etc.

Examples of some relevant legislation include:

• Animal Products Act Notices;
• Australia New Zealand Food Standards Code; or
• Food Standards Notices under the Food Act (including the Food Notice: Maximum Residue Levels for
Agricultural Compounds).

4.8.2 Operator-defined limits

Operator-defined limits are measurable limits that are established by you to manage the fitness for intended
purpose of your products. These are limits that are essential for food safety but have not been set in
legislation for the specific product or risk factor of concern.

Examples of operator-defined limits are:

• intrinsic parameters of the final product (e.g. pH, moisture content, water activity, etc.);
• microbiological criteria defining the maximum acceptable level of a hazard in a product for food safety.
An example is the absence of C. botulinum in shelf-stable low-acid canned product;
• maximum levels of physical hazards (e.g. foreign material such as metal, bone, glass, etc.); or
• maximum levels of chemical hazards.

Operator-defined limits are not generally expected for raw animal products that have not undergone further
processing, however, there are exceptions to this, e.g. the PSP Notice requires processors of mechanically
separated meat to set operator-defined limits for the process hygiene indicators of aerobic plate count and E.
coli.

When setting operator-defined limits, you should consider the process, shelf life, intended use and intended
consumer of the product. Products that are ready-to-eat or are intended for vulnerable populations may have
lower microbiological limits than products that are to be processed further or require cooking by the consumer.
Keep in mind that the microbiological limits are a measure of what is to be achieved when the product leaves
the RMP, rather than at the end of its shelf life, and so you may set these lower than the limits applied at the
point of sale or consumption.

You will need to show that the operator-defined limit(s) you have selected are appropriate to your product,
considering its intended use, intended consumer and expected handling after leaving the RMP. You must
retain the information justifying each operator-defined limit [AP Reg12].

Evidence to justify the selection and level of operator-defined limits may include:
• Operational Codes, COPs and RMP templates (see 3.1 Codes and Templates);
• peer-reviewed scientific information (see 3.5 Peer-reviewed Scientific Information);
• predictive models (mathematical modelling) (see 3.6 Predictive Models);
• scientific information from a person or organisation known to be competent (e.g. the Compendium of
Microbiological Criteria for Food issued by FSANZ); or
• international standards or journal articles.

Referring to the source from which you have taken your operator-defined limits should be adequate
justification if the parameter is taken directly from one of the above sources. If not, you will need to prove that
the selected parameter is valid. You may use validation data from your own trials, validation studies or
historical knowledge/data on performance of the control measure. Refer to Part 5 of this manual.

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4.8.3 Actions to be taken when limits are not met

You must document the actions that will be taken if any regulatory or operator-defined limits are not met [AP
Reg13]. Actions will include restoration of control, production disposition, corrective actions and preventative
actions. The actions need to include any specific responses prescribed by Animal Product Notices (e.g.
increased sampling, reprocessing, downgrading or disposal).

4.9 Other product details

You may also include other details in the product description where appropriate, e.g. requirements for post-
mortem examination, packaging, storage, shelf-life, labelling, etc.

4.10 Process description

You must document every process or operation carried out under your RMP, including:
a) all inputs; including rework; and
b) the main activities or steps; and
c) all outputs that are animal material or animal product [AP Reg 9].

The simplest way to describe your process is to use process flow diagrams.

These diagrams provide the foundation for hazard and other risk factor identification and hazard analysis.

Inputs can include:

• animal materials or animal products, e.g. raw milk, live sheep, red meat, fish, eggs, honey, etc.;
• other ingredients, e.g. starch, water, salt, spices, etc.;
• additives or processing aids, e.g. preservatives, antioxidants, colourings, gaseous packing agent, etc.;
and
• packaging.

Your flow diagrams should include the main activities or steps in the process, e.g. any rework, recycling or
multiple processing stream, etc. If you are submitting the ‘required parts’ of an RMP for registration, inclusion
of key process parameters, e.g. processing times and temperatures, will assist MPI to assess your RMP and
minimise the amount of further information that may be requested. Outputs (all animal materials or animal
products) leaving your RMP are to be shown irrespective of their intended use e.g. human consumption,
animal consumption, industrial/technical use or waste.

4.11 Supporting systems/Good Operating Practices (GOP)

Supporting systems include GOP, as described in Part 2 of the AP Regs, that are designed to ensure animal
materials or animal products are consistently produced that are fit for their intended purpose. GOP is an
overarching term and includes several interacting components such as good manufacturing practice (GMP),
good hygienic practice (GHP) and good agricultural practice (GAP). Supporting systems may also be referred
to Standard Operating Procedures (SOPs), Sanitation Standard Operating Procedures (SSOPs), or pre-
requisite programmes (PRPs). For ease of use the terms supporting systems and GOP are used in this
manual interchangeably.

General guidelines:
• The development, implementation and maintenance of GOP are necessary to support the processing
of animal material and product that is fit for its intended purpose at all stages in an operation, from

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reception through to the final product. GOP assist in managing hazards and other risk factors in animal
material or animal product.
• GOP manages many sources of hazards and other risk factors to animal material or animal product
and should ensure that they are processed in an environment in which the presence of contaminants is
minimised. Properly applied GOP provides the foundation for effective application of HACCP
principles.

These procedures must meet the requirements of AP Reg 10 and cover:

• good operating practices (GOP) [AP Reg Part 2];
• the matters set out in sections 17(2) and 17(3) of the APA;

4.11.1 Areas covered by supporting systems

You must ensure that your supporting systems meet all relevant regulatory requirements and include all
procedures that are necessary for your operation [AP Reg 10 & Part 2]. This is likely to include, the following
list. Note that not all regulatory requirements have been listed below and that the regulatory requirements will
be amended from time to time. It is your responsibility to ensure that you have accessed and incorporated the
most recent requirements into your procedures.
• design, location, construction of premises, places, facilities, equipment and essential services [AP Reg
42; PSP Notice Part C1];
• operation of premises etc. [AP Reg 43];
• operation of essential services including lighting, ventilation & process gases [AP Reg 45; PSP Notice
C1.25 - C1.27];
• water [AP Reg 46; PSP Notice Part C1 subpart 4];
• waste management [AP Reg 47; PSP Notice Part C1 subpart 3];
• calibration of measuring equipment & monitoring equipment [AP Reg 48; PSP Notice C1.10];
• cleaning and sanitising procedures [AP Reg 50; PSP Notice C1.6];
• maintenance [AP Reg 51; PSP Notice C1.7];
• use of maintenance compounds [AP Reg 53; PSP Notice C1.8];
• pest control [AP Reg 54; PSP Notice C1.12];
• personal hygiene, health of persons, and clothing & equipment [AP Reg 55; PSP Notice Part C2];
• personnel competencies and training [AP Reg 19 & 20];
• corrective action procedure for managing unforeseen circumstances (i.e. unforeseen types loss of
control) [AP Reg 18(2) and 18(3)];
• verification by operator [AP Reg 22];
• record keeping and document control and record keeping [AP Reg 23 & 24];
• notification requirements;
• reporting requirements [AP Reg 25];
• allergen management;
• labelling and identification [AP Reg 66; PSP Notice Part C3];
• packaging and packing [AP Reg 68; PSP Notice Part C3];
• non-conforming products [AP Reg 70; PSP Notice Part C6];
• traceability [AP Reg 103];
• recall [AP Reg 105];
• receipt of incoming materials [AP Reg 134];
• control of processing operations [AP Reg 58];
• transport [PSP Notice Part C5];
• product specific procedures (e.g. environmental pathogen monitoring) [PSP Notice Part D3];
• Listeria requirements for processors of certain ready-to-eat animal products [PSP Notice Part L3].

In many cases, MPI has incorporated requirements into sector-specific Operational Codes. It is recommended
that you use these documents to help develop your supporting systems.

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4.11.2 Recommended content of each supporting system

The procedures must be appropriate to the operation and contain sufficient detail to enable people with
responsibilities (e.g. staff, managers) to know what to do, to assist in personnel training and to ensure clear
understanding others (e.g. verifiers and evaluators, etc.). Written procedures should be simple and easy to
understand for all personnel. We recommend that your procedures contain the following:
• purpose and scope;
• general requirements and procedures;
• procedures covering:
– control measures (see 4.11.3 Procedures for Process Control)
– monitoring (see 4.11.4 Procedures for Monitoring GOP);
– corrective action (see 4.11.5 Procedures for corrective actions); and
– verification by the operator (see 4.11.7 Procedures for operator verification of GOP)
• records; and
• references to other relevant documents.

The RMP Operator Resource Toolkit was developed to assist you to develop your RMP. The toolkit contains
example forms and procedures that can be modified to suit your operations.

4.11.3 Procedures for process control

Process control procedures should include:

• the procedures for each process step, including rework;
• instructions necessary to make the product correctly (what, when, where, how and by whom); and
• sufficient detail including any critical measurements at each process step (e.g. pH during curing, time
and temperature requirements for cooking, etc.).

After the identification of hazards and their control measures in the HACCP plan, the control measures are
determined to be controlled by GOP or at CCPs (for significant hazards) in the HACCP plan.

Caution should be exercised to ensure accurate translation of validated control measures for the control of
significant hazards at CCPs from the HACCP plan to process control procedures (operation, monitoring,
corrective action and operator verification).

The process control procedures for a CCP are likely to be more detailed than for control measures that are
managed by GOP.

4.11.4 Procedures for monitoring

You need to monitor your GOP procedures to ensure that they are properly implemented and effective. The
frequency of monitoring will depend on the purpose of the GOP procedure and the impact on the animal
material or product’s fitness for intended purpose.

Monitoring procedures should include the:

• identification of the person(s) or position(s) responsible for carrying out the monitoring [AP Reg 19];
• method of monitoring;
• acceptable criteria(s) or limit(s);
• frequency and sampling regime (must be appropriate to ensure consistent control); and
• records to be kept.

Refer to section 4.12.8 of this manual for monitoring of critical limits at CCP in the HACCP system.

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4.11.5 Procedures for corrective actions

As part of your GOP procedures, you must document the specific corrective actions that will be taken if the
results of monitoring of the GOP procedure indicates that there has been a loss of control (for example,
monitoring indicates that your cleaning and sanitation procedures have not been effective). You need to
document how control will be restored; how any affected animal material and animal product will be identified,
managed, or disposed of will, and the action to be taken to prevent the problem from recurring [AP Reg 18].

Your corrective action procedures, should include:

• the identity of the person(s) or position(s) responsible for carrying out the corrective action [AP Reg
19];
• root cause analysis of the non-conformance (if needed);
• procedures for how control is restored;
• procedures for the control & disposition of non-conforming product (e.g. checking the product back to
the last compliant result, etc.);
• any action necessary to prevent reoccurrence of a loss of control
• escalation of the response if corrective action fails;
• follow-up that the corrective actions and preventative actions taken have been effective; and
• the records to be kept including;
– the actions taken;
– any investigations carried out; and
– the disposition of the affected product.

Refer to section 4.12.9 of this manual for corrective action to be undertaken when monitoring results indicate
a loss of control at CCP in the HACCP system.

4.11.6 Corrective action procedure for unforeseen circumstances

You must have a corrective action procedure that will be followed when a problem occurs for which a specific
corrective action has not been documented in the RMP. This includes things like natural disasters or fire, but
may also include smaller points of failure that may impact on the fitness for intended purpose of animal
material and product.

The procedure must specify how you will identify person(s) with the skills suitable to manage the event, and
the records kept in relation to the loss of control and the corrective actions taken [AP Reg 18(2) & (3)]. The
appropriate person may be different for each scenario depending on the skills needed.

The identified person is responsible for aspects such as:

• identification, retention and assessment of non-conforming product (e.g. review of relevant processing
records, analyses to be undertaken, inspection of animal material or animal product, expert advice,
literature review, etc.);
• product disposition5 as appropriate to the nature of the problem and the intended use of the product
(e.g. rework, reject, release under restricted conditions, regrade for alternative use where permitted
under the RMP, etc.); and
• records and reporting to the verifier or verifying agency about any loss of control that adversely affects
the suitability of animal material for processing or the fitness for intended purpose of animal product
[AP Reg 36(1)].

5 Exception reporting and disposition of non-conforming dairy material and dairy product must be undertaken as outlined
in Animal Products Notice: Disposal of Non-conforming Dairy Material or Dairy Product and PSP Notice Part D1.

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4.11.7 Procedures for operator verification

You must undertake operator verification to check that the GOP procedures have been implemented
effectively, monitoring is occurring where planned, and that appropriate corrective actions are taken when
requirements are not met.

Note:
Operator verification is often an area that is not done as frequently or as thoroughly as it should be. It is
important that these procedures are well developed and implemented. Your operator verification is
commonly checked as part of your verification by verifier.

For additional guidance for development and implementation of operator verification procedures, refer MPI
Guidance Document: Operator Verification.

Your procedures for operator verification should specify the responsible persons by name or position,
activities to be performed, their frequency, actions when verification shows that GOP is not effective and
matters to be recorded or reported [AP Reg 19].

Procedures for operator verification must include:

a) regularly checking that all procedures for managing risk factors are appropriate, effective, and
consistent with the regulatory requirements;
b) regularly checking that records are generated as required by the RMP and contain all required
information to demonstrate GOP is effective;
c) regularly checking whether staff are following the documented procedures, including any
validated parameters; and
d) checking, after any significant amendment to the RMP has come into effect, that all parts of the
supporting systems that may be affected by the amendment are effective and properly
implemented [PSP Notice B1.1].

Refer to section 4.12.10 of this manual for operator verification in relation to HACCP and section 4.11.14 for
operator verification of the RMP.

4.11.8 RMP documents and procedures for document control

(Sections 17(1)(a) of the APA)
Every document or part of a document that makes up an RMP must be:
a) legible;
b) dated or marked to identify its version;
c) authorised prior to use, either directly or within the document control system, by:
i) the operator; or
ii) the day-to-day manager of the programme; or
iii) a person nominated to do so in the programme’s document control procedures.
d) available in a readily accessible form when required by any person with responsibilities under the
programme [AP Regs 24, 31, 32 & 33].

The operator of a RMP must have an up-to-date version of the RMP [AP Reg 31(1)].

There is flexibility in how you can document your RMP.

You should ensure that the format used for the RMP is user friendly for relevant personnel, the verifier and
evaluator. The D-G can require you to amend your RMP if it is not clear enough [APA 26A].

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If a RMP document (e.g. a GOP procedure) has become obsolete, it needs to be archived. You will need to
keep a copy of the document for the longer of:
a) 4 years; or
b) the shelf life of the animal material or animal product to which the RMP relates.

They need to kept in a manner that will protect them from damage and deterioration, and prevents confusion
with documents currently making up the RMP [AP Reg 32].

The registered RMP, all reference material relating to the RMP, and any archived documents must be readily
accessible and made available within 2 working days of any request to:
a) a recognised person or agency;
b) an animal product officer;
c) the Director-General; and
d) persons authorised by the Director-General [AP Reg 33].

4.11.8.1 Authorisation or “sign-off” of documents

All RMP documents must be authorised by a person with appropriate authority (e.g. day-to-day manager of
the RMP or the person or position assigned the responsibility) before the RMP is registered and after any
amendments are made [AP Reg 19 & 24(6)].

Authorisation can be done either by signing each page of the RMP or by some other way described in the
document control system, e.g.:
• signing a document list or contents page that shows the current dates or versions and number of
pages of each document; or
• electronic signatures, so long as there are sufficient controls on access to passwords and authorisation
codes.

An electronic signature must:

a) identify the person who has signed the document;
b) indicate the person who signed the document is approving the information in the document (for
example by placing the electronic signature at the end of the information in the document);
c) be reliable given the purpose and circumstances for which it is required; and
d) not be altered, or if it can be altered, any alteration must be able to be identifiable.

4.11.8.2 Amendments

Your document control procedures for effectively controlling of all RMP documents must include how:
a) significant and minor amendments will be made so that the RMP is current and reflects the actual
operation;
b) amendments, or the nature of the amendments will be identified or described;
c) documents are authorised prior to issue and use; and
d) all amended parts of the RMP will be removed from use and replaced with the current version at
all locations without unnecessary delay after authorisation and, where necessary, after
registration of a significant amendment [AP Reg 24(1) & (2)].

These should also include procedures for:

• documenting the amendment in a legible manner (Twink™ should not be used);
• deciding if the amendment is significant with appropriate justification;
• if an amendment is significant, proceeding with evaluation and registration described later in 8.4.1
Significant Amendments to your RMP;

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• if an amendment is minor (with or without notification to MPI), follow with procedures described in 8.4.2
Minor Amendments to RMPs;
• implementing the amendment.

Examples of ways to indicate amended parts of an RMP are:

• increasing the version number of amended pages or sections;
• placing a line in the margin of relevant pages showing where amendments have been made;
• highlighting or otherwise changing the format of the amended sections;
• describing the changes in an amendment page or register.

4.11.9 Record keeping

(Section 77H and 77G of the APA)

Records are the evidence which demonstrate your compliance with the RMP. Record keeping procedures
must ensure that all records necessary to demonstrate compliance with the RMP are:
a) legible; and
b) stored for 4 years, or for the shelf life of the product to which the records relate (whichever is
longer) in a manner which protects the records from damage, deterioration or loss; and
c) can be retrieved and made available within two working days of any request [AP Reg 23 & 33]

Any records relating to monitoring, corrective action, and operator verification must:
a) specify when the activity occurred (including the date);
b) give a description of the results of the activity; and
c) identify who performed the activity [PSP Notice B1.2].

All records relevant to the RMP must be made available to the following persons on request:
a) recognised persons;
b) animal product officers;
c) the Director-General; and
d) persons authorised by the Director-General [AP Reg 33].

Refer to Part 5.2.5 of this manual for the additional requirements for the retention of records and information
resulting from validation.

4.11.9.1 Electronic records

Where records are kept electronically, the operator should ensure that:
• electronic records cannot be altered without authorisation;
• any alterations are noted;
• records cannot be lost or damaged for the required time; and
• records are accessible to relevant people.

4.11.10 Competencies and skills

Where MPI have set specific training or knowledge requirements in law, these are referred to as
“competencies”. If specific competencies have not been set, it is up to you to identify the skills needed to
perform a task or role.

4.11.11 Persons responsible for key tasks

[AP Reg 19]

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You need to include in your procedures, the people by position, or name and position, responsible for carrying
out the following key tasks (including any within supporting systems) and any competencies or skills to carry
out those tasks:
• sign-off on documents that make up part of the programme before they are implemented;
• monitoring at a critical control point;
• corrective actions (e.g. restore control, product disposition, prevent recurrence, etc.);
• operator verification (e.g. record checks, internal audits, RMP review, etc.);
• recalls; and
• any other key tasks that are specified as such in a supplementary notice.

The task assignments will depend on the complexity of the operation. In simple operations, one person may
be responsible for all of the tasks. In more complex operations, several people may be responsible for
different tasks. You may designate these responsibilities to different people at different times, e.g. by roster,
etc. You should also document how back-up personnel are assigned to cover for holidays and absences.

4.11.12 Mandatory competencies

There are some mandatory competency requirements for people who are responsible for certain operations or
activities under an RMP. Some of these mandatory competencies are found in the following locations in the
PSP Notice:
• PSP Notice Part D3, D3.19(3)(b) Validation of defined heat treatments;
• PSP Notice Part F3, subpart 5: Ante-mortem and post-mortem examiners;
• PSP Notice Part H2, H2.6 Competency of personnel processing fish for human consumption;
• PSP Notice Part H3, H3.24 Competency requirements for BMS depuration;
• PSP Notice Part L1 Thermal processing of low-acid commercially sterilised product; and
• PSP Notice Part L3, L3.6 Competencies of personnel (Listeria requirements for processors of certain
ready-to-eat animal products).

If a staff member has completed a course or unit standard that has expired or is no longer available, as long
as the course is listed in the relevant Notice this will still be acceptable. You will need to ensure that the
knowledge gained from these competencies are maintenance on a regular basis.

4.11.13 Suitable skills

You must ensure that anyone carrying out a task that could affect the animal material or product fitness for
intended purpose is suitably skilled. To do this you must:
• identify the tasks which are considered “key tasks”;
• document the required skills needed to carry out the tasks effectively and how they will be achieved
and maintained; and
• keep training records for each staff member [AP Reg 20].

For example, people responsible for HACCP development and implementation should have appropriate skills
in the application of HACCP principles and knowledge of the RMP. This may be done through a variety of on-
the-job training, training courses6, observing and asking questions or e-learning modules [AP Reg 20].

An example of how you could do this is shown in Table 6: Skills of responsible Persons.

6
The New Zealand Qualifications Authority (NZQA) provide the framework for competency standards and courses in
various manufacturing or primary processing sectors.

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Table 6: Skills of responsible persons

Person Authorities and Training, knowledge or experience
responsibilities
Operator of RMP Legal representative for the RMP Has a good understanding of relevant regulatory
(see 4.3 Operator, Business and requirements under the APA including operator
RMP Identification) duties and the Food Standards Code (if
applicable)
Day-to-day Responsible for the day-to-day Has thorough knowledge of:
manager(s) of the management of the RMP (see • food safety of relevant animal materials and
RMP (including any 4.5.1 Day-to-day Manager of the animal products and hygienic procedures and
deputies) RMP) practices
• regulatory requirements, including
responsibilities, related to the effective
implementation of the RMP
• particular product/process (e.g. appropriate
technical competencies, etc.) and relevant
experiences
Able to liaise and communicate effectively with
personnel and MPI
RMP authoriser(s) Signs off the RMP documents Same as for the day-to-day manager of the RMP
and any amendments to the but only in relation to the part(s) of the RMP they
documents (see 4.11.8.1 are responsible for authorising
Authorisation or “sign off” of
documents)
Person(s) responsible Confirms that the HACCP The relevant level of HACCP expertise
for application of principles have been properly
HACCP or part of the applied and if a plan is relevant
HACCP team has been appropriately
implemented
Person(s) Confirms that the RMP is Same as for the day-to-day manager of the RMP
undertaking appropriate, complete, effective, but only in relation to the part(s) of the RMP they
document checks and complies with legal requirements, are responsible for validating. For example,
validation RMP and is implemented effectively persons validating aspects of an RMP should be
skilled in that aspect (cook-chill, pathogen
monitoring etc).
Persons responsible See 4.11.3 Procedures for Has thorough knowledge of:
for control activities process control, 4.12 Application • relevant operations, processes and systems
of HACCP and 4.13 Identification in the RMP
and Control of Risks to • control measures for each activity they are
Wholesomeness responsible for and how to recognise loss of
control
• appropriate response when there is a loss of
control
Persons responsible See 4.11.4 Procedures for • Same as for persons responsible for control
for monitoring Monitoring and 4.12.8 Establish activities
activities CCP Monitoring and 4.13 • Monitoring procedures for each activity they
Identification and Control of Risks are responsible for
to Wholesomeness • Relevant NZQA Unit Standard qualifications

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Person Authorities and Training, knowledge or experience

responsibilities
Persons responsible See Part 4.11.5 Corrective Action • Same as for persons responsible for control
for corrective action Procedures; 4.11.6 Corrective activities
activities action procedures for unforeseen • Corrective action procedures for each activity
circumstances, 4.12.9 Establish they are responsible for
Corrective Actions and 4.13 • Ability to identify product non-conformances
Identification and Control of Risks • Relevant NZQA Unit Standard qualifications
to Wholesomeness
Verification by See Part 4.11.7 Procedures for • Same as for day-to-day manager of the RMP
operator Operator Verification, 4.11.14 • Operator verification procedures for each
Operator verification of RMP and activity they are responsible for
4.12.10.2 Operator verification • Ability to interpret records and results. This
(HACCP) procedures may be demonstrated by appropriate internal
audit training
• Effecting corrective actions if needed
Persons responsible See 4.11.18 Recall Procedures • Thorough understanding of recall policies and
for recall procedures, including carrying out the mock
recalls
• Relevant NZQA Unit Standard qualifications

4.11.14 Operator verification of the RMP

Operator verification of the entire RMP are the checks carried out to confirm that the RMP is accurate,
effective and properly implemented. Well developed and implemented operator verification procedures will
confirm that the RMP:
• is consistently producing animal material or product that is fit for its intended purpose;
• is applicable to the operations carried out;
• continues to comply with all legislative requirements; and
• continues to be operated as written (or appropriate amendments are made as the process changes).

Your operator verification procedures should include:

• activities to be performed (e.g., internal audits, reality checks), and the activities’ frequency;
• the identity of the person(s) or position(s) responsible for carrying out operator verification activities;
• when ongoing operator verification is to be carried out;
• how it will be done;
• follow-up action to be taken if a non-compliance is detected; and
• the records to be kept and reporting, as appropriate.

Ideally the person carrying out operator verification activities should be independent of the processes being
verified, i.e. they should not check their own work. In small operations, this may not always be possible.

It is important that you identify non-compliances within your RMP and that these are dealt with appropriately,
rather than being picked up by your verifier. Operator verification can be viewed as ‘marking your own work’ –
if you are not picking up your mistakes and rectifying them, it is an indication there is a lack of operator control
and your current operator verification activities are inadequate and should be reviewed.

Also see Section 4.11.7 Operator Verification of GOP and 4.12.10 Operator Verification (HACCP).

For additional guidance for development and implementation of operator verification procedures, refer MPI
Guidance Document: Operator Verification.

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4.11.15 Notification and reporting requirements

Your RMP must include a procedure for notifying MPI of any of the following changes:
a) position, or name and position of the person(s) responsible for the day-to-day management of the RMP
(notify MPI Approvals at [email protected]); and
b) any emerging, new, or exotic biological hazards or new chemical hazards that come to the operator's
attention [AP Reg 25 & 37].
An emerging, new, or exotic biological or new chemical hazard can be thought of as something that is not in
our hazard database, or that has not historically been seen in your product sector. RMP operators are usually
best placed to identify any emerging, new or exotic biological hazards or new chemical hazards and to notify
them to the MPI as soon as practicable after its discovery, so that appropriate actions can be taken.

Please notify such events to: [email protected] with the subject line “Notification to MPI of
emerging, new, or exotic biological hazard or chemical hazard”.

Your RMP must also document a procedure for notifying your verifier or verifying agency, of any of the
following issues:
a) any significant concern about the fitness for intended purpose of animal material or animal
product; or
b) where the RMP is no longer considered to be effective; or
c) where the premises identified as being used by the programme is not or no longer suitable for
use; or
d) where anything within the physical boundaries of the programme is used for additional purposes
or by other persons not covered by the programme and the RMP has not adequately considered
relevant hazards or other risk factors relating to that use; and the programme has not adequately
considered relevant hazards or other risk factors relating to that use; or
e) there has been a critical non-compliance by the operator; or
f) any loss of control that occurs is due to unforeseen circumstances and adversely affects the
suitability of animal material for processing or the fitness for intended purpose of animal product
[AP Reg 25 & 36].

When you notify your verifier or agency, you must do so in writing and without unnecessary delay [AP Reg
36]. The information should also be provided in a form that is easy to access, understand and interpret.

4.11.16 Traceability and recall procedures

(Section 77B and 77C of the APA, AP Reg Part 5)

Your RMP must include procedures for tracing and recalling animal material or animal products including
conducting simulations or mock recalls to confirm their effectiveness.

4.11.17 Traceability
[AP Reg 103 & 104]

RMP operators must implement traceability procedures that enable animal material and animal product to be
traced from the supplier to the operator, and from the operator to the next recipient in the supply chain (other
than the final consumer). Procedures must also enable you to identify and locate animal material and animal
product while it is with the physical boundaries of your operation.

This information must be sufficient to allow an effective recall to be carried out if required.

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If a request is made by the D-G or an animal product officer to provide traceability information, you must be
able to provide the information in a readily accessible format within 24 hours after the request, or within any
reasonable shorter period specified in the request.

4.11.18 Recall Procedures

In the event that non-conforming animal materials or products are produced, you should take appropriate
corrective actions and determine the disposition of affected products. If the non-conformance is detected
before any of the affected products are released for distribution, it will be a trade level recall. However, if
products are in the distribution chain or with the consumer, you may need to initiate a consumer level recall to
recover the products as quickly as possible.

You must document recall procedures where, due to the nature of the product, it is possible for your product
to be recalled [AP Reg 105]. Your business may not require a recall procedure if your product is intended to
be consumed immediately, e.g. a takeaway.

Your recall procedure must include:

a) the criteria for deciding when a recall will be initiated;
b) how retrieval and disposition of the animal material or animal product will be managed;
c) a system for notifying MPI (the D-G or animal product officer) of a recall within 24 hours [AP Reg
106], and the verifier as soon as possible without unnecessary delay [AP Reg 36]; and
d) how you will provide the following details to the D-G or animal product officer in a readily
accessible format within 24 hours after the recall [AP Reg 106(2)]:
i) the animal material or animal product affected by the recall; and
ii) the reason for the recall.

You must notify MPI at [email protected]

You can find a guide to assist you in developing recall procedures on the MPI website by searching for ‘Recall
Guidance’.

4.11.19 Simulated/mock recall

[APA Section 77B, AP Reg 107 & 108]

You must ensure your recall plan is periodically tested using a ‘simulated’ or mock recall exercise. The
simulation must demonstrate the effectiveness of the operator’s traceability and recall procedures. The
simulated recall must be carried out at least every 12 months after a previous simulated recall or after a
genuine recall, if the recall demonstrated the traceability and recall procedures to be effective. Your recall
procedure should state when you will carry out each simulated recall.

4.11.20 Validation of Supporting systems/GOP

You must demonstrate that your RMP meets regulatory requirements with GOP (e.g. hygiene and
maintenance, personnel health, approved chemicals, water quality).

Refer to section 5 of this manual and Appendix D for those supporting systems that are likely to require
validation.

4.12 Application of HACCP

(Section 17(3) of the APA)

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You must apply HACCP Principles to your process (including all inputs) [APA 17(3)]. This ensures a
systematic approach to the identification, analysis and control of hazards. The application of HACCP is based
on the expectation that supporting systems are effectively implemented prior to applying the HACCP
Principles.

The Principles of HACCP as defined by Codex Alimentarius are:

(1) Conduct a hazard analysis and identify significant hazards. Identify control measures;
(2) Determine the Critical Control Points (CCPs);
(3) Establish validated critical limits for each CCP;
(4) Establish a system to monitor control of each CCP;
(5) Establish the corrective actions to be taken when monitoring indicates a deviation from a critical limit at
a CCP has occurred (i.e. a particular CCP is not under control);
(6) Validate the HACCP plan and then establish procedures for verification to confirm that the HACCP
system is working as intended; and
(7) Establish documentation concerning all procedures and records appropriate to these principles and
their application.
For further guidance on HACCP, refer to the following:

• Hazard Analysis and Critical Control Point;

• Standardisation of Hazard Analysis and Critical Control Point (HACCP); and
• Codex GPFH.

The application of HACCP principles must be documented. The person or people assigned to this task should
have the appropriate knowledge and skills regarding HACCP and the particular processes.

You must review your application of HACCP whenever there are changes in the product, process and/or
premises [APA 16].

4.12.1 Types and sources of hazards

A hazard is described as a biological, chemical or physical agent in, or condition of, food with the potential to
cause an adverse human or animal health effect. Hazards can be:
• biological, includes microorganisms (e.g. Salmonella spp., L. monocytogenes, etc.), parasites (e.g.
Taenia saginata, etc.) and biotoxins7;
• chemical, includes heavy metals, pesticides and veterinary medicines. Some food additives may also
be hazardous if present in excessive or toxic amounts (e.g. nitrite, etc.); and
• physical, includes objects in food that may cause illness or injury (e.g. glass, metal fragments, stones,
bone slivers, shotgun pellets, etc.).

You should not confuse the source or cause of the hazard (e.g. faecal contamination, etc.) with the hazard
itself (e.g. enteric pathogens, etc.) as this may impact on the selected control measures.

4.12.2 Conduct a hazard analysis

Hazard analysis consists of identifying potential hazards and evaluating them to determine which are
significant to your operation (refer to Codex GPFH for guidance).

7 Biotoxins could instead be listed under chemical hazards. Either approach is acceptable.

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The hazard identification and analysis must be documented, this includes any uncontrolled hazards [AP Reg
14 &16] (see 4.12.4 Uncontrolled Hazards for more information). Hazards may occur as a result of:
• an input (e.g. an ingredient, additive, etc.);
• the process itself (e.g. a process step may be the source of a hazard or may increase the level of an
existing hazard, etc.); or
• contamination from other sources (e.g. personnel, water, air, pests, wastes, processing equipment,
etc.).

You should only consider hazards that are “reasonably likely to occur” in your hazard identification.

Definition of ‘reasonably likely to occur’

“Reasonably likely to occur” means that:
• the particular hazard is known to occur in the particular food based on scientific reports, industry or
company results, COPs and information from MPI; and
• the hazard is known to occur in New Zealand or if using imported ingredients, is known to occur in those
ingredients (care should be taken when considering overseas information).

You may use generic HACCP plans developed by MPI or others as a basis for your hazard identification. You
should also consider whether there are additional hazards that are reasonably likely to occur for your specific
product, process and operation. This is particularly important for unusual or novel products (e.g. placentas,
glands, etc.) where information may not be readily available and will require you to carry out your own
research.

Hazards may be identified as groups based on their common characteristics, source and/or control, e.g.
enteric pathogens in beef trimmings, marine biotoxins in shellfish, chemical residues in fresh meat, enteric
pathogens in raw milk, etc. However, certain hazards that require specific controls must be explicitly identified.
Some examples are listed below:
• Campylobacter in raw chicken and raw milk;
• Staphylococcus aureus in cooked ham;
• Listeria monocytogenes (Lm) in certain ready-to-eat products;
• tutin toxin in honey;
• the pesticide 1080 in possums; or
• metal fragments in meat and bone meal.

You should avoid vague descriptions of hazards. For example, “foreign objects in a manufactured meat
product” or “foreign matter in a dairy product” should not be used as it does not clearly identify the hazard
(e.g. metal, bone, plastic, etc.), which may require different control measures.

Identification of hazards from inputs

You should identify the hazards that are reasonably likely to occur for each input. Typically, supplier quality
assurance programmes are the most practical way to manage certain hazards. The assurance programme
places reliance on your supplier to control certain hazards to known levels and identifies those that may still
be present and may need to be controlled by your process. Any supplier quality assurance programme should
be documented in the RMP and may include:
• agreed material specifications or procedures;
• supplier declarations for live animals;
• certificates of analysis for ingredients;
• supplier audits; or
• periodic testing of incoming materials.

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Hazard identification from inputs can be presented in a table, as shown in Table 7: Hazard Identification for
Inputs.

You can use the hazard database on the MPI website to assist with identifying hazards.

Table 7: Hazard identification for inputs

Inputs Description/ Biological hazard Chemical hazard Physical hazard

Specifications (B) (C) (P)
Beef cuts • Sourced from company Enteric pathogens, e.g. Chemical residues • Bone
and with a registered RMP Campylobacter jejuni, • Metal
trimmings • Chilled or frozen as per Clostridium spp.,
company specification Salmonella spp.,
• Boneless cuts Pathogenic E. coli (e.g.
STEC), etc.
Raw milk • Sourced from farm • Non-spore forming • Chemical • Glass
dairy with registered pathogens, e.g. Residues from • Metal etc.
RMP Listeria feed,
• Chilled storage monocytogenes agricultural
(Lm), compounds,
Campylobacter, veterinary
Pathogenic E. coli medicines, and
(STEC), maintenance
Mycobacterium compounds etc.
bovis (TB), • Environmental
Salmonella, contaminants
coagulase positive
Staph aureus
• Spore forming
pathogens, e.g.
Bacillus cereus
Salt • Food grade None None None
Spices • Decontaminated Spore forming Chemical residues, Stones
organisms, e.g. e.g. herbicides,
Bacillus cereus, fumigant, etc.
Clostridium spp., etc.
Egg pulp • Pasteurised None None Egg shell
• Frozen
Bivalve • Sourced from • E. coli spp. (STEC) Marine biotoxins Shell
molluscan registered grower • Salmonella spp.
shellfish • Vibrio spp.
Plastic bag • Suitable as food None None None
(packaging) contact material [AP
Reg 68]
• Protected from
contamination

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Identification of hazards at each process step

In addition to identifying hazards from inputs, you should identify the hazards that are introduced to the
product as a consequence of applying the process step itself. You can do this by performing hazard
identification for each process step.

The potential impact of the process step on any existing hazard should also be considered during hazard
analysis.

Hazard analysis

Once you have identified the relevant hazards, you will need to analyse whether the level of hazard is
potentially acceptable or unacceptable based on the information available to you. You can obtain this
information from your ingredient suppliers, regulatory or client testing programmes.

There are many risk assessment tools to help you conduct your hazard analysis:
• risk ranking – explains the approach to prioritising food safety risks and lists all the documents that
relate to this process;
• risk profiles – MPI has published some risk profiles relevant to food or hazard, you can find them on
the MPI website by searching for ‘Food Risk Profiles’; or
• quantitative and qualitative risk assessment – evaluating the probability and severity of foodborne
illnesses as a result of these hazards.

4.12.3 Identification of control measures

Once you have identified and analysed the relevant hazards, you should determine the control measures for
each hazard at each process step. A control measure is any action or activity that is applied to:
• control the initial level of the hazard (e.g. testing and rejection of unacceptable ingredients, good
animal production practices, etc.);
• prevent an unacceptable increase of the hazard (e.g. chilling, reduction of water activity, use of
preservatives, acidification, etc.); and
• reduce or eliminate the hazard (e.g. pasteurisation, commercial sterilisation, use of antimicrobial
agents, trimming, washing, etc.).
(for guidance refer to Codex GPFH)

4.12.4 Uncontrolled hazards

If control measures do not exist at any of the steps in the process or are inadequate to control a particular
hazard to the required level, you should:
• redesign the process or add other control measures to control the hazard; or
• leave the hazard uncontrolled when it is appropriate to do so considering the intended use of the
product and clearly indicate this in the documented hazard analysis.

There must be sufficient documentation to support your decision to leave the hazard uncontrolled [AP Reg
16]. You should also consider whether you need to inform a further processor, retailer or consumer (such as
by providing cooking instructions on the label) about the uncontrolled hazard so that food safety can be
assured prior to consumption.

4.12.5 Determine the Critical Control Points (CCPs)

A CCP is a step in the process (or a combination of process steps) at which control of one or more hazards is
applied and is essential for food safety (e.g. meeting any regulatory or operator-defined limits relating to
specific hazards(s) in your product, etc.). You must determine whether there are any CCPs in your process.

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When determining if control is essential at a particular step, you should consider the:
• degree of hazard control that is achieved at the step in relation to meeting the acceptable level of
hazard;
• likelihood of failure to control the hazard at that step; and
• consequence of a failure to control the hazard at that step considering the intended use and consumer
(i.e. risk to health).

Generally essential steps are those that are specifically designed to eliminate the hazard or reduce it to an
acceptable level.

You should use a systematic process to hazard identification and analysis and CCP determination for every
process covered by the RMP. Tools that may be used to help with your assessment include decision trees
(Figure 3: Decision Tree for Hazard Analysis and CCP Determination) and table (Table 8: Hazard Analysis
and CCP Determination Template). These tools have been adapted from the Codex decision tree for use by
the animal products industry.

When you identify a CCP, the remaining HACCP principles must be applied (see 4.12.7 Establishing validated
critical limits for each CCP).

If no CCPs have been identified, operator verification, documentation and record keeping is still required (see
4.12.10 Establish Operator HACCP Verification Procedures.

You must document the justification for each identified critical control point (CCP) [AP Reg 15]. Justification
can be evidence such as historical records, technical publications, Operational Codes, COPs or information
provided by MPI.

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Figure 3: Decision tree for hazard analysis and CCP determination

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Table 8: Hazard analysis and CCP determination template (includes an example of receiving honey supers)
Process Inputs Hazard reasonably Justification Q1. Is there a control measure(s) for Q2. Is the control measure at this CCP No.
step likely to occur on or the hazard at this step? step essential to food safety as
in the product at If yes, identify the control measure and defined by a regulatory or operator-
this step then answer Q2. defined limit?
If no, consider hazard at next step. If yes, this step is a CCP.
If no, this step is not a CCP.
Receiving Supers B – bacterial Bacterial spores No No
pathogens (e.g. Bacillus spp.,
Clostridum spp.) are
likely to occur
C – tutin toxin Reported incidence Yes – harvest declaration confirming Yes 1
of tutin in NZ honey beekeeper controls and options 1-5 (from
Food Standard: Tutin in Honey 2016)
C – Chemical Residues may occur Yes – harvest declarations confirming No
residues in honey beekeeper controls

To clarify the use of Table 8, each column is discussed in Table 9: Further Explanation for Headings of Table 8 below. You should go through the series of questions for each
step in the process. The hazard analysis must show any hazard that is still there or uncontrolled at the end of the process [AP Reg 16]. Examples of the use of this table can be
found in a number of MPI COPs. Some HACCP applications can be found in RMP templates.

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Table 9: Further explanation of headings in Table 8

Column 1 Process step Each process step should be written in column 1 in the order that they
occur in the process, as shown in the process flow diagram
Column 2 Inputs All inputs added at the particular step should be indicated in column 2.
This should align with the process flow diagram
Column 3 Hazard identification The hazards reasonably likely to occur at each process step should be
identified considering:
• hazards introduced by inputs at that step;
• hazards introduced or transferred as a consequence of applying the
process step itself (e.g. metal from mincers);
• hazards carried over in the product from the previous step; and
• any adverse impact of process step on existing hazards (e.g. growth
of microorganisms)
Column 4 Justification A brief justification for each identified hazard should be provided. This
should include the identification of the source or cause of the hazard.
Justification may include:
• company experience and records;
• peer-reviewed scientific literature;
• surveys;
• industry reports;
• HACCP plans;
• MPI Operational Codes, COPs, templates; and
• other MPI guidance documents
Column 5 Identification of control You should identify the control measure(s) for each hazard. The
measures procedures to be followed for all control measures should be documented
in the RMP (e.g. in supporting systems, etc.)
The document number or title of the particular supporting system that
contains the relevant procedures should be given in this table to help with
evaluation, verification and review of your RMP
Hazards that are not completely eliminated at a step should be carried
forward to the next step to ensure that the impact of any succeeding step
is considered. In particular, bacterial hazards should be carried over to
succeeding steps since there is potential for their growth
Hazards that are unlikely to be affected by succeeding process steps (i.e.
the hazard will not grow or increase) do not need to be carried forward to
the next steps in the hazard analysis table to reduce repetition. However,
the hazard must be reintroduced to the table at the step that it is
controlled, or it must be shown at the last process step, as either
remaining in the product or as uncontrolled
For example, if a chemical hazard is not controlled, changed any further
or removed and is still present at the final step in the process, it does not
need to be recorded at each step as a ‘hazard reasonably likely to occur
on or in the product at this step’, but does need to be written into the row
at the final process step where it is still likely to occur (i.e. present)
Column 6 CCP determination Decide whether or not a step is a CCP by determining if the control at that
step is essential, by itself or in combination with other steps, to achieve
any regulatory or operator-defined limits for the specific hazard(s). If there
is no regulatory or operator-defined limit, there is no CCP. Note: not all
regulatory limits require a CCP, for example APC and E. coli limits
specified for process control.

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4.12.6 Other CCPs that may be identified

You may be required to identify other CCPs in your process to satisfy an overseas market access or customer
requirement. No further justification for the identification of these CCPs is necessary, however, they should be
clearly identified as market access CCPs, or customer requirements to ensure their appropriate external
verification. The verifier will verify any market access CCP against the relevant OMAR.

4.12.7 Establishing validated critical limits for each CCP

You must define and justify critical limit(s) for each CCP [AP Reg 15].

A critical limit is a criterion, observable or measurable, relating to a control measure at a critical control point
(CCP) that separates acceptability from unacceptability of animal material or animal product [AP Reg 3].

Critical limits should be:

• linked to meeting a regulatory or operator-defined limit related to food safety; and
• parameters that can be monitored in short term, real time and on an on-going basis.

You must document the:

a) parameters to be monitored (e.g. pasteurisation time and temperature, etc.); and
b) limit for each parameter (e.g. 72°C for 15 seconds, etc.); and
c) justification for each critical limit [AP Reg 15].

You must show that they are consistently capable of controlling the hazard to an acceptable level [APA 17(2)b
& AP Reg 34].

For guidance, refer to section 5.2 Validation of this manual and Codex GPFH - Establish validated critical
limits for each CCP.

Validation of control measures is also further described more fully in the Codex document - Guidelines for the
Validation of Food Safety Control Measures (CXG 69 – 2008).

4.12.8 Establish CCP monitoring

You must document monitoring procedures that will be applied for each CCP [APA 17(3)(d)]. These should
include the:
• identity of the person(s) or position(s) responsible for monitoring at that CCP;
• monitoring method;
• monitoring frequency and sampling regime; and
• records to be kept.

Monitoring can be continuous (e.g. using an automatic measuring and recording device that provide results in
real-time) or based on an established frequency or statistical sampling plan. The frequency of monitoring
should be adequate to ensure the consistent control at that CCP. Other factors to consider when establishing
frequency include:
• the nature of the product;
• the likelihood of being unable to meet the limits;
• the cost of monitoring;
• the ability to retrieve all product since the last compliant CCP monitoring result;
• the consequence of failure (including risk to human health); and
• expected corrective actions (especially with respect to product disposition).

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Limits that cannot be monitored at the required frequency in real-time are not appropriate, e.g. microbiological
limits where the results may not be available for a number of days (this would be considered verification rather
than a monitoring activity).

Monitoring records must as a minimum [PSP Notice B1.2(1)]:

a) specify when the activity occurred (including the date); and
b) give a description of the results of the activity; and
c) identify who performed the activity.

4.12.9 Establish corrective actions

You must document corrective action procedures and ensure they are implemented when monitoring
indicates a critical limit at a CCP is not met [APA 17(3) and AP Reg 10(3)c)].

Corrective action procedures should include [AP Reg 18(1)]:

• identity of the person(s) or position(s) responsible for carrying out the corrective action;
• procedures for how control is restored;
• procedures for identifying, managing or disposition of non-conforming product (e.g. checking the
product back to the last compliant result);
• any action necessary to prevent re-occurrence of a loss of control;
• escalation of the response if preventative action fails;
• follow-up that corrective actions taken have been effective; and
• records to be kept including [PSP Notice B1.2]:
– a description of the results of the activity (e.g. the actions taken, any investigations carried out, the
disposition of the affect product); and
– specifying when the activity occurred (including the date); and
– identifying who performed the activity.

Disposal of non-conforming dairy material or dairy product

The disposal of non-conforming dairy material or dairy product is specified in the Animal Products Notice:
Disposal of Non-conforming Dairy Material or Dairy Product.

4.12.10 Validation of the HACCP plan and Operator Verification (HACCP)

Procedures
4.12.10.1 Validation of the HACCP plan

Validation is necessary to ensure that the HACCP plan is capable of controlling the significant hazards
relevant to the animal product business and produces animal product that is fit for its intended purpose.

You should check the application of HACCP after completing the hazard analysis and CCP determination
initially and when reviewing the HACCP system, to ensure plan is and remains effective. The following should
be considered:
• are all the regulatory limits accounted for in the HACCP application?
• are the operator-defined limits appropriate and achievable?
• are the identified CCPs essential to meeting the regulatory or operator-defined limits for particular
hazard(s)?
• are the critical limits appropriate and achievable?
• can the critical limits be monitored effectively and in real time?
• are all the identified hazards adequately controlled by supporting systems and/or a CCP(s)? If not, do
you need to modify the process or add other control measures?

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• are there any uncontrolled hazards? If so, are you required by legislation to control it/them to a
specified level?
– do you need to consider redesigning the process/product?
– do you need to inform a further processor, retailer or consumer about the uncontrolled hazard so
that food safety can be assured prior to consumption (e.g. by providing feedback to suppliers,
notifying further processing, or cooking/handling instructions, etc.)?

Refer to section 5 of this manual and Codex GPFH for guidance on validation

4.12.10.2 Operator verification (HACCP) procedures

You must document procedures for operator verification to confirm that the HACCP system is working
effectively on an ongoing basis. These include procedures to verify that the CCPs are operating effectively,
monitoring is occurring as written and that appropriate corrective actions are taken when critical limits are not
met.

The procedures should include:

• identity of the person(s) or position(s) responsible for operator verification;
• how operator verification will be carried out;
• frequency;
• follow-up actions to be taken if:
– the CCP is not operating correctly;
– procedures are not being followed; or
– a non-compliance occurs; and
• records to be kept [PSP Notice B1.2].

These verification procedures may form part of GOP and/or RMP operator verification.

4.12.11 Establish HACCP documentation and record keeping

You must document all matters relating to the application of HACCP in your RMP [APA 17(3)(g)]. This
includes:
• appropriate reference to RMP scope, product description and process description;
• any changes made to the HACCP plan; and
• all evidence and justifications for the decisions made.

Records must be kept to demonstrate that the HACCP application has been implemented and continues to be
operated effectively [AP Reg 23; PSP Notice B1.2]. Examples of records can include:
• critical limit validation records;
• CCP monitoring records;
• CCP corrective action records; and
• HACCP operator verification records.

4.12.12 Common HACCP mistakes

MPI has identified some common problems among food businesses when they conduct their HACCP
analysis, along with suggested actions on how to reduce these mistakes. This is discussed in Table 10:
Common HACCP Mistakes.

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Table 10: Common HACCP mistakes

Common HACCP mistakes Actions you can take to minimise these mistakes
Step(s) where a hazard is eliminated or Make sure all processing steps are identified in the
reduced to an acceptable level is not clearly process flow diagram, and this is reflected in the Hazard
identified analysis and CCP Determination table
Hazards being carried through the entire Make sure all processing steps are identified in the
analysis even when they have been removed process flow diagram, and this is reflected in the Hazard
by a particular process step analysis and CCP Determination table
Hazards disappearing without a clear step in Review your HACCP plan to identify which control
the process where the control has been applied measures are relevant to the hazard of concern
Identifying too many CCPs. This can be Follow through Figure 3: Decision Tree for Hazard
resource intensive and a distraction from the Analysis and CCP Determination to identify the relevant
true CCPs CCPs
Look for COPs, RMP templates relevant to your animal
product as a reference
Relevant CCPs have not been identified so the Follow through Figure 3: Decision Tree for Hazard
steps essential to food safety lack the Analysis and CCP Determination to identify the relevant
appropriate level of control CCPs
Look for COPs or RMP templates relevant to your animal
product as a reference

4.13 Identification and control of risks to wholesomeness

(Section 4 of the APA)

Wholesomeness means that the product does not contain or have attached to it, enclosed with it, or in contact
with it; anything that is offensive, or whose presence would be unexpected or unusual in product of that
description.

In other words if a consumer would think “yuck” then it is likely that this is a wholesomeness risk factor. This is
greatly dependent on the:
• intended use;
• intended consumer;
• nature of the product; and
• packaging/identification of the product.

Application of HACCP principles is not required for risks to wholesomeness but MPI recommends that you
systematically assess each input and step in the process to identify and control any wholesomeness risk
factors.

4.13.1 Identification of risks to wholesomeness

You must identify any risks to wholesomeness that are reasonably likely to occur within your process for each
animal material or animal product or group of materials or products [AP Reg 14]. This can be based on:
• an industry Operational Code or COP;
• your knowledge or experience of your product and process (including a review of internal records and
reports); and
• any customer/consumer complaints.

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Opinions about what is offensive, unexpected or unusual will vary. Common sense should be used to
determine any problems that would be offensive, unexpected or unusual. See Table 11: Examples of Risks to
Wholesomeness and their Controls.

Table 11: Examples of risks to wholesomeness and their controls

Product Wholesomeness risk Examples of control measures

factor
Whole chickens • feathers • correct set up of plucker
• inspection of birds
Hamburger patty • bones • supplier assurance programme
• bone eliminator
Milk (farm dairy operator) • foreign or objectionable • ensure teats are clean
matter (e.g. insects, • filter milk
faeces, dirt or dust) • bulk milk tank secure from environmental
contamination
• lidded vats closed at all times except from
emptying milk until cleaning complete
Whole shell eggs • roundworms • worming programme for free-range hens
Mussel meat • pea crabs • inspection and removal
Honey • fermentation • control of moisture content control
• heating
Canned corned beef • plastic • inspection of raw meat blocks, and removal
• use of coloured liners
Meat • spoilage • temperature control
• hygienic practices

4.13.2 Controls for risks to wholesomeness

Where you have identified a risk to wholesomeness, you must establish and document the control measures
(see Table 11: Examples of Risks to Wholesomeness and their Controls for examples) and all other matters
required by APA 17(2), and AP Reg 10 & 18 for the scope of procedures.

The control measures may be documented within process control procedures, supporting systems or a
specific wholesomeness supporting system. If the control measures are documented in different parts of the
RMP, we recommend that you explain this clearly and provide references to the relevant controls for each
identified risk factor. An example of how this can be done is shown in Table 11: Examples of Risks to
Wholesomeness and their Controls.

You are not required to set operator-defined limits for wholesomeness risk factors, however, you may if you
wish to do so. Where an operator-defined limit has been set you must document actions to be taken if those
limits are not met [AP Reg 11 - 13].

4.14 Identification and control of risks from false or misleading

labelling
All animal materials and animal products must meet legislative requirements related to labelling including:
• the Animal Product Regulations 2021, Part 2, subpart 7 and 246;

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• the Food Regulations 2015, regulations 149 – 152;

• Part 1.2 of the Australia New Zealand Food Standards Code;
• PSP Notice Part C3; and
• the Agricultural Compounds and Veterinary Medicines Act 1997.

When identifying risk factors, you should consider the type of animal material and/or product, its intended use
and the requirements of systems to authenticate claims (e.g. species, composition, active ingredients,
organics, free range, genetically free (GM) free, claims of effectiveness, etc.) and specific consumer groups
(e.g. religious groups, people with allergies, etc.).

Application of HACCP principles is not required for risks from false or misleading labelling.

4.14.1 Identification of risks from false or misleading labelling

You must identify risk factors associated with false or misleading labelling that are reasonably likely to occur
for each animal material or animal product, or group of materials or products [AP Reg 14]. This can be based
on:
• an industry Operational Code or COP;
• your knowledge or experience of your product and process (including from review of internal records
and reports); and
• any customer/consumer complaints.

For simple products and processes, there may be little opportunity for these risk factors to occur. A common
sense approach should identify those risk factors that are reasonably likely to occur for the operation. See
Table 12: Examples of risks from false or misleading labelling and their controls below.

Table 12: Examples of risks from false or misleading labelling and their controls

Labelling Risk Likely Cause Control Measures

Factor
Incorrect design (label • Lack of research into label content • Conduct adequate research
content/format) • Using inaccurate or incomplete • Checks on label design
information • Sign-off before release to
processing
Incorrect claims • Lack of research into research to back • Conduct adequate research to
claims support claims made
• Limited understanding of the • Understand the requirements
requirements around claims around making claims
Process deficiencies • Errors in processing, e.g. wrong product • Training and supervision
resulting in the flow, inadequate separation, etc. • Processing procedures
product not matching • Wrong formulation • Formulation control procedures
its label • Cross-contamination from equipment • Clean down
with unwanted ingredients, e.g. peanuts, • Order of processing
etc. • Compliance to raw material
• Inputting wrong information into labeller, specifications
e.g. species, etc. • Material tracking
• Wrong packaging materials • Inventory control
• Changes in raw materials or suppliers, • Label checks
e.g. inadequate supplier quality
assurance procedures, etc.

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4.14.2 Control of risks from false or misleading labelling

Where you have identified a risk to false or misleading labelling, you must establish and document all control
measure(s) (see Table 12: Examples of Risks from False or Misleading Labelling and their Controls) and any
other matters required by APA 17(2), and AP Reg 10 & 18 for the scope of procedures.

The control measures may be documented within process control procedures, supporting systems or a
specific labelling supporting system. If the control measures are documented in different parts of the RMP,
MPI recommends that this is explained clearly with references to the relevant controls for each identified risk
factor. An example of how this can be done is shown in Table 12: Examples of Risks from False or Misleading
Labelling and their Controls.

You are not required to set operator-defined limits for false or misleading labelling risk factors, however, you
may if you wish to do so. Where an operator-defined limit has been documented you must document actions
to be taken if those limits are not met [AP Reg 11-13].

4.15 Validation of RMP effectiveness

You must have evidence to validate the effectiveness of the RMP, when it is necessary to demonstrate that it
is capable of consistently producing animal material or animal product that is fit for its intended purpose [AP
Reg 34(1)].

Refer to section 5 of this manual for more detail on RMP validation.

4.16 Provision for verification activities

(Section 77E of the APA)

Before you apply for registration of the RMP, you must get written confirmation from a recognised verifying
agency indicating that they will verify your RMP [AP Reg 26(1)(a)]. This is typically a letter and must be
submitted with your other documentation for registration.

You are responsible for contracting and paying for the services of a verifier.

You can find a list of recognised verifying agencies on the MPI website from “Agency name or NZBN’ or the
“Search Agency” tool

See 8.3 Verification by recognised verifier for further details about verification.

4.17 Additional requirements for Dual Operator Butchers

(Section 71 of APA)

A dual operator butcher (DOB) is a retail butcher who:

• is listed by the D-G as a homekill or recreational catch service provider; and
• processes homekill or recreational catch (unregulated product) at the same premises or place as the
retail butcher processes or trades in regulated animal product.

MPI has developed guidance to assist DOBs on interpreting the phrase “same premises or place”: Homekill:
Activities occurring at the “same premises or place”.

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DOBs must have a registered RMP before trading regulated animal product to ensure that any such product is
fit for its intended purpose [APA 71(1)(c)].

In addition to the components required for a standard RMP, a DOB RMP must include:
• the identification and control of the risk factors introduced to the regulated product from homekill or
recreational catch that is processed in the same place;
• control measures to ensure that homekill and recreational catch products are processed and stored
separately from, and are not mistaken for, regulated animal products, and do not enter trade (except
for rendering as permitted under APA 69(3)(b)); and
• control measures to ensure that product from the business is not exported [APA 71(1)(d)].

A DOB must also document specific inventory control measures to comply with the Animal Products Notice:
Homekill and Recreational Catch Service Provider Records which gives the minimum requirements for record
keeping and traceability of homekill products.

You can find the DOB RMP template on the MPI website. This template has been approved, and a waiver has
been granted so RMPs that are fully based on it do not need to be evaluated by a recognised evaluator prior
to registration.

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5 Checks and validation

(Sections 16, 17(2)(b) and 20 of the APA)

Once you have developed or amended your RMP, you should check that it contains all the required
information and meets the regulatory requirements. You need to check that:
• RMP documentation is complete and complies with all relevant legislative requirements;
• premises and equipment are ready to operate in accordance with RMP procedures and other
legislative requirements; and
• the RMP is capable of consistently producing animal material or animal product that is fit for its
intended purpose.

Refer to Table 13: Summary of Document Checks and Validation of the RMP for a list of checks you should
perform prior to having your RMP or significant amendment evaluated. In most cases these checks will
provide sufficient evidence and you should make any existing compliance records available to the evaluator
during evaluation.

If validation information is required and is collected before registration of the RMP, this will need to be
provided to your recognised evaluator. If evidence needs to be collected after your RMP is registered, a
validation protocol on how you will collect the evidence must be provided to the evaluator.

Table 13: Summary of document checks and validation of the RMP

What to look for Evidence required When is the evidence Is a validation

required protocol needed?

RMP documentation checks

• is complete • RMP document Before evaluation of N/A
• complies with all • the use of a checklist is RMP
relevant legislative recommended to indicate
requirements where the relevant
legislative requirements
have been addressed within
the RMP
Premises and equipment checks
• ready to operate • actual design and • before evaluation of N/A
• meets the construction of premises is RMP, unless a pre-
requirements of all complete assessment
relevant legislative • equipment is available and procedure is
requirements ready to operate followed
• commissioning reports and • before or after Yes, if commissioning
calibration certificates for registration of RMP after registration
certain equipment, e.g.
retort, drier, etc.
Supporting systems checks
• achievement of Records of compliance to: • before or after A protocol is not
supporting system • documented procedures, registration required for most
requirements e.g. monitoring records, • any existing supporting systems
internal audit reports; and evidence should be See Appendix D:
made available to Procedures and

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What to look for Evidence required When is the evidence Is a validation

required protocol needed?
• measurable support system the evaluator before Processes Requiring
requirements, e.g. product registration Validation for those
load-out temperatures operations that would
require a protocol

Validating the RMP

• setting the • limits are appropriately Before or after Yes, if validation after
regulatory and chosen for the process, e.g. registration registration.
operator-defined from AP Notices, FSC etc.
limits • records of compliance to
• product relevant critical limits,
characteristics regulatory and operator-
related to food defined limits
safety and shelf • validation information from
stability previous validation studies
• process or trials
parameters • results from microbial
• GOP is effectively modelling and lethality
implemented calculations

5.1 Checks
5.1.1 RMP documentation

Before you have your RMP evaluated, you should check that all of the required components of your RMP:
• are documented and complete; and
• meet all relevant legislative requirements, including any regulatory limits (i.e. by systematically
checking it against the legislation).

To assist the evaluation (refer to 6 Evaluation) it is recommended that you prepare a checklist of the relevant
legislation and references to where these requirements are addressed in the RMP.

5.1.2 Premises and equipment are ready to operate

You must ensure that the design and construction of premises and equipment are complete. All equipment
necessary for the processes described in your RMP must be available, ready to start processing and can be
viewed during the on-site assessment (unless exempt, see 6.1.4 for details) by the recognised evaluator as
part of the evaluation [AP Reg 78].

Certain equipment (e.g. retorts, rendering driers, pasteurisers, chillers, etc.) may need to be validated. If this is
to be done after registration, then the equipment validation must be included in your validation protocol [AP
Reg 34] (also see 6.3 Evaluation after completing validation).

5.2 Validation
Validation is the process of collecting evidence (e.g. scientific technical information or records) to show that
your RMP is capable of consistently producing the desired outcome (i.e. to produce animal materials or
animal products that are fit for their intended purpose). An RMP that is not properly validated cannot provide

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assurances that hazards and other risk factors are effectively managed. Validation maybe completed before
and/or after RMP registration [AP Reg 34] .

There are two distinct elements to validation:

• The scientific or technical justification that demonstrates that the designed process can control the
identified hazard.
• Gathering evidence (wherever possible under productions conditions) to demonstrate the system can
perform as expected.

Validation many range from running simple trials on your process to designing robust trials with a statistically
valid sampling plan and analysing your data to determine if the desired outcomes have been achieved. For
new processing equipment, relying on manufacturer specifications or performance claims is unlikely to be
sufficient (especially for equipment that is used to deliver a critical processing step, e.g. thermal processing).
You will need to obtain evidence to validate that new machinery is functioning as intended.

You may also use a technical expert/consultant to undertake the validation or to help prepare the protocol.

Specific animal products (e.g. infant formula) may have additional validation requirements, please refer to the
relevant Animal Products Notices for these requirements or Operational Codes for additional guidance.

5.2.1 Validation procedure

You can find the validation guide ‘What is Validation?’ on the MPI website. Validation examples are included
in Appendix E: Validation Examples.

5.2.2 Desired outcomes of validation

This is shown in Table 14: Example of Desired Outcomes to be Achieved and Possible Evidence.

Table 14: Example of desired outcomes to be achieved and possible evidence

Examples of desired outcomes Examples of evidence

Setting regulatory and operator-defined limits, New Zealand food legislation:
e.g. product characteristics, acceptable level • APA Notices
of hazards in a product is achieved, process • Food Standards Code (FSC)
parameters, etc.
Operator-defined limits:
Note – A common mistake is for RMP • Operational Codes, COPs
operators to set inappropriate operator- • internationally recognised standards
defined limits. It is a requirement to justify • published scientific literature industry agreed criteria
how these limits have been set to ensure this
has been given sufficient consideration e.g. if Referring to the source should be adequate justification if
you set a limit for Salmonella spp. - why have the parameter is taken directly from one of the above
you selected this pathogen and the limit? sources. If not, you will need to prove that the selected
parameter is valid. You must ensure that the conditions
(e.g. raw materials, relevant hazards, combination of control
measures, intended use or distribution, etc.) in your
operation do not differ from the conditions under which the
limit or control measure was validated in sources above.
Product characteristic related to food safety • data from previous or current validation studies
and shelf stability, e.g. pH, moisture content, (including experiments such as challenge trials)
water activity, etc. This can be an acceptable • monitoring records of a control point (CP)
level of hazard in a product, e.g.

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Examples of desired outcomes Examples of evidence

microbiological criteria, maximum levels of
chemical residues or metal contaminants,
etc.
Process parameters, e.g. pasteurisation time • equipment commissioning reports
and temperature, thermal process lethality • equipment calibration reports or certificates
such as 6-log reduction in Listeria • heat treatment validation reports (by a recognised
monocytogenes or cooling rate, etc. person or suitably qualified person)
• data from previous or current validation studies
(including experiments such as challenge trials)
• trials to show process parameters, e.g. time and
temperature, and flow rate are met during commercial
operation
• monitoring records of a critical control point (CCP)
Shelf life (Note - Food must meet the • own shelf-life studies
requirements of the Food Standards Code, • historical information on similar or related food products
Standard 1.2.5) • challenge studies
• predictive modelling
• Operational Codes, COPs
• published scientific literature
• a combination of these approaches
For further detailed information, refer to the MPI guide: How
to Determine the Shelf Life of Food available on MPI
Website.
Supporting Systems are effectively • records generated for each supporting system, e.g.
implemented training and cleaning records, water test results, water
checklist, etc.

5.2.3 Protocol for validation

When there is insufficient evidence to demonstrate the effectiveness of the RMP before registration (e.g. for a
new businesses or a new process, etc.) and the validation information is necessary under AP Reg 34(1), you
must document a validation protocol for how you will collect the evidence. The protocol will need to be
submitted to the evaluator as part of the evaluation and to MPI when applying for registration.

If a validation protocol is developed, it must contain:

• details of the evidence required and how it is to be collected;
• a proposal for the disposition of animal material or animal product produced during implementation of
the protocol;
• the estimated time frame for completion of the validation [AP Reg 34(2)];
• the aspects of the RMP to be validated (including any criteria or limits to be met);
• any competencies for persons undertaking validation;
• details of the information required to demonstrate the effectiveness of the aspect of the RMP to be
validated, including how evidence is to be collected and analysed; and
• any other trial design features and conditions [PSP Notice B1.3(2)].

Once the RMP is registered, you must follow the protocol and any conditions imposed by MPI at registration.
Refer to section 6.3 of this manual.

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5.2.4 Trial design

5.2.4.1 Validation trial design

When designing a validation trial that will involve measuring, counting, or evaluating a process or product
parameter, you should consider the “quality of the data” that will be collected. If poor quality data is collected
then this could affect the value of a trial or experiment and in some cases invalidate the results.

It is important to consider the following when designing your sampling plan:

• Variability of raw materials and processing;
• bias and how it can be managed (e.g. the impact of non-random sampling);
• accuracy (i.e. ensuring a measurement is as close as possible to the actual value); and
• precision or repeatability (i.e. achieving consistent measurements).

5.2.4.2 Uncontrolled parameters

When conducting a validation trial, there may be factors that are out of your control. These factors may
influence the results and the validity of your results e.g.:
• environmental changes (e.g. fluctuations in temperature and/or humidity);
• different personnel handling the samples; and
• alternating between different suppliers that have different raw material specifications.

To manage these uncontrolled factors, you should design your trials with the following principles in mind:
• have controls (e.g., test the product without any treatment to minimise experimental bias);
• randomise your trials (e.g. run your trials in a random order to minimise potential bias);
• replication (e.g. repeat trials to increase confidence that your results are a true representation); and
• controlling the conditions of the experiment as much as possible.

If any significant parameters weren’t controlled during the validation trials, this needs to be highlighted in the
validation report

5.2.4.3 Microbiological challenge testing

A microbiological challenge test should be designed to demonstrate that the desired outcomes, e.g. 6-log
reduction in a particular microorganism, have been achieved. Operators should account for the specific
product and packaging characteristics as well as environment factors, e.g. uncontrolled parameters, etc., to
ensure the results obtained are valid. For example, a microbiological challenge test can demonstrate a
process will achieve the required inactivation. If carried out in a commercial production setting, this may be
done by using surrogate microorganisms, in place of pathogenic target microorganism.

Microbiological challenge tests require a lot of expertise and planning, it is recommended that you discuss this
with an expert in challenge trials prior to starting. Typically, this form of validation is suited to research
environments rather than commercial processing operations.

5.2.5 Records of validation information

You must keep your validation information and records for the lifetime of the process or activity to which it
relates (i.e. as long as the process or activity is in operation), until it is re-validated or new records are
created.

If the process, activity or product ceases, or new validation information is created, the obsolete validation
information and records must be archived for another 4 years or for the shelf life of the animal material or

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animal product it relates to, whichever is longer [AP Reg 32 & PSP Notice B1.2(2)]. Updates to the validation
information should be kept together for easy reference and readily accessible.

Table 15: Expectations for validation information, gives some examples of what you can include in your
validation report to meet the requirements of PSP Notice B1.3(1).

Table 15: Expectations for validation information

Section Requirement in Notice Suggested examples of what to include

1 The aspect of the RMP that the • what is the desired outcome?
validation relates to • Are you trying to show validation of an operator-defined
What am I trying to validate? or regulatory limit, CCP, CL is being met, or that
supporting systems are effective?
2 Any persons with required • person(s) responsible for validation and any required
competencies involved in validation competencies
• are you relying on external or in-house technical
expertise?
• any training for personnel working on the process line
prior to starting validation trials?
3 Equipment • identify the equipment to be validated
• commissioning reports
• calibration reports or certificates
• maintenance schedule
4 Criteria against which effectiveness • regulatory or operator-defined limits, e.g. product
will be determined characteristics, acceptable level of hazards in a product
or process parameters
• any product characteristics, e.g. water activity,
formulation, pH, etc.
• the process and any process parameters, e.g.
pasteurisation, Ultra High Temperature (UHT), high
pressure processing, etc.
• GOP requirements, e.g. water testing, effectiveness of
cleaning and sanitation
5 How the validation information was Either:
generated and the evidence and its • do you have any previous data, records or reports to
analysis demonstrating the demonstrate what you are trying to validate is effective?
effectiveness of the process or Make sure the data is collected under your current
activity processing conditions
Or e.g.:
• run trials (consider trial design, equipment set-up, any
specific trial conditions you need to meet e.g. worst-case
operating conditions), any other variables that need to
be considered
• what data will be collected
• sampling design (consider types of samples, number of
samples to be collected, location of sampling sites, how
often, replicates). Your sampling plan should be
statistically valid
• method of analysis: in-house, external (accredited or
non-accredited method, sensitivity of your method,
repeatability and consistency)

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Section Requirement in Notice Suggested examples of what to include

• Note repeated testing of the same product until desired
results are obtained is not acceptable
6 The findings from the validation (i.e. • the data collected (raw data should be included in the
results) appendices)
• analysis or interpretation of the data (outliers should
not be discarded without good justification)
7 Conclusion, including any • have the desired outcomes been met?
amendments to the process or • does the evidence support the conclusions made? If not,
activity / RMP you will need to adapt your trial design
• have validated parameters been transferred to operating
procedures?
8 Where validation information has • confirmation that adequate animal material or animal
been collected under a validation product disposition has occurred
protocol (e.g. Animal Products Notice: Disposal of Non-
conforming Dairy Material or Dairy Product)
9 If a validation protocol was • the contents of the validation protocol (see section 5.2.3
developed, the validation of this manual)
information must include

5.2.6 Amendments to the RMP

You must re-validate whenever there is an amendment to your RMP or if new scientific or regulatory
information becomes available [AP Reg 34] that would invalidate the previous validation information. In the
case of a significant amendment to your RMP, this can be something that results in a change in the control of
hazards within your RMP (e.g. new equipment, raw materials, critical control points, critical limits etc.). You
may also need to re-validate when there is a system failure or if non-conformances indicate the current control
measures are ineffective.

5.2.7 Common validation mistakes

Table 16 Common Validation Mistakes and Corresponding Remedial Actions lists some common mistakes
made during validation. Remedial actions have been suggested.

Table 16: Common validation mistakes and corresponding remedial actions

Mistakes Remedial actions

Omitting data that does not Results cannot be excluded simply because it does not fit the expected
appear to be logical or only pattern. You should analyse these results critically as they may indicate areas
reporting data that fits of improvement in your written procedures, process parameters, GOP, etc.
within the critical limits, e.g.
outliers You must have a written justification based on known facts if you are going to
exclude certain data points, i.e. transcription errors, or sampling errors
Failing to set up a ‘worst When you design the protocol, you must consider how the process will
case’ scenario perform under the worst-case conditions that you will encounter during
commercial processing If a process is effective when operating under these
conditions, then all products made during normal production will most
probably achieve the limits too. It is important that you properly assess what
“worst case” means, as sometimes this is not obvious.

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Mistakes Remedial actions

Not enough replicates The trial design should be statistically valid, i.e. have a suitable number of
runs so the results are reliable and repeatable. The number of replicates
required will depend on the experimental design
Not using suitable Any equipment used to make critical measurements should have a suitable
measuring equipment accuracy and be calibrated

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6 Evaluation
(Section 20 of the APA)

Evaluation is the independent assessment of your RMP to ensure that it meets the requirements and when
implemented, is capable of producing animal material and animal product that is fit for its intended purpose.
Evaluation is necessary for most RMPs, however, the D-G may waive or modify the requirement for
evaluation if:
a) your RMP is based on a template for which evaluation has been waived see: Waiver of the
Requirement to Provide a Copy of an Independent Evaluation Report);
b) your RMP is a multi-business RMP approved by the D-G in accordance with section 17A of the
APA; or
c) the risks to human or animal health is such that an evaluation is considered not necessary [AP
Reg 29].

Once your RMP has been assessed as valid by an evaluator, it can then be recommended to MPI for
registration. The evaluator will prepare an evaluation report for you. This process has been summarised in
Figure 4 Evaluation and Registration Process.

You can search for the following guidance documents on evaluation on the MPI website:
• Recognised Evaluators of Non-dairy Risk Management Programmes;
• Evaluation Manual (For evaluating Risk Management Programmes which do not cover Dairy Products;
• Guidance Document - Dairy: Recognition of Agencies and Persons; and
• Dairy Operational Guidelines and Approved Criteria (Approved criteria (for reference only, as these are
now withdrawn), codes of practice, and guidance for dairy).

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Figure 4: Evaluation and registration process

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6.1 Evaluation of RMPs

6.1.1 Selection of a recognised evaluator

You will need to contract a recognised evaluator to evaluate your RMP. You should check the evaluator has
skills and knowledge appropriate to your operation. In some cases, it is mandatory to use an evaluator who
has been recognised for certain activities, e.g. low-acid canned foods; general dairy manufacture [PSP Notice
Tables 24 & 25]. The evaluator may also obtain technical assistance from technical experts or other
recognised evaluators as necessary e.g.: for dairy heat treatment evaluation.

You can find a list of recognised evaluators and their activities on the MPI website by selecting ‘RMP
Evaluation’ under Recognition Function and clicking ‘Search Person’. You can also select an activity to narrow
down the options.

You cannot use the same person to develop and evaluate your RMP within a period of 2 years (unless the
Director-General agrees otherwise in writing), as this would be a conflict of interest (refer to AP Reg 74). The
same rules apply to any technical expert used in the evaluation (i.e. they cannot have been involved in the
development of the RMP for a period of 2 years).

You are responsible for costs associated with evaluation.

6.1.2 Evaluations of RMPs that cover both dairy and non-dairy

RMPs may cover both dairy and non-dairy material and products. The evaluator can evaluate an RMP which
includes dairy only if they are recognised to do so, as detailed under the PSP Notice. If an evaluator is
presented with an RMP that contains both ‘principally dairy’ and non-dairy animal materials and/or products,
they may need to consider if 2 separate evaluations are needed, or if a dairy evaluator is needed to support
the lead RMP evaluator. Refer to the guidance procedure for principally dairy determinations in Section 10:
Principally dairy determination for multi-ingredient foods of this (RMP) manual for definition of ‘principally
dairy’.

6.1.3 Desk-top assessment

The recognised evaluator will carry out a desk-top review of all RMP documentation to ensure that it is
complete, meets all the regulatory requirements and that the proposed controls will deliver animal material
and animal product that is fit for its intended purpose.

If you intend to submit only “Parts” of your RMP for registration, your evaluator will also check that the parts of
RMP provided to them accurately reflect the content of the full RMP [AP Reg 27] (see section 7.1.1 of this
manual for details of the Parts that must be submitted).

This desk-top assessment may occur at the premises or at some other location and typically occurs prior to
the on-site assessment.

6.1.4 On-site assessment

When an RMP is to be first registered, the evaluator must conduct an on-site assessment to assess the
appropriateness of the RMP against the physical boundaries, design and construction of the premises or
place and the operations described in the programme [AP Reg 78]. You may be exempt from the need for an
on-site assessment under AP Reg 79 if certain criteria are met, for example if the level of risk to human or
animal health is such that an on-site visit is unnecessary. In this case, the evaluator applies to MPI for the
exemption and provides justification as to why they believe an on-site assessment is not necessary.

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The on-site assessment for the purpose of the evaluation report must be performed when the premises and
equipment are ready to operate. If your premises is not operational at the time of evaluation (e.g. if it is a new
premises or new process), you must make reasonable attempts to demonstrate or explain normal operation.

When carrying out an evaluation of a significant amendment to an RMP, the evaluator may decide that an on-
site assessment is not necessary and must give the reasons for that decision in the evaluation report [PSP
Notice N3.4(1)(e)]. An exemption is not needed in this case. (Also see section 6.4 of this manual).

During the on-site assessment the evaluator will:

• conduct a reality check of your operation against the documented RMP;
• confirm that the scope of your RMP is appropriate (include checking the physical boundaries);
• check the design and construction of your facilities and equipment and confirm that they are suitable
and ready to operate (Note: dairy evaluators will get this information from heat treatment and premises
evaluation reports);
• check the GOP and supporting systems to ensure that the RMP is capable of delivering animal
material or animal product that is fit for its intended purpose;
• review the application of HACCP principles, e.g. your HACCP plan;
• talk to key personnel (including managers) to ensure an acceptable understanding of the RMP; and
• check relevant documents and records, including any validation.

More than one on-site assessment may be required. In many cases, the initial on-site assessment will
highlight a range of issues still to be addressed (e.g. constructional issues) which may require further on-site
assessments.

If your RMP covers a number of businesses or sites, depending on the nature of operations, the evaluator
may only need to visit selected sites. If it is an evaluation to register an RMP, the recognised evaluator will
need to apply to MPI for an exemption from the on-site assessment for the sites that will not be visited.

6.1.5 Resolving RMP deficiencies

It is your responsibility to resolve any deficiencies identified by the evaluator. If changes are made, you should
check whether any consequential changes to the RMP are necessary to ensure consistency, e.g. to other
procedures, GOP, the document list, version numbers etc.

If your RMP is not satisfactory, the evaluator may provide you with feedback in general terms stating where it
is deficient. To ensure impartiality and independence is maintained, the evaluator cannot provide solutions to
the deficiencies if they wish to remain as your evaluator.

6.2 Evaluation report

When your RMP is satisfactory, your evaluator will prepare an evaluation report, including any conditions to
be applied by MPI upon registration. You will need to provide your evaluation report as part of the registration
documentation and as it is only valid for 6 months, you should apply for registration as soon as possible after
you receive your report. The evaluation must be repeated if this timeframe is exceeded.

The evaluation report will meet the requirements in AP Reg 75 and PSP Notice N3.4 and N3.5.

6.3 Evaluation after completing validation

If your RMP was incompletely validated at the time of registration you must complete the validation in
accordance with your protocol and provide the validation information and any amendments to the RMP as a
result of that work to your evaluator. These will be evaluated and may require an on-site assessment.
Deficiencies should be resolved in accordance with 6.1.5 Resolving RMP Deficiencies of this manual.

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The evaluator will prepare a supplementary evaluation report once satisfied that validation is complete. The
contents of the report are in PSP Notice N3.4(4). You must then provide this report, together with any RMP
amendments to MPI to satisfy the registration conditions.

6.4 Evaluation of significant amendments

If a significant amendment is made to your RMP, you will need to update the RMP to include all new systems
and procedures necessary to operate the amendment and ensure that staff are aware of the changes and
know what to do. This must then be evaluated and registered.

The evaluator will assess all parts of the RMP that are affected by the amendment. The degree to which a
part will need to be re-evaluated will depend on the degree to which it has been modified. An on-site
assessment may or may not be required depending on the nature of the amendment and whether it involves
the physical premises. An on-site assessment would be expected for most significant amendments involving
design and construction. The evaluator must provide reasons in the evaluation report where an on-site
assessment has not occurred. When the significant amendment is satisfactory, the evaluation report will be
prepared by the evaluator.

You will need to provide your evaluation report as part of the registration documentation and as it is only valid
for 6 months and so you should apply for registration as soon as possible after you receive your report. The
evaluation must be repeated if this timeframe is exceeded.

The evaluation report will meet the requirements in AP Reg 75 and PSP Notice N3.4 and N3.5.

Refer to AP Reg 30 for details on the kinds of amendments to an RMP that require registration as a significant
amendment and Appendix G: Guidance on Difference between Significant and Minor Amendments of this
manual.

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7 Registration
(Sections 19 and 22 of the APA and AP Reg Part 1, subpart 2)

Once your RMP has been evaluated, apply to MPI Approvals at [email protected] for it to be registered.
Your RMP must be registered with MPI before you can start producing animal material or product that can be
traded [APA 3(1)(a)].

MPI will aim to process applications within 10 working days. Complexity, quality and size of an application
may affect this timeframe. MPI has developed guidance about the Application process – New or Amended
RMP. During the applications process MPI may request further information to make sure all requirements are
met. Your application will lapse if the information is not supplied within 6 months from the date of request, or
within an extended date as agreed with MPI.

In some instances where an RMP assessment is complex or takes longer than anticipated, MPI will require an
additional assessment fee. This is calculated on an hourly basis.

Once the RMP assessment is complete, you will be emailed to confirm that your RMP has been registered,
and the following documents will be attached:
• a letter confirming registration;
• a notice of registration;
• a notice of conditions if applicable (additional legal requirements that you must comply with); and
• a copy of the registered RMP or required parts of the RMP.

Your RMP verifying agency will also be provided with copies of these documents. The original authorised
documents will be held by MPI.

Once a RMP is registered, the registration details will be put on the public register (Registered Risk
Management Programmes). It is your responsibility to ensure you comply with any RMP conditions. If a
condition timeframe is exceeded, MPI may apply additional conditions, or the registration may be revoked.

If MPI considers that your RMP has not met the requirements, or an operator does not meet the criteria for
registration, registration may be refused (see 7.3 Refusal to Register for more details).

7.1 Application for registration

You must use the correct application form when you are applying to register your RMP. See below for a list of
the application forms:
• AP4: Registration of Risk Management Programme;
• AP5: Registration of Risk Management Programme under New Operator;
• AP6: Registration of Amendment to Risk Management Programme;
• AP50: Minor Update to Risk Management Programme Details; and
• AP55: Registration of RMP under Special Circumstances.

You can find these forms on the MPI website by typing the relevant AP form number into the search bar.

The application form will prompt you to include all other information that will be required for registering the
RMP, including:
• the entire RMP or RMP required parts (see 7.1.1 RMP “required parts” to be submitted for registration);
• validation protocol (if there is one);

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• the evaluation report (no more than 6 months old) if required (see 6.2 Evaluation report) (for dairy
processors, the evaluation report may include heat treatment and/or premises evaluation reports, if
required);
• confirmation that the recognised agency has agreed to verify the RMP (see 4.16 Provision for
Verification Activities);
• the application fee; and
• AP49: Processing Categories Tables.

The person who signs the declaration on the application form must have the appropriate authority to act on
your behalf.

7.1.1 RMP “required parts” to be submitted for registration

You have the option of submitting either your entire RMP or just the “required parts” for registration [APA
20(2)(a)]. If you chose to submit the ‘required parts’ only, these are specified in AP Reg 27 and includes:
• name and address (including the electronic address, if available) of the operator and the business(es)
covered by the programme [APA 17(1)b & c];
• identification of —
a) the animal material or animal product being produced or processed; and
b) the premises or place to which the programme applies; and
c) any other businesses to which the programme applies (if it does not apply only to the business of
the person applying for registration) [APA17(1) b & c];
• the trading name (if applicable) of the business [AP Reg 5];
• the position, or name and position, of the person responsible for the day-to-day management of the
programme [AP Reg 5];
• the registration number or other unique identifier of the programme, when available [AP Reg 5];
• any unique location identifier (ULI) of the premises or place (dairy only) [AP Reg 5 & PSP Notice D3.2];
• the location and type of premises or place covered by RMP including [AP Reg 5] —
a) its physical address; or
b) if the premises are mobile, the location where the premises are based principally; or
c) if the premises are a vehicle, any vehicle registration number and the location where the vehicle
is based principally; or
d) if the premises are a craft or fishing vessel, the name of the craft or fishing vessel, the physical
address of the operator of its RMP, and (if applicable) the fishing vessel registration number
under the Fisheries Act 1996
• physical boundaries of the RMP [AP Reg 6];
• description of any other activities occurring within the physical boundaries [AP Reg 7];
• animal material and animal product and intended use [AP Reg 8];
• process description (including all inputs, all outputs and the main activities or steps) [AP Reg 9];
• all relevant regulatory and operator-defined limits [AP Reg 11];
• identification and justification of CCPs & critical limits [AP Reg 15];
• the hazard identification and management information required by section 17 (3)(a) to (c) of the APA
(described in 4.12.2 – 4.12.7);
• list of all the documents that comprise the RMP, including the date or version of each document [AP
Reg 26 & 27].

For multi-business RMPs, the information listed above, specific to each business must be identified. Where a
large number of businesses are covered by the multi-business RMP, providing information about the
document or recording system where this information is kept may be sufficient, but should be checked with
MPI.

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7.1.2 Electronic applications vs hard copy applications

MPI prefers email applications. If you submit documents electronically they should be in Microsoft Word, PDF
or a format agreed with MPI prior to submission. If your document file size is too large to email, contact MPI
Approvals at [email protected] to request a ShareFile link. ShareFile enables secure, convenient file
sharing with MPI.

If you submit your application as a hard copy via the post or courier, please ensure you retain copies of the
documents you’ve sent to MPI for your own records.

Please choose either electronic or hard copy submission. Submitting a mix of emailed and posted documents
to MPI will likely cause delays in processing your application.

7.2 Pre-registration assessment of RMP documentation

Substantial work is involved in developing an RMP, and where a business is also constructing new facilities,
the work required is even greater. MPI requires time to complete the registration process and this can be
prolonged if problems are encountered with the application, which can be frustrating for the operator,
evaluator and MPI.

A pre-registration assessment of RMP documentation is an option available for businesses with premises at a
stage of ‘practical completion’. This is to assist with the registration process and to reduce the time required to
complete the registration once premises construction is complete.

‘Practical completion’
‘Practical completion’ requires the exercise of judgement, but the principle is that the construction of the
building envelope, services and equipment should be substantially complete to the point where the facility is
ready for engineering commissioning.

The use of this option is limited to situations where the:

• RMP documentation is complete and has been evaluated;
• RMP documentation is unlikely to change prior to registration; and
• premises construction is at a stage of ‘practical completion’.

This option cannot be used when the RMP documentation is not complete, i.e. an operator cannot use this
option to have documentation assessed in a piecemeal fashion.

7.2.1 Pre-registration assessment procedure

The following summarises the pre-registration procedure to be followed.

(1) The operator completes all RMP documentation:
a) this will include the validation protocol; and
b) all design and construction requirements must have been finalised and construction is at a stage
of ‘practical completion’.
(2) The operator contracts an evaluator to undertake the evaluation:
a) this will involve a desk-top assessment to ensure the RMP documentation is complete and likely
to deliver animal material or product that is fit for intended purpose;
b) the evaluator may choose to undertake an on-site assessment at this time, as this may be useful
in highlighting any design and construction issues which need resolution. However, as the
construction is not complete, a further on-site assessment for the purposes of the evaluation
report will be necessary; and

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c) if satisfied, the evaluator will prepare an interim evaluation report, the contents of which will meet
PSP Notice N3.4(1) (a-c) (except d-f) & N3.4(2). The evaluator will need to clearly state that this
is an interim evaluation report and indicate any areas of the RMP that are still incomplete.
(3) The operator will submit the interim evaluation report, the RMP documentation and the application
forms (including the applicable fee) to the D-G for pre-assessment.
(4) The D-G will assess the documentation (within 10 working days wherever possible):
a) the operator will make any amendments that are required as a result of the assessment; and
b) the application will be put on hold by MPI until the construction and on-site assessment is
completed.
(5) Once the construction is complete, the operator will arrange for the evaluator to complete the on-site
assessment.
(6) Once satisfied, the evaluator completes the evaluation report as required by AP Reg 75 and PSP
Notice N3.4 and 3.5. Any amendments to pre-assessed RMP documentation that have been made as
a result of the completion of the evaluation must be highlighted in the RMP by the operator and in the
evaluation report by the evaluator.
(7) The operator submits all remaining information to the D-G for completion of the registration process. If
the RMP is satisfactory, the RMP will be registered without delay:
a) when significant changes have been made to the RMP, the original assessment will have to be
repeated and there may be little reduction in the time required to complete the registration; and
b) the operator will be charged for all the time involved in the assessment of the RMP (including
initial assessment and any re-assessments).

7.3 Refusal to register

(Section 23 of the APA)

You will be notified in writing if MPI refuses to register your RMP, clearly stipulating the reasons. You will be
given a reasonable opportunity to make written submissions or be heard in respect of the notification to refuse
registration (i.e. within 10 working days or as agreed).

Under Section 162 of the APA, you may apply for a review of the decision if a person other than the D-G
makes the original decision to refuse registration of your RMP. However, if the D-G makes the original
decision, there is no right of review.

Your application for review should be in writing and state the reasons why you consider that the original
decision was inappropriate. This should be provided to the D-G within 30 days of the original decision being
notified.

The review will be carried out by the D-G or a designated person not involved in the original decision.

The D-G’s decision is final and subject to judicial review.

7.4 Condition close-out after completion of validation

If your RMP was incompletely validated when registered (i.e. if you had developed a validation protocol), it
would’ve included a condition requiring validation to be completed. After you have completed your validation
you must forward the evaluation report along with any other required documents as evidence to MPI
Approvals at [email protected]. MPI will then assess the documentation and notify you in writing of the
outcome of the assessment and any changes to your RMP conditions (see section 6.3 of this manual).

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7.5 Registration of significant amendments

Where you make a significant amendment to your RMP, under section 25 of the APA you must apply for
registration of the amendment with MPI Approvals at [email protected] using form AP6: Registration of
Amendment to Risk Management Programme [AP Reg 29]. This must be accompanied by:
a) the entire RMP with the changes clearly identified; or
b) the “required parts” of the RMP (see section 7.1.1 of this manual) with the changes clearly
identified; and
c) the evaluation report (no more than 6 months old), unless this requirement is waived under APA
s 20, AP Reg 29(3)); and
d) a validation protocol, if validation information under AP Reg 34(1) is necessary and is not
available before the application for registration.

The process for registering a significant amendment is the same as for initial registration of the RMP. Refer to
8.4.1 Significant Amendments to your RMP for more information. For an explanation of what is a significant
amendment refer to AP Reg 30 and Appendix G: Guidance on Difference between Significant and Minor
Amendments.

7.6 Change of registration details

(Section 16, 24 and 25 of the APA)

You must notify MPI Approvals at [email protected] of any of the following changes to your RMP [AP
Reg 37].

7.6.1 Change in operator or operator name only

Registration of an RMP may not be transferred to a different operator. Where a change in “operator” or
“operator name” is the only change to your registered RMP, complete application form AP5: Registration of
Risk Management Programme under a New Operator (e.g. a change of the company name, a change to the
(number of) members of a partnership, or a change in the names of directors).

In the event of the operator’s death, bankruptcy, receivership, or liquidation, a new registration must be made
using the application form AP55: Registration of RMP: Special Circumstances.

7.6.2 Change in day-to-day manager of an RMP

When there is a change to the name, position or designation of the person(s) responsible for the day-to-day
management of the RMP, you must notify MPI Approvals at [email protected] of this change using the
AP50: Minor Update to Risk Management Programme Details application form [AP Reg 37]. This is not a
significant amendment to your RMP.

7.6.3 Change in recognised agency

You must notify MPI Approvals at [email protected] as soon as possible of a change in your verifying
agency using form AP60: Change of Recognised Agency for Verification Purposes. This is not a significant
amendment of your RMP [APA 16(2)].

7.7 Multi-business RMP registration

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, if required. The documents submitted differ slightly. For a multi-

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business risk management programme, the operator of the programme must also provide the following
information:
a) evidence in writing that the operator will have sufficient control, authority, and accountability for
all matters covered by the programme in relation to the businesses; and
b) evidence in writing that the operator has obtained the consent or otherwise taken into account
the views of any person whose business is to be covered by the programme [AP Reg 28].

MPI must be satisfied that the requirements in Section 17A of the APA has been met before the RMP is
registered.

8 Operating your RMP

This section summaries your responsibilities once the RMP is registered.

You can only commence processing product for trade from the date your RMP is registered. You are required
to operate in accordance with your RMP and must comply with any conditions specified upon your registration
[APA 16(1)]. It is illegal to operate outside the scope of your RMP.

8.1 RMP operators’ duties

You have the following duties as an RMP operator:
a) to ensure that the operations of your business do not contravene the relevant requirements of the
APA, including the requirements set out in your RMP;
b) to ensure that your RMP is consistent with the requirements of regulations and notices under the
APA;
c) to adequately implement and resource all operations under your RMP, including providing
instruction, competency and supervision of personnel to ensure the delivery of product that is fit
for intended purpose;
d) to ensure that the capability and capacity of your premises, facilities, equipment and personnel
are adequate for your operation’s throughout and to deliver product that is fit for intended
purpose; and
e) to give the verifying agency such freedom and access to carry out their functions and activities
under the APA [APA 16(1)].

If you fail to meet your duties, you will be in breach of Part 10 of APA. 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; and
• prosecution where appropriate.

8.2 Conflict between RMP and the Act, Regulations or Notices

Where there is any conflict between your registered RMP and requirements under the APA, the requirements
under the APA prevail [APA 30].

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8.3 Verification by recognised verifier

The verification requirements for RMPs are in part 4 of the AP regulations. These requirements are expanded
on in the Animal Products Notice: Production, Supply and Processing in Chapter M, and include the
verification frequencies.

The frequency at which your RMP will be verified will depend on your level of compliance with your registered
RMP and, if exporting, any applicable export requirements. If your operation complies with your RMP and is
consistently effective, the verifier may be able to reduce the frequency of verification. A higher frequency will
be applied if the RMP is not being implemented correctly.

More frequent verification may also be required if your business is exporting and your product requires official
assurances. Please refer to clauses M1.3 and M1.5 of the PSP Notice for additional information on the
verification steps that may apply to different official assurance export business(es) and moving up or down
verification steps.

8.4 Amendments to the RMP

You must amend your RMP and apply for registration where any change, event, or other matter means that it
[APA 25]:
a) 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
b) 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 of APA.

If you amend your RMP for any reason, the amendment will be classified as significant or minor. AP Reg 30
specifies the kinds of amendments that require registration as a significant amendment under section 25 of
the APA. To determine if an amendment is significant or minor, MPI has provided some guidance in Appendix
G: Guidance on the Difference between Significant and Minor Amendments.

You may also consult your verifier, an evaluator or a technical expert for advice. Additionally, if your product is
intended for export, MPI strongly recommends that you discuss proposed amendments with your verifier to
identify any potential market access implications.

Transitional arrangements

Until 1 November 2023, an amendment made to an RMP registered before 1 July 2022 solely to meet the
requirements of the new animal product regulations and notices are considered minor amendments and
don’t need to be registered with MPI [AP Reg Schedule 1(2)].

8.4.1 Significant amendments to your RMP

(Section 25 of the APA)

A significant amendment to your RMP will need to be evaluated by an evaluator prior to being registered with
MPI (unless the requirement for evaluation is waived). The evaluation is to make sure the changes to the
amended RMP still meets regulatory requirements and will produce animal material and animal product that is
fit for its intended purpose.

If the significant amendment needs to be validated, this can be done either before or after registration of the
amendment. As is the case when initially registering your RMP, will require a validation protocol if this is to
occur after registration.

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For a significant amendment, your application will need to include the information in section 7.5 of this
manual.

You must apply for registration of the significant amendment as soon as practicable [APA 25(2)]. If you do not
comply with registration requirements when you significantly amend your RMP, you will be in breach of the
APA. Depending on the circumstances this could result in:
• suspension of the RMP;
• de-registration of the RMP; or
• prosecution.

8.4.2 Minor amendments to RMPs

(Section 26 of the APA)

Minor amendments can be made without evaluator or MPI involvement. For a minor amendment, you will
need to document and keep the following evidence on file:
• a description of the change;
• written justification detailing why the change is not considered a significant amendment; and
• if you have sought advice from a recognised evaluator, verifier, technical expert or MPI to determine
the amendment as minor.

If the changes are editorial, e.g. to improve the clarity of a procedure or to correct typographical errors, no
evidence is required. If you are making a number of minor amendments, it may be considered a significant
amendment if the changes make the RMP no longer appropriate. You should discuss with your verifier to see
if this is applicable.

All minor amendments will be checked by the verifier as part of their verification.

8.4.3 Notifications to MPI

[APA 26]

To ensure the registration details shown on the RMP public register are up-to-date and accurate, some
changes should be notified to MPI. Notify MPI Approvals at [email protected] of the changes using the
AP50: Minor Update to Risk Management Programme Details application form. See the form for details on
which changes can be notified. Make sure you attach any relevant documentation to assist with the
amendment.

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9 Ceasing operations or registration of an RMP

The section provides guidance for when you cease operating your RMP or your business is removed from the
coverage of a multi-business RMP. If only a part of your RMP ceases operation, you should consider any
impact on the parts of your RMP that are still operating.

You will need to give consideration to the control and disposition of any remaining animal material and animal
product that may be in your possession on removal of your registration.

9.1 Surrender of registration

If you decide to surrender your RMP (permanently, as opposed to seasonal closure) you must notify the D-G
in writing [APA 29(1)].

You (or where appropriate a liquidator, receiver, executor, or other successor to title of the operator) must,
within 30 days of cessation:
a) notify MPI Approvals at [email protected] in writing (the AP50: Minor Update to Risk
Management Programme Details form may be used for this), and include how any remaining
animal materials or animal products covered by the RMP will be dealt with;
b) surrender the notice of registration to MPI Approvals at [email protected]; and
c) notify your recognised verifying agency [APA 29(2)].

When you notify MPI of a surrender and include how you intend to deal with any remaining animal material or
animal product covered by the RMP and MPI will either:
a) approve or agree to the proposal; or
b) direct you to take appropriate actions to deal with any affected animal material or animal product
and use Animal Product Officers or other MPI employees to act on their behalf. All associated
costs will then be recovered from you [APA 29 and 82].

You should make sure that eligibility documents for official assurances are raised for all animal product that
you intend to export prior to surrender of your RMP. You will not be able to raise any eligibility documents
after surrendering your RMP.

MPI will notify the relevant territorial authority [APA 32] when a surrender involves a secondary processor who
has elected to operate under an RMP rather than under the Food Act, if necessary.

9.2 Suspension of operations

(Section 27 of the APA)

9.2.1 Suspension by MPI (mandatory suspension)

MPI may suspend part of, or the whole operation (including one or more businesses under a multi-business
RMP) under a registered RMP for a period of up to 3 months if there are reasonable grounds to believe that
the:
• RMP may not be or is no longer effective; or
• animal product produced under the RMP does not meet the requirements of the APA.

MPI will notify the recognised verifying agency of any suspension of an RMP and record the suspension on
the public register [APA 27(5)]. The suspension may be notified in the Gazette [APA 27(6)].

You will be given a written notice of the suspension specifying the following:

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a) the reason for the suspension;

b) the period of the suspension;
c) the date and time of commencement of the suspension (which may not be earlier than the date
and time of notification);
d) the operations to which the suspension applies; and
e) any conditions or requirements in relation to the suspension [APA 27(3)].

Where a person acting under the delegated authority of the D-G suspends any operations, you may seek a
review of the suspension by applying in writing to MPI within 30 days of notification [APA 162].

MPI may direct you to take appropriate action to deal with any affected animal material or animal product or
may use animal product officers or other MPI employees to act on their behalf. All costs associated with this
will be recovered from you [APA 82].

The period of suspension may be extended for an additional 3 months if there are reasonable grounds. MPI
must notify you in writing of an extension to the period of suspension before the expiry of the original
suspension. However, this extension can only take place after you have been notified of the proposed
extension, the reasons for it, and have had a reasonable opportunity to respond [APA 27(4)].

9.2.2 Suspension by operator (voluntary suspension)

RMP operators may suspend all or any operations under the RMP for a minimum of 3 months and a
maximum of 12 months. You must notify MPI Approvals at [email protected] of the suspension using
AP50: Minor Update to Risk Management Programme Details application form.
a) An operator who suspends operations under subsection 4A of APA 27 must give the Director-
General a notice in writing stating — the date on which the suspension starts, which must be a
date after the date of the notice; and
b) the date on which the suspension ends; and
c) which operations are suspended; and
d) how the operator intends to deal with any affected animal material or product [APA 27(4)B].

Businesses that process animal products, and who choose to temporarily cease operations, are still subject to
PSP Notice M1.7. This requires that the RMP may still undergo verification with the limited verification scope
to cover the activities that continue (e.g. storing of animal products) and the verifier may apply a higher
verification step. It is expected that the operator should advise the verifier or verifying agency before resuming
other processing activities.

MPI is also able to impose conditions and requirements in respect of the implementation and operation of the
suspension and it is likely that voluntary suspensions will be imposed with a condition requiring a verification
prior to restarting.

MPI will notify the verifying agency of any suspension of an RMP [APA 27(5)].

9.3 Deregistration of the RMP

(Section 28 of the APA)

MPI may deregister an RMP or remove any animal product business from the coverage of a multi-business
RMP if:
• repeated suspensions have occurred;
• a serious failure of operations has occurred;
• the fitness for intended purpose of the animal product is in doubt;
• you are not considered fit to continue operating your RMP; or

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• your RMP has ceased to be relevant to your current operations.

Oral or written notice of the intention will be given to you (giving reasons) where MPI intends to deregister
your RMP or remove your business from the coverage of a multi-business RMP. You will be given the
opportunity to respond.

The date that deregistration or removal takes effect will be given by MPI. Notification of deregistration or
removal will also be given to your verifying agency. MPI may notify any deregistration in the Gazette.

If a person acting under the delegated authority of the D-G deregisters your RMP or removes your business
from the coverage of a multi-business RMP, you may seek a review of the decision by applying in writing to
MPI within 30 days of notification [APA 162].

MPI may direct you to take appropriate action to deal with any affected animal material or animal product or
may use animal product officers or other MPI employees to act on their behalf. All costs associated with this
will be recovered from you [APA 82].

10 Principally dairy determination for multi-ingredient food

If you manufacture, process, or sell products that contain dairy, MPI has developed guidance: Procedure for
Principally Dairy Determinations to help you determine whether a multi-ingredient food is considered to be a
dairy product under New Zealand Standards. This includes products such as tablets, supplements, and
fortified foods that contain dairy ingredients. This guidance is provided to help manufacturers to make the
determination.

MPI encourages operators to do their own determinations, or discuss this with their verifier.

If clarification is required (e.g. for difficult situations or when an operator and verifier disagree), MPI can be
contacted for a principally dairy determination by completing the Principally Dairy Determination Form and
submitting it to MPI by emailing [email protected], making sure you have included the
formulation, product name, list of ingredients and label. Mock-up or proposed artwork is accepted if the
product is still in the development phase. Any additional proposed marketing material is also helpful, or links
to websites with information about the product.

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Appendix A: Businesses requiring RMPs

You must operate under a registered RMP if you are producing or processing animal material or animal
product (subject to the exclusions described in Appendix B: Businesses Not Requiring RMPs) if one of the
following applies to you [APA 13]:
• primary processors of animal material;
• secondary processors of animal products, except to the extent that they are subject to the Food Act;
• retail butchers who are dual operator butchers; or
• other persons specified by Order in Council under section 15 of the APA;
• producers of chicken as specified by AP Reg 40A as per the AP Reg amendment 2022.

A.1 Primary processors (including dairy processors)

(Section 4 of the APA)

Because the term ‘primary processor’ determines who must have an RMP, the term is specifically defined in
the APA (copied below in italics).

Primary processor means a person who, for reward (otherwise than as an employee) or for purposes of
trade:
a) slaughters and dresses mammals or birds; or
b) dresses mammals or birds that are killed wild animals or are killed as if they were wild animals; or
c) removes or extracts or harvests any animal material from live animals for the purpose of
processing for human or animal consumption; or
ca) is a dairy processor; or
d) in the case of-
i) finfish or shellfish, or animal material derived from finfish or shellfish; or
ii) a mammal or bird, or animal material derived from a mammal or bird, if in the opinion of
the Minister it is appropriate that the primary processing of that mammal or bird or animal
material should extend beyond the matters referred to in paragraphs a) and b); or
iii) any other animal, or animal material derived from any other animal -
processes those animals or that animal material to the extent specified by the Minister by notice
(see subsection (4) after consultation in accordance with section 163 and after having
regard to the following matters;
iv) industry practice in relation to the animal material concerned;
v) the degree of processing and number of processing operations required in relation to the
animal material;
vi) the risk factors involved in processing the animal material;
vii) whether or not the processing of the animal material is or may be appropriately addressed
by any legislative regime other than this Act;
viii) such other matters as the Minister considers relevant in the particular circumstances;
but does not include hunters within the meaning of paragraph (2) of the definition of primary producer.

“Dairy processor” is included within the APA definition of “primary processor”. The APA then defines dairy
processor, as provided below. The result is that for dairy processors, primary processing extends to the point
that the animal material goes for retail sale or export.

Dairy processor means a person who, for reward (otherwise than as an employee) or for purposes of trade,
carries out dairy processing; and:
a) includes –
i) a farm dairy operator:

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ii) a transporter of dairy material from a farm dairy to a place of processing or manufacture:
iii) a transporter of dairy material from one place of processing or manufacture to another:
iv) an operator of any premises where dairy material is processed or manufactured or stored:
v) a transporter of dairy material to the place of export or sale for consumption or end use for
purposes other than consumption:
b) does not include -
i) persons (such as airline or shipping staff or stevedores) handling dairy material at the port
of export:
ii) Wholesalers of other persons (other than retailers) handling dairy material at the place of
sale for consumption or use: or
iii) retailers doing any or all of the following at the place of sale for consumption or use:
A) handling dairy material:
B) dividing or combing dairy material into smaller or larger quantities: or
C) repackaging dairy material

Paragraph (d) of the definition of primary processor within the APA allows additional processes to be added to
the definition by Notice, where the definition within the Act is not clear enough for some industries. The Animal
Products (Definition of Primary Processor) Notice 2000 defines the following persons as primary processors if
they process for reward (otherwise than as an employee) or for purposes of trade:
a) a person who harvests and candles8 eggs obtained from layer hens or other birds including quail,
geese, ducks, ostriches and emus, where the eggs are intended for human or animal
consumption;
b) a person who removes or extracts or harvests or undertakes drying, slicing, grinding or
preserving of deer velvet;
c) a person who, in land based fish premises, carries out the first methodical assessment (this
includes a visual check to ensure that the fish are in a satisfactory condition for processing to a
product fit for human or animal consumption) of the suitability of the fish for processing is made,
and the fish are processed. To clarify this general statement, the following operations carried out
on-shore are included in primary processing (whether or not coupled with a methodical
assessment of suitability for processing):
i) the deheading, gutting, or filleting of finfish;
ii) the tubing of squid;
iii) the wet-storage, depuration, or shucking of shellfish;
iv) the removing of roe from kina;
v) the holding of crustaceans live (otherwise than in a marine farming operation), or their
tailing; or
vi) in relation to fish to be sold whole or after processing at sea, any steps (including washing,
chilling, freezing, or packing) taken to ensure their delivery to a buyer in good condition
d) a person who, in fish processing at sea, carries out any of the following operations:
i) the filleting of finfish (but not their mere deheading, gutting, or scaling; and not including
the filleting of fish that are to be consumed by the crew of the vessel concerned), i.e.
factory vessels;
ii) in respect of fish of any species processed at sea for the purposes of export that are not to
be delivered to an on-shore primary processor, any other process normally applied to fish,
including;
iii) washing, chilling, freezing, and preserving;

8In this clause “candling” means the testing of eggs for freshness, fertility, or defects (by use of light, electronic means,
or any other commercially accepted means).

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iv) deheading, gutting, scaling, and tubing; or

v) packing, transport, and storage.

A.2 Secondary processors of animal products

(Sections 13 and 32 of the APA)

All secondary processors of animal products intended for human consumption must have an RMP, unless
they operate under the Food Act.

Some secondary processors of animal products intended for animal consumption may be exempt from RMP
requirements if they meet certain conditions. More information on this can be found here.

A secondary processor of animal products intended for export with an official assurance must have an RMP to
comply with overseas market access and official assurance requirements.

Note: secondary processing is not applicable to dairy processing because all dairy processing is primary
processing.

A.3 Dual Operator Butchers

(Section 71 of the APA)

Dual operator butchers (DOBs) are butchers who deal with both homekill (unregulated meat not for trade) and
retail meat (regulated meat) at the same premises or place. They must have an RMP covering processing of
their regulated product and describe how they will ensure a clear separation between processing and of the
product itself between homekill and regulated meat. There are also additional requirements for them to meet
(see 4.17 Additional Requirements in Relation to Homekill and Recreational Catch for Dual Operator
Butchers).

A.4 Specific requirement to operate under an RMP

The following processing must be carried out under an RMP [AP Reg 39 & 40]:
a) rendering9 and blood-drying operations in relation to mammal and bird material or product that is
not intended for human consumption;
b) technical grade dairy product10 processed at the same place as dairy product for human or
animal consumption, where that dairy product must be processed under an RMP or the technical
grade dairy product is for export requiring an official assurance.

9 “rendering” means the breaking down of animal tissues into constituent fat and protein elements, whether by the
application of heat and pressure or otherwise [APA 4(1)]
10 Technical grade dairy product means dairy product for sale or export that is not intended for human or animal

consumption [AP Reg 40(2)].

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Appendix B: Businesses not requiring RMPs

(Section 13 of the APA)

The following persons are not required to have RMPs:

a) certain exemptions for operators from requirements to have registered RMP in respect of the
operations specified in Schedules 2 and 3 of the AP Reg, some of which are mentioned below.

B.1 General and product specific inclusions and exemptions

The following persons are not required to have an RMP. Some operators will instead need to operate under a
risk-based measure under the Food Act regime. These have been marked * in the list below:
a) those operating fishing boats where the fish is not landed in New Zealand nor claimed to be a
product of New Zealand [AP Reg 262];
b) those whose products are covered by the Medicines Act 1981 (except where required for official
assurances) under the conditions as outlined in AP Reg 258;
c) those who process certain dairy products that are consumed on the premises* [AP Reg schedule
2, section 15];
d) those who process certain dairy products that are food* (e.g. multi-ingredients foods such as
cakes, biscuits, soups and pastries, caffeinated or alcoholic drinks) except those who process
multi-ingredient foods that consist principally of dairy (see Section 10: Principally Dairy
determination for multi-ingredient food), ice cream, or where required for official assurances [AP
Reg schedule 2, section 16];
e) those who are primary processing animal material for purposes other than human or animal
consumption (but excluding technical grade dairy products requiring official assurances), e.g.
skinning and shearing [AP Reg Schedule 3, section 2];
f) those who process dairy material for the New Zealand or Australian market only* and elect to
operate under a Food Act risk-based measure but excluding farm dairy operators [AP Reg
schedule 2, section 12];
g) those who transport dairy material or dairy product for export without official assurance or for the
New Zealand market* (Food Act risk-based measure such as NP1 applies for transport of food
for human consumption) [AP Reg schedule 2, section 12] ;
h) those who manufacture or store dairy material for animal consumption for the domestic market, if
no other operations at the same premises require an RMP [AP Reg schedule 2, section 13];
i) registered RCS farm dairy operators who produce and process RCS raw milk (raw drinking milk)
[AP Reg schedule 2, section 14];
j) a registered RCS depot operator who stores RCS raw milk (raw drinking milk) on behalf of farm
dairy operators [AP Reg schedule 2, section 14];
k) a transport operator who transports RCS raw milk on behalf of farm dairy operators [AP Reg
schedule 2, section 14];
l) those processing animal food in accordance with the Food Act, e.g. raw meat suitable for human
consumption is sold by a supermarket delicatessen as petfood* [AP Reg schedule 3, section 1];
m) those who transport animal material or animal product (other than dairy material or dairy product)
for animal consumption for export without official assurances or for the domestic market. [AP Reg
schedule 3, section 5];
n) those who have fish on a retail premises and fish is sold by retail or a combination of retail and
wholesale, where no fish from those premises are exported* [AP Reg schedule 2, section 2];
o) those who operate temporary holding and storage places for fish [AP Reg schedule 2, section 4];
p) those who operate limited processing on registered limited processing fishing vessels [AP Reg
schedule 2, section 5];
q) those who process only fish bait, fish berley, chum or ground bait [AP Reg schedule 2, section 6];
r) those who operate certain tourists or charter fishing vessel and fishing guides [AP Reg schedule
2, section 3];

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s) those who harvest and provide limited processing of whitebait, sells for consumption or
processing [AP Reg schedule 2, section 7];
t) muttonbird primary processors [AP Reg schedule 2, section 9];
u) certain primary processors of eggs (those with 100 or less female birds and who sell directly to
the consumer – not through a third party) [AP Reg schedule 2, section 1];
v) airline holding facilities operators [AP Reg schedule 3, section 3];
w) those who harvest, collect, store, grade or transport raw deer velvet [AP Reg schedule 2, section
10];
x) apiarists who harvest, store and transport bee material or product [AP Reg schedule 2, section
11];
y) taxidermists (so long as no part of the animal is traded for human or animal consumption –
except to rendering operations under an RMP, and homekill and recreational catch services are
not carried out on the same premises) [AP Reg schedule 3, section 4];
z) primary processing of fish, other than BMS, that are caught at fishing competitions and sold by
auction, for cultural, benevolent, philanthropic, or charitable purposes if they comply with certain
conditions as outlined in AP Reg schedule 2, section 8; and
aa) further petfood processing i.e. secondary processing of animal material or animal product
intended for cats or dogs under certain conditions as outlined in AP Reg schedule 2, section 17.

B.2 Exemptions from RMPs

MPI may grant limited exemptions under exceptional circumstances, under section 14 of the APA, from the
requirement to have all or part of an RMP.

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Appendix C: Examples of limits

For guidance purposes only, some examples of limits are given below. You should also check the current edition of the documents or references (mentioned here) as they are
amended from time to time.

Table 17: Example of limits for products for human consumption

Product Regulatory Limits Operator-defined Limits Controls

Notice Food Standards Code

RAW, NOT FURTHER PROCESSED

Raw red meat and offal Limits are set out in Part 3 of the NMD ---- Operator may define microbiological GOP
Notice and defect levels

Poultry Salmonella Performance Target, ---- Operator may define microbiological GOP
Campylobacter Performance Target and and defect levels
Prevalence Performance Target for
Campylobacter (limits in NMD Notice)
Mechanically separated meat ---- ---- Operator must define microbiological GOP
(MSM) - red meat and poultry limits for aerobic plate count and E. coli
[PSP Notice L2.3(6)]
Wetfish ---- Histamine level ≤ 200 mg/kg Operator must establish a requirement GOP
for viable parasites to be absent, if it
known that fish is to be eaten raw
Bivalve molluscan shellfish for E. coli/g: E. coli/g: ---- GOP
consumption in raw state other n=5 c=1 m=2.3 M=7 [PSP Notice H3.5] n=5 c=1 m=2.3 M=7
than scallops
Raw crustacean (not live) ---- Coagulase Positive Staphylococci/g: Operator should establish limit for GOP
n=5 c=2 m=102 M=103 marine biotoxins if likely to be harvested
Salmonella/25g: n=5 c=0 m=not detected in 25 g from contaminated waters
SPC: n=5 c=2 m=5x105 /g M=5x106 /g
---- Specified additive levels (e.g. sulphur dioxide, sodium and ---- GOP
potassium sulphites ≤ 100 mg/kg)

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Product Regulatory Limits Operator-defined Limits Controls

Specifications Food Standards Code

FURTHER PROCESSED
Ready-to-eat food in which ---- Listeria monocytogenes/g: If heat treated operator may CCP – cooking
growth of Listeria n=5 c=0 m=not detected in 25 g define lethality (e.g. 6D
monocytogenes can occur destruction of Listeria
monocytogenes), or cooking time
and temperature that will achieve
required lethality.
Ready-to-eat food in which ---- Listeria monocytogenes/g: ----
growth of Listeria n=5 c=0 m=102 cfu/g
monocytogenes will not occur
Casings Water activity ≤ 0.83 [PSP Notice F3.36] Sulphur dioxide and sodium and potassium sulphites ≤ 500 ---- GOP
mg/kg
Sausage and sausage meat ---- Sulphur dioxide and sodium and potassium sulphites ≤ 500 ---- GOP
containing raw, unprocessed mg/kg
meat Ethyl lauroyl arginate ≤ 315 mg/kg
Processed meat & poultry ---- Specified additive level ---- GOP if curing mix
products (e.g. patties, sausage, (e.g. nitrate ≤ 125 mg/kg) used. May be a
etc.) CCP when nitrite
added on its own
---- ---- Operator may define hazard GOP or CCP –
levels (e.g. microbiological, metal detection
physical hazard level, etc.)
Packaged cooked cured/salted ---- Coagulase Positive Staphylococci/g: ---- CCP – cooking
meat n=5 c=1 m=102 /g M=103 /g
Salmonella:
n=5 c=0 m=not detected in 25 g
---- Specified additive level ---- GOP if curing mix
(e.g. nitrite ≤ 125 mg/kg) used. May be a
CCP when nitrite
added on its own

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Product Regulatory Limits Operator-defined Limits Controls

Specifications Food Standards Code

FURTHER PROCESSED
Packaged heat-treated meat ---- Salmonella/g: CCP – Cooking
paste and paté n=5 c=0 m=not detected in 25 g
---- Specified additive level ---- GOP if curing mix
(e.g nitrite ≤ 125 mg/kg etc.) used. May be a
CCP when nitrite
added on its own

Uncooked comminuted fermented ---- Coagulase Positive Staphylococci/g: Operator must define pH and CCP –
meats11 n=5 c=1 m=103 M=104 water activity. fermentation,
E. coli/g: maturation
n=5 c=1 m=3.6/g M=9.2/g
Salmonella/g:
n=5 c=0 m=0/25 g
---- Sorbic acid and sodium, potassium and calcium sorbates ≤ ---- GOP if curing mix
1500mg/kg used. May be a
Primaricin (natamycin) ≤ 1.2 mg/dm2 CCP when nitrite
Nitrite ≤ 500 mg/kg added on its own
Cooked uncured meats ---- ---- Operator must define CCP – cooking
(e.g. roast beef, chicken, etc.) microbiological levels (e.g. same GOP post-cook
as that for cooked cured meats, handling
etc.)
---- Specified additive level ---- GOP

11
For more information on uncooked comminuted fermented meats (UCFM) please refer to the UCFM Standard.

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Product Regulatory Limits Operator-defined Limits Controls

Specifications Food Standards Code

FURTHER PROCESSED
Dried meat & poultry ---- ---- Operator should define CCP – drying/
(e.g. jerky; freeze dried meat, microbiological levels (e.g. cooking
etc.) Salmonella, Staphylococcus,
STEC), water activity and/or
moisture content
---- Specified additive level ---- GOP if curing mix
(e.g. nitrite ≤125 mg/kg, sorbic acid and sodium, potassium used. May be a
and calcium sorbates ≤ 1500 mg/kg) CCP when nitrite
added on its own
Cooked crustacean ---- Coagulase Positive Staphylococci/g: Operator must define lethality CCP – cooking
n=5 c=2 m=102 M=103
Salmonella:
n=5 c=0 m=not detected in 25 g
SPC/g:
n=5 c=2 m=105 M=106
Ready-to-eat processed finfish Histamine level ≤ 200 mg/kg ---- GOP
other than retorted (e.g. smoked
fish, vacuum packaged cooked
fish, manufactured fish products,
etc.)
Dried shelf stable fish ---- ---- Operator should define water GOP
activity and/or moisture content
Fish or fish products with pH<4.4 ---- ---- Operator should define pH<4.4 CCP – acidification
(e.g. marinated mussels, etc.)
Processed egg product ---- Salmonella/g: ---- CCP –
n=5 c=0 m=not detected in 25 g pasteurisation

(processed, in relation to egg product, for the purposes of

Schedule 27 of FSC, means pasteurised or subjected to an
equivalent treatment)

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Product Regulatory Limits Operator-defined Limits Controls

Specifications Food Standards Code

FURTHER PROCESSED
Low-acid canned foods ---- ---- Commercially sterile by CCP – retorting
application of a 12D thermal
process for C. botulinum
---- Specified additive level ---- GOP
(e.g. nitrites ≤ 50 mg/kg, etc.)
Edible fat/oils ---- Specified additive level ---- GOP
Dried deer velvet ---- ---- Operator should define water GOP
activity and/or moisture content
Honey ---- Moisture content ≤ 21% ---- GOP
Reducing sugars ≥ 60%
---- Tutin level ≤ 0.7 mg/kg ----

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Table 18: Examples of limits for products for animal consumption

Product Regulatory Limits Operator-defined Limits Control

Raw meat and offal ---- Operator may define microbiological and defect levels GOP
Rendered products Does not contain biological hazards (such as vegetative ---- CCP – rendering or
bacteria, viruses, protozoa) or chemical substances at levels drying
potentially harmful to animals that will consume the product GOP post-CCP
[PSP Notice L2.2]
---- Operator should define moisture content GOP
Heat treated, not shelf stable meat products that No viable hydatids Operator may define microbiological levels CCP – cooking
include offal (liver and lungs) of ruminants and pigs [Biosecurity Controlled Area Notice 294]
that are intended to be consumed by dogs without
further processing (e.g. dog rolls, etc.)
Dried meat products (e.g. jerky, etc.) ---- Operator should define water activity and/or moisture CCP – drying/
content cooking
Low-acid canned foods ---- Commercially sterile by application of a 12D thermal CCP – retorting
process for C. botulinum

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Table 19: Examples of limits for dairy material and dairy products for human consumption

Further detail on dairy limits can be found in PSP Notice D1.3 - D1.7 and the Food Standards Code. You should also check any other Notices and OMARs that may be relevant to
your product and situation.

Product Regulatory Limits Operator-defined Limits Control

All dairy products for human Dairy product must not exceed the following Microbiological Limits at any time during the product’s GOP
consumption shelf life (assuming the product is stored and handled according to manufacturer guidelines):
General Specific
Salmonella spp. ND 5x25g ND 250g
ND 60x25g (infant formula
products and foods for special
medical purposes)
L. monocytogenes ND 5x25g ND 5x25g
100 cfu/g (applies only to ready-to- ND 10x25g (infant formula
eat dairy product in which growth of products and foods for special
L. monocytogenes will not occur)12 medical purposes)
Coag. Pos. Staphylococci 1000 cfu/g 100 cfu/g
10 cfu/g (infant formula
products)
B. cereus 1000 cfu/g 100 cfu/g
E. coli 100 cfu/g 10 cfu/g
Cronobacter spp. NA ND 30x10g
IF(infant formula) 0-6 months
Dairy material and dairy product must not contain chemical residues and contaminants exceeding the GOP
limits specified in the PSP Notice D1.4.

12
as defined by the Food Standards Code, Standard 1.6.1 clause 4

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Product Regulatory Limits Operator-defined Limits Control

Nitrate (mg/kg) Nitrite (mg/kg)
Powdered formula for infants and young children up to 50 5
36 months (excluding dairy ingredients)
Milk powders (including ingredients for dairy product 150 5
intended for infants and young children but excluding
buttermilk powder) - General population
Protein Products 150 15
(including dairy ingredients) – General population
Buttermilk powder 150 20

All dairy products Dairy products must comply with the microbiological limits in the Food Standards Code Operator may define additional
microbiological levels for in-process
or final product
Dairy products must not contain any residues exceeding the limits specified in the Food Notice: Operator may define additional GAP on farm
Maximum Residue Levels for Agricultural Compounds residue limits
Levels of contaminants and toxins should not exceed the limits specified in the Food Standards Code
(refer to Standard 1.4.1 Contaminants and Natural Toxicants)
Further detail is contained in PSP Notice Chapter D
All infant formula and follow-up Refer to Food Standards Code ----
infant formula for human
consumption

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Appendix D: Procedures and processes requiring validation 4 December 2023

Appendix D: Procedures and processes requiring validation

Validation is the process of collecting evidence to show that your RMP is effective in producing the desired
outcome. You must validate your procedures and processes when first developed, when there are significant
changes to your existing processes/products or when new products/processes are introduced [AP Reg 34].

The following tables provides guidance on GOP or processes that may need to be validated. Where no
validation is required, this has been based on the assumption that procedures comply with a COP that is
acceptable to MPI. Procedures that deviate from a COP may require validation.

Table 20: Supporting system

Procedures/operation Unlikely to Likely to Comments

require require
validation validation
Design and construction of premises, facilities, ✓
equipment
Untreated water - town supply ✓
Water - Other sources ✓ Water requirements
must already be met
before RMP is
implemented
Water supply for fishing vessel ✓
Supply of process gases, compressed air ✓ Evidence to show that
PSP Notice C1.27 is
met.
Receipt, handling, storage of additives, processing ✓
aids, etc.
Cleaning of facilities and equipment ✓ Evidence to show that
(normal circumstances) cleaning and sanitation
is effective. May be
achieved through
ongoing monitoring and
verification.
Cleaning of facilities and equipment ✓ E.g. alternating between
(prior to switching to processing materials or products manufacture of animal
with stricter requirements) and human consumption
products. Evidence
maybe needed e.g.
management of Listeria
monocytogenes if
processing certain RTE
products.
Cleaning (post-CCP areas for ready-to-eat products) ✓
Waste management ✓
Control of chemicals ✓
Health of personnel ✓
Pest control ✓ May be achieved
through ongoing

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Procedures/operation Unlikely to Likely to Comments

require require
validation validation
monitoring and
verification.
Repairs and maintenance of facilities and equipment ✓
Calibration of equipment and measuring devices ✓ Evidence to show that
calibration under PSP
Notice C1.10 is met.
Packaging (composition, use, handling) ✓ Evidence that packaging
is suitable [AP Reg 68,
PSP Notice C3.5].
Labelling ✓

Table 21: Supply of Animal Material

Procedures/operation Unlikely to Likely to Comments

require require
validation validation
Supply of animals (eligibility, locations, supplier ✓
declarations, etc.)
Hygienic handling and dressing of killed mammals ✓ Validation required if
COP not used
Cooling and transportation of killed mammals ✓
Supply of deer velvet ✓
Supply of fish ✓
Holding in animal material depots ✓

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Table 22: Primary Processing of animal products

Procedures/operation Unlikely to Likely to Comments

require require
validation validation

Farmed mammals, killed mammals, farmed birds, live possums

Reception (animal health status, supplier ✓
declarations)
Identification and control of suspect animal material ✓
Ante-mortem and post-mortem examination ✓
Hygienic slaughter and dressing ✓ Validation required if
COP not used
Washing of carcasses of mammals ✓
Cooling of poultry to 7°C ✓
Chilling or freezing cooler than 7°C ✓
Chilled and frozen storage (maintenance) ✓
Capability of freezers/chillers when reducing ✓
temperature to preservation temperature
Deer velvet
Reception ✓
Fish products
Reception ✓
Handling and processing ✓ Histamine level is
specified in FSC but it is
not expected to be
measured routinely, but
periodic verification
likely. Effectiveness also
demonstrated by
compliance to
established procedures.
Chilling and freezing to preservation temperature ✓
Capability of freezers and chillers ✓
Bivalve Molluscan Shellfish
Reception ✓
Wet storage and depuration ✓ Refer to PSP Notice Part
H3 subparts 2 and 3
Shucking ✓
Heat shocking if used for pathogen inactivation (e.g. ✓ Refer to PSP Notice,
L. monocytogenes, Vibrio spp.) H3.8
Chilling and freezing to preservation temperature ✓

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Procedures/operation Unlikely to Likely to Comments

require require
validation validation
Capability of freezers and chillers ✓
Eggs
Whole Flock Health Scheme ✓
Reception of birds ✓
Pulping ✓
Pasteurisation ✓
Bird management ✓
Harvesting and handling of eggs ✓
Washing of eggs ✓ Needed if criteria in MPI
approved RMP
Template for Harvesting,
Candling, or Packing
Eggs is not followed
Candling and packing ✓
Storage ✓

Table 23: Secondary processing

Procedures/Operation Unlikely to Likely to Comments

require require
validation validation

General
Cleaning, sorting, grading of materials ✓
Cutting, boning, size reduction, mechanical ✓ Mechanical separation
separation may require validation
Thawing/tempering of meat and poultry ✓ Validation required if
COP not used
Mixing ✓
Honey and bee products
Reception ✓
Handling, processing, packing ✓ Validation of blending
equipment used to
reduce tutin levels likely
to be needed
Storage ✓
Handling material that may introduce allergens ✓ Will need to show how
the allergens will be
controlled

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Procedures/Operation Unlikely to Likely to Comments

require require
validation validation

Thermal processing
Commercial sterilisation (aseptic, in container ✓
retorting)
Pasteurisation and thermisation ✓
Cooling of thermally processed product ✓ Cooling is not critical for
small products that cool
rapidly (e.g. cooked
frankfurters).
Validation may not be
necessary for such
products.
Heat processing other than sterilisation, thermisation ✓ Heating for other
and pasteurisation (i.e. non-lethal heating) technical reasons (e.g.
grill marking of patties,
heating of honey to
reduce viscosity) does
not require validation but
time in danger zone to
be managed.
Drying ✓
Smoking
Hot smoking ✓
Cold smoking of ready-to-eat products ✓
Cold smoking of products that require further cooking ✓ Smoking for flavour only
by the consumer does not require
validation but time in
danger zone to be
managed.
Cooling
Chilling/freezing of mechanically separated meat ✓
Cooling of hot boned products to 7°C ✓
Salting, curing, brining ✓

Acidification
Addition of acid for preservation (pH control), e.g. ✓
marinated mussels/fish
Addition of acid for flavour only ✓
Fermentation ✓

High pressure processing ✓

Extraction, expression ✓

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Procedures/Operation Unlikely to Likely to Comments

require require
validation validation

Evaporation, concentration for preservation ✓

Rendering
Rendering ✓ Achievement of 90°C for
10 minutes must be
validated for medium risk
material
Drying ✓
Refining of fats and oils ✓

Packing ✓ May require validation if

necessary for food
preservation, e.g. seal
integrity, MAP
Storage
Refrigerated storage (cold store) ✓
Dry storage ✓
Transport
Meat and meat products above 7°C ✓
Meat and meat products at or cooler than 7°C ✓
Other products (non-refrigerated) ✓
Other product specific processors
Cleaning and processing of green offal and runners ✓
Salting of casings ✓

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Appendix E: Validation examples 4 December 2023

Appendix E: Validation examples

Further examples of validation can be found in the Codex Guidelines for the Validation of Food Safety Control
Measures (CAC/GL69-2008).

E.1 Biological hazards

Example 1: Limit for a biological hazard (e.g. absence of Listeria monocytogenes in 25 g of packaged heat
treated meat paste).
(1) Conduct a hazard identification and analysis. Think about the following:
a) what sort of packaging will you be using? Is it going to promote the growth of specific pathogenic
bacteria?
b) do you know the bacterial count on your incoming raw materials?
(2) Identify the regulatory limit appropriate to the hazard and the product. Determine the appropriate
performance criteria (e.g. log reduction, etc.) or process parameters (e.g. time and temperature
profiles, etc.) required to achieve the regulatory limits.
Consider other microbiological hazards associated with your product and process and whether they
have a regulatory limit and or/similar control measures that may be able to be validated together.
Reference any New Zealand or international literature that confirms the chosen performance criteria or
process parameters are capable of and appropriate to achieving the regulatory limit. Resources that
may be useful in obtaining information on validation:
a) OCs, COPs, Guidance Documents (e.g. Further Processing, etc.); and
b) MPI Science reports (e.g. Standardising D and Z values for cooking raw meat).
(3) You can also determine your own performance criteria and process parameters by the following steps:
a) establish the incoming microbiological load of the pathogen, unless already well established
within food sector;
b) establish the required reduction of microbiological pathogens to meet regulatory limit for the
product;
c) develop a process to meet product requirements (you will need to establish the key process
parameters that are critical to achieving your regulatory limit); and
d) run trials to prove the key process parameter can achieve the required reduction in
microbiological pathogens (e.g. challenge trials, predictive modelling with experimental data,
lethality calculations).
(4) Develop process to meet performance criterion (including establishment of key process parameters).
(5) Prove you can achieve the required regulatory limit by:
a) collecting new evidence (e.g. running trials during commercial operation conditions, etc.); and
b) using existing evidence (e.g. data from previous validation studies, monitoring records of a
control point, predict modelling such as the Tom Ross Model for UCFM products, etc.).
(6) Analyse your evidence. If your process is unable to achieve the required regulatory limit, adapt your
process (e.g. check your lethality calculations and extend your processing time, etc.) and repeat step
(4) above until you can achieve the regulatory limit.

E.2 Chemical hazards

Example 2: Limit for a chemical hazard (e.g. 10 mg/kg sulphite in dried apricots, 125 µg/200ml Vitamin A in
vitamin fortified milk powders, the level of histamine in fish or fish products must not exceed 200 mg/kg, etc.).
(1) Identify the regulatory limit appropriate to the hazard and the product.

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(2) Reference any New Zealand or international literature that confirms that the chosen measures are
capable of and appropriate for achieving the regulatory limit.
Literature searches may assist in validation using MPI or international information, e.g. temperature
controls to limit toxin development, chemical degradation curves, processing losses, etc.
(3) Where the chemical is an additive, calculate the ingoing level from all sources/ingredients, expected
losses during processing, and final product levels of chemical. Consider the impact of either manual or
automated delivery systems on accuracy and homogeneity of mixing.
(4) Prove achievement of the regulatory limit. Samples (taken from commercial production runs) must be
tested or achievement demonstrated by other acceptable means to MPI, e.g. histamine, etc.
(5) Where sampling occurs, it is recommended that 3-5 production batches are tested taking:
a) at least 3 samples per batch of homogenous material; or
b) at least 8 samples per batch of non-homogenous material.

E.3 Evidence to justify operator-defined limits

You must decide whether an operator-defined limit is needed for any of the hazards identified during the
HACCP application. Operator-defined limits should only be considered if there is no regulatory limit for that
hazard and control of that hazard is essential for food safety, e.g. setting a limit for water activity in dried
product, a microbiological limit for ready-to-eat product where there is no limit in the legislation, etc.

You must document the basis for selection of an operator-defined limit, including:
• where the limit came from (e.g. industry or MPI COP, literature, an overseas regulatory agency, own
trials, etc.);
• what hazard and food the limit applies to;
• why the limit is set at the particular level; and
• provide evidence to show the limit has been appropriately set.

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Appendix F: Example of an RMP site plan 4 December 2023

Appendix F: Example of an RMP site plan

Figure 5 is an example of a site plan showing how the RMP boundary can be displayed. The site plan should
also indicate any excluded areas, e.g. areas within the boundary that come under another RMP, or are
subject to the Food Act, etc. The site plan should include the name, address, the version (dated) and the
boundary.

Figure 5: Example site plan

Chiller Packaging/ingredients store

Processing
2

Boundary of RMP

RMP
Processing
1

Vehicle storage Receipt area Amenities & Office

Address Date

Version

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Appendix G: Guidance on the difference between significant and minor amendments 4 December 2023

Appendix G: Guidance on the difference between significant

and minor amendments
For guidance purposes only, this section provides some examples on the difference between significant and
minor amendments. This guide cannot cover every possible scenario and may not be representative of every
situation. Each amendment will need to be considered on a case by case basis.

It is your responsibility to document the justification to determine whether an amendment is significant or

minor.

If clarification is required (e.g. for difficult or unclear situations), it is recommended you discuss with your
verifier or a suitably qualified technical expert. If you require assistance from MPI Approvals
[email protected] to make a determination, ensure you include the documented justification and any
verifier/expert support with your request.

Determining whether an amendment is significant or minor

Regulation 30 of AP Reg has a list of what is considered a significant amendment to the RMP. To help you
determine if an amendment is significant or minor, you can use the following guiding principles:

Figure 6: Guiding principles to determine between a significant or minor amendment to your RMP

Will the change introduce new risk factors, or adversely impact on existing risk factors
[AP Reg 30]?

New risk factors can be new hazards or anything that may affect the fitness for
purpose of the animal product. Refer to 4.12.2 Conduct a Hazard Analysis (Hazard
Identification and Analysis)

A significant amendment is likely if the A minor amendment is likely if the change

change introduces new risk factors, or may does not introduce new risk factors, or does
adversely impact on existing risk factors not adversely impact on existing risk factors

To assist with the guiding principle above, you should consider the following questions:
• will the change introduce new biological, chemical or physical hazards? Do they need to be controlled?
• will the change affect an existing CCP? If yes, how will this be managed?
• will the change mean hazards may be present at a higher concentration such that the current controls
are no longer effective?
• will the change result in changes to existing processes, procedures or documented systems? These
will need to be updated and communicated to the staff;
• do you need to re-validate your process? If yes, do you have a validation protocol?
• will the product be affected by exposure to the new hazards (e.g. is it exposed, or enclosed in
packaging)?

You should refer to 8.4 Amendments to the RMP on the procedures to following when making a change to
your RMP and the information that should be documented. Sections 8.4.1 Significant Amendment to your
RMP and 8.4.2 Minor Amendment to RMPs goes into detail on what sort of information to include to support
the significant and minor amendments respectively.

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Use Figure 6: Breakdown of the Type of Amendments and Corresponding Section of Appendix G to determine
which section of Appendix G you should read for the type of amendment you want to make. Each section
gives examples of significant and minor amendments.

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Figure 7: Breakdown of the types of amendments and the corresponding section of Appendix G

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Appendix G: Guidance on the difference between significant and minor amendments 4 December 2023

G.1.1 Changing the physical boundaries of the RMP

In general, increasing the physical boundaries is a significant amendment. However, where the increase in
boundary does not introduce new hazards and/or affect processes, the amendment may be considered minor.

Where the physical boundaries of the RMP are reduced this would be minor, unless the change adversely
impacts on your RMP. Regardless of whether the change in physical boundary is significant or minor, you
should notify your recognised agency and provide an updated site plan.

Examples of Typical Significant Amendments Examples of Typical Minor Amendments

Increasing the RMP boundary to include a new Decreasing the RMP boundary to remove a disused
processing premises or redundant part of the factory
Increasing the RMP boundary to include a container
load-out area

G.1.2 Removal of buildings and/or facilities

When deciding whether removal of buildings/facilities is a significant or minor amendment, you should
consider:
• what consequential changes are needed as a result of removing the buildings and/or facilities?
• if as a consequence, processes are moved to other existing facilities, are any new hazards or other
risk factors introduced as a result of altered process flows, new environmental conditions, etc.?

Examples of Typical Significant Amendments Examples of Typical Minor Amendments

Removal of facilities/equipment that prevents Removal of redundant or disused facilities/buildings
essential processes from being carried out, e.g.
removal of a blast freezer if a blast freezer is
required

G.1.3 Construction of new buildings and/or facilities

When deciding whether building construction is a significant or minor amendment, you should consider:
• whether the construction results in duplication of existing processes;
• any impact on the existing buildings, facilities, operations or essential services (e.g. water, electricity,
etc.); and
• any change to the physical boundaries of the RMP.

Examples of Typical Significant Amendments Examples of Typical Minor Amendments

Construction of a new store, new processing room, Inclusion of an additional raw milk silo
new filleting room etc. where this is not a duplication
of an existing operations or facilities
Construction on a new site Construction of additional dry storage where the
RMP covers dry storage and there are existing dry
storage facilities

G.1.4 Alterations to existing buildings and/or facilities

When deciding whether alterations to existing buildings/facilities is a significant or minor amendment, you
should consider:

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Appendix G: Guidance on the difference between significant and minor amendments 4 December 2023

• the extent of alterations needed;

• the impact of the alterations on the process and operations, e.g. changes to process flow, new process
steps, etc.;
• whether the alterations will change the use of the existing facilities, room or area; and
• whether the change impacts on the effectiveness of a CCP.

Examples of Typical Significant Amendments Examples of Typical Minor Amendments

Changes that can alter the processing environment Small changes in temperature or humidity that do
and impact on ability to control temperature and/or not introduce new hazards
humidity, so new hazards are introduced or existing
hazards not controlled to same extent.
For example: major changes to the temperature and
humidity for packing rooms used for dry powder
packing
Reconfiguration or reconstruction of a processing Reconfiguration or reconstruction of a processing
area where there has been a substantial change to area where it can be shown that the process has not
the process or a new hazard or risk is identified changed and no new hazard or risk has been
identified
An accumulation of minor changes which together Minor alterations to processing facilities such as:
would be the equivalent of a significant amendment • repairs and maintenance;
• changes to equipment layout to improve process
flows where this does not introduce new
hazards;
• introduction of a new production line, which
duplicates an existing line within an existing
area;
• equipment changes to bag sealing;
• changing slaughter methods to halal;
• alterations to shelf-stable ingredients storage;
• alterations to animal holding facilities; or
• changes to essential services where this does
not introduce new hazards or impact on the
ability to control existing hazards
Changing the use of a room from a lower hygiene Construction in non-processing areas such as
standard to a higher hygiene standard, e.g. support amenities, support facilities and engineering
facility to a process room, petfood to human facilities, but not to change them to a higher
consumption, raw to cooked, or becoming part of a standard of use
critical hygiene area
Any changes to dairy heat treatment equipment and Removal of a storage silo
processes
Altering floor layouts in standard hygiene areas
Addition of a separate retail shop selling honey
within the physical boundaries of an RMP
processing honey

G.1.5 Relocating process operations

Relocating process operations to a new physical address (except where this is already permitted for mobile
premises and vessels) is a significant amendment [AP Reg 30].

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G.1.6 Adding new processing equipment

When deciding whether new processing equipment is a significant or minor amendment, you should consider:
• the process for installation, commissioning and/or validation, location, hygiene, maintenance, etc.;
• what the equipment will be used for, e.g. whether it is used for a process step that is essential for food
safety, etc.;
• how the new equipment may affect the process flow; or
• whether the new equipment duplicates existing equipment.

Examples of Typical Significant Amendments Examples of Typical Minor Amendments

New processing equipment that is essential for food New processing equipment that is not essential for
safety, e.g.: food safety, e.g.:
• new technology, e.g. high pressure processing, • new conveyor belts;
filtration as a microbiocidal step; • new mixers, blenders; or
• new equipment used for heat shocking mussels • new cutting equipment, e.g. cheese curd cutting
for listericidal effect; machine
• adding or reducing plates in a pasteuriser; or Note: Addition of blenders for dry dairy products is
• alterations to pasteuriser flow rates considered a significant amendment
New processing equipment that can be detrimental A new type of egg washing system (parameters
to food safety if not set up and operated correctly, would be subject to any necessary validation)
e.g. new type of machine for mechanically
separating meat
A new retort that is a different make and model to A new retort that is the same make and model as an
any existing retorts covered by the existing RMP existing retort covered by the existing RMP (would
still be subject to validation by the qualified canner)
Any change to dairy defined heat treatment
equipment
Major changes to rendering equipment, e.g. A new jet coder being installed on an existing
changing from batch well cookers to continuous low packing line
temperature cookers, etc.

G.2.1 Adding new animal material or animal product

Processing animal material or animal product that is not covered by the existing RMP is a significant
amendment, except:
a) where the product and process are similar; and
b) documented risk factor identification and hazard analysis has shown that all risk factors
associated with that animal material product are already adequately addressed by the RMP [AP
Reg 30].

Examples of Typical Significant Amendments Examples of Typical Minor Amendments

Processing of a new dairy material not currently Processing of a new dairy material not currently
covered by the RMP where new hazards are covered by the RMP, where the dairy material and
introduced product are similar and the process is the same, and
no new hazards are introduced.
Addition of a dairy powder operation where RMP Addition of other dairy powders where operation
does not already cover the production of powder already covers production of powder products, e.g.
products

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Examples of Typical Significant Amendments Examples of Typical Minor Amendments

addition of blending whey powders to an RMP
covering blending of milk powders.
Addition of raw milk processing of a different species
to an existing RMP, e.g. addition of goat, sheep or
deer milk to existing RMP only covering cow milk,
etc.
Addition of dairy heat treatment of a different
species to an existing RMP, e.g. sheep milk to
existing RMP of heat treatment of caprine milk
Reducing testing frequencies or relaxing a test limit Increasing testing frequencies or tightening a test
limit

G.2.2 Adding new animal material within primary processing (non-dairy only)

Primary processing of a new animal material not currently covered by the RMP is usually considered a
significant amendment. Where an amendment is not significant, you can notify MPI Approvals at
[email protected] of some minor amendments so that accurate registration information can be
maintained.

Column 1 Column 2 Column 3

Animal Material Significant Amendment Minor Amendment and
Notification to MPI
• Ostriches/emus Changing between animal Changing between sheep and
• Alpacas/llamas materials bulleted in column 1 goats
• Bobby calves (case by case basis for wild
• Buffaloes/bison/cattle hybrids animals) Changing between non-farmed
• Cattle types (i.e. from wild to game
• Chamois Changing from farmed to non- estate or to farmed gone feral or
• Deer farmed (e.g. wild/game vice versa)
estate/farmed gone feral, etc.)
• Horses/other equines
and vice versa Addition of a wild deer when the
• Pigs
RMP already processes farmed
• Possums deer and other wild mammals
• Rabbits/hares
• Sheep/goats
• Thar
• Wallabies
• Fish other than Bivalve Changing between animal Changing within a bullet in column
molluscan shellfish (BMS) (i.e. materials bulleted in column 1 1
finfish, non BMS shellfish, except as listed in column 3
crustaceans) Adding live BMS processing if
• Bivalve molluscan shellfish already covers fish, but not if wet
(BMS) storing or depurating the live BMS

Changing from farmed to non-

farmed species and vice versa

Adding paua or kina if already

covers BMS

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Column 1 Column 2 Column 3

Animal Material Significant Amendment Minor Amendment and
Notification to MPI
• Chickens/ poussin/ fowl/ Changing between animal Changing within a bullet in column
ducks/ geese/ pheasants/ materials bulleted in column 1 1
quail/ guinea fowl
• Turkey Changing from farmed to non-
• Layer hens farmed (e.g. wild/game
estate/farmed gone feral, etc.)
and vice versa
• Table eggs Changing between farm methods
(e.g. caged, barn, free range, etc.)
for harvesting if using the RMP
Template for Harvesting,
Candling, or Packing Eggs.

Change of bird type e.g. chicken

to duck, etc.
• Deer velvet N/A N/A

G.2.3 Adding new animal product within secondary processing (non-dairy only)

Some new animal products can be added to your RMP without the need for a significant amendment. In this
case a minor amendment would be made to the RMP and MPI Approvals at [email protected] can be
notified. To decide if a significant amendment is required, refer to AP49: Processing Categories Tables.

To use the categories table, turn to the secondary processing sections. Each process category (listed in the
left hand column) to be undertaken with the new animal product should be considered.

The types of animal product for each process category are specified across the table. The rules for using the
table are:
• addition of a new animal product described in a white box is a significant amendment;
• addition of a new animal product described in a shaded box, where the RMP only covers animal
products described in a white box is a significant amendment; and
• addition of a new animal product described in a shaded box where the RMP covers at least one other
animal product described in another shaded box is a minor amendment which can be notified to MPI
Approvals at [email protected]

Where the amendment would be considered significant under any process category a significant amendment
must be registered.

An example of secondary processing amendment to an RMP

An operator with a registered RMP covering boning/cutting of red meat for human consumption wishes to
amend their RMP to cover boning/cutting of poultry carcasses for human consumption.
The process category to be considered is boning/cutting. Refer to the secondary processing for human
consumption table within the categories table, part of this is copied below:

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SECONDARY PROCESSING FOR HUMAN CONSUMPTION

Process Animal material or animal product
Category
Acidification Red meat Poultry Fish BMS Hides & skins Eggs
Aseptic Red meat Poultry Fish BMS Paua Bee Eggs
processing Products
Blending/Mixing Red meat Poultry Fish BMS Gelatine Bee Deer Eggs
Products Velvet
Boning/Cutting Red meat Poultry Ostrich & Fish BMS
Emu
Collection Red Poultry Fish BMS Foetal Foetal Beeswax Hides and
meat blood tissue skins (refer
rules)

The RMP will already cover red meat for the boning/cutting process category. Since this appears in a
shaded box, addition of poultry (also in a shaded box) can be made as a minor amendment with notification
to MPI Approvals at [email protected]

Note: You would also need to consider whether other factors, e.g. construction, would make the change a
significant amendment by working through the other sections of this appendix.

G.3.1 Processing for a different consumer

Your written justification should consider:

• the intended consumer currently covered by your RMP; and
• if changing from general consumers to specific at-risk groups, does your RMP ensure that product is fit
for this new intended purpose, e.g. for infants, elderly, pregnant women or immuno-compromised
people.

Examples of Typical Significant Amendments Examples of Typical Minor Amendments

Where the RMP only covers processing for animal If all product is produced to human consumption
consumption and the operator wants to start standards according to the RMP, but the operator
processing for human consumption now wants to divert to animal consumption e.g.
petfood
Note: that risks involved in production of animal
feed will need to be managed in the RMP.
Management of a loss stream product needs to be
considered as a product output. Notify the verifier
and MPI Approvals at [email protected]
Where the RMP only covers processing for
consumption by the general population and the
operator wants to start processing for susceptible
population consumption
The addition of ‘industrial use’ or inedible products
(e.g. hides and skins) to an existing registered
RMP, including those that use the Stores RMP
Template.

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G.3.2 Changes to processing categories

Adding new categories of processing not currently covered by the RMP is almost always a significant
amendment.

Refer to application form AP49: Processing Categories Tables for the complete list of primary and secondary
process categories. Process categories are listed in the left hand column.

Examples of Typical Significant Amendments Examples of Typical Minor Amendments

Adding a brining process step to a cheesemaking Adding non-refrigerated storage to a store that
operation that did not previously cover brining previously only covered refrigerated storage
Addition of transport to a processing facility

G.3.3 Adding new process or process modifications

Setting up a new process or process modification that is not covered by the current RMP is always a
significant amendment, except:
a) where the process or process modification is similar to existing processes; and
b) a documented risk factor identification and hazard analysis has shown that all risk factors
associated with that process are already adequately addressed by the RMP [AP Reg 30].

When the existing documentation does not adequately describe the new/amended process, you should
consider:
• what has changed in the new process?
• have the steps that are essential for food safety altered? Can they still manage the hazards to the
appropriate level?
• does the process or critical product parameters align with what is specified in a COP (refer to 3.1.1
Operational Codes and COPs)? If not, do you have the evidence to support you the parameters are
appropriate for your product?

Examples of Typical Significant Amendments Examples of Typical Minor Amendments

Making the process less effective e.g. extending Altering a drying process but still achieving the
storage times at temperatures that allow growth of critical product parameter for water activity
pathogens or slower cooling rate for a cooked
product, except where the operator can
demonstrate that they still meet the relevant criteria
in an approved COP
Changing from cold boning to hot boning, unless Different thermal process where operator can
the operator is following the relevant criteria in the demonstrate that they still meet the relevant criteria
Operational Code: Post Slaughter Activity, Red in an approved COP
Meat Code of Practice Chapter 9 (COP 9)

Boning processes outside those covered under A new thawing/tempering process that complies
COP 9 are considered a significant amendment with COP 9
Where processing of ready-to-eat product is to Making a new flavour in an existing line of products,
occur and the RMP does not cover this e.g. a range of soups containing the same or similar
animal products; or the same or similar animal
products containing different sauces or marinades,
etc.

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Examples of Typical Significant Amendments Examples of Typical Minor Amendments

Addition of a CCP that requires the process to be Tempering and thawing of cheese
revalidated e.g. using a new type of preservation
such as drying that is not currently covered under
the RMP
Changes to a CCP or amendments to the process Addition of operator defined finished product limits
flow, e.g. additional fitted filters that affect flow rates to the RMP
to heat treatment equipment, etc.
Removal of a CCP e.g. removing a pathogen kill Changes to test pieces used for CCP (x-ray or metal
step, changing from hot smoked mussels process, detection) with increasing sensitivity
where hot smoking is a listericidal step, to cold
smoking which is not a listericidal step, etc.
Re-designation of a control measure as a CCP as it
was incorrectly identified
Blending/additions to honey (e.g. bee venom, etc.)
if the new process is not already covered by the
RMP where new hazards are introduced
New process e.g. changing from in-container DOB or meat processors wanting to sell meat at
sterilisation to aseptic processing in a cannery stalls/farmers market can add a clip-on RMP
template
Egg shelf life extensions e.g. beyond 35 days for
whole eggs for a specific export or domestic market
requirement

G.3.4 Changes to supporting systems

When deciding whether alterations to current supporting systems (cleaning and sanitation, pest control, etc.)
is a significant or minor amendment, your written justification should consider:
• the extent of changes to be made to your supporting systems;
• do the changes need to be validated?; and
• the impact of the alterations on the process and operations, e.g. changes to process flow, new process
steps, etc.

Examples of Typical Significant Amendments Examples of Typical Minor Amendments

Changes to the water treatment facility that may
introduce new hazards and/or affect processes that
are essential for food safety
Change pest management contractor or cleaning
contractor
Reducing swabbing points to an existing dairy Adding swabbing points to an existing
environmental testing programme environmental testing programme
Expanding the number of microorganisms
monitored for
Changes to the dairy environmental testing Swapping suppliers for the same cleaning solution
programme that may affect verification of the (e.g. like for like).
effectiveness of the Listeria control measures Changing a brand of cleaning chemical if it is like for
like

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G.4.1 Merging RMPs

Merging two or more registered RMPs is a significant amendment [AP Reg 30].

G.4.2 Splitting an RMP

Splitting a registered RMP into two or more RMPs can be done via a significant amendment [AP Reg 30]; or
alternatively will require a new application for the new RMP and a minor amendment application for removal of
certain activities from the existing RMP.

G.4.3 Changing from a single-business to a multi-business RMP

Changing an RMP from a single-business RMP to a multi-business RMP is a significant amendment [AP Reg
30].

G.4.4 Adding a business to a multi-business RMP

Adding a business to a multi-business RMP except where the D-G’s approval under section 17A of the APA
applies to a type of business, premises or place, rather than to specific businesses, is a significant
amendment. Adding a farm onto an existing multi-business farm dairy RMP is a minor amendment.

G.4.5 Formatting changes to the RMP

Formatting changes to the RMP are unlikely to be a significant amendment to the RMP.
However, multiple minor amendments to an RMP that have an effect on the fitness for intended purpose of
animal material or animal product, or on the validity of the programme would be a significant amendment [AP
Reg 30].
An example of a minor amendment is:
a) when the entire RMP has been reviewed, re-ordered and reformatted with no content change;
and
b) updates to legislation references are made.

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