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Review of Requirements for the Transport and some Storage of Animal Materials and Products

7 Appendix (2): Detailed Analysis of Options

General criteria
Good Regulatory Practice Criteria
7.1 Option 1: Revert to RMP Regime in Place before the 2008 Exemptions
7.2 Option 2: Make the 2008 Exemptions Permanent
7.3 Option 3: Amend Regulatory Requirements

This section sets out an analysis of policy options considered by the NZFSA. Each option is analysed against two sets of criteria outlined below. These are:

• general criteria; and

• Good Regulatory Practice Criteria.

The general criteria have been derived from requirements that have to be met so that products achieve fitness for purpose and to enable NZFSA to issue official assurances between governments. The criteria are used in this analysis to assist decision-making on what is the appropriate level of risk management control.

General criteria

Criterion One: Design, Construction and Equipment

The transportation unit and or equipment should be designed and constructed to maintain the status of the animal product or material as suitable for processing or fit for intended purpose and to minimise hazards and risks.

Criterion Two: Hygiene and Maintenance

Operators should ensure that the hygiene and maintenance of the transportation unit and equipment must be such that contamination and deterioration of the animal material or product is minimised.

Criterion Three: Security and Access of Consignments

Operators should ensure there is no loss in the traceability of the animal products and materials and that the security of the consignment is maintained so as to prevent tampering or substitution.

Criterion Four: Training and Awareness of Specific requirements

Operators should ensure that persons transporting animal material or product for export are aware of the relevant specifications and are adequately trained in order to comply with relevant specifications and maintain the product’s fitness for purpose.

Criterion Five: Compliance with Labelling Instructions

Operators should ensure that persons transporting animal material and products comply with labelling instructions on the packaging and/or the transportation outer.

Criterion Six: Documented Contingency Plan to Deal with any Failure to Comply with Specifications

Operators should have a documented contingency plan to deal with any failures to comply with specification which may have an effect on the consignments’ fitness for intended purpose or eligibility for official assurances.

Good Regulatory Practice Criteria

In addition to the above general criteria, NZFSA must take into account the generic requirements set out under the New Zealand’s Code of Good Regulatory Practice⁸, which comprises the following criteria:

Efficient – The approach must be administratively efficient and not require excessive NZFSA time and resources to administer, or be onerous to industry in terms of administrative time and costs.

Effective – The approach must be effective in addressing the issue and provide a long-term solution that can effectively manage new issues that may arise.

Transparent – The approach must allow for transparency in regards to NZFSA policy and procedures.

Clarity – The approach must provide clarity to industry and not cause any ambiguity or confusion around what provisions are required and the responsibility of transport operators and exporters.

Equity – The approach should be the same across the animal products sector.

7.1 Option 1: Revert to RMP Regime in Place before the 2008 Exemptions

This option requires all transport operators involved in the transport of animal products and materials for export with official assurances to operate under a registered RMP. Transporters of animal products for animal consumption for the export and domestic market would be required to operate under an RMP, as would all dairy transport.

Policy Rationale

This option requires no action to be taken by government.

7.1.1 Description of an RMP

The risk management system under the APA provides for:

• the management of identified risk factors and hazards to ensure that products are for intended purpose (for human or animal consumption); and

• facilitating access to overseas markets.

An RMP is a documented programme designed to identify and control hazards and other risk factors in relation to the production and processing of certain animal material and products, in order to ensure that the resulting animal products are fit for intended purpose.

Part 2, sections (11) and (12) of the APA describe in full the purpose of an RMP.

7.1.2 Contents and Requirements of an RMP

In summary, an RMP includes the need to specify the following information:

• name and address of the operator and the animal product business;

• identify the animal products and material being produced/processed;

• set out the procedures the operator will use for identifying, controlling, managing, eliminating or minimising risk factors;

• describe the steps the operator will take to confirm the programme is working effectively;

• provide for corrective action;

• set out appropriate and auditable documentation and record keeping;

• comply, as appropriate, with any relevant animal standard or regulation under the APA, and any relevant specifications set by the Director General under section 167; and

• the RMP must be registered and verified by an agency recognised for verifying RMPs.

7.1.3 Analysis against Criteria

Policy Criteria
Consistency Across the APA	This option is consistent with the regulatory framework provided in the APA, but the framework itself treats the categories of animal products in an inconsistent manner.
Fitness for Intended Purpose	A registered RMP sets specific requirements and procedures (Good Operating Practice) necessary to: • maintain the hygienic status of animal products and materials during transport; • effectively implement the RMP; and • meet regulatory requirements. RMPs, therefore, provide a high level of certainty that animal products and materials transported for export maintain their ‘fitness for intended purpose’.
Design, Construction and Equipment	RMPs set specific requirements for the design, construction and equipment (including use) of transporters.
Hygiene and Maintenance	As above, RMPs set specific requirements for ensuring a transport vehicle and operators are hygienic and that the latter is suitably maintained.
Security and Access of Consignments	A registered RMP requires operators to use a unique business identifier for each consignment, and to contact an external verifier to authorize verification activities. These processes provide certainty that the security and identity of animal products and materials are maintained and that verification activities are carried out.
Compliance with Labelling Instructions	RMPs must be compliant with relevant requirements and regulations under the APA. This includes compliance with labelling requirements set out in OMARs as well as in New Zealand standards, unless exempted under section 60B of the APA.
Training and Awareness of Specific Requirements	Requirements for operators to be trained and aware of specific requirements for transporting animal products and materials could be provided for by RMP provisions.
Good Regulatory Practice Criteria
Efficiency	For exporters currently transporting animal products under a general OMAR or under other provisions and specifications that effectively manage the risks and hazards, this approach would not be efficient due to the costs and time associated with developing an RMP.
Effective	An RMP is an effective mechanism for meeting the policy criteria above.
Transparent	The provisions for RMPs are documented on the NZFSA website and are available to industry and the general public.
Clarity	RMPs with additional guidance material would increase clarity around statutory and generic requirements for the transportation of export products, particularly where uncertainty exists.
Equity	RMP regime is not equitable since it assumes that the transportation requirements, potential hazards and risks are sufficiently similar across all animal products and materials, therefore the same level of regulatory controls should apply across transport operators, facilities and operations.

7.2 Option 2: Make the 2008 Exemptions Permanent

Under this option, the current temporary exemption granted to operators who transport non-dairy animal products for export with official assurances would be made permanent.

Policy Rationale

This option requires minimal action to be taken by government and would maintain the regulatory environment currently in place.

7.2.1 Analysis against Criteria

Policy Criteria
Consistency Across the APA	This option is not consistent with the overall aim of the regulatory regime provided in the APA; it is not the appropriate mechanism to address the issue of whether an RMP is the required level of regulatory control. It perpetuates the inconsistent treatment of dairy transport and does not address identified gaps in the regulatory framework.
Fitness for Intended Purpose	This option would not provide the high level of certainty required for the issuing of official assurances that the animal products and materials transported for export maintained their ‘fitness for intended purpose’. It does not provide sufficient authority for verifiers to verify that operators comply with the measures necessary to ensure that the products are ‘fit for intended purpose’ and eligible for official assurances.
Design, Construction and Equipment	Specifications in notices allow for specifications pertaining to the design, construction and equipment of transport vehicles.
Hygiene and Maintenance	Specifications on the hygiene of transporters and operators could in notices provide the same level of clarity of required standards as in individual RMPs.
Security and Access of Consignments	Specifications in notices identify any necessary requirements to ensure the continued security of a consignment.
Compliance with Labelling Instructions	Specifications in notices can provide labelling instructions for requiring transport operators.
Training and Awareness of Specific Requirements	Specifications requiring transport operators to be trained could be set under specifications.
Good Regulatory Practice Criteria
Efficiency	This option is efficient only in that it addresses the issue that triggered the review, which was the non-compliance of a particular transportation sector with the requirements of the APA. It is not efficient across the whole animal products transport sector.
Effective	This option is effective for this particular transport sector only.
Transparent	This option is not transparent. There is no justification of the different treatment of dairy and non-dairy transportation for export with official assurances or of the inequitable treatment of transport of products for animal consumption.
Clarity	This option provides clarity only for this particular transport sector.
Equity	This option is not equitable since it applies regulatory measures inconsistently. It differentiates between transportation of dairy and non-dairy products for export with official assurances. It also does not address the anomalous situation of operators transporting products for animal consumption for whom the current regulatory framework does not provide a mechanism for alternative regulatory control.

7.3 Option 3: Amend Regulatory Requirements

7.3.1 Regulated Control Scheme for Export with Official Assurances

This option involves the establishment of an RCS under section 38(2)(b) of the APA to regulate transport of animal products for export.

7.3.1.1 Nature of regulated control schemes

Section 38(1) of the APA provides for regulated control schemes which impose risk management measures in circumstances where-:

(a) it is not feasible or practicable for the relevant risk factors to be managed by individual animal products business operators within the individual risk management programmes (whether or not those operators would ordinarily be required to have a risk management programme): or

(b) having regard to considerations of economic efficiency, or to legal considerations that may require the exercise of statutory authority for the successful management of risk factors, it is necessary or appropriate that the measures be imposed generally rather than being dealt with by way of individual risk management programmes; or

(c) the measures are additional to those normally required to meet animal product standards and are necessary to meet market access requirements of overseas markets as notified or made available under section 60.

Section 38 (2) states that a RCS may be imposed:

(a) by way of regulation made under section 166 on the recommendation of the Minister, supplemented by specifications and other requirements set by the Director-General under section 40:

(b) In the case of measures required to meet access requirements of overseas markets that have been notified or made available under section 60, by way of specifications and requirements set by the Director-General under section 40.

Policy Rationale

This proposal would:

• improve the consistency and coherency of transportation provisions for animal products and materials across the APA;

• provide for a flexible and responsive model that can manage different levels of risk and hazards associated with transporting animal products and materials for export;

• increase certainty about what provisions apply to transporters of export products and materials;

• clarify the role and responsibility of transport operators for the transportation of exported animal products and materials;

• provide for new provisions for transporters, wharf and airline operations not currently covered by existing provisions.

7.3.1.2 Analysis against Criteria

Policy Criteria
Consistency Across the APA	The option would provide for consistency across the APA as an RCS fits within the Risk Management Framework established by the Act.
Fitness for Intended Purpose	Specifications under an RCS would allow for the same level of clarity and certainty for individual operators about the particular standards and requirements they would have to meet as by retaining the APA requirement of individual RMPs.
Design, Construction and Equipment	Specifications under an RCS can set specific controls around the design, construction and equipment of transport vehicles. These controls would allow for the same level of clarity and certainty for individual operators about the particular standards and requirements they would have to meet as by retaining the APA requirement of individual RMPs.
Hygiene and Maintenance	Specifications under an RCS on the hygiene of transporters and operators would allow for the same level of clarity and certainty for individual operators about the particular standards and requirements they would have to meet as by retaining the APA requirement of individual RMPs.
Security and Access of Consignments	Specifications under an RCS can identify any necessary requirements to ensure the continued security of a consignment.
Compliance with labelling Instructions	Specifications requiring transport operators to ensure compliance with labelling instructions can be provided for in an RCS. This would provide the same level of clarity and certainty as would be provided by an individual RMP.
Training and Awareness of Specific Requirements	Specifications requiring transport operators to be trained could be set under specifications.
Good Regulatory Practice Criteria
Efficient	An RCS would be efficient for transportation of products for export with official assurances that are currently exempted from being regulated under an RMP and consequently the operators’ compliance with appropriate risk management measures cannot be adequately verified. An RCS would be more cost efficient to exporters and transport operators than a requirement for individual RMPs.
Effective	An RCS would be effective in setting controls for animal products for export with official assurances. It would incorporate all existing mechanisms already used to manage food safety risks without the additional costs for operators to complete individual RMPs.
Transparent	An RCS provides the same level of transparency as an RMP.
Clarity	An RCS would provide clarity to exporters what conditions for transporting products are required to receive export certification and official assurances.
Equity	This option is equitable as it would impose obligations and standards consistently and be derived from and reflect the similarities between the various types of animal products.

7.3.2 Compliance with Animal Consumption Specification Notice

Policy Rationale

This proposal would address the gap in the APA framework by providing operators transporting animal material and products for animal consumption with a mechanism for an exemption from the RMP requirement, should such an exemption be considered appropriate.

NZFSA considers that an RMP is not the most appropriate and efficient tool to manage the transportation of animal products for animal consumption because there are other means to provide sufficient safeguards to ensure that a product maintains its ‘fit for purpose’ status while in transit, and that if any problems occur, they are appropriately handled and reported.

This proposal would align the level of requirements for the transportation of products for animal consumption for export and domestic market with the requirements pertaining to transportation of animal products for human consumption for these markets. It is not equitable that transporters of products for human consumption are able to choose not to operate under an RMP and instead operate under an alternative regime when a choice is unavailable to transporters of products for animal consumption/pet food. It is incongruous that at present the requirements for transportation of products and material for animal consumption are more onerous than for those for human consumption. This proposal would maintain consistency between the level of regulatory controls required for transportation of products for human consumption and for animal consumption intended for the export and domestic markets.

7.3.2.1 Analysis against Criteria

Policy Criteria
Consistency Across the APA	The option would provide for consistency across the APA as is would provide the transport of products for animal consumption with the equivalent of the risks management provisions applicable to transport of products for human consumption.
Fitness for Intended Purpose	Specifications in the Notice could allow for the same level of clarity and certainty for individual operators about the particular standards and requirements they would have to meet as by retaining the APA requirement of individual RMPs.
Design, Construction and Equipment	Specifications allow specific controls around the design, construction and equipment of transport vehicles.
Hygiene and Maintenance	Specifications on the hygiene of transporters and operators would allow for the same level of clarity and certainty for individual operators about the particular standards and requirements they would have to meet as by retaining the APA requirement of individual RMPs.
Security and Access of Consignments	Specifications identify any necessary requirements to ensure the continued security of a consignment.
Compliance with labelling Instructions	Specifications can provide labelling instructions for requiring transport operators. This would provide the same level of clarity and certainty as current requirements.
Training and Awareness of Specific Requirements	Specifications requiring transport operators to be trained could be set under specifications.
Good Regulatory Practice Criteria
Efficient	Compliance with Animal Consumption Specifications Notice would be efficient for transportation activities that are currently allowed in law to be exempt from being regulated under an RMP but unable to do so in practice. Compliance with a the Notice would be more cost efficient to exporters and transport operators than an RMP option.
Effective	Compliance with the Notice would likely be most effective in setting controls for animal products for export without official assurances and domestic market as it would cover all existing requirements already used to manage food safety risks without the additional costs for operators to complete individual RMPs.
Transparent	The Notice provides the same level of transparency as an RMP.
Clarity	The Notice would provide clarity to transporters about what requirements they have to meet in transporting the products.
Equity	This option would introduce equity into the transport framework by providing the transporters of products for animal consumption with options already available to those transporting products for human consumption.

7.3.3 Compliance with Dairy Specification Notice

Policy rationale

This option proposes a management framework for transport of dairy products intended for export and domestic markets that is based on the levels of risks and hazards arising from the actual nature of the transported products, unlike the current framework which is derived solely from the definition of dairy transport as primary processing.

7.3.3.1 Analysis against Criteria

Policy Criteria
Consistency Across the APA	The option would provide for consistency across the APA as this option fits within the APA’s Risk Management Framework and reflects the risks inherent in the actual products.
Fitness for Intended Purpose	Specifications in Notice could allow for the same level of clarity and certainty for individual operators about the particular standards and requirements they would have to meet as by retaining the APA requirement of individual RMPs.
Design, Construction and Equipment	Specifications could allow specific controls around the design, construction and equipment of transport vehicles.
Hygiene and Maintenance	Specifications on the hygiene of transporters and operators would allow for the same level of clarity and certainty for individual operators about the particular standards and requirements they would have to meet as by retaining the APA requirement of individual RMPs.
Security and Access of Consignments	Specifications identify any necessary requirements to ensure the continued security of a consignment.
Compliance with labelling Instructions	Specifications can provide labelling instructions for requiring transport operators. This would provide the same level of clarity and certainty as current requirements.
Training and Awareness of Specific Requirements	Specifications requiring transport operators to be trained could be set under specifications.
Good Regulatory Practice Criteria
Efficient	Compliance with Dairy Specifications Notice would be efficient. Compliance with a Notice would be more cost efficient to exporters and transport operators than a RMP option.
Effective	Compliance with a Notice would likely be most cost effective in setting controls for the transport of products for the domestic and export markets. It would cover all existing requirements already used to manage food safety risks without additional cost for operators to complete individual RMPs.
Transparent	A Notice provides the same level of transparency as RMP.
Clarity	A Notice would provide clarity to transporters about what requirements they have to meet in transporting the products.
Equity	This option would introduce equity into the transport framework by providing the transporters of dairy products for animal consumption with a management framework option that is commensurate with the level of risk inherent in the product, instead of derived from its definition only.

⁸ Ministry of Economic Development, 2006

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