In addition to the requirements in section 17 of the Act, a risk management programme must set out the following information:

A risk management programme must—

The operator of a risk management programme must ensure that the effectiveness of the programme is not compromised when a person uses areas within the physical boundaries of the programme for any activity that is not covered by the programme.

The risk management programme must describe—

A risk management programme must set out, in relation to animal material or animal product to be processed,—

A risk management programme must set out every process or operation carried out under the programme, including—

A risk management programme must set out procedures that are appropriate and effective in relation to the requirements of section 17(2) and (3) of the Act, so that animal material and animal product is fit for its intended purpose.

A risk management programme must include procedures that are appropriate and effective in relation to the requirements of Part 2.

The procedures must—

A risk management programme must include a procedure for a particular activity or other matter that is specified by supplementary notice.

The operator of the risk management programme must—

A risk management programme must set out—

The operator of a risk management programme must retain the information justifying each operator-defined limit.

A risk management programme must set out procedures for the actions to be taken when any regulatory limit or operator-defined limit is not met.

When identifying risk factors for the purposes of section 17(2) of the Act, the operator of a risk management programme must—

A risk management programme must set out, in relation to any significant hazards identified for the purposes of section 17(3) of the Act,—

If an uncontrolled hazard is likely to be present in animal material or animal product leaving the physical boundaries of a risk management programme, the programme must set out why the operator of the programme considers it appropriate for the animal material or animal product to leave the physical boundaries of the programme.

In this regulation, uncontrolled hazard means a hazard that—

A risk management programme must set out any critical measurements.

A risk management programme must set out corrective action procedures, in relation to foreseen types of loss of control, for—

A risk management programme must set out a general procedure for managing unforeseen types of loss of control for which no specific corrective action is set out in the programme under subclause (1).

The procedure under subclause (2) must specify that the operator of the risk management programme must nominate an appropriate person—

A risk management programme must identify by position, or by name and position, the persons responsible for the following key tasks:

A risk management programme must identify in relation to the key tasks in regulation 19—

The operator of a risk management programme must ensure that anyone carrying out a task that is not a key task and that could affect the suitability of animal material for processing or the fitness for intended purpose of animal product is suitably skilled to carry out the task.

Supplementary notices may do any or all of the following in relation to the key tasks and competency of persons referred to in regulation 20(1):

The Director-General may approve for 1 or more named persons an alternative training or qualification if it is at least equivalent to the one specified in the supplementary notice.

The Director-General may approve, in regard to 1 or more named persons, the persons’ knowledge and experience as being at least equivalent to the training or qualification set out in the supplementary notice.

A risk management programme must set out procedures for verification of the programme by the operator of the risk management programme.

The procedures must—

An operator must comply with any detailed requirements specified in a supplementary notice in relation to verification by the operator.

The risk management programme must set out a procedure for record keeping.

The operator of a risk management programme must store records for whichever is the longer of 4 years or the shelf life of the animal material or animal product to which the records relate.

The operator of a risk management programme must ensure that all records are legible and are stored—

A risk management programme must set out procedures for effective control of the documents that make up the risk management programme.

Those procedures must include provisions specifying—

A risk management programme must identify all the documents that make up the programme.

A multi-business risk management programme must identify which documents relate to which business.

All the documents that make up the programme must be legible, and dated or marked to identify the programme’s version.

One of the following people must authorise each document before it is implemented into the risk management programme:

A risk management programme must set out a procedure for meeting reporting requirements under the Act.

A person applying for registration of a risk management programme under the Act must provide—

A person applying for registration of a risk management programme must ensure that the information that is provided with the application accurately represents the programme at that time.

For the purposes of section 20(2)(a)(ii) of the Act, an application for registration of a risk management programme under the Act must be accompanied by—

A person applying for approval of a multi-business risk management programme to apply to the business of another person under section 17A of the Act must provide the following information, whether at the time of application for registration of the programme or at the time of application for registration of a significant amendment to the programme:

An application to register a significant amendment to a risk management programme must identify the amendments to the programme, and be accompanied by—

A person applying to register a significant amendment to a risk management programme must ensure that the information that is provided with the application accurately represents the programme at that time.

The Director-General may waive or modify the requirement to provide a copy of an independent evaluation report in a particular instance if—

The kinds of amendments to a risk management programme that require registration as a significant amendment under section 25 of the Act are—

The operator of a risk management programme must have an up-to-date version of the risk management programme.

Every document, or part of a document, that makes up a risk management programme must be accessible to any person with responsibilities under the programme.

The operator of a risk management programme must keep a copy of every document that has formed part of a risk management programme but has since been—

The operator must keep the copy for the longer of the following:

The operator must keep the copy in a manner that—

The operator of a risk management programme must ensure that the programme, all reference material relating to the programme, any record, and any archived documents are readily accessible or can be retrieved and made available, upon request, within 2 working days to the following persons:

The operator of a risk management programme must have evidence available to validate the effectiveness of the programme, when it is necessary to demonstrate that the programme is capable of consistently producing animal material or animal product that is fit for its intended purpose.

If validation information under subclause (1) is not available before the application for registration, the operator of a risk management programme must develop a validation protocol that sets out—

After registration, the operator of a risk management programme who has developed a validation protocol must—

Supplementary notices may set further requirements for validation, which may include—

The operator of a risk management programme must notify the verifier or verifying agency in writing and without unnecessary delay if—

Information that must be provided under subclause (1) must be provided in an easily accessible form.

The operator of a risk management programme must provide a copy of each evaluation report to their verifier or verifying agency.

The operator of a risk management programme must notify the Director-General of any emerging, new, or exotic biological hazard or new chemical hazard in relation to the programme as soon as practicable after its discovery.

The operator must notify the Director-General in writing, without unnecessary delay, of any change to the position, or name and position, of the person responsible for the day-to-day management of the programme.

The operator of a risk management programme must report to the Director-General or the operator’s verifier or verifying agency if the operator has reasonable grounds to believe that information a supplier provides about animal material or animal product is materially false or misleading.

A person who carries out the following operations for trade purposes in relation to mammal or bird material or product that is not intended for human consumption must operate under a registered risk management programme:

A person who processes technical grade dairy product must operate under a registered risk management programme if—

In this regulation,—

A chicken producer must operate under a registered risk management programme.

A reference in this Part to the processing of animal material includes, with the necessary modifications, the production of animal material by an operator of a risk management programme who is a chicken producer.

Operators are exempt from the requirement to have a risk management programme in respect of the operations specified in Schedules 2 and 3.

The operator of a risk management programme must ensure that premises, places, facilities, equipment, and essential services are located, designed, and constructed so that—

For the purposes of subclause (1), the operator must have regard to the following:

The operator of a risk management programme must ensure that premises, places, facilities, equipment, and essential services are operated in a manner that minimises and manages the exposure of animal material, animal product, or other input to risk factors.

For the purposes of subclause (1), the operator must have regard to the following:

Supplementary notices may specify matters relating to premises, places, facilities, equipment, and essential services, for the purposes of regulations 42 and 43, including—

The operator of a risk management programme must ensure that—

The operator of a risk management programme must ensure that water is fit for its intended purpose at its point of use, and of sufficient quantity for the operations of the animal product business.

The operator of a risk management programme must ensure that waste is collected, managed, and disposed of in a manner that—

The operator of a risk management programme must ensure that measuring equipment or monitoring equipment used for critical measurements—

For the purposes of regulations 45 to 48, supplementary notices may specify detailed requirements relating to—

The operator of a risk management programme must ensure that cleaning and sanitising procedures are carried out using materials (including maintenance compounds) and equipment in a manner that ensures—

Supplementary notices may, for the purposes of this regulation, specify further requirements relating to cleaning and sanitising procedures, including the materials and equipment used.

The operator of a risk management programme must ensure that premises, places, facilities, equipment, and essential services are maintained to a standard that ensures—

The operator of a risk management programme must cease processing if—

Supplementary notices may, for the purposes of this regulation, specify further requirements relating to maintaining premises, places, facilities, equipment, and essential services.

The operator of a risk management programme must carry out maintenance in a manner that does not adversely affect, directly or indirectly, the suitability of animal material for processing or the fitness for intended purpose of animal product.

The operator of a risk management programme must cease processing in a situation where maintenance is adversely affecting animal material or animal product, if it is necessary to cease processing to address those effects.

Supplementary notices may, for the purposes of this regulation, specify further requirements relating to maintenance during processing.

The operator of a risk management programme must use, store, transport, and handle maintenance compounds in a manner that ensures—

The operator of a risk management programme who uses maintenance compounds must ensure that the maintenance compounds—

Supplementary notices may specify—

The operator of a risk management programme must minimise opportunities for pests to infest, soil, or contaminate animal material, animal products, associated things, premises, places, facilities, equipment, or essential services.

Supplementary notices may, for the purposes of subclause (1), specify detailed requirements relating to minimising opportunities for infestation, soiling, or contamination by pests.

The operator of a risk management programme must ensure that any person at the premises or place—

The operator of a risk management programme must ensure that any person at the premises or place who is known to have or suspected of having an illness or condition does not, directly or indirectly, contaminate animal material or animal product.

Complying with subclause (2) includes that the operator must ensure that—

For the purposes of this regulation, illness or condition means an illness or a condition that can be transmitted from humans through animal material or animal product.

The operator must ensure that any person whose presence or actions may contaminate, directly or indirectly, animal material or animal product wears appropriate clothing and equipment that minimises the risk of contamination.

Supplementary notices may, for the purposes of this regulation, specify detailed requirements for the prevention and management of contamination relating to people at premises or places, illnesses and conditions, and appropriate clothing and equipment.

The operator of a risk management programme must ensure that animal material, animal product, and other inputs that the operator produces or receives from a supplier are suitable for processing.

The operator of a risk management programme must—

Supplementary notices may specify matters in relation to ensuring suitability of animal material, animal product, and other inputs, including—

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.

The operator of a risk management programme must ensure that animal material, animal product, and other inputs are protected from adulteration.

For the purposes of regulation 58, supplementary notices may specify matters in relation to processing, including—

The Director-General may exempt an operator from 1 or more of the requirements of regulation 56 or 58 if satisfied that the resulting risk to human or animal health would be negligible.

The exemption may be subject to conditions.

The operator of a risk management programme must not process animal material or animal product from animals imported live for slaughter, unless the Director-General gives approval under regulation 120.

The operator of a risk management programme must ensure that premises, places, facilities, equipment, essential services, animal material, animal product, and associated things are examined, sampled, and tested where necessary to ensure the suitability of animal material for processing and the fitness for intended purpose of animal product.

The operator of a risk management programme who is a chicken producer must also ensure that anything in the environment at the operator’s premises or place is examined, sampled, and tested where necessary to ensure the suitability of the animal material for production.

The Director-General may exempt an operator from 1 or more of the requirements of subclause (1) if the Director-General considers that the risks to animal or human health of doing so are negligible.

The exemption may be subject to conditions.

The operator of a risk management programme must take corrective action if examination, sampling, or testing identifies that any premises or place, equipment, essential services, animal material, animal product, or associated things—

The operator of a risk management programme must ensure that any person (other than a recognised agency or person) carrying out examination, sampling, or testing—

For the purposes of regulations 62 to 64, supplementary notices may specify matters in relation to examination, sampling, and testing, including—

The operator of a risk management programme must ensure that any labelling or identification clearly relates to the animal material or animal product to which it applies.

The operator of a risk management programme must ensure that any relevant labelling and identification of animal material or animal product is appropriately and accurately amended if the animal material or animal product is no longer fit for its original intended purpose.

Supplementary notices may, for the purposes of regulation 66, specify requirements relating to the labelling or identification of animal material or animal product.

The operator of a risk management programme must ensure that any packaging (including reusable packaging and inner and outer packaging of any kind) used for animal material or animal product is designed, made, stored, and used in a manner that—

Supplementary notices may, for the purposes of regulation 68, specify requirements relating to packaging, including—

The operator of a risk management programme must ensure that non-conforming animal material that is not suitable for processing or non-conforming animal product that is not fit for its intended purpose is not—

However, the operator may do the following things if in accordance with their risk management programme and any relevant supplementary notice referred to in regulation 71:

Supplementary notices may, for the purposes of regulation 70, specify requirements relating to disposing of or dealing with non-conforming animal material or animal product, or animal material or product suspected to be non-conforming, including—

This Part, except for the regulations specified in subclause (2), applies to an operator of a risk management programme who is a chicken producer and the animal material produced by the operator, with the following modifications:

Regulations 56 to 61 do not apply to an operator of a risk management programme who is a chicken producer or to the animal material produced by the operator.

Regulations 71B to 71E do not limit other regulations in this Part.

An operator of a risk management programme who is a chicken producer must ensure that feed that is produced by the operator or received from a supplier—

Supplementary notices may specify detailed requirements relating to feed management by chicken producers.

An operator of a risk management programme who is a chicken producer must ensure that any vehicle entering the place is managed in a way that minimises the risk of contamination of animal material and a production area.

Supplementary notices may specify detailed requirements relating to managing the risk of contamination of animal material and a production area by vehicles.

An operator of a risk management programme who is a chicken producer must ensure that equipment and a production area are cleaned and sanitised to manage the risk of contamination of animal material.

Supplementary notices may specify detailed requirements relating to cleaning and sanitising of equipment and a production area to manage the risk of contamination of animal material.

An operator of a risk management programme who is a chicken producer must manage the risk of contamination of animal material by animals and animal material in a production area.

An operator of a risk management programme who is a chicken producer must manage the risk of contamination related to the movement of animals and animal material within and between production areas at the operator’s premises or place.

Supplementary notices may specify detailed requirements to manage the risk of contamination—

This subpart applies to evaluators and evaluations generally.

An evaluation of a risk management programme or a significant amendment to a risk management programme may only be carried out by an evaluator.

An evaluator who was involved in the design or development of a risk management programme 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 Director-General agrees otherwise in writing.

An evaluator must not use a technical expert for the purposes of regulation 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 Director-General agrees otherwise in writing.

An evaluator must, after carrying out the evaluation of a risk management programme or a significant amendment to the programme, provide the operator of the business with a report of the evaluation.

The report must—

This subpart applies to the evaluation of a risk management programme for the purposes of registration under section 20 of the Act.

An evaluator must assess a risk management programme to determine whether the programme is valid in terms of sections 12 and 17 of the Act.

The evaluator may request that the operator provide any information about the animal product business that the evaluator reasonably requires to carry out the evaluation.

An evaluator must obtain supporting reports and assistance from a technical expert or other evaluator for any aspect of the risk management programme evaluation that is outside their area of expertise.

When carrying out an on-site assessment, the evaluator must assess the appropriateness and accuracy of the risk management programme against—

The evaluator must carry out an on-site assessment of each premises or place covered by the risk management programme.

The Director-General may grant an exemption from the requirement to carry out an on-site assessment of particular premises or places as part of the evaluation of a proposed risk management programme, if satisfied that—

The Director-General must provide the exemption in writing and may include conditions.

The evaluator must attach a copy of the exemption to the evaluation report.

An exemption granted under this regulation is secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements), unless the exemption applies only to 1 or more named persons.

This subpart applies to the evaluation of a significant amendment to a risk management programme for the purposes of its registration under section 25 of the Act.

An evaluator must assess the significant amendment to the risk management programme to determine whether it is valid in terms of sections 12 and 17 of the Act.

The evaluator may request that the operator provide any information about the animal product business that the evaluator reasonably requires to carry out the evaluation.

The evaluator must obtain supporting reports and assistance from a technical expert or other evaluator for any aspect of the risk management programme evaluation that is outside their area of expertise.

Supplementary notices may, for the purposes of this regulation, specify details of how an evaluation must be carried out for a significant amendment to a risk management programme.

An animal product business is subject to the verification requirements and must be verified as set out in this Part and any relevant supplementary notices if it—

Verification under this Part must be carried out by a verifier or verifying agency.

A verifier must not verify a risk management programme 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 Director-General agrees otherwise in writing.

An animal product business that is subject to verification must ensure that an initial verification is carried out within the time frame specified in a supplementary notice.

An animal product business that is subject to verification must ensure that verification takes place with the verification frequencies specified in a supplementary notice.

An animal product business that is subject to verification must move between verification frequencies as specified in the supplementary notice.

An animal product business must ensure that verification is carried out in relation to other matters as specified in the supplementary notice.

The timing for the beginning of verification after the initial verification of a business must be calculated from the date on which the initial verification begins.

The Director-General must take into account 1 or more of the following when issuing a supplementary notice that sets verification frequency:

The Director-General may, in respect of a particular animal product business that is subject to verification, change the time frame for the initial verification or vary the verification frequency from that specified in the supplementary notice referred to in regulation 85(2) in the following circumstances:

The Director-General may, in respect of a particular animal product business that is subject to verification, vary the time frame for verification calculated by reference to the verification frequencies specified in the supplementary notice referred to in regulation 85(2) if matters outside the business’s control mean that the verifier or verifying agency has not been able to carry out verification within the calculated time frame.

The Director-General may require a verifier or verifying agency to carry out an unscheduled verification of an animal product business that is subject to verification if the Director-General considers there are issues with the fitness for intended purpose of animal material or animal product or there are risks to facilitating access to overseas markets.

The Director-General may require an unscheduled verification referred to in subclause (1) because of 1 or more of the following:

The Director-General—

The verifier or verifying agency must—

Verification of a multi-business risk management programme must be carried out in relation to the proportion of businesses subject to the programme that are required to be verified on each occasion and any other matters as specified in the supplementary notice referred to in regulation 85(2).

For the purposes of any subsequent verification of a multi-business risk management programme,—

The Director-General may, in respect of a particular multi-business risk management programme, decide which businesses must be verified generally or on any particular occasion and may vary the proportion of businesses that must be verified generally or on any particular occasion from that specified in the supplementary notice.

Verification of a multi-site business risk management programme must be carried out in relation to the proportion of sites required to be verified on each occasion and any other matters specified in a supplementary notice.

For the purposes of any subsequent verification of a multi-site business risk management programme,—

The Director-General may, in respect of a particular multi-site business risk management programme, decide which sites must be verified generally or on any particular occasion and may vary the proportion of sites that must be verified generally or on any particular occasion from that specified in the supplementary notice.

After carrying out verification of an animal product business, the verifier or verifying agency must—

An acceptable outcome must be assigned if the verifier or verifying agency is satisfied that the animal product business substantially complies with the applicable regulatory requirements.

An unacceptable outcome must be assigned if—

For the purposes of subclause (3)(b), the verifier or verifying agency must consider whether any corrective action has been, or is being, carried out appropriately.

In assigning an acceptable outcome or an unacceptable outcome, the verifier or verifying agency must consider the matters specified in a supplementary notice.

A verifier or verifying agency that reasonably considers applicable regulatory requirements are not being complied with by an animal product business must require the business—

The animal product business must carry out the corrective action to the satisfaction of the verifier or verifying agency within the time frame specified under subclause (1)(b).

If a verifier or verifying agency assigns an unacceptable outcome to the verification of an animal product business, the verifier or verifying agency and the animal product business must—

The animal product business must comply with the corrective action plan to the satisfaction of the verifier or verifying agency within the time frame specified under subclause (1)(b).

The verifier or verifying agency must meet the detailed requirements for conducting a verification that are specified in a supplementary notice.

An animal product business subject to verification under this Part may seek a reconsideration of a verification outcome by applying,—

The verification frequency resulting from an unacceptable outcome continues to apply until the animal product business is notified of the reconsideration decision.

The person or body responsible for reconsidering the verification decision must—

Regulation 92 applies, with any necessary modifications, to the reconsideration of a verification decision.

The Director-General may exempt any animal product business from any verification requirements during an emergency if the verification requirements applying to some or all types of animal product businesses are impossible or impracticable to achieve.

An exemption is secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements), unless it applies only to 1 or more named animal product businesses.

An animal product business that is subject to verification must comply with any matter in relation to giving access or assistance specified in a supplementary notice.

A person who is subject to verification requirements must give a verifying agency—

An animal product business that is subject to verification must pay the costs of the verification.

A verifier or verifying agency must report to the Director-General any critical non-compliance that it identifies or that is reported to them under regulation 36 or 38.

The report must include any actions that the verifier or verifying agency recommends that the Director-General should take.

For the purposes of regulations 92 and 100, supplementary notices may specify matters in relation to reporting by verifiers and verifying agencies, including—

This Part applies to—

An operator that this Part applies to must have in place and implement traceability procedures that enable the operator—

The operator must ensure that the information required under subclause (1) or by a supplementary notice referred to in subclause (4) is accurate.

The operator must ensure that the information required under subclause (1) is also sufficient to allow an effective recall to be carried out.

Supplementary notices may specify details of further matters required in traceability procedures.

When requested to do so by the Director-General or an animal product officer, an operator that this Part applies to must provide information about the matters in regulation 103(1) or required by a supplementary notice—

An operator that this Part applies to must—

Supplementary notices may specify further matters required in recall procedures.

If an operator that this Part applies to decides to recall animal material or animal product, the operator must notify the Director-General or an animal product officer as soon as practicable, but no later than 24 hours after making the decision.

The operator must also provide the Director-General or animal product officer with the following details within 24 hours after the recall:

The operator must provide the information required under subclause (2) in a readily accessible format.

An operator that this Part applies to must carry out a simulated recall of animal material and animal product using their traceability and recall procedures.

The simulation must demonstrate the effectiveness of the operator’s traceability and recall procedures.

In this Part, effectiveness is measured by—

Supplementary notices may specify matters that must be tested by a simulated recall and matters relating to measuring the effectiveness of traceability and recall procedures.

An operator that this Part applies to must carry out a simulated recall referred to in regulation 107 at least every 12 months—

A supplier or other person in charge of farmed animals must ensure that, if farmed animals under their control have been treated with, been fed, or had access to any agricultural compound, veterinary medicine, or other substance that is likely to adversely affect the suitability of animal material for processing, they are managed to ensure that they are suitable for processing.

A supplier or other person in charge must not supply a farmed animal for processing for human consumption if the animal has been treated with an unregistered veterinary medicine that is not exempt from registration under the Agricultural Compounds and Veterinary Medicines Act 1997, unless approval is given under regulation 120.

A supplementary notice may, for the purposes of this regulation, specify detailed requirements relating to—

A game estate operator or hunter must ensure that, if game estate animals kept on the game estate (whether all of the time or only some of the time) are treated with, fed, or allowed access to, any agricultural compound, veterinary medicine, or other substance that is likely to adversely affect the suitability of animal material for processing, they are managed to ensure that they are suitable for processing.

A game estate operator or hunter must not supply game estate animals for processing for human consumption if the animal has been treated with an unregistered veterinary medicine that is not exempt from registration under the Agricultural Compounds and Veterinary Medicines Act 1997, unless approval is given under regulation 120.

A supplementary notice may, for the purposes of this regulation, specify detailed requirements relating to—

A hunter, supplier, or other person in charge of game estate animal material—

A hunter, supplier, or other person in charge of animal material must not present animal material for primary processing from a wild animal, game estate animal, or an animal that was farmed but has gone feral if the animal was procured from an area of land specified in a supplementary notice.

A supplementary notice may, for the purposes of this regulation, specify—

A supplier or other person in charge of farmed animals for primary processing for human or animal consumption must—

In this regulation, generally healthy means that an animal appears outwardly healthy and the supplier or other person in charge has no reason to suspect that the animal is or was moribund or infected with disease that would make the animal unsuitable for processing.

A supplier or other person in charge of farmed mammals or farmed birds for primary processing for human or animal consumption must—

A supplier or other person in charge of animals or animal material must not supply animal material derived from an animal imported live into New Zealand for slaughter unless the Director-General gives approval under regulation 120.

A supplier or other person in charge must comply with any further detailed requirements, related to supply of animal material from animals imported live, specified in a supplementary notice.

A hunter supplying animal material for human consumption must be listed in accordance with Part 10.

A hunter must ensure that any animal material they supply to a primary processor for human or animal consumption—

A supplier or other person in charge of animal material must not present it for primary processing if the animal material has been used in experiments, trials, or research, unless approval is given under regulation 120.

A supplier or other person in charge must also comply with any further detailed requirements, related to supply of animal material used in experiments, trials, or research, specified in a supplementary notice.

A supplier or other person in charge of animal material must not present it for primary processing unless—

The Director-General may give approval in writing for a supplier or other person in charge of particular animal material that does not meet regulatory requirements to present the material for primary processing if—

The Director-General may give the approval subject to conditions.

A supplier, other person in charge of animal material, game estate operator, or hunter must ensure that they and their personnel (if any) are suitably skilled to carry out tasks that could affect—

A supplier, other person in charge of animal material, game estate operator, or hunter must meet any competency or other requirements specified in a supplementary notice.

A supplementary notice may, for the purposes of this regulation, specify requirements relating to competency and other matters, including—

The Director-General may approve for 1 or more named persons an alternative training requirement or qualification that is at least equivalent to the one specified in the supplementary notice.

The Director-General may approve, in regard to 1 or more named persons, the person’s knowledge and experience as being at least equivalent to the training or qualification set out in the supplementary notice.

A supplier, other person in charge of animal material, game estate operator, or hunter must carry out regular checks to ensure that they are compliant with regulatory requirements.

The checks must be carried out in accordance with any requirements specified in supplementary notices.

Supplementary notices may specify requirements in relation to checks, including—

A hunter, supplier, or other person in charge of animal material for supply must,—

A person required by notice issued under section 167(1) of the Act for the purposes of section 81A of the Act to complete and supply a declaration must use the form approved by the Director-General, if a form has been approved.

A form approved by the Director-General is secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements), unless the form is approved for use only by 1 or more named persons.

A supplier, other person in charge of animal material, game estate operator, or hunter must keep records—

The supplier, other person in charge of animal material, game estate operator, or hunter must ensure that the records are legible and are stored—

This subpart applies to the operator of any 1 or more of the following that is storing animal material for human consumption, except to the extent that they operate under a risk management programme or a regulated control scheme that covers a matter dealt with in this subpart:

The operator of an animal material depot must ensure that activities at the depot are restricted to storing.

In this regulation, storing includes processes incidental to storage that ensure the suitability of the animal material for processing.

The operator of an animal material depot must apply for the animal material depot to be listed in accordance with Part 10.

Subclause (1) does not apply to the operator of an animal material depot storing only deer velvet.

The operator of an animal material depot must ensure that the animal material depot is—

The operator of an animal material depot must comply with any detailed requirements specified in a supplementary notice in relation to animal material depot location, design, and construction.

The operator of an animal material depot must ensure that the animal material depot is operated—

The operator must ensure that all persons accessing or using the animal material depot are adequately trained and comply with any relevant requirements specified in a supplementary notice.

The operator must ensure that—

The operator of an animal material depot must ensure that any packaging used for animal material—

The operator of an animal material depot must ensure that any person at the depot—

The operator must ensure that any person at the depot who is known to have or suspected of having an illness or condition does not, directly or indirectly, contaminate animal material.

For the purposes of this regulation, illness or condition means an illness or a condition that can be transmitted from humans through animal material.

An operator that this subpart applies to must—