This Part sets animal product standards for the purposes of Part 4 of the Act, and provides for matters in relation to the making of specifications.

(1) Animal material used for processing into animal product must be suitable for that purpose.

(2) Where required by specifications, the supplier of animal material for processing into animal product must provide information, in accordance with the specifications, relating to the status of the animal material when it is presented for processing, namely, its—

• (a) origin:

• (b) nature:

• (c) description:

• (d) exposure to risk factors, if any.

(3) The information provided must be accurate.

(4) Before making specifications for the purposes of this regulation, the Director-General must be satisfied of at least 1 of the matters referred to in regulation 21.

(1) Taking into consideration its intended use, animal product must be free from—

• (a) biological, chemical, and physical hazards in amounts that may be directly or indirectly harmful to humans or animals:

• (b) extraneous objects, material, and substances of a kind not expected to be in animal product that is prepared or packed for trade in accordance with good trade practices:

• (c) animal material in amounts that may be directly or indirectly harmful to humans and animals for which the animal product is intended.

(2) For the purposes of subclause (1), specifications may specify—

• (a) unacceptable hazards, objects, materials, and substances in relation to any type or class of animal product:

• (b) acceptable or unacceptable levels of hazards, objects, materials, and substances in relation to any type or class of animal product.

(1) All risk management programme operators, and all other categories of processor of animal material or animal product specified in specifications for the purposes of this subclause, must ensure that the composition of the animal material and animal product complies with any relevant composition levels and requirements set out in the specifications.

(2) Specifications setting composition levels or requirements may include limitations and requirements for ingredients and additives in relation to any type or class of animal material or animal product.

Animal product must not be associated with a false or misleading representation of any kind concerning its—

• (a) fitness for intended purpose:

• (b) nature:

• (c) origin:

• (d) composition:

• (e) ingredients or other constituents:

• (f) proportion of ingredients or other constituents.

All specified persons must ensure that animal material and animal product in their charge is processed in a manner that minimises the contamination or deterioration of the animal material or animal product.

All specified persons must ensure that the premises, places, facilities, equipment, and essential services for which they are responsible in relation to the processing of animal material or animal product are—

• (a) designed, constructed, and located to enable suitability of the animal material to be maintained, and the fitness for intended purpose of the animal product to be achieved and maintained, having regard to—

  • (i) the animal material or animal product to be processed; and

  • (ii) the nature of the processes involved; and

  • (iii) the range of the animal products to be produced; and

• (b) operated to minimise and manage the exposure of animal material or animal product or associated things to risk factors, having regard to—

  • (i) the animal material or animal product to be processed; and

  • (ii) the operational capability and capacity of the premises or place, facilities, equipment, and essential services; and

  • (iii) the range of animal products to be produced.

(1) All specified persons must establish and carry out effective procedures to—

• (a) ensure appropriate and adequate maintenance, cleaning, and sanitation of processing premises, places, facilities, essential services, and equipment (including conveyances); and

• (b) manage waste; and

• (c) control pests.

(2) For the purposes of subclause (1), a procedure is effective if it minimises the exposure of animal material and animal product and associated things to risk factors associated with waste, pests, and inappropriate or inadequate maintenance, cleaning, and sanitation.

(3) All risk management programme operators, operators of animal material depots, and other persons specified in specifications for the purposes of this subclause must, in relation to premises or places used for processing, ensure that maintenance compounds are stored, handled, and used in a manner that minimises contamination by the maintenance compounds of animal material, animal product, and associated things.

(4) The Director-General may—

• (a) by specifications, provide that in certain areas, or for certain uses or equipment, only maintenance compounds that are listed in the specifications or approved by the Director-General may be used:

• (b) impose conditions on the use of those maintenance compounds, whether in the specifications or in the approval.

(5) In deciding whether to impose requirements under subclause (4), the Director-General must assess the risk of contamination of animal material or product, and the ability to control the risk through conditions.

All risk management programme operators, persons who transport animal material or animal product from the place or premises of a primary processor, and other categories of person specified in specifications for the purposes of this regulation must ensure that persons, including visitors, whose presence or actions, at any premises or place where animal material or product is processed, may result in contamination of animal material or animal product—

• (a) wear appropriate protective clothing, where necessary; and

• (b) follow an appropriate personal hygiene routine; and

• (c) behave in such a manner as may be necessary or desirable to minimise contamination to animal material, animal product, and associated things.

All specified persons must ensure that persons, including visitors, who are known to be, or suspected of being, infected by or a carrier of a disease or illness of public health concern (including a notifiable infectious disease listed in section A of Part 1 of Schedule 1 of the Health Act 1956) that is likely to be transmitted through animal material, animal product, or associated things are precluded from—

• (a) working in areas where animal material or animal product is processed, if that may result in contamination of animal product; or

• (b) handling animal material, animal product, or associated things that may result in contamination of animal product.

(1) All specified persons must ensure that measuring equipment that is used to carry out a critical measurement is properly calibrated and functions as intended.

(2) In this regulation, critical measurement means a parameter identified as critical in any—

• (a) specifications or regulated control scheme; or

• (b) risk management programme, being a parameter of the nature of the parameters referred to in section 17(3)(c) of the Act in relation to points at which hazards of significance occur.

All risk management programme operators, and all other categories of person specified in regulations or specifications for the purposes of this regulation, must ensure that—

• (a) animal material, animal product, and associated things are examined, sampled, and tested in accordance with any relevant specifications that are appropriate to the class or description of the animal material or animal product or process concerned, or the risk factor to be managed, or any combination of these; and

• (b) any necessary actions arising as a result of the examination, sampling, or testing are taken.

All risk management programme operators, operators of animal material depots, and other categories of person specified in specifications for the purposes of this regulation must ensure that any packaging materials (including reusable packaging and inner and outer packaging of any kind) used for animal material, animal product, and associated things are designed, made, stored, and used in a manner that—

• (a) maintains the status of the animal material as suitable for use in processing; and

• (b) maintains the status of the animal product as fit for its intended purpose; and

• (c) minimises contamination of the animal material or animal product.

All persons engaged in the carriage and delivery of animal material or animal product must as far as practicable ensure that the means of carriage and delivery are designed, made, maintained, and operated to minimise contamination or deterioration of animal material or animal product.

(1) All operators of risk management programmes, all exporters, and all other categories of person required by specifications to do so, must have a tracking system that—

• (a) allows for the identification of animal material and animal product; and

• (b) enables the movement of the animal material or animal product to be traced—

  • (i) where required by specifications, from the origin, through the supplier and the operator's business premises to the next recipient of the animal material or product; or

  • (ii) where specifications do not require tracing from origin, from the supplier and the operator's business premises to the next recipient of the animal material or product.

(2) The Director-General may, by specifications, require persons other than operators of risk management programmes and exporters to maintain a tracking system.

(3) Before making specifications for the purposes of subclause (2), the Director-General must be satisfied of at least 1 of the matters referred to in regulation 21.

(1) Animal material and animal product must be labelled or identified in accordance with any relevant specifications.

(2) Any labelling or identification required by specifications must—

• (a) clearly relate to the animal material or animal product to which it applies; and

• (b) contain information that accurately describes or differentiates so as to identify the animal material or animal product to which it applies.

(3) The Director-General may, by specifications, require risk management programme operators or other categories of person to label or identify animal material or animal product in accordance with the specifications.

(4) Before making specifications for the purposes of subclause (3), the Director-General must be satisfied of at least 1 of the matters referred to in regulation 21.

All records that are required by specifications to be kept and all returns that are required by specifications to be made by any risk management programme operator or other category of person in respect of animal material, animal product, or associated things must be—

• (a) complete:

• (b) accurate:

• (c) of sufficient quality:

• (d) appropriately stored and readily accessible (in the case of records):

• (e) promptly supplied (in the case of returns).

Before making specifications of the kinds referred to in regulations 5, 18(2), and 19(3), the Director-General must be satisfied that at least 1 of the following factors applies in relation to the proposed specifications:

• (a) it is not feasible or practicable for the relevant risks to be managed in some other way:

• (b) the specifications are reasonable on the grounds of economic efficiency.

(1) The Director-General may, by specifications made for the purposes of any of Parts 2 to 5 of the Act,—

• (a) specify the obligations of primary producers and other intermediate owners and suppliers of animals or animal material intended or provided for primary processing, whether generally or in relation to any particular class of producer, owner, supplier, animal, or animal material:

• (b) specify requirements as to the procurement and presentation of animals and animal material intended or provided for primary processing, including requirements relating to the provision or obtaining of information pertaining to the suitability of any animal or animal material for processing for human or animal consumption.

(2) Before making specifications for the purposes of subclause (1), the Director-General must be satisfied that—

• (a) it is not feasible or practicable for the relevant risks to be managed in another way; or

• (b) the setting of the specifications is reasonable on the grounds of economic efficiency; or

• (c) the specifications are necessary to meet overseas market access requirements.

(3) In any particular situation where the requirements of the specifications cannot be met, the Director-General may nevertheless, on application made before the relevant animal or animal material is presented for primary processing, grant approval in writing for the animal or animal material to be presented and accepted for processing, if satisfied that—

• (a) there is good reason in the special circumstances of the case why the requirements of the specifications cannot be met; and

• (b) acceptance of the animal or animal material would not prejudice the fitness for its intended purpose of the resulting product.

(4) The approval may be subject to conditions, including requirements for documentation.

(5) No person may present, and no processor may accept, any animal or animal material for processing unless either—

• (a) the person has complied with any relevant specifications referred to in subclause (1); or

• (b) the animal or animal material is presented in accordance with an approval given under subclause (3) and any conditions to which the approval is subject.

(6) Failure to comply with subclause (5) constitutes an offence for the purposes of section 135(1)(b) of the Act.

(1) The Director-General may, by specifications made for the purposes of any of Parts 2 to 5 of the Act, require that specified classes of supplier of specified animal material for processing must have a specified level of competency, qualification, or experience in order to present animals or animal material for primary processing.

(2) Before making specifications for the purposes of subclause (1), the Director-General must be satisfied that—

• (a) it is not feasible or practicable for the relevant risks to be managed in another way; or

• (b) the specifications are necessary to meet overseas market access requirements.

(3) No person may present, and no processor may accept, any animal or animal material for primary processing unless the person presenting it has the level of competency, qualification, or experience required by specifications made under subclause (1).

(4) Failure to comply with subclause (3) constitutes an offence for the purposes of section 135(1)(b) of the Act.

(1) No person may take responsibility for, or sign, a risk management programme evaluation report required by section 20(2)(b) of the Act if—

• (a) the person is not currently accredited under the Act to carry out risk management programme evaluation functions and activities; or

• (b) the person was involved in the design or development of the risk management programme to which the evaluation report relates; or

• (c) any person actively involved in carrying out the evaluation or any part of it was involved also in the design or development of the risk management programme being evaluated.

(2) Failure to comply with subclause (1) constitutes an offence for the purposes of section 135(1)(b) of the Act.

(1) If a particular function or activity is required under the Act to be carried out by a recognised agency or an accredited person, then the person with responsibility for ensuring that the function or activity is carried out must ensure that the function or activity is carried out only by—

• (a) an agency recognised under the Act to undertake responsibility for that function or activity; or

• (b) a person accredited under the Act to undertake that function or activity.

(2) If a particular function or activity is required under the Act to be carried out by an accredited person under the management of a recognised agency, a recognised agency must offer and use for that function or activity only the services of a person properly accredited under the Act to carry out the function or activity.

(3) Failure to comply with subclause (1) or subclause (2) constitutes an offence for the purposes of section 135(1)(b) of the Act.

(1) In this regulation, approved or specified system or device means a system or device approved or specified by the Director-General under section 158(1)(a) of the Act, and notified as such under section 167 of the Act, for the purposes of the identification, differentiation, or security of—

• (a) animal material or animal products subject to the Act; or

• (b) premises or places where such animal material or products are or may be produced or processed, held, stored, or transported; or

• (c) things of any nature that come or may come into contact with such animal material or products, or may otherwise affect the suitability of the animal material or the fitness for its intended purpose of the animal product.

(2) A person who operates or applies an approved or specified system or device must,—

• (a) if the Director-General also approves or specifies under section 158 of the Act the persons who may operate or apply the system or device, be a person who meets the requirements of the approval or specification; and

• (b) comply with any conditions specified by the Director-General under section 158 of the Act on the acquisition, use, or security of the system or device.

(3) A person who is a manufacturer of an approved or specified system or device must comply with any requirements for manufacturers specified by the Director-General under section 158 of the Act as to the manufacture, transport, storage, sale, and security of the system or device.

(4) Failure to comply with subclause (2) or subclause (3) constitutes an offence for the purposes of section 135(1)(b) of the Act.

The Animal Products Regulations 1999 (SR 1999/345) are revoked.