Risk management for generic research in animals

A significant amount of generic research, in which animals are fed or treated with substances that are not and will not become trade name products, is carried out in New Zealand. The research usually studies general physiological functions or responses in animals rather than contributes to the knowledge about a specific trade name product.

Regulatory control of research on trade name products is adequately dealt with via the conditions imposed on provisional registrations. The conditions ensure that:

• the research is carried out under adequate security and supervision;
• the welfare of the experimental animals is attended to;
• the trade name product is not used on any animal other than the ones in the approved research; and
• the animals or produce from the animals are not used for food production except as specified in the conditions of registration.

Therefore, a provisional registration under the ACVM Act, or the Animal Remedies Act, covers research into and development of a trade name product. These Acts cannot be used conveniently to regulate generic research because the registration process is focused on trade name products rather than generic substances. Nevertheless, generic research is still under regulatory control.

The Animal Remedies Act makes it illegal to sell a generic substance as an unlicensed trade name product.

The Animal Welfare Act 1999 is used to ensure the animals used in the research are treated in a humane manner and not subjected to unnecessary manipulation. Research cannot be carried out without Animal Ethics Committee approval, and the committees review all research protocols to ensure that the use of animals is justified in the first instance, and their welfare is being attended to.

Food Safety is assured via the Animal Products Act 1999 for meat and meat products and the Dairy Industry Regulations 1990 for milk and milk products. Risk management programmes (Animal Products Act) and product safety programmes (Dairy Industry Regulations) impose requirements to ensure that animals and produce used in the production of food are fit for that purpose and do not contain hazards that would adversely affect the health of people. MAF is in consultation with the industry groups that have members who might be developing or reviewing their risk management or product safety programmes to ensure that they take special care if they are going to source animals or produce from organisations or operations that carry out generic research.