Animal Remedy Board Policy Decisions

The Animal Remedies Board’s decisions in regard to the regulatory control of in-feed antibiotic growth promotants in New Zealand are:

1. In recognition of the urgent need for inter-agency co-ordination of activities related to antibiotic resistance in animal and human health, the Board recommends the establishment of a joint ministerial committee to ensure co-operation, co-ordination and ongoing review of policies and criteria for regulatory control of in-feed antibiotics.

2. The Board supports the development of standards, guidelines and codes of practice for the use of agricultural antibiotics by veterinarians and industry, and will provide endorsement of codes considered appropriate to manage antibiotic resistance.

3. The Board considers that the following matters must be addressed in the licensing of new antibiotic products for growth promotion and re-assessment of existing products:
 The implications for public health of the concurrent use of a functionally related product in human medicine in New Zealand or Australia;
 The implications for public health of the subsequent introduction of a functionally related product in human medicine in New Zealand or Australia;
 The implications for public health for products that produce resistance or cross-resistance to systemic antibiotics used in human medicine;
 Product use should be compatible with a zero withholding period;
 The impact of the product on animal welfare;
 The impact of the use of the product on the concurrent availability of the same or functionally related product as a therapeutic agent for animal disease;
 The efficacy of the product; and
 The impact of the product on international trade in primary produce.

4. In addition to the above, the Board considers that the following matters must be addressed in the licensing of new antibiotic products for prophylactic use and re-assessment of existing products:
 The impact of the use of the drug in animals on the use of a functionally related product in human medicine for the treatment of serious disease in people for which there is no suitable alternative. Such drugs include: fluoroquinolones, glycopeptides, streptogramins and third generation cephalosporins;
 Efficacy of the drug and establishment of optimum dose and treatment duration; and
 The impact of resistance selection on animal and human health.

5. That re-assessment of existing growth promotant and prophylactic antibiotic products, requiring the above matters to be addressed for continued licensing, should occur as soon as possible, with priority given to re-assessment of avoparcin products.
Where licensing solely for growth promotion cannot be supported following re-assessment, consideration must be made of the use of that product for disease prevention and treatment purposes to ensure that a product, essential for the health and welfare of the animals, is not inadvertently and precipitately removed from the market.

6. The Board notes the voluntary withdrawal of the existing oral fluoroquinolone animal remedy for food-producing animals, and that similar products in the future are unlikely to meet the criteria established by the Board for licensing.

7. That the current moratorium on the licensing of any new antimicrobial growth promotants will continue until appropriate modification of Regulations are able to be made to allow re-assessment of existing products and licensing of new products. The moratorium will be reviewed at the next meeting of the Animal Remedies Board. During the period until the next Animal Remedies Board meeting, the Board will accept public comment on the need to refine the policies detailed above.

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