Somatotropin policy

The operational policy on the registration of somatotropins has been finalised.

The policy states in general terms that somatotropin trade name products may be registered if:

• there is no Ministerial direction or Ministry of Agriculture and Forestry (MAF) policies excluding registration;
• they do not breach any of the risk thresholds specified in the risk policy, including risks to trade, animal welfare and agricultural security; and
• any hazards posed can be adequately managed by imposing any or all of the following conditions on registration:

  a) any application would also have to meet the requirements of the relevant standards for registration;
  b) use under prescription of a registered veterinarian according to registration conditions; and
  c) use subject to a control programme involving identification of treated animals, recording and reconciliation of distribution of product, and verification of the programme.

Bovine somatotropin (BST) is not allowed in the European Union, a major trading partner with New Zealand. At present, there is no effective mechanism for separating milk from treated and untreated animals in New Zealand, and no analytical method of detection. Therefore, BST will not be licensed in New Zealand at the present time.

Provisional registration (for trial activity) could be approved if the applicant can demonstrate that the produce from any experimental animals does not enter the food chain.

Other somatotropins may be licensed for use in New Zealand if the associated risks can be adequately mitigated through the usual licensing process. All somatotropins will be classified and considered as hormonal growth promotants even if they are registered for other uses. This ensures that treated animals can be identified.

The full policy is available on the ACVM website under Publications/ Current Policies. A summary of the submissions considered can be found in the Draft Policy (Archived) area of the website.