A team of nine people from the European Commission (EC) visited New Zealand from 28
April until 9 May to review the regulatory process controlled by MAF. The purpose of the
visit was to review the production of meat, meat products, milk and milk products intended
for sale in the European Union (EU), and to evaluate the control of residues in live
animals and their products.
ACVM Group inspection
The role of the ACVM Group in licensing animal remedies, in the control of residues
through the application of withholding periods, and in the management of the use of animal
remedies that contain active ingredients and formulants that are banned in the EU but are
approved for use in New Zealand* came under scrutiny by the Commission inspectors.
The management of the licensing, importation, sale and use of hormonal growth
promotants (HGPs) was of particular importance to the inspectors because the use of these
products is banned in the EU.
Main issues
The main issues reported from the inspection that are of significance to the ACVM Group
are:
- a requirement for improved accuracy in accounting for all doses of HGPs passing through
the distribution chain;
- implementation of a system that assures that no obsolete MAF leaflets and user
documentation are distributed to end users of HGPs at the point of sale;
- a requirement for the administration of HGPs and completion of the associated records to
be carried out independently of the farmer;
- a requirement for tighter control on use of animal remedies that contain active
ingredients that are banned from use in the EU.
Corrective actions
The implementation of corrective actions has been started by the ACVM Group and other MAF
Groups where it is appropriate under their legislation. With respect to the issues
identified above, the following actions are being put into operation.
- The review of HGP records of distributors will be a key focus of site inspections, and
inspectors will be required to fully understand the dose distribution and reconciliation
systems used by individual distributors.
- A complete and current set of user documentation has been reissued to all distributors
of HGPs with a requirement that all old MAF leaflets are destroyed. Any further revisions
of user documentation will be coordinated through a regular meeting of the ACVM Group and
the Animal Products Group of MAF.
- HGPs are categorised as PAR Class I animal remedies and may be administered only by a
veterinary surgeon, or under and in accordance with the authority or prescription of a
veterinary surgeon. It is clearly impractical to stipulate a requirement for all HGPs to
be implanted only by veterinarians. MAF is therefore proposing to approve service
providers (i.e. commercial groups who may contract to farmers to implant HGPs) and give
the independence required by the EU. Such service providers currently offer a range of
on-farm services to farmers.
- Regarding the control of products containing actives banned in the EU, the ACVM Group is
proposing to take a layered approach to the resolution of the issue as follows:
a) The
proprietor of a product containing an EU banned substance will be required to reformulate
the product with an alternative acceptable substance.
b) If reformulation is not possible, the proprietor will be required to remove any
claims for use in cattle, sheep or horses from the licence and label. In addition it will
be a requirement to specify ‘for use only in (species)’ on the
product label. These products will be designated as PAR Class I.
c) If actions under b) above are not attained in the timeframe specified, the licence
of the product will be revoked, making manufacture, importation, sale and use of the
product illegal and subject to enforcement activity.
d) If, in the view of the Decision Making Committee, the assignment of PAR Class I to a
particular product will create an absurd precedent, the ACVM Group will provide
information through appropriate channels to the EC and license the product for general
sale. (An example of this situation might be a product for the treatment of conditions of
home aquarium fish that, by their nature, are packed only in non-commercial quantities and
could not be expected to enter the food chain.)
* The EU banned active ingredients that are used in licensed products in New Zealand
are chloroform, dimetridazole, metronidazole, furazolidone, ronidazole and furaltadone. |
