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Provisional Registration (Generic Research)

Currently the ACVM Group provides a provisional registration for experimental work to be performed on animals prior to registration using the final end-use formulation that is to be marketed. With this provisional registration, a section 63a approval, which allows for the slaughter and entry of animals into the food chain after assessment of the residue risk, is supplied. Conservative default withholding periods are assigned or, if the applicant can supply sufficient argument (such as a residue data package), then shorter withholding periods may be considered.

Managing risks
It is important to note that the ability to use primary produce from such studies remains a concession from other regulatory groups that deal directly with animal products and dairy produce. The ACVM Group is relied upon to analyse and manage the risks associated and, at any time, these groups retain the right to intervene and modify concessions, should these impact on the risks the groups have to manage.

From the above it is clear that the intent of the provisional registration is for use in products that are about to be marketed, where the final formulation has been decided.

Produce from generic research
Because a great deal of basic generic research is performed by New Zealand agricultural companies, an important issue has arisen as to how best to manage the produce of animals that have been treated with products used in this type of research. Some of the trials undertaken may be as basic as ascertaining the effect of vitamin supplementation on milk production. The ACVM Group was approached by various organisations to manage these issues and to provide a risk analysis as to whether and when such produce might enter the food chain.

As a consequence, an additional provisional registration, called a provisional registration (generic research), is being created. It will be required to undertake research on animals or plants using an agricultural compound not yet characterised as an end-use formulation, where the treated animals or plants or their produce are to be sold, i.e. have the potential to enter the food chain.

Provisional registrations (generic research) will be issued by the ACVM Group, on behalf of other groups within the Ministry of Agriculture and Forestry (MAF), in order to aid in the management of residues in animals, plants or their produce that enter the food chain.

The research may also be subject to a Risk Management Programme under the Animal Products Act 1999 or to a Product Safety Programme under the Dairy Industry Regulations 1990. Either of these programmes may require that a provisional registration or provisional registration (generic research) is obtained.

NB:
Such research must comply with all other relevant statutory requirements.

Information required
In order to obtain an approval for sale of animals, plants or the produce used or produced in the course of work done under a provisional registration or a provisional registration (generic research), the applicant must provide information or data to support the approval. Where no data or information is provided, the animals, plants or their produce must be destroyed.

For provisional registrations, residue data or information to support the use of a default ‘time to sale’ period is required. For provisional registrations (generic research), a risk analysis of the research substances is required.

Where supporting data or information is provided, the ACVM Group Technical Assessor will make a recommendation on a ‘time to sale’ period, if appropriate.

NB:
Any treated animals, plants or their produce that enter the food chain may also be subject to other legislation, e.g. the Food Act, Animal Products Act, Dairy Industry Act, etc.