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Quality Control under the ACVM Act

There has been considerable discussion concerning the use of the ACVM Act 1997 to control the quality of agricultural compounds. It has been argued that it is impossible to separate the management of risks in the risk areas identified in the Act from controlling the quality characteristics of trade name products. MAF agrees with this point of view for some characteristics.

However, MAF also notes that there are many characteristics of products that the importer or manufacturer may wish to control, or that the consumer may wish to have controlled, that do not pose risks that are relevant to the ACVM Act. Those characteristics may pose risks relevant to the Hazardous Substances and New Organisms Act or the consumer protection statutes and should be managed under those Acts.

To clarify the characteristics of agricultural compound or veterinary medicine products that will be controlled (if necessary) under the ACVM Act, MAF has developed the following regulatory control principles:

• quality characteristics related solely to market preferences in a trade name product itself or in primary produce from animals and plants exposed to that product would not be regulated under the ACVM Act;

• if there were official competent authority import specifications in regard to quality characteristics (eg the use of agricultural compounds that have a negative effect on taste or smell in dairy products), then conditions would be imposed to meet those specifications;

• efficacy (how well a product does what is claimed) would not be controlled, unless inefficacy could result in a significant negative trade or animal welfare impact, ie cause unacceptable (unnecessary) pain or suffering;

• other quality characteristics such as sterility and purity would be regulated only if animals or plants would be exposed to harmful consequences, eg where parenteral administration of a product could lead to septicaemia or toxicity from contaminants;

• the Minister may, after consultation with interested and affected parties, issue a policy directive to control a quality characteristic because it is in the national interest to do so. Conditions would then be imposed to control that characteristic.

These principles are still in a state of refinement and any comments on the issue of quality control under the ACVM Act would be appreciated. Comments may be addressed to:

Debbie Morris
MAF Regulatory Authority
Post Office Box 2526
WELLINGTON