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AgVetLink Issue 64, October 2007, Special Issue on Regulatory Reform

Agricultural Compound and Veterinary Medicine Regulatory Reform

Background

The ACVM Act replaced the Animal Remedies, Fertilisers and Stock Foods Acts. In conjunction with the Hazardous Substances and New Organisms (HSNO) Act, it also replaced the Pesticides Act.

Since then, the ACVM Act has been the primary piece of legislation governing the regulatory control of agricultural compounds at a trade name product level. While the HSNO Act provides the initial approval for the import or manufacture of substances, the ACVM Act provides the context for control of products containing substances with HSNO approvals to be used in the management of plants and animals.

Legislation

At the time the ACVM Act was passed, operational decisions were made in order to manage risks and avoid duplication of regulatory intervention (which is associated with unnecessary compliance costs). These decisions were based principally on a 'best guess' of the interrelationship between the new ACVM Act and the new HSNO Act. They were also based on assessments of the interface between the ACVM Act and the Food Act, Medicines Act, Misuse of Drugs Act, and the other legislation administered by MAF, including the Animal Products Act, Dairy Industry Act (since repealed), Biosecurity Act and the Animal Welfare Act.

It was always intended that the ACVM Act would control agricultural compounds and veterinary medicines to help achieve the regulatory outcomes set under those other Acts.

Changes

Now, ten years down the track, NZFSA has reviewed its ACVM regulatory role as mentioned in the introductory article by Director Debbie Morris.

Given these challenges and the evolution of the regulatory environment, NZFSA has embarked on a reform of the administration of the ACVM Act. There are some basic principles at the heart of this reform.

Reform principles

1. Agricultural compounds and veterinary medicines should be:

• properly assessed and authorised

• what they are supposed to be and do what they are supposed to do

• represented on their labels and in advertisements/promotions in a manner that is consistent with their authorisations

• used in a responsible manner that avoids harm to people, animals/plants, the environment in general and avoids negative effects (such as non-compliant residues) on food and food-related products.

2. People involved in importation, manufacture, sale or use of agricultural compounds or veterinary medicines should:

• act in a responsible manner to avoid relevant risks

• be able to be held responsible for their actions

• be brought to task for failing to meet their obligations.

3. Regulatory control should be efficient, practical and no more intrusive than is necessary to manage the relevant risks.

4. Within the scope of the ACVM Act a whole of government approach should be taken to regulate agricultural compounds and veterinary medicines so that the collective outcomes can be achieved. It has been made clear in the process of preparing the ACVM Act Amendment Bill that it is the most practical context in which to manage agricultural compounds and veterinary medicines at a trade name product level to achieve the collective government outcomes.

These principles will drive the proposals that NZFSA will develop in the ACVM Reform Programme. At this stage it is anticipated that issues will be addressed in the following manner.

Regulatory decision rationale

To set the stage for reform, in late October/early November NZFSA will release a discussion document on the fundamental rationale for regulatory control under the ACVM Act. The document will highlight the need to expand the interpretation of what is/is not an agricultural compound and what constitutes sufficient reason to impose regulatory control to manage relevant risks. The document will also address the risk areas of:

• public health (to be introduced in the amendment to the ACVM Act)

• trade in primary produce

• biosecurity

• animal welfare.

Thresholds for regulatory intervention and criteria by which to judge if those thresholds have been exceeded will be proposed. Product groups will be reviewed in light of the decision rationale, and NZFSA’s views on regulatory needs will be presented for your consideration.

The outcome of this initial consultation will provide the basis for more in-depth regulatory proposals for each of the product groups identified as requiring regulatory control.