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

Notice of change: product classification system

As part of the reform process, NZFSA has considered the way it separates kinds of agricultural compounds into classes with common characteristics. It has found that its terminology is out of step with the terminology used in industry and that is commonly used internationally. To eliminate confusion NZFSA has decided to revise its classification to facilitate both the upcoming public discussion on reform proposals and ongoing regulatory control of agricultural compounds.

Based on similarities of purpose and potential risks, NZFSA proposes five subclasses for all agricultural compound products:

• agricultural chemicals

• veterinary medicines

• oral nutritional compounds

• fertilisers

• vertebrate toxic agents.

Agricultural chemicals

These are products applied to invertebrate animals, plants, places, water, soil (but not directly to vertebrate animals) to:

• manage plants directly or indirectly or

• control invertebrate animals for pest control purposes or

• manage invertebrate animals such as bees, molluscs, and crustaceans that are used for food production.

In the past this group was known as 'plant compounds'. That term is too limiting and causes significant confusion which will be exacerbated when NZFSA proposes to regulate a wider range of products as agricultural compounds. Therefore, the name of the subclass has been changed to 'agricultural chemicals'.

The agricultural chemical subclass is extremely diverse, covering public health and industrial products used to manage plants and animals as well as those products traditionally associated with agricultural production.

Products in this subclass will be considered in groups with similar characteristics and risk profiles. The groups are likely to be:

• pesticides – herbicides, fungicides, insectides etc

• plant growth regulators and other products that act on the physiology of plants

• cleaners and sanitisers

• antifouling products

• water treatment products

• timber treatment products but not timber preservatives.

The consultation process may identify other groups that should be included, so this is a tentative list.

Veterinary medicines

These products are applied directly to vertebrate animals. It includes products that are clearly therapeutic or pharmacological treatments (including anti-parasiticides), biological products like vaccines, dermatological products, first aid and disinfectant products applied directly to animals, allografts/xenografts and blood products. The group also includes any other product that is directly administered to animals, such as cosmetics, shampoos and other cleaning products. Suture material is included but surgical instruments, syringes and needles, vaccinating and drenching guns are not.

Oral nutritional compounds

These are oral products for vertebrate animals used to achieve a nutritional benefit. This class includes all kinds of animal feeds and nutritional supplements for livestock and companion animals (pets). They are orally administered and contain only nutrients and non-therapeutic/non-pharmacological feed additives. The products are variable in their formulation, with ingredients changing with the availability of feed commodities, nutrients and feed additives. The claims must be limited to those relating to nutritional benefits.

These products could have been classed as veterinary medicines but they do not have the same risk profile as therapeutic or pharmacological products, so it was considered more appropriate to put them in a class on their own.

Fertilisers

This class includes fertilisers to be applied to soil/water or plants, fertiliser additives (chemical and biological), fertiliser additives such as lime or DCD when used by itself, soil conditioners and any other kind of product intended to be used to promote plant growth directly or indirectly or to promote animal growth indirectly via the supply or facilitated uptake of nutrients by plants.

The products are variable in their formulation, with ingredients changing with the availability of fertiliser commodities, nutrients and fertiliser additives. The claims must be limited to management of plants or animals via the supply of nutrients to plants.

Vertebrate toxic agents

This subclass covers any product that is intended to control vertebrate pests, including products designed to have a negative effect on the reproduction of such animals.

Multi-purpose products

Multi-purpose products that fall into more than one of the above subclasses will likely be assessed for each of the relevant subclasses.

For example, products that fit one of the intended purposes of agricultural chemicals, but are administered directly to animals, will most likely be considered veterinary medicines as well, even though they are not strictly intended to manage the animals. This is because the mode of application to land is via an animal, which poses risks to the animal as if the products were veterinary medicines.