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

Reform Issues

NZFSA considers that the following issues must be addressed in the reform of the administration of the ACVM Act:

• manufacturing agricultural compounds

• providing information about agricultural compounds, particularly advertising/promotion

• using compounds that are not sold as agricultural compounds for an agricultural compound purpose

• using agricultural compound trade name products in a manner that has not been assessed and authorised (ie off-label use).

As mentioned previously, these activities have hazards associated with them that could pose significant risks in the areas relevant to the ACVM Act. NZFSA considers that the current means of regulating these activities could be improved. The issues will be introduced here but will be discussed in much more detail during the public consultation phase.

Manufacturing

The majority of veterinary medicine products are manufactured by parties who have good manufacturing practice (GMP) approval from NZFSA or who have an equivalent approval from the regulatory authority in the country in which the product is manufactured. The manufacturing requirements are aligned with international standards, which have been adopted by NZFSA into its ACVM Standard and Guidelines for Good Manufacturing Practice.

NZFSA made its GMP standard generic so that the minimum requirements would be relevant to the manufacture of any kind of agricultural compound product that is to be registered. Following the new scheme of the ACVM Act, the minimum requirements in that standard have to be prescribed in Regulations with the advice put into guidelines (or into notices if that is considered desirable by the regulated parties).

NZFSA considers that basic minimum requirements should apply to the manufacture of any kind of agricultural compound product whether or not it requires registration. This is considered necessary to avoid errors in formulation and production, contamination, cross-contamination with other products, errors in labelling and packaging, storage and transport. NZFSA has had cases involving each of these situations and considers that statutory obligations should be set to deal with them, if they should happen again.

NZFSA recognises that the risks posed by manufacturing hazards can vary considerably from one kind of product to another. The level of regulatory intervention in manufacturing should be commensurate with the risks posed. NZFSA is also of the view that there should be regulatory control to ensure that products are always:

• what they are supposed to be

• in compliance with their approved manufacturing specification

• labelled in accordance with their approved label content.

Providing information about agricultural compounds

NZFSA is constantly investigating suspicions or allegations that products are being advertised or promoted in a way that misrepresents the product or is actually contrary to its conditions of registration or exemption from registration. At times the information about a product is provided by a party who is not directly involved in the importation, manufacture, sale or use of the product. Nevertheless, the information provided still misrepresents the product and can cause the same harm.

NZFSA intends to propose that minimum requirements in the current guideline for labelling and advertising products should be prescribed in Regulations. It should be noted that the minimum requirements for labelling will be incorporated into the Regulations governing manufacturing because it is a manufacturing step. NZFSA also considers that all parties should be made responsible for the information that they provide about agricultural compounds.

In February 2008 NZFSA intends to release a public discussion document addressing manufacturing and advertising as a first step in proposing new Regulations governing these activities.

Compounds not sold as agricultural compounds but used for an agricultural compound purpose

Currently NZFSA has the ACVM Standard for Own Use of Agricultural Compounds. This has been promulgated as a code of practice and an exemption from registration provided in Schedule 1 of the ACVM Regulations 2001 creates a legal basis under which parties can use generic substances/chemicals that are not sold as agricultural compounds for an agricultural compound purpose without registering the substance/chemical.

Under the new scheme of the Act the minimum requirements in that standard should be prescribed in Regulations. Consultation on this will also begin early in 2008.

Off-label use

NZFSA considers that a more robust and transparent regime is required to govern the common practice of using registered agricultural compound trade name products in a manner that was not assessed and approved at the time of registration. This is commonly referred to as off-label use and in international terms is often referred to as 'minor use minor species’ (MUMS) use. In many cases it is unavoidable because no party is likely to request a registration for a product specifically to treat the small quantity of minor crops or small numbers of minor animal species for rare or unusual conditions. A significant proportion of New Zealand’s horticultural and livestock production falls into the MUMS category.

There is a condition on the registration of most trade name products permitting off-label use to a greater or lesser degree. However, there is very little guidance provided about how that condition should be met and what care should be taken.

NZFSA intends to address the practice of off-label use of authorised products to ensure that such use does not cause harm. Minimum requirements for own use and off-label use are likely to be prescribed, removing any need for the current ACVM Standard for Own Use and providing a more informative foundation for governing off-label use than the current discretionary use condition on the registrations of trade name products. NZFSA will release proposals on this early in 2008.

All of this work will be done as part of the reform project and, as many parties have advised NZFSA in its early discussion on these matters, the principles may be reasonable but the ‘devil is in the detail’. Therefore, NZFSA hopes that interested and affected parties will participate in the consultation process. We want the outcome to be practical and effective in managing risks, and your input is appreciated.