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AgVetLink: Number 60, February 2007

Review of Regulatory Control

Background

NZFSA has begun a review of its policies for the administration of the Agricultural Compounds and Veterinary Medicines Act 1997. The purpose of this review is to update its operational policies to ensure that the implementation of the ACVM Act manages the risks posed by the use of agricultural compounds and veterinary medicines while remaining within the powers and scope of the Act. It is also to ensure that the implementation is consistent with the principles and objectives of NZFSA and other regulatory authorities such as Biosecurity New Zealand, ERMA New Zealand, the Ministry of Health and the Department of Labour.

There is an amendment to the ACVM Act that is in Select Committee. The public consultation period for the Amendment Bill closed 23 February and the Select Committee should begin considering the Bill in March.

While the amendment includes provisions that will affect the purpose of the Act, such as introducing public health as a relevant risk, the operational policies being reviewed do not directly relate to the provisions of the Amendment Bill. They relate to the interpretation of existing provisions. These include:

• The definition of an agricultural compound;

• The scope of products that are included under that definition;

• The definition of the relevant risk areas; and

• The thresholds and criteria for determining whether or not a risk is acceptable.

Policies

Interpretations for these areas were formulated into operational policies via public consultation when the ACVM Act was passed but before it came into effect (because of the delay in the commencement of the hazardous substances provisions of the Hazardous Substances and New Organisms [HSNO] Act 1996). At that time, it was uncertain what the operational policies of the Environmental Risk Management Authority (ERMA) would be and how the two regulatory regimes would complement each other to achieve comprehensive regulatory control of veterinary medicines and products used in the agricultural and horticulture sectors.

Predictions were made about the future regulatory environment. Operational policies that would be appropriate to guide the administration of the ACVM Act through this formative period were promulgated. These have been the foundation for decisions as to what products were considered to be agricultural compounds and what would constitute an unacceptable risk that needed to be managed. The principle applied was that there should be no more regulatory intervention, using the full range of statutes, than was necessary to provide adequate management of risks posed by the importation, manufacture, sale and use of agricultural compounds and veterinary medicines.

Risk management gaps

Since the operational policies were initially formulated, the implications and effects of the interface between the ACVM and HSNO Acts have become more obvious. Risk management gaps have appeared as a result of:

• the differences between placing controls on substances because of the presence of hazards under the HSNO regime and imposing conditions on trade name products to manage certain risks under the ACVM regime;

• the differences in the focus of the two Acts (trade in primary produce, agricultural security, animal welfare and residues in food under the ACVM Act, and health and safety of people and the environment under the HSNO Act); and

• ACVM risks that must be managed when there are no substances with a hazard classification that would prompt regulatory control under the HSNO Act.

Expanded focus

In addition, in the same period, Government has consolidated the regulatory control of food and food- related products, and placed the responsibility for it with NZFSA. In addition to commercial food production, this control includes home grown produce and recreational collection of wild foods. Therefore, the area of interest of the ACVM Group of NZFSA relative to home garden products and possibly products used for initial processing of primary produce has expanded.

Issues have also arisen in regard to the interface between the ACVM Act and the Animal Products and Food Acts. While risks to food may occur because of the use of chemicals, that use may or may not be relevant to the definition of an agricultural compound, e.g. the use of disinfectants in pre-slaughter facilities.

Because of these clarifications or changes in the regulatory environment, the ACVM Group has made ad hoc changes in its operational policies over the last few years to cater for the revised focus.

Comprehensive review

This current review of the policy base is intended to be comprehensive, restating all the changes that have been made since the interpretation of the ACVM Act was first considered. NZFSA considers that it is essential to re-establish a sound operational policy basis for regulatory control of agricultural compounds and veterinary medicines to gain the full benefit from the amendment to the ACVM Act, and to get agreement from interested and affected parties as to a reasonable interpretation of the Act to ensure its administration will be fair, transparent and predictable.

It is intended to address the review in a step-by-step process to build up a comprehensive policy foundation for the administration of the ACVM Act. Initially reviews will be carried out within the ACVM Group with consultation with other NZFSA business groups. However, it is anticipated that the interpretations and policy proposals will be fundamental, requiring extensive external consultation.

Public consultation

The ACVM Group will ask for advice from external experts, and position papers and proposals will be prepared for industry and public consideration. It is expected that the interpretation and policy are going to have a significant impact on many regulated parties, making it likely that Government approval for consultation will be necessary.

Two areas of interpretation and policy areas for review have been identified:

• definition of ‘agricultural compound’ and other crucial terms

• definition of relevant risk areas and the thresholds at which intervention is warranted.

Definition of terms

The following terms have been identified as being crucial to the administration of the ACVM Act and the interface between that Act and other Acts administered by NZFSA:

• agricultural compound (veterinary medicine)

• animal

• direct management

• harvest (and an equivalent term for the collection of animal produce from live animals)

• pest

• processing.

Definition of relevant risk areas

Exactly what is meant by risks to trade in primary produce, animal welfare and agricultural security will be reviewed; and new thresholds that recognise the crucial role NZFSA plays as the primary ‘hands on’ regulatory agency for the importation, manufacture sale and use of agricultural compound trade name products will be set. Public health risks area

It is likely that the amendment of the Act will introduce a new public health risks area. This is not intended to detract from or duplicate the public health activities of ERMA, the Ministry of Health or the Department of Labour.

It is intended to fill the gaps in the present regulatory arrangements to ensure that issues such as antibiotic resistance and the use of agricultural compounds and veterinary medicines to enhance public health objectives can be addressed. It is also intended to ensure that there is adequate mandate to carry out effective approval and compliance activities.

Risk management

Once the new policy foundation has been agreed upon, NZFSA will consider how it will use the new regulatory provisions that may be available as a result of the amendment to the Act to bring the risks posed by agricultural compounds down to an acceptable level and to encourage sustainable and responsible use of such products.

Readers are advised to watch AgVetLink for notification of discussion papers and to participate in those discussions to help NZFSA adjust its regulatory control to be as efficient and effective as possible from a whole of government regulatory control perspective.