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The ACVM Act and Regulations

507 ACVM 03/05

THE AGRICULTURAL COMPOUNDS AND VETERINARY MEDICINES (ACVM) ACT 1997

The Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 is one of the outcomes of a wide reform of New Zealand’s agricultural legislation begun by Government in the late 1980s. The ACVM Act replaced the Animal Remedies Act 1967, Pesticides Act 1979, Fertilisers Act 1960 and Stock Foods Act 1946 on 2 July 2001.

PURPOSE

The purpose of the ACVM Act is to:

a. prevent or manage specific risks associated with the use of agricultural compounds –

• risks to trade in primary produce

• risks to animal welfare

• risks to agricultural security;

b. ensure that the use of agricultural compounds does not result in breaches of domestic food residue standards;

c. ensure the provision of sufficient consumer information about agricultural compounds..

AGRICULTURAL COMPOUNDS

The legal definition of an Agricultural Compound, as stated in the ACVM Act, is:

... any substance, mixture of substances, or biological compound, used or intended for use in the direct management of plants and animals, or to be applied to the land, place, or water on or in which the plants and animals are managed, for the purposes of—

a. Managing or eradicating pests, including vertebrate pests; or

b. Maintaining, promoting, or regulating plant or animal productivity and performance or reproduction; or

c. Fulfilling special nutritional requirements; or

d. The manipulation, capture, or immobilisation of animals; or

e. Diagnosing the condition of animals; or

f. Preventing or treating conditions of animals; or

g. Enhancing the effectiveness of an agricultural compound used for the treatment of plants and animals; or

h. Marking animals;—

and includes any veterinary medicine, any substance, mixture of substances, or biological compound used for post-harvest pest control or disinfestation of raw primary produce, and any substance, mixture of substances, or biological compound declared to be an agricultural compound for the purposes of this Act by Order in Council made under subsection (2).

Administratively, agricultural compounds have been divided into three groups for regulatory purposes:

• plant compounds

• veterinary medicines

• vertebrate toxic agents.

Plant compounds include such things as bactericides, fungicides, herbicides and insecticides. Veterinary medicines include such things as anaesthetics, antibiotics and vaccines. Vertebrate toxic agents, previously classified under veterinary medicines as vertebrate poisons, e.g. 1080 and cyanide, are now considered to be a separate category of agricultural compound because their purpose is different from veterinary medicines.

REGULATORY OPTIONS

Where agricultural compounds are not exempt by Regulation (see page 2), registration is required. The legislation also requires registrants to apply for approval of any:

• variation made to the product

• additional claims made about the product

• changes to the approved label content.

CONDITIONS

Under the ACVM Act conditions are placed on the registration of products to manage or reduce risks. These conditions may be either generic or product specific, potentially affecting importers, registrants, distributors and users. For example, one of the conditions placed on a registration for a Class III prescription animal remedy veterinary medicine is a restriction for administration only by a veterinarian.

Any condition that specifies an obligation on users or a limitation on the use of a product will be stated explicitly on the label, which includes written material provided with the product.

CODES OF PRACTICE

The ACVM Act allows for the approval of codes of practice for importing, manufacturing, selling, or using any agricultural compound. These codes provide guidance to help people comply with conditions of registration. Currently approved codes of practice include:

• The Administration of Boluses

• Code of Practice for the Discretionary Use of Human and Veterinary Medicines by Registered Veterinarians

• New Zealand Code of Good Manufacturing Practice for Compound Feeds, Premixes and Dietary Supplements

• Code of Practice for the Sale of Fertiliser in New Zealand

• New Zealand Police Code of Practice for the Use of Prescription Animal Remedies.

THE ACVM REGULATIONS 2001

The ACVM Regulations 2001 provide exemptions from the requirement to be registered for certain groups of agricultural compounds. (See the Regulations at: http://www.nzfsa.govt.nz/acvm/legislation.) In most cases the groups are defined by the intended purpose; that is, if a trade name* product is sold for a use that is specified in one of the first three Schedules of the Regulations, then the product may be imported, manufactured, sold or used without registration as long as the product complies with the conditions prescribed in the Regulations.

* Because the levels of relevant risks are closely associated with particular formulations and use, the provisions of the ACVM Act are focused on the regulatory control of ‘trade name products’. A trade name product is an agricultural compound (or veterinary medicine) identified and packaged under a trade name for a specified use or uses.

RISK ANALYSIS

In deciding if a group of agricultural compound products could be exempted from registration and how the exemptions should be worded, the ACVM Group carries out a general risk analysis for the whole group. If the risks posed by all the products in the group can be managed by prescribing conditions common to the whole group, then registration is not considered necessary. However, the group must be defined carefully and the conditions must be simple and not ambiguous.

SCHEDULES

There are eight Schedules in the Regulations. Schedules 1 to 3 provide exemptions from registration.

Schedule 1 lists products that are exempt from registration with no conditions other than to comply with an approved code of practice if one exists. If there is no approved code of practice, then there are no conditions that must be met. Examples of products in Schedule 1 are:

• compounds prepared by a person for use on their own animals or plants

• topical non-absorbent and non-solvent cleaning products, including non-medicated shampoos, soaps, tear-stain removers, and toothpaste

• antisapstains.

Schedules 2 and 3 deal with products such as topical skin preparations for animals, spray markers, sunblocks for plants, general first aid preparations. Examples of conditions that may be imposed on exemption from registration of these products include:

• "Must be manufactured in accordance with good manufacturing practice"

• "Must not be used on animals from which animal material is intended to be used for the production of human food or human pharmaceutical products"

• "Must not be used on food crops unless they contain only a substance or substances described in Part B of Schedule 7..."

For all the exemptions and conditions, refer to the Regulations.

Schedule 4 relates to exemptions for oral nutritional compounds, giving conditions about labelling, fitness for purpose, etc. for such products.

Schedule 5 relates to exemptions for fertilisers and fertiliser additives, giving conditions about labelling, fitness for purpose, etc. for such products.

Schedule 6 provides a list of plants that may not be included in oral and topical herbal preparations that are exempt from registration, e.g. all species of Amanita.

Schedule 7 provides interpretation and limitations for substances Generally Recognised As Safe (GRAS) in oral nutritional compounds and plant compounds.

Schedule 8 lists substances prohibited from use as agricultural compounds (or as ingredients in agricultural compounds), e.g. DDT.

NON-COMPLIANCE

Non-compliance with the Act, Regulations or conditions of registration is an offence and could result in prosecution with fines of up to $30,000 for a person and $150,000 for a corporation. However, there are other mechanisms besides prosecution that are used alone or in combination to apply sanctions for non-compliance. These other mechanisms are:

• increased monitoring, imposed with associated charges that must be paid by the person not complying with conditions;

• prohibition notices that prevent further import, manufacture, sale or use until the non-compliance is remedied;

• the registration of a product may be reassessed and its conditions changed or its registration may be withdrawn;

• accreditation of facilities, systems or personnel may be withdrawn; and

• any other post registration approvals may be withdrawn.

If any approval is withdrawn and the conditions can no longer be met, importation would not be allowed, or continued manufacture or sale of the product would be an offence. Illegal product may be seized.

The mechanism that is used in any particular case, depends on the seriousness of the non-compliance and the cooperation of the affected parties to remedy the non-compliance. Affected parties are advised of the intended action and the reasons for the action being taken.

For more information visit the ACVM Group website (www.nzfsa.govt.nz/acvm) or contact the ACVM Group directly at:

ACVM Group

New Zealand Food Safety Authority

PO Box 2835

Wellington, New Zealand

Phone: 04 463 2550

Fax: 04 463 2566

Disclaimer: This publication is intended only as a guide.

It is not a legal interpretation of the legislation discussed.