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Implementation of the ACVM Act: Regulatory changes

5 Own use/off-label regulations

This section is about managing the use of substances as agricultural compounds that have not been assessed and authorised by NZFSA, and the use of authorised products in a manner that has not been assessed.

Substances used as agricultural compounds have often not been sold for that use. They become agricultural compounds because of the way they are used. For the purposes of this discussion document the practice will be considered in three forms:

• own use

• off-label/MUMS use

• provision of professional services.

Own use is currently covered under the first entry in Schedule 1 of the ACVM Regulations 2001.

For own use, NZFSA proposes to make regulations that will:

• include the existing requirements that apply to persons who use generic substances, mixture of substances or biological compounds as an agricultural compound

• include an exemption from registration, and prescribe an obligation to take due care to ensure that the relevant risks are kept to an acceptable level

• prohibit marketing, manufacture, sale or distribution that states or implies in any way that the substance, mixture of substance or biological compound can be used as an agricultural compound.

For off-label/MUMS use, NZFSA proposes to:

• place a condition on the registration of most products that allows off-label use, but imposes requirements on responsible parties and on users to take due care to avoid negative effects, tying the use to the same requirements for own use of generic substances.. These requirements will, for the most part, not be new. The main change will be in the type of regulatory mechanism, in line with the revised, more transparent scheme of the ACVM Act.

For the provision of professional services, NZFSA proposes to:

• exempt from registration preparations compounded as part of specified professional services, and prescribe minimum requirements that must be complied with. These will be new requirements, as the specified professional services have not been regulated under the ACVM Act to date.

5.1 Use of terminology and definitions

Agricultural compound as per section (2) of the ACVM Act, but focusing on the regulatory control of persons who, by their actions:

• convert non-agricultural compound substances or products into agricultural compounds, or

• use agricultural compound products in a manner that was not specifically assessed and authorised under the ACVM Act.

Compounding means preparing a substance (or mixture of substances) to be used as an agricultural compound to treat animals or plants on a small scale. The term is used with reference to herbalists, homeopathic practitioners and veterinarians who prepare medications to use as veterinary medicines or as preparations to manage plants. It is also used when referring to contract chemists/pharmacists commissioned by those practitioners. It is not used when referring to the manufacture of herbal, homeopathic or chemical preparations for sale as proprietary products (ie preparations offered for sale to the public outside the context of a professional service). The manufacture of proprietary products offered for sale is covered under the manufacturing section of this paper.

Contract application refers to the use of agricultural compounds by persons who provide an application service to clients. For example this includes spray contactors, who provide aerial or ground application (and may provide the product along with the application service).

Distribute means to send an agricultural compound that has been manufactured for sale to wholesalers, retailers and/or end users; and includes transport and storage in any intermediate step to the end user. Distribution has an impact on the status of both the substance/product and the actions of the parties involved. If a non-agricultural compound is used by a party only on their own animals or plants the activity would be relevant to this section. However, if that person distributes it to other parties to be used as an agricultural compound it would not be considered “own use”. Such distribution implies sale and, if the product is not properly authorised, the action would be an offence under the ACVM Act.

Label in relation to any agricultural compound or any container used to contain an agricultural compound, means any written, pictorial, or other descriptive matter under which the compound is sold or to be sold and which purports to give some information about the compound (ref: section 2 ACVM Act). Labelling requirements have no practical meaning when a party converts a non-agricultural compound for use on their own animals or plants. However, labelling is relevant when a professional practitioner prepares a preparation to be used as an agricultural compound as part of a service, as is done by herbalists, homeopathic practitioners and some veterinarians.

Manufacture means to make up, prepare, produce, or process an agricultural compound and includes packing and labelling for the purposes of sale. The term relates to any part of the process from manufacture of the active ingredients to the end-use formulation. NZFSA considers that “manufacturing” also includes storage and transport by the manufacturer. The definition is also relevant to the activities of parties who compound a preparation as part of a service. The principles of responsible manufacturing are the same, and all parties should be subject to those principles.

Operating plan refers to the documented description of a process, either in general or as it refers to the compounding or use of a specific agricultural compound substance or product. There may be circumstances in which the activities of people may have to be subject to operating plans to ensure that due care is taken to keep risks relevant to the ACVM Act down to an acceptable level. The use of this term in this section is most relevant to the recognition of professional practitioners.

Own use refers to persons using agricultural compounds (generic chemical or off-label use of registered products) to manage their own animals or plants (or animals or plants that they are responsible for) either by direct applications to those animals or plants or application to land, places or water that are also under the control of that person, for any of the purposes listed in the definition of an agricultural compound. It usually refers to the use of generic chemicals or other substances or biological compounds that have been sold without any agricultural compound use claim or instruction. Off-label or minor use/minor species (MUMS) use is sufficiently similar to warrant discussion in this section.

Own use includes contract application when the application remains the responsibility of the owner, as opposed to responsibility being transferred to the person providing the application service.

It is recognised that the criteria for own use does not fit very well in regard to the activities of professional practitioners providing product with services to third parties. For this reason the activities of some professional groups have been considered in separate proposals in this section. At this stage the proposals relating to the activities of professional groups do not include spray contractors.

Sale includes barter, and also includes offering, exposing, or attempting to sell, or having in possession for sale, or sending or delivering for sale, or causing or allowing to be sold, offered, or exposed for sale; and also includes delivering or disposing of by way of gift, loan or otherwise; and giving or distributing, in the course of business, as a sample or otherwise, without charge (ref: section 2 of the ACVM Act). The proposals in this section prohibit sale, except in the very limited context of providing a professional service as is done by herbalists, homeopathic practitioners and some veterinarians.

5.2 Own use

5.2.1 Current regulatory regime

“Own use” as specified in schedule 1 of the ACVM Regulations 2001 refers to the use of a substance/product by persons on their own animals or plants on land or water or in a place under their own control. It does not include the sale of such substances as agricultural compounds to third parties. Own use is managed through a combination of regulations, conditions of registration and standards.

The generic chemicals or substances involved in own use are usually readily available. Their use as agricultural compounds has not been assessed by NZFSA. Technically, it could be an offence under the ACVM Act to intentionally use them as agricultural compounds. However, due to the frequency of own use practices, they have been covered by an exemption from registration. Examples of own use of generic chemicals include:

• epsom salts (magnesium sulphate) to control the colour of hydrangea flowers

• copper sulphate footbaths to prevent/treat footrot in sheep

• zinc oxide to prevent facial eczema

• tincture of iodine or solutions of potassium permanganate to treat minor wounds

• garlic oil to repel undesirable insects away from fruit/vegetable crops

• seaweed or greenwaste compost to be used as fertilisers.

In the past, own use was limited to simple, traditional uses based on a narrow range of readily available chemicals. The risk of causing harm was small and regulatory control was not considered necessary. In addition, there was an expectation that persons engaged in own use would comply with the rules. The technical breaches that occurred before an exemption was included in the ACVM Regulations 2001 were overlooked because the common own use practices at the time were not likely to exceed acceptable risk thresholds in trade in primary produce, animal welfare or agricultural security, and unlikely to lead to breaches of the domestic residue standard.

With the increasing availability of a vast range of quite sophisticated chemicals, the potential for harm from own use now poses risks far beyond acceptable thresholds. NZFSA does not consider that, in general, a system of permits for own use is practical under New Zealand conditions. Furthermore, prohibiting own use is neither practical nor desirable.

5.2.2 Proposed regulatory regime

NZFSA proposes to set regulatory requirements that must be complied with by any person who uses generic substances, mixture of substances or biological compounds as an agricultural compound.

The requirements to be prescribed will, for the most part, not be new. The main change will be that the regulatory mechanism will be made consistent with the revised, more transparent scheme of the ACVM Act.

All affected parties are already regulated through requirements in the ACVM Standard for Own Use of Agricultural Compounds (the approved code of practice for own use).

NZFSA considers that putting requirements around own use into regulations is the most transparent and effective way to minimise non-compliance. People will be held accountable for their actions when converting generic substances into agricultural compounds or when using a registered product in a manner that has not been assessed. It might be possible to deal with both these issues in the same regulations, but it seems clearer to NZFSA to promulgate two sets of regulations – one for own use and one for off-label/MUMS use.

The current requirements in the ACVM Standard for Own Use of Agricultural Compounds include:

• prohibition on use of specified substances as agricultural compounds

• prohibition on use of new organisms, including genetically modified organisms, unless approved by ERMA NZ under the HSNO Act

• obligation to ensure that maximum residues limits set under the Food Act (and maximum permissible limits set under the Animal Products Act) are not exceeded

• obligation to ensure that treated (exposed) animals are not subjected to unnecessary or unreasonable pain or distress

• obligation to make the use known when animal products are collected for human consumption

• prohibition on sale of the substances as an agricultural compound, and

• obligation to ensure the compound is fit for purpose and due care is taken when using it.

NZFSA proposes that the regulations will include an exemption from registration. This would provide the authorisation required under the ACVM Act, and create the mechanism by which the minimum requirements could be imposed. The proposed regulations would place an obligation on every person to take due care to ensure that the relevant risks are kept to an acceptable level. They would also prescribe what constitutes due care, such as a proactive effort to gather information to support a particular use pattern. They would restrict the use to animals or plants that are owned by that person. They would also restrict the location in which the use can occur to land, water or a place owned (or managed) by that person. This would ensure that the risks are contained, and that third parties would not be involved or inadvertently exposed to potential harm. The proposed regulations would address the circumstances in which responsibility has been conferred on a person but actual ownership is not involved.

The proposed regulations would prohibit marketing, manufacture, sale or distribution that states or implies in any way that the substance, mixture of substance or biological compound can be used as an agricultural compound.

It would be an offence not to comply with the proposed regulations. Compliance would not be an excuse to justify non-compliance with any other regulatory requirements, such as those set under the Animal Welfare Act, Biosecurity Act, Hazardous Substances and New Organisms Act, Resource Management Act or any maximum residue limits under the Food Act or maximum permissible limits under the Animal Products Act.

5.3 Off-label use or MUMS

NZFSA proposes to place a condition on the registration of most products that allows off-label use (specifically prohibiting in the conditions of registration uses that it considers would pose significant risks), but imposes requirements on responsible parties and on users to take due care to avoid negative effects.

As is the case for own use, the requirements will, for the most part, not be new. The main change will be in the type of regulatory mechanism, in line with the revised, more transparent scheme of the ACVM Act.

Current regulatory regime

New Zealand producers are forced to consider off-label uses because no one is pursuing registration for products to meet their particular needs. Off-label or MUMS use is a reflection of the mismatch between overseas authorisation of trade name products for common livestock and crop species, and the focus in New Zealand agriculture on minor crops and minor animal species. Off-label uses include:

• pest control in herbs, unusual tree crops and other minor crops

• cattle or sheep vaccines used on ratite birds such as emu and ostrich

• therapeutic products for cattle or sheep used on deer, pigs, goats and other animals.

Currently, off-label use is authorised via a condition of registration. The off-label condition refers to use on animals or plants or, very rarely, on both. If use on neither animals nor plants is specifically referred to, off-label use is not authorised. The off-label condition states minimum requirements. For products used to manage plants, the minimum requirement is to take due care to avoid non-compliant residues. For products used on animals there is also a requirement to avoid unnecessary or unreasonable pain or distress in the treated animals, and to seek veterinary advice if necessary before use. If NZFSA considers off-label/MUMS use cannot be allowed, then the off-label use condition is not applied or is specifically restricted (which can require a specific permit from NZFSA).

In New Zealand, off-label use is allowed as a general rule, and only restricted where there are regulatory concerns to be managed. Managing off-label use is an international problem. Some countries manage it via special authorisations or permits, while others prohibit it. NZFSA considers neither of these solutions to be practical under New Zealand conditions. New Zealand often has no specifically authorised products when it comes to minor uses or in minor animal/plant species. There are so many MUMS circumstances that it is highly unlikely that anyone would want go to the expense and trouble to register products dedicated to those uses. Prohibition of off-label use would have serious negative effects on business – and a permits system could introduce a costly level of regulatory intervention.

The current regulatory regime has been satisfactory for the most part but specific cases of non-compliance have lead NZFSA to the conclusion that it does not provide sufficient instruction to regulated parties about what they have to take into consideration when choosing to use a registered product in a manner that has not been specifically authorised. The negative effects can be very significant; for example, a farmer recently used a product on his cattle and deer that had only been approved for use on plants. This resulted in millions of dollars in trade losses and seriously undermined international confidence in New Zealand as a source of safe food.

Proposed regulatory regime

NZFSA would prefer to manage the risks associated with uses that have not been assessed by placing a condition on the registration of most products that allows off-label use (specifically prohibiting in the conditions of registration uses that it considers would pose significant risks), but imposes requirements on responsible parties and on users to take due care to avoid negative effects. The proposed minimum requirements would be similar to those that would be imposed for the use of generic chemicals as agricultural compounds because it cannot be presumed that assessment and authorisation for one use provides a sound platform for a different use.

NZFSA proposes to place an obligation to comply with the regulations in the conditions of registration, while retaining the practice of specifying in the conditions of registration any specific limitations on off-label/MUMS use.

It should be noted that this proposal does not relate to the off-label/MUMS use of most products that are currently exempt from registration in the ACVM Regulations 2001 because the use is fundamental to the exemption. For example, if therapeutic claims are made about an oral nutritional compound product, then that product no longer fits the definition of an oral nutritional compound and is not exempt. This means that a person may not be able to use a product that is exempt from registration in an off-label manner without nullifying the exemption and making him/herself liable to register the product.

5.4 Provision of professional services

The third activity relevant to the own use proposals relates to certain professional groups who offer services to manage the health and productivity of animals and plants.

NZFSA proposes to exempt from registration preparations compounded and provided in conjunction with specified professional services. NZFSA also proposes to prescribe minimum requirements that practitioners must comply with in the provision of these specified services.

Compounding as part of a service is not regulated at the moment because the outcome cannot practically be managed via registration. Nevertheless, parties must be responsible for the way they manufacture their preparation just like any other manufacturer.

The professional services that have been identified as relevant at this stage are:

• herbalists

• homeopathic practitioners

• pharmacists

• veterinarians.

Current regulatory regime

These professional groups compound their own preparations as needed in the services they provide. The preparations are not manufactured and sold as trade name products, but prepared to meet a particular case or patient’s needs. In most cases, it is the service that is sold, not the preparation. The preparations are agricultural compounds, but they cannot practically be regulated via registration. An exemption from registration has been prescribed for some of these preparations, but the conditions do not adequately address the potential for harm across the wide range of relevant preparations.

Currently there are exemptions from registration for oral and topical homeopathic and herbal veterinary medicines, and homeopathic products used to manage plants. Minimum requirements are specified in the exemption, but NZFSA considers that these are too generic for the wide range of preparations that are made by practitioners in the course of providing professional services.

Proposed regulatory regime

The conditions on the proposed exemption will require practitioners to be recognised by NZFSA under section 62 of the ACVM Act to carry out compounding of the relevant kinds of products. Either minimum requirements for compounding will be incorporated into technical and professional standards, which can be issued under section 62, or there will be a requirement to comply with a section governing compounding in the proposed manufacturing regulations. If the former mechanism is used, failure to comply will result in loss of recognition. Without recognition the preparation used will not comply with the conditions of exemption and administering them will be an offence. If the latter mechanism is used, failure to comply with the regulations will also be an offence.

NZFSA is considering the role of operating plans in the regulatory control regime. It proposes to require that these professionals must have operating plans to cover their compounding activities and the link with their professional services. It has not been decided whether such plans would need NZFSA approval. NZFSA needs to discuss the matter with industry groups before that decision is made, and the decision may not be the same for all of the groups in every case.

This proposal does not make a distinction about mode of administration. The current exemptions limit administration to topical or oral. This proposal could cover all modes of administration, and set minimum requirements as necessary based on the risks posed. This would mean that preparations could be compounded by these practitioners even for injection or for application to eyes and ears. NZFSA also needs to discuss this with industry groups to ensure that the minimum requirements are necessary, sufficient and relevant to the affected parties.

This proposal will not cover the manufacture of products to be sold to the public outside the context of providing a specified professional service. Such products will be subject to the rules of registration or relevant exemption from registration, and to the proposed manufacturing regulations.