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Codes of Practice Under the ACVM Act

ACVM INFORMATION PAPER 14 April 2002

1 INTRODUCTION

This is to provide clarification of the role that codes of practice approved under section 28 of the ACVM Act might play in the regulatory control of veterinary medicines or plant compounds. The ACVM Act does not make it clear how codes of practice are to be used and how they might relate to either conditions on registration or as the basis for conditions on agricultural compounds exempted from the requirement to be registered. This paper discusses the relevance of codes of practice and describes the rationale for their use.

2 APPROVAL OF CODES OF PRACTICE

2.1 Statutory basis for codes of practice

Section 28 gives MAF the power to approve, amend or revoke codes of practice for importing, manufacturing, selling or using any agricultural compound. While there is an obligation on MAF to consult when exercising this power, failure to do so does not affect the decision in regard to the code in question. The section places process obligations on MAF to ensure that the public is aware that a decision has been made in regard to a code of practice. The public notice must state how people can have access to the relevant code and the MAF decision on its approval. This does not necessarily mean that the public can have copies of the code (see discussion of property rights below).

Section 28 does not give MAF the power to develop or create a code of practice. This implies that codes will be developed by some other party who will approach MAF for statutory recognition of the code. The section does not provide any criteria that must be taken into consideration when approving, amending or revoking a code of practice. It also does not explain how the power to amend or revoke a code can be achieved when the code itself is not under the control of MAF. It would appear that the only matter that is practically in the control of MAF is the actual approval of the code as adequate for some reason. Section 28 should be viewed as a mechanism to provide statutory recognition of a code of practice without specifying why such recognition would be necessary or desirable. From an operational perspective, it will be policy to approve codes of practice only in cases in which the proponent(s) of the code could justify that approving the code would provide more consistent management of the risks specified in section 4 of the ACVM Act without unduly restricting the rights of individuals to manage those risks in some other way. MAF would approve the code on the basis that it is deemed to be an appropriate way to manage those relevant risks.

MAF considers it inappropriate to dictate compliance with a code of practice to any party. Since the code itself is likely to be owned by some other party (e.g. the biomedical, pharmaceutical, animal feed or fertiliser industry or a company), amendment of the code should be up to the proponents of the code. The proponents should approach MAF with a proposal to alter the code, and MAF should make a judgement as to whether the code should still be approved if it were amended according to the proposal.

Even though the ACVM Act provides the power, MAF will not revoke a code, but remove the approval instead. This focuses the power in section 28 on the approval of a code to achieve a desired regulatory outcome.

2.2 Role of approved codes of practice in regulatory control

The ACVM Act does not say why or under what circumstances MAF would approve a code. It also does not say how or when a code of practice should be used to regulate agricultural compounds. Therefore, there is no inherent direct correlation between MAF approval and the use of a code of practice as the regulatory control mechanism. It is necessary to create a regulatory context for the use of codes of practice. The following are circumstances in which, from a statutory intervention perspective, codes of practices could play a progressively more stringent role in regulating agricultural compounds.

2.2.1 Statutory recognition of a voluntary code of practice.

There will be occasions in which an industry wants to encourage consistency in managing the ACVM relevant risks. That industry may feel that MAF's judgement that the code is an acceptable way of managing the risks would encourage parties to adopt it. In this case there would be no statutory consequence in the form of obligations or protections. It may simply enhance the reputation of the code.

Section 28 does not specifically limit the risks that can be managed via an approved code of practice. However, MAF will approve only a code of practice (or part of a code) that is designed to manage risks that are relevant to the purpose of the ACVM Act. MAF will not approve a code of practice that was designed to achieve industry consistency over market-preference quality characteristics of products. The public notification in this case would not include an express statement that MAF considers compliance to the code would be evidence that a party is taking adequate measures to comply with regulatory conditions.

2.2.2 Compliance with an approved code of practice as an acceptable way of meetingstatutory conditions.

Section 23 gives MAF the power to impose conditions specifying that persons, facilities, systems and products must meet certain conditions. This is most likely to be done without any reference to a code of practice. However, an approved code of practice could be recognised by MAF as an acceptable means of meeting the required conditions. Compliance to the code would be deemed by MAF as taking adequate measures to comply with statutory conditions. In this case, adopting the code of practice would be one way to comply with the conditions. There may be other codes of practice(s) that could be judged as equivalent, but there would be no assurances beforehand that these other unapproved codes or practices would be considered by MAF to be adequate. The certificate of registration would expressly state that standards must be met, but there would be no statement that a particular code of practice must be adopted. 

When a code is approved with the intent that it would serve as an acceptable means of complying with statutory conditions, there would be a statement in the Gazette notice that compliance to the code would be deemed to be adequate measures to comply with statutory conditions.

2.2.3 Compliance to a code as a condition of registration

The most stringent option would be to require compliance to a particular code of practice as a specific condition of registration. Section 23(f) gives MAF the power to impose a condition requiring codes of practice approved by MAF under section 28 to be followed when importing, manufacturing, selling or using the trade name product. This would be done only in cases in which it was considered that no other procedure would be adequate to meet the statutory conditions. In most cases, this would be hard to justify because there is usually more than one way to achieve the same purpose. However, there may be extenuating circumstances (such as an international standard or a particular import requirement affecting access of primary produce to a significant overseas market) that would warrant such a prescriptive action.

In this case, the Gazette notice may be the same as in the previous option, but the certificate of registration would expressly state that compliance with the approved code of practice is a condition of registration. It might be argued that the Gazette notice would always be different, but the need to be prescriptive may be focused on particular products and the code may be relevant to a wider range of products. Consequently, there may not always be a direct correlation with the acceptability of the code and the need to be prescriptive, producing an overlap in the second and third options.

3 PROPERTY RIGHTS FOR CODES OF PRACTICE

As mentioned above, there must be a public notice stating how people can have access to the relevant code and MAF's decision on its approval, but this does not necessarily mean that the public can have copies of the code. MAF considers that, in most cases, a code belongs to the party that develops it and asks for it to be approved. The proponents take responsibility for developing, maintaining and amending the code. Considerable costs could be involved and the proponent may choose to write a single code that also includes control of characteristics that are not relevant to the ACVM Act. Rather than requiring the proponent to go to the expense of preparing two codes, MAF intends to approve only those parts of a code that relate to the ACVM Act. Therefore, there will be occasions when a code contains material that the proponent does not want to be given to the public. MAF must allow people to look at an approved code of practice but it will not give anyone copies. The inquirer will be referred to the owners of codes. Whether or not the owners are prepared to release copies of their codes is up to them.

The exception to this rule is in regard to the third and most stringent option described in 2.2.3. If there is a statutory obligation to comply with a particular code then MAF considers that code must be a public document.

4 CONCLUSION

MAF has adopted the above regulatory context in which codes of practice may be useful and their use be predictable. A register of codes of practice approved by MAF may be found on the ACVM Group web site under Registers and Lists.

The codes of practice that have been approved may be regarded as real examples of where codes of practice are used to help regulate agricultural compounds.