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AgVetLink June 2003

SPECIAL ISSUE FOR VETERINARIANS

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Codes of practice becoming ACVM standards

Some parties have expressed confusion in regard to the nature and content of codes of practice approved under section 28 of the ACVM Act. Other parties have suggested that some of the codes of practice that have been developed by the ACVM Group and approved under section 28 do not have the commonly accepted characteristics of codes of practice.

For example, the Code of Practice for Own Use of Compounds is a statement of the regulatory expectations in regard to such use, but it does not provide any operational detail that would guide practice. This code is better described as a standard similar in content to schedule 4 of the ACVM Regulations that specifies the requirements for oral nutritional compounds. The New Zealand Feed Manufacturers Association was able to use schedule 4 to develop a more traditional type code of practice that provides practical guidance to meet the requirements specifications in the schedule.

It is highly unlikely that the ACVM Group would have a need or be in a position to develop a true code of practice specifying operational requirements in any detail. The ACVM Group sees the soundness of the distinction between standards and codes of practice. Consequently, the Group will develop ACVM standards to state explicitly the regulatory expectations in regard to particular activities. The standards will be used when reviewing codes of practice submitted for approval under section 28 of the ACVM Act.

Standards will be put forward for public consultation as they are developed. There will be standards for other activities developed, but the following will be priority topics:

• use of prescription animal remedies by non-veterinarians;
• trading in prescription animal remedies; and
• distribution, sale and use of vertebrate toxic agents.

For the time being the Code of Practice for Own Use of Compounds will remain an approved code of practice to provide a basis for the first exemption in schedule 1 of the ACVM Regulations. However, it will be duplicated as an ACVM standard to be used to review any relevant code of practice proposed by third parties.

 

What is AVMAC?

The Agricultural Compounds and Veterinary Medicines Advisory Council was set up to give balanced and comprehensive advice to the Director of the ACVM Group. It is not a decision-making body but it does form a very important part of the consultation process, given the range of organisations that are represented and the perspectives that they bring to the table.

AVMAC meetings are held every quarter. ACVM standards, guidelines and operational policies (including changes) are all endorsed at AVMAC meetings as part of the development process. ACVM Group staff are not members of AVMAC but they often attend meetings in order to hear the full discussion by AVMAC of relevant papers and issues because this assists in refining operational policies prior to fuller consultation where this is taking place.

Initially the ACVM Group concentrated on aligning AVMAC membership to the primary purposes of the ACVM Act, namely managing risks to trade in primary produce, animal welfare, and agricultural security. More recently we have added a representative of a consumer organisation to bring a new perspective to the discussions at AVMAC meetings.

 

Adoption of VICH* guidelines

The following are final guidelines that were endorsed by AVMAC members at a recent meeting.

GL28 Safety studies for veterinary drug residues in human food: Carcinogenicity studies. (October 2003) 

GL 31 Studies to evaluate the safety of residues of veterinary drugs in human food: Repeat dose (90 days). (October 2003) 

GL32 Studies to evaluate the safety of residues of veterinary drugs in human food: Developmental toxicity testing. (October 2003) 

GL33 Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to testing. (October 2003) 

The NZFSA proposes to apply these Step 4 guidelines (as appropriate) in its standards and guidelines for the registration of veterinary medicines under the ACVM Act and Regulations, and in any related legislation. Details of the VICH process and the finalised guidelines can be found on the website (http://www.nzfsa.govt.nz/policy-law/vich/guidelines).

* VICH is a group of regulators and industry from USA, EU, Japan (members), Australia/New Zealand and Canada (observers) working to harmonise registration requirements for veterinary medicines.