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AgVetLink April 2003

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Workshops on standards

The ACVM Group held workshops on 24 March 2003 in Auckland to explain finalised and proposed changes to some of the ACVM standards and guidelines.

The workshops discussed the revision of three standards:

• chemistry (plant compounds)
• residues (veterinary medicines) and
• residues (plant compounds).

In the morning, plant compound participants were guided through the changes made in the ACVM Registration Standard and Guideline for the Chemistry of Plant Compounds, which is now in effect. The finalised standard and a summary of the submissions received is on the website (http:// www.nzfsa.govt.nz/acvm/publications/standards-guidelines/index.htm).

In a concurrent session, veterinary medicine participants were given a rundown on changes to the ACVM Registration Standard and Guideline for Determination of a Residue Withholding Period for Veterinary Medicines. The finalised version of this standard is available at the website address above.

The equivalent residue session was held for plant compound participants in the afternoon. The submission period for the plant compound standard is still open. Any comments on the draft ACVM Data Requirements for a Food or Feed Use Clearance: Plant Compounds should be received by 26 April 2003. The draft document can be found on the website (http://www.nzfsa.govt.nz/acvm/publications/discussion/standards-guidelines/index.htm).

While there was limited participation from interested parties, those who attended the workshop found it informative.

NOTE: Users of the veterinary medicine residue standard should note that some changes have been made to the version originally posted on the website. Please ensure that the standard used to prepare an application for a veterinary medicine withholding period is the version 39 ACVM 03/03.

Quadrilateral meetings

The 12 th Food Safety Quadrilateral meeting (between New Zealand, Australia, Canada and the United States) was held alongside the Animal Health meeting in Queenstown from 17-20 March 2003. The Food Safety meeting was chaired by NZFSA Executive Director Dr Andrew McKenzie as head of the host country delegation, and New Zealand again took the opportunity to bring the two meetings together for one of the days to discuss common issues. A number of ACVM related issues were covered in the joint meeting including emergency response and animal feeds.

In the Food Safety meeting, topics of interest included antimicrobial resistance, bioterrorism, imported food and feed programmes, BSE/ TSE, Codex issues, and contaminants. The meetings provide a great opportunity to meet with regulators from the Quad countries and to share a range of information and experiences. The next meeting will be held in Canada in 2004.

Product specific approvals on registrations

The ACVM Group has identified a limitation in the way registrations are documented. Currently, there is no obvious place in the registration certificate that states the statutory obligations on parties other than the registrant, manufacturer or user.

Under the ACVM Act the importation, manufacture, sale and use of agricultural compounds can be regulated. Where necessary, the ACVM Group imposes conditions on the registration of trade name products to control any of these activities that pose significant risks. For example, manufacturing is a common point of control and all registered products have a manufacturing condition explicitly stated on the registration certificate that must be met by the registrant and manufacturer. For prescription animal remedies access is restricted and sale is limited to persons holding a bone fide veterinary prescription. Therefore, users of such products will find their regulatory obligation explicitly stated on the product label.

The present registration certificate does not explicitly state the statutory obligations of other parties. Consequently, from now on the documentation of a current registration will include a part called the 'product specific approval'. This part will state the statutory obligations and the kinds of persons (importer, distributor, veterinarian, etc.) who must comply with the obligations regarding importation, distribution, promotion, product security, record keeping, reporting or any other activity that poses relevant risks. There will be a general condition applied to the registration certificate stating that every person must comply with the requirements specified in the product specific approval part of the current registration. The product specific approval will be on the public register so that all parties can readily see their statutory obligations.