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AgVetLink June 2003

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VICH Food Safety Expert Working Group

At a meeting in Brussels on 28 - 30 April 2003, this working group finalised the last two draft guidelines to complete the mandate to produce the guidelines necessary for the provision of harmonised toxicology data packages supporting the registration of veterinary medicines used in food-producing animals. These were the chronic toxicity guideline, and one for the establishment of a microbiological Acceptable Daily Intake. The guidelines will be put out for comment prior to their formal adoption after any modifications that may be necessary following the comment period (which is to end in November 2003).

Microbiological ADI guideline

The ‘Microbiological ADI’ guideline is completely new, incorporating new concepts relating to microbial resistance and drug effects on the gut microflora. It was drafted after a thorough review of the current scientific literature.

Chronic toxicity guideline

The ‘chronic toxicity’ guideline does not represent a fully harmonised approach by the regulatory authorities. The current state of toxicological knowledge does not allow a differentiation between the potential need for chronic studies generated in two species as opposed to only one species required for proper assurance of the long-term safety of the consumption of veterinary drug residues in foods. Generally, the data (comparing the information obtained from the many assessments of chronic toxicity data carried out by international bodies) showed that one species gave all information that was used in the estimation of an ADI.

However, assessment of data on one or two substances did provide extra data that would not have been found except for the second test. The different ADI estimated was not greatly less than that obtained in the least sensitive animal in these cases, and the decision as to whether to require data from only one species, or whether data from two species was required came down to the choice between conservatism and the need to limit the use of animals in toxicity testing.

The six countries/regions represented at the working group were split evenly with Japan, Canada and Australia opting for the need for two species to be tested, and USA, Europe and New Zealand opting for only one species.

Action to be taken

The working group will:

• finalise these two guidelines when the comment period is over
• ensure all the toxicity guidelines are fully compatible, and
• make a single coherent package for proprietors and regulators to use.

Copies of the draft guidelines are available on the NZFSA website (http://www.nzfsa.govt.nz/policy-law/vich/index.htm).

The Australia/New Zealand rep-resentative on the working group is John Reeve who can be contacted at john.reeve@nzfsa.govt.nz.

Data requirements for veterinary medicine exotic disease claims

The ACVM Group currently applies the following rule in relation to allowing claims for diseases and parasites that do not occur in New Zealand to appear on veterinary medicine product labels:

Labels must refer only to diseases/parasites that occur in New Zealand. For the purposes of harmonisation with Australia, diseases/parasites occurring in Australia may be included accompanied by a disclaimer, for example, ‘This disease/parasite does not occur in New Zealand’.

In the event of such an exotic disease/parasite becoming established in New Zealand, it would be difficult and costly to both industry and regulatory groups to undertake a post registration review to ascertain whether such claims are supportable. In addition, although some of these diseases are not endemic to New Zealand, situations arise where prophylactic treatment of animals for export or post importation is required.

Registrants should note that exotic disease/parasite claims are subject to the normal ACVM registration procedure that requires assessment of efficacy, safety and/or residue data where necessary to support the proposed claim. This requirement is not specifically stated in any of the current ACVM standards and guidelines. However, it will be added to the Registration Information Requirements at the next update.