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AgVetLink August 2003

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Default milk withholding period for long-acting veterinary medicines

The ACVM Group no longer permits ‘Do not use’ statements in place of a withholding period (WHP) where no data or technical argument have been supplied to enable an assessed or allocated WHP to be approved where good agricultural practice (GAP) requires a WHP to be established. For short-acting veterinary medicines, the default milk withholding period of 35 days will apply in such circumstances. This withholding period was never intended for application to long-acting products.

Although the use of long-acting products with extended milk withholding periods in lactating animals producing milk for human consumption is not considered GAP, the use of such products may be GAP during the dry period. The continued application of ‘Do not use’ statements for these products is no longer considered consistent with the principles of good risk management.

The ACVM Group holds sufficient data to be confident that, regardless of the product type, violative milk residues will occur only while violative meat residues are present. However, insufficient data are held to enable a ‘one fits all’ default to be set for long-acting preparations with approved meat withholding periods longer than 35 days.

In consequence, the ACVM Group has adopted the following policy: 
For any long-acting product with an approved meat withholding period in excess of 35 days for which no milk residue data is supplied, the default milk withholding period approved will be the same period approved as the meat withholding period.

This change will be enforced when products are updated or an application is made to alter an already updated label. Should registrants wish to supply data and/or technical argument to reduce the ‘default’ withholding period, they may be provided at the time of update. A separate application will not be required; however, the ACVM Group will charge the standard hourly rate ($108.00 plus GST) for the time taken to complete the assessment.

 

Compliance

There has been a big increase in the number of compliance incidents reported over the last quarter.

In general, it appears that most of those reported are for products that fall within the oral nutritional compound category. This has always been an area where marketers have confusion on what should or shouldn’t require registration. It is timely to remind you that ingredients such as condroiton and glucosamine require registration. This is in addition to shark cartliage and green lip mussel. However, it is not just the ingredients that determine whether a product requires registration or not.

A number of incidents concerning advertising and the claims that have been made have been reported. We can assure you that these complaints and all complaints are thoroughly investigated, and the offenders are advised of the appropriate action to rectify the non-compliance.

If your company is unsure about what you can or can’t say in marketing your products, then we strongly suggest that you consult our assessment team. This will avoid complaints against your products.

The ACVM Group has been working closely with the Compliance and Investigation Group on breaches of the ACVM Act and advise that we will, if necessary, take further prosecution action.

 

MRL Update

The second MRL consultation round in 2003, which proposed a MRL for pymetrozine in lettuce and an exemption for 9,10- anthraquinone in grapes, started on 15 May and finished on 13 June.

The permission for pymetrozine in lettuce was gazetted on 17 July but submissions on the exemption for 9,10-anthraquinone are still being considered.