- Print Friendly - Help

AgVetLink December 2003

Previous page  | Contents |  Next page

---

ACVM Group liaison with:

Ministry of Health

The last meeting of the Ministry of Health Antibiotic Resistance Expert Working Group produced a number of recommendations and actions.

• The advisory group agreed that it should encourage research to underpin decision making criteria for the safety of animal remedies.
• The advisory group commended the NZFSA antibiotic resistance surveillance initiative and offered support through its surveillance subcommittee. The chair is to nominate a surveillance subcom-mittee member to participate in the project design. The ACVM Group is to progress discussions with the Ministry of Health, industry sectors and other interested parties to develop an initial proposal.
• The advisory group recommended additional support to Medsafe in developing principles and guidelines regarding the use of antibiotics in animals to minimise the development of antibiotic resistance.
• It was agreed that the advisory group should meet more frequently and be more active in providing advice and guidance.

Since this meeting, the ACVM Group has experienced operational difficulties with the Ministry of Health’s risk management concerns on products being updated to the ACVM Act.

A meeting held in November resulted in a number of actions to try and resolve concerns about the range of antibiotics used in veterinary medicines, as well as in the management of bees, and for fire-blight in tomatoes and apples.

ERMA New Zealand

We have recently identified an issue of concern with the ERMA New Zealand process relating to the setting of PDEs (potential daily exposures) for food for excipient products. This issue has come to light with a recent ERMA New Zealand decision on a substance as a new registration. Other similar products are caught by the transitional provisions but have not been affected to date because there have been no equivalent limits set for these substances.

The product contains a relatively common excipient product (identified as ‘Component B’). Some of the issues that we have identified to date are:

• Setting an ADE (acceptable daily exposure) and a PDE _food for an excipient creates a difficult situation for the ACVM Group if that excipient is in several pesticides and veterinary medicines used in the production of food. The final residue in any food at harvest will be from the sum of residues from all trade name products (TNPs) with that excipient in them used in the production of that food (less any breakdown). It will generally not be related to the residue that is found in any trial of each individual TNP, and the latter residue information is the only data that we can require any individual registrant to provide. This means that the ACVM Group will not be able to require the provision of residue data reflecting the true residue at harvest, and hence will not be in a position to know if the requirement that the PDE _food not be exceeded by the potential daily intake of that excipient is actually met or not. It also means that the current method of controlling products by conditions on registration is unlikely to be effective.
• One practical way of telling the actual residue at harvest would be for the Government to fund the residue trials because the need to sample sufficient produce from sufficient producers would be prohibitive for each excipient. This is likely to be extremely costly and has not been taken into account in the ERMA New Zealand costs/benefits consideration for the substance.
• No other regulatory authority that we are aware of seeks such data, and the difficulty of requiring its provision, as outlined in the first point, is probably one of the reasons why. Excipients are generally looked at in a generic manner and decisions made to allow their use or not. New Zealand is not likely to ever be the first to consider the suitability of an excipient, and those used have almost always been put through regulatory processes overseas.
• Many excipients will not have full toxicology data available for them, and their loss is likely to see the related TNPs disappear from New Zealand rather than see companies invest in their ‘defence’ for a market the size of New Zealand.
• There is also a potential problem in whether a PDE _food is or is not a ‘food residue standard’. If it is, then it must be taken into account in the consideration of the registration of a TNP. But, as described above, we have no way of ascertaining whether a use on a food crop could lead to a breach of the PDE _food .

The ACVM Group has had initial discussions with ERMA New Zealand staff who understand the problem, but at this stage are required by the Regulations to follow the prescribed process. The next step is for the NZFSA Policy and ACVM Groups and ERMA New Zealand to initiate discussions with the Ministry for the Environment to try to develop some solutions.