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AgVetLink December 2002

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Compliance update 

Border activity

Maree Zinzley and Linley Thorburn have been working with the MAF Quarantine staff at the border and have been assisting in their training for the ACVM Act appointments. We expect several hundred MAF Border Services staff to be appointed under the ACVM Act prior to Christmas. Already this work has seen some positive results - an increased awareness has resulted in a higher than usual number of products being questioned at the border prior to release.

ACVM Group appointments as inspectors

All of the ACVM Group advisors and technical assessors have now been appointed as 'inspectors' under the ACVM Act, along with the Programme Manager (ACVM Verification) and the Programme Manager (ACVM Operations). This will assist in the role that is becoming increasingly important to the ACVM Group activity under the ACVM Act of ensuring compliance with the ACVM Act.

NZFSA Compliance and Investigation Group

The NZFSA Compliance and Investigation Group (CIG), headed by Geoff Allen, has taken over some of the enforcement staff previously reporting to Jockey Jensen. CIG is now responsible for all enforcement activity for the NZFSA in addition to their previous responsibilities. The balance of CIG staff who will be working in the investigation area for the ACVM Act will be appointed as soon as possible. The ACVM Group will continue to have some contact with compliance activities in the biosecurity area because of the overlapping responsibilities for animal welfare and for agricultural security.

The ACVM Group is working with CIG to set the strategy for the coming year, and will also be revising the ACVM Compliance Policy in the near future.

ACVM Act powers

The ACVM Act has a number of powers that are proving useful in ensuring compliance, without taking the time-consuming, costly step of prosecuting breaches.

Section 64 of the Act provides powers of entry for inspection for the purpose of determining whether or not any person is complying with the Act. It provides the opportunity to take samples and query records and, more importantly, to order the person in charge to identify and hold any agricultural compound for up to five working days. This power can be used with importers, manufacturers, distributors (including veterinarians) or users.

Section 65 provides that inspectors (or authorised persons) who have reasonable grounds to believe that anyone is manufacturing, selling or using any agricultural compound in contravention of the Act and Regulations, or the conditions of registration, can issue prohibition notices. These can cover manufacture, sale or use until the breach is rectified to the satisfaction of the inspector.

Both of these sections have the effect of stopping the potential breach of the Act at an early stage, and encourage any offender to comply as quickly as possible because of the financial considerations.

The CIG team has used the prohibition notice for ACVM Act breaches. In other situations, companies have come into compliance when advised of the process that is being initiated.

Future appointments

In addition to the activity with CIG, it is also likely that both MAF Verification Agency (MAFVA) staff and AgriQuality staff will be appointed as 'authorised persons' under the ACVM Act. Section 61 allows for the appointment of people for certain functions. The MAFVA staff work with the Animal Products Act on farm and in processing facilities, and such appointments would be useful in their investigation of breaches in their areas of responsibility. Likewise, AgriQuality staff functions (when they are undertaking audits on behalf of the ACVM Group or other parts of NZFSA) would be enhanced with the ACVM Act 'authorised person' status.

Compliance activity

Most compliance activity results from either adverse event reporting or complaints received by the ACVM Group. There is some activity that occurs as a result of the monitoring systems in place in either the Animal Products area, the Dairy and Plants area, or work done in response to animal welfare complaints. The NZFSA related ones are usually about the residue monitoring programmes run for the various sectors.

Since the start of the ACVM Act there has been an increase in the numbers of complaints relating to unregistered products - some 21 in the fivemonths since the implementation of the Act, compared with 40 in the whole of last year. Many of these complaints regard products that fit in one or other of the exempt categories. We expect that this will continue to be a confusing area as the class determinations for such products rely on a combination of the ingredients in the product and the claims made in relation to it.

Adverse event activity

There have been 31 adverse reports notified and investigated for the period 1 August - 31 October 2002 Most of the adverse events have been answered to our satisfaction, although we will review the incidents longer term and will follow up in the next round of GMP inspections. One product is likely to be reviewed as a result of the adverse events received in this period.

In the first instance the ACVM Group will be obtaining information from the registrants and industry groups concerned.

Complaints

There have been 17 complaints received in the period from 1 August to 31 October 2002. While each individual complaint is followed through to our satisfaction, the information the ACVM Group holds showed that a number of them had a common source. This has resulted in ACVM Group staff visiting the company in question. A number of issues raised in the visit are being followed up. Several of the other complaints have been passed on to the CIG for further investigation.

Work in this area since the ACVM Act implementation has shown that enforcement is extremely complex. It is crucial to distinguish the role that a particular person or organisation is playing in the process. In one case relating to a horse trainer, it appeared that the trainer could have been acting as the distributor, manufacturer and user, or a varying combination of these roles depending on the form of the contract that he had with the feed supplier and each of the owners, and the activities that he undertook in relation to feeding each of the animals he was looking after. It is clear that when the ACVM Group places conditions on products, it must specify exactly which party is bound by those conditions.

Dairy Industry Act moving into the Animal Products Act

The NZFSA Policy and Dairy teams are working hard to progress the movement in this area. It is hoped that the legislation will have its first reading in the house in December this year. There are plans for an imple-mentation date of June 2003 for the legislation with a period of three years for the changes to occur.

Anyone interested in the details of the changes should keep an eye on the Policy and Dairy parts of the NZFSA website. One of the first areas of consultation will be in the draft specifications with workshops being proposed on the topic in January 2003. Details are also available in the Dairy Connection news-letter on the website.