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AgVetLink February 2004: Page 3

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DAS business rules

The Data Assessment Service (DAS) process has been in operation for six months. This has allowed applicants to use parties other than the ACVM Group to undertake DAS reports. Over this period a few issues that need clarification have arisen.

The main issues surround lack of understanding of business rules that applicants and third party assessors need to follow when undertaking DAS reports. Although these were covered in a series of ACVM workshops, we appreciate that not all applicants attended these workshops.

Consequently, we have not been rigorously enforcing these business rules during the ‘settling in’ period for this new system but now we would like to remind applicants of the following:

1. It is preferred that DAS reports, while they may be prepared by a person in the applicant organisation, be done by someone other than the regulatory affairs personnel for reasons of independence.

2. We require the CV of the person who undertakes the DAS report. This is particularly important where specialised reports (e.g. efficacy, animal safety etc.) have been undertaken. The purpose of this is to assure the ACVM Group that the person has the relevant qualifications and/or experience. If you are unsure whether the ACVM Group already has the person’s CV, check first with us before submitting the report.

3. Applications submitted into the regulatory system based on third party DAS reports will be audited. The level of auditing will depend on a number of factors, e.g. appropriateness of the report author’s qualifications. Where the ACVM Group needs to seek verification of a report, such as seeking advice from its own advisors, the ACVM Group will stop the clock until this verification is complete.

4. Persons undertaking DAS reports need to ensure that they relate the applicant’s information to appropriate ACVM standards and guidelines. If the information does not conform, then this should be brought to the applicant’s attention. It is then the responsibility of the applicant (not the DAS assessor) to provide extra information or request an information waiver to support the non-submission of the information.

On a related matter, it has been noted that the qualifications of some of the persons undertaking a DAS report are either not appropriate or are marginal. For example, the person may have a number of years of experience and/or qualifications (such as entomology) but not in the area relating to the review of information (pathology) for a DAS report. This is of particular relevance to the efficacy and animal safety reports. Therefore, it is important that applicants only use persons with relevant and suitable qualifications and/or experience, otherwise the ACVM Group, as mentioned above, will undertake a detailed audit of the reports.

Finally, it should be noted that a favourable DAS report (irrespective of whether the person who undertook the writing of the report had appropriate qualifications or not) does not necessarily mean the application will be approved by the ACVM Group. This is because the ACVM Group is responsible for managing risks under the ACVM Act via the regulatory process, whereas DAS reports only identify hazards.

New Zealand Total Diet Survey

In November, the NZFSA released the first round of results from the New Zealand Total Diet Survey (NZTDS). The foods were collected from supermarkets and shops in Auckland, Napier, Christchurch and Dunedin in July and August. They were then sent to ESR in Christchurch where they were prepared, as they would normally be consumed, before being sent for testing for chemical residues, contaminants and selected nutrients.

NZTDS Project Leader Cherie Flynn says there are no surprises in the results.

"The results so far are as we expected them to be. This is the first quarter to be completed. The other three will be completed over the next nine months," Mrs Flynn said.

The NZFSA’s media release on the first results can be found on the NZFSA website ( http://www.nzfsa.govt.nz/publications/media-releases/2003/2003-11-21-nztds.htm ).

The NZTDS also has a dedicated webpage ( http://www.nzfsa.govt.nz/science-technology/research-projects/total-diet-survey/index.htm ).