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New Process for Setting & Licensing of Somatotropins

New Process for Setting

Maximum Residue Limits

The transfer of the administration of the Food Act 1981 and Regulations from the Ministry of Health to the Ministry of Agriculture and Forestry has prompted the development of a new process for setting maximum residue limits in New Zealand. The responsibility for this process will lie within the ACVM Group, which will be known as the Agricultural Compounds, Veterinary Medicines and Chemical Contaminants Group of the Food Assurance Authority.

Briefly, the process being developed by a working party led by John Reeve will utilise advice from ERMA NZ as to the ’tolerable exposure limit' (TEL) (which is a portion of the acceptable daily intake [ADI] allotted to human exposure via food), and comparison of this figure with the potential daily intake of the substance estimated from food intake figures and assessed residue data. The process will also require the estimation of the TEL for those substances that may need a residue limit set but do not trigger the HSNO thresholds, eg via any of the criteria in the eco-toxicity threshold, in particular the biocide rider mentioned in the March issue of AgVetLink.

Any new residue limit will be set in the New Zealand Food Residue Standard _ a process which will not require a change in Regulations as is required under the present system. Therefore, the process should not be subject to the time delays associated with amendment of Regulations.

Maximum residue limits in the current process

The Ministry of Health has advised MAF that the New Zealand Food Residue Standard, which will replace Regulation 257 of the Food Regulations 1984, was signed by the Minister of Health on 8 April 1999 and will come into force on 13 May 1999. The applications for residue limits that are currently in the system awaiting formal setting are now progressing with finalisation of the public consultation document. Setting the residue limits has also been delayed because of a review of the possibility that residue limits for antibiotics (several were included in the group currently being assessed) may cause antibiotic resistance. The review has been completed and the applications will proceed. The public consultation will last for six weeks. The Ministry of Health has advised that the process should be completed within three to four months and the new residue limits will be included in the New Zealand Food Residue Standard.

Conditions imposed

The conditions that will be imposed will be designed to reduce hazards. They will not be designed to mitigate the impact of exceeding thresholds. In effect, regulatory control under the ACVM Act will contribute to risk management only to the extent that the control reduces specific hazards.

Example

For example, one of the outcomes of the first function listed above will be specific statements about the maximum residue limits for substances that will be tolerated. Once a maximum residue limit has been set the applicant must address the hazards in relation to that limit. The only information that will be required from the applicant in regard to residues will be that which shows whether or not the residue limit will be less than the specified maximum limit when the product is used as recommended.

Each of the thresholds will be dealt with in the same way as in the residue example above. The threshold will be set outside the scope of the ACVM Act and the applicant must provide the information that shows whether or not a particular threshold will be exceeded when the product is used as recommended.

This will be explained in the public statement on MAF's rationale for regulating agricultural compounds and veterinary medicines. However, potential applicants should take note that the risks will be assessed by MAF and the thresholds specified. The applicant will be responsible for providing the technical information and assessment of the hazards posed by their products.

Licensing of Somatotropins

The Animal Remedies Board has recently asked the Animal Welfare Advisory Committee for an opinion on the animal welfare issues associated with the use of somatotropins under New Zealand conditions.