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Proposals to Amend the New Zealand (Maximum Residue Limits of Agricultural Compounds) Food Standards 2008

9 Proposal to set an MRL for Neomycin

It is proposed that an MRL is set for neomycin when used as a veterinary medicine for cattle. It is proposed that Schedule One of the NZ (MRL) Food Standards 2008 be amended by deleting the following entry:

As a replacement for the deleted entry, it is proposed that Schedule One of the NZ (MRL) Food Standards 2008 be amended to include the following entry:

The final entry for Neomycin in Schedule One of the NZ (MRL) Food Standards 2008 will therefore read:

Amendment Rationale

The proposed MRL represents the setting of a New Zealand MRL for neomycin in cattle milk that will be harmonised with MRLs set internationally by Australia, the European Union and by the Codex Alimentarius Commission.

It is intended that the increase in the MRL will allow the milking withholding period to be decreased allowing a greater flexibility in the use of neomycin in the treatment of bacterial infections and mastitis

Chemical Information

Good Agricultural Practice

Neomycin is currently approved in New Zealand as an antibiotic treatment for bacterial infections and mastitis in cattle way of intramammary or injection, with withholding periods ranging from 3-5days for milk and 30-35 days for meat.

Residues Information

The proposed MRL has been determined by Codex to represent a suitable international standard for residues.

Dietary Risk Assessment

The potential daily exposure via food (PDE_(food))is used for dietary intake calculation where a value has been set. An appropriate acceptable daily intake (ADI) is used in the absence of a PDE_(food).

The chronic dietary exposure to neomycin is estimated by the National Estimated Dietary Intake (NEDI) calculation encompassing all registered uses of the chemical and food consumption data based upon the 1997 National Nutritional Survey for adults and the 1995 National Nutrition Survey of Australia, for children. The NEDI calculation is made in accordance with Guidelines for predicting dietary intake of pesticide residues (revised) [World Health Organisation, 1997].

The NEDI for neomycin is equivalent to 15% of the ADI. It is therefore concluded that the chronic dietary exposure is small and the risk is acceptable.

Toxicological / Public Health Assessment

Promulgation of the proposed MRL for neomycin as an antibiotic treatment for bacterial infections and mastitis in cattle is very unlikely to pose any health risks from consumption of milk from treated cattle.

Other International MRLs

To meet New Zealand’s obligations under the Agreement on the Application of Sanitary and Phytosanitary Measures the proposed MRL will be notified to the World Trade Organization. Any country may choose to comment if they believe the proposed MRL represents a barrier to their trade.