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Proposals to Amend (No. 2) the New Zealand (Maximum Residue Limits of Agricultural Compounds) Food Standards 2008

7 Proposal to set MRLs for Monepantel

It is proposed that MRLs are set for monepantel when used as an anthelmintic for sheep. It is proposed that Schedule One of the NZ (MRL) Food Standards 2008 be amended to include the following; this will be the resulting entry for monepantel in Schedule One of the NZ (MRL) Food Standards 2008:

Amendment Rationale

The proposed MRLs for monepantel represent a new veterinary medicine active ingredient that is proposed for registration in New Zealand. The proposed MRLs will allow the use of this product for the treatment of gastro-intestinal parasites in sheep according to the following good agricultural practice (GAP).

Chemical Information

Good Agricultural Practice

Monepantel is a novel veterinary medicine active in New Zealand. The proposed GAP is the application of 2.5mg monepantel/ kg liveweight and a withholding period of 7 days.

Residues Information

Residues of monepantel, determined as the metabolite monepantel-sulphone, at 7 days after treatment are not expected to exceed 7mg/kg in sheep fat, 5mg/kg in sheep liver, 2mg/kg in sheep kidney and 0.7mg/kg in sheep muscle.

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 monepantel 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 Organization, 1997].

The NEDI for monepantel is equivalent to 1% of the ADI. It is therefore concluded that the chronic dietary exposure is small and the risk is acceptable.

Toxicological / Public Health Assessment

It has been determined that the use of monepantel as a veterinary medicine for use on sheep, according to the GAP specified above, is very unlikely to pose any health risks from consumption of animal product commodities.

Other International MRLs

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