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

5 Proposal to set MRLs for Fenbendazole

It is proposed that MRLs are set for fenbendazole when used as a veterinary medicine for cattle, deer, goats, horses and sheep. It is proposed that Schedule One of the NZ (MRL) Food Standards 2008 be amended by deleting the following MRLs:

As a replacement for the deleted MRLs, 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 fenbendazole in Schedule One of the NZ (MRL) Food Standards 2008:

Amendment Rationale

The proposed MRLs represent the expansion of the New Zealand MRLs for meat and edible offal to harmonise with MRLs set internationally and by the European Community. The proposal also seeks to refine the commodity names to better reflect the intent of the MRLs and correct an error in the residue definition.

Chemical Information

Good Agricultural Practice

Fenbendazole is currently approved in New Zealand as an anthelmintic treatment for gastro-intestinal round-worms, lungworms and tapeworms in cattle, deer, goats, horses and sheep use may be through oral or topical administration.

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 fenbendazole 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 current NEDI for fenbendazole is equivalent to 0.7% of the ADI, with accommodation of the proposed MRLs the NEDI increases to 2.5% 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 increase of the fenbendazole MRLs for mammalian fat, muscle and kidney to 0.05mg/kg is very unlikely to pose any health risks from consumption of the animal product commodities.

Other International MRLs

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.