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Proposals to Amend the New Zealand (Maximum Residue Limits of Agricultural Compounds) Food Standards 2007

4 Proposal to set MRLs for Marbofloxacin

It is proposed that MRLs be set for marbofloxacin in pig fat, meat and offal when used as an antibiotic for treatment of Mastitis Metritis Agalacticae syndrome. It is proposed that Schedule One of the NZ (MRL) Food Standards 2007 be amended to include the following entries:

The final entry for marbofloxacin in Schedule One of the NZ (MRL) Food Standards 2007 will therefore read:

Amendment Rationale

The proposed MRLs represent a reassessment of a currently approved use pattern for marbofloxacin in pigs. The assessed data indicates that MRLs of 0.05mg/kg in fat and 0.15mg/kg in other tissues are suitable to manage the good agricultural practice (GAP) (see below) of this compound.

Chemical Information

Good Agricultural Practice

Marbofloxacin is approved for use as an injectable antibiotic for pigs. Treatment is over 3 days, at 0.2mgai /kg bw with a withholding period after treatment of 4 days.

Residues Information

Residue data for pigs support MRLs of 0.15 mg/kg for meat, kidney and liver, and 0.05mg/kg for fat at 4 days after the last treatment. MRLs of 0.15mg/kg for meat, kidney and liver, and 0.05mg/kg for fat are therefore proposed to support GAP.

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 marbofloxacin 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 marbofloxacin is equivalent to 13.2% 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 Marbofloxacin as an antibiotic for use in pigs, according to the GAP specified above, is very unlikely to pose any health risks from consumption of the harvested commodity.

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.