8 May 2002
Final Assessment Report
Full Report [ pdf 228kb ]
EXECUTIVE SUMMARY
· This Application seeks to amend Maximum Residue Limits (MRLs) for the antibiotics ampicillin and cloxacillin in cattle milk in the Food Standards Code.
· The current Application (A440) is a routine application from the National Registration Authority for Agricultural and Veterinary Chemicals (NRA), to update the Food Standards Codein order to reflect current registration status of antibiotics in veterinary use in Australia.
· On 24 November 2000, the Australia New Zealand Food Standards Council (ANZFSC) adopted theAustralia New Zealand Food Standards Code (published as Volume 2 of the Food Standards Code). Subsequently, all applications to amend MRLs will now also be incorporated into Volumes 1 and 2 of the Food Standards Code (Standard A14 and Standard 1.4.2 respectively). Consequently, all references throughout this document to the Food Standards Code are references to both Volumes 1 and 2 of the Food Standards Code.
· The agreement between the Commonwealth of Australia and the Government of New Zealand to establish a system for the development of joint food standards (the Treaty) excluded MRLs for agricultural and veterinary chemicals in food. Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary chemicals in food.
· The NRA have assessed appropriate toxicology, residue, animal transfer, processing and metabolism studies, in accordance with the Guidelines for Registering Agricultural and Veterinary Chemicals, the Agricultural and VeterinaryRequirements Series, 1997, to support the use of chemicals on commodities as outlined in this application.
· The Therapeutic Goods Administration (TGA) of the Commonwealth Department of Health and Ageing has undertaken a toxicological assessment of the antibiotic cloxacillin and has established an acceptable daily intake(ADI).
· The proposed MRL for ampicillin is at the limit of quantification (LOQ) and as detectable residues should not occur, ANZFA is satisfied that the residues associated with the proposed MRL do not represent an unacceptable risk to public health and safety.
· The Expert Advisory Group on Antimicrobial Resistance (EAGAR) has advised ANZFA that they consider that the residues associated with the proposed MRLs in this Application do not appear to pose a resistance risk.
· None of ANZFA' s section 10 objectives are compromised by the proposed changes. The requested variations to the Food Standards Code should commence on gazettal.
The Regulation Impact Assessment supports the requested MRLs. ANZFA considers that this application raises matters that constitute a potential Sanitary and Phytosanitary matter and raised a World Trade Organization (WTO) notification at Initial/Draft Assessment. No WTO Member has made a submission on this Application.
· The NRA' s proposed increase in the MRL for cloxacillin in cattle milk is not supported, as ANZFA considers this increase is unnecessary and is not consistent with the achievable LOQ.
Full Report [ pdf 228kb ]