8 May 2002
Final Assessment Report
Full Assessment Report [ pdf 245kb ]
Executive Summary
· This Application seeks to amend Maximum Residue Limits (MRL) for antibiotic residues in the Food Standards Code.
· The current Application (A422) is a routine Application from the National Registration Authority for Agricultural and Veterinary Chemicals (NRA), to update the Food Standards Code in 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 Therapeutic Goods Administration (TGA) of the Commonwealth Department of Health and Ageing has undertaken an appropriate toxicological assessment of the antibiotics and has established relevant acceptable daily intakes(ADI).
· The NRA has 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.
· ANZFA is satisfied from the dietary modelling that the residues associated with the proposed MRLs 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 represent an unacceptable risk to public health and safety.
· None of ANZFA' s section 10 objectives of food regulatory measures are compromised by the proposed changes. The requested variation to the Food Standards Code should commence on gazettal.
· ANZFA at initial assessment made a Sanitary and Phytosanitary notification to the World Trade Organization. No WTO Member has made a submission.