111. The Committee recalled that at the last session it had requested Australia to revise document CX/RVDF 96/7 in light of advice provided by JECFA, for circulation and comment prior to the current session[47]. The Delegation of Australia presented the discussion paper contained in CL 1998/4-RVDF. It was stated that the paper had been prepared with a focus on consumer safety and residue surveillance but the discussion of the 48th JECFA had not been included as the report of the 48th JECFA had not been available at the time of its preparation. The Committee was advised that JECFA supported the CCRVDF initiative. The Committee was provided with the outcome of the JECFA consideration of this matter at its 48th Meeting[48].
112. The paper explained the procedures for situations where a single-dose had potential for toxicological/pharmacological effects and where no such effects were expected. In the former situation, the paper proposed that estimated intakes should not exceed acute reference doses and that a withdrawal period should be set in such a manner that the residues at injection sites would deplete below the acute reference dose. In the latter situation, the MRLs were to be set in the usual manner.
113. A number of delegations welcomed the paper in view of the potential health risk if high level residues at injection sites were consumed. Some delegations stressed the importance of addressing acute toxicity and requested that acute reference doses be allocated by JECFA for compounds of concern. In this connection, the Committee was informed of the recommendations of the Joint FAO/WHO Expert Consultation on Food Consumption and Exposure Assessment of Chemicals and current activities of the Codex Committee on Pesticide Residues regarding acute hazard exposure assessment. It was also proposed that a specific sampling plan be developed for analysis of residues at injection sites, including extra-label use of veterinary drugs. The Committee might seek the assistance of the CCMAS in this regard.
114. Other matters raised included the deletion of the second sentence of paragraph 22 of the document, whether injection sites should be specified and whether veterinary practices on injection sites should be regulated at the international or national level.
115. The Committee requested Australia to prepare Guidelines on Residues at Injection Sites based on the discussion paper, information contained in the Report of the 48th JECFA and comments provided or made at the session for circulation and comment at Step 3 before the next session of the Committee. The Delegation of the Netherlands expressed caution that injection site residues might not be a rare event and that in order to reduce the evidence of injection site residues, the irritating properties of substances and the persistency of formulations should be evaluated, and offered to provide data on this subject to Australia. The EC and COMISA would also send their comments to Australia
