110. The Committee recalled that its last session had agreed that the Delegation of Australia should prepare Proposed Draft Guidelines on Residues at Injection Site on the basis of its earlier discussion paper, the advice provided by JECFA and the discussions held at that session.
111. The Delegation of Australia presented the revised document and highlighted the main areas for discussion, in the light of the comments received: the need to clarify the purpose of the acute reference dose in relation to MRL setting and the withdrawal period; the classification of drugs in two classes (section 5.1); the procedures for sampling and monitoring, in particular the number of samples collected.
112. The Committee expressed its appreciation to the Delegation of Australia for its important work on a complex subject and considered the Proposed Draft Guidelines at Step 4. However it was not possible to consider the text section by section in view of time constraints and the Committee had an exchange of views on the areas which should be clarified or further developed.
113. Several delegations welcomed the approach taken in the document and agreed that there was a need for guidance to address the problem of residues at injection sites. Some delegations questioned the application of the acute reference dose for veterinary drugs at injection sites and pointed out that single dose effects should be integrated into the risk assessment process in order to set an MRL which would ensure health protection; it was also pointed out that the division into two classes of products was not justified.
114. The Committee noted that some measures were left to the responsibility of national authorities but it would be preferable to ensure a harmonized approach.
115. Several delegations questioned the assumption of the paper that the consumption of meat including injection sites occurred very rarely.
116. Some delegations expressed the view that the sampling procedures were not adequate; the decision tree proposed was not easily applicable practically; it was pointed out that when sampling at port of entry, a second sample would not be useful since it might not come from the same animal; however, the results obtained for one sample of ground meat could be considered as conclusive.
117. The opinion was expressed by some delegations that the main focus should be on risk management strategies directed at minimizing the chances of injection site residues occurring, e.g. formulation which caused high residue level at injection sites should be avoided.
118. The Observer from Consumers International expressed the view that in addition to acute effects, the document should address the potential for chronic effects resulting from consumption of the injection site, including chronic effects on a pregnant woman during a critical developmental period. The Observer from COMISA stressed the importance of considering acute aspects of dietary exposure, as recommended by the Commission and noted that COMISA had provided elements of risk analysis in its written comments.
119. Some delegations expressed the view that at this stage there was not enough consensus on the basic concepts reflected in the guidelines to advance it to Step 5 and welcomed the offer of Australia to proceed with its work on the current document. The Chairperson invited member countries to send relevant epidemiological data and consumption of meat that includes injection site to the Delegation of Australia.
Status of the Proposed Draft Guidelines for Residues at Injection Sites
120. The Committee agreed to return the Proposed Draft Guidelines to Step 3 for redrafting by the Delegation of Australia in the light of the comments received and the above discussion, for circulation and consideration at the next session.
