It is also essential that such an evaluation is carried out for every class of antibiotic. A lack of data because appropriate studies have not been performed should not be accepted as showing there is not a problem with a particular antibiotic. In the past a lack of data and information has been interpreted as meaning there has been no problem with antibiotic resistance transferring through the food chain to humans. This should not be acceptable in the future. This could be a qualitative or quantitative risk analysis.
Definition is required for the levels of acceptable risk from a given hazard.
With the current wording there is a fear that it must be demonstrated that there is no risk. It would not be sufficient to only conduct such an evaluation prior to the approval of a drug, because the extent of the emergence and dissemination of antimicrobial resistance is difficult to precisely predict prior to the approval of an antimicrobial agent. Therefore, to ensure that the use of an antimicrobial agent continues to be safe, antimicrobial resistance should be continuously monitored and there should be frequent risk-based evaluations of the potential human health effects of use of that antimicrobial drug in food animals. Such risk-based evaluations should include projections of future risk, based on current trends. Where risk-based evaluations can be made, the level acceptable risk needs to be defined.