Some of these same isolates also displayed a reduced sensitivity to the quinolone family of antimicrobials. The hazards and risks of an adverse public health impact from antimicrobial use in food animals have not been clearly identified, nor quantified. There are significant research needs to assess risk and to determine appropriate actions to mitigate any risk to the public health. At the same time, however, there is a great need to ensure that regulatory action or inaction does not unnecessarily affect drug availability. CVM approves new antimicrobials based on standards of safety, efficacy and quality.
Safety includes both the animal patient and the human consumer of the food produced by the animal.
In the past, the evaluation of human safety was to ensure that residues in food from treated animals were safe for consumption by humans. CVM now believes that the safety evaluation must alleviate concerns over antimicrobial resistance in zoonotic pathogens. It has also been proposed that sponsors must agree to voluntarily stop sale of a product if CVM deems the product to present a risk to public health. Currently, the approval process for new antimicrobials for food animals is proceeding slowly. The agency's efforts in this area are being hampered by a lack of scientific data.