The American Academy of Pediatrics, American Public Health Association, Environmental Defense, Food Animal Concerns Trust, and Union of Concerned Scientists have filed a formal regulatory petition with the Food and Drug Administration requesting that the agency withdraw approvals for herdwide/flockwide uses of seven classes of antimicrobials. The petitioners have requested that the antimicrobials no longer be used as agricultural feed additives to promote growth or for routine use in disease prevention and control in chickens, swine, and cattle.
The seven classes are penicillins, tetracyclines, macrolides, lincosamides, streptogramins, aminoglycosides, and sulfonamides.
The petition alleges that continued use of these antimicrobials as agricultural feed additives fails to comply with the safety criteria in the FDA's guidance document on agricultural antimicrobials, Guidance No. 152. Issued in 2003, the guidance document was intended to aid in evaluating the safety of antimicrobial new animal drugs with regard to their microbiologic effects on bacteria of human health concern.
The petitioners state in the document that they do not intend for complete withdrawal of existing approvals that allow the use of antimicrobials for disease prevention and control. Instead, they have requested that the FDA amend the approvals to permit use of the antimicrobials only for disease prevention and control that involve administration to an animal or for a select group of animals, or in response to an outbreak of diagnosed bacterial disease within a building, house, or feedlot. The petition does not cover any uses of these drugs for disease treatment.
The petition incorrectly states that the AVMA opposes restrictions on use of agricultural antimicrobials. The true position of the AVMA supports a national, coordinated, and appropriate response to the issue of antimicrobial resistance in bacteria that includes an open or public FDA-approval process that is rigorous, and that includes an assessment of food safety to approve or remove approvals of animal health products. The AVMA supports the science-based processes of the FDA in the regulation of antimicrobials. Also, in another position statement updated in 2002, the AVMA concluded that currently, there is not enough evidence to justify legislative or regulatory prohibition of classes of use of antimicrobials in livestock feeds, such as herdwide/flockwide uses for disease prevention and control or growth promotion. Instead, each approved use needs to be scientifically evaluated.
The petition was timed to coincide with reintroduction of bipartisan legislation—The Preservation of Antibiotics for Medical Treatment Act—that would ensure a prompt phaseout of the drug uses covered by the petition.
To view the petition, log on to www.KeepAntibioticsWorking.com.