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Dockets Management Branch (HFA-305)
Food and Drug Administration
12420 Parklawn Drive
Room 1-23
Rockville, MD 20857

Re: Proposed Rule (21 CFR part 530) - Extralabel Drug Use in Animals

The American Society for Microbiology (ASM), is the world's largest single biological sciences organization, with over 42,000 members. ASM members include scientists in medical microbiology (infectious and immunological diseases), molecular microbiology and genetics, industrial and food microbiology, biotechnology and public health, agriculture, environmental sciences, dental microbiology, and veterinary medicine. While the above referenced proposed regulations address concerns regarding residues of antimicrobials, the ASM is concerned about the failure of the proposal to address the hazard of antimicrobial resistance.

The membership of the ASM is deeply concerned about the national and global increase in antimicrobial resistance and the complex issues surrounding this public health threat. Infections caused by resistance pathogens result in morbidity and mortality from treatment failures and increased health care costs as new, more expensive antibiotics are needed to treat common infectious. As resistance spreads, involving more antibiotics and more pathogens, infections may occur which cannot be treated effectively with antibiotics. Due to increasing drug resistance in animal pathogens and changes in food production practices, there is a growing threat to food, the food industry, and hence the U.S. economy.

The approval for humans and the approval for animals are distinct and should be preserved for antimicrobials. The ASM encourages modification of the rule to include a strategy for the extralabel use of antimicrobial drugs in veterinary medicine that would minimize the public health impact associated with antimicrobial resistance. The strategy should separate extralabel use of those antimicrobial drugs approved for veterinary uses and those which are approved for human use only. Culture and sensitivity testing should guide the selection of agents included in this strategy. In order to prescribe an approved human antimicrobial agent for animal use, the culture and sensitivity testing must document the need.

The risks associated with the public acquiring antimicrobial resistant pathogens from food animals is of great concern to the ASM. The proposed regulation should be consistent to prohibit the extralabel administration of antimicrobial drugs in water as section 530.11 already prohibits the administration in animal feeds. Administration of antimicrobial drugs in water would allow the indiscriminate medication of populations of animals (herds, flocks, schools of fish, etc.), which can result in the rapid development of antimicrobial resistance. If dosing in water is not prohibited, it would likely result in an environmental impact of which an assessment would be required.

The ASM recommends that antimicrobial drugs that are essential in human medicine, such as fluoroquinolones and glycopeptides (including vancomycin), be added to the list agents whose extralabel use is prohibited in animals. A list of antimicrobial agents should be included in the final rule. However, this list should not be all inclusive as additional drugs become available and are continually under development. As needs warrant, these drugs should be analyzed for inclusion in the list of prohibited list of agents for extralabel use.

The ASM would like to thank you for the opportunity to provide these comments. If you have any questions, please contact the ASM's Office of Public and Scientific Affairs.