September 5, 1996 - Notice of Filing of Gentamicin Sulfate Petition

Public Response and Program Resources Branch
Field Operations Division (7506C)
Offices of Pesticide Programs
Environmental Protection Agency
401 M St. SW
Washington, DC 20460

Re: Federal Register, August 7, 1996: Docket No. PF - 667: Initial Filing PP5F4449

The American Society for Microbiology (ASM) would like to submit comments to the Environmental Protection Agency (EPA) regarding the notice of filing of Quimica Agronomica de Mexico to allow residue of the fungicide/bactericide gentamicin sulfate on apples. The ASM is the largest single life science society in the world with over 42,000 members, who include academic, government, clinical and industrial scientists. Their research activities cover a broad spectrum of science that impacts the well-being of humans, plants, animals and the environment.

The ASM has a long-standing position on the appropriate use of antibiotics that includes principles to minimize the emergence of antibiotic resistance in target organisms, especially those compromising human health. These principles include not using antibiotics in agriculture that are considered essential for combating human diseases because of the evidence of transferable drug resistance and selection for drug resistance upon prolonged, widespread or unnecessary exposure. Thus, ASM is opposed to the petition by Quimica Agronomica de Mexico to permit the use of gentamicin sulfate in or on apples at any concentration regardless of the residue concentration.

Some of the critical uses of gentamicin sulfate in human medicine include: Bacteriemia, septicemia, burn wounds, intra-abdominal infections, e.g. peritonitis, appendicitis, diverticulitis, fever, ocular infections, ear infections, pneumonia, sexually transmitted diseases, septic arthritis, and infective endocarditis. The bacteria involved in these diseases affecting human health include: Enterobacter aerogenes, Klebsiella sp., Serratia sp. (drug of choice), Francisella tularensis, Brucella abortus, Yersinia pestis, Streptococcal spp., Enterococcus faecalis, and Staphylococcus aureus.

Gentamicin sulfate, as proposed, would be directly consumed, and, indirectly by exposing microorganisms, especially bacteria, to this antibiotic. The prospects of transferable drug resistance are high. The proposed use of this antibiotic then appears particularly damaging. ASM supports responsible and prudent antibiotic usage and favors antibiotics for agricultural purposes that are clearly different from those in use for human medicine. Gentamicin is one of a group of aminoaglycoside antibiotics for which cross-resistance is also a significant problem.

Further, gentamicin is often used in combination with other antibiotics, especially in serious or apparently intractable infections.

In summary, ASM is concerned that approval to allow gentamicin sulfate residue on apples will needlessly compromise its use in human medicine. Enclosed for your information is a report of the ASM Task Force on Antibiotic Resistance detailing the growing problem of resistant microorganisms. The ASM would be pleased to discuss this issue with EPA should you need to do so. Thank you for your consideration.