In a boiled-down description, ethanol production is relatively simple. An ethanol producer grinds up a starch-like feedstock such as corn, adds warm water to make a mash, adds yeast, and then waits as the yeast ferments the starch into ethanol and carbon dioxide. The liquid ethanol and carbon dioxide are removed from the fermentation tank and processed as fuel. A byproduct of ethanol fuel production is the leftover mash, or distillers grains (DGS), which ethanol producers typically then sell as animal feed. During ethanol production, however, fermentation tanks routinely become contaminated with bacteria. Yeast is necessary in the fermentation process to convert starch to ethanol, but bacteria can convert those same sugars to lactic or acetic acid. “If the bacteria get out of control, ethanol production yields can drop significantly, an estimated 1 to 5 percent, which is no small economic problem” for ethanol manufacturers. To kill and control bacteria, ethanol producers use antibiotics. These antibiotics are identical, or substantially identical, to antibiotics used in human medicine, including penicillin, virginiamycin, erythromycin, tylosin, or tetracycline. Upon completion of the fermentation process, antibiotics remain in the leftover mash, which is fed to food-producing animals such as poultry, hogs and beef and dairy cattle.
FDA studies, industry-funded studies, and nonprofit organizations’ studies all confirm that distillers grains sold as animal feed contain antibiotics. Food-producing animals therefore, in addition to receiving antibiotics as additives to feed or drinking water in an amount approaching 30 million pounds annually, also receive additional non-therapeutic doses of antibiotics through distillers grains. FDA currently does not regulate, monitor, or require reporting of this antibiotic use as required by Section 105 of the annual Animal Drug User Fee Amendments of 2008 (ADUFA) reports. Their use is thus completely at the discretion of the pharmaceutical and ethanol industries. As the sale of DGS can be fully 20% of an ethanol plant’s revenue stream, this Petition is not seeking to stop the sale of DGS to animal producers, who rely on DGS for a nutritious and cost-efficient feed; the Petition seeks simply to ensure that the DGS sold to animal producers are free of any antibiotics.
Antibiotic resistance in humans and animals already is a harmful reality, is continuing to increase, and is driven by persistent antibiotic use and overuse. FDA has recognized the problem and committed to address it, and has acknowledged that antibiotic use must be undertaken “judiciously” and eliminated where it is not appropriate or necessary. Antibiotics are not necessary in ethanol production, and their presence in the byproduct fed to animals producing our meat, poultry, dairy and egg products for human consumption is wholly illegal under the FFDCA and the APA.
This Citizen Petition submitted by the Petitioners and the undersigned signatories seeks to prohibit and enjoin the inappropriate and unnecessary use of antibiotics in the manufacture of ethanol where the byproduct is consumed by millions of food-producing animals, and requests the promulgation of regulations prohibiting such antibiotic use. Alternatively, should FDA determine it legally cannot or will not prohibit or enjoin such antibiotic use, petitioners request via this citizen petition that FDA regulate the antibiotic use by requiring new animal drug applications.
Read the complete, fully-cited petition.