Two agricultural organizations have filed a citizen petition with the Food and Drug Administration (FDA) seeking to ban the use of antibiotics in ethanol production so that the leftover mash, known as “distillers grains with solubles (DGS),” which is fed to livestock, does not add to the levels of antibiotics used in the production of poultry and meat in the United States and thus contribute to the development of “superbugs,” that is, bacteria resistant to multiple antibiotics. In re Ctr. for Food Safety, No. n/a (FDA, filed March 15, 2013). In the alternative, the petitioners request that FDA adopt regulations that deem antibiotics sold to ethanol producers for DGS production as new animal drugs, require drug sponsors to seek FDA approval for their use and ban the sale of antibiotics that have not been approved as new animal drugs.

According to the Center for Food Safety and Institute for Agriculture and Trade Policy, ethanol producers use antibiotics to manage bacterial outbreaks in their fermentation vats. The DGS left over from ethanol production is then “repurposed and sold as livestock feed to cattle, dairy, swine and poultry producers. Therefore, in addition to receiving enormous amounts of antibiotics intentionally added to their feed or drinking water, food-producing animals also receive non-therapeutic doses of antibiotics through DGS.” The petition claims that FDA tested DGS in 2008 and 2010 and found antibiotics, such as penicillin, virginiamycin, erythromycin, tylosin, and tetracycline, in DGS and that “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.” Contending that antibiotics are unnecessary in ethanol production and have in fact been replaced by major producers, the petitioners call the practice “wholly illegal under the [Federal Food, Drug, and Cosmetic Act] and the [Administrative Procedure Act].”

Among other matters, the petitioners allege, “In the ten year period from 2000 to 2010, DGS production increased 1,264% from 2.5 to 34.1 million metric tons per year [and] is growing at such a fast clip that DGS are replacing corn and soybeans in the U.S. animal feed market.” They also allege, “Without any dosage limitations or medical oversight, ethanol producers have full discretion over the quantity and frequency of antibiotic use in manufacturing fuel. FDA does not track antibiotic sales to ethanol producers as it does for use in animals. It is thus nearly impossible to estimate with any accuracy the amount of antibiotics the ethanol industry uses.” See Center for Food Safety Press Release, March 15, 2013.