FDA becomes ethanol regulator, Phibro files petition

By Kris Bevill | March 05, 2009
Web exclusive posted April 10, 2009, at 11:10 a.m. CST

Phibro Animal Health Corp. is in the process of filing a petition with the U.S. Food and Drug Administration to approve its trademarked brand of the antibiotic virginiamycin as an animal feed additive. However, the filing has nothing to do with an associated risk of antibiotic resistance or human consumption of the drug according to division president Michael Giambalvo. The real reason is much less exciting: it's simply a matter of regulatory procedure.

Giambalvo told Ethanol Producer Magazine that the FDA now holds regulatory jurisdiction over ethanol because its coproduct - distillers grains - is used as animal feed. Therefore, the agency is now requiring all manufacturers of antibiotics and other products used in the production of ethanol to file food additive petitions so they can determine guidelines for acceptable residues in the distillers grains. The FDA's action directly affects Phibro as it is the only known producer of virginiamycin for ethanol production, according to Giambalvo. He said Phibro is willing to oblige the FDA and the company has taken a proactive role in getting their petition filed. "We believe this is a good thing," he said. "We want clarity on the safety of our products being used."

Giambalvo said Phibro's ethanol performance group has been marketing its version of virginiamycin, Lactrol, to ethanol producers for years and the antibiotic itself has been used in ethanol production for decades. In 1993, the FDA was approached by SmithKlineBeecham, the then-producer of Lactrol, and asked to approve the antibiotic as an animal food additive. The FDA issued a letter of no objection in response and Lactrol has since been used by the ethanol industry with no problems. According to Giambalvo, the FDA's recent interest in virginiamycin stems from the recent increased use of distillers grains as animal feed. "Our data indicates there are no (antibiotic) residues in distillers grains," he said. "The FDA knows that and they know this product. It's been around for a long time."

University of Nebraska-Lincoln animal science professor Galen Erickson specializes in examining the nutritional value of distillers grains. He said that while it is critical to test distillers grains for antibiotic residues, virginiamycin is "technically not a problem" because the drug is approved for animal consumption. Extremely high amounts of the antibiotic could be an issue, but the antibiotic is typically destroyed during the ethanol production process so Erickson does not believe it is a real issue. Tests have proven that no amount of the antibiotic exists in the meat so there is no chance of humans consuming the antibiotic, Erickson said.

Any reports of ethanol production contributing in any way to the spread of antibiotic-resistant bacteria are inaccurate, according to Giambalvo. The concept has gained publicity but there is no real evidence to back those claims. "The fact is that if customers use our product according to its dosage, we expect that there will never be any residues (in distillers grains) because the virginiamycin never makes it through the production process. This whole antibiotic resistance theory falls apart when considering our product because it never gets into the animal tissue."

Giambalvo said the company is moving forward with its FDA approval petition "as fast as the FDA will let us go" and they expect the approval to be issued with no problems.