With the Food Safety Modernization Act's new regulations on antibiotic use, a great deal of confusion exists about its use as an anti-microbial agent in ethanol production.
Richard Coulter, senior vice president for scientific and regulatory affairs for Phibro Animal Health, cleared up some of the misperceptions in a recent webcast.
The Food Safety Modernization Act is a significant initiative developed to ensure a strategic approach to managing risk in the food chain, Coulter said. It requires that producers evaluate potential risks in the food chain and develop strategies to identify, evaluate and rectify particular risks.
Since ethanol plants produce dried distillers grains, which are deemed by the FDA to be animal feed, ethanol plants are included in the list of facilities that must develop such a food safety plan.
"We see a lot of confusion at the moment with ethanol producers looking at adapting the Food Safety Modernization Act," Coulter said, especially in the use of antimicrobial agents used to control bacterial contamination in ethanol production.
Part of the reason behind the confusion is because of another initiative that involves veterinary medicines and veterinary medicines used for food animals.
A new veterinary drug initiative requires that after 2016, no antimicrobials may be used for food animals without the specific authorization of a veterinarian. However, the Veterinary Feed Directive does not apply to the use of antimicrobials used in ethanol production, since ethanol coproducts are not medicated feeds.
Some ethanol producers, since they make DDG that is considered animal feed, believe they would potentially need a veterinarian to write them a prescription or a veterinarian feed directive to allow them to use antimicrobial products in ethanol.
"That is not true," Coulter said. "The two initiatives are entirely separate.
There are three approaches by which am anti-microbial production aid may be used in ethanol production, Coulter said.
First is the definition for DDG by the American Association of Feed Control Officials, which is very broad and does not prohibit, restrict or prevent the use of antimicrobials in the production of ethanol and DDG.
Secondly, plants could have an approved food additive petition, a mechanisms which gives FDA approval to any microbial used in the ethanol production process.
The last way the product may be used legally is the generally-regarded-as-safe (GRAS) designation, which requires a scientific evaluation to ensure it does not constitute a hazard to animals that consume the feed or in any direct usages of the resulting DDG.
That third GRAS designation is the one that has allowed products such as Phibro's Lactrol to be used regularly in the ethanol industry for the last six to seven years.
Since corn coming into an ethanol plant arrives as a non-sterile material, it could bring undesirable bacteria into the ethanol production system. Anti-microbial products such as Lactrol help producers manage contamination in an ethanol fermentation system.
The majority of anti-microbial agents used in ethanol would be covered by GRAS, Coulter said. Such GRAS-approved products leave no unacceptable or dangerous residues that would persist in DDG and cause a hazard to animals or the foods they produce.
When analyzing hazards applying to ethanol plants, ethanol producers can state that the uses of Lactrol or other GRAS-approved anti-microbials are being used as directed as their hazard control strategy.
Coulter suggested that ethanol producers may want to ask their suppliers on what legal basis their anti-microbial production aid is marketed under.
"If they don't give the answer that it is marketed as a crude food additive or general regarded as safe, then the producer probably shouldn't use that product because it potentially is not a legally marketed product," he said.
Cheryl Anderson can be reached at cheryl.anderson@dtn.com.
(MZT/CZ)
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