Some ethanol plants who just spent thousands of dollars altering equipment to make hand sanitizer are fuming after the Food and Drug Administration (FDA) reversed its guidance that relaxed alcohol regulations for hand sanitizer production.
FDA updated policy guidelines Wednesday that say “because of the potential for the presence of potentially harmful impurities due to the processing approach, fuel or technical grade ethanol should only be used if it meets The United States Pharmacopeia or Food Chemicals Codex grade requirements.”
Renewable Fuels Association President and CEO Geoff Cooper told Agri-Pulse the new guidance contradicts language published March 27.
“Here we are a few weeks later and FDA is changing the rules midstream and we don’t understand why,” he said. “We haven’t heard of any issues or concerns coming from any of the customers or buyers of this alcohol.”
Cooper argued the March 27 guidance essentially said alcohol made by fuel ethanol plants did not need to be USP or FCC certified if it met the other quality criteria and guidelines. It also had to meet quality conditions specified by buyers, he said.
The updated guidance further states that if a facility wants to supply ethanol that does not meet USP or FCC requirements, it will have to submit information about the level of impurities listed in USP along with other potentially harmful impurities that may be present.
Cooper said requiring USP or FCC certification would immediately halt production of alcohol for hand sanitizer by many ethanol plants.
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“The amount of time, effort, and money it would take to get USP or FCC certification for these facilities is impractical,” he said. “Some plants have invested six figure-type numbers — more than $100,000 to do re-piping and installing new filtration devices.”
Cooper said he is aware of nearly two dozen ethanol facilities making alcohol for hand sanitizer.
Growth Energy CEO Emily Skor said on a rural conference call hand sanitizer production will not be enough to keep plants’ doors open for several more months but said plants want to do what they can to help communities fight COVID-19.
“Ethanol plants are getting calls directly from hospitals, from governors, from local businesses just desperate for access to hand sanitizer,” she said. Skor noted alcohol production for hand sanitizer is minuscule compared to the amount of gallons used to produce fuel ethanol.
Referring to RFA data to date, Cooper said some 8 billion gallons of ethanol production have come offline.
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