New Ethanol Hand Sanitizer Guidelines Fall Short

Cindy Zimmerman

Renewable Fuels Association President and CEO Geoff Cooper says revised guidance on the production of ethanol for hand sanitizer are clearer but will not help alleviate the hand sanitizer shortage in any meaningful way.

“We welcome the specificity in the new guidance, but the new interim limits for certain impurities are overly restrictive and create a roadblock for producers who could otherwise supply huge volumes of safe, clean, high-quality ethyl alcohol to hand sanitizer manufacturers,” said Cooper. “For example, FDA’s new limits for certain impurities are eight times more restrictive than what is typically found in a glass of red wine and twenty times more restrictive than what has been allowed in hand sanitizer by other countries, including Canada, during the COVID-19 pandemic.”

“Meanwhile, as hospitals, first responders, nursing homes, restaurants, retail stores, churches, and other public and private spaces seek out new sources of hand sanitizer to address the shortage, the U.S. continues to significantly ramp up imports of hand sanitizer from China and other countries. It is unfortunate that we are importing this product from China, when abundant supplies of high-purity American-made ethanol could be used instead. Still, we will continue to work with the FDA to ensure ethanol producers can do their part to combat COVID-19 and provide larger quantities of ethyl alcohol for hand sanitizer.”

The Food and Drug Administration Monday night issued revised guidelines for the ethanol industry regarding use in hand sanitizer “to ensure that harmful levels of impurities are not present if ethanol is used in these products.”

Based on careful review and consideration of available data, we are specifying interim levels of certain impurities that we have determined can be tolerated for a relatively short period of time, given the emphasis on hand hygiene during the COVID-19 public health emergency and to avoid exacerbating access issues for alcohol-based hand sanitizer.

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