FDA releases hand sanitizer guidance for ethanol plants; RFA dissatisfied
The Food and Drug Administration updated its guidance on the production of alcohol for hand sanitizers by ethanol plants, but the Renewable Fuels Association said the limits for impurities are “overly restrictive” and will not reduce the shortage of hand sanitizer.
“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,” FDA said.
RFA President and CEO Geoff Cooper said in a news release, “While we appreciate that FDA responded to RFA’s request for more clarity and specific interim impurity limits, we do not believe the new guidance will 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. 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 20 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.”
Sen. Chuck Grassley, R-Iowa, noted to reporters he and Sen. Joni Ernst, R-Iowa, had asked the USDA to issue the clarification. ❖
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