Ethanol plants seek rule changes to fill need for hand sanitizer
DES MOINES, Iowa (AP) — As hospitals and nursing homes desperately search for hand sanitizer amid the coronavirus outbreak, federal regulators are preventing ethanol producers from providing millions of gallons of alcohol that could be transformed into the germ-killing mixture.
The U.S. Food and Drug Administration’s roadblock has been frustrating the health care and ethanol industries, which have been calling for a relaxed regulation to deal with the public health care emergency.
“Hand sanitizer is a big part of our lives,” said Eric Barber, CEO of Mary Lanning Healthcare, a hospital in Hastings, Nebraska. “We can’t get any. We order it and it’s just not available.”
The problem for the ethanol industry is that most plants make food-grade ethanol, one step below the highest pharmaceutical grade. But since the plants aren’t certified to comply with stringent production standards designed to protect quality of medicines, food ingredients and dietary supplements, the FDA doesn’t want the alcohol used for a product to be applied to the skin.
In addition, the alcohol is not denatured or mixed with a bitter additive to make it undrinkable. The FDA insists this step is “critical” because of cases of poisoning, sometimes fatal, among young children who have accidentally ingested hand sanitizers.
An FDA spokesman said Thursday that regulators have already seen a rise in poisonings linked to hand sanitizers in recent weeks, “heightening this public concern.”
The FDA is also skeptical of industry claims that undenatured sanitizers could be distributed in a way that would keep them away from children.
“It is unclear what, if any, measure could be instituted to ensure that the product does not make its way into consumer hands, where children could have access,” FDA’s Jeremy Kahn said in an emailed statement.
Facing a nationwide shortage, Barber said the FDA should temporarily relax regulations to allow alternative production.