DES MOINES, Iowa (AP) – As hospitals and nursing homes are desperately searching for hand sanitizers in the midst of the coronavirus outbreak, federal regulators are preventing ethanol producers from providing millions of gallons of alcohol that can be turned into a germicidal mixture.
U.S. The Food and Drug Administration’s roadblock has frustrated the health care and ethanol industry, which has called for relaxed legislation to manage public health care.
“Hand cleaners are 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 simply not available.”
The problem for the ethanol industry is that most plants produce ethanol of food quality, one step below the highest pharmaceutical quality. But since the plants are not certified to meet strict production standards designed to protect the quality of drugs, food ingredients and supplements, the FDA does not 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 non-potable. The FDA insists that this step is “critical” because of cases of poisoning, sometimes fatal, among young children who have accidentally taken hand cleansers.
A FDA spokesman said Thursday that regulators have already seen an increase in poisoning related to hand sanitizer in recent weeks, “to increase this general concern.”
The FDA is also skeptical of industry claims that undenatured cleansers could be distributed in a way that would keep them away from children.
“It is unclear what, if any, action can be taken to ensure that the product does not enter consumer hands where children can access,” FDA Jeremy Kahn said in an email.
Against a nationwide shortage, Barber said the FDA should temporarily relax regulations to allow alternative production.
“You talk about alcohol. Does it matter if it’s fuel quality or whatever they’re trying to price gold now? I think it’s common sense,” he said.
The American Hospital Association encouraged flexibility to help protect patients and caregivers, without thinking directly about the remediation dispute.
“We may need to consider a number of possible solutions that were not on the table before the pandemic,” Nancy Foster, a vice-chair of the group, said in an email to AP.
The Consumer Brands Association, a former food business manufacturer, has had talks with the FDA to pressure the agency to review its guidelines. The group, which represents branded goods, consumer products and beverage companies, said that hand sanitizer supplies are so low that its members have had to ration it to workers in stores, distribution centers and manufacturing facilities.
“We need a temporary solution,” said Mike Gruber, vice president of regulatory and technical issues at the industry organization. “This goes towards ensuring basic food safety practices.”
Distillers producing vodka, whiskey and other alcoholic beverages have been granted some regulatory exemptions from the Alcohol and Tobacco Tax and Trade Bureau which allows them to produce hand sanitizer. Many have done so, but they produce much less alcohol than an ethanol plant could produce. They also receive a benefit in the Senate-approved stimulus proposal.
The United States Distilled Liquor Board, which represents dozens of large and small distillers, applauded Congress for easing taxes on distillers who do hand sanitizers.
Under the stimulus package approved late Wednesday, distillers do not have to pay federal excise taxes on alcohol used for hand sanitizers until January 1, 2021.
“Hundreds of American distillers are rising to produce hand sanitizers, and they should not suffer a huge tax cut to produce this much-sought-after item, especially at a time when so many of them are struggling,” said Chris Swonger, the group’s chairman and CEO.
But the council said it was urging the FDA to update its guidance and allow distillers to use undenatured alcohol for hand cleaning. The stimulus bill requires distillers to follow the FDA’s guidance if they want tax relief.
The FDA has waived dozens of regulations in recent weeks to increase the production of medically important supplies, including coronavirus testing, ventilators, gloves and hand sanitizers.
Under the latest FDA guidelines, regulators maintain alcohol standards, requiring new manufacturers to use alcohol that meets federal or international standards for use in either drugs or food products.
The regulatory barriers are particularly frustrating for ethanol producers in the Midwest who are facing a fuel demand and a petroleum struggle between Saudi Arabia and Russia that caused prices to fall. The factors force more plants to limit production and shut down.
For ethanol producers, relaxed rules, including a requirement for the hard-to-reach denaturant, would allow them to go into relief in a national emergency.
“If we could get the FDA to say yes, you could use the beverage rate and for this acute duration at least for a certain time here over the next two weeks, you could forgo denaturing agents we would literally have millions of gallons of hand sanitizer available within a few days, “Says Monte Shaw, CEO of the Iowa Renewable Fuels Association, an ethanol trade group.” Each of our plants has been contacted by people who want this and we can’t send it to them. “
Andrew Vrba’s owner of Pacha Soap, a soap shop in Hastings, Nebraska, had just completed the renovation of a former 100,000-square-foot bread factory as a project to grow society. Now he is preparing to set up hand-cleaning production there to deliver to hospitals. He has received calls from hospitals in Nebraska, Florida and New York City seeking hand cleaners.
“We’re literally three miles from a plant that has as much ethanol as you can imagine,” he said. “We sit on millions of liters of alcohol. If we could gather the federal government to say look if you just let us work with local ethanol producers that we have expertise in, we have the ability to provide hand sanitizer to hospitals not only in Nebraska but across the country that only extends through mine network that says if you could send us hand sanitizer we are out. “
Retail writer Anne D’Innocenzio contributed from New York City, Health Writer Matthew Perrone of Washington and Auto Writer Dee-Ann Durbin of Ann Arbor, Michigan.