Ethanol plants want to help make hand sanitizer

FDA reluctant to loosen regulations.

Posted: Mar 26, 2020 6:43 PM

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.

“You’re talking about alcohol. Does it matter if it's fuel grade or whatever the stuff is they’re trying to price gouge now? I think its common sense,” he said.

The American Hospital Association encouraged flexibility to help protect patients and caregivers, without directly weighing in on the sanitizer dispute.

“We may need to consider a range of possible solutions that were not on the table before the pandemic,” said Nancy Foster, a vice president with the group, in an emailed statement to the AP.

The Consumer Brands Association, formerly the Grocery Manufacturers Association, has had conversations with the FDA to push the agency to reconsider its guidelines. The group, which represents branded food, consumer products and beverage companies, said that hand sanitizer supplies are running so low that its members have had to ration it out to workers in stores, distribution centers and manufacturing plants.

"We need a temporary solution," said Mike Gruber, vice president of regulatory and technical affairs at the trade association. “This goes toward ensuring basic food safety practices.”

Distillers that produce vodka, whisky and other alcoholic drinks have been given some regulatory waivers by the Alcohol and Tobacco Tax and Trade Bureau allowing them to produce hand sanitizer. Many have done that, but they produce much smaller volumes of alcohol than an ethanol plant could produce. They also receive a benefit in the Senate-passed stimulus bill.

The Distilled Spirits Council of the United States, which represents dozens of large and small distillers, applauded Congress for easing taxes on distillers who make hand sanitizer.

Under the stimulus package passed late Wednesday, distillers don’t have to pay federal excise taxes on alcohol used for hand sanitizer through Jan. 1, 2021.

“Hundreds of U.S. distillers are stepping up to produce hand sanitizer and they should not be hit with a huge tax bill for producing this much-needed item, especially at a time when so many of them are struggling,” said Chris Swonger, the group’s president and CEO.

But the council said it’s urging the FDA to update its guidance and let distillers use undenatured alcohol for hand sanitizer. The stimulus bill requires distillers to follow the FDA’s guidance if they want to receive the tax breaks.

The FDA has waived dozens of regulations in recent weeks to boost production of key medical supplies, including coronavirus tests, ventilators, gloves and hand sanitizers.

Under the latest FDA guidelines, regulators maintain standards for alcohol, requiring new producers to use alcohol that meets federal or international standards for use in either drugs or food products.

The regulatory hurdles are especially frustrating for Midwest ethanol producers who are facing plunging fuel demand and a petroleum fight between Saudi Arabia and Russia that caused prices to plummet. The factors are forcing more plants to curtail production and close.

For ethanol producers relaxed rules, including a requirement of the hard-to-acquire denaturant, would allow them to step in an help in a national emergency.

“If we could get the FDA to say yes you can use the beverage grade and for the duration of this emergency at least for some point in time here for the next two weeks you can waive the denaturant we would literally have millions of gallons of hand sanitizer available within a matter of days,” said Monte Shaw, CEO of Iowa Renewable Fuels Association, an ethanol trade group. “Every one of our plants has gotten contacted by people who want this stuff and we can’t send it to them.”

Andrew Vrbas owner of Pacha Soap, a boutique soap shop in Hastings, Nebraska, had just finished renovating a 100,000-square-foot former bread factory as a project to boost the community. Now, he’s preparing to set up hand sanitizer production there to supply to hospitals. He’s received calls from hospitals in Nebraska, Florida and New York City seeking hand sanitizer.

“We are literally three miles from a plant that has as much ethanol as you could imagine,” he said. “We’re sitting on millions of gallons of alcohol. If we could rally the federal government to say look if you just let us work with local ethanol producers we have the expertise, we have the ability to provide hand sanitizer to hospitals not only in Nebraska but all across the country that are just reaching out through my network saying if you could send us hand sanitizer, we’re out.”

Minnesota Coronavirus Cases

Data is updated nightly.

Cases: 768112

Reported Deaths: 8639
CountyCasesDeaths
Hennepin1533481923
Ramsey63323978
Dakota56954525
Anoka53854520
Washington33598331
Stearns28397253
St. Louis23627358
Scott21603160
Wright21301171
Olmsted18125120
Sherburne15480115
Carver1361255
Clay1023599
Rice9966131
Blue Earth964559
Crow Wing9467109
Kandiyohi834397
Chisago833563
Otter Tail8020105
Benton7472111
Beltrami652879
Mower645440
Douglas627590
Goodhue619485
Itasca615382
Winona611254
McLeod593770
Steele585225
Isanti569274
Morrison556066
Becker532762
Polk510778
Freeborn487642
Nobles480852
Lyon454856
Carlton445566
Nicollet433352
Pine427031
Cass423144
Mille Lacs415367
Brown409947
Todd398836
Le Sueur385332
Meeker356253
Waseca327231
Martin326236
Wabasha29516
Hubbard289944
Dodge273310
Roseau263827
Fillmore243212
Redwood239643
Wadena236629
Houston231017
Renville227349
Faribault220230
Pennington216527
Sibley210612
Cottonwood196628
Kanabec191330
Chippewa190240
Aitkin182543
Watonwan170811
Pope16128
Yellow Medicine156620
Rock155019
Jackson146514
Koochiching138319
Clearwater136018
Swift134519
Marshall134320
Murray134311
Pipestone133327
Stevens124511
Lake109121
Wilkin102214
Lac qui Parle98324
Mahnomen89312
Norman8729
Big Stone7974
Lincoln7825
Grant7819
Kittson60822
Red Lake5899
Unassigned529124
Traverse5125
Lake of the Woods4714
Cook2460

Iowa Coronavirus Cases

Data is updated nightly.

Cases: 474151

Reported Deaths: 6785
CountyCasesDeaths
Polk74657729
Linn29194394
Scott24733274
Black Hawk20335358
Woodbury19207244
Johnson17988100
Dubuque15834229
Pottawattamie14276200
Dallas14109108
Story1288551
Warren774296
Cerro Gordo6951110
Webster6950111
Clinton6929101
Des Moines667594
Marshall641885
Muscatine6352113
Wapello5936137
Jasper578279
Lee565689
Sioux565676
Marion508191
Buena Vista491746
Plymouth463487
Henry389847
Jones370861
Washington366856
Benton359257
Bremer357168
Boone350937
Carroll346353
Crawford339347
Mahaska322856
Dickinson301052
Clay279133
Buchanan279039
Jackson273546
Kossuth271873
Hardin270249
Tama264976
Fayette260649
Delaware258546
Cedar249526
Page249328
Wright243645
Hamilton233954
Winneshiek233338
Floyd221845
Harrison217777
Madison216925
Clayton214558
Poweshiek211741
Iowa208029
Butler206638
Cass201557
Jefferson201040
Mills199929
Allamakee194753
Cherokee193844
Lyon192941
Hancock187639
Winnebago186633
Calhoun186116
Appanoose180850
Shelby178439
Louisa171052
Grundy168537
Humboldt167727
Emmet167146
Franklin164628
Mitchell164043
Union162637
Chickasaw159318
Sac157924
Guthrie155434
Montgomery142342
Palo Alto142032
Clarke141328
Keokuk139635
Monroe134335
Howard128222
Ida118641
Greene116315
Davis115225
Lucas113724
Pocahontas111423
Monona108738
Worth10818
Adair105335
Osceola94017
Fremont86111
Van Buren84221
Decatur82612
Taylor79713
Wayne74824
Ringgold67727
Audubon66814
Adams5095
Unassigned380
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