FDA Reversal May Block Ethanol Plants from Hand Sanitizer Market

April 17, 2020

Print This Article Share it With Friends

by Ben Nuelle (Agri-Pulse) Some ethanol plants who just spent thousands of dollars altering equipment to make hand sanitizer are fuming after the Food and Drug Administration (FDA) reversed its guidance that relaxed alcohol regulations for hand sanitizer production.

FDA updated policy guidelines Wednesday that say “because of the potential for the presence of potentially harmful impurities due to the processing approach, fuel or technical grade ethanol should only be used if it meets The United States Pharmacopeia or Food Chemicals Codex grade requirements.”

Renewable Fuels Association President and CEO Geoff Cooper told Agri-Pulse the new guidance contradicts language published March 27.

“Here we are a few weeks later and FDA is changing the rules midstream and we don’t understand why,” he said. “We haven’t heard of any issues or concerns coming from any of the customers or buyers of this alcohol.”

Cooper argued the March 27 guidance essentially said alcohol made by fuel ethanol plants did not need to be USP or FCC certified if it met the other quality criteria and guidelines. It also had to meet quality conditions specified by buyers, he said.

The updated guidance further states that if a facility wants to supply ethanol that does not meet USP or FCC requirements, it will have to submit information about the level of impurities listed in USP along with other potentially harmful impurities that may be present.

Cooper said requiring USP or FCC certification would immediately halt production of alcohol for hand sanitizer by many ethanol plants.

“The amount of time, effort, and money it would take to get USP or FCC certification for these facilities is impractical,” he said. “Some plants have invested six figure-type numbers — more than $100,000 to do re-piping and installing new filtration devices.”

Cooper said he is aware of nearly two dozen ethanol facilities making alcohol for hand sanitizer.

Growth Energy CEO Emily Skor said on a rural conference call hand sanitizer production will not be enough to keep plants’ doors open for several more months but said plants want to do what they can to help communities fight COVID-19.

“Ethanol plants are getting calls directly from hospitals, from governors, from local businesses just desperate for access to hand sanitizer,” she said. Skor noted alcohol production for hand sanitizer is minuscule compared to the amount of gallons used to produce fuel ethanol. READ MORE

Biofuel plants brace for potential shutdowns (Agri-Pulse)

Commonwealth Agri-Energy makes hand sanitizer ethanol for companies across Southeastern U.S. (Kentucky New Era)

Member Spotlight: Award-Winning Ethanol Plant Makes Iowa Safer With SIREtizer (Renewable Fuels Association)

GranBio Technologies Repurposes Biorefinery Research Facility in Georgia for Hand Sanitizer Production (GranBio Technologies/CISION/PR Web)

POET: From Biofuels to Sanitizer (KSOO)

FDA DEALS ETHANOL LATEST BLOW WITH NEW SANITIZER GUIDELINES (Brownfield Ag News; includes AUDIO)

U.S. calls ingredients in some ethanol-based hand sanitizers unsafe (Reuters)

Sanitizer Confusion Gives Ethanol Makers New Governmental Target (BloombergQuint)

RFA Seeks Sanitizer Clean Slate: FDA Guidance Still Complicating Ethanol Alcohol for Sanitizer During Pandemic (DTN Progressive Farmer)

Industry urges FDA to loosen regs on hand sanitizer (E&E News)

Ernst, Grassley urge FDA to clarify hand sanitizer guidelines (Ethanol Producer Magazine)

Ernst, Grassley push FDA to allow ethanol plants to make hand sanitizer (KELO)

Iowa Senators question FDA about ethanol use in hand sanitizers (Radio Iowa)

Coronavirus (COVID-19) Update: FDA Takes Action to Protect Public Health; Increase Supply of Alcohol-Based Hand Sanitizer (Food and Drug Administration)

RFA: FDA Sanitizer Guidance Brings Clarity But Won’t Resolve Shortage (Renewable Fuels Association)

FDA updates hand sanitizer guidance (Ethanol Producer Magazine)

U.S. temporarily to allow certain impurities in hand sanitizer (Reuters)

Trump administration reverses course, will allow impurities in hand sanitizers temporarily (The Hill)

Some impurities allowed in hand sanitizers due to shortages, FDA says. Does it matter? (Charlotte Observer)

Latest FDA policy on ethanol for hand sanitizer still falls short: RFA (OPIS)

FDA Pulls Back on Sanitizer Restriction: Temporary Guidance Allows Higher Levels of Some Chemicals in Hand Sanitizer (DTN Progressive Farmer)

FDA NEW GUIDANCE ON ETHANOL FOR HAND SANITIZER RESTRICTS PRODUCTION (Brownfield Ag News)

FDA issues revised guidance on ethanol for hand sanitizer: Interim limits for certain impurities could be overly restrictive and create roadblock for ethanol producers. (Feedstuffs)

New Ethanol Hand Sanitizer Guidelines Fall Short (Energy.AgWired.com)

Some impurities allowed in hand sanitizers to ease supply shortage (Fox News)

FJ Live: FDA Hand Sanitizer Rules Provide Clarity but Not Help (Farm Journal AgWeb)

FDA releases hand sanitizer guidance for ethanol plants; RFA dissatisfied (Fence Post)

Ernst, Grassley want FDA to ease ethanol rules for sanitizer (E&E News)

Grassley, Ernst urge FDA to revise hand sanitizer guidance (Ethanol Producer Magazine)

Fewer Cars Mean More Hand Sanitizer (NC State University News)

Hand Sanitizer Donations Make an Important Impact in Central Wisconsin (Renewable Fuels Association)

A Defining Moment for Ethanol (Ethanol Producer Magazine)

EPA issues guidance for ethanol plants producing hand sanitizer (Ethanol Producer Magazine)

FDA warns of sharp increase in hand sanitizer products contaminated with methanol (Fox 28)

More articles about hand sanitizer

Excerpt from Renewable Fuels Association: The U.S. Food and Drug Administration Monday night issued revised guidance on the production of ethanol for hand sanitizer. The following is a statement from Renewable Fuels Association President and CEO Geoff Cooper:

“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 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.” READ MORE

Excerpt from Charlotte Observer: The impurities mentioned by the FDA wouldn’t normally be present in a typical fermentation or distillation process of alcohol found in hand sanitizer but may be found when making fuel or technical-grade ethanol because of the use of certain chemicals, containers or equipment, the FDA says.

But the FDA said on Monday it was still hearing of smaller hospital systems and facilities, along with consumers, having trouble finding hand sanitizer or keeping stock of it.

“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,” the FDA said in the release.

Both benzene and gasoline are known cancer-causing agents, the FDA says. READ MORE

Excerpt from Reuters: “We do not believe the new guidance will help alleviate the hand sanitizer shortage in any meaningful way,” Cooper said, adding that benzene is not present at any level in the ethanol the industry provides for sanitizer or other purposes. READ MORE

Excerpt from Ethanol Producer Magazine: Given such horrific market conditions and unprecedented challenges, nobody would blame the industry if it retreated, waited for the public health crisis to pass, and became consumed solely with its own survival. But that is just not in this industry’s DNA. When the U.S. ethanol industry sees a challenge, it steps up to help. Period. In the face of the COVID-19 scourge, many ethanol producers have volunteered to be foot soldiers in the effort to protect public health and the food-delivery systems. I have never been prouder.

Recognizing the need for significantly increased supplies of hand sanitizer to protect the general public and help stem the spread of the virus, several RFA member companies retooled to be able to produce the higher-quality alcohol used in sanitizer. And working with local partners, ethanol producers have dramatically increased supplies of ethanol for this purpose.

The switch from fuel-grade ethanol to the high-purity grades required a lot of work behind the scenes to encourage government agencies to relax burdensome regulations and remove roadblocks, at least temporarily. In response to requests and input from RFA, both the U.S. Department of the Treasury and U.S. Food and Drug Administration moved quickly to issue guidance and slightly modify regulations to enable fuel ethanol plants to increase production of the grades of alcohol suitable for hand sanitizer. More than two dozen plants are doing so now, many for the first time, working with local businesses and charities to get the product out to hospitals, first responders, the general public and those who need it the most.

Another example of the U.S. ethanol industry helping out in the fight against COVID-19 and the havoc it has wrought on our economy is our work to help maintain a reliable supply of carbon dioxide. CO2 is used in the processing, packaging, preservation, and shipping of many foods and beverages. In addition, CO2—in different forms—is used in various aspects of the healthcare industry, and is also an important component in many municipal water treatment systems. It is a ubiquitous and critically important component of our food supply and public health. Approximately 45 ethanol plants capture and sell CO2 to a variety of customers; in fact, ethanol plants capture 3 to 3.5 million tons of CO2 annually, representing 40 percent of the national supply.

In April, the RFA joined with the beer industry, the North American Meat Institute, and the National Turkey Federation, among others, in a letter to Vice President Mike Pence stressing the importance of maintaining a reliable CO2 supply and preventing shortages of this critical product in the face of such a widespread reduction in fuel ethanol output. READ MORE