Replacing Spirits with Sanitizers

Spirit Distillers Take on the Hand Sanitizer Shortages

In the two months since COVID-19 first reared its ugly head in New York, the initial panic appears to be settling down, or at least, toilet paper is back in stock. Unfortunately, the same can’t be said for personal protective equipment (PPE), with hand sanitizer being no exception.

At the time of writing, these shortages are no longer news; they’re more just a depressing reality of the many ways in which we are unprepared for this pandemic. Although the exact number is difficult to calculate, it’s estimated that the total demand for hand sanitizer in hospitals and grocery stores in New York State alone is around half a million gallons per week.

Hand-washing remains one of the most effective way to prevent exposure to the virus, but accessibility to a faucet is not a viable option in many circumstances, making hand sanitizer a vital asset.

This lack of supply is forcing major producers, like Purell, to prioritize workers serving on the front lines. With what limited supplies being redirected to essential workers, many vulnerable people are left without access to this vital disinfectant.

While this sounds daunting, hope arose from an unexpected place: independent spirits distillers swooped in as the unsung heroes of the COVID-19 hand sanitizer shortage.

“Mr. Dean” hand sanitizer by 888 Distillery of Nantucket, Mass.

World Health Organization

The shortage prompted the World Health Organization (WHO) to re-release their 2010 hand sanitizer guidelines. This document, paired with a subsequent loosening of FDA regulations, has enabled distillers to retool their production lines in a way that mirrors the domestic war effort that took place during WWII.

Unlike breweries and wineries, distilleries are uniquely equipped to handle the hazards associated with the high concentration of ethanol (60-80%) that are required to inactivate the virus.

Specialized equipment, like explosion-proof pumps and ventilators, are required in most distilling facilities as safety measures against the extremely low flash point associated with such high concentrations of alcohol. The flashpoint, which is a general indicator of the flammability or combustibility of a liquid, is around 68 F for 80% ethanol, making it dangerously volatile at room temperature. In short: very large explosions are a very real risk.

The dangers associated with such high concentrations of ethanol are what makes it such an effective sanitizer: the alcohol destabilizes the outer layers of the virus, which greatly reduces its ability to infect our cells.

Safety aside, producing hand sanitizers isn’t all that different from making flavored vodka or gin; just replace the juniper berries with glycerol (glycerin). Hydrogen peroxide is another ingredient that distinguishes the WHO’s hand sanitizers from glycerol-flavored moonshine, which is included to inactivate spores in “less than [pharmaceutical] grade containers”.

The simplicity of the formula is by design: its intended application is for low resource settings. However, as demand continues to rise, and supplies remain precariously low, this formulation has become increasingly popular among craft beverage distillers worldwide.

Filling the gap

Despite the simplicity of the formula, the logistics of retooling a distillery for this purpose is anything but.

Since this idea first came to light, it has spread like wildfire, but the information infrastructure is lagging behind. This is where Cornell’s Craft Beverage Institute (CCBI) steps in. Senior Extension Specialist Chris Gerling has the resources to help streamline information sharing to make the transition as easy as possible for distillers who are eager to help.

CCBI Senior Extension Specialist Chris Gerling

 

“I don’t want to make it sound like [the CCBI is] the leader or savior of this effort,” Gerling clarified. “We’re a hub. We’re just trying to keep the information moving in all directions.”

Sourcing supplies

What originally piqued Gerling’s interest was a Facebook post requesting local breweries and wineries to send in their finished products to be distilled for hand sanitizer. Although the sentiment was in the right place, this method for sourcing ethanol is actually very inefficient for the purpose.

As noted on the CCBI’s website “most distilleries [would] be better served acting as sanitizer blenders […] rather than ethanol producers”.

So where is this alcohol coming from, if not directly from the alcoholic beverage industry?

Weirdly enough, the fuel industry. Specifically, bioethanol plants, which crank out ethanol in the tens of thousands of gallons every day for E-10 fuel. However, with a large portion of the population no longer commuting, these plants are desperate for a new market.

The production of biodiesel from waste cooking oil or newly produced plant oil is increasingly gaining favor in the developed world. (Photo from Wikimedia Commons)

This is a win-win for distillers, because bioethanol is significantly cheaper, and enables distillers to sell their consumable assets, like gin and whiskey, for a greater profit.

Regulations

In addition to sourcing components, Gerling helps distillers navigate convoluted and rapidly-changing regulatory hurdles. Normally, hand sanitizer is regulated as an over-the-counter drug, which means only drug manufacturers have approval to produce it. However, after global cases of COVID-19 surpassed one million, the FDA responded by loosening production restrictions for the coveted substance, a temporary measure that has resulted in more than 1,500 additional manufacturers registering with the agency.

Many of these new manufacturers are spirit distillers, who are now temporarily allowed to produce hand sanitizer, but only if they follow the FDA dictated-approach. The FDA approved formula requires denatured alcohol, a distinguishing feature from the WHO formula.

This distinction is important when it comes to taxing alcohol, a task overseen by the Alcohol and Tobacco Tax and Trade Bureau (TTB). In the wake of these shortages, the TTB has suspended taxing alcohol used for sanitizers, but only if that alcohol is denatured.

Denatured alcohol is ethanol that has been modified to make it less appealing for consumption, usually with the addition of isopropyl alcohol, sucrose octaacetate, and denatonium benzoate. To clarify, this provision serves no antiseptic purpose but is implemented to deter consumer ingestion.

In terms of sanitizing power, the difference between the WHO and FDA’s formulas is negligible, but there is some legitimacy to the FDA’s concern about consumer safety, as demonstrated by the 79% increase in calls to the National Poison Data System regarding ingestion of hand sanitizer in March as compared to 2019.

People drinking hand sanitizer isn’t the only thing that keeps the FDA up at night. The agency is also apprehensive of sanitizers sold with unproven or sensationalized claims. This was the case with Prefense LLC, which made the dangerously misleading claim of conferring protection “from pathogens for up to 24 hours or for 10 hand washes”. Since there no known evidence for such a claim, they potentially put the consumer at greater risk by providing a false sense of security.

Meeting demand

Although the regulatory aspect is considered one of the major bottleneck steps in sanitizer production, the challenges don’t end there.

Effectively and efficiently matching the supply to the demand isn’t a straightforward task. While producers seem to have no issue finding a home for their product, often through social network interactions, there’s a need for a centralized database to ensure that less-tech savvy groups and organizations aren’t slipping through the cracks.

Compared to big-chain grocery stores, which have the capacity and personnel to find these resources, small businesses and local municipalities, like the Geneva Fire Department in upstate New York, have less time an staff to devote to sourcing.

Fortunately, the CCBI is not alone in its efforts, as other academic groups are helping to close the information gap. For example, a group of data science students and volunteers at the Southern Methodist University (SMU) have developed a website that actively maps out distilleries involved in this effort, with the intention of connecting needs and resources.

Knowledge is power

The scale, complexity, and unprecedented nature of the COVID-19 pandemic has left us with a lot of uncertainty. That creates a pressing demand to know the right questions to ask, and for ways to relay information to those who desperately need it. Gerling and the rest of the CCBI team feel that they’re fulfilling their extension mission by providing these services. As Dr. Viktor Frankl said in his seminal book Man’s Search For Meaning (1945), “suffering ceases to be suffering at the moment it finds a meaning.”

Or as Gerling puts it: “This isn’t what I thought I’d be doing, but it feels good to be a part of something so rewarding.”

 

References

  1. Word Health Organization. (2010). Guide to Local Production: WHO-recommended Handrub Formulation [https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf]. Geneva, Switzerland: World Health Organization.
  2. Westreich, S. (2020, April 21). Science Monday: What Soap Types Work on COVID-19? Retrieved May 28, 2020, from https://medium.com/swlh/science-monday-what-soap-types-work-on-covid-19-20fdb7909a83
  3. Gerling, C. (2020). Guidance on the Production of Hand Sanitizer. Retrieved May 28, 2020, from https://cals.cornell.edu/cornell-agritech/our-expertise/craft-beverage-production/guidance-production-hand-sanitizer
  4. FDA. (2020, April 27). Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns [Press release]. Retrieved 2020, from https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-ensure-availability-alcohol-based-hand-sanitizer-during
  5. Ashley, D. D. (2020). Warning Letter [Letter written April 23, 2020 to Prefense LLC]. Retrieved 2020, from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prefense-llc-605488-04232020
  6. Gwyn, C., Johnson, A., MacKay, V., & The American Distilling Institute. (2020). Distilleries Producing Hand Sanitizer [Map]. In DISTILLERIES FIGHTING COVID. Retrieved 2020, from https://www.distilleriesfightingcovid.com/