As a key member of the chemical supply chain, Rocky Mountain Reagents wants to help clarify the state of the alcohol market given the impact of the COVID-19 crisis and outline our response.
Key Hand Sanitizer Information
The nationwide demand for disinfectant has led to a dramatic increase in the number of manufacturers of hand sanitizer, which has created supply shortages. The only recommended formulations for hand sanitizers are ones containing Isopropyl Alcohol (IPA or Isopropanol) and/or Ethyl Alcohol (Ethanol). Certain Specially Denatured Alcohol (SDA) blends of ethanol are potentially allowed for use in making hand sanitizer, however most are not safe for use on human skin. No Completely Denatured Alcohol (CDA) blends are acceptable, including our 710 Spirits® blend. We reference two SDA formulas below but recommend referring to the FDA for more details and to their recent rule revision related to this issue (link below).
While the World Health Organization does not specify, the FDA recommends using USP, NF or Food Chemicals Codex (FCC) grade chemicals. The United States Pharmacopia states that if these alcohol grades are unavailable, using chemically pure, analytical reagent grade, or American Chemical Society-certified (ACS) – is acceptable.
In response to the increased demand for hand sanitizer following the COVID-19 pandemic, the Alcohol and Tobacco Tax and Trade Bureau (TTB) is now expediting new permit applicants who wish to procure specially denatured alcohol (SDA) formulas for making hand sanitizer. Current permit holders (such as distilled spirit makers) no longer need to obtain any additional permits to use specially denatured alcohol in manufacturing ethanol-based hand sanitizer. Please see TTB link below for further information.
Companies making isopropyl alcohol are working to remove regulatory roadblocks for producing alcohol-based hand sanitizers and disinfectants. Additionally, the stimulus bill, approved by the Senate and under review in the House (H.R. 748), would waive the tax for other alcohol used to make hand sanitizer. The Bill does not waive taxes for beverage producers that want to send raw alcohol to sanitizer manufacturers. Health care facilities and first responders identified as critical users will be priority for receiving disinfecting supplies as they are available.
Supply Chain Status
Demand for all IPA/Ethyl blends is straining supply lines. Going forward, Rocky Mountain Reagents/710 Spirits® will not be sourcing new SDA formula blends as we focus on supplying our existing customer base during this nation-wide shortage of alcohols.
Furthermore, reflecting the ongoing supply chain impacts, our inventory of Isopropyl Alcohol, Ethanol, and Completely Denatured Ethanol (710 Spirits®) is on allocation from our vendors and will be subject to increased lead-times and limited availability to established customers. Costs may also be dramatically affected as suppliers begin to raise their prices. The situation is highly dynamic and subject to daily change.
From our positions on the front lines of the chemical supply chain, we see these supply disruptions potentially lasting for several months. During this time, we will do our best to satisfy the needs of all our alcohol customers within these constraints and provide updates accordingly.
Formulas allowed to denature alcohol for antiseptic hand sanitizer manufacturing:
SDA Formula No. 40-B: To every 100 gallons of alcohol add: One-sixteenth avoirdupois ounce of denatonium benzoate,17 N.F., and 1⁄8 gallon of tert-butyl alcohol OR To every 100 gallons of alcohol add: One-sixteenth avoirdupois ounce of denatonium benzoate, 18 N.F. Alternative
SDA Formula No. 40-A: To every 100 gallons of alcohol add: One pound of sucroseoctaacetate and 1⁄8 gallon of tert-butyl alcohol OR To every 100 gallons of alcohol add: One pound of sucrose octaacetate
- FDA Rule Revision: https://www.fda.gov/media/136118/download
- USP (United States Pharmacopia) Statement: https://www.usp.org/sites/default/files/usp/document/about/public-policy/usp-covid19-handrub.pdf
- Bloomberg Environment Article: https://news.bloombergenvironment.com/environment-and-energy/disinfectant-shortage-to-last-weeks-without-raw-materials