As the United States suffers from a shortage at both industrial and personal levels, many distilleries and breweries shifted from making beer and alcohol to making hand sanitizer. On March 18 the Alcohol Tobacco Tax and Trade Bureau authorized ‘distilled spirit permittees’ to produce hand sanitizer without requiring new product approval. These guidelines run until June 30 with the possibility of extension.
The permittees (DSPs) are directed to follow the World Health Organization’s Guide to Local Production for Handrub Formulation. Part A of the document provides recipes for producing two different types of hand sanitizer, ethanol or isopropyl alcohol, in different batch sizes. Quality control, labeling instructions, notes about production facilities, and storage guidelines are also included in the first part. Part B of the document covers the nonproduction details around safety, costs, and the World Health Organization’s recommendations for sanitizing objects. The American Craft Spirits Association also released guidelines for making hand sanitizer with an eye on its member businesses. Their bulletin talked about production but also brought in the idea of insurance risks based on safe production, labeling, and child-resistant containers. ASCA further discussed the FDA’s Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19 ) Guidance for Industry document, with help for distillers to register with the FDA Drug Registration and Listing System. A Safety Data Sheet template is also included for suppliers to ship with their product, along with two great graphics from Lallem and Craft Distiling showing best practices for optimized sanitizer yields from corn-based and molasses-based distilling.
The TTB bulletin notes that hand sanitizer made with denatured ethanol is not subject to federal excise tax, but undenatured ethanol producers would need to pay the taxes. Undenatured alcohol intended for human consumption is subject to taxes that range from $2.70 to $13.34 per gallon. Distilled Spirits Council of the United States (DISCUS) is one of the organizations lobbying Congress and the FDA to remove the taxes, or remove the provision that a bitterant needs to be added to undenatured hand sanitizer. The FDA is concerned with consumer safety while distillers are worried these added ingredients to make their hand sanitizer undrinkable will affect their equipment’s long-term production capability.
American manufacturers have embraced the shifting of production from alcohol and beer to hand sanitizer. Industry groups are now helping distillers to deal with production, financial, legal and sustainability concerns. The one certainty is that this new COVID-19 world is going to need large amounts of hand sanitizer for a long time to come.