The US FDA is temporarily allowing the use of fuel-grade ethanol with impurities for the production of hand sanitiser, in order to meet continuing high demand during the coronavirus Covid-19 pandemic.
On 1 June, the agency updated its guidelines on alcohol-based hand sanitisers with specific levels permissible for several impurities, such as methanol, acetaldehyde and acetal.
These impurities wouldn’t normally be present in a typical fermentation or distillation process of alcohol found in hand sanitiser, but can sneak in when making fuel or technical-grade ethanol because of the use of certain chemicals, containers or equipment, the FDA says.
Many manufacturers of fuel ethanol began making hand sanitisers in response to the increased demand for the product and a decrease in demand for fuel during the coronavirus pandemic.
The FDA says it has identified levels of impurities that "can be tolerated for a relatively short period of time", given the current need for hand hygiene. During the Covid-19 public health emergency, the administration "does not intend to take action" against manufacturers producing products with impurities up to these levels, it said.
The interim limits are:
- 630 parts per million (ppm) for methanol;
- 2 ppm for benzene;
- 50 ppm for acetaldehyde;
- 50 ppm for acetal;
- 4,400 ppm for acetone;
- 1,000 ppm for 1-propanol;
- 2,200 ppm for ethyl acetate;
- 6,200 ppm for 2-butanol;
- 21,700 ppm for 2-methyl-1-propanol;
- 1,000 ppm for 1-butanol;
- 4,100 ppm for 3-methyl-1-butanol; and
- 4,100 ppm for amyl alcohol.
The FDA stressed that it is continually assessing the need for the temporary limits and will "update, modify or withdraw these policies as appropriate".
As it stands, demand for hand sanitiser remains high, according to the agency, in both healthcare settings and from consumers.
Keeping risk in mind
US NGO, the Environmental Working Group (EWG) called for keeping human health risks in mind while rules are relaxed. "While hand sanitiser is an important tool in reducing the risk of infection from coronavirus, it is imperative that every effort is made to ensure that ethanol not be contaminated with gasoline, benzene and petrochemical impurities at levels that unnecessarily increase the risk of cancer," said David Andrews, a senior scientist at EWG.
The American Cleaning Institute (ACI) affirmed that manufacturers "take safety very seriously", and that hand sanitisers will remain safe when properly used according to label instructions.
The ACI also stressed the FDA’s guidelines apply only to the temporary production of ethanol hand sanitisers using WHO formulations, and not to the FDA-registered products that have long been on the market.
Meanwhile, the US ethanol trade body, the Renewable Fuels Association, said the new guidelines will not help the shortage.
"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 sanitiser manufacturers," it said in a statement.