O2023: Are the Hand Sanitizers Provided in United States K-12 Schools Safe and Effective?

Background: Hand hygiene is an effective way to prevent the spread of infectious disease. Given the convenience of hand sanitizer, many schools have implemented its widespread use. However, uncertainties of the safety of alcohol-based hand sanitizers (ABHS) manufactured during the pandemic under the U.S. Food and Drug Administration’s (FDA) temporary manufacturing policy have emerged. Despite imposing limits on potentially dangerous chemical impurities, recent studies have shown a high percentage of consumer and community hand sanitizers with excess levels of these chemicals [1,2,3]. While the FDA’s temporary policy has been rescinded and associated products are not meant to be sold after March 31, 2022, previously stocked products may unknowingly remain in facilities well beyond this time. In addition to chemicals of concern, sub-standard levels of alcohol ( < 60%) have been found [2,3] and may relate to the use of bulk “soap-style” refillable dispensers that were not specifically designed for volatile chemicals like ethanol [3]. Given these observations, it is possible that schools with pandemic-purchased ABHS may be at risk of inferior and potentially dangerous product. The objective of this study was to start to understand the prevalence of these products in K-12 schools.

Methods: ABHS samples from four U.S. school districts were collected and analyzed between the months of May 2021 and January 2022 as previously described3. A total of 54 individual samples were collected. Samples were analyzed for chemical impurities (benzene, acetaldehyde, methanol, acetal) and alcohol content according to published methods[3].

Results: As reported previously [4], 67% of the 9 samples from School District #1 had acetaldehyde levels in excess of FDA interim limits of 50ppm for this analyte. One-third of these samples had a second impurity, acetal, in excess of FDA interim limits of 50ppm. Of the 40 samples analyzed from School District #2, no excess chemical impurities were detected, but 82% of samples had ethanol levels below 60%. As previously reported, bulk-refillable dispenser misuse appears to have resulted in ethanol evaporation [3]. All 3 new samples analyzed from School District #3 had both acetal and acetaldehyde levels in 10x excess of FDA interim guidelines for each analyte. The two samples from School District #4 were found to be compliant with FDA interim guidelines on impurity levels. Additionally, all samples from School District #1, #3 and #4 had alcohol content above 60%.

Conclusion: Results from this limited sample of four school districts suggest that the potential risk is high - for schools to unknowingly supply ABHS with either low ethanol concentration (resulting in an ineffective product) or excess levels of impurities (potentially posing a health risk to staff and students). While further data are needed to understand the full extent of this problem, school districts need to be informed now of these risks.