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Preventing the spread of germs remains a key concern for the 2021-22 academic year. Hand hygiene is a proven, effective way to help kill and/or wash away germs that can cause illness in schools. However, in order to be effective, hand hygiene must be performed properly and with proven products. For effective infection control in schools, the Center for Disease Control and Prevention (CDC) recommends practicing good hand hygiene, often and at key moments during the day. This guidance includes washing hands with soap and water for at least 20 seconds or using an alcohol-based hand sanitizer (ABHS) if soap and water are not readily available.
Given the convenience of ABHS, which allows students and staff to clean their hands in a time-efficient manner, many schools have implemented its widespread use during the pandemic. However, not all sanitizers are created equally. According to the CDC, hand sanitizers must have at least 60% ethyl alcohol (ethanol) or 70% isopropyl alcohol (isopropanol or 2-propanol) to be effective. Lower alcohol concentrations or non-alcohol-based hand sanitizers may be less effective in killing germs.
Additionally, new ABHS manufacturing and use practices have emerged during the pandemic, leading to concerns about inferior and unproven products. Here, we explain these concerns and how they have emerged, share a case study of two school districts, and discuss what steps to take to assess whether your school’s hand sanitizer is fit for use.
Does the FDA regulate sanitizers?
In the U.S., hand sanitizers are regulated by the Food and Drug Administration (FDA) as over-the-counter (OTC) drugs. The FDA is responsible for the regulation of hand sanitizers as OTC drugs. It provides requirements for their formulation and manufacture before they can be released into the market. During the early phases of the pandemic, as the number of infections rose quickly, so did the demand for ABHS.
With need for sanitizer quickly exceeding available supply, the FDA temporarily relaxed regulations to enable more hand sanitizer to be manufactured. The FDA’s temporary policy allowed companies that were not previously registered drug manufacturers to make ABHS, if they follow specified guidelines. The guidance and rules outlined in the temporary policy specify approved ingredients, labeling, and claims.
With the desire to increase manufacturing, the FDA also recognized the limited availability of high-grade (pharmaceutical-quality) alcohols, and temporarily allowed the use of lower quality alcohols, many containing higher levels of specific contaminants than the pharmaceutical-grade ethanol previously used for hand sanitizers. Methanol, benzene, acetaldehyde, and acetal are four impurities with maximum limits established by the FDA’s interim policy on the manufacturing of ABHS, due to toxicological (safety) concerns associated with these chemicals (Table 1). The interim impurity levels specified by the FDA are believed to be acceptably safe for a relatively short period of time, in an effort to increase the availability of hand sanitizer.
Table 1. Interim levels of hand sanitizer impurities allowed by the FDA
Source: https://www.fda.gov/media/136390/download (Accessed 9/15/2021)
How prevalent are chemical impurities in hand sanitizers?
Prior to the pandemic and the implementation of the FDA’s interim policy for the manufacturing of ABHS, the risk of toxicity from any of these impurities, including methanol, was very low. However, starting in June 2020, as new hand sanitizers were released into the market, the FDA issued warnings about methanol found in hand sanitizers labeled to contain ethanol. According to the FDA, methanol, or wood alcohol, is a chemical that can be toxic when absorbed through the skin or ingested. The list of banned products including those containing methanol continues to grow, with 256 listed in September 2021.
With an increasing concern of potentially dangerous chemical impurities in hand sanitizers, several organizations initiated independent testing of products in the market. One recent scientific publication reported 11 out of 42 products tested (26.1%) to be noncompliant with interim Health Canada guidelines (similar to FDA guidelines) containing elevated levels of acetaldehyde. In the U.S., recognizing the growing concern on chemical impurities in consumer hand sanitizers, Valisure (an independent company dedicated to assessing the chemical composition of medications) called for the submission of hand sanitizer samples for free-of-charge impurity analysis. Of 260 samples from 168 brands tested, 8% were found to contain benzene at levels exceeding the FDA’s interim guidance.
What about efficacy against germs?
There are many factors that influence the antimicrobial efficacy (germ-killing ability) of hand sanitizers. The level and type of alcohol, the volume used, product formulation, and use of excipients (ingredients that help the formulation perform better) are critical factors for germ-kill. In fact, a recent publication showed considerable differences in antibacterial performance of commercially available hand sanitizers purchased from national chain stores.
In addition to differences between formulations, one practice has emerged during the COVID-19 pandemic that could significantly impact product efficacy: the opening and refilling or topping-off of dispensers with available hand sanitizer (also called “bulk refilling”). It’s a common practice sparked by product shortages and continues in many school districts. A major concern related to this practice is the evaporation of alcohol leading to an ineffective and non-FDA-compliant hand sanitizer (e.g., containing ethanol below 60%). Evaporation is due, in many cases, to the inappropriate use of dispensers and/or refill cartridges that were not specifically designed for alcohol-based formulations (e.g., soap dispensers).
How widespread is the concern for schools?
During the current COVID-19 pandemic, most schools have adopted and continue to practice increased hand hygiene. Fortunately, compared to the beginning of the pandemic, there is currently an adequate supply of high-quality ABHS. However, many school districts continue to utilize surplus stock donated or purchased at the beginning of the pandemic, when products with unknown impurities and efficacy were readily available, and in many cases, were the only ones obtainable.
Given the high prevalence of potentially unsafe and ineffective product in the consumer market, it is likely that K-12 schools with early-pandemic ABHS stocks also have inferior and potentially dangerous product.
In order to start to understand the magnitude of risk in school settings, we partnered with Valisure to conduct sampling from two U.S. school districts (one located in the Southeast and the other located in the Northeast) in May and June of 2021.
A total of nine samples were collected from School District #1 in the Northeast. Of these samples, 67% had acetaldehyde levels in excess of FDA interim limits. Two of the six samples with unacceptable levels of acetaldehyde additionally had a second impurity, acetal, in excess of FDA interim limits. Of the 41 samples analyzed from School District #2 in the Southeast, 78% had ethanol levels below 60%. Dispensers at this school district appear to have an issue with ethanol evaporation, associated with bulk refilling practices used in this district.
Taken together, results from these two school districts would 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). Key decision-makers in school districts need to be made aware of these risks and prioritize sourcing and supply of products produced from established brands.
What can you do to ensure your school's sanitizer is fit for use?
Here are a few tips on what to look for (or avoid) when assessing whether your school’s hand sanitizer is fit for use:
- Choose a hand sanitizer with at least 60% ethyl alcohol or 70% isopropyl alcohol. This will be clearly listed on the label.
- Ensure the product is in the original packaging with appropriate labeling (including drug facts, lot number, expiration date, and manufacturer contact information).
- Check the product’s expiration date, which is typically two to three years after the date of manufacture of that product. If no expiration date is provided on the label, contact the manufacturer for the recommended shelf life.
- Stick with well-known, proven brands. With more than 250 hand sanitizers banned by the FDA in the past 18 months, check the FDA list to ensure you are not inadvertently supplying one of these products.
- Avoid the practice of refilling dispensers with bulk product.
- Avoid hand sanitizers with poor aesthetic qualities, such as an undesirable smell, poor product consistency, stickiness, or those that irritate or dry hands. Children (and staff) are more likely to regularly use hand sanitizer if they like the consistency, feel, and smell of it.
If you are unsure or concerned about the integrity of your school’s sanitizer, Valisure is conducting a nationwide campaign to assess hand sanitizers in K-12 schools. Visit https://www.valisure.com/crowdsourced-study-is-your-schools-hand-sanitizer-safe-and-effective-2/ to request sample analysis or contact Valisure for more information (https://www.valisure.com/).
Written by Dawn Yeomans and Chip Manuel. This article was sponsored by GOJO Industries, Inc., the makers of PURELL® hygiene solutions.
The United States Food and Drug Administration. “Temporary policy for manufacture of alcohol for incorporation into alcohol-based hand sanitizer products during the Public Health Emergency (COVID-19); Guidance for industry U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) 2020.” https://www.fda.gov/media/136390/download. Accessed 09/15/2021.
The United States Food and Drug Administration. “FDA updates on hand sanitizers consumers should not use.” https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use. Accessed 9/15/21.
Tse, TJ, Nelson, FB, and Reaney, MJT. Analyses of Commercially Available Alcohol-Based Hand Rubs Formulated with Compliant and Non-Compliant Ethanol. Int. J. Environ. Res. Public Health 2021, 18(7), 3766.
Valisure. “Re: Valisure Citizen Petition on Hand Sanitizer Products Containing Benzene Contamination
and Other Significant Issues.” https://www.valisure.com/wp-content/uploads/Valisure-FDA-Citizen-Petition-on-Hand-Sanitizer-v4.14.pdf. Accessed 09/15/2021.
M. Chojnacki, C. Dobrotka, R. Osborn, W. Johnson, M. Young, B. Meyer, E. Laskey, R. A. F. Wozniak, S. Dewhurst, P. M. Dunman. Evaluating the Antimicrobial Properties of Commercial Hand Sanitizers. mSphere Mar 2021, 6 (2) e00062-21.