April 21, 2022

Managing Alcohol-Based Hand Sanitizer Produced Under Temporary FDA Policies

On October 13, 2021, the Food and Drug Administration (FDA) withdrew temporary policies on alcohol-based hand sanitizer production and distribution. [86 FR 56960]These policies were implemented during the beginning of the COVID pandemic to allow non-drug manufacturers to produce hand sanitizer to help meet demand.

Effective December 31, 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies had to cease production. Hand sanitizers manufactured under the temporary guidance prior to that date could no longer be sold or distributed after March 31, 2022. Thus, manufacturers of the hand sanitizers may have to dispose of excess hand sanitizer produced under the temporary policies. In RO 14941, EPA discusses waste management options within the RCRA regulations for alcohol-based hand sanitizers.

From a RCRA standpoint, alcohol-based hand sanitizers are ignitable hazardous wastes (D001) when disposed of. To ease the regulatory burden, hand sanitizer manufacturers who are not large quantity generators (LQGs) may be able to use the episodic generation provisions in Part 262, Subpart L. These provisions allow for very small quantity generators (VSQGs) and small quantity generators (SQGs) to maintain their generator category when an event generates enough hazardous waste to otherwise elevate their generator category. Not all states have adopted the episodic generator provisions in Part 262, Subpart L.

Another option for manufacturers is to legitimately recycle hand sanitizer (e.g., by reclaiming the alcohol). Under §261.2, the sanitizer would be considered a commercial chemical product being sent for reclamation. The sanitizer in this case would not be a solid waste. If a material is not solid waste, it cannot be hazardous waste. Keep in mind, in RCRA, all recycling must be done in compliance with the legitimate recycling regulations in §260.43. If the manufacturer decides to recycle the sanitizer, it can be stored and shipped as a commercial chemical product (i.e., not subject to RCRA regulation). Companies must be prepared to provide documentation that there is a market or other use for the material and demonstrate the material is not a waste §261.2(f).

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This document addresses issues of a general nature related to the federal environmental regulations. Persons evaluating specific circumstances dealing with the environmental regulations should review state and local laws and regulations, which may be more stringent than federal requirements. In addition, the assistance of a qualified professional should be enlisted to address any site-specific circumstances.