In 2020, even the hand sanitizer is potentially suspect. Retailers, distributors and corporate purchasers are now grappling with the added problem of clearing their shelves of it and stopping employees from using the Food and Drug Administration (FDA) recalled product.
Earlier this year, to combat the novel coronavirus, the FDA issued temporary guidance to streamline regulatory processes for manufacturing alcohol-based hand sanitizer (typically ethanol or isopropyl alcohol) to get product quickly to market. Many manufacturers (generally foreign manufacturers), however, then distributed toxic or defective product to U.S.-based distributors. As such, the FDA issued a recall for certain hand sanitizer products beginning in June 2020. Over the following months, it has expanded this recall, citing risks that some products pose a risk of poisoning users with methanol and wood alcohol or leaving customers exposed to COVID-19 as a result of either adulteration or ineffective ingredients.. The FDA has advised importers, consignees, distributors, retailers and others not to distribute or sell certain hand sanitizers, even if the manufacturer of the product has not recalled it, due to the dangers of methanol contamination, including death.
Companies that have purchased the FDA-recalled hand sanitizer now face the logistical challenge of how to handle this material. In some instances, there may be an opportunity to return these items to the vendor. If the company that purchased the FDA-recalled hand sanitizer must instead dispose of the material, there is an even greater complication –with its high alcohol content, hand sanitizers are considered ignitable and are therefore regulated as hazardous waste when discarded. 40 C.F.R. § 261.21. This means that depending on the volume of FDA-recalled hand sanitizer that a company disposes, a company may inadvertently trigger Resource Conservation and Recovery Act (RCRA) hazardous waste requirements.
A key factor to whether RCRA applies is whether these recalled products are a “waste.” If either the manufacturer/supplier or the purchasing company immediately concludes that the FDA-recalled hand sanitizer should be discarded, then it is likely that many states will consider this material a “waste” at the company level, subject to the full panoply of RCRA regulatory management standards for hazardous waste. However, where there is a plan to return the recalled hand sanitizer to the manufacturer for further evaluation, testing, or potential reuse for its intended purpose, there is a strong argument that the hand sanitizer, albeit recalled, remains a “product” (rather than a “waste”) and is not (or at least not yet) subject to RCRA. Thus, a company’s knowledge of product disposition and a reasonable expectation of product reuse is key. Unfortunately, some manufacturers, particularly non-U.S. manufacturers, have chosen not the respond to FDA’s recall as of the date of this article, which may mean many U.S. companies have no option other than disposal at the company level. In this instance, the company should carefully consider the applicable RCRA requirements related to onsite management, transportation, and disposal.
The FDA recall could also implicate new RCRA requirements (under EPA’s 2019 Management Standards for Hazardous Waste Pharmaceuticals rule) applicable to the reverse distribution (including safety recall) of pharmaceuticals, which has been adopted in some states but not others. 84 FR 5816; 40 C.F.R. § 266.503(a). In states that have adopted this new rule, there will be other potential options for consolidating and managing these materials. 84 FR 5816; 40 C.F.R. § 266.501(g)(3) and (4). Moreover, in adoptive states, the new rule may exempt recalled product from complying with RCRA if managed under an FDA program. These considerations are further complicated by states, particularly California, that have heightened waste disposal regulation for hand-sanitizers as Over-the-Counter Pharmaceuticals (OTCs).
Companies must be mindful not to simply dismiss RCRA responsibility under this new, expanded FDA recall and should ensure compliance with applicable federal and state RCRA requirements when complying with this latest FDA recall notice.