Over the last few years, as the U.S. Consumer Product Safety Commission (CPSC) has moved slowly in its rulemaking efforts to address tip-overs of dressers. Without a final rule, the agency has sought to use other methods to address dresser incidents, specifically its authority to investigate potentially hazardous products and its ability to request – and even compel – recalls. The agency’s process has been straightforward: It has obtained samples of countless brands and models of dressers, tested them against the relevant voluntary standard, and, where testing suggested the samples did not meet the standard, sent letters requesting recalls.

The result has been that the CPSC has issued at least 20 recalls for dressers since 2017. All have noted that the dressers did not meet the voluntary standard, and 17 have noted that no incidents had been reported for the recalled products, suggesting that the CPSC was relying solely on the standard to support the recall.

Now it appears that the CPSC may employ the same process to address another product for which it has not issued a final rule: Adult portable bed rails (APBR).

Bed-Rail Basics

APBRs are removable barriers that can be installed on ordinary consumer-grade (i.e. non-hospital) beds to make occupants less likely to fall out of them. The CPSC reports that it is aware of 247 reports of fatalities associated with APBRs and estimates there were nearly 200,000 injuries between 2003 and 2019. (Memo, p. 3). The agency estimates that the “societal costs of fatal and nonfatal APBR injuries may be as much as $464 million per year,” (Tab B, p. 28), though it’s not clear if the CPSC has included the benefits of falls and injuries avoided in its calculations.

Currently, APBRs are covered by a voluntary consensus standard, ASTM F3186, that was developed in collaboration with CPSC staff. In 2013, advocacy groups petitioned the CPSC either to issue a mandatory standard or to ban APBRs altogether. Chief among their concerns were reports of consumers being entrapped either in gaps in bed rails themselves or between bed rails and mattresses, beds, or other objects.

Per its rules, later that year, the CPSC put the petitions out for comment, receiving 99. Of those, 92 – many of them similar or identical form comments – supported regulation or a ban, while seven opposed CPSC action, generally arguing that bed rails’ benefits outweighed any risks. At CPSC staff’s recommendation, the Commission voted to defer the petition, keeping open the possibility that it would engage in rulemaking but giving the voluntary consensus standard committee time to revise the standard to eliminate potential entrapment risks, which would obviate any need for CPSC rulemaking.

In 2017, the committee revised ASTM F3186 to reduce the risk of entrapment. And in its July 2020 update, CPSC staff conclude that the revised standard provides adequate protection against entrapment, but that the APBR products in the market generally do not adhere to the standard. Staff reached this conclusion after buying and testing samples of 35 APBR models. Of those 35, staff report that only two met the standard’s entrapment performance requirements, while none met the standard’s requirements for labels, warnings, and instructions. Staff recommended that the Commission “work with ASTM and the industry to increase market awareness of, and compliance with, the voluntary standard.” But staff did not say how they expected to achieve this result.

Regulation by Recall

It appears that the CPSC will try to push APBR manufacturers toward ASTM F3186 in the same way the agency has been trying to increase the furniture industry’s compliance with the dresser standard: by recalls.

It appears that the CPSC has sent letters to at least some APBR manufacturers whose products were among those the CPSC tested as part of its market compliance survey. These letters indicate that the CPSC believes the company’s product does not meet the standard, is therefore hazardous, and should be recalled. As with the CPSC’s recalls of dressers, these demands for recalls do not seem related to whether a particular model has been associated with any incidents.

The CPSC’s actions raise an important question: if a standard is voluntary, how can it be the sole basis for a recall demand? Here is the answer: In theory, voluntary consensus standards are voluntary, but in practice they are not.[1] In 2006, the CPSC issued an interpretive rule explaining how voluntary standards interact with defect determinations. This rule provides that “whether a product is in compliance with applicable voluntary safety standards may be relevant to the Commission staff’s preliminary determination of whether that product presents a substantial product hazard.” The agency’s intent was to show that it carefully balanced factors, but in practice, non-compliance with a voluntary standard tends to create in the agency’s mind a rebuttable but strong presumption of a defect. We’ve seen this both in the dresser example noted above and also in other cases, such as when the agency publicly “urge[d]” hoverboard manufacturers to comply with that “voluntary” standard, even though that standard was just an “outline of investigation,” not a formally adopted voluntary standard.

What to Do?

So how should you handle a CPSC letter that asks you to recall your ABPR or any other product based on an allegation that it doesn’t comply with a voluntary standard? Of course, if you find the CPSC’s argument for a recall persuasive, you should say so and work with the agency to craft the appropriate message and the appropriate remedy. If you do not think a recall is appropriate, you have some options.

First, you can choose to fight. Even when the CPSC can cite to a mandatory rule, it still must demonstrate that a product’s non-compliance presents a “substantial product hazard” to mandate a recall. It would need to convince a neutral Administrative Law Judge (ALJ) and potentially, Article III federal courts that a recall is warranted. The agency typically tries to avoid litigation and has fully litigated only one recall this century, and that case is still in the courts more than eight years after the agency filed its administrative complaint.

Companies too may find the time and expense of litigation daunting. However, when a company firmly believes in its product and its position – and especially when a recall creates existential risk to the company – demanding your day in court can be the right call.

Second, because the CPSC prefers to avoid recall litigation, the agency is generally willing to negotiate with companies to try to find consensus to address a potential hazard more quickly, rather than spend years fighting. Companies should understand that there are limits as to what they can expect the CPSC to accept and refrain from making offers or demands that could be interpreted as a lack of good faith. However, well-crafted arguments – ideally backed by strong facts like robust testing protocols – can help the parties find a middle-ground recall remedy that may be less severe than what the CPSC initially requests.

With the right approach, a company can help the CPSC achieve its goals of an adequate corrective action while avoiding protracted litigation against a safety agency and the more sweeping recall mandates that litigation could produce.

[1] Of course, it may be irrelevant whether the CPSC treats a standard as all-but-mandatory because other players in the consumer product ecosystem – that is, retailers or consumers – can demand that a product meets the standard before they’ll engage with a product.