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We are going to try a little experiment. For a moment, let’s try to put aside all of the arguments over whether the Consumer Product Safety Improvement Act of 2008 (“CPSIA”) is a good law, whether it should be changed, and if so, how. Forget about everything we know about the law and how it was written and implemented by the Consumer Product Safety Commission (“CPSC”), and forget about partisan politics. Instead, we want to consider something very basic: what does the word “safe” mean?
If we asked the average fifth grader (yes, likely a “child” under the age of 12), she might come up with a definition of “safe” roughly equivalent to some of the common dictionary meanings “free from risk,” or “secure from harm, danger, or evil.” (Webster’s II New College Dictionary (1999)) Put another way, this concept of safety could be equated to a “zero risk” definition. For example, in their statement of April 7, 2011 in opposition to some aspects of a draft piece of legislation to “fix” the CPSIA, the three Democratic Commissioners said “[t]here is no known safe level of lead.” That statement suggests that they are applying this “absence of risk” or “zero risk” definition of what is “safe”. Is that the only way to view the word “safe”? Is it the most practical approach for a regulatory agency or society?
Generally, Congress—with a few exceptions—did not impose this complete “absence of risk” definition on regulatory agencies and the marketplace. Instead, in the Consumer Product Safety Act (“CPSA”) and other comparable laws, Congress viewed safety in a more relative fashion. It chose to give agencies the authority not to regulate every risk but only those that are “unreasonable.” In essence, Congress determined that an absolutist, zero risk definition of safety has shortcomings. Let us explore why.
First, nearly every product in the marketplace (and I define product to include automobiles, foods, drugs, cosmetics, pesticides, industrial products and other items not under the jurisdiction of the CPSC) presents some risk of injury. Being able to consider factors such as cost to reduce the risk, the utility of the product and the aspect of the product that causes the risk, the availability of alternative products, the nature of the user and manner of use, and other factors allows regulators not to eliminate every single product from the marketplace. In a “zero risk” world, you cannot have a drug that might save millions of people from having heart attacks if it also causes side effects in a few. In such a world, we would have to revert back to a time before our ancestors invented tools or discovered fire because obviously there is risk associated with them. More sophisticated products like those that run on electricity, internal combustion engines, and even video games, computers, and televisions would definitely have to go.
Second, if the standard to be used by regulatory agencies were a “zero risk” standard, an agency would have no basis for intelligently allocating its resources among the many products that present different levels of risk. If level of risk did not matter, every risk, no matter how large or small, must equally be eliminated. However, safety agencies do not have infinite resources. In a “zero risk” environment would an agency like CPSC make these decisions based solely on a “first discovered, first resolved” basis? Or would they prioritize based on the letter of the alphabet of the product, whoever shouted loudest about a particular product, or some other non-risk related factor?
Third, a zero risk standard assumes we know enough to recognize and anticipate risk and make decisions based on that knowledge. We are all experts at recognizing a risk after it manifests itself in an injury or health effect. Therefore, we are better at measuring and anticipating common risks based on events that occur frequently. However, we are not very good at discerning and anticipating relatively rare events. For example, to obtain drug approval a firm must undertake a series of clinical trials to “prove” the safety and effectiveness of a drug before it ever is allowed on the market. However, there is a huge difference between the detection of fairly common side effects or risks during such trials, and putting a product on the marketplace where it may be used for some time by millions or conceivably billions of users. Unfortunately, the latter approach is the most effective one for identifying lower probability risks and those that take more time to manifest. And in some cases, improved technology and scientific knowledge allow us to detect risks that were not detectable earlier when the product was initially evaluated.
Fourth, in a zero risk world, one might need to spend the same amount, or conceivably much more, to reduce a 1 in 1,000,000,000 risk as to address a 1 in 100 risk. (There is some reason to believe that the marginal cost of eliminating exceedingly small risks exceeds the costs of addressing common, more serious risks.) Put another way, Congress recognized that it might not be reasonable to impose ever higher costs on the marketplace to reduce lower and less significant risk. (In the case of many agencies, such as CPSC, it mandated some consideration of costs and benefits.)
Everyone would prefer to be “safe” in an absolutist, zero risk sense. We would like assurances that any new chemical or product that we, or our families, might use is absolutely risk free before it appears in the marketplace. However, despite all reasonable efforts to identify risk it is usually impossible to know the full extent of risk before the product is in the marketplace and is widely used over an extended period of time. And sometimes, there is no “safe” alternative for an imperfectly risky product. Further, it is likely that no product is entirely without risk, and we probably would not be able to afford it if it were. It is easy to see why generally Congress has applied a more relativist “unreasonable risk” definition of “safe” to most regulatory schemes.
So Where Does this Lead Us?
A realistic discussion of the CPSIA, and any potential amendment to it, or implementation of it needs to be based in a realistic appraisal of what “safe” can and should mean. People who argue that Congress and regulators should consider the cost of reducing risk and the benefits of such risk reduction are not “baby killers” or “money grubbers.” They are looking at safety from a “relativist”, “reasonable risk” position. This approach to “safety” has largely been the basis for the CPSA and similar regulatory schemes and has taken hold in most areas of the law of product liability. People who make impassioned arguments for “safe” products free of risk are taking an absolutist, some might say “idealist” point of view. While the latter position reflects our aspirations, experience suggests the former is the more practical, real-world approach and likely the one that saves the most lives and reduces the risk of injury most effectively.
Regardless of whether you agree with the “zero risk” or “reasonable risk” definition, having a common understanding of what someone means by the term “safe” or “safety” might lead to insight into their arguments and a more rational discussion of how to proceed. Common understanding of the language is necessary to find common ground.
Eric Stone is a partner in the Washington, D.C. office of K&L Gates, LLP where he counsels a wide range of clients on compliance with CPSC's laws. From 1977 to 2008 he served as an attorney, then Director of the Legal Division, and finally as Acting Director of the Recalls and Compliance Division in the Office of Compliance and Field Operations at CPSC. He can be reached by e-mail at eric.stone@klgates.com or by phone at 202-778-9014.
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