Upcoming phthalate regulations give CPSC an opportunity to reexamine its risk exposure policies.
Unfortunately, the precautionary principle is alive and well at the Consumer Product Safety Commission (CPSC). Traditionally disfavored by American regulators, the precautionary principle holds that activities or substances suspected of causing harm to the public—even when evidence of harm is lacking—should be limited or banned until safety can be demonstrated. This posture is easy for politicians or regulators to explain to the public, but needlessly stringent regulation can be costly and lead to unwelcome consequences. And the CPSC’s mission is to protect the public from unreasonable risks, not all risks. The Commission’s recent use of the precautionary principle departs from its historic practice of looking at risk and exposure to assess a risk’s reasonableness before adopting safety standards or banning products.
Our past practice of careful risk analysis was laid aside for key actions after Congress passed the Consumer Product Safety Improvement Act of 2008 (CPSIA). A prime example is the Commission’s lead regulation, where the precautionary principle drove out balanced decision making. It remains to be seen whether the Commission will continue down this road as it regulates other chemicals. We will have the opportunity to debate the right approach when the Commission considers phthalate regulation later this year.
While lead exposure can cause serious health problems for children, the mere presence of lead in a product without an exposure route does not present the same risk. But in the CPSIA, Congress adopted the precautionary principle by legislating a cap on lead content in children’s products regardless of any risk of lead exposure.
Congress imposed the cap in three stages. In the first two stages, the cap was set automatically—at 600 parts per million (ppm), then 300 ppm—leaving no leeway for the Commission. In the last stage, Congress imposed a 100 ppm cap unless the Commission determined that the cap was not technologically feasible. To put this in context, a 100 ppm cap means that a product is 99.99% lead free; products that met the 300 ppm cap were already 99.97% lead free. In other words, we were regulating for trace amounts.
It was here that we could have considered risk, exposure, and costs. The agency’s scientists told us that substantial health benefits had already been achieved and that any additional health benefit from further restriction of lead content would be minimal at the very best. And, based on a limited economic analysis, we learned that the lower cap would create significant costs. The Commission’s economics team estimated cost increases likely to come from the cap, but these costs were not seriously considered by the Commission. It was argued that there was no known safe level of lead, an argument that ignored exposure data and insisted that opponents of the excessively stringent lead cap do the impossible by proving a negative.
A few examples demonstrate how prohibitive these costs can be. Recycled plastics and metals in children’s products will have to be abandoned for virgin plastics and metals, raising costs by up to 100%. This is not because these recycled materials have excessive amounts of lead, but because it is impossible to get consistent test results showing compliance. Similarly, heavy redesign and component costs drove a quarter of children’s bike makers to stop selling youth bikes even though there has never been any suggestion that riding a bike exposes a child to lead poisoning. Recognizing the unworkability of the 100 ppm lead cap and after the Commission had acted, Congress exempted bicycles components from the 100 ppm cap three years after enacting the CPSIA.
The difficulty of consistently achieving and testing for compliance with the 100 ppm cap was a consistent theme, and the associated costs—for failures, including false positives, and recalls—were “quite significant.”
Again, exposure routes were not considered, and, consequently, there was no evidence presented of a safety risk from lead content at such trace levels. What is more, otherwise positive actions by Congress and the Commission only strengthen the conclusion that the precautionary principle is guiding federal decision making here. Last year, responding to some of the concerns about the disproportionate burdens the CPSIA imposed, Congress amended the law to allow the Commission to grant exceptions to the 100 ppm cap for children’s products that pose exceedingly low risks to children. The Commission granted an exception earlier this year for children’s ride-on tractors whose foot pedals contain trace amounts of lead above 100 ppm. And although this action gives relief to those who spent the time and money to demonstrate the safety of products about which no safety issues have been raised, the exceptions process does not come close to acknowledging or correcting the unjustified costs of the 100 ppm lead cap. This state of affairs represents the precautionary principle on steroids.
Will the Commission repeat this mistake when it comes to regulating phthalates later this year? Phthalates are a class of chemicals used to soften substances. In the CPSIA, Congress treated phthalates similarly to lead: it imposed some hard and fast requirements, but it also gave the Commission some breathing room to make reasonable judgments about safety. Three phthalates were banned permanently; three others temporarily, until the Commission decides whether the ban should be extended.
Before making that determination, the Commission will consider the still pending conclusions of a scientific panel on the temporarily-banned phthalates’ health effects. Further, the Commission will decide after notice-and-comment rulemaking, which can include the type of data-driven analysis that the Commission declined to engage in during the lead cap debate. The outcome cannot be predicted at this early date, but a return to our former practice of assessing risk and exposure in making health and safety regulatory decisions would be welcome.