Phthalates NPR: Flawed Theory Supported by Flawed Data

risk_measurement_400_clr_5483-300x300On March 16, 2015, the comment period will close for the CPSC’s proposed rule banning specified concentrations of phthalates in children’s toys and child care articles.  While those who make and use phthalates are well aware of this proceeding, it has much broader implications for the entire regulated community.

The proposed rule is flawed not only in terms of substance but also of process.  The manner in which it used a cumulative risk assessment to justify banning products that contribute little, if any, exposure to phthalates has broad and troubling implications that extend well beyond this proceeding.

The proposed rule comes out the report of the Chronic Hazard Advisory Panel (CHAP), established by the CPSIA.  Using a cumulative risk assessment, the CHAP advised, and the Commission majority agreed, that concentrations of the phthalate DINP should be banned in all children’s toys and child care articles.  The CHAP found that “food, rather than children’s toys or child care articles, provides the primary source of exposure to both women and children….”  Nevertheless, the CHAP expressed its concern “that toys and child care articles may contribute to the overall exposure.” (See staff briefing package, “Prohibition of Children’s Toys and Child Care Articles Containing Phthalates”, page 13, emphasis added.)

Cumulative risk assessments can be a useful analytic tool in certain circumstances where risks come from identified multiple sources. However, in this instance, it is very clear that the CHAP had issues about how to do the risk assessment and then how to use it.  Cutting through the scientific jargon, the CHAP report and the CPSC’s proposed rule based on it address a potential health risk by proposing to ban a speculative contributor to the risk.  The notion that this rule will make the marketplace safer is belied by the fact that the CHAP report describes the many other and more primary exposure routes from the other products that contain phthalates—most of which are outside the jurisdiction of the CPSC and many of which are not being used by children.

I believe that the CHAP fell far short of carrying out its duties.  Since the CHAP believed that certain phthalates present health risks, it should have called upon those agencies with jurisdiction to initiate appropriate action rather than just issue its tepid call for more interagency study.   However, for the CHAP go on and “cya”  by recommending regulation of a product class that contributes little, if anything, to the hazard as a way to protect human health is akin to emptying a lake with a teaspoon—lots of effort; little results. And it is an intrusion into a policy area where it has no expertise.

These concerns are amplified by the fact that the CHAP based its findings on stale data, when there is ample evidence that had it used the most recent data available to it, the analysis may well have reached a different conclusion.  For the CPSC, which prides itself on being a “data-driven agency”, to acquiesce in such an inexplicable use of flawed data, much less base a proposed rule on it, is puzzling.  It might lead a cynic to wonder if this was a politically driven decision rather than a scientifically driven one.

Commissioner Beurkle has addressed the shortcomings of the CHAP report in a statement explaining why she could not support the NPR.  It is worth reading.

However, going forward, if the CPSC is going to use cumulative risk assessments to justify banning substances that contribute little if anything to a risk and do so based on stale data and flawed analysis, then all CPSC stakeholders should be concerned.  This is an issue that affects not just the chemical industry.  Those who make and sell products subject to the jurisdiction of the CPSC should weigh in on this troubling dumbing down of science in the name of science.

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