US CPSC Likely to Approve Phthalates Ban Despite Data Concerns

A legal settlement may bar the US Consumer Products Safety Commission (CPSC) from changing a proposed regulation banning the phthalate DINP in children's products before voting on it on 18 October, even though questions have been raised about the statistical data underpinning the proposals.

The commission issued a proposed rule in late 2014 to ban five phthalates in toys and various other children's products at levels greater than 0.1%. These are:

> diisobutyl phthalate (DIBP);

> di-n-pentyl phthalate (DnPP or DPENP);

> di-n-hexyl phthalate (DnHP or DHEXP);

> dicyclohexyl phthalate (DCHP); and

> diisononyl phthalate (DINP).

The rule would expand an interim ban on DINP, which currently applies only to toys that can be placed in the mouth, to all toys.

Four of the phthalates are not widely used in children's toys and childcare articles, and discussion at the commission's 11 October meeting focused on DINP.

The High Phthalates Panel of the American Chemistry Council (ACC) has criticised the decision on DINP as "arbitrary and capricious," arguing that the most current data "demonstrates that the cumulative exposure to the phthalates that are the subject of the rule is actually well below any level of concern".

The two Republican commissioners on the CPSC have questioned the adequacy of the data and the criteria for deciding what level of exposure meets the statutory mandate to ensure a "reasonable certainty of no harm".

But Republican Commissioner Joseph Mohorovic said they are "hamstrung" by a legal agreement. This is because the CPSC agreed to vote on a final rule by 18 October to settle a lawsuit brought by NGOs that complained about that the delay in finalising the proposal.

The settlement does not specify the content of the rule. But Commissioner Mohorovic noted that the commission's procedural rules require public comment, and so the commissioners are effectively barred from making substantial changes to the proposed rule before voting on it.

"If this final rule is not a logical outflow of the proposed rule, we would be prohibited by the court order of having a rule that would stand up in court by getting the additional notice and comment," he said.

The rule would lift interim bans on two phthalates, DNOP and DIDP, which the commission staff concluded have not been shown to have the antiandrogenic effects that the rule addresses.

DEHP, BBP and DBP are already banned above de minimis levels in children's products.