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Risk Analysis Division's Comments to Consumer Product Safety Commission on Proposed Chemical Ban

Below are the comments submitted by RAD to the Consumer Product Safety Commission in response to a proposed rule to ban children’s toys and child care articles containing specified phthalates.

I am writing on behalf of the Risk Analysis Division (RAD) of the National Center for Public Policy Research. RAD is concerned with the proliferation of regulations that impinge on consumers’ access to safe and affordable products.

We have been concerned about the process that led up to the proposed rule known as “Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates.”
Docket ID: CPSC-2014-0033

The Chronic Hazard Advisory Panel (CHAP) on Phthalates was fraught with precautionary approaches that made a recommendation of extending a ban on phthalates in certain applications nearly a foregone conclusion. From the CHAP report’s controversial use of cumulative risk assessment to the use of no-longer relevant exposure data, to the unorthodox failure to open up the study to public peer review consistent with OMB Information Quality Bulletin for Peer Review, the CHAP report is a flawed basis for developing what should be science-based regulations.

One especially ill-conceived aspect of the proposed rule illustrates why the failures in process lead to failures in policy-making.

The proposed rule would extend the ban on DINP from a temporary ban on mouthable children’s toys and child care articles containing DINP, to a permanent ban on even non-mouthable children’s products.

The justification cited by the Consumer Product Safety Commission to support this heavy-handed rule was that non-mouthable products are touched- and that can also cause exposure, thus adding to the cumulative exposure from other phthalates, such as DEHP.

But DINP is among the least potent phthalates. And exposure from toys and child care articles, even mouthable ones, is a very minor source of DINP exposure in the first place, and an even more minor concern in terms of cumulative phthalate risk, given DINP’s low potency.

Cumulative exposure from DINP in children’s products may have conceivably been a concern when overall phthalate exposure was much higher prior to the legislative ban on certain phthalates, but with overall exposure much lower now, DINP exposure from touching should barely even be considered de minimis.

Yet the CHAP report failed to take today’s lower exposure levels into account, instead relying on data that was not only old, but no longer relevant given the bans of more potent phthalates. A cumulative assessment based on exposure levels we know to be no-longer accurate renders the CHAP report irrelevant when considering cumulative exposures.

What’s worse, even though CPSC was aware of this fatal flaw in the CHAP report, it relied on this aspect of the report, ignoring these concerns that would have surely been raised had the CHAP report been subject to open peer review.

The supposed logic of the extension of the DINP ban is that all exposure, no matter how remote, is a problem.

The CHAP report didn’t even justify an expansion in a direct manner, rather leaving CPSC to conjecture as to a basis for the ban.

In fact, the CPSC wrote,

“The Commission notes that the CHAP assessed the risks of DINP both in isolation and in combination with other phthalates. Considered in isolation, staff concluded that DINP would not present a hazard to consumers because the MoE (830 to 15,000) is well in excess of 100. (CHAP, 2014, p. 99). This is consistent with previous work. (CHAP, 2001; CPSC, 2002). “

Instead, the CPSC relies on the cumulative risk theory:

“the Commission agrees with the CHAP that DINP is antiandrogenic and contributes to the cumulative risk. Specifically, the CHAP found that 10 percent of pregnant women and up to 5 percent of infants have a HI greater than one. Therefore, as discussed previously, the Commission concludes that the cumulative risk of male developmental reproductive effects should be considered ‘to ensure a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals with an adequate margin of safety.’”

This, all despite outdated data. Yet nonetheless, CPSC writes,

“The Commission believes that the expansion in scope is appropriate because exposure occurs from handling children’s toys, as well as from mouthing. (CHAP, 2014, Appendix E1). The additional exposure from handling toys would add to the cumulative risk. Therefore, the Commission concludes that expanding the scope of the DINP prohibition to include all children’s toys is necessary to ensure a reasonable certainty of no harm to children with an adequate margin of safety.”

It should be noted that not even the precautionary European Commission (EC) goes this far.

In fact, the EC submitted a comment to this docket addressing this point. (see:!documentDetail;D=CPSC-2014-0033-0032 )
To justify going beyond even the EC, the proposed rule states:

“As discussed in the CHAP report, there are multiple studies related to the male developmental reproductive effects of DINP, many of which were published after 2005, the date of the EC directive. Thus, the Commission concludes that because the CHAP report addresses uncertainties regarding the potential hazard associated with DINP, an expansion of the prohibition on DINP to all children’s toys is appropriate.”

Yet at the same time, the CPSC ignores the most relevant change related to phthalates between then and today: that is, a range of other, more potent phthalates have been banned and thus the cumulative risk has fallen precipitously. To suggest that the EC directive is too lenient on DINP because it relies on old science is an insult to the intelligence of even the most casual observer who is aware that the CHAP report’s assessment of cumulative risk is based on data that we know, because of the recent ban, to be out of date and no longer relevant, especially when attempting to gauge cumulative risk.

Even more troubling to a policy analyst, is that the proposed CPSC rule comes close to acknowledging the scientific weakness of the case to extend the ban on DINP to non-mouthable products, by arguing that the effect of the ban would be minimal. “Additionally, we expect that expanding the scope to all children’s toys would have a minimal effect on manufacturers because few products would need to be reformulated to comply with the broader scope. (See Tab A of the staff’s briefing package.) In practice, children’s toys and toys that can be placed in a child’s mouth all require testing for phthalates. The testing costs are the same in either case. The only change caused by expanding the scope to all children’s toys is that toys too large to be mouthed could not be made with DINP.”

First, CPSC doesn’t bother to consider any effect on consumers or the potential that in the future, smaller manufacturers would be burdened by this regulation, which offers no demonstrated public health benefits in exchange for even “minimal” costs.

Second, the CPSC fails to take into account the potential for future uses of DINP in non-mouthable children’s products.

Third, the notion that the effect on manufacturers is supposedly minimal is a weak basis for keeping a safe and useful chemical out of the hands (but not mouths) of consumers, even children.

When Congress passed the Consumer Product Safety Improvement Act in 2008, it did not give the CPSC power to remove safe products from the marketplace if the effect of such a ban would be minimal. It simply didn’t give CPSC power to remove products that were safe, or that could only be shown to present a risk based on old exposure data we know to be no-longer accurate.

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