June 30, 2009

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By Product Safety Letter staff

CPSC’s heard last week that there might be a conflict between the need to get good data for its in-the-works Chronic Hazard Advisory Panel (CHAP) that will look at phthalates and the EU’s REACH data-protection provisions. More on that development is in the current edition of Product Safety Letter. Meanwhile, what exactly is a CHAP? Assembling one is such a rare activity – the most recent one did its work a decade ago from 1999 to 2001 – that soon after the passage of the CPSIA, some agency staffers expressed confusion about the process. Presumably that has changed in the intervening months, but here is some background:

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Rules for CHAPs are in Section 28 of the Consumer Product Safety Act. The committees consist of seven members, chosen from a list of nominees created by the National Academy of Sciences. They can be neither U.S. government employees nor have financial conflicts of interest related to the target products. Further, they must have demonstrated ability to assess chronic hazards. Once assembled, they vote two members to be chairman and vice chairman. Their decisions are by majority rule. They are paid at a federal employee GS-18 rate for each day they do work for the pan­­el. They must request and disclose information only through the commission.

Although the agency has not revealed the names of the candidates – including via a PSL FoIA request – it presumably has a list. In February, the agency told the National Academy of Scien­tists that it wanted a list of 21 scientists from whom it would pick the seven members of the committee. The agency asked that the nom­inees have expertise in seven areas: exposure assess­ment, reproductive/developmental toxicity, general tox­i­city, risk assessment of mixtures/cumulative risk assess­ment, risk assessment for children, epidemiology/biosta­tistics, and biomonitoring/pharmacokinetic modeling. Then, in May, it sent an emergency request to the Office of Management and Bud­get for approval under the Paper­work Reduction Act for infor­ma­tion collection approval related to a survey of candidates.

As for the CHAP’s work, Section 108 of the CPSIA specifies that it will (verbatim):

(i) examine all of the potential health effects (including endocrine disrupting effects) of the full range of phthalates;

(ii) consider the potential health effects of each of these phthalates both in isolation and in combination with other phthalates;

(iii) examine the likely levels of children’s, pregnant women’s, and others’ exposure to phthalates, based on a reasonable estimation of normal and foreseeable use and abuse of such products;

(iv) consider the cumulative effect of total exposure to phthalates, both from children’s products and from other sources, such as personal care products;

(v) review all relevant data, including the most recent, best-available, peer-reviewed, scientific studies employ objective data collection practices or employ other objective methods;

(vi) consider the health effects of phthalates not only from ingestion but also as a result of dermal, hand-to-mouth, or other exposure;

(vii) consider the level at which there is a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals and their offspring, considering the best available science, and using sufficient safety factors to account for uncertainties regarding exposure and susceptibility of children, pregnant women, and other potentially susceptible individuals; and

(viii) consider possible similar health effects of phthalate alternatives used in children’s toys and child care articles.

The three temporarily banned phthalates are diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), and di-n-octyl phthaltes (DnOP). Permanently banned are di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl (BBP).

Portions of this article appeared in the September 15, 2008 edition of our premium sister service, Product Safety Letter. It is just one of the hundreds of similar stories that subscribers read over the course of an annual subscription. Subscription information is here