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From Products Liability Law Daily, July 22, 2014

CHAP Report: direct ingestion not toys leads to highest levels of phthalate exposure

By Pamela C. Maloney, J.D.

The highest phthalate exposure among children, pregnant women, and other susceptible persons was via direct ingestion of food, beverages, and drugs, “not children’s toys and their personal care products,” the Chronic Hazard Advisory Panel (CHAP) concluded in its report to the Consumer Product Safety Commission. CHAP, which was convened by CPSC in compliance with the Consumer Product Safety Improvement Act of 2008 (CPSIA), completed its study of the effects on children’s health of all phthalates and phthalate alternatives as used in children’s toys and child care articles and issued final recommendations to the Commission on whether the use of additional phthalates or phthalate alternatives in children’s toys and child care articles should be restricted (Chronic Hazard Advisory Panel on Phthalates and Phthalate Alternatives Final Report, July 18, 2014).

Background. Under Sec. 108(b)(2) of the CPSIA, CHAP was required to complete an examination of the full range of phthalates that are used in products designed for children. This examination was to include, among other things: (1) an examination of the potential health effects of the full range of phthalates; (2) the potential health effects of each phthalate in isolation and in combination with other phthalates; (3) the likely levels of exposure for children, pregnant women, and others, based on a reasonable estimation of normal and foreseeable usages as well as the abuse of these products; (4) the health effects not only from ingestion of phthalates but also from dermal, hand-to-mother, or other exposure; (5) the level at which there was a reasonable certainty that phthalates posed no harm to children, pregnant women, or other susceptible individuals and their offspring; and (6) the possible health effects of phthalate alternatives used in children’s toys and child care articles.

Findings. Among its many findings, the CHAP Report discovered that overall, food, beverages, and drugs via direct ingestion, and “not children’s toys and their personal care products,” constituted the highest phthalate exposures to all subpopulations, and that the highest exposure was dependent upon the phthalate and the products which contained it. Diisononyl phthalate (DINP) was found to have the maximum potential for exposure to infants, toddlers, and older children, with exposure coming from food, mouthing teethers, and toys, as well as from dermal contact with child care articles and home furnishings.

The report cautioned that the lack of exposure information available for analysis left large uncertainties, especially for some items deemed critical to the completion of CHAP’s tasks. Further information was needed on the use and release rates of phthalates for products during use. However, human bio-monitoring data could produce reasonable estimates of the overall phthalate exposure and resulting risk.

The panel also examined the effects of phthalate metabolites on human fetal testis explants obtained during the first and second trimesters, reviewed several studies, and xenograft experiments to determine the effects phthalate exposure had on unborn children. The report concluded that phthalates were capable of driving down fetal androgen syntheses in humans.

Recommendations. The recommendations made by CHAP were divided into four categories: (1) phthalates permanently banned by the CPSIA, (2) phthalates subject to an interim ban, (3) phthalates not regulated by the CPSIA, and (4) phthalate alternatives.

Permanently Banned Phthalates. CHAP recommended no further CPSC action with regard to dibutyl phthalate (DBP), butylbenzyl phthalate (BBP), or di(2-ethylhexyl) phthalate (DEHP) because these phthalates are already subject to a permanent ban in children’s toys and child care articles at levels greater than 0.1%. However, CHAP recommended that U.S. agencies responsible for dealing with DBP, BBP, and DEHP exposures from food and other products conduct the necessary risk assessments with a view to supporting risk-management steps.

Interim Banned Phthalates. CHAP recommended that the interim ban on the use of DINP in children’s toys and child care articles at levels greater than 0.1% be made permanent and that U.S. agencies responsible for dealing with DINP exposures from food and other products conduct the necessary risk assessments with a view to supporting risk-management steps. CHAP found that di-n-octyl phthalate (DNOP) and diisodecyl phthalate (DIDP) did not appear to possess antiandrogenic potential and recommended that that the current ban be lifted. However, CHAP noted that U.S. agencies responsible for dealing with DNOP and DIDP exposures from food and child care products conduct the necessary risk assessments with a view to supporting risk-management steps.

Phthalates Not Banned. CHAP recommended that no action be taken on dimethyl phthalate (DMP) or diethyl phthalate (DEP) but again recommended that U.S. agencies responsible for dealing with DEP exposures from food, pharmaceuticals, and personal care products conduct the necessary risk assessments with a view to supporting risk-management steps. CHAP was unable to make recommendations with regard to CPSC’s recent detection of di(2-propylheptyl) phthalate (DPHP) in some children’s toys, noting that there was a lack of publically available information on this phthalate.

Phthalate Alternatives. Although data on most phthalate alternatives was limited, there was no evidence that any of the alternatives considered by CHAP presented a hazard to infants or toddlers from mouthing toys or child care articles. Therefore, the CHAP recommended no action at this time. However, CHAP did recommend that the appropriate U.S. agencies obtain the necessary exposure and hazard data to estimate total exposure to the phthalate alternatives and assess the potential health risks.

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