Abstract  Dialkyl phthalates are plasticizers used in household products made from polyvinyl chloride (PVC). Diisononyl phthalate (DINP) is the principal phthalate in soft plastic toys. Because DINP is not tightly bound to PVC, it may be released when children mouth PVC products. The potential chronic health risks of phthalate exposure to infants have been under scrutiny by regulatory agencies in Europe, Canada, Japan, and the U.S. This report describes a risk assessment of DINP exposure from children's products, by the U.S. Consumer Product Safety Commission (CPSC) staff. This report includes the findings of a CPSC Chronic Hazard Advisory Panel (CHAP) which: (1) concluded that DINP is unlikely to present a human cancer hazard and (2) recommended an acceptable daily intake (ADI) level of 120 microg/kg-d, based on spongiosis hepatis in rats. The risk assessment incorporates new measurements of DINP migration rates from 24 toys and a new observational study of children's mouthing activities, with a detailed characterization of the objects mouthed. Probabilistic methods were used to estimate exposure. Mouthing behavior and, thus, exposure depend on the child's age. Approximately 42% of tested soft plastic toys contained DINP. Estimated DINP exposures for soft plastic toys were greatest among children 12-23 months old. The mean exposure for this age group was 0.08 (95% confidence interval 0.04-0.14) microg/kg-d, with a 99th percentile of 2.4 (1.3-3.2) microg/kg-d. The authors conclude that oral exposure to DINP from mouthing soft plastic toys is not likely to present a health hazard to children. The opinions expressed by the authors have not been reviewed or approved by, and do not necessarily reflect the views of, the U.S. Consumer Product Safety Commission. Because this material was prepared by the authors in their official capacity, it is in the public domain and may be freely copied or reprinted.

Abstract  This document presents the scope of the risk evaluation to be conducted for n-methylpyrrolidone. If a hazard, exposure, condition of use or potentially exposed or susceptible subpopulation has not been discussed, EPA, at this point in time, is not intending to include it in the scope of the risk evaluation. As per the rulemaking, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (TSCA), with respect to conditions of use in conducting a risk evaluation under TSCA, EPA will first identify “circumstances” that constitute “conditions of use” for each chemical. While EPA interprets this as largely a factual determination—i.e., EPA is to determine whether a chemical substance is actually involved in one or more of the activities listed in the definition—the determination will inevitably involve the exercise of some discretion.

Abstract  Background: Maternal risk factors have been tabulated for women of childbearing age using defined age ranges. However, statistics for factors strongly related to age may be overly influenced by values for the youngest and oldest women in a range, because pregnancies are most likely for ages 20-35. Objective: This report evaluates adjustment methods, based on the probability of pregnancy, for calculating estimates of risk factors for women of childbearing age. Methods: Adjusted and unadjusted estimates for environmental and nutritional variables were calculated from the 1999-2008 National Health and Nutrition Examination Survey (NHANES) for women aged 16-49. U.S. births were used to determine the probability of pregnancy. Results: Adjusted and unadjusted estimates differed for some, but not all, examined variables. More marked differences were observed for the environmental variables compared with the nutritional variables. Adjusted estimates were within about 5% of the unadjusted estimates for the nutritional variables. Adjusted geometric means for lead and mercury were about 7%-10% lower, and for polychlorinated biphenyl (or PCB) about 25% lower, than their respective unadjusted geometric means. With few exceptions, different adjustment methods led to similar estimates. Conclusion: When calculating statistics for women of childbearing age, the decision to adjust for age or not to adjust appears to be more important than the choice of adjustment method. Although the results suggest only small differences among adjustment methods, approaches based on the NHANES design and sample weighting methodology may be the most robust for other applications.