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Addo Ntim S.,U.S. Food and Drug Administration | Thomas T.A.,Us Consumer Product Safety Commission | Noonan G.O.,U.S. Food and Drug Administration
Food Additives and Contaminants - Part A Chemistry, Analysis, Control, Exposure and Risk Assessment | Year: 2016

Research focused on assessing potential consumer exposure to nanoparticles released from nano-enabled food-contact materials (FCMs) has often reached conflicting conclusions regarding the detection of migrating nanoparticles. These conflicting conclusions, coupled with the potential for nanoparticles to be unstable in certain food simulants, has necessitated a closer look at the role played by food simulants recommended for use in nanoparticle migration evaluation. The influence of aqueous food simulants on nanoparticles under migration evaluation conditions is reported herein. The stability of silver nanoparticles (AgNP) spiked into three food simulants (water, 10% ethanol and 3% acetic acid) was investigated using asymmetric flow field-flow fractionation (AF4), ultrafiltration, electron microscopy (EM), and single-particle inductively coupled plasma mass spectrometry (sp-ICP-MS). While 3% acetic acid induced significant oxidative dissolution of AgNP to silver ions, there were very minor to no changes in the physicochemical properties of AgNP in water and 10% ethanol. © 2016, Taylor & Francis. All rights reserved.


Batra E.K.,Penn State College of Medicine | Midgett J.D.,Us Consumer Product Safety Commission | Moon R.Y.,Goldberg Center for Community Pediatric Health | Moon R.Y.,George Washington University
Journal of Pediatrics | Year: 2015

Objective To analyze reported mechanisms of injury and characterize risk factors for infants and young children ≤2 years of age who died in sitting and carrying devices. Study design A retrospective review of deaths involving sitting and carrying devices (car seats, bouncers, swings, strollers, and slings) reported to the US Consumer Product Safety Commission between 2004 and 2008. Results Of the 47 deaths analyzed, 31 occurred in car seats, 5 in slings, 4 each in swings and bouncers, and 3 in strollers. The reported elapsed time between the last time a child was seen by a caregiver and found deceased varied greatly, with a mean of 26 minutes in slings; 32 minutes in strollers; 140 minutes in car seats; 150 minutes in bouncers; and 300 minutes in swings. The cause of death was asphyxiation in all cases except one. Fifty-two percent of deaths in car seats were attributed to strangulation from straps; the others were attributed to positional asphyxia. Conclusion Infants and children 2 years of age and younger should be properly restrained and not be left unsupervised in sitting and carrying devices. Car seats should not be used as sleeping areas outside of the vehicle, and children should never be in a car seat with unbuckled or partially buckled straps. Infants in slings should have their faces visible and above the edge of the sling, should not have their faces covered by fabric, and their chins should not be compressed into their chests. © 2015 Elsevier Inc.


Pirela S.V.,Center for Nanotechnology and Nanotoxicology | Pyrgiotakis G.,Center for Nanotechnology and Nanotoxicology | Bello D.,University of Massachusetts Lowell | Thomas T.,Us Consumer Product Safety Commission | And 2 more authors.
Inhalation Toxicology | Year: 2014

An association between laser printer use and emissions of particulate matter (PM), ozone and volatile organic compounds has been reported in recent studies. However, the detailed physico-chemical, morphological and toxicological characterization of these printer-emitted particles (PEPs) and possible incorporation of engineered nanomaterials into toner formulations remain largely unknown. In this study, a printer exposure generation system suitable for the physico-chemical, morphological, and toxicological characterization of PEPs was developed and used to assess the properties of PEPs from the use of commercially available laser printers. The system consists of a glovebox type environmental chamber for uninterrupted printer operation, real-time and time-integrated particle sampling instrumentation for the size fractionation and sampling of PEPs and an exposure chamber for inhalation toxicological studies. Eleven commonly used laser printers were evaluated and ranked based on their PM emission profiles. Results show PM peak emissions are brand independent and varied between 3000 to 1300000particles/cm3, with modal diameters ranging from 49 to 208nm, with the majority of PEPs in the nanoscale (<100nm) size. Furthermore, it was shown that PEPs can be affected by certain operational parameters and printing conditions. The release of nanoscale particles from a nano-enabled product (printer toner) raises questions about health implications to users. The presented PEGS platform will help in assessing the toxicological profile of PEPs and the link to the physico-chemical and morphological properties of emitted PM and toner formulations. © 2014 Informa Healthcare USA, Inc.


PubMed | FDA CDER, Us Consumer Product Safety Commission, EPA NHEERL EPHD CIB, ILS and U.S. National Institutes of Health
Type: | Journal: Journal of applied toxicology : JAT | Year: 2017

The replacement of animal use in testing for regulatory classification of skin sensitizers is a priority for US federal agencies that use data from such testing. Machine learning models that classify substances as sensitizers or non-sensitizers without using animal data have been developed and evaluated. Because some regulatory agencies require that sensitizers be further classified into potency categories, we developed statistical models to predict skin sensitization potency for murine local lymph node assay (LLNA) and human outcomes. Input variables for our models included six physicochemical properties and data from three non-animal test methods: direct peptide reactivity assay; human cell line activation test; and KeratinoSens assay. Models were built to predict three potency categories using four machine learning approaches and were validated using external test sets and leave-one-out cross-validation. A one-tiered strategy modeled all three categories of response together while a two-tiered strategy modeled sensitizer/non-sensitizer responses and then classified the sensitizers as strong or weak sensitizers. The two-tiered model using the support vector machine with all assay and physicochemical data inputs provided the best performance, yielding accuracy of 88% for prediction of LLNA outcomes (120 substances) and 81% for prediction of human test outcomes (87 substances). The best one-tiered model predicted LLNA outcomes with 78% accuracy and human outcomes with 75% accuracy. By comparison, the LLNA predicts human potency categories with 69% accuracy (60 of 87 substances correctly categorized). These results suggest that computational models using non-animal methods may provide valuable information for assessing skin sensitization potency. Copyright 2017 John Wiley & Sons, Ltd.


Stokes W.S.,U.S. National Institutes of Health | Wind M.,Us Consumer Product Safety Commission
Altex | Year: 2010

Advances in science and innovative technologies are providing new opportunities to develop test methods and strategies that may improve safety assessments and reduce animal use for safety testing. These include high throughput screening and other approaches that can rapidly measure or predict various molecular, genetic, and cellular perturbations caused by test substances. Integrated testing and decision strategies that consider multiple types of information and data are also being developed. Prior to their use for regulatory decision-making, new methods and strategies must undergo appropriate validation studies to determine the extent that their use can provide equivalent or improved protection compared to existing methods and to determine the extent that reproducible results can be obtained in different laboratories. Comprehensive and optimal validation study designs are expected to expedite the validation and regulatory acceptance of new test methods and strategies that will support improved safety assessments and reduced animal use for regulatory testing.


Rodgers G.B.,Us Consumer Product Safety Commission | Franklin R.L.,Us Consumer Product Safety Commission | Midgett J.D.,Us Consumer Product Safety Commission
Injury Prevention | Year: 2012

Objective To quantify the relationship between imitative behaviour and poisonings in children. Setting USA. Methods This study is based on the evaluation of a large national database of unintentional oral ingestion poisonings involving children aged <5 years treated in US hospital emergency departments during 2004 and 2005. It begins with the premise that, among other factors, oral drug poisonings can result from children observing and imitating adult behaviour, but that non-oral drug and non-drug poisonings (to be referred to as non-drug poisonings) generally do not, because children do not see adults ingesting non-drug products. The study then compares and contrasts the child poisonings between the two poisoning categories. Differences in the poisoning rate between the oral drug and non-drug categories are estimated by the age and sex of the children. A binary logistic regression analysis is also conducted using non-drug poisonings as a control group to compare against oral drug poisonings. Results There was a significant increase in the relative likelihood of oral drug poisonings beginning at age 20e23 months that is consistent with the expected onset of complicated imitative behaviours in children. Based upon our analysis, imitative behaviour may have contributed to about 17 300 child poisonings treated annually in the emergency department, possibly accounting for about 20% of poisonings involving children aged <5 years and 30% of the poisoning injuries involving children aged 20e59 months. Conclusions Comprehensive efforts to prevent poisoning need to address the problem of imitative behaviour in children. Caregivers should never ingest medications in the presence of children.


Stefaniak A.B.,U.S. National Institute for Occupational Safety and Health | Duling M.G.,U.S. National Institute for Occupational Safety and Health | Lawrence R.B.,U.S. National Institute for Occupational Safety and Health | Thomas T.A.,Us Consumer Product Safety Commission | And 3 more authors.
International Journal of Occupational and Environmental Health | Year: 2014

Background: Factors that influence exposure to silver particles from the use of textiles are not well understood. Objectives: The aim of this study was to evaluate the influence of product treatment and physiological factors on silver release from two textiles. Methods: Atomic and absorbance spectroscopy, electron microscopy, and dynamic light scattering (DLS) were applied to characterize the chemical and physical properties of the textiles and evaluate silver release in artificial sweat and saliva under varying physiological conditions. One textile had silver incorporated into fiber threads (masterbatch process) and the other had silver nanoparticles coated on fiber surfaces (finishing process). Results: Several complementary and confirmatory analytical techniques (spectroscopy, microscopy, etc.) were required to properly assess silver release. Silver released into artificial sweat or saliva was primarily in ionic form. In a simulated "use" and laundering experiment, the total cumulative amount of silver ion released was greater for the finishing process textile (0·51±0·04%) than the masterbatch process textile (0·21±0·01%); P<0·01. © W. S. Maney & Son Ltd 2014.


Rodgers G.B.,Us Consumer Product Safety Commission | Garland S.,Us Consumer Product Safety Commission
Injury Prevention | Year: 2012

Objective To evaluate the effectiveness of the immersion protection requirements of a voluntary safety standard for portable handheld hair dryers in preventing electrocution deaths in the USA. Methods The present work was an interrupted time series study design. Data on annual hair dryer-related electrocution deaths resulting from water contact were developed for the 1980e2007 study period. A multivariate Poisson regression model for rate data was used to evaluate the impact of the immersion protection requirements during the post-intervention period. The analysis controlled for the estimated number of hair dryers in use and the estimated number of US homes equipped with ground fault circuit interrupters, safety devices that would address hair dryer electrocutions even in the absence of the immersion protection requirements of the voluntary standard. The implementation of the 1987 and 1991 immersion protection requirements of the voluntary standard for portable handheld hair dryers was the intervention studied. The main outcome measure was the estimated reduction in the hair dryer electrocution rate associated with the immersion protection requirements of the voluntary standard. Results After controlling for covariates, the immersion protection requirements were estimated to reduce the rate of hair dryer immersion electrocution deaths by 96.6% (95% CI, 90.8% to 98.8%). This suggests the prevention of about 280 immersion electrocution deaths involving hair dryers during the post-intervention period (1987e2007). Conclusions The immersion protection requirements of the voluntary safety standard for hair dryers have been highly effective in reducing hair dryer electrocutions.


Rodgers G.B.,U S WEST | Topping III J.C.,Us Consumer Product Safety Commission
Archives of Pediatrics and Adolescent Medicine | Year: 2012

Objective: To evaluate the effectiveness of the requirements of the voluntary safety standard for drawstrings on children's upper outerwear garments in preventing child deaths resulting from drawstring entanglement. Design: An interrupted time series design. Annual estimates of drawstring-related child deaths were developed for the study period of January 1985 to December 2009. A Poisson regression model for rate data was used to evaluate the effectiveness of the drawstring requirements during the postintervention period. Setting: United States. Subjects: Children aged 14 years and younger. Intervention: The application of the drawstring requirements of the voluntary standard that were adopted in 1997. Main Outcome Measure: The estimated percentage reduction in the drawstring-related child mortality rate associated with the application of the drawstring requirements. Results: The drawstring requirements of the voluntary standard were associated with a 90.9% (95% CI, 83.8%-96.1%) reduction in the drawstring-related mortality rate. This suggests the prevention of about 50 child deaths from 1997, when the voluntary standard was adopted, through the end of our study period in 2009. Conclusions: The requirements of the voluntary safety standard for drawstrings have been highly effective in preventing deaths resulting from the entanglement of draw-strings in children's upper outerwear garments.


Tulve N.S.,U.S. Environmental Protection Agency | Stefaniak A.B.,U.S. National Institute for Occupational Safety and Health | Vance M.E.,Virginia Polytechnic Institute and State University | Rogers K.,U.S. Environmental Protection Agency | And 6 more authors.
International journal of hygiene and environmental health | Year: 2015

Due to their antifungal, antibacterial, antiviral, and antimicrobial properties, silver nanoparticles (AgNPs) are used in consumer products intended for use by children or in the home. Children may be especially affected by the normal use of consumer products because of their physiological functions, developmental stage, and activities and behaviors. Despite much research to date, children's potential exposures to AgNPs are not well characterized. Our objectives were to characterize selected consumer products containing AgNPs and to use the data to estimate a child's potential non-dietary ingestion exposure. We identified and cataloged 165 consumer products claiming to contain AgNPs that may be used by or near children or found in the home. Nineteen products (textile, liquid, plastic) were selected for further analysis. We developed a tiered analytical approach to determine silver content, form (particulate or ionic), size, morphology, agglomeration state, and composition. Silver was detected in all products except one sippy cup body. Among products in a given category, silver mass contributions were highly variable and not always uniformly distributed within products, highlighting the need to sample multiple areas of a product. Electron microscopy confirmed the presence of AgNPs. Using this data, a child's potential non-dietary ingestion exposure to AgNPs when drinking milk formula from a sippy cup is 1.53 μg Ag/kg. Additional research is needed to understand the number and types of consumer products containing silver and the concentrations of silver in these products in order to more accurately predict children's potential aggregate and cumulative exposures to AgNPs. Published by Elsevier GmbH.

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