Us Consumer Product Safety Commission

Bethesda, MD, United States

Us Consumer Product Safety Commission

Bethesda, MD, United States
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Kleinstreuer N.C.,National Health Research Institute | Sullivan K.,Physicians Committee for Responsible Medicine | Allen D.,Integrated Laboratory Systems, Inc. | Edwards S.,U.S. Environmental Protection Agency | And 7 more authors.
Regulatory Toxicology and Pharmacology | Year: 2016

An adverse outcome pathway (AOP) helps to organize existing knowledge on chemical mode of action, starting with a molecular initiating event such as receptor binding, continuing through key events, and ending with an adverse outcome such as reproductive impairment. AOPs can help identify knowledge gaps where more research is needed to understand the underlying mechanisms, aid in chemical hazard characterization, and guide the development of new testing approaches that use fewer or no animals. A September 2014 workshop in Bethesda, Maryland considered how the AOP concept could improve regulatory assessments of chemical toxicity. Scientists from 21 countries, representing industry, academia, regulatory agencies, and special interest groups, attended the workshop, titled Adverse Outcome Pathways: From Research to Regulation. Workshop plenary presentations were followed by breakout sessions that considered regulatory acceptance of AOPs and AOP-based tools, criteria for building confidence in an AOP for regulatory use, and requirements to build quantitative AOPs and AOP networks. Discussions during the closing session emphasized a need to increase transparent and inclusive collaboration, especially with disciplines outside of toxicology. Additionally, to increase impact, working groups should be established to systematically prioritize and develop AOPs. Multiple collaborative projects and follow-up activities resulted from the workshop. © 2016 Elsevier Inc.

Strickland J.,ILS | Zang Q.,ILS | Kleinstreuer N.,ILS | Paris M.,ILS | And 7 more authors.
Journal of Applied Toxicology | Year: 2016

One of the top priorities of the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM) is the identification and evaluation of non-animal alternatives for skin sensitization testing. Although skin sensitization is a complex process, the key biological events of the process have been well characterized in an adverse outcome pathway (AOP) proposed by the Organisation for Economic Co-operation and Development (OECD). Accordingly, ICCVAM is working to develop integrated decision strategies based on the AOP using in vitro, in chemico and in silico information. Data were compiled for 120 substances tested in the murine local lymph node assay (LLNA), direct peptide reactivity assay (DPRA), human cell line activation test (h-CLAT) and KeratinoSens assay. Data for six physicochemical properties, which may affect skin penetration, were also collected, and skin sensitization read-across predictions were performed using OECD QSAR Toolbox. All data were combined into a variety of potential integrated decision strategies to predict LLNA outcomes using a training set of 94 substances and an external test set of 26 substances. Fifty-four models were built using multiple combinations of machine learning approaches and predictor variables. The seven models with the highest accuracy (89–96% for the test set and 96–99% for the training set) for predicting LLNA outcomes used a support vector machine (SVM) approach with different combinations of predictor variables. The performance statistics of the SVM models were higher than any of the non-animal tests alone and higher than simple test battery approaches using these methods. These data suggest that computational approaches are promising tools to effectively integrate data sources to identify potential skin sensitizers without animal testing. Published 2016. This article has been contributed to by US Government employees and their work is in the public domain in the USA. Published 2016. This article has been contributed to by US Government employees and their work is in the public domain in the USA.

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.

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.

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