Center for Risk Science Innovation and Application

Washington, DC, United States

Center for Risk Science Innovation and Application

Washington, DC, United States
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Bellmann S.,TNO | Carlander D.,Nanotechnology Industries Association | Fasano A.,Harvard University | Momcilovic D.,U.S. Food and Drug Administration | And 7 more authors.
Wiley Interdisciplinary Reviews: Nanomedicine and Nanobiotechnology | Year: 2015

Many natural chemicals in food are in the nanometer size range, and the selective uptake of nutrients with nanoscale dimensions by the gastrointestinal (GI) tract is a normal physiological process. Novel engineered nanomaterials (NMs) can bring various benefits to food, e.g., enhancing nutrition. Assessing potential risks requires an understanding of the stability of these entities in the GI lumen, and an understanding of whether or not they can be absorbed and thus become systemically available. Data are emerging on the mammalian in vivo absorption of engineered NMs composed of chemicals with a range of properties, including metal, mineral, biochemical macromolecules, and lipid-based entities. In vitro and in silico fluid incubation data has also provided some evidence of changes in particle stability, aggregation, and surface properties following interaction with luminal factors present in the GI tract. The variables include physical forces, osmotic concentration, pH, digestive enzymes, other food, and endogenous biochemicals, and commensal microbes. Further research is required to fill remaining data gaps on the effects of these parameters on NM integrity, physicochemical properties, and GI absorption. Knowledge of the most influential luminal parameters will be essential when developing models of the GI tract to quantify the percent absorption of food-relevant engineered NMs for risk assessment. © 2015 The Authors.

Szakal C.,U.S. National Institute of Standards and Technology | Tsytsikova L.,Center for Risk Science Innovation and Application | Carlander D.,Nanotechnology Industries Assoc | Duncan T.V.,U.S. Food and Drug Administration
Comprehensive Reviews in Food Science and Food Safety | Year: 2014

This article is one of a series of 4 that report on a task of the NanoRelease Food Additive (NRFA) project of the International. Life Science Institute Center for Risk Science Innovation and Application. The project aims are to identify, evaluate, and develop methods that are needed to confidently detect, characterize, and quantify intentionally produced engineered nanomaterials (ENMs) released from food along the alimentary tract. This particular article offers an overview of the NRFA project, describing the project scope and goals, as well as the strategy by which the task group sought to achieve these goals. A condensed description of the general challenge of detecting ENMs in foods and a brief review of available and emerging methods for ENM detection is provided here, paying particular attention to the kind of information that might be desired from an analysis and the strengths and weaknesses of the various approaches that might be used to attain this information. The article concludes with an executive summary of the task group's broad findings related to the 3 topic areas, which are covered in more detail in 3 subsequent articles in this series. The end result is a thorough evaluation of the state of ENM measurement science specifically as it applies to oral uptake of ENMs from human dietary sources. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

Harper S.,Oregon State University | Wohlleben W.,BASF | Doa M.,U.S. Environmental Protection Agency | Nowack B.,Empa - Swiss Federal Laboratories for Materials Science and Technology | And 3 more authors.
Journal of Physics: Conference Series | Year: 2015

Hazard studies of "as-produced" nanomaterials are increasingly available, yet a critical gap exists in exposure science that may impede safe development of nanomaterials. The gap is that we do not understand what is actually released because nanomaterials can change when released in ways that are not understood. We also generally do not have methods capable of quantitatively measuring what is released to support dose assessment. This review presents a case study of multi-walled carbon nanotubes (MWCNTs) for the measurement challenge to bridge this gap. As the use and value of MWCNTs increases, methods to measure what is released in ways relevant to risk evaluation are critically needed if products containing these materials are to be economically, environmentally, and socially sustainable. This review draws on the input of over 50 experts engaged in a program of workshops and technical report writing to address the release of MWCNTs from nanocomposite materials across their life cycle. The expert analyses reveals that new and sophisticated methods are required to measure and assess MWCNT exposures for realistic exposure scenarios. Furthermore, method requirements vary with the materials and conditions of release across life cycle stages of products. While review shows that the likelihood of significant release of MWCNTs appears to be low for many stages of composite life cycle, measurement methods are needed so that exposures from MWCNT-composites are understood and managed. In addition, there is an immediate need to refocus attention from study of "as-produced" nanomaterials to coordinated research on actual release scenarios. © Published under licence by IOP Publishing Ltd.

Szakal C.,U.S. National Institute of Standards and Technology | Roberts S.M.,University of Florida | Westerhoff P.,Arizona State University | Bartholomaeus A.,University of Canberra | And 4 more authors.
ACS Nano | Year: 2014

The risks and benefits of nanomaterials in foods and food contact materials receive conflicting international attention across expert stakeholder groups as well as in news media coverage and published research. Current nanomaterial characterization is complicated by the lack of accepted approaches to measure exposure-relevant occurrences of suspected nanomaterials in food and by broad definitions related to food processing and additive materials. Therefore, to improve understanding of risk and benefit, analytical methods are needed to identify what materials, new or traditional, are "nanorelevant" with respect to biological interaction and/or uptake during alimentary tract transit. Challenges to method development in this arena include heterogeneity in nanomaterial composition and morphology, food matrix complexity, alimentary tract diversity, and analytical method limitations. Clear problem formulation is required to overcome these and other challenges and to improve understanding of biological fate in facilitating the assessment of nanomaterial safety or benefit, including sampling strategies relevant to food production/consumption and alimentary tract transit. In this Perspective, we discuss critical knowledge gaps that must be addressed so that measurement methods can better inform risk management and public policy. © 2014 American Chemical Society.

Canady R.,Center for Risk Science Innovation and Application | Lane R.,PepsiCo | Paoli G.,Risk science International RSI | Wilson M.,Risk science International RSI | And 6 more authors.
Critical Reviews in Food Science and Nutrition | Year: 2013

Threshold of Toxicological Concern (TTC) decision-support methods present a pragmatic approach to using data from well-characterized chemicals and protective estimates of exposure in a stepwise fashion to inform decisions regarding low-level exposures to chemicals for which few data exist. It is based on structural and functional categorizations of chemicals derived from decades of animal testing with a wide variety of chemicals. Expertise is required to use the TTC methods, and there are situations in which its use is clearly inappropriate or not currently supported. To facilitate proper use of the TTC, this paper describes issues to be considered by risk managers when faced with the situation of an unexpected substance in food. Case studies are provided to illustrate the implementation of these considerations, demonstrating the steps taken in deciding whether it would be appropriate to apply the TTC approach in each case. By appropriately applying the methods, employing the appropriate scientific expertise, and combining use with the conservative assumptions embedded within the derivation of the thresholds, the TTC can realize its potential to protect public health and to contribute to efficient use of resources in food safety risk management. © 2013 Copyright Taylor and Francis Group, LLC.

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