Book Description

Particles and Health is an international conference taking place in October 2021 addressing issues in science and regulation. Regulatory initiatives in the European Union (EU) have suggested uniform hazard classifications for all poorly soluble low toxicity particles (PSLTs). Examples of PSLTs include carbon black, titanium dioxide and iron oxide, among others. Approaches have also been proposed for setting workplace exposure limits for PSLTs such as those of the German MAK Commission. The conference will include specific sections over a two day period of about 25 presentations, associated with PSLTs regarding the following major topics: (1) human studies, (2) animal inhalation studies associated with lung cancer,(3) animal and human studies associated with non pulmonary impacts, including reproductive, genetic and cardiac effects, and (4) regulatory application of scientific studies. This conference will include presentations regarding: Definition of PSLT’s with attention to both similarities and differences among these substances. • Address scientific studies regarding human health effects of PSLTs. The value of human studies over animal studies-when human-exposed populations can be studied adequately- will be emphasized. • Address translational toxicology challenges, including the appropriateness of rats as models for human lung pathogenesis (particularly lung cancer) in light of lung overload phenomena and species differences. • Serve as a platform to present current scientific information about PSLTs important for regulatory action. • Publication of pertinent conference presentations in the peer reviewed scientific literature will allow the presentations to live beyond the conference and subsequently be reviewed part of regulatory deliberations. • Establish an interdisciplinary setting for industry, academia and regulatory professionals to interact on an important topic. Such interaction can facilitate enhanced understanding of the science and ideally, more appropriate regulations, appropriate classification and labeling as well as for setting exposure limits, among others. • Recommend areas for further clarifying research regarding the significance of the rat as a model for translation toxicology. The goal of this conference is to present current scientific evidence regarding the numerous dimensions of particles and health and to facilitate interaction and discussions among attendees with expertise in toxicology, epidemiology, occupational and pulmonary medicine and exposure assessment. Interactions between these disciplines will aid in the sound and evidence-based scientific underpinning of regulatory considerations regarding PSLTs. Although regulatory concern regarding PSLTs has focused on lung cancer risk as a result of rat inhalation overload studies, this conference will address all relevant health end points, including genetic and reproductive issues as well, consistent with ECHA guidelines. Sample of Topics related to substances that may be characterized as PSLTs, including carbon black, coal, titanium dioxide, cerium oxide, aluminum oxide barium sulfate and iron oxide, among others. • Defining PSLTs • Epidemiological studies of PSLTs • Inhalation studies evaluating human cellular response to particles • Basic research studies on inflammatory to malignancy pathways • Animal studies, PLSTs and human risk: “New Insights into old data.” • New studies on PSLTs; 2 year carcinogenicity assays • Animal studies and gender specific responses to PSLTs. How does the USA National Cancer Institute (NCI) and National Institute of Environmental Health Sciences (NIEHS) address this challenge of extrapolating rodent data to human risk assessment? • Role of the rodent model in human risk assessment of PSLTs and lung cancer risk • Adverse Outcome Pathways (AOPs) and Modes of Action (MOA): identification and recommendations for closing gaps in knowledge for rodents and humans. • Are there lessons to be learned from how the pharmaceutical industry’s approach to translational science (safety and efficacy) as evolved in recent years? • Setting exposure limits for PSLTs and Translational Toxicology. • Genotoxicity and Reproductive toxicity studies of PSLTs.