A Pragmatic Analysis of the Regulation of Consumer Transcranial Direct Current Stimulation (TDCS) Devices in the United States

Several recent articles have called for the regulation of consumer transcranial direct current stimulation (tDCS) devices, which provide low levels of electrical current to the brain. However, most of the discussion to-date has focused on ethical or normative considerations; there has been a notable absence of scholarship regarding the actual legal framework in the United States. This article aims to fill that gap by providing a pragmatic analysis of the consumer tDCS market and relevant laws and regulations. In the five main sections of this manuscript, I take into account (a) the history of the do-it-yourself tDCS movement and the subsequent emergence of direct-to-consumer devices; (b) the statutory language of the Federal Food, Drug and Cosmetic Act and how the definition of a medical device—which focuses on the intended use of the device rather than its mechanism of action—is of paramount importance for discussions of consumer tDCS device regulation; (c) how both the Food and Drug Administration (FDA) and courts have understood the FDA\u27s jurisdiction over medical devices in cases where the meaning of ‘intended use’ has been challenged; (d) an analysis of consumer tDCS regulatory enforcement action to-date; and (e) the multiple US authorities, other than the FDA, that can regulate consumer brain stimulation devices. Taken together, this paper demonstrates that rather than a ‘regulatory gap,’ there are multiple, distinct pathways by which consumer tDCS can be regulated in the United States

The Social Context of “Do-It-Yourself” Brain Stimulation: Neurohackers, Biohackers, and Lifehackers

The “do-it-yourself” (DIY) brain stimulation movement began in earnest in late 2011, when lay individuals began building stimulation devices and applying low levels of electricity to their heads for self-improvement purposes. To date, scholarship on the home use of brain stimulation has focused on characterizing the practices of users via quantitative and qualitative studies, and on analyzing related ethical and regulatory issues. In this perspective piece, however, I take the opposite approach: rather than viewing the home use of brain stimulation on its own, I argue that it must be understood within the context of other DIY and citizen science movements. Seen in this light, the home use of brain stimulation is only a small part of the “neurohacking” movement, which is comprised of individuals attempting to optimize their brains to achieve enhanced performance. Neurohacking itself is an offshoot of the “life hacking” (or “quantified self”) movement, in which individuals self-track minute aspects of their daily lives in order to enhance productivity or performance. Additionally, the home or DIY use of brain stimulation is in many ways parallel to the DIY Biology (or “biohacking”) movement, which seeks to democratize tools of scientific experimentation. Here, I describe the place of the home use of brain stimulation with regard to neurohackers, lifehackers, and biohackers, and suggest that a policy approach for the home use of brain stimulation should have an appreciation both of individual motivations as well as the broader social context of the movement itself

Identifying causes of poor water quality in a Polish agricultural catchment for designing effective and targeted mitigation measures

The Gowienica Miedwiańska catchment is a small agricultural catchment located in the NW of Poland draining into Lake Miedwie, on which a drinking water source for the city of Szczecin is located. The catchment is characterized by very rich soils. Subsequently, agriculture is intensive and this is thought to influence the poor water quality in the local area. Despite more than 20 years since first programmes of measures towards protection of water quality have been introduced into the catchment, these have not been produced the expected results, and the local farming community cites other sources such as poor sewage management rather that agricultural activity, as responsible for this problem. Evaluation of flow pathways in the catchment and identification of the areas responsible for the highest impact on local water quality was therefore conducted within the EU funded project Waterprotect. The aim of this study was to clarify sources of pollution precisely in space and time, in order to increase trust from stakeholders, so that targeted measures can be used effectively to improve water quality. The study included water quality monitoring, isotopic analysis and numerical flow modelling. Results showed that water quality in the catchment is spatially and temporally variable. 93% of nitrogen loadings into the Miedwie lake have been attributed to agriculture and only 7% to wastewater inputs. The local hydrology and hydrogeology play an important role in the distribution of the impacts from these inputs. As a result, three sub-catchments were identified which are differentiated by dominant pollution source, land use, and hydraulic characteristics. The highest inputs from agriculture have been identified in the most upper sub-catchment and this area have been pointed out as most suitable for implementation of agricultural best management practices towards protection of water quality at a local level

Syntactic architecture and its consequences I: Syntax inside the grammar

This volume collects novel contributions to comparative generative linguistics that “rethink” existing approaches to an extensive range of phenomena, domains, and architectural questions in linguistic theory. At the heart of the contributions is the tension between descriptive and explanatory adequacy which has long animated generative linguistics and which continues to grow thanks to the increasing amount and diversity of data available to us. The chapters address research questions on the relation of syntax to other aspects of grammar and linguistics more generally, including studies on language acquisition, variation and change, and syntactic interfaces. Many of these contributions show the influence of research by Ian Roberts and collaborators and give the reader a sense of the lively nature of current discussion of topics in synchronic and diachronic comparative syntax ranging from the core verbal domain to higher, propositional domains. This book is complemented by volume II available at https://langsci-press.org/catalog/book/276 and volume III available at https://langsci-press.org/catalog/book/277

Syntactic architecture and its consequences I: Syntax inside the grammar

This volume collects novel contributions to comparative generative linguistics that “rethink” existing approaches to an extensive range of phenomena, domains, and architectural questions in linguistic theory. At the heart of the contributions is the tension between descriptive and explanatory adequacy which has long animated generative linguistics and which continues to grow thanks to the increasing amount and diversity of data available to us. The chapters address research questions on the relation of syntax to other aspects of grammar and linguistics more generally, including studies on language acquisition, variation and change, and syntactic interfaces. Many of these contributions show the influence of research by Ian Roberts and collaborators and give the reader a sense of the lively nature of current discussion of topics in synchronic and diachronic comparative syntax ranging from the core verbal domain to higher, propositional domains. This book is complemented by volume II available at https://langsci-press.org/catalog/book/276 and volume III available at https://langsci-press.org/catalog/book/277

Syntactic architecture and its consequences I: Syntax inside the grammar

This volume collects novel contributions to comparative generative linguistics that “rethink” existing approaches to an extensive range of phenomena, domains, and architectural questions in linguistic theory. At the heart of the contributions is the tension between descriptive and explanatory adequacy which has long animated generative linguistics and which continues to grow thanks to the increasing amount and diversity of data available to us. The chapters address research questions on the relation of syntax to other aspects of grammar and linguistics more generally, including studies on language acquisition, variation and change, and syntactic interfaces. Many of these contributions show the influence of research by Ian Roberts and collaborators and give the reader a sense of the lively nature of current discussion of topics in synchronic and diachronic comparative syntax ranging from the core verbal domain to higher, propositional domains. This book is complemented by volume II available at https://langsci-press.org/catalog/book/276 and volume III available at https://langsci-press.org/catalog/book/277

Syntactic architecture and its consequences I: Syntax inside the grammar

This volume collects novel contributions to comparative generative linguistics that “rethink” existing approaches to an extensive range of phenomena, domains, and architectural questions in linguistic theory. At the heart of the contributions is the tension between descriptive and explanatory adequacy which has long animated generative linguistics and which continues to grow thanks to the increasing amount and diversity of data available to us. The chapters address research questions on the relation of syntax to other aspects of grammar and linguistics more generally, including studies on language acquisition, variation and change, and syntactic interfaces. Many of these contributions show the influence of research by Ian Roberts and collaborators and give the reader a sense of the lively nature of current discussion of topics in synchronic and diachronic comparative syntax ranging from the core verbal domain to higher, propositional domains. This book is complemented by volume II available at https://langsci-press.org/catalog/book/276 and volume III available at https://langsci-press.org/catalog/book/277

Syntactic architecture and its consequences I: Syntax inside the grammar

This volume collects novel contributions to comparative generative linguistics that “rethink” existing approaches to an extensive range of phenomena, domains, and architectural questions in linguistic theory. At the heart of the contributions is the tension between descriptive and explanatory adequacy which has long animated generative linguistics and which continues to grow thanks to the increasing amount and diversity of data available to us. The chapters address research questions on the relation of syntax to other aspects of grammar and linguistics more generally, including studies on language acquisition, variation and change, and syntactic interfaces. Many of these contributions show the influence of research by Ian Roberts and collaborators and give the reader a sense of the lively nature of current discussion of topics in synchronic and diachronic comparative syntax ranging from the core verbal domain to higher, propositional domains. This book is complemented by volume II available at https://langsci-press.org/catalog/book/276 and volume III available at https://langsci-press.org/catalog/book/277

Syntactic architecture and its consequences I: Syntax inside the grammar

This volume collects novel contributions to comparative generative linguistics that “rethink” existing approaches to an extensive range of phenomena, domains, and architectural questions in linguistic theory. At the heart of the contributions is the tension between descriptive and explanatory adequacy which has long animated generative linguistics and which continues to grow thanks to the increasing amount and diversity of data available to us. The chapters address research questions on the relation of syntax to other aspects of grammar and linguistics more generally, including studies on language acquisition, variation and change, and syntactic interfaces. Many of these contributions show the influence of research by Ian Roberts and collaborators and give the reader a sense of the lively nature of current discussion of topics in synchronic and diachronic comparative syntax ranging from the core verbal domain to higher, propositional domains. This book is complemented by volume II available at https://langsci-press.org/catalog/book/276 and volume III available at https://langsci-press.org/catalog/book/277