Science and Technology Law Commons^™

Pesticides: Problems Facing The Industry In Submitting Proprietary Scientific Data To An International Organization, Alexander R. Nemajovsky

Georgia Journal of International & Comparative Law

No abstract provided.

U.S. Private On-Orbit Space Situational Awareness Systems And Services: Legal And Regulatory Challenges, Michael Mineiro

Space Traffic Management Conference

One component of Space Traffic Management (STM) is on-orbit Space Situational Awareness (SSA) systems and services. Advances in technology and a growing demand for SSA services, information, and data, coupled with U.S. Government policy that promotes the purchase and use of commercial SSA capabilities, means that private commercial sector is likely to have an important role to play. To date, there is no federal agency with clear jurisdiction over on-orbit remote sensing operations. This paper examines the current regulatory framework, identifies gaps and limitations, and identifies possible ways forward.

On Presidents, Agencies, And The Stem Cells Between Them: A Legal Analysis Of President Bush's And The Federal Governments Policy On The Funding Of Research Involving Human Embryonic Stem Cells, Yaniv Heled

Yaniv Heled

On August 9, 2001, President George W. Bush announced his policy on research involving human embryonic stem cells and proclaimed that federal funding would be allocated only to research involving human embryonic stem cell lines produced prior to his announcement (the Directive). Immediately thereafter, the National Institutes of Health (NIH) announced that it would act in accordance and full compliance with the Directive and took action to implement it. Since then, the Directive has dictated the nature and extent of scientific research involving human embryonic stem cells. Yet, astonishingly, despite being the subject of a boisterous debate, the Directive’s legality …

"Do No Harm": A Comparative Analysis Of Legal Barriers To Corporate Clinical Telemedicine Providers In The United States, Australia, And Canada, Ian R. Landgreen

Georgia Journal of International & Comparative Law

No abstract provided.

One Hundred Nos: An Empirical Analysis Of The First 100 Denials Of Institution For Inter Partes And Covered Business Method Patent Reviews, Jonathan R. K. Stroud, Jarrad Wood

Jonathan R. K. Stroud

Tasked in 2011 with creating three powerful new patent review trial regimes, the U.S. Patent and Trademark Office—through the efforts of their freshly empowered quasi-judicial body, the Patent Trial and Appeals Board—set to creating a fast-paced trial with minimal discovery and maximum efficiency. In the first two years of existence, the proceedings have proved potent, holding unpatentable many of the claims that reach decisions on the merits. Yet a small subsection of petitions never make it past the starting gate, resulting in wasted time and effort on the parts of petitioners—and likely sighs of relief from the rights-holders. Parties on …

Regulation Of Chemical Risks: Lessons For Tsca Reform From Canada And The European Union, Adam Abelkop, John D. Graham

Adam Abelkop

The United States Congress is considering reform of the Toxic Substances Control Act (TSCA) of 1976. This Article compares recent reforms in Europe and Canada in order to draw lessons for TSCA reform. In 2006, the European Union enacted the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation while Canada used existing authority under the Canadian Environmental Protection Act (CEPA) of 1999 to initiate the 2006 Chemicals Management Plan (CMP). Focusing on the tens of thousands of industrial chemicals now in use in the US, we offer several suggestions for TSCA reform based on the European and Canadian experiences. …

The Costs And Benefits Of Regulatory Intervention In Internet Service Provider Interconnection Disputes: Lessons From Broadcaster-Cable Retransmission Consent Negotiations, Rob Frieden

Rob Frieden

This paper considers what limited roles the FCC may lawfully assume to ensure timely and fair interconnection and compensation agreements in the Internet ecosystem. The paper examines the FCC’s limited role in broadcaster-cable television retransmission consent negotiations with an eye toward assessing the applicability of this model. The FCC explicitly states that it lacks jurisdiction to prescribe terms, or to mandate binding arbitration. However, it recently interpreted its statutory authority to ensure “good faith” negotiations as allowing it to constrain broadcaster negotiating leverage by prohibiting multiple operators, having the largest market share, from joining in collective negotiations with cable operators. …

Drones, Henry H. Perritt Jr., Eliot O. Sprague

All Faculty Scholarship

Abstract

Drone technology is evolving rapidly. Microdrones—what the FAA calls “sUAS”—already on the market at the $1,000 level, have the capability to supplement manned helicopters in support of public safety operations, news reporting, and powerline and pipeline patrol, when manned helicopter support is infeasible, untimely, or unsafe.

Larger drones–"machodrones”–are not yet available outside battlefield and counterterrorism spaces. Approximating the size of manned helicopters, but without pilots, or with human pilots being optional, their design is still in its infancy as designers await greater clarity in the regulatory requirements that will drive airworthiness certification.

This article evaluates drone technology and design …

Drones, Henry H. Perritt Jr., Eliot O. Sprague

Henry H. Perritt, Jr.

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Journal Articles

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

Response To Questions In The First White Paper, 'Modernizing The Communications Act', Randolph J. May, Richard A. Epstein, Justin (Gus) Hurwitz, Daniel Lyons, James B. Speeta, Christopher S. Yoo

Daniel Lyons

The House Energy and Commerce Committee has begun a process to review and update the Communications Act of 1934, last revised in any material way in 1996. As the Committee begins the review process, this paper responds to questions posed by the Committee that all relate, in fundamental ways, to the question: "What should a modern Communications Act look like?" The Response advocates a "clean slate" approach under which the regulatory silos that characterize the current statute would be eliminated, along with almost all of the ubiquitous 'public interest' delegation of authority found throughout the Communications Act. The replacement regime …

Agenda: Fracking, Water Quality And Public Health: Examining Current Laws And Regulations, Network For Public Health Law, American Society Of Law, Medicine & Ethics, Public Health Law Research Program

Fracking, Water Quality and Public Health: Examining Current Laws and Regulations (March 20)

Improved technology developments in directional drilling and hydraulic fracturing, more commonly known as "fracking," have resulted in an oil and gas production boom nationwide. Fracking involves pumping pressurized water, sand, and chemicals down wells to crack bedrock, freeing petroleum and natural gas. Wastewater discharges, hydraulic fracturing fluid releases, and other accidental spills pose potential water quality risks, sparking concern for public health.

This webinar will examine the laws and regulations governing water quality issues related to fracking, recent state court decisions affecting regulations, and implications for public health.

Slides: Best Management Practices For Oil And Gas Development And Comparative Water Quality Database Of Regulations Relating To Shale Oil And Gas, Matt Samelson, University Of Colorado Boulder. Getches-Wilkinson Center For Natural Resources, Energy, And The Environment. Intermountain Oil And Gas Bmp Project

Fracking, Water Quality and Public Health: Examining Current Laws and Regulations (March 20)

Presenter: Matt Samelson, J.D., Attorney, Consultant for Intermountain Oil and Gas Best Management Practices (BMP) Project, Getches-Wilkinson Center for Natural Resources, Energy and the Environment, University of Colorado Law School

34 slides

Federal And State Authority For Network Neutrality And Broadband Regulation, Tejas N. Narechania

Tejas N. Narechania

For the second time in less than four years, the D.C. Circuit has rebuffed the Federal Communications Commission’s attempt at imposing network neutrality rules on internet traffic. But in so doing, the D.C. Circuit affirmed the FCC’s theory of jurisdiction based on section 706 of the Telecommunications Act of 1996. This ruling has the significant effect of transforming a questionable source of authority into what may become the Commission’s most significant font of regulatory power.

Surprisingly, section 706 seems to give the Commission the power to implement a slightly revised set of network neutrality rules. By narrowing the scope of …

Response To Questions In The First White Paper, 'Modernizing The Communications Act', Randolph J. May, Richard A. Epstein, Justin (Gus) Hurwitz, Daniel Lyons, James B. Speeta, Christopher S. Yoo

All Faculty Scholarship

The House Energy and Commerce Committee has begun a process to review and update the Communications Act of 1934, last revised in any material way in 1996. As the Committee begins the review process, this paper responds to questions posed by the Committee that all relate, in fundamental ways, to the question: "What should a modern Communications Act look like?"

The Response advocates a "clean slate" approach under which the regulatory silos that characterize the current statute would be eliminated, along with almost all of the ubiquitous 'public interest' delegation of authority found throughout the Communications Act. The replacement regime …

Speculative Tech: The Bitcoin Legal Quagmire & The Need For Legal Innovation, Paul H. Farmer Jr.

Journal of Business & Technology Law

No abstract provided.

Will More, Better, Cheaper, And Faster Monitoring Improve Environmental Management?, Ryan P. Kelly

Ryan P Kelly

Two critical problems in environmental management are a lack of primary data and the difficulty of assessing the environmental impacts of human activities. Producing the information necessary to address these twin challenges is often difficult and expensive, which impedes decisionmaking in environmental management. I focus here on the possibility of making data collection more powerful and more cost-effective with a suite of analyses made tractable by emerging technology for genetic analysis. More, better, cheaper, and faster information about the planet’s living resources promises to influence a wide range of legal and policy processes—from Clean Water Act compliance and related public …

Maryland's Social Networking Law: No "Friend" To Employers And Employees, Alexander Borman

Journal of Business & Technology Law

No abstract provided.

Procedural Architecture Matters: Innovation Policy At The Federal Communications Commission, J. Brad Bernthal

Publications

This Article examines the puzzle of whether today's Federal Communications Commission ("FCC" or the "Agency") is institutionally suited to craft telecommunications innovation policy and, if not, what changes are needed to better equip the Agency to respond to twenty-first century realities. Evaluation of FCC innovation policy performance is stubbornly difficult. Some criticize the FCC as a brake on innovation yet, under the FCC's oversight, the United States' communications industry has become an innovative engine propelling the overall economy more than ever before. It is difficult to untangle whether the FCC deserves credit for helping usher in today's communications age, whether …

Technological Determinism And Its Discontents, Christopher S. Yoo

All Faculty Scholarship

This book review takes a critical review of the claim advanced by Susan Crawford in Captive Audience that the merger between Comcast and NBC Universal would harm consumers and that policymakers should instead promote common carriage regulation and subsidize municipal symmetrical gigabit fiber-to-the-home (FTTH). First it evaluates the extent to which next-generation digital subscriber lines (DSL) and wireless broadband technologies can serve as effective substitutes for cable modem service, identifying FCC data showing that the market has become increasingly competitive and likely to continue to do so. Furthermore, the market is not structured in a way that would permit the …

Layers Of Law: The Case Of E-Cigarettes, Eric A. Feldman

All Faculty Scholarship

This paper, written for a symposium on "Layers of Law and Social Order," connects the current debate over the regulation of electronic cigarettes with socio-legal scholarship on law, norms, and social control. Although almost every aspect of modern life that is subject to regulation can be seen through the framework ‘layers of law,’ e-cigarettes are distinguished by the rapid emergence of an unusually dense legal and regulatory web. In part, the dense fabric of e-cigarette law and regulation, both within and beyond the US, results from the lack of robust scientific and epidemiological data on the behavioral and health consequences …

A System Of Men And Not Of Laws: What Due Process Tells Us About The Deficiencies In Institutional Review Boards, Greer Donley

Articles

Governmental regulation of human subjects research involves unique agency action. It delegates power to non-expert committees, Institutional Review Boards, to decide whether research protocols are "ethical" according to vague federal regulations. Without IRB approval, the protocol cannot be investigated. The empirical evidence regarding this system demonstrates that IRBs render deeply inconsistent and inaccurate outcomes. This Article argues that the lack of due process in the IRB system is to blame for such arbitrary agency action. By juxtaposing the levels of process required for IRB approval or research with FDA new drug approval--agency action involving similar interests--this Article highlights that IRBs …

Enlightened Regulatory Capture, David Thaw

Articles

Regulatory capture generally evokes negative images of private interests exerting excessive influence on government action to advance their own agendas at the expense of the public interest. There are some cases, however, where this conventional wisdom is exactly backwards. This Article explores the first verifiable case, taken from healthcare cybersecurity, where regulatory capture enabled regulators to harness private expertise to advance exclusively public goals. Comparing this example to other attempts at harnessing industry expertise reveals a set of characteristics under which regulatory capture can be used in the public interest. These include: 1) legislatively-mandated adoption of recommendations by an advisory …