Volume 16, Issue 2 (Spring 2015)

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Autonomous and Automated and Connected Cars—Oh My! First Generation Autonomous Cars in the Legal Ecosystem
(Minnesota Journal of Law, Science & Technology, 2015) Glancy, Dorothy, J.
This Article considers the legal system that awaits the first fully autonomous passenger vehicles to reach consumer markets. These first generation autonomous cars will be an initial step beyond conventional, human-directed automobiles into a future in which ever more advanced vehicles, which do not need humans as drivers, will predominate. In a sense, the first generation of autonomous cars will play a transitional role, linking familiar, human-driven cars with advanced autonomous vehicles that may be configured very differently from the cars we know today.
Should You Know About the Pesticides in Your Clothes? Nanosilver and the Treated Articles Exemption to FIFRA
(Minnesota Journal of Law, Science & Technology, 2015) Meinert, James
This Note explores EPA’s statutory authority to regulate pesticides, and the policies EPA has adopted to regulate pesticides used to preserve consumer products. The use of nanosilver—small particles of silver under 100 nanometers (nm)—as an antimicrobial pesticide has brought some recent attention to EPA’s policies on articles treated with pesticides. Some public health and environmental advocates have been critical of EPA for approving the use of nanosilver as an antimicrobial in textiles and other consumer products. In general, advocates are concerned that nano-scale particles might have increased toxicity due to their size—that the tiny particles may pass through membranes and organs that ordinarily filter and block pollutants, and then accumulate in places that larger particles cannot. There is a mixed scientific literature on the toxicity profile of nano-scale particles, but nanosilver has at least the same toxicity as non-nanosilver and there are some indications of greater toxicity. In Section I, this Note documents some of the toxicity issues with nanosilver. Section II discusses those concerns within the regulatory framework EPA uses to assess and regulate pesticide risks. Section III discusses the treated articles exemption to FIFRA and how the lack of hazard labeling under the exemption could run counter to the statutory provision that allows for regulatory exemptions to “carry out the purposes of [the Act].” Section IV explores the history of the treated articles exemption, and argues the exemption does not represent a statutory limitation and can be challenged with proposals to label downstream treated articles. This perspective prioritizes EPA’s mandate to prevent adverse effects on human health and the environment, and does not prioritize society’s interest in rapid technological advances in protection from pests. However, even if a reader would allow more benefits from new pesticide products despite increased risks, this Note hopes to satisfy all readers that the treated articles exemption is not a statutory limitation of FIFRA itself. This Note aims to provide historical context for the treated articles exemption to explain the exemption’s statutory parameters. Hopefully, this Note will be helpful in efforts to allow more information to pass to consumers in the marketing and labeling of treated articles, and to help consumers better understand the technologies in our products, and the risks and benefits of pesticides in our products.
Is Groundwater that Is Hydrologically Connected to Navigable Waters Covered Under the CWA?: Three Theories of Coverage & Alternative Remedies for Groundwater Pollution
(Minnesota Journal of Law, Science & Technology, 2015) Kvien, Allison L.
The EPA’s interpretation that directly connected groundwater is within the scope of the CWA’s jurisdiction has been accepted with varying degrees of success among the federal district and circuit courts. Some courts have concluded that jurisdiction over such connected groundwater is warranted because (1) the CWA’s goal is to protect navigable waters, or (2) because the EPA is entitled to some level of deference on the issue. Other courts have decided that the CWA was simply not meant to cover groundwater, citing pieces of legislative history to support that position. A majority of courts have concluded that the CWA does cover connected groundwater, but the Supreme Court has yet to rule on the issue. This Note will explore the arguments that courts on both sides of the divide have accepted in concluding that groundwater hydrologically connected to navigable waters is or is not covered, the three potential theories for finding CWA jurisdiction over connected groundwater, what scientific factors courts have used in making case-specific determinations about whether hydrologically connected groundwater is covered, and alternative remedies that may be used to regulate or control pollution to groundwater under existing regulations.
The Hydropower Regulatory Efficiency Act: Not Giving a Dam for Negative Externalities or Stakeholder Oversight
(Minnesota Journal of Law, Science & Technology, 2015) Cumming, Catherine
In an effort to streamline FERC’s regulatory process and promote the development of small-scale hydropower projects, Congress passed the Hydropower Regulatory Efficiency Act of 2013 (the Act), also known as the 1040-EZ of hydropower. This Note contends that in an effort to promote the development of small-scale hydropower projects and streamline FERC’s regulatory process, it appears that Congress favored efficiency over oversight, and failed to recognize the negative externalities of the dams the Act seeks to utilize. Part I of this Note introduces the relevant background information and the regulatory process for hydropower development. Within Part I, nonpowered dams and their potential for hydropower development is introduced. Part I concludes with a look at the current regulation of hydropower dams and how the Act seeks to streamline the relicensing process by reducing regulatory burdens. Part II considers whether the aggregate increase in hydropower outweighs the environmental, economic, and social externalities of maintaining dams and installing hydropower infrastructure. This Part also considers whether the Act values efficiency and hydropower gained from streamlined regulations over community and stakeholder oversight. Part III proposes that FERC and Congress consider a more concentrated and efficient approach to increased hydropower generation and energy policy.
Biosimilar Regulation: Bringing the United States Up To Speed with Other Markets
(Minnesota Journal of Law, Science & Technology, 2015) Banthia, Vinita
In light of the expected end of patent terms for many large molecule drugs called biologics, there has been a rise in the development of biosimilars—non-branded, copycat versions of biologics. Unlike generic drugs, which are non-branded versions of small molecule chemical drugs, biosimilars are not identical to the biologic they reference, since biologics are derived from living organisms and are often injected into the patient, which makes them impossible to replicate perfectly. Despite their complexities, biologics exist to treat important diseases such as AIDS, Alzheimer’s, and cancer. In 2010, the Biologics Price Competition and Innovation Act (Biosimilars Act) was added to the Public Health Service Act (PHS Act), outlining the approval process and regulatory plan for biosimilars. The Food and Drug Administration (FDA) subsequently released six Draft Guidance Documents (Guidance Documents) to clarify some of the provisions in the Biosimilars Act and to define ambiguous terms and phrases. Although biosimilars have been an important treatment option in many countries for over twenty years, none have been approved in the United States. On March 15, 2015, the FDA approved Sandoz’s Zarxio after the FDA’s Oncological Drugs Advisory Committee recommended approval by the agency. However, on May 5, 2015, the Appeals Court for the Federal Circuit granted an injunction preventing Sandoz from selling Zarxio until further arguments are heard. The FDA may be progressing toward a more lenient view on biosimilar approvals; however, the court’s injunction indicates that the United States lags in its exploitation of biosimilars, and revisions to the current law will allow for a robust biosimilars market. Previous scholarship has outlined the barriers to biosimilar acceptance in the United States and acknowledged the potential benefit of higher approval rates. This Note analyzes the Biosimilars Act and the Guidance Documents, and proposes revisions to these documents and to the current structure of the insurance and health care systems in relation to biosimilars. These adaptations will allow the United States to improve access to key medical treatments across the country and catch up with other biosimilar markets.
The SDVs Are Coming! An Examination of Minnesota Laws in Preparation for Self-Driving Vehicles
(Minnesota Journal of Law, Science & Technology, 2015) Peck, Spencer; Fatehi, Leili; Douma, Frank; Lari, Adeel
Self-driving vehicles (SDVs) are predicted to be the future of automotive transportation. The significant potential benefits of SDVs to safety, congestion reduction, land use, and productivity are hard to ignore. Although fully automated vehicles are still a ways away, the technology is rapidly advancing and becoming more legally accepted. For example, the National Highway Traffic Safety Administration (NHTSA) requires all newly manufactured cars to have at least a low-level of autonomous vehicle technology and suggests widespread adoption of more advanced technology by 2020. Four states and the District of Columbia have some form of legislation expressly allowing SDVs or the testing of such vehicles within state boundaries. In fact, two states—California and Nevada—have even issued comprehensive regulations for both private use and testing of SDVs. Several companies, most notably Google, are aggressively pursuing the technology and advocating for legal changes in support of SDVs. But what does this all mean for Minnesota drivers, laws and lawmakers, and local economies? This Article explores the development of SDVs and related technology and how states have responded to this development as context for more substantive discussion about why and how Minnesota might move to adopt and adapt to this transformative technology. Specifically, this Article will explore how current laws may already permit SDVs and how the law could be, or in some cases must be, modified to authorize testing and use of SDVs in the state. Finally, this Article will describe why SDVs and the related legal changes needed to support their development and adoption can greatly benefit Minnesota’s citizens and economy.
Driving into the Digital Age: How SDVs Will Change the Law and Its Enforcement
(Minnesota Journal of Law, Science & Technology, 2015) Palodichuk, Sarah Aue
The Future of Autonomous Vehicle Technology as a Public Safety Tool
(Minnesota Journal of Law, Science & Technology, 2015) Sykora, Robert
Every year, clever people with wonderfully innovative ideas bring legislation to their state capitols and to Congress. They have great hope that their innovations will make the world a better place. It does not always work out. Often these smart people can be seen standing in the corridor outside meeting rooms whispering to each other anxiously. They have looks of shock and disappointment on their faces, usually just after their bill was unceremoniously disemboweled in a committee hearing. The legislative process necessarily is one of compromise, and few competing interests demand more compromise than those brought to the table by Public Safety and Homeland Security representatives. This Article is a satirical exploration of how autonomous vehicle regulation may unfold in public policy forums over the next few decades. The piece will be perceived as dystopian by some, utopian by others.
Climbing Mount Next: The Effects of Autonomous Vehicles on Society
(Minnesota Journal of Law, Science & Technology, 2015) Levinson, David
The United States spent almost the entire twentieth century climbing Mount Auto. From the 1920s onward, the automobile was the dominant mode of travel for Americans, accumulating more miles per capita than other modes. While the Great Depression slowed the auto’s growth, it did not result in decline. There was a brief downturn during World War II, and a few hiccups in the steady rise of mileage. But the later 2000s and 2010s have seen a sharp downturn in motor vehicle use per capita. This drop is greater than the drop during World War II in absolute terms (though the War saw a drop of twenty-three percent off the pre-war peak, and the 2012 drop is seven percent below 2005). It is complemented by an apparent plateauing in total miles of paved roads since 2008. Within the transportation sector there have been small shifts over the past fifteen years, which cannot explain much of the decline of travel. There are active transportation modes, like walking and biking, which work well for short trips, and certainly have niches they can grow into if land development intensifies and people reorganize their lives to enable them. For instance, I am one of the seven percent of Minneapolitans who walk to work. The numbers are much lower outside core cities, and nationally, at three percent. Transit ridership per capita is up ever so slightly. There are a slew of “new mobility options” which use information technologies to allow travel without owning an automobile, but are not yet visible in the transportation statistics. These include peer-to-peer taxi and ridesharing services and dynamic real-time rental cars. While these are useful in their niches, they likely are not cost-effective enough to be the main transportation mode for the vast majority of the population with the given technology. Today these new mobility options are supplements when the main mode does not solve the job to be done. In the future, that might change. Technologies allow people to do more of the same, and they allow people to do new things. It is easier to predict more of the same than new things.
The Increasing Importance of Vehicle Based Risk Assessment for the Vehicle Insurance Industry
(Minnesota Journal of Law, Science & Technology, 2015) Gage, Thomas; Bishop, Richard; Morris, Jonathan
Insurance is a data driven world of actuarial analysis. Insurance carriers rate drivers and price coverage based on past driving performance, credit score (which is highly correlated to, but obviously not causal of, driving behavior), and increasingly Usage Based Insurance (UBI). Insurance carriers also factor in annual mileage, where the vehicle is garaged and driven, and the type and value of the vehicle. Modest increases in data and analysis can provide one insurance company with an important advantage over its competitors. Now a new opportunity (and challenge) awaits the insurance industry. Crash Avoidance (CA) technologies such as electronic stability control, lane departure avoidance, and forward collision avoidance are poised to revolutionize auto safety. These crash avoidance technologies are fast becoming widely available and are aimed at reducing the approximately six million annual vehicle crashes on U.S. roads. Each auto manufacturer is developing its own versions of CA technologies, with different capabilities and likely different degrees of efficacy. This means that different makes and models of vehicles with different CA technologies, and different generations of the technologies, will perform differently. Soon, knowing about the driver’s driving behavior will be insufficient for insurance companies. It will be vital to know what type and generation of CA technology is on the driver’s vehicle and how that technology performs in various driving environments. It will be many decades before the entire U.S. vehicle fleet is equipped with CA technologies of one generation or another. And even longer before most of the fleet is fully automated. This interim period provides an opportunity for insurers to move beyond just understanding drivers to also better understanding vehicles and their CA effectiveness.
Self-Driving Vehicles and Policy Implications: Current Status of Autonomous Vehicle Development and Minnesota Policy Implications
(Minnesota Journal of Law, Science & Technology, 2015) Lari, Adeel; Douma, Frank; Onyiah, Ify
Whether you call them self-driving, driverless, automated, or autonomous, these vehicles are on the move. Recent announcements by Google (which drove over 500,000 miles on its original prototype vehicles) and other major automakers indicate the potential for development in this area. Driverless cars are often discussed as “disruptive technology” with the ability to transform transportation infrastructure, expand access, and deliver benefits to a variety of users. Some observers estimate limited availability of driverless cars by 2020, with wide availability to the public by 2040. This Article includes examination of the current status of this technology, and the implications for road safety, capacity, travel behavior, and cost. This Article also considers the regulatory framework and policy challenges this technology may face. In particular, this Article presents a Minnesota perspective. As the Minnesota Department of Transportation implements the Twenty-Year Minnesota State Highway Investment Plan and establishes priorities for the next several decades, state officials need information about the potential for this technology to transform Minnesota’s transportation system. The Metropolitan Council also needs to pay serious attention, as self-driving cars can potentially change the way we live and travel within the Council’s planning horizon. Additionally, Minnesota policymakers will need to consider whether current policy accommodates the deployment of this driverless technology. Finally, this Article summarizes the current consensus about self-driving vehicles, considers the implications for Minnesota, and suggests steps that policymakers in Minnesota can take to prepare for such technology.
The Legal and Policy Road Ahead: An Analysis of Public Comments in NHTSA’s Vehicle-to-Vehicle Advance Notice of Proposed Rulemaking
(Minnesota Journal of Law, Science & Technology, 2015) Boustead, Anne E.; Stanley, Karlyn D.
As motor vehicle accidents have overwhelming human and economic costs, policy interventions that lower the risk of accidents have tremendous potential to improve public health and safety. One particularly promising innovation is Vehicle-to-Vehicle (V2V) communication technologies, which transmit information between nearby automobiles in order to warn drivers of an imminent collision. V2V communications may enable drivers to avoid or mitigate harmful accidents, but only if widely adopted. The National Highway Traffic Safety Administration (NHTSA) has begun planning for the implementation of V2V technology, and has recently completed the public comment period of an Advance Notice of Proposed Rulemaking (ANPRM) in preparation for rulemaking in this area. In this Article, we qualitatively and quantitatively analyze the public comments received by NHTSA in response to its ANPRM concerning V2V communications technologies. Over 800 individuals and groups responded to the ANPRM; almost ninety-five percent of comments were provided by members of the general public. We discuss major considerations articulated by various stakeholder groups, including industry, policy advocacy groups, and the public as a whole. In particular, we focus on three concerns identified by NHTSA as potential barriers to acceptance of V2V communications technology by both interested stakeholder groups and the public: implications for privacy, threats to security, and potential liability. We then discuss the implications of our analysis for public acceptance of V2V communications technology and NHTSA’s upcoming privacy impact assessment of V2V communications devices.