Articles by mjlst

Let’s Talk: The Cold & Flu Season & Personalized Medicine

November 13, 2015
Drug Policy, FDA, Pharmaceuticals, Public Health

Allison Kvien, MJLST Managing Editor

As we approach cold and flu season, it is time we all start thinking about properly taking care of ourselves. Many individual factors have been linked to your heath. A Newsweek article reported that people who get less than 5 hours of sleep a night are 4.5 times as likely to become ill. According to The L.A. Times, an elevated heart rate could mean that a cold is on the way. Finally, an article from Harvard found a link between your popularity and how early in the season you become ill (yes, really—and I guess this explains why I haven’t gotten the flu since I was a kid). While this is all helpful information, it represents only a few factors that contribute to a person’s overall health. Over the years, the practice of medicine has become more accepting of the concept that “one size does not fit all” and that patients may need more personalized medicine.

One interesting development in personalized medicine was ten years ago, in 2005, when FDA approved the first race-specific drug, BiDil. As Dorothy E. Roberts explained in her MJLST article, BiDil, is “a combination drug that relaxes the blood vessels, [and] was authorized to treat heart failure in self-identified black patients.” Many scholars and citizens alike have found the approval of BiDil controversial, for a variety of reasons, legal, political, ethical, and otherwise. It may be, however, simply one more step on the path to personalization of medicine for patients. As Roberts reported, “BiDil increased survival by an astonishing 43 percent. Hospitalizations were reduced by 39 percent.” Roberts’s opinion, however, was that BiDil should have been approved for all heart failure patients, regardless of race because there was no underlying genetic difference in African Americans that the drug relied on for its positive results. The economic results of the BiDil drug may prevent others from going developing race-specific drugs for a while, though; BiDil has been described as a “flop.”

Cold season medicine is normally pretty generic. Think: Airborne, Sudafed, Advil, and cough drops, my favorite of which are the less-than-pleasant tasting Fisherman’s Friends that completely numb your throat—seriously, try them. I think the concept of personalized cold and flu medicine is particularly interesting because our current cold season medicine is normally over-the-counter and generalized. Can you imagine a future where you pick up a cold medicine tailored specifically to your genetic background? Well, it may already be happening. Just two years ago, FDA approved personalized flu vaccines for three groups: the elderly, children, and those with allergies. These personalized vaccines may allow some groups of our population to receive them when they wouldn’t otherwise be able to, or to at least receive them more safely. Specifically for flu vaccines, anyway, this step in personalization may not also reflect increased overall effectiveness in preventing illness. But let’s not give you an excuse to not get your flu vaccine. Go get that flu shot that was made just for you!

The Legal Persona of Electronic Entities – Are Electronic Entities Independent Entities?

November 13, 2015
Data, Intellectual Property, Internet

Natalie Gao, MJLST Staffer

The advent of the electronic age brought about digital changes and easier accessibility to more information but with this electronic age came certain electronic problems. One such problem is whether or not electronic entities like, (1) usernames online, (2) software agents, (3) avatars, (4) robots, and (5) artificial intelligence, are independent entities under law. A username for a website like eBay or for a forum, for all intents and purposes may well be just a pseudonym for the person behind the computer. But at what point does the electronic entity become an independent entity, and at what point does the electronic entity start have the rights and responsibilities of a legally independent entity?

In 2007, Plaintiff Marc Bragg brought suit against Defendants Linden Research Inc. (Linden), owner of the massive multiplayer online role playing game (MMORPG) Second Life, and its Chief Executive Officer. Second Life is a game with a telling title and it essentially allows its players to have a second life. It has a market for goods, extensive communications functions, and even a red-light district, and real universities have been given digital campuses in the game, where they have held lectures. Players of Second Life purchase items and land in-game with real money.

Plaintiff Bragg’s digital land was frozen in-game by moderators due to “suspicious” activity(s) and Plaintiff brought suit claiming he had property rights to the digital land. Bragg v. Linden Research, Inc., like its descendants including Evans v. Linden Research, Inc. (2011), have been settled out of court and therefore do not offer the legal precedents it could potentially have had regarding its unique fact pattern(s). And Second Life is also a very unique game because pre-2007, Linden had been promoting Second Life by announcing they recognize virtual property rights and that whatever users owned in-game would be belong to the user instead of to Linden. But can the users really own digital land? Would it be the users themselves owning the ditigal land or the avatars they make on the website, the ones living this “second life”, be the true owners? And at what point can avatars or any electronic entity even have rights and responsibilities?

An independent entity is not the same as a legal independent entity because an latter, beyond just existing independently, has rights and responsibilities pursuant to law. MMORPGs may use avatars to allow users to play games and avatars may be one step more independent than a username, but is that avatar an independent entity that can, for example, legally conduct commercial transactions? Or rather, is the avatar conducting a “transaction” in a leisure context? In Bragg v. Linden Research, Inc., the court touches on the issue of transactions but it rules only on civil procedure and contract law. And what about avatars existing now in some games that can play itself? Is “automatic” enough to make something an “independent entity”?

The concept of an independent electronic entity is discussed in length in Bridging the Accountability Gap: Rights for New Entities in the Information Society. Authors Koops, Hildebrandt, and Jaquet-Chiffelle compares the legal personhood of electronic artificial entities with animals, ships, trust funds, and organizations, arguing that giving legal personhood to basically all (or just “all”) currently existing electronic entities bring up problems such as needing representation with agency, lacking the “intent” required for certain crimes and/or areas of law, and likely needing to base some of their legal appeals in area of human/civil rights. The entities may be “actants” (in that they are capable of acting) but they are not always autonomous. A robot will need mens rea to assess responsibility, and none of the five listed entities do not have consciousness (which animals do have), let alone self-consciousness. The authors argue that none of the artificial entities fit the prima facies definition of a legal person and instead they moved to evaluate the entities on a continuum from automatic (acting) to autonomic (acting on its own), as well as the entity’s ability to contract and bear legal responsibility. And they come up with three possible solutions, one “Short Term”, one “Middle Term”, and one “Long Term”. The Short Term method, which seems to be the most legally feasible under today’s law, purposes creating a corporation (a legally independent entity) to create the electronic entity. This concept is reminiscent of theorist Gunther Teubner’s idea of a using a hybrid entity, one that combines an electronic agent(s) with a company with limited liability, instead of an individual entity to give something rights and responsibilities.

Inevitably, even though under the actual claims brought to the court, Bragg v. Linden Research, Inc. mostly seems more like an open-source licensing issue than an issue of electronic independent entity, Koops, Hildebrandt, and Jaquet-Chiffelle still tries to answer some questions that may be very salient one day. Programs can be probabilistic algorithms but no matter how unpredictable the program may be, their unpredictability is fixed in the algorithm. An artificial intelligence (AI), a program that grows and learns and create unpredictability on its own, may be a thing of science fiction and The Avengers, may one day be reality. And an AI does not have to be the AI of IRobot; it does not have to have a personality. At what point will we have to treat electronic entities as legally autonomic and hold it responsible for the things it has done? Will the future genius-programmer, who creates an AI to watch over the trusts in his/her care, be held accountable when that AI starts illegally funneling money out to the AmeriCorp bank account the AI was created to watch over, into the personal saving accounts of lamer non-MJLST law journals in the University of Minnesota? Koops, Hildebrandt, and Jaquet-Chiffelle argues yes, but it largely depends on the AI itself and the area of law.

EPA Revises Agricultural Worker Protection Standard, to the Disappointment of Agriculture Industry Groups

November 13, 2015
Administrative Law, Environmental Law, EPA

Jody Ferris, MJLST Staffer

An important development on the regulatory front has some agriculture industry groups shaking their heads. The U.S. Environmental Protection Agency has released finalized revisions to the 1992 Agricultural Worker Protection Standard on Sept. 28, 2015 (40 CFR 170). These regulations apply to millions of agricultural workers in fields, forests, orchards, and greenhouses across the country. The regulations are meant to enforce the observation of good safety practices in the use of pesticides by agricultural workers.

The changes to the current requirements include:

-a new minimum age requirement that prohibits children under the age of 18 from handling pesticides.

-mandatory posting of no-entry signs on fields that have been recently treated with highly dangerous pesticides.

-whistleblower protections to protect employees who alert authorities to illegal practices.

-increased frequency of employer provided safety training (now required annually, up from the previous requirement of every five years).

-recordkeeping requirements (records of training must be kept for two years, previous requirements did not require any record keeping).

-increased requirements for use of safety equipment, including fit testing and employee training on use of safety equipment. Recordkeeping of completion of safety equipment training and fit testing is also required. The previous requirements did not require any training, formal fit testing, or record keeping.

Agricultural industry groups are unhappy with many of the revisions to the regulations. A coalition including the National Association of Wheat Growers, the National Council of Farmer Cooperatives, the American Farm Bureau Federation, and the American Seed Trade Association submitted a 14-page comment letter during the public comment period and claim that their comments were not taken under proper consideration in the final revision of the rule. The coalition argued that since the original regulations were introduced in 1992, there have been significant improvements in worker safety and that acute poisoning events have been greatly reduced, thereby eliminating the need for more stringent regulations. In addition, they argue that the EPA has severely underestimated the financial costs that the new requirements place on agricultural producers. Criticism from the Agricultural Retailers Association includes the concern that the new rules will put employers at risk for increased liability without significantly increasing worker safety.

It is currently unclear whether any regulated parties will seek to challenge the revised regulations in court. It also remains unclear precisely how great a burden the new requirements will place on agricultural producers or how much they will improve the safety of workers until they are followed in practice for some time. It remains to be hoped that the new requirements will indeed significantly improve the safety of agricultural workers on the job and justify any increased burden on employers.

The “Patent Dance” for Now: Rehearing Denied in Amgen v. Sandoz

November 9, 2015
Biotechnology, Patents, Pharmaceuticals

Jeff Simon, MJLST Staffer

On July 21, 2015, the Federal Circuit’s decision in Amgen v. Sandoz established that a biosimilar applicant does not have to follow the patent dispute resolution procedures set forth by the Biologics Price Competition and Innovation Act. The BPCIA’s “patent dance,” located at 42 U.S.C. § 262(l)(2)(a), sets forth procedures requiring biosimilar applicants to disclose the biosimilar application and information describing the methods and procedures of its production to the sponsor of the reference biologic drug. The Federal Circuit’s fractured decision denied the compulsory nature of the “patent dance,” while still holding that biosimilar applicants are required to provide the biologic drug sponsor 180 days advanced notice of the first commercial marketing of its biosimilar product in accordance § 262(l)(2)(a).

Considering that the decision of the court was split by favoring the biosimilar applicants regarding the issue of the “patent dance” while favoring the biologic sponsor when it came to market disclosure, the decision was far from a satisfying result for either party as neither party came out as the clear victor. As such, both Amgen and Sandoz filed petitions for an en banc rehearing on August 20, 2015. Amgen’s petition for review once again contended that the language of § 262(I)(2)(a) as stated by congress, specifically the use of the word “shall,” indicates that the “patent dance’s” procedures are mandatory. Sandoz contended among other things that the 180-day provision necessarily increases the exclusivity period from 12 years to 12 and a half years and further that the court incorrectly asserted that notice was mandatory and enforceable. Both parties submitted amicus curiae briefs in agreement that, as a matter of first impression, it was appropriate for an en banc rehearing.

However, despite a fractured panel deciding a matter of first impression, Federal Circuit denied a rehearing in decision on October 16, 2015. The decision came as surprise to many of those associated with the biologic drug industry, especially considering the novelty and discord upon the issues. Considering the fact that both parties sought a rehearing, the court may have decided that the issue was undeserving of the court’s continued interest and resources. Both parties may file petitions for certiorari.

In regards to the future implications of the decision, it’s important to note that many of the high revenue pioneer biologic drugs are set to have their US patents expire within the next few years. This expected “patent cliff’ is certain to drive momentum within the biosimilar market. This wave of biosimilar applications is sure to have large implications upon the BPCIA, and particularly whether the “patent dance” is optional. All considered, the issues presented in Amgen may be approaching a level of importance that draws the attention of SCOTUS. It’s possible that a grant of certiorari may be in order to settle the debate on the BPCIA’s “patent dance” and market disclosure requirements, particularly considering the economic ramification of the anticipated biologics’ patent cliff.

Data Breach and Business Judgment

November 9, 2015
Business Law, Cyber Security, Data, Internet

Quang Trang, MJLST Staffer

Data breaches are a threat to major corporations. Corporations such as Target Co. and Wyndham Worldwide Co. have been victim of mass data breaches. The damage caused by such breaches have led to derivative lawsuits being filed by shareholders to hold board of directors responsible.

In Palkon v. Holmes, 2014 WL 5341880 (D. N.J. 2014), Wyndham Worldwide Co. shareholder Dennis Palkon filed a lawsuit against the company’s board of directors. The judge granted the board’s motion to dismiss partially because of the Business Judgment Rule. The business judgement rule governs when boards refuse shareholder demands. The principle of the business judgment rule is that “courts presume that the board refused the demand on an informed basis, in good faith and in honest belief that the action taken was in the best interest of the company.” Id. The shareholder who brings the derivative suit has the burden to rebut the presumption that the board acted in good faith or that the board did not base its decision on reasonable investigation.

Cyber security is a developing area. People are still unsure how prevalent the problem is and how damaging it is. It is difficult to determine what a board needs to do with such ambiguous information. In a time when there is no set corporate cyber security standards, it is difficult for a shareholder to show bad faith or lack of reasonable investigation. Until clear standards and procedures for cyber security are widely adopted, derivative suits over data breaches will likely be dismissed such as in Palkon.

Marijuana Industry Continues to Search for Banking Solution

November 9, 2015
Business Law, Competition, Economics

Neal Rasmussen, MJLST Managing Editor

While the legal marijuana industry continues to rapidly expand in the United States, a major question still looms: Where should the millions of dollars generated by the industry be placed? Up to this point the nation’s banks have refused to take money for fear of federal repercussions. The lack of banking is one of the biggest problems the industry currently has and creates a dangerous all cash environment. While it continues to be an industry dominated by cash vaults and armed guards, change could soon be on the way.

While the provisions of the unlicensed money remitter statute, 18 U.S.C. § 1960, the money laundering statutes, 18 U.S.C. §§ 1956, 1957, and the Bank Secrecy Act (BSA) still remain in effect with respect to marijuana-related business, the marijuana industry had hoped to take advantage of the new rules issued by the U.S. Treasury Department in 2014 which “clarifie[d] how financial institutions can provide services to marijuana-related businesses consistent with their BSA obligations, and aligns the information provided by financial institutions in BSA reports with federal and state law enforcement priorities.” In addition to the new rules, the Justice Department produced a memorandum calling for relaxed enforcement of the relevant federal banking laws so long as they followed the new rules. However, the most recent attempt by a Colorado state-chartered credit union, The Fourth Corner Credit Union, to take advantage of the new rules and memorandum has faced major opposition from the Federal Reserve Bank, who must provide clearance before the credit union can open.

The Federal Reserve Bank refused to grant the permission need to access the national banking system and The Fourth Corner Credit Union has sued in Federal Court demanding equal access to the federal system. While it remains unclear whether the presiding judge, R. Brooke Jackson, will hear the complaint, most view The Fourth Corner Credit Union as fighting a losing battle. Most believe that entering the federal banking system will be nearly impossible until marijuana becomes legal at the federal level. For now it will remain unclear as to where the industry should place its money.

The TPP – Commercial or Foreign Policy Victory?

October 28, 2015
Competition, Economics, International Law

Jing Han, MJLST Staffer

The Trans-Pacific Partnership (TPP) is a proposed trade among twelve Pacific Rim countries, which are Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, United States, Singapore and Vietnam, concerning a variety of matters of economic policy, about which agreement was reached on October 5, 2015 after 5 years of negotiations. The 12 countries including the United States of America have agreed to build a new cooperation structure through this agreement. TPP’s 30 chapters have set binding rules on everything from service-sector regulation, investment, patents and copyrights, government procurement, financial regulation, and labor and environmental standards, as well as trade in industrial goods and agriculture. The combined Gross Domestic Product-GDP of the world’s largest pact of these 12 countries is nearly 28 trillion dollars. Those dozen states account for roughly forty percent of global gross domestic product, thirty percent of global exports and twenty-five percent of global imports.

Some people believe that one of the reasons for the recent push for new trade initiatives is a feeling that the WTO system is not working. This view is probably not an uncommon one. But is it correct? It is worth looking at just what the WTO does, and how it compares to the TPP as a possible alternative trade agreement and organization.

First, all 159 WTO members have made promises not to charge tariffs above rates that are set out in legally binding schedules. The TPP does have the potential to go further than the WTO in terms of tariff reductions and services liberalization. Of course, such commitments would be preferential, only given to a handful of trading partners, and thus would not be truly free trade. There are significant economic benefits to having free trade cover as many countries as possible, including the avoidance of complex and trade-restricting rules of origin.

Second, WTO rules also discipline special tariffs imposed against dumping and subsidies. Through the WTO, these tariffs are subject to detailed rules to prevent them from being abused, which they frequently have been over the years. The TPP will not address anti-dumping/countervailing duties or subsidies at all. And the WTO’s rules on regulatory protectionism are already working quite well, so it is difficult to imagine what the TPP would do in this regard.

Third, WTO rules govern customs procedures, including valuation and classification issues, to prevent these procedures from being used as a disguised means of protection. Furthermore, WTO rules include general prohibitions on using domestic regulations and taxes for protectionist purposes. The WTO’s jurisprudence on these issues is widely respected, and WTO rulings have addressed a range of regulatory protectionism. The TPP would also go beyond the WTO in areas such as intellectual property protection, foreign investment protection, and environmental and labor regulation. But further is not necessarily better. These items have been added to the trade agenda to drum up new support. However, they have also stirred up a good deal of new opposition, and made trade negotiations more complex and difficult.

Fourth, Congress recognized “the growing significance of the Internet as a trading platform in international commerce” and instructed President Obama to achieve objectives concerning digital trade in goods and services and cross-border data flows. The Obama administration wants “digital trade rules-of-the-road” in the TPP agreement. These rules could mark a turning point in the global governance of digital commerce. The importance of digital technologies to trade has grown without multilateral rules keeping pace. The WTO is the main source of multilateral trade agreements, but it was established before the Internet transformed how companies produce, sell, and deliver products and services. In a declaration of 1998, WTO members agreed not to impose customs duties on electronic transactions and recognized the need to address e-commerce directly. However, the WTO’s e-commerce work program has not progressed much because WTO members disagree on various issues.

Fifth, beyond the commercial implications, many experts regard the TPP as a key part of American foreign policy. Amid the rise of China and its increasing exercise of political and military power in East Asia, the Obama administration has said it would turn its attention more to the East, the so-called pivot to Asia, in an effort to strengthen U.S influence in that region. The challenge for China, should it wish to join the TPP, is undertaking the reforms that the agreement would require. For instance, joining TPP will require opening markets in areas such as services and investment and agreeing to new rules in sensitive areas such as the role of state-owned enterprises and access to the Internet. That said, many of the reforms that becoming a TPP party would require are consistent with the internal reforms that China has already identified as being necessary, including reform of its financial sector, strengthening the role of services in the Chinese economy, and encouraging innovation.

In sum, The WTO is an excellent system. Its great strength is its multilateral framework, incorporating most of the world’s nations. However, with the advent of the 21st century, the limits of the WTO’s functions have become increasingly apparent. The Doha Round, marked by conflict between the opinions of developed and emerging nations and the subsequent stalling of negotiations, stands as a symbol of these limits. With more nations participating and more comprehensive liberalization being pursued, it is unavoidable that negotiations will face difficulties. In relation to the TPP, a former senior U.S. official is said to have commented that the U.S. sought to demonstrate its level of commitment to the Asia-Pacific region through its active involvement in the agreement negotiations. The Asia-Pacific region is becoming increasingly important to the U.S., and this fact is manifested in the nation’s initiatives in relation to the TPP. In this respect, the TPP has more political implications compared with its commercial considerations.

UN Countries Strive to Develop Legal Framework for Climate Deal

October 28, 2015
Energy Law, Environmental Law, International Law

Vinita Banthia, MJLST Articles Editor

In December 2009, over a 100 world leaders gathered in Copenhagen, Denmark for the United Nations Climate Change Conference, which included the 15th Conference of the Parties (COP 15) to the United Nations Framework Convention on Climate Change (UNFCCC), and the 5th Conference of the Parties for the Meeting of the Parties to the Kyoto Protocol (COP/MOP 5). The international gathering culminated in the “Copenhagen Accord,” which member countries of the UNFCCC agreed generally to “take note of,” but failed to promise more substantial action.

While the Accord endorsed the Kyoto Protocol and included specific omission reduction targets for some countries, it did not set out any legal framework or structure for the enforcement of these guidelines. Developed countries agreed to provide $100 billion per year by 2020 to developing countries for climate improvement. Again, however, no strategy was developed for the implementation of this funding, and countries continue to disagree on the amount and sourcing of the funds.

Fast forward six years later to the meeting in Bonn, Germany last week, where delegations convened once again to negotiate an international climate agreement. In December, the delegations will reconvene in Paris for the 21st Conference of the Parties to the UNFCCC to further discuss the terms of an international climate deal, and ideally, all 195 attending countries will adopt it. However, many of the issues that prevented a deal from being developed in Copenhagen continue to haunt current discussions.

Frist, developing countries are concerned about the amount of funding developed countries are willing to provide for their transition to clean and sustainable energy sources. In addition, most countries are hesitant to agree to a predetermined emissions reduction target and prefer a self-guided, non-legally-binding requirement that is informally tracked. The members in attendance at the climate conference in Bonn took this strategy and allowed countries to determine their own emissions goals. These compromises allowed the nations to conclude the Bonn meeting with a draft agreement that is predicted to be more successful than the Copenhagen Accord, during the final round of negotiations in Paris. However, it will be important for nations to avoid the temptations of diluting the provisions too much to gain approval of a large number of nations. Instead, nations should take a more heavy-handed approach to ensure important actions are taken, while implementing a legal structure to enforce the provisions of any final agreement.

H.R.8 and the Hydropower Improvement Act of 2015—Another Missed Opportunity

October 28, 2015
Energy Law, Environmental Law, Regulatory

Catherine Cumming, MJLST Lead Note & Comment Editor

While many people see the hydropower industry as a clean and sustainable energy source, most hydropower facilities are decades old and have severe environmental, economic, and social externalities. Relicensing provides an opportunity to bring aging dams up to modern environmental standards and compliance requirements. Over the past thirty years, American Rivers and the Hydropower Reform Coalition used the licensing process to improve hydropower dams and restore rivers. With over 6,000 megawatts of hydropower due for relicensing within the next five years, there are hundreds of dams and thousands of miles of river with an opportunity for improvement. Recent legislation, however, has failed to address the amount of hydropower due for relicensing and the opportunities it presents for increased energy production and environmental compliance. When Congress passed the Hydropower Regulatory Efficiency Act of 2013, it failed favored efficiency over oversight and failed to the amount of hydropower due for relicensing and the opportunity it provided for efficiency upgrades.

This fall, Congress missed yet another opportunity to modernize hydropower and decrease its negative externalities. Rather than “modernize” hydropower, the Energy & Commerce Committee’s approval of a hydropower amendment to H.R.8, the “North American Energy Security and Infrastructure Act of 2015” and Senator Lisa Murkowski’s “Hydropower Improvement Act” ignore the opportunity for increased efficiency and sustainability by creating compliance loopholes for the hydropower industry. If enacted, these bills would allow energy companies to opt out of Clean Water Act, Endangered Species Act, and state water quality and wildlife protections; allow dam owners to pass the costs and burdens of obeying water quality standards, wildlife laws, and cleaning up pollution caused by dams to taxpayers; and transfer state and federal agency authority to protect natural resources to the Federal Energy Regulatory Commission. While 2011 was the “Year of the River,” 2015 is becoming the “Year of Hydropower.” Community interest groups and environmental organizations are concerned that H.R.8 and the “Hydropower Improvement Act” will “turn back the clock and take the hydropower industry back to a time when they could destroy rivers with impunity.”

Shape Up or Ship Out: E.P.A. Forced to Reevaluate Their General Ballast Water Regulation Permit

October 20, 2015
Environmental Law, EPA, Invasive Species

John Biglow, MJLST Staffer

In the recently decided Natural Resources Defense Council v. U.S. E.P.A., — F.3d — (2d Cir. Oct. 5, 2015), the Second Circuit granted the petitioners’ motion, in part, for a review of the Environmental Protection Agency’s 2013 Vessel General Permit (VGP) regulating the discharge of ballast water from ships. The petitioners, four environmental conservation organizations, argued successfully that the EPA acted arbitrarily and capriciously in a number of ways when it set the technology based effluent limits (TBELs) and water quality-based effluent limits (WQBELs) which must be complied with under its VGP. In so deciding, the Second Circuit has remanded the matter to the EPA for proceedings consistent with their opinion, and has kept the 2013 VGP in place until the EPA issues a new VGP.

The EPA has the authority to regulate ballast discharge under §402(a) of the Clean Water Act (CWA). When freighter ships take on or unload cargo, they adjust for changes in weight by taking on or discharging ballast water. As the court stated, this amount “can range from hundreds of gallons to as much as 25 million gallons.” The regulation of ballast discharge is an important aspect of environmental conservation due to its role as a conduit for the spread of invasive species and pollutants. When a ship takes on ballast water in a polluted or infested area, it is possible for these organisms and pollutants to get sucked up with the water, surviving in the ballast tanks before being discharged in some distinct body of water. One study referenced by the court estimated the damage from invasive species to be upwards of $137 billion annually, making the prevention of their spread both a top environmental and economic priority.

The first set of arguments made by the petitioners centered on whether the TBELs set by the EPA were arbitrary and capricious. The petitioners first argued that in setting the TBEL standard to mirror the standard adopted by the International Maritime Organization in 2004 (the IMO standard), the EPA acted arbitrarily and capriciously. The Court agreed, primarily because a higher standard was attainable. The CWA requires the EPA to apply the “best available technology economically achievable” (BAT) when setting their TBELs. In its investigation of the available technology, the EPA employed the Science Advisory Board (SAB) to issue a report on the different available systems. According to their report, there were a number of ballast-water treatment systems that would be able to achieve standards 10 to 100 times greater than the IMO in the near future. By ignoring this potential and instead setting the standard at the IMO, the court found that the EPA acted arbitrarily and capriciously.

Next, the petitioners argued that the EPA acted arbitrarily and capriciously when it limited the SAB’s investigation of ballast treatment systems to shipboard treatment; ignoring onshore treatment options. The court agreed, refusing arguments from the EPA that these systems were not considered because the facilities needed to implement them were not yet in existence. The court reasoned that the time and expense of creating onshore treatment infrastructure was similar to that required for shipboard treatment, and that it was arbitrary and capricious to ignore the possibility. In remanding this issue back to the EPA, the agency will need to fully consider onshore treatment options before adopting or dismissing them in their new VGP.

The petitioners further argued that the EPA was arbitrary and capricious in exempting ships built before 2009 that only sail the great lakes water system (pre-2009 Lakers). The court agreed, reasoning that there was no true distinction between pre- and post-2009 Lakers. The court further stated that exempting ships because they did not currently have the technological capacity to adopt the technology necessary to meet the VGP requirements conflicted with the CWA’s BAT requirement, which seeks to force technology to keep up with contemporary environmental demands.

The petitioners next argued that several facets of the WQBELs were arbitrary and capricious. The WQBELs were designed as a safeguard to be utilized when the TBELs alone are insufficient to meet and maintain water quality standards. In its 2013 VGP, the EPA refused to set numerical values for its WQBELs, instead stating simply that “Your discharge must be controlled as necessary to meet applicable water quality standards in the receiving water body or another water body impacted by your discharges.” The court agreed that setting a narrative WQBEL was arbitrary and capricious, noting that it fails to give ship owners clear guidance as to whether or not they are in compliance with the WQBELs.

The petitioners also argued that the monitoring requirements of the WQBELs was arbitrary and capricious. The 2013 VGP required only that ship owners monitor the expected time, place, and volume of their ballast discharges. The court agreed, reasoning that the EPA could consider requiring ship owners to monitor the actual statistics on their ballast discharges, rather than the expected ones.

It is a critical victory for environmentalists that the Second Circuit is requiring the EPA to revisit what was an incomplete and insufficient 2013 VGP; however, it is critical that the EPA get it right the second time around. The economic and environmental impact of ballast discharges is significant and due to the cost and time requirements involved in creating the infrastructure necessary to meet the VGP system requirements, we are likely to be stuck with whatever the EPA sets as the BAT for a very long time.

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