Administrative Law

Recalling History With the FDA’s Safety Alerts

April 4, 2017
Administrative Law, Food and Drug Law, Pharmaceuticals, Regulatory

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: MJLST is pleased to welcome back Tommy Tobin for another series on Food and FDA law. This is #1 of 3 in April. You can find his earlier posts here.]

The FDA’s Safety Alerts for Human Medical Products provide insight on how the agency is protecting the American consumer. For example, through the agency’s online list of alerts, consumers are warned against using suppositories that claim that they can cure cancer. Such alerts harken back to the agency’s origins at the turn of the twentieth century.

While Dr. Harvey Washington Wiley is not a household name to most Americans today, his legacy is felt each day in our households. Dr. Wiley spent decades calling for increased protections for consumer safety. His “Poison Squad” experiments pitted healthy young volunteers against food additives to determine the effects on health. With the passage of federal legislation in 1906, the organization that was to become the FDA was on its way to its modern-day role.

One of Wiley’s remarkably prescient articles was his 1914 co-authored piece “Swindled Getting Slim,” which he wrote after leaving government service. Even at that time, Dr. Wiley found that “the whole list of obesity-cures would strain credulity to the breaking point.” Rallying against fakes, frauds, and fad diets, the piece warned the public about purveyors of weight-loss remedies that presented “simple old-time frauds under new names and new auspices, with marvelous scientific explanations of how they do the work.”

One of the products that Dr. Wiley had in his cross-hairs was the titular “Get Slim.” In his article, Wiley wrote that “Pink lemonade costs five cents a glass at the circus, but when you buy it in the form of ‘Get Slim,’ $1 is the price of a ‘twelve days’ dose.’” Not only was “Get Slim” expensive, it was also dangerous. A 1916 issue of Good Housekeeping updated readers about the story:

In the January, 1914 Good Housekeeping was published an article by Dr. Wiley and Anne Lewis Pierce entitled “Swindled Getting Slim.” In it the true character of several so-called obesity-cures was made plain, among them “Get Slim,” manufactured by Jean Downs, of New York City. The demand for “Get Slim” rapidly fell off, and the manufacturer, convinced that Good Housekeeping had caused it by calling her “cure” a fake, brought suit for $50,000. After various delays…the case was brought to trial…December 15^th, 1915. Two days were spent in taking testimony, Jean Downs telling how she made the stuff and several chemists and biologists testifying that, if made as she said she made it, it was more dangerous than Dr. Wiley had said. In his charge to the jury Justice Lehman said that a magazine was within its rights in criticizing a preparation offered to the public and that unless they thought the publication of the article was inspired by malice they must find in favor of the defendant. The jury so found. Thus endeth “Get Slim.”

One of the ways the modern-day FDA carries on the work of Dr. Wiley is to warn the public against dangers lurking in their household products. For example, the FDA has issued numerous Safety Alerts against products with undisclosed drug ingredients—including several weight loss products—in recent years.

“Pink Bikini” and “Shorts on the Beach” were capsules marketed by Texas-based Lucy’s Weight Loss System. These weight loss products were the subject of a nationwide recall in 2016 when the FDA found that their ingredients included several active, undisclosed pharmaceutical ingredients. These included Sibutramine, an appetite suppressant withdrawn from the American market years earlier because it created cardiovascular risks, and Phenolphthalein, a known carcinogen which also had been disallowed due to serious health concerns. In its safety alert, the FDA noted that the offending pills should “not be consumed.”

In 2014 alone, the FDA noted over 35 public notices and recalls for products with undeclared drug ingredients. This is in addition to warnings and recalls related to consumer dangers with bacterial contaminations, glass particles, and other issues with dozens of nutritional, drug, and medical device products.

To date this year, the FDA has warned the public that certain injectable products labeled “latex free” contained latex, which could be life-threatening for those with allergies. In addition, the FDA issued a Safety Alert for certain male sexual enhancement supplements, including one with the name XtraHRD, for containing active drug ingredients. Without proper identification, consumers may take such products without knowing they contained drugs. As such, consumers are advised not to take these capsules and to return any in their possession to the company for a refund. In considering the danger to the public, the Safety Alert noted “Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. [Erectile dysfunction] is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.”

Public health and safety is at the core of the FDA’s mission. The FDA’s modern-day efforts toward this mission honor its roots as well as the work of Dr. Wiley and others.

Ensuring Quality and Avoiding Bad Eggs: Food Executives, Food Safety and Criminal Sanctions

February 22, 2017
Administrative Law, Criminal Law, Food and Drug Law, Regulatory

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: This post is last and #4 in a series on current FDA issues. You can find the previous post here, here and here.]

Food can—and all too often does—make people sick. Anyone who has suffered from food-borne illness would be unlikely to want to repeat the experience. The safety of our food relies in large part on compliance with food safety protocols. From Upton Sinclair’s The Jungle to today, the processing and manufacturing of food is rife with stories of poor practices leading to public health problems.

Maintaining the safety of the nation’s food supply is an ongoing challenge for regulators and businesses. The FDA requires that food be processed or produced using good manufacturing practices, or else risk food being labeled “adulterated” as it was produced under “unfit” conditions. Producing food in such a way as to avoid being “contaminated with filth” seems like a worthwhile goal.

Ensuring food safety sometimes means throwing away product, but it can be a matter of life and death. For example, Listeria concerns prompted Blue Bell Ice Cream to remove all of its product from store shelves in 2015. Three deaths were reported from the ice cream. In the midst of its food safety issues, Chipotle closed all locations across the US on February 8, 2016 to focus improving food safety protocols.

What happens when individuals upend the delicate balance of food safety? In the wake of several high-profile trials, food executives charged with food safety violations may be walking on eggshells. As Food Safety News put it, “Not so long ago, errant food industry managers and executives did not have to worry about going to jail. But they do now.”

What changed? In part, peanut butter, cantaloupe, and eggs. These products might seem like an unlikely combination, but these foods—or rather some of the companies behind them—demonstrate the “New Normal” in food safety enforcement.

Taking peanut butter first, a nationwide Salmonella outbreak sickened hundreds of Americans and killed nine. Stewart Parnell, the executive behind the Peanut Corporation of America, approved shipments of peanut butter that his company had tested positive for Salmonella and those that were known to be “partially covered in dust and rat crap.” Instead of jettisoning product for public safety, he instead demanded, over email, that “[expletive deleted], just ship it. I can’t afford to loose [sic] another customer.” According to the Washington Post, prosecutors sought a life sentence, but he was ultimately sentenced for 28 years. One man, quoted by the Post, whose mother had died due to the peanut butter said, “As far as I’m concerned, he’s a murderer.”

As for cantaloupe, Eric and Ryan Jensen—two Colorado brothers—pled guilty to six counts arising from their role in a 2011 Listeria outbreak. According to the FDA, the Jensen brothers knew they were putting the public at risk by not sufficiently washing their produce and maintaining the fruit in “unsanitary conditions.” As a result, the deadly cantaloupes were linked to 147 hospitalizations and 33 deaths. You read that right; 33 lives were ended due to contaminated cantaloupe.

With regard to eggs, the DeCosters of Quality Egg, LLC may have presented the courts with the most significant responsible corporate officer liability ruling in over forty years, according to the venerable FDA Law Blog. Jack DeCoster and his son Peter, the owner and COO of the company, respectively, were sentenced to three month’s imprisonment for their part in food safety outbreaks that caused an estimated 56,000 Americans to fall ill.

As noted in the Eighth Circuit opinion upholding the prison sentence, the company pled guilty to bribing a food safety inspector and introducing misbranded and adulterated eggs into interstate commerce. The opinion details the conditions at Quality Egg’s Iowa operations in August 2010:

The FDA inspected the Quality Egg operations in Iowa from August 12–30, 2010. Investigators discovered live and dead rodents and frogs in the laying areas, feed areas, conveyer belts, and outside the buildings. They also found holes in the walls and baseboards of the feed and laying buildings. The investigators discovered that some rodent traps were broken, and others had dead rodents in them. In one building near the laying hens, manure was found piled to the rafters; it had pushed a screen out of the door which allowed rodents into the building. Investigators also observed employees not wearing or changing protective clothing and not cleaning or sanitizing equipment.

The FDA concluded that Quality Egg had failed to comply with its written plans for biosecurity and salmonella prevention. One government expert reported that “there were minimal to no records from the poultry [ ] barns to indicate that company personnel [had] implemented the written plans [to eliminate salmonella].” The agency also discovered that the company’s eggs tested positive for salmonella at a rate of contamination approximately 39 times higher than the current national rate, and that the contamination had spread throughout all of the Quality Egg facilities. In October 2010 the FDA instructed Quality Egg to euthanize every hen, remove the manure, repair its facilities, and disinfect its barns to prevent the risk of another outbreak.

As responsible corporate officers, the DeCosters pled guilty to misdemeanor violations of the Food, Drug, and Cosmetic Act (FDCA). In their plea agreements, they stipulated that they “had not known that the eggs were contaminated at the time of shipment, but stipulated that they were in positions of sufficient authority to detect, prevent, and correct the sale of contaminated eggs had they known about the contamination.”

An important question before the Eighth Circuit panel was the requisite knowledge required for imposing criminal penalties, particularly imprisonment, on responsible corporate officials. In the cantaloupe and peanut butter cases reviewed above, each executive knew of food safety violations, but the record in this case did not reveal that the DeCosters had actual knowledge. The three judge DeCoster panel issued a three-opinion ruling, with the majority advancing a concept of responsible corporate officer liability arising from the FDCA and the Supreme Court’s ruling in United States v. Park, 421 U.S. 658 (1975). Under Park, responsible corporate officials were prosecuted under a lower standard than normally used for criminal cases, whether under theories of negligence or strict liability.

The DeCoster majority noted that the FDCA and Park enabled criminal sanctions for responsible corporate officials for their own failure to prevent or remedy the conditions giving rise to the food safety claim. The judges in the majority agreed that vicarious liability was not applicable here, instead it was the executives’ own duty to be aware of, to prevent, and to address potential violations of the FDCA that gave rise to criminal penalties. Writing in concurrence, Judge Gruender reasoned that the DeCosters “are responsible for their own failures to exercise reasonable care to prevent the introduction of adulterated food.” In the absence of actual knowledge, the DeCoster majority ascribed constructive knowledge to the DeCosters in running their operation. They “knew or should have known” of the unsanitary conditions and failed to address or prevent them.

Writing in dissent, Judge Beam reasoned that the DeCoster’s sentence was inappropriate. Judge Beam would reject negligence as an appropriate standard for corporate officer liability under the FDCA, substituting a mens rea requirement similar to that found elsewhere in criminal law. The dissent noted, “there is no precedent that supports imprisonment without establishing some measure of a guilty mind on the part of these two individuals, and none is established in this case” and that “no person associated with Quality Egg had knowledge of salmonella contamination at any relevant time.”

Given the three-opinion decision, the DeCoster case was appealed for an en banc rehearing within the Eighth Circuit, which was denied in September 2016. Petition for certiorari was filed in January 2017, and the case may make it to the Supreme Court.

Public health requires vigilance, especially on the part of those involved with producing and processing the nation’s food supply. The FDA and other food safety regulators work with businesses to maintain public health and safety. Unfortunately, all too often there are bad eggs whose decisions, or lack of awareness, may put the public at risk. Time will tell whether the Supreme Court weighs in on the proper standard for criminal liability for food safety violations in the wake of several recent high-profile cases.

Haiti, Hurricanes and Holes in Disaster Law

October 31, 2016
Administrative Law, Climate Change, Environmental Law, Regulatory, Social Welfare

Amy Johns, MJLST Staffer

The state of national disaster relief is one that depends greatly on the country and that country’s funds. Ryan S. Keller’s article, “Keeping Disaster Human: Empathy, Systematization, and the Law,” argues that proposed legal changes to the natural disaster laws (both national and international) could have negative consequences for the donative funding of disaster relief. In essence, he describes a potential trade–off: do we want to risk losing the money that makes disaster relief possible, for the sake of more effectively designating and defining disasters? These calculations are particularly critical for countries that rely heavily on foreign aid to recover after national disasters.

In light of recent tragedies, I would point to a related difficulty: what happens when the money is provided, but because of a lack of accountability or governing laws, the funds never actually make it to their intended purposes? Drumming up financial support is all well and good, but what if the impact is never made because there are no legal and institutional supports in place?

Keller brings up a common reason to improve disaster relief law: “efforts to better systematize disaster may also better coordinate communication procedures and guidelines.” There is a fundamental difficulty in disaster work when organizations don’t know exactly what they are supposed to be doing. A prime example of the lack of communication and guidelines has been seen in Haiti, in which disaster relief efforts are largely dependent on foreign aid. The fallout from Hurricane Matthew has resurrected critiques of the 2010 earthquake response—most prominent was the claim of the Red Cross to build 130,000 homes, when in fact it only built six. Though the Red Cross has since disputed these claims, this fiasco pointed to an extreme example of NGOs’ lack of accountability to donors. Even when such efforts go as planned and are successful, the concern among many is that such efforts build short—term solutions without helping to restructure institutions that will last beyond the presence of these organizations.

Could legal regulations fix problems of accountability in disaster relief? If so, the need for those considerations is imminent: climate change means that similar disasters are likely to occur with greater frequency, so the need for effective long-term solutions will only become more pressing.

A New Option for Investors Warry of High Frequency Trading

October 24, 2016
Administrative Law, Regulatory, Securities Law

Spencer Caldwell-McMillan, MJLST Staffer

In his recent paper, The Law and Ethics of High Frequency Trading, which was published in the Minnesota Journal of Law, Science, and Technology Issue 17, Volume 1, Steven McNamara examined the cost and benefits of a high frequency trading (HFT) on stock exchanges. He observed that problematic practices such as flash orders and colocation can provide HFT firms with asymmetrical information compared to retail or even sophisticated institutional investors.

In June, a new type of exchange was approved by the Securities and Exchange Commission (SEC). IEX Group Inc. was granted exchange status from the SEC. Before this designation the firm was handling less than 2% of all equity trades, with this new designation the exchange is likely to see volume increase as orders are routed to the exchange. IEX uses 38 miles of looped fiber optic cable to combat some of the information asymmetry that HFT firms exploit. IEX uses this coil to slow incoming orders down by about 350 microseconds. This is roughly half the time a baseball makes contact with a baseball bat. While this may seem like an insignificant amount of time, the proposal proved extremely controversial. The SEC asked for five revisions to IEX application and released the decision at 8 PM on a Friday.

This speed bump serves two purposes: to stop HFT firms from taking advantage of stale prices found on IEX orders and to prevent them from removing liquidity on other exchanges so that IEX’s customer are unable to fill their orders. Critics of this system claim that the speed bump violates rules that requires exchanges to fulfill orders at the best price. However, IEX pushes back on these points to arrangements like colocation that allows firms to pay for faster access to markets by buying space on the servers of the stock exchanges. These policies allow HFT firms to get information faster than even the most sophisticated investors because of their proximity to the data. IEX began operations as an exchange in August and time will tell whether it can generate profits without compromising their pro-investor stance.

This debate is likely to continue long after public attention has faded from HFT. Institutional investors are the most likely beneficiaries of these changes, in fact, in a letter to the SEC the Teacher Retirement System of Texas, claimed that using IEX to process trades could save the fund millions of dollars a year. More recently, Chicago Stock Exchange has submitted a proposal to include a similar speed bump on its exchange. Taken together these two exchanges would represent a small fraction of the order volume being processed by U.S. exchanges but these changes could have a lasting impact if they drive institutional investors to change their trading behavior.

The Path of Pollutants Under the Clean Water Act

March 19, 2016
Administrative Law, Environmental Law

Ted Harrington, MJLST Staffer

In 1972, the Clean Water Act set forth a lofty goal—to “[r]estore and maintain the chemical, physical, and biological integrity of the nation’s waters.” (33 U.S.C. §1251(a)). Yet, the Clean Water Act only regulates point sources that discharge pollutants into navigable waters (33 U.S.C. §1251(a)(1)). As a result, many forms of water pollution escape federal jurisdiction, most notably, groundwater. This is because CWA regulation depends on how a pollutant reaches navigable water, instead of focusing on the end result. This added constraint is hardly logical when juxtaposed against the stated goal.

For example, if a pollutant is discharged into groundwater, and eventually reaches navigable Water Body B, the CWA does not have the ability to regulate the groundwater. In other terms, if the polluted effluent passes through groundwater, considered a “nonpoint source,” before it reaches Water Body B, no CWA regulation occurs.

To combat this issue, Federal District Courts in Hawai’i, North Carolina, and Pennsylvania have begun adopting the “Conduit Theory” (See Allison Kvien note Volume 16). The conduit theory states that if a body of water (groundwater) simply acts as a conduit, it should be viewed as an extension of the point source from which it is receiving the pollutant. This theory directs its attention to the ultimate result—the pollution of Water Body B. It is only logical that if Water Body B is being polluted, the source should fall under CWA jurisdiction. Why should we leave a source of pollution unregulated simply because the effluent isn’t being directly discharged into a navigable water? As the Court in Rapanos v. United States noted, “The [Clean Water] Act does not forbid the ‘addition of any pollutant directly to navigable waters from any point source,’ but rather the ‘addition of any pollutant to navigable waters.’”

The issue of groundwater as a pollutant is receiving increasing attention in the courts. In the Northern District of Iowa, a case concerning the discharge of groundwater through tile drains is currently in litigation‑ Board of Water Works v. Sac County Board of Supervisors. This could be an opportunity for Iowa to take one of the first stances on the conduit theory in the 8th Circuit. Stay tuned!

Circumventing EPA Regulations Through Computer Programs

December 16, 2015
Administrative Law, Data, Environmental Law

Ted Harrington, MJLST Staffer

In September of 2015, it was Volkswagen Group (VW). This December, it was the General Electric Company (GE) finalizing a settlement in the United States District Court in Albany. The use of computer programs or other technology to override, or “cheat,” some type of Environmental Protection Agency (EPA) regulation has become seemingly commonplace.

GE uses silicone as part of its manufacturing process, which results in volatile organic compounds and chlorinated hydrocarbons, both hazardous byproducts. The disposal of hazardous materials is closely regulated by the Resource Conservation and Recovery Act (RCRA). Under this act, the EPA has delegated permitting authority to the New York State Department of Environmental Conservation (DEC). This permitting authority allows the DEC to grant permits for the disposal of hazardous wastes in the form of an NYS Part 373 Permit.

The permit allowed GE to store hazardous waste, operate a landfill, and use two incinerators on-site at its Waterford, NY plant. The permit was originally issued in 1989, and was renewed in 1999. The two incinerators included an “automatic waste feed cutoff system” designed to keep the GE facility in compliance with RCRA and the NYS Part 373 Permit. If the incinerator reached a certain limit, the cutoff system would simply stop feeding more waste.

Between September 2006 and February 2007, the cutoff system was overridden by computer technology, or manually by GE employees, on nearly 2,000 occasions. This resulted in hazardous waste being disposed of in amounts grossly above the limits of the issued permits. In early December, GE quickly settled the claim by paying $2.25 million in civil penalties.

Beyond the extra pollution caused by GE, a broader problem is emerging—in an increasingly technological world, what can be done to prevent companies from skirting regulations using savvy computer programs? With more opportunities than ever to get around regulation using technology, is it even feasible to monitor these companies? It is virtually certain that similar instances will continue to surface, and agencies such as the EPA must be on the forefront of developing preventative technology to slow this trend.

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

November 13, 2015
Administrative Law, Environmental Law

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.

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

October 20, 2015
Administrative Law, Environmental Law

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.

Awaiting an Important Decision on the Gulf of New Mexico “Dead Zone” Lawsuit

September 5, 2015
Administrative Law, Environmental Law

Allison Kvien, MJLST Managing Editor

In 2013, the U.S. Environmental Protection Agency was ordered to set limits on nitrogen and phosphorous levels in U.S. waterways. These nutrients contribute to the loss of oxygen and cause what is called hypoxia to occur in the water, killing marine life. This year, the “dead zone” in the Gulf is larger than Connecticut and Rhode Island combined. While this is larger than average, it is not a record. The oxygen levels are so low in this zone that it was reported that even starfish are suffocating.

An appeals court recently decided that the district court should determine, based on the Clean Water Act (CWA), whether the EPA gave adequate reasons for its refusal to set limits on the nutrients in U.S. waterways. Environmental groups, such as the NRDC, are optimistic that the original ruling requiring the EPA to set nutrient limits will be reaffirmed by the district court.

This CWA ruling is analogous to the 2007 Supreme Court Clean Air Act (CAA) case, Massachusetts v. EPA, which ruled that the EPA must have good reasons, based on the CAA, for refusing to regulate greenhouse gases (GHGs). The Supreme Court found that the EPA’s rationale for not regulating GHGs was inadequate and required the EPA to come back with a reasonable basis for not regulating GHGs in order to avoid being forced to regulate GHGs.

If the outcome of this CWA lawsuit is that the EPA is required to regulate nutrients causing the enormous hypoxia zone, the EPA will embark on a hugely collaborative journey to set appropriate limits for these nutrients all over the country. For instance, the NRDC reports that Chicago, over one thousand miles away from the Gulf, was found to be the single largest contributor to the “dead zone” in the Gulf.

State Agency Deference Under PURPA

January 29, 2015
Administrative Law, Environmental Law

Doug Kincaid, MJLST Staff Member

Recently, in Exelon Wind L.L.C. v. Nelson, 766 F.3d 380 (5th Cir. 2014), the Fifth Circuit Court of Appeals (Fifth Circuit) held that state agencies are entitled to deference under the Public Utilities Regulatory Policies Act of 1978 (PURPA) – a cooperative federalism regulatory scheme. The case revolved concerned the Texas Public Utilities Commission (PUC), which claimed that under state law a wind farm generating intermittent power (“non-firm”) power could not enter into a legally enforceable obligation (LEO) under Texas law, and that such an obligation was not required under PURPA. Unable to enter into a fixed price agreement, the generator was subject to highly variable market prices, increasing the financial risk of the project dramatically.

The Federal Energy Regulatory Committee (FERC) responded by declaring that federal law required all qualifying facilities under PURPA have the option to enter into a LEO. The Fifth Circuit, faced with competing state and federal interpretations, upheld the state interpretation despite the fact that FERC authored the relevant statutes. Because wind and solar energy, by nature, cause scheduling difficulties and extra costs to state agencies overseeing regional energy grids, an incentive may exist for other state agencies to follow the PUC’s lead. The Fifth Circuit’s holding in Exelon frustrates renewable energy development by refusing renewable generators the option to enter into LEOs and expands the deference state agencies are entitled to in a cooperative federalism regulatory scheme.

To the extent federal and state agencies disagree on the interpretation of a cooperative federalism statute, district courts are fragmented and little scholarship exists regarding how to resolve these conflicts. In determining whether to defer to a state agency’s interpretation of federal law, five out of six federal circuits which have considered the issue elected to give state agencies no deference. The underlying basis for federal deference in these cases was a sentiment favoring federal supremacy. The Fourth Circuit, an outlier, granted deference to state agencies citing state agency expertise in tailoring federal regulations to local conditions. Here, the Fifth Circuit in Exelon v. Nelson created a novel line of reasoning on this issue.

In relevant part, PURPA states that “Each qualifying facility shall have the option either: (1) To provide energy. . . based on the purchasing utility’s avoided costs calculated at the time of delivery; or (2) To provide energy or capacity pursuant to a legally enforceable obligation.” The plain meaning of this language, under traditional principles of statutory interpretation, creates a mandatory choice vested in the qualifying facility. The Fifth Circuit, however, read the statute as a bare-bones framework on which state agencies can project any regulation not expressly denied by the statutory language. Because PURPA contains no specific language addressing the obligation of firm or non-firm generators to form LEOs, the PUC regulation presents no facial conflict with PURPA.

The creative judicial interpretation employed to circumvent the mandatory choice interpretation reveals that the Fifth Circuit treated state sovereignty as a controlling concern in the examination of conflicting state and federal agency interpretations. A previous holding in F.E.R.C. v. Mississippi, 456 U.S. 742 (1982), held that PURPA subtly circumvents the anti-commandeering doctrine by allowing states to “comply with the statutory requirements by issuing regulations, by resolving disputes on a case-by-case basis, or by taking any other action reasonably designed to give effect to FERC’s rules.” Perceiving a potential Tenth Amendment conflict caused by forcing state governments to implement FERC’s PURPA regulations, the court hesitated to “wade unnecessarily into such murky waters” and instead elected to defer to the PUC. Exelon v. Nelson may remain an outlier, but considering the importance of state and federal agency cooperation in the energy sector, granting deference to state agency interpretations on constitutional grounds could have a significant effect on energy law. Nonetheless, in terms of implementation of PURPA, the court’s ruling is a setback for renewable energy and may require legislative action to clarify the intent of the law.

PURPA serves to promote renewable generation by creating a mandatory purchase provision for small generation facilities, an increasingly important function considering the massive carbon footprint of the power sector. The holding in Exelon v. Nelson reduces FERC’s power to promote renewable power. A simple legislative fix would preserve state implementation authority under PURPA while eliminating the state’s ability to frustrate renewable energy development through state regulations dictated by purchasing utilities.

Congress sets forth in PURPA’s text three express purposes: “to encourage (1) conservation of energy supplied by electric utilities; (2) the optimization of the efficiency of use of facilities and resources by electric utilities; and (3) equitable rates to electric consumers.” Congress should enact a fourth purpose for PURPA: “to encourage” renewable resources and long-term reduction of carbon emissions. Pursuant to this change, the purpose of PURPA would in fact change very little as renewable energy is already a key component of the statute. State regulations singling out renewable generators would be necessarily rejected in federal or state court pursuant to the express will of Congress. The amendment would honor the structure of cooperative federalism inherent to PURPA by balancing the state role of implementation with the federal role of enforcement, while strengthening the benefits derived by renewable generators from the mandatory purchase requirement.

In sum, Exelon v. Nelson presents a new and potentially significant holding on cooperative federalism – a staple legislative tool in today’s agency intensive power sector. It remains to be seen whether this case will bear significantly on future agency deference or remain an outlier, but the holding certainly calls into question the ability of renewable energy generators to enter into LEOs under PURPA. To counteract this negative effect, Congress should make “encouraging renewable resources and long-term reduction of carbon emissions” an express goal of PURPA, cementing the purpose that the statute already serves.

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