Food and Agriculture

Genetically Modified Foods And The Consumer Quest For Disclosure

Nicholas Ratkowski, MJLST Staffer

In 2000, the Minnesota Journal of Law, Science, and Technology (MJLST) proudly published its first issue, spanning a variety of issues between Patent Protection of Computer Programs to an analysis of the First Amendment through the lens of Jesse Ventura. One Note addressed how genetically modified foods (GMOs) should be labeled, if at all. In the seventeen years since MJLST’s inception, much has changed – how has the landscape of GMO labeling progressed?

In 2000, the principal argument was whether or not GMOs should be specially labeled as such; the author references unexpected concomitant protein allergies and environmental effects as prime concerns. As of 2000, scientists had not identified any negative effects from consuming GMOs. The Note notes different approaches between Europe and the United States, with the former relying on strict disclosure requirements, and the latter ignoring the issue (for the most part). At the time of authorship, “[m]ore than 4,500 GM plants ha[d] been tested, and at least 40 ha[d] passed government reviews” and “as much as 70% of processed foods contain[ed] GM components. The Note “propose[d] that the most appropriate method of resolving the labeling issue involves developing a new, international, voluntary labeling standard for products that have not been developed through genetic engineering techniques or do not contain genetically engineered ingredients.”

Now to the fun part – has anything changed? The short answer is not really. In 2013, Connecticut became the first state to “successfully enact a law requiring food containing genetically modified ingredients to be labeled as such, though it comes with the unusual requirement that four other states must pass similar legislation.” As of 2017, more than 70 bills across 30 states have been proposed in an effort to require labeling of GMOs. Only two states (Vermont and Maine) have joined Connecticut’s lead in forcing disclosure of genetically modified foods. Maine’s disclosure law requires disclosure, but is subject to a litany of exceptions. Vermont’s seems a bit more stringent, but is also easily circumvented. See §3043(d) and §3044 (for example, “Any processed food that would be subject to subsection 3043(a) of this title solely because it includes one or more materials that have been produced with genetic engineering, provided that the genetically engineered materials in the aggregate do not account for more than 0.9 percent of the total weight of the processed food”).

It is perhaps surprising then that GMOs remain mostly invisible to the average consumer in the United States, considering “[m]ore than 70 percent of Americans say they don’t want genetically modified organisms in their food” and “92 percent of Americans want genetically modified foods to be labeled,” according to a 2014 Consumer Reports survey. I’m not smart enough to tell you whether or not eating GMOs has any effect on health, much less whether that effect would be positive or negative. I can, however, posit a theory to explain this paradox, albeit not a novel one – the Pro-GMO lobby is simply too powerful for states to butt heads with in the courts on the taxpayers’ dime. With Monsanto leading the charge, the pro-GMO lobby has spent tens of millions of dollars to fight state-level labeling initiatives. In 2013, lobbyists spent $9,300,000 to prevent GMO disclosure requirements. In just the first quarter of 2014, lobbyist spent another $9,000,000. How can states compete?

If the U.S. ever makes the policy decision to implement widespread labeling requirements for GMOs, doing so will require federal legislation; states have been shown to lack the resources necessary to fight the purveyors of incomplete information that are GMO lobbyists. On the other hand, would labeling have any discernable effect on consumers? Maybe not, but I believe consumers should have the choice to pick what they eat, and how their food is sourced.


Recent Ninth Circuit Ruling an Important One for State and Local Governments Seeking to Regulate Genetically Modified Plants

Jody Ferris, Note & Comment Editor

Genetically modified plants (GMOs) are and have always been a hot topic in agriculture and food policy.  Since they were first developed, groups have been lobbying at various levels of government to impose regulations on how they are grown or to have them banned outright. A noteworthy decision has come down for those following legal challenges to GMO regulation. In Alika Atay et al. v. County of Maui et al., the Ninth Circuit court in Hawaii has ruled that state and local governments may regulate the production of GMOs in their jurisdictions.

The original suit was filed by GMO proponents after the County of Maui enacted a ban on genetically modified crops.  The court held that federal regulation of GMOs does not preempt state and local regulation after the variety is commercialized. This means that the United States Department of Agriculture holds jurisdiction over all GMO varieties prior to commercialization, which is the period during development and testing before the variety is sold on the market. According to the Ninth Circuit, after the variety is commercialized, however, state and local governments are free to enact regulations, including outright bans of GMO production, without the need to worry about federal preemption.

Interestingly, the county regulations in Hawaii that were at issue in the suit were nonetheless stricken down by the court because the State of Hawaii already has a comprehensive regulatory scheme which the court held to preempt county GMO regulations.  This outcome disappointed local environmental and anti-GMO groups due to their support of the new county level GMO restrictions.  However, the decision will help clarify the respective regulatory responsibilities between individual counties and the State of Hawaii. Despite the disappointment of these groups, the decision that there is no federal preemption on regulation of commercialized GMO varieties is an important one for many of the states in the Ninth Circuit, as there are counties in Washington and California, for example, which have also enacted bans on GMO production.

This decision will likely be an encouraging one for states wishing to enact their own regulations for how GMO varieties are grown and handled.  It is also encouraging for individual counties who wish to enact GMO bans or county level regulations, should state level regulations not be preemptive.  It will certainly be interesting to follow how state and local governments structure any future regulatory activities in light of this ruling.


Food “Hot Off the Printing Press”: Insights into 3-D Printed Food

Theodore Harrington, MJLST Managing Editor

Would you food hot off the 3D printing press? In Jaspers Tran’s article, 3-D Printed Food, he explores the potential legal issues surrounding the commercialization of 3D printed food. (see here).

The article suggests that “. . . the 3D printer may become the fundamental daily appliance in every household . . . .” The pros are easy to see—As the demand for food increases at an exponential rate, the ability to create food quickly and avoid the current environmental impacts caused by food production would be a game-changer. The benefits here are fairly obvious and easy to wrap our heads around. However, large barriers still remain.

A tougher point for me to grasp is Tran’s suggestion that 3D printing will solve issues related to malnutrition, particularly over-nutrition, or obesity. Tran seems to leap from personalized nutritional food (tailored to an individual’s exact nutritional needs) to an obesity solution. This reminds me of the old adage, “you can lead a horse to water, but you can’t make him drink.”

Even if 3D printers end up in every household, my gut-feeling is that it will be a very long time before people are accepting of the idea of eating food that was just spit out of a machine (although there is a large amount of processing in today’s food, it goes on behind closed doors. Ignorance is bliss.). As Malcolm Gladwell suggests in his book Blink, the way we taste food is as much psychological as it is physical (see example of declining sales in a pork product when a life-like pig was placed on packaging instead of a cartoon pig).

Something to chew on.


The Large Effect of Food Advertising on Children

Zach Berger, MJLST Staffer

The goal of advertising is to persuade consumers to purchase the advertised product. Advertising, as a form of commercial speech, is given considerable legal protection. Despite these protections, and with the rise of obesity in the you of America, advertising has become a topic of debate in the past several decades. As discussed in the Minnesota Journal of Law, Science & Technology article Food Advertising and Childhood Obesity: A Call to Action for Proactive Solutions by Roseann B. Termini, Thomas A. Roberto, and Shelby G. Hostetter, many theorists believe food advertising targets children “who are too young an immature to distinguish advertising puffery from truth.” Children have limited cognitive abilities, and assume the advertised food products are healthy. Without government regulation or parental intervention, these children can maintain these misconceptions and carry the unhealthy habits they developed at a young age into adulthood.

Unfortunately, the percentage of obese children has only gone up since the aforementioned article was written. According to a recent study, 20.5% of twelve to nineteen year olds are considered obese in the U.S., as well as 17.7% of children age six to eleven. As mentioned by Termini et al., food advertising can contribute to childhood obesity in several different ways: Time spent watching TV detracts from time that could be engaged in exercise, food advertisements encourage unhealthy choices, food products partnering with TV/movie characters encourages children to buy unhealthy products, and children snack excessively while watching TV. Although some companies have attempted to self-regulate, these attempts are not always successful.

Termini et al. suggested several solutions to limited the damage done to children by unhealthy food advertisements. These included: banning fast-food advertising on child-targeted TV, regulating food advertisements directed at children as well as the companies that produce them, eliminating tax breaks for food advertising, and increasing parental intervention. One such solution was recently reintroduced with the announcement of the Stop Subsidizing Childhood Obesity Act. This law would amend the tax code by eliminating tax deductions for advertising that is directed at children and which promotes unhealthy food and drink. The revenue this law would bring will go towards funding the U.S. Department of Agriculture’s “Fresh Fruit and Vegetable Program.” As the name states, this program provides fresh fruit and vegetables to all students at participating schools.

Overwhelming evidence suggests that the programs children watch on TV influences their eating habits. Although some of the onus is on the parents to supervise what their children eat, more consistent regulation of food advertising can help reduce childhood obesity. There is still a long way to go, but we need to be proactive if we want to have any chance of halting childhood obesity in its tracks.


3D Food Printing and Its Legal Complications

Riley Conlin, MJLST Staffer

According to a recent article in Bloomberg, the FDA has recently approved the use of a drug that was 3D printed for the first time. The first drug the FDA approved is Spritam, which was created by Aprecia Pharmaceuticals. The drug is to be administered orally to treat adults and children for epilepsy. The 3D printing process supposedly allows the pill to dissolved quickly, which means it will enable the pill to act faster in the case of an oncoming seizure. When this approval occurred several attorneys voiced concern, because of the intellectual property issues related to 3D printing. First, it would be difficult to determine the manufacturer of the drug, making the assignment of IP rights quite challenging. Second, because it would be difficult to determine the manufacturer, it would also be difficult to identify liable parties in potential litigation.

While there are undoubtedly legal issues related to 3D printing, a forthcoming article in the Minnesota Journal of Law Science and Technology Symposium argues that the benefits far outweigh potential legal issues that could slow the adoption of 3D technology in the area of food production. Symposium author, Jasper Tran, notes that there are “endless possibilities” associated with 3D food printing. First, the ability to print food has the potential to significantly impact the global food shortage crisis, because healthy food can be mass-produced via 3D printers. He also argues that 3D printing has the potential to reduce environmental harms associated with current food production. However, he does note that there are legal liability issues with 3D printing, including (1) short-term food poisoning on an individual scale or mass scale and (2) long term impacts of food printing. Despite these concerns, Tran argues the legal risks are far outweighed by the potential global benefits of mass-producing food via 3D printers.

As discussed in the Bloomberg article and in Tran’s note, 3D food and drug printing is the future. It is the responsibility of government organizations to take a proactive approach and attempt to enact rules and regulations that anticipate the new legal issues and challenges associated with the process.


The Threat of Antibiotic Resistance: The Use of Antibiotics in Animal Agriculture and Proposed Regulations to Increase the Involvement of the Food and Drug Agency

Jody Ferris, MJLST Staffer

Antibiotic resistance purportedly caused by the immoderate use of antibiotics in animals raised for human consumption is currently a hot button issue in the news today. It is an issue important to human health and to the food and agriculture industries.   In her note, Slowing Antibiotic Resistance by Decreasing Antibiotic Use in Animals, Jennifer Nomura discusses this issue and makes recommendations regarding which government agency should regulate antibiotic use in animals and how it should best be regulated.

According to Nomura, antibiotics that had been used to treat animal diseases are also being utilized for growth purposes. She says that, “it is now common in the United States for farm animals to be fed low doses of antibiotics on a daily basis.” The species in which antibiotic use is most common are pigs and poultry. She states that “[b]ecause farmers have been feeding antibiotics to animals for so many years, animals are becoming resistant to the effects of these drugs.”   She also states that it is also possible for the antibiotic resistant bacteria in animals to pass to humans and that, “as humans become resistant to antibiotics, health care for treatable diseases becomes more costly. Antibiotic resistance can lead to hospitalization, longer-term care, and potentially even death.” However, despite the grave risk that antibiotic resistance poses, Nomura states that “no direct connection has been established” between antibiotic use in animals and antibiotic resistance in humans. Some studies have showed a causal link between the two.

Over the course of her note, Nomura argues convincingly that the primary authority for the regulation of antibiotic use is the Food and Drug Agency in connection with the United States Department of Agriculture and the Center for Disease Control, along with the World Health Organization and the European Union. She proposes that the Food and Drug agency should enact a full scale ban on the animal use of any antibiotic that is also used in the human population. Her note also suggests that the Food and Drug Agency should then establish a monitoring program to keep an eye out for any threats posed to human health through the continued use of antibiotics that would not be covered by the ban.

One regulation that has since been promulgated by the Food and Drug Agency since Nomura authored her note, is the Veterinary Feed Directive rule. This rule will require agricultural producers to get prescriptions for the animal use of antibiotics “considered important to human health, such as penicillin or sulfa” (see Nikki Work’s article Veterinary Feed Directive Will Impact Whole Livestock Industry, But Many Aren’t Aware of the Regulation at http://www.greeleytribune.com/news/20358154-113/veterinary-feed-directive-will-impact-whole-livestock-industry#). The rule will be fully implemented on Jan. 1, 2017.

While the above regulation does not go so far as Nomura’s proposal to ban all antibiotic use in animals when the medications may also used for human health purposes, it is a step in the direction of increased oversight of antibiotic use by the Food and Drug Agency. It will certainly be interesting to follow future regulations in this area as they appear on the horizon, and how the Veterinary Feed Directive impacts antibiotic use and food production.


Just Not Mayo

Nolan Hudalla, MJSLT Staffer

In August 2015, the U.S. Food and Drug Administration (FDA) issued a warning letter to Hampton Creek Foods, the makers of the popular vegan mayonnaise substitute “Just Mayo.” This letter informed the company that its product had a misleading name and label imagery, because, by FDA regulation, mayonnaise must contain one or more eggs. This opinion by the FDA was in response to a high-profile lawsuit brought against Hampton Creek by Unilever (the makers of Hellmann’s Mayonnaise) and a similar class action filed in Florida state court, both alleging violation of the Florida Deceptive and Unfair Trade Practices Act and unjust enrichment. But, in an era of healthier alternatives – a world of Whole Foods, Thanksgiving Tofurky, and even eggless mayo – is the FDA missing the point? Instead of relying on food recipes enshrined in agency regulations from the 1970’s to identify whether an eggless substitute is mayonnaise or not, maybe the FDA needs to modernize its definitions instead.

In an effort to demonstrate just how committed the government is to keeping Just Mayo from poaching the traditional mayo market, consider the American Egg Board’s (AEB) response to Just Mayo. The AEB, a group appointed by the US Department of Agriculture, may have used public funds to conspire against Just Mayo. According to a Guardian article, “the government-backed egg lobby had organized a concerted effort to tackle Hampton Creek, a company described in leaked emails as a ‘major threat’ and ‘crisis’ for the $5.5bn-a-year egg industry.” This investigation led to the resignation of the AEB’s CEO Joanne Ivy. In addition, the FDA sent Just Mayo its warning letter despite an enormous show of popular support against the agency’s policy. Over 112,000 petitioners scrambled to sign a petition started by Food Network star Andrew Zimmern entitled “Stop Bullying Sustainable Food Companies,” to Unilever Chairman Michael Treschow. This public uprising boiled to the point that Unilever voluntarily dropped its initial lawsuit within two days of filing.

Even if the Florida state court suit amounts to nothing, this issue will not be over easy for the FDA. As demonstrated by the petition, consumer preferences are changing, and not just for mayonnaise. Similar battles are being fought over peanut butter, milk, yogurt, and ice cream. Retail sales of vegan products rose by over 6% last year, and 36% of U.S. consumers use milk or meat alternatives. This raises the question of whether it is really worth all of the government’s money and effort to maintain 1970’s ideas of food. Instead of deviling these modern alternatives, maybe the FDA should buy in too. After all, it’s just mayo.


Honeybee Protection in the Ninth Circuit

Ian Blodger, MJLST Note & Comment Editor

In Pollinator Stewardship Council v. U.S. E.P.A., the Ninth Circuit recently took action to protect honeybees from dangerous chemicals approved by the Environmental Protection Agency. The case is a unique situation because the great deference with which the court reviews the EPA’s pesticide approval decisions means these approvals are rarely overturned.

The EPA has the authority to approve pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). FIFRA allows the EPA to deny approval for pesticide licensing if doing so would prevent unreasonable adverse effects, including risks to the environment. 7 U.S.C. § 136a(a). In approving the use of a new pesticide, the EPA may choose to approve the pesticide conditionally or unconditionally. Conditional approval essentially means the EPA has insufficient data to determine the overall effects of the pesticide, and will allow use of the pesticide for a limited time to determine its impacts. Unconditional approval indicates the EPA has sufficient data to know the pesticide’s environmental effects. The court reviews the EPA’s decision to approve a new pesticide “if it is supported by substantial evidence when considered on the record as a whole” 7 U.S.C. § 136n(b).

This specific case centers around three new pesticides for which Dow Agrosciences sought approval. Each of these pesticides contained sulfoxaflor as its main ingredient. Following testing on individual bees, the EPA concluded sulfaxaflor was highly toxic to bees. After completing additional, though limited studies, the EPA concluded that there would be no way to determine the ultimate impact of the pesticide on the honeybee population unless the pesticide underwent testing under real world conditions. As such the EPA initially proposed to conditionally approve the use of sulfaxaflor pesticides while the agency collected additional data.

The EPA then reconsidered its previous conclusion, and decided to grant unconditional approval to the pesticide so long as certain mitigation measures were put in place. The EPA had no evidence as to the effectiveness of these measures.

Looking to this, the court determined that the record as a whole did not support the EPA’s decision to unconditionally approve the three sulfaxaflor based pesticides. The court’s decision rested on the fact that there was no evidence in the record suggesting the mitigation measures were sufficient to protect honeybees. As a result, the court vacated the EPA’s approval of the pesticides, and remanded the case to the EPA for further studies.

While this outcome does not prevent the EPA from conditionally approving sulfaxaflor, the Ninth Circuit’s analysis will hopefully serve as a reminder to agencies tasked with protecting valuable national resources to take their task seriously.


An Injunction in the Des Moines Water Works Lawsuit Won’t Hurt Farmers, Here’s Why Not

James Meinert, MJLST Lead Managing Editor

Last spring, the public water utility for the Des Moines, Iowa metro area filed suit in federal court alleging that agricultural drainage districts are emitting nitrates to the Raccoon River in violation of the Clean Water Act (CWA). The utility’s remedy under the citizen suit provision of the CWA would be an injunction; and in the alternative, the utility’s associated common law claims could yield injunctive relief and damages (The utility’s private nuisance claim in particular seems likely to survive pre-trial dispositive motions, if not win outright at trial, as Iowa Code § 657.2(4) makes it a nuisance to “render[] unwholesome . . . the water of any river . . . to the injury or prejudice of others.”). Most commentators have focused on the novel CWA claim, that nitrate pollution flowing from tile drain outlets is point source pollution and thus subject to NPDES permitting just like a factory outfall. If successful, the CWA claim would categorize nitrate pollution from tile drains as a third type of flow off agricultural fields that is separate from otherwise exempt “agricultural stormwater” and “return flows from irrigated agriculture” (33 U.S.C. § 1362(14)).

The utility has been criticized by the Governor of Iowa, State senators, and farming associations, for not collaborating with the upstream farming communities, and for not waiting to see if they State’s two year old nutrient reduction strategy will lead to lower pollution over time. Is this a real dichotomy—suing versus working collaboratively?

The CWA has never had a strong regulatory regime for nonpoint source pollution. Section 303 says that “States shall” complete a number of planning activities: first, decide what uses each water should have (wildlife habitat, recreation, drinking water, etc.); then set water quality standards protective of those uses; then maintain lists of waters impaired under these standards; and finally calculate total maximum daily loads (TMDLs) the impaired waters could receive and still be clean enough for their use (33 U.S.C. § 1313(d)). There is no actual implementation or regulatory requirement for nonpoint sources. After the TMDL, there are federal grants to identify best management practices, and more grants for parties who volunteer to implement the identified activities. These are in addition to grant money farmers could receive from USDA to implement similar practices through EQIP or CRP contracts, but all of the implementation measures are voluntary.

Iowa has largely completed the planning steps, the Raccoon River has TMDLs for nitrates, and specifically tailored best management practices for the watershed, but traditionally Iowa has not spent its federal grants directly at pollution on farm fields, but rather on broader projects like a K-12 state-wide education program to foster a “culture of conservation,” or creating wetlands areas upstream of lakes to mitigating silting and nutrient-based algae blooms.

There is an entire sector of Iowa’s economy surrounding the study and development of agricultural practices, however, there has been little governmental urgency in directing resources towards implementation of agricultural conservation practices for water quality improvement. In 2010, Iowa voters approved a constitutional amendment to create a 3/8ths of one percent state sales tax to fund water quality initiatives and to protect natural areas. However, the State legislature has yet to collect any revenue through the tax. Iowa even has its own grant funding program to pay farmers to implement water quality practices under the nutrient reduction strategy. But Governor Branstad has vetoed attempts by the legislature to fund those programs, last year vetoing the $22.4 million the Iowa house and Iowa senate agreed to appropriate for water quality initiatives.

In the world of Clean Water Act regulation of nonpoint source pollution, a lawsuit is the only way to get everyone to the table to get something done. In the 1980s and 1990s, most states completely ignored the impaired waters lists and TMDL requirements until citizens filed lawsuits in 35 states arguing progress was so slow that States and EPA had violated duties under the act. In general, courts held a duty was breeched only if the States and EPA truly did nothing, a low standard to meet, but nonetheless, EPA settled most of the suits and entered court-administered consent decrees to promulgate tens of thousands of TMDLs across the country. In the DMWW suit, the utility asks the court to “frame an injunction that permits sufficient flexibility for the Drainage Districts to comply with the injunction without undertaking an unreasonable burden.” Under such a request, the parties would be negotiating a binding timeline for farmers to take advantage of otherwise voluntary measures. If Governor Branstand doesn’t veto the State legislature’s appropriation for water quality grants this coming year farmers could implement best practices on the taxpayer’s dime, something Iowa voters asked for years ago. The utility could try for specific requirements like that all landowners physically abutting the Raccoon River make every effort to enroll in state and federal grant programs to conserve land and improve water quality. But whether the requirements are buffer strips funded by USDA Conservation Reserve Program contracts, or best practices from Iowa’s nutrient reduction strategy, that’s for the utility and farmers to negotiate in settlement conference.


USDA Heightened Country of Origin Labelling Laws: Good Start, Can be Tightened

Vinita Banthia, MJLST Staff Member

The Country of Origin Labeling (COOL) laws have long been debated and amended in the Unites States. COOL regulation dictates the degree to which a product’s label must indicate which countries were involved in the production of the product. Currently, a product’s countries of origin must be labelled for the all of its ingredients, with the exception of where the product has been processed. These standards apply to food such as meat that had been born and raised in the United States but contains elements that have been produced in other countries like China. Hence, all raw foods and its ingredients must be labelled, including “raw muscle cuts, ground commingled meat, or live imported animals are not excluded.”

However, if meat has been born and raised in the United States, and then shipped to China for processing, then shipped back to the United States for consumption, it does not need to be labelled as being processed in China. Except for locations of processing, meat must be labelled for the countries where the animal lived during its life, and where it was subsequently “raised, slaughtered, butchered, and prepared for sale.” These laws have become increasingly strict since changes in the U.S. Department of Agriculture (USDA) consumer information policies in 2009 and 2013.

The recent Note, Country of Origin Labeling Revisited: Processed Chicken from China and the USDA Processed Foods Exception published in the Minnesota Journal of Law, Science, and Technology, by Daniel Schueppert highlights the stringent COOL requirements for raw and live foods. The Note discusses the recent change in the USDA funding and regulation policies that allowed the United States to export chicken to China for processing, and then import it back in to the US for commercialization without labelling the meat’s journey. The agricultural industry and grocery stores have been largely opposed to the laws as requiring excessive labelling for non-processed meats. Canada and Mexico have challenged the U.S. COOL laws at the WTO, stating that the COOL requirements for non-processed meat are overly burdensome on Canadian and Mexican beef exporters, thereby creating an unfair advantage for U.S. domestic beef. In October 2014, the WTO ruled in favor of Canada and Mexico. Canada has threatened retaliatory actions if the U.S. does not relax its COOL laws.

In contrast, Schueppert argues that some, limited COOL standards should also be applied to meat processed in China. This position supports greater restrictions not only for non-processed and raw foods, but also for processed meats. In addition, Schueppert argues that the current definition of processed foods is too broad and over-inclusive, leading to potential safety concerns in non-processed products. This argument holds more ground that the views of industries and countries unwilling to invest greater resources in ensuring the safety and disclosure of products. The USDA should continue to take measures to ensure that meat products are increasingly safe and well-labelled for consumers.