Ten Things Every Lawyer Should Know About GMOs
The number of genetically engineered products are increasing each year, and will only get larger. Science is getting more innovative in its ability to feed the global population and treat its health care needs, or find more profitable ways to solve age-old consumer goods problems. Simultaneously some consumers are asking more questions about the ethical use of genetically engineered technology, and governments are struggling with how to handle related product failures. So here are a few concepts every lawyer should consider when representing a client on issues related to genetically engineered organisms.
- "GMO" is the wrong term. While the press and even many attorneys use "GMO" and "GE" interchangeably, this is incorrect. There are scientific and legal distinctions between a genetically modified organism (GMO) and a genetically engineered (GE) organism. Scientifically people have been genetically modifying organisms to enhance desirable traits for centuries. Genetically modified foods include everything from crossbreeding to cloning, but genetically engineered foods are created using recombinant DNA technology. It is the interchange of these two terms that is a big cause of why the debate around genetically modified and genetically engineered organisms gets so confusing for people. As an attorney, making sure you use the correct term will ensure clarity for you, your client, and your audience.
- "GMOs" is not one thing: "GMOs" are thousands of things. "GMOs" are often thought of as one product in the press, with headlines asking whether "GMOs" are safe or dangerous as if this was a question to be applied to every organism equally. But in reality there are thousands of GM and GE organisms, all with very distinct origins and DNA and more are being created every day. Their uses range from apples that do not brown (which are used to increase consumer appeal) to mice that are more susceptible to cancer (which are used to speed up medical research and results) to pigs that provide diabetics a daily dose of insulin in a more appetizing dose (this should be self-explanatory to those that like the taste of pork products). "GMOs" are more of a pantheon of ideas than a single item. If you are working on a policy issue it may be possible for you to refer to these organisms collectively, but if you are representing a client with a stake in a product they will likely need you to articulate how their product is distinctive.
- Consider the supply chain – where something is now, where it has been, and where it is going. Did your item begin in Brazil and travel to a port, only to be shipped via container across the United States to Arkansas? Will it then be made into another item, and shipped to another state? This is a fairly common scenario that has a wide variety of international, national, state, local legal considerations. An attorney must thoroughly consider, compare and contrast the item/organism as it would have existed as non-GMO organism and as GMO organism in order to give proper advice to your client.
- If you are researching a GE legal issue in the U.S., look first to the "Coordinated Framework." All domestic GM and GE issues fall under a document created in the 1980s called the "Coordinated Framework for Regulation of Biotechnology," originally published in 1986 at 51 Fed. Reg. 23,303. The document is more of an interagency memo than a regulation, and is now over 100 pages long. It is a very powerful framework that determines which federal agency regulates which type of GM or GE product or issue. In July 2015 the Obama Administration announced a major initiative to rework the coordinated framework, the first in over 20 years. If you have legal question regarding domestic use of GM or GE organisms, make sure you start your research with the most recent version of the Coordinated Framework and it will save you a lot of time.
- In the United States, genetically engineered plants are regulated by USDA’s Animal & Plant Health Inspection Service (APHIS). Genetically engineered plants have been in wide use for several decades now in the United States, and some estimates say that as much as 80% of certain crops such as soy, cotton and corn are now genetically engineered crops. There are thousands of approved genetically engineered plants already, with more coming on the market each year. Genetically engineered plants are regulated under the Plant Variety Protection Act (7 U.S. 104 (1970)). The increasing information about the large number of consumer goods containing these plants is at the center of the controversy over labeling foods that contain ingredients made from genetically engineered organisms: the food industry says that the practice is safe and so widespread as to be ubiquitous, and consumer groups are asking for the opportunity to make their own choices on this issue.
- In the United States, genetically engineered animals are regulated by FDA’s Center for Veterinary Medicine. The regulation of genetically engineered animals is a relatively new regulatory area in the United States and there are relatively few approved genetically engineered animals. The genetically engineered animals that are approved are mostly for animal testing or for pets. These animals are regulated under the FDA’s Center for Veterinary Medicine under the Guidance for Industry on Regulation of Genetically Engineered Animals Containing Heritable recombinant DNA Constructs, 74 Fed. Reg. 3,057 (Jan. 16, 2009), which is under the Animal Drug User Fee Act, which is part of the Federal Food, Drug & Cosmetics Act (Animal Drug User Fee Act, 21 U.S.C. § 379(j)-21 (2008); Federal Food, Drug & Cosmetic Act. 21 U.S.C. §§ 201, et. seq.)). The most famous GE animal proposed for approval is Aquabounty’s AquaAdvantage salmon, which combines two different types of salmon and another type of sea creature to get to market weight much quicker than even farmed salmon and is engineered for human consumption. There has been a high level of public controversy over this application and as of the submission of this article, the approval has yet to be granted after a number of years and appeals. In the interim, several other genetically engineered animal companies have chosen to close their doors or gone bankrupt. If your client is in the genetically engineered animal business be prepared for a very slow and cautious approval process, and engage a public relations firm immediately.
- If you are researching GE issues that will pass between international boarders, you must also research the applicable trade agreements. A myriad of international trade agreements have applicable clauses that govern genetically engineered organisms. If you are dealing with an import/export issue and new to this area, please remember that it is not enough to simply look at the various laws and regulations of the two (or more) countries involved, you must also look at the trade agreements that apply as well. The World Trade Organization (WTO) has several agreements that apply, including the Agreement on the Application of Sanitary and Phytosanitary Measures. There are regionally specific agreements between various countries and/or regions, and certain product specific agreements that only apply to certain items such as bananas. And there are agreements that the United States does not currently acknowledge or participate in but could, given international controversies, apply in the future such as the Cartagena Protocol on Biosafety. Given the complex nature and constantly changing landscape of trade issues, not to mention the scope of pending trade agreements, seeking an expert opinion is a wise investment especially when an attorney is new to trade practice. Or to put it another way: here be dragons.
- Broaden your mind when considering genetically engineered organisms: GMOs are not just used for food. While food products tend to get most of the press when it comes to GMOs and GE organisms, there are far greater uses for the technology. The U.S. has six approved uses for GE animal products alone, and human consumption is just one of those uses. Consider for example xenotransplantation – a process that involves using (usually GE) biological material from a nonhuman in a human for medical purposes. The consumer objections to using genetically engineered materials for medical purposes have always been far lower, and as with food materials the demand for biological materials is projected to far exceed the supply as the years progress. In 2015 if you are reading about xenotransplantation there is a good chance you are reading about pig organ donation, as that has long been seen as one of the most promising and most potentially profitable areas of xenotransplantation. This is widely considered to be the future: especially with our aging population, and scientists increasing ability to be precise in their ability to target infected areas. The concept is that one day your doctor will not be talking to you about removing your entire failing organ – instead he or she will be talking to you about removing only the cells that are failing or cancerous, and replacing only those cells with specially engineered matches, from either a pig or another species. This is just one example of alternate GE uses. This also means that the food industry, which has traditionally borne all of the consumer controversy concerns over GMO and GE use, will not be alone much longer as consumers start to ask more questions about this science. It will not be long until other industries are being asked these questions as well, and a wise lawyer will ask their client how they are prepared to handle these issues as there are significant legal implications embedded in the way information is communicated regarding genetically engineered organisms.
- You are not alone. If you are considering these issues in Arkansas, the University of Arkansas has great resources food law and agricultural law research. The School of Law had one of the first masters of law degrees in the world on these topics, and the Journal of Food Law & Policy was the first student-edited journal in the United States to address these issues. As a result the law library in Fayetteville has a great collection of food and ag law topics, and many of your Arkansas colleagues are more well-versed on these topics than you might think. Additionally the National Agricultural Law Center is housed at the University of Arkansas as well and has a wide variety of online resources for attorneys researching these issues. Need an extra hand? Consider hiring a clerk or an associate: given the great education the UofA offers, a current or recent graduate who studied these issues will be up-to-date on many of the recent developments of the law of genetic engineering and could save you a lot of time.
- Science will always move much faster than the law. GE? While it has the attention of the headlines, it is actually already old news. One of the hottest, and most unstable, topics in science over the past few years is synthetic biology: the "design of biological components that do not already exist in the natural world." While lawyers, lawmakers, consumers and the media are debating the merits of manipulating the DNA of that currently exists, scientists have advanced to creating new life.
Margie Alsbrook practices food law at the Hoeller Law Firm. She was the first editor-in-chief of the University of Arkansas’ Journal of Food Law & Policy and her scholarly articles have been cited by numerous courts, books, and other sources. This article originally appeared in The Arkansas Lawyer, the official magazine of the Arkansas Bar Association.