How the FDA regulates genetically modified organisms (GMOs)
Opponents of GMOs make it seem as if GMOs are virtually unregulated. This is partly because they want to frighten the public, but it also has to do with the informal, case-by-case regulatory structure that has formed around GMOs.
From the time transgenic crops were being grown in realistic farm settings, even if still at an experimental stage, they must receive the approval of the United States Department of Agriculture, who ensures that the crop is safe to grow (regardless of whether it is consumed as food by anything). At some point the Environmental Protection Agency must check to make sure the GMO is safe to the environment. Finally comes the Food and Drug Administration (FDA) whose role is to protect humans from consumption of foods made from GMOs (which I refer to as GM foods). I know very little about the manner in which the USDA and EPA regulates, but I have researched FDA’s role in GMO regulation, and this article is the story of that investigation.
When I first began investigating how the FDA regulates GMOs it indeed seemed like there was no regulation. There was no public legislation detailing exactly how food made from transgenic crops would be evaluated. When I tried to establish communications with the FDA they refused to talk to me—me, a professor from an agricultural college who generally approves of both the FDA and GMOs. They would not even answer some relatively simple questions. I had never been ignored by the USDA or EPA, so I admit, it made me a little suspicious of the degree to which they acted in the public’s interest. If they wouldn’t talk to me I had to wonder: what are they hiding?
Then I noticed that I had a difficult time finding anyone whom I could publicly cite regarding how FDA regulates GMOs. There were some individuals who would converse with me and provided useful information (information I later corroborated with others), but they would not let me cite them.
When GMO opponents were contacted they generally resisted talking to me as well, but when they did I only received conspiracy stories, some of which had some truth, but their unwillingness to think of GMOs as anything other than a grand conspiracy by a few corporations seemed more than a little outlandish. Agricultural economists are naturally skeptical, and I am more skeptical than most, so I did not have much confidence in the information food activists provided.
The more I learned about the GMO controversy the better I understood FDA’s reluctance to talk to me. If they made one innocent mistake in what they said, and if I was not a reasonable a person as I claimed to be, their unfortunate mistake could be used against them forever, compromising their ability to protect the public. Food activists would never let them retract an inaccurate statement, or allow them to correct a misunderstanding.
One mistake the FDA has made is to participate in the revolving-door system where people who once worked for the Monsanto corporation went to work for the government agencies that regulated Monsanto, and then returned to Monsanto, and so on. For those naturally adverse to corporations, it must have been infuriating to hear that the person in charge of developing FDA’s policy towards GMOs, Michael Taylor, once worked for Monsanto, then returned to Monsanto as a Vice-President, and as of 2013 was the U.S. Food Safety Czar. Of all the food activists battling GMO corporations , Jeffrey Smith of the Institute for Responsible Technology gets the most face-time on television, and the main thrust of his argument seems to be the Michael Taylor story.
Individuals active in the blogosphere and in food had a good chance of coming across this diagram showing fifteen people with formal ties to both the Monsanto corporation and the federal government (including Hillary Clinton). They likely also encountered the story of how the Syngenta corporation (a pesticide and GMO producer) hacked into the email of scientist Tyrone Hayes, threatened his family, and attempted to discredit him publicly simply because he refused to conceal his research showing the harmful effects a pesticide had on the development of frogs. It seemed to confirm Hollywood’s perpetual depiction of corporations as evil empires that will stop at nothing for a few extra bucks. If Syngenta’s behavior is the corporate norm, and if corporations have deep ties with regulators ... how can you also trust the regulators? I have to admit, the whole thing was making even me a little fearful of GMOs.
But I trust the scientists
Even though I do not believe Syngenta’s behavior is the norm, I don't trust corporations completely. Nor do I trust regulatory agencies, as they are ultimately accountable to politicians, and no one trusts politicians. But I do trust the scientific organizations that exist in modern democracies. There is no other organization I trust more than the U.S. National Academy of Science. Perhaps this is partly because I am a social scientist myself, but it is also because my familiarity with the scientific establishment has given me ample reasons to trust it. I know how the institution of peer-reviewed journals operates, and though it is far from perfect, it has more integrity than politicians, regulatory agencies, food activist organizations, or the private sector.
It isn’t that scientists have more integrity that other people, but that the system in which scientists compete generally leads to the discovery of truth. Scientists are competitive and ambitious, just like corporate vice-presidents and politicians, and science itself is like a grand tournament, where we all compete for publication in the best peer-reviewed journals. The only way scientists can emerge from this tournament victorious is to provide the best explanations for the world we observe around us. Scientists are ultimately measured by empirical fact, and when scientists start to make claims inconsistent with facts they are quickly put into their place by other scientists. Scientists are often wrong, and sometimes unethical, but their behavior is quickly checked and exposed. For me personally, I am skeptical of everything in the world except science.
Out of this reverence for the scientific establishment, I came to have confidence in the USDA, EPA, and most importantly, the FDA, because it seemed that the process they established for regulating GMOs were based firmly on judgements made by scientific organizations.
The most important scientific judgement regarding GMOs concerned something called substantial equivalence. Scientists concluded that since the DNA of all organisms is built from the same material but different instructions, regulation should only take into account the actual composition of the GMO, not the process used to create the GMO. That is, it matters little whether a new soybean variety was created using selective breeding, radiation-induced mutation, or genetic modification. All that matters is the actual soybean’s DNA and behavior. This meant that if a company could prove that a transgenic soybean plant was essentially equivalent in its chemical composition and behavior to other non-GMO soybeans, there is little reason to treat the transgenic soybean any different than traditional varieties. This is indeed how the FDA views GMOs, and because it is consistent with the scientific consensus, I approve of the FDA’s regulatory philosophy.
... no conceptual distinction exists between genetic modification of plants and microorganisms by classical methods or by molecular techniques that modify DNA and transfer genes ... the product of genetic modification and selection should be the primary focus for making decisions about the environmental introduction of a plant or microorganism and not the process by which the products were obtained.
—Committee on Scientific Evaluation of the Introduction of Genetically Modified Microorganisms and Plants into the Environment. 1989. Field Testing Genetically Modified Organisms: Framework for Decisions. National Research Council. National Academy of Sciences.
You still haven’t said how the FDA regulates GMOs
It works like this. A company is going to notify the FDA as soon as it begins developing a new GMO. The company could simply go ahead and develop and sell the product without the FDA’s blessing, but this leaves them more vulnerable to lawsuits and FDA recalls, so it seeks this blessing early. Once the FDA is informed that a company has created a new GMO it sends the company a list of questions about it.
After the their questions are answered the FDA is likely to have more questions, which might include requests for experiments, tests, and/or additional data. All information the FDA requests is collected by the company, and this has understandably made some suspect that the companies manipulate the data or report only the experiments favorably to the company. However, there are serious consequences if they are caught doing this, and if the FDA is properly managed it wouldn’t allow the companies to collect and report data if they did not believe it was in the company’s self-interest to be honest. Moreover, this is the norm in regulation. For instance, when a pharmaceutical company seeks FDA approval for a new drug the FDA requests certain experiments, and it is the company that adminsters the experiments and reports the data.
This correspondence between the FDA and the company continues until the FDA finally sends the company a notice that they have no more questions. Although neither party would admit to this, my sources have convinced me that this notice essentially serves as the FDA’s blessing, allowing the company to begin selling the product commercially.(G1,N1) Sometimes the FDA might indicate that it is acceptable for the crop to be used for some purpose but not others (like the Starlink cases discussed below), and the companies will oblige accordingly.
During this question-and-answer consultation process the FDA will request information on the chemical composition of the final product to see if it is comparable to its non-GMO counterpart. If the product is a GM canola, for instance, the FDA might want to know about its triglyceride and fatty acid content. Information will also be asked of its behavior. For instance, in the case of a transgenic cotton the FDA may want to know how long it takes the GM cotton to mature and flower, in order to see if it behaves like other non-GM cotton varieties. Other requests may concern information on its nutrients, antinutrients, toxicants, and allergens.
To give an example, a transgenic soybean plant was once created by inserting the DNA of a Brazil nut into the soybean’s DNA. Because nuts are known allergens, the FDA would never lend its approval without scientific confirmation that it would not cause allergies in humans. The company then undertook a series of skin-prick tests, confirming that it did indeed cause allergies. Regardless of whether the company ceased the project because it was the responsible thing to do, because it wanted to avoid lawsuits, or because it new the FDA disapproved of the soybean, the fact that the project was ceased gives us at least one piece of evidence that the U.S. food system is safe.
Of course, there is evidence not to trust the system also. A GM corn variety called Starlink did not pass the allergy test and so was restricted for use as animal feed only, and the GMO controversy was made even more intense when it was discovered this corn had slipped the human food system, eaten directly by humans. Though no evidence of any health harm was detected, the accident showed that GMOs may be easier to regulate in theory than in practice.
From this we conclude that FDA uses an unstructured series of consultations to ensure the safety of a GMO. Rigid rules are perhaps not used because each potential GMO is different, requiring the FDA to ask different sorts of questions. The reason that there are no hard-and-fast regulatory rules is that the nature of GMOs requires the FDA to be more flexible, and the consultation process allows this flexibility. The FDA probably could establish and follow a more transparent regulatory process, and doing so might cause the public to be more confident about the food system, but after investigating the matter the informal consultation process does not bother me.
What does it mean when the FDA has given its blessing for the sale of a, say, transgenic apple? It doesn’t mean that the FDA knows the apples to be safe, only that there is no reason to believe the transgenic apple to be any less safe than conventional apples. This is the FDA’s philosophy on GMOs, and it is derived from the judgement of scientists like those at the National Academy of Science—this is the reason why I support the use of GMOs in agriculture, and why I have considerable confidence in regulatory agencies, including the FDA, the EPA, and the USDA.
Familiarity and trust in various information sources
This article has described my journey from initially being suspicious of the FDA to finally applauding their handling of transgenic crops. Most Americans feel the same, according to the results of a survey from agricultural economist Jayson Lusk (full disclaimer: he is also a very good friend of mine). Administered over the telephone in 2014, Lusk asked Americans how familiar they were with certain information sources and the extent to which they trust them.(L2) Organizations most familiar to people are high on the y-axis and those most trusted are farther right on the x-axis. The FDA is high and to the right, indicating people not only are familiar with the FDA, but trust them as well.
Figure 1—Trust (x-axis) and familiarity (y-axis) in information sources
(reprinted with permission from Lusk)
To my dismay, a Texas A&M or Harvard professor is low on familiar and medium on trust—my peers and I must do better! Though professors are not trusted as much as the FDA we are trusted about the same as ABC News. Not surprisingly, corporations like McDonald’s and Tyson Foods are very familiar but least trusted. Given the familiarity of and trust in the FDA, perhaps if Americans were more aware of how GMOs are regulated, they would be more receptive to transgenic crops. Indeed, the purpose of this lecture is to communicate FDA’s role in GMOs. Perhaps, here at the end, you have come to the same conclusions about GMOs as me. If not, that’s okay. So long as your decisions are better informed, I am doing my job, regardless of what your decision might be.
Related articles
The best investigative journalism on the regulation of GMOs is a series of articles at Grist. Largely a liberal / environmental publication they arrive at roughly my same views on how GMOs are regulated. It is partially because of these articles that I came to believe in the story my sources were telling.
