By Michael Fernandez, GW Food Institute Senior Fellow
When Science magazine named CRISPR, the most powerful and recognized tool for editing genes, its “Breakthrough of the Year” in 2015, the reasons were obvious. CRISPR lets bioengineers target specific DNA sequences for genetic modification, allowing them to “edit” the genes of any plant or animal (including humans) without the introduction of foreign DNA. Moreover, because CRISPR is relatively easy and cheap to use, it is democratizing genetic engineering. As one Harvard scientist said, “any molecular biology lab that wants to do CRISPR can.”
And nowhere is this more evident than in the world of food and agriculture. Venture capital funded start-ups like Caribou Sciences and Calyxt, established industry giants, and academic scientists alike have jumped head long into gene editing, working on everything from heart healthy oils to hornless cattle.
It is clear that companies and scientists are moving full steam ahead……..but are the rest of us ready?
While the pace of scientific innovation picks up, work on regulatory updates to accommodate this new technology is barely out of the starting gate. In January of 2017, the outgoing Obama Administration proposed revisions to USDA regulations governing genetically engineered crops, including new provisions to address the products of gene editing. As part of its larger deregulatory efforts, the Trump administration formally withdrew the proposal in November of 2017, leaving in place existing regulations that all sides agree are not set up to address gene editing.
Also in January of 2017, the FDA released draft guidance on the regulation of gene edited animals. As with its approach to the first generation of genetically engineered animals, FDA proposed that animal products of gene editing would require approval under its New Animal Drug authorities. That position has historically been highly controversial – the animal drug approval process is burdensome, expensive and slow – and the draft guidance has not been finalized. Tensions over the regulation of gene edited animals have flared again recently, with some members of Congress suggesting that authority to regulate them should be transferred to USDA, sowing further uncertainty
And the third agency with primary jurisdiction over genetically engineered foods, the EPA, has produced no guidance of any kind on gene editing.
This regulatory uncertainty hasn’t stopped new developers, though, and they are increasingly knocking on regulators’ doors seeking clarity. A number of developers have reached out to USDA in particular, sending so-called “Am I Regulated?” letters to understand the regulatory status of new gene edited plant products. To date, USDA has taken a hands-off approach to gene edited plants. To be clear, USDA has not determined that these new products are safe, but rather that they fall outside the scope of USDA’s existing regulatory authorities all together. Agriculture Secretary Sonny Perdue recently reiterated this position, stating that “USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques.” With no formal guidance on how USDA will decide what could otherwise have been developed through traditional breeding techniques, however, developers are working in a gray area. And food companies, and their customers, are facing the prospect of a new generation of bioengineered ingredients that have received no regulatory review from the Department of Agriculture.
GMO Labeling: Semi-transparency
In another recent and much anticipated development, USDA issued proposed regulations to implement the National Bioengineered Food Standard. Signed into law in 2016, the labeling bill was prompted by the passage of individual state GMO labeling laws (most notably in Vermont) and designed to establish a single, uniform national standard for mandatory labeling of GMO foods. Unfortunately, the proposal raises as many questions as it answers.
Foremost among these is whether gene edited products will be covered at all. The law states that it covers foods with genetic modifications that “could not otherwise be obtained through conventional breeding or found in nature,” but leaves it up to USDA to define what that means. The proposed regulations offer some alternatives, but provide no real clarity. Taken together with Secretary Perdue’s “public clarification” of USDA’s regulatory approach, however, it appears that USDA is heading towards a labeling standard that will not require many products of gene editing, especially those that do not involve insertion of foreign DNA, to be labeled as bioengineered.
Let’s be clear. Despite the rhetoric about comparisons to conventional breeding and foods that can be found in nature, gene editing is a high tech, cutting edge genetic engineering technology. It is a very sophisticated form of genetic manipulation that meets any common sense definition of bioengineering. That doesn’t make it unsafe – in fact, the added precision of gene editing will generally enhance safety – but it does create a reasonable expectation that gene edited foods will be labeled as bioengineered. If the purpose of labeling is to provide clarity for consumers, a standard that leaves out an entire class of bioengineered products would be semi-transparent at best.
Because no mainstream gene edited food products have hit the market, we don’t have a lot of information about how consumers will react. If our experiences with first generation GMOs are any indication, however, the response is likely to be mixed. Survey results have consistently shown that awareness of GMO foods is relatively low, that significant percentages of consumers have concerns about the safety of GMOs, and that large majorities support GMO food labeling. In practice, though, US consumers have been routinely buying and eating GMO foods for years, whether they knew it or not, as the vast majority of processed foods contain some GMO ingredients.
There is no question that people are more interested in food than ever – where it comes from, how it’s made and what’s in it – and food companies are responding. Companies are busy reformulating to create more ‘clean label’ products, acquiring faster growing organic brands, investing in innovative new food start-ups, and building more transparent supply chains to capture this growing interest. The big question is where does gene editing fit into the mix?
To the extent that gene editing offers more direct consumer benefits than the first generation of GMOS – healthier, more nutritious or tastier products – there is good reason to believe that consumers will respond positively. However, these kinds of benefits have proved elusive thus far. They are always on the horizon, but never quite a reality. And the early focus of gene edited crops seems to be on the kinds of agronomic properties that are important to farmers but offer less obvious benefits to consumers. Nonetheless, if gene editing is able to deliver on this promise it would likely shift public perceptions.
Advocates of gene editing are keenly aware that consumer acceptance is critical to long term success and have been open about the need for better communications to avoid repeating the mistakes of the first generation GMO introduction. But we have seen numerous efforts to “change the conversation” around GMOs pop up only to fade away, and none have appreciably moved the needle on public opinion. A better, or at least different, communications strategy alone is not the answer.
Developers do believe that they have a better story to tell this time, however. By emphasizing gene editing as a form of advanced breeding – and being able to avoid the stigma associated with foreign DNA in the first generation of GMO products – they believe they will have a more compelling consumer narrative. But remember, developers have been making this same argument, using almost identical language, since the very first genetically engineered products hit the market. GMO Answers, a website funded by the biggest ag biotech companies, calls first generation GMOs “just an extension of natural plant breeding and evolution,” for example. Consumers have found this to be a decidedly underwhelming argument in the past, and it is unclear that they will see it any differently now.
Where is the food industry?
Food companies have a lot to gain from gene editing technology…..but also a lot to lose. They are hoping that it will help boost yields and solve pest and disease problems that threaten the long term supply of key ingredients. They also eagerly anticipate the kinds of direct consumer benefits that will help them attract and delight new customers. Several of the biggest food companies are supporting gene editing research on both fronts.
At the same time, they want to avoid controversies that could threaten reputation. Consumers are increasingly looking at the companies behind the brands they love and want to support those that they believe are aligned with their values. The leading food companies have taken notice, providing greater transparency about both their products and the impacts of the complex supply chains behind them. In a particularly relevant example, even before the national GMO labeling bill was enacted, a number of food companies decided that they would label all of their US products to meet the Vermont GMO labeling standard. To be sure, this was in large measure driven by logistics – it would be very difficult for national brands to label products for a single state – but also signaled an increased openness to helping consumers make informed choices.
Would a GMO labeling standard that leaves out gene edited foods be consistent with that approach? Most food companies have sought to avoid being pulled into the GMO labeling debate, seeing it as a distraction from the stories they wanted to tell about their brands. The development of the new labeling standard puts them squarely in the middle of the debate, though, and they face some crucial choices that could have lasting impacts on reputation.
Pending decisions on how we will regulate gene edited foods also present important choices for food companies. Consumer acceptance will, at least in part, be influenced by confidence in the regulatory system. An overly burdensome regulatory regime that stifles innovation is in no one’s best interest, but a “stamp of approval” that is backed by a credible system can help build trust. And how US regulations align with other those in other countries has implications for food companies as well. Different regulations in different markets can disrupt trade and complicate supply chains.
Gene editing is a powerful bioengineering tool with seemingly limitless promise that could very well transform food and agriculture, and it’s coming fast. The choices we make now – on how we govern gene editing and how we inform consumers – will make or break the future of this technology. Food companies may have the most at stake because they sit at the interface between producers and consumers, and they can’t afford to sit on the sidelines. They are uniquely positioned to influence the development of gene edited foods, but only if they engage. And the time to engage is now.