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What a year it was! It is hard to remember the last time we had a year as eventful for innovation in agricultural biotechnology as was 2018. Here’s a brief recap of some of the biggest developments and surprises in my own eclectic rank-ordering, starting with the most important.
SCIENTISTS ENGINEER A SHORTCUT FOR PHOTOSYNTHESIS, BOOSTING CROP GROWTH BY 40 PERCENT: The first draft of this year-end retrospective started with the CRISPR babies story (see below). But on January 4th, the most important paper in years was published in the journal Science. Yes, that makes it 2019, but it was submitted for publication in 2018, and the research took place over the past several years—so, never mind. This is too important to wait. This could be the proverbial “game changer.” In short: Researchers with USDA and University of Illinois announced they had tweaked the cellular mechanism of photosynthesis in tobacco plants to make them 40 percent more efficient than unmodified plants in converting sunlight into biomass. Previous work has shown promise in the same space, but the latest report represents a new and giant step forward. If these findings can be transferred to major commodity crops—and there would seem to be no insurmountable technical obstacles—then this could pave the way for a transition to a dramatic ramp-up of the renewable biofuels-based economy and commensurate downsizing of fossil fuels to the role of providing feed stock for organic chemistry. Watch this space; tectonic shifts are being generated herein.
CRISPR BABIES: While not, strictly speaking, an ag-biotech development, probably the most important event in biology over the past 12 months was the news that broke on October 25th that renegade Chinese scientist He Jiankui had gene edited two embryos resulting in the birth of twin baby girls. We have written about this elsewhere, and compiled timelines of significant events leading up to He’s announcement, as well as in the larger world of gene editing. This event was important not only because it brought the klieg lights to bear on the rapid pace of technological innovation in biology, but also because it provided what is certain to become the paradigm example of how not to do it. To recapitulate, “…this was an epic scientific misadventure that flout[ed] international ethical norms. It was crazy, reckless and needless, unethical and dangerous.” We can only hope policymakers do not overreact in ways that would unnecessarily impair the use of these techniques to address the myriad challenges awaiting their more ethical application.
CRISPR APPLICATIONS EXPLODE: Notwithstanding major rapid developments in recent years, 2018 was arguably the year CRISPR really blew the doors off, in a good way. The past year saw a huge expansion in the already impressive list of applications of CRISPR-mediated gene editing to develop solutions to challenges farmers face that are otherwise much more difficult to address. The pace of innovation has been such that keeping track would be a full-time job. We’ve tallied at least a partial summary. The bottom line is that innovations in agricultural biotechnology, driven principally by CRISPR-mediated gene editing, are on a path toward radically reconfiguring virtually every aspect of the relationship between humans and our environment, in exactly the manner Rachel Carson hoped would happen (see Silent Spring, Chapter 17, paragraph 2). It is one of the great ironies of our age (one that would not have surprised Carson) that so called “environmental NGOs” have been the principal barrier to the biological innovations that are rapidly delivering what they claim they want: a form of agriculture that treads more gently on the land.
Bt EGGPLANT FLOURISHES IN BANGLADESH: On November 21st, a paper was published in the peer-reviewed scientific literature with this mellifluous title: “Bt eggplant (Solanum melongena L.) in Bangladesh: Fruit production and control of eggplant fruit and shoot borer (Leucinodes orbonalis Guenee), effects on non-target arthropods and economic returns.” Reporting on a well-designed field trial, seven Bangladeshi scientists and two Americans documented the impacts of biotech insect-protected varieties of eggplant (brinjal) on farms and farmers in Bangladesh, concluding: “Bt varieties had increased fruit production and minimal [pest] fruit infestation… all Bt lines had higher gross returns than their non-Bt isolines… Bt brinjal lines are extremely effective at controlling BFSB in Bangladesh without affecting other arthropods, and provide greater economic returns than their non-Bt isolines.” At one level, this paper simply confirms what we have long known—that biotech-improved crops are safe, and that they deliver major economic and environmental benefits to the farms, farmers, environments and citizens of the countries where they are grown. But at a deeper and more important level, this paper shines the spotlight on a phenomenon long present but gaining momentum: Recognizing the considerable environmental and economic benefits of biotech crops, farmers (no fools, they), have long been willing to do whatever they must to gain access to biotech-improved seeds, and where ignorant policies block the path, the law be damned. But Bangladesh is leading the way among developing countries in planting biotech seeds, in this case developed by their own scientists, as other countries begin to defy European green imperialism. Jared Diamond summed it up thusly (Guns, Germs and Steel, W.W. Norton, 1998, p. 257):
Any society goes through social movements or fads, in which economically useless things become valued or useful things devalued temporarily. Nowadays, when almost all societies on Earth are connected to each other, we cannot imagine a fad’s going so far that an important technology would actually be discarded. A society that temporarily turned against a powerful technology would continue to see it being used by neighboring societies and would have the opportunity to reacquire it by diffusion (or would be conquered by neighbors if it failed to do so).
USDA TAKES INTELLIGENT ACTION ON GENE EDITING: On 28 March, U.S. Agriculture Secretary Sonny Perdue announced that USDA would not impose regulatory oversight on some products of gene editing “that could otherwise have been developed through traditional breeding techniques as long as they are not plant pests or developed using plant pests.” Taken together with the “Am I Regulated” process through which innovators can seek an opinion as to whether or not their product must be subjected to the full panoply of (scientifically indefensible) regulatory scrutiny, this moves USDA a big step in the direction of restoring scientific credibility to the regulatory process, though it does not go far enough. But they’re moving in the right direction, which is something that cannot be said of other players both in the U.S. and overseas (see below).
THE EUROPEAN COURT OF JUSTICE FUBARS EU POLICY ON GENE EDITING: On July 25th, the EU Court of Justice made a hoary acronym from World War II relevant again: FUBAR—“[Fouled] up beyond all recognition.” While the EU’s scientifically indefensible process-based approach to regulating crops improved through biotechnology has been widely excoriated, some had hoped a saner path would be charted for products of gene editing. Although an initial opinion provided a credible rationale under which the EU could have avoided making its existing regulatory train wreck even worse, the ECJ defied expectations and ruled that the existing directives cover gene-edited products as well as so called “GMOs.” Whether or not the decision is legally sound, it is an absurd policy disaster. It has made the lunacy of existing EU regulation of biotech innovations in agriculture stark and undeniable, and triggered massive condemnation from scientists and governments around the world. If this actually results in EU regulations being brought into less open conflict with science and reason, it may produce some good. But so far there is little sign this will happen any time soon.
JAPAN SHOWS EUROPE (AND FDA) HOW TO DO IT BETTER: In late August, the Japanese government announced that gene-edited crops will not be subjected to “GMO”-like regulation if they are used only to tweak genes already in a genome; “GMO”-like regulation would continue to be reserved for crops and livestock into which chunks of novel DNA has been inserted. Japanese regulators have even signaled they will take a similar attitude towards gene editing of human embryos. This builds on the kind of approach announced earlier by USDA, but it represents the opposite of the approach taken by the EU and FDA, both of whom could learn much from parsing Japan’s thoughtful reasoning.
BAYER + MONSANTO: On June 7th, Bayer and Monsanto announced they had reached final agreement on a merger more than two years in the making. It was significant on many levels: It retired a pioneering company brand that had been a feature of U.S. and global industry for over a century while elevating a no-less recognized European and global brand to new heights. In some ways it was a brilliant sleight of hand, depriving protesters around the world of a favorite target (in different polls the most hated company on earth and one of the best places to work) by grafting it onto a company with one of the most rock-solid reputations in the corporate world, synonymous with relieving pain. It seemed to be a match made in heaven. But more fundamentally, it represents another result from one of the most powerful societal forces we’ve seen sustained over at least the last two centuries: the relentless demand from consumers for food at ever lower prices. As companies selling genetically improved seed to farmers, both Bayer and Monsanto felt this pressure, which was exacerbated as other mergers in the agricultural chemicals and seed space brought greater returns in innovation from the companies’ investments in R&D. By merging, they are better positioned to leverage their investments in further innovation delivering greater efficiency and returns. We can only hope that the setting of the sun on the Monsanto brand will reduce the future incidence of reflexive opposition to biotech innovations that has occluded so much of the public discourse on how to improve the sustainability of agriculture, an issue identified with no company more than Monsanto.
FDA CONTINUES TO FLOUNDER ON GENE EDITING: Widely recognized as exemplifying the gold standard for regulatory agencies charged with ensuring food safety, one area where FDA leadership has persistently fallen short is in dealing with bioengineered animals. After taking years to decide to apply their authorities under the New Animal Drug Act, and years more to approve the first genetically modified animal for food uses, FDA recently doubled down on its counterproductive approach with respect to gene-edited animals, proposing that all of them be required to undergo extensive premarket regulatory review regardless of whether or not it made sense to do so. And it doesn’t. The move elicited considerable criticism, even prompting a bipartisan group of lawmakers to urge FDA and other agencies to take a rational approach to risk management that would allow for innovation. Commissioner Gottlieb knows better, and although recent indicators suggest FDA may be re-thinking this approach, other clear signals suggest it remains intent on following a foolish path. We can only hope regulators wake up and do the right thing.
JOHNSON v MONSANTO: In August, a jury voted against Monsanto in the first glyphosate/cancer lawsuit alleging glyphosate was responsible for cancer afflicting a Vallejo, CA groundskeeper. The jury awarded Dewayne Johnson $39.3 million in recompense for lost earnings and $250 million in damages. To reach their verdict, the jurors had to ignore the fact that there is no plausible causal mechanism for glyphosate carcinogenicity; no evidence from animal studies to support any suspicion of such a link; and abundant evidence that the one supposedly scientific organization opining otherwise cooked the books to reach its preferred conclusion at odds with the massive weight of evidence and the overwhelming consensus among the global scientific and regulatory communities including the author of one of the papers cited in support. The judge, clearly, had reservations about the verdict for which Monsanto has a strong basis for an appeal. One hopes that the judge in a new trial will more effectively constrain “flagrant misconduct” by the plaintiff’s attorneys and take a gimlet eye toward mischaracterizations of the science, and more aligned with other court decisions that have been more in accord with data and experience.
CRISPR PATENT DISPUTE RESOLVED, RAPIDLY OVERTAKEN BY EVENTS: On September 10th, a federal appeals court rejected an appeal by the University of California, Berkeley, in a dispute over patents covering CRISPR gene-editing technology. But on July 4th, a paper was published detailing “highly specific genome editing by both Cas9 and Cpf1 (Cas12a) nucleases.” This was taken primarily as confirmation of the safety of CRISPR-mediated genome editing by confirming the rarity of so-called “off target” effects wherein genetic changes might be made at places in the genome other than the specific locations where they were desired; so, good news for fans of innovation. But an overlooked implication of possibly even larger import was the fact that this CRISPR-mediated editing depended not on Cas9, but an entirely different moiety, Cas12 (for a refresher on how CRISPR/Cas works, please see here or here). In other words, while Berkeley and the Broad were duking it out over patents for applications of CRISPR-Cas9, entirely different families of CRISPR-mediated gene editing were being developed that would likely fall outside those patents, thus making them less important, less worth fighting over, and less relevant (though still important) to future innovation. How many different Cas proteins are there? We don’t know, but it’s not a small number—at least 45; almost certainly hundreds. In other words, the pace of innovation is so breakneck that even the patent attorneys are being left in the dust. Some might be forgiven for thinking this is not altogether a bad thing.
FARMERS FIND THEIR VOICES: “We call on the countries of Latin America and the world to have their governments make decisions based on scientific evidence and not on myths or misinformation,” declared more than 100 young biotechnology leaders from 17 Latin American nations. And they were not alone. “We’ve had enough talk,” said Patience Koku of Nigeria, who was named farmer of the year by the Cornell Alliance for Science. “We need to adopt this technology now.” Koku’s sentiment was further echoed by Hon. Nana Brempong, a member of the Ghanaian Council of State who is also a commercial farmer: “I am advising the Nigerian president to consider GMOs because I’ve seen it and know the benefits….” Farmers have long been active on social media, trying to educate city folk about the challenges farmers face and the tools they use to overcome them, which have provided us today with the most abundant, nutritious, diverse and safest food supply in history. But in 2018, we saw the voices of farmers emerge full throat as farmers from the developing world, especially Africa, stood up to demand their right to choose to use the same tools used by their counterparts in industrial nations. Twitter and Facebook have been important platforms, but mainstream films on the big screen also gained traction. There is no going back.
GENETICALLY MODIFIED LABELING POLICIES: MOVING FORWARD OR BACKWARD? On December 20th, the U.S. Department of Agriculture published its final rule on implementing the mandatory disclosure of “GMO” status imposed by Congress in 2016. There is no scientific basis for this requirement, which represents a purely political “fix” to the problem of proliferating, nonsensical “GMO” labeling rules at the state level, for which FDA already had all the necessary tools (which is not to say the requisite political courage). History books are replete with examples of legislators screwing things up when they pass laws in areas they don’t understand, and this case provides yet another example. But as train wrecks go, USDA did a reasonable job of mitigating the damage: it ditched the intrinsically misleading and deceptive term “GMO” in favor of the much less bad “bioengineered;” it adopted a neutral-to-positive symbol, abjuring the kind of skull and crossbones for which opponents clamored; and it provided food companies with options including websites and telephone numbers through which they can provide more full and accurate disclosure than is possible on the limited and crowded landscape of a food label. All these things are good, as far as it goes. But perhaps the best thing about these new regulations is that they have the dogmatic opponents of ag-biotech innovation enraged. There is no surer sign the public interest has been served.
CONSUMERS DISGUSTED WITH MISLEADING LABELS: Unscrupulous food marketers have long pushed to see how much they could get away with by misleading claims on food labels—from sugary breakfast cereals claiming to be “Part of a balanced breakfast!” to indulgent sorbets playing up the fact they’re “Fat Free!” In 2018, however, pushback on such deceptive practices gained serious momentum. Our own petition to FDA to enjoin perhaps the biggest offender, the NonGMO project, deconstructed their baseless claims that genetically improved foods are somehow unhealthy and illuminated their multiple violations of US food labeling laws in ways Congress clearly intended FDA to prohibit. Meanwhile, PeelBacktheLabel crowdsourced the cataloguing of inaccurate and misleading labels and called out a broad swath of food company miscreants. At the same time, some companies plumbed new depths of foolishness, none more so than Smirnoff, widely excoriated for emblazoning bottles of vodka, a first class potent carcinogen, with a NonGMO label in a ludicrous attempt to bolt on a health halo (they also claim it’s “gluten free”). Since some corporations are willing to sacrifice their own brands and credibility in the pursuit of ephemeral advantage from fear-based marketing, they should be concerned that FDA has now been encouraged to rise from its torpor and enforce the law that prohibits such corporate misbehavior. Citizens concerned about the safety and integrity of foods are watching with increasing impatience.
HOUSEPLANTS TO DETOXIFY INDOOR AIR POLLUTION: Last but not least, in a development that should play to the worried well of the Whole Foods cohort, biologists at the University of Washington have genetically engineered a house plant to help remove toxins from indoor air. They did this by taking a bunny gene that helps break down volatile organic compounds, some of which may be carcinogenic when present above threshold levels, and inserting it into the genome of a robust houseplant known as pothos ivy (a.k.a., “Devil’s ivy”). “The result was a highly active detoxification plant cultivar they named pothos ivy VD3. They tested it against two of the most common VOCs and the effect was incredibly strong when compared to wild type versions. Benzene breakdown increased 4.7-fold and chloroform was even more surprising as the wild type plants had no prior capability to break it down. VD3, meanwhile, reduced a concentration of 800 milligrams per cubic meter to 0 in the span of 6 days, an incredibly rapid degradation as well.” Already approved for commercial sale in Canada, it could clear regulatory hurdles in the United States and be made available to consumers soon, whereon we may hope it will help raise the level of dinner party conversations that touch on GMOs, if nothing else.