GMOs 2.0: Is Synthetic Biology Heading to a Food or Drink Near You?

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Old school stevia.

Old school stevia plant made by nature.

This article was originally published in Huffington Post.

By Stacy Malkan

Our culture is smitten with the notion that technology can save us – or at least create great business opportunities! Cargill, for example, is working on a new food technology that mimics stevia, a sugar substitute derived from plant leaves, for the “exploding sports nutrition market.”

Cargill’s new product, EverSweet, uses genetically engineered yeast to convert sugar molecules to mimic the properties of stevia, with no need for the plant itself.

It was developed using synthetic biology (or “synbio” for short), a new form of genetic engineering that involves changing or creating DNA to artificially synthesize compounds rather than extract them from natural sources – a process sometimes referred to as GMOs 2.0.

On June 1, U.S. Food and Drug Administration cleared the way for EverSweet with a “generally recognized as safe” (GRAS) designation. Eventually it could be used in “everything from dairy to tabletop sweeteners and alcoholic beverages, but low or zero calorie beverages are the sweet spot,” according to Food Navigator.

And so begins the next new food technology revolution: corporations racing to move food production from the land to the lab without laws or regulations in place that require scientific assessments or transparency.

How will they sell synthetic biology to consumers?

A big challenge facing synthetic biology is that today’s consumers want fresh natural foods with simple clear labels – what Food Business News dubbed the “trend of the year” last year.

“Why would we want synbio foods?” Eve Turrow Paul, a writer and corporate brand advisor, asked rhetorically in The Huffington Post. “Well, a few reasons. Number one on the list is climate change.”

Climate change is the number one reason for synthetic biology? What about capturing the exploding sports nutrition market?

Therein lies the PR challenge facing new food technologies: how to position food products created with strange-sounding lab techniques for the purposes of patents and profits as something safe that actually benefits consumers.

The largest agribusiness, food and synthetic biology companies got together in San Francisco in 2014 to discuss this PR challenge.

Dana Perls of Friends of the Earth, who attended the meeting, described it as “an alarming insight into the synthetic biology industry’s process of creating a sugar-coated media narrative to confuse the public, ignore the risks, and claim the mantle of ‘sustainability’ for potentially profitable new synthetic biology products.”

PR strategists at the meeting recommended avoiding terms like “synthetic biology” and “genetic engineering” (too scary, too much backlash), and suggested going with more vague descriptions such as “fermentation derived” and “nature identical.”

They recommended focusing the media on stories of hope and promise, capturing public emotion, and making food activists “feel like we are we are all marching under the same banner” for food sustainability, transparency and food sovereignty.

Targeting transparency

Somebody was listening. The story about Cargill’s big stevia opportunity didn’t mention genetic engineering or synthetic biology, but did describe “fermentation as a path.” It ended with a promise that Cargill has nothing to hide about how the ingredients are made and will clearly and accurately label products.

“We have targeted this space in a completely transparent manner,” said Steve Fabro, Cargill global programs marketing manager.

The new ingredient coincides with big changes at Cargill. After two years of declining profits, America’s largest private company is repositioning itself “to satisfy consumers in Western markets who are shying away from the mainstream food brands that rely on low-cost, commoditized ingredients that have been the specialty of companies like Cargill,” reported Jacob Bunge in the Wall Street Journal.

Consumers “want to know what’s in their food, who made it, what kind of company is it, are they ethical, how do they treat animals?” Cargill Chief Executive David MacLennan told Bunge.

With synthetic biology ingredients, that could prove to be a challenge.

When asked exactly how they plan to label EverSweet, Cargill communications lead Kelly Sheehan responded via email, 

“Consumers should be able to tell the difference on a label between stevia from leaf and steviol glycosides produced through fermentation. Stevia from leaf in the US is currently labeled as ‘stevia leaf extract.’ EverSweet will be labeled in the US as ‘steviol glycosides’ or ‘Reb M and Reb D.’ In the EU the expectation is EverSweet would receive a modified E number to differentiate the two products.”

 Sheehan added, “Cargill is committed to transparency and sharing product information at Cargill.com from ‘stevia leaf extract’ to ‘non-GMO stevia leaf extract.’”

Confusing? Perhaps, but labeling decisions may be left up to the companies. As with first-generation GMOs, labeling is not required in the U.S. (although Vermont will require GMO labeling starting July 1 unless Congress intervenes) and companies are free to market their products as “natural” (although FDA is reviewing use of that term). There are no safety standards and no testing requirements for foods developed with synthetic biology.

This lax system pleases the companies eager to patent new food technologies.

As Perls described the synthetic biology PR meeting, “A clear theme at the meeting was that the fewer government regulations the better, and industry self-regulation is best. There was a general consensus in the room that the public should not be concerned about a lack of data on safety; however, the internal and self-funded corporate studies are proprietary and cannot be shared with the public.”

Where have we heard this story before?

Proprietary information, patents, lack of transparency and industry self-scrutiny have been the hallmarks of first-generation GMOs – and the fuel for growing consumer distrust and demands for transparency that have caught the food industry off guard.

The corporations that profit from traditional GMOs – primarily Monsanto, Dow and other big chemical-seed companies – have responded to the backlash as big corporations often do: by throwing huge amounts of money at PR operations to attack critics and spin their products as necessary to feed the world.

The marketing promises have failed to materialize. A May 2016 report by the National Academy of Sciences found no evidence that GMO crops had changed the rate of increase in yields, and no clear benefits for small, impoverished farms in developing countries.

Nevertheless, GMO proponents claim, as Bill Gates did in a Wall Street Journal interview, that Africans will starve unless they embrace climate-friendly, vitamin-enriched GMO crops. Gates neglected to mention that these crops still don’t exist after 20 years of trials and promises.

Instead, most genetically engineered crops are herbicide-tolerant crops that are raising concerns about health problems linked to chemical exposures. These crops have increased sales of chemicals owned by the same corporations that own the patents for GMO seeds – an excellent profit model, but one that is turning out to be not so great for health and ecology.

The promise of synthetic biology

The same sorts of promises that failed to materialize in 20 years of GMO crops are fueling the buzz around next-generation genetic engineering.

Synthetic biology techniques “could deliver more-nutritious crops that thrive with less water, land, and energy, and fewer chemical inputs, in more variable climates and on lands that otherwise would not support intensive farming,” reported Josie Garthwaite in The Atlantic.

While proponents focus on possible future benefits, skeptics are raising concerns about risks and unintended consequences. With no pre-market safety assessments for synthetic biology foods, environmental and health impacts are largely unknown, but critics say there is one area in which the dangers are already apparent: economic damage to indigenous farmers as lab-grown compounds replace field-grown crops. Farmers in Paraguay and Kenya, for example, depend on stevia crops.

“By competing with poor farmers and misleading consumers about the origins of its ingredients, EverSweet and other examples of synthetic biology are generating bitterness at both ends of the product chain,” wrote Jim Thomas and Silvia Rabiero of The ETC Group in Project Syndicate.

The path forward for synthetic biology

As battle lines get drawn on the new food frontier, some difficult questions arise. How can we ensure that innovations in agriculture benefit society and consumers? How can new food technologies developed to capture markets, patents and corporate profits ever prioritize sustainability, food security and climate change solutions?

It’s going to take more than marketing slogans, and the clock is ticking to figure it out as new technologies race forward.

As Adele Peters reported in Fast Company, a new gene morphing technology called CRISPR, which makes it “possible to quickly and easily edit DNA,” is coming to a supermarket near you.

“If editing a single gene might have taken years with older techniques, now it can happen in a matter of days with a single grad student,” Peters reported.

What could possibly go wrong?

In April, the U.S. Department of Agriculture decided that a CRISPR mushroom will not be subject to regulation.

On June 1, scientists announced the start of a 10-year project that aims to synthetically create an entire human genome. The project is called Human Genome Project – Write, “because it is aimed at writing the DNA of life,” reported Andrew Pollack in The New York Times.

On June 8, the National Academy of Sciences released a report about “gene drives,” a new type of genetic engineering that can spread gene modifications throughout an entire population of organisms, permanently altering a species.

Gene drives “are not ready to be released into the environment,” NAS said in its press release calling for “more research and robust assessment.” Unfortunately, the NAS report failed to articulate a precautionary regulatory framework that would protect people and the environment.

Could synthetic biology, gene editing and gene drives have benefits for society? Possibly yes. But will they? And what are the risks?

If corporations are allowed to deploy genetic engineering technologies for commercial gain with no government oversight, no independent scientific assessments, and no transparency, benefits to society will be left off the menu and consumers will be in the dark about what we’re eating and feeding our families.

Stacy Malkan is the co-director of U.S. Right to Know, a nonprofit food industry research group. She also does consulting work with Friends of the Earth. Follow her on Twitter @StacyMalkan

U.S. Review of GMOs Finds Risks, Rewards; Calls for Transparency

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By Carey Gillam

A new study of genetically modified crop technology by the National Academies of Sciences, Engineering, and Medicine offers a mix of observations about the controversial crops, and takes U.S. regulators to task for an ongoing lack of transparency that is fueling distrust by consumers and calls for mandatory labeling of GMO foods.

The lengthy report, sponsored in part by the U.S. Department of Agriculture, runs roughly 400-pages and seeks to address a range of environmental, health, social and regulatory issues surrounding genetically engineered (GE) crop technology. It is the culmination of work by a committee that includes scientists specializing in ecology, genetics and crop health from several state universities, as well as experts from the International Food Policy Research Institute, and other groups.

The release is timely, coming as Congress is debating whether or not GMO foods should be labeled, and as the Environmental Protection Agency assesses if glyphosate, a widely used herbicide whose use has increased with the commercialization of glyphosate-tolerant GMO crops, should be restricted.

Both critics and fans can point to findings they deem favorable, but the broad take-away from the committee’s work is that while GMOs on the market today appear not to pose a risk to human health, there should be greater accountability to a wary public and more independent study of a range of potential risks.

The committee steered clear of taking a stand on the current hot-button issue of GMO labeling, declining to clearly endorse either the consumer groups who want mandatory labeling of GMO foods or the food and agribusiness players who want to block mandatory labeling like the law set to take effect in Vermont on July 1. But the committee did state that GMO labeling “serves purposes that go beyond food safety.”

“There clearly are strong non-safety arguments and considerable public support for mandatory labeling of products containing GE material. The committee does not believe that mandatory labeling of foods with GE content is justified to protect public health… however, product labeling serves purposes that go beyond food safety. U.S. policy-makers and the private sector have the ability to address the broader social and economic issues and to balance the competing interests involved.”

The committee further stressed a need for public accountability when it discussed regulatory reviews of these GMO crops.

“Transparency and public participation have been shown by research to be critically important for appropriate, sound, and credible governance of all aspects of the development, deployment, and use of GE crops.”

The committee said that much of the information submitted to regulatory agencies seeking approval of new GMO products is kept secret, treated as “confidential business information.” This lack of public access to health and safety data submitted by developers creates distrust, the committee said.

“Given a developer’s self-interest in getting a product approved and its control over the material considered by the agency, the lack of access creates skepticism about the quality of the data.”

The committee pointed out that in 2002 the U.S. General Accounting Office (now Government Accountability Office) recommended that the Food and Drug Administration randomly verify raw test data provided by a GMO developer, but there is no evidence FDA has adopted that recommendation.

The committee said when it comes to environmental problems, the committee did not find conclusive cause-and-effect evidence of environmental problems from the GE crops. “However, evolved resistance to current GE characteristics in crops is a major agricultural problem.”

The committee criticized USDA’s Animal and Plant Health Inspection Service (APHIS) for not requiring post-market controls and monitoring of GMO crops, which the committee said could have mitigated resistance problems before they spread.

When seeking to address a number of concerns about the health impacts of consumption of foods made with GMO crops. the committee said that there was little evidence of specific links:

“The committee concluded that no differences have been found that implicate a higher risk to human health safety from these GE foods than from their non-GE counterparts. The committee states this finding very carefully, acknowledging that any new food—GE or non-GE—may have some subtle favorable or adverse health effects that are not detected even with careful scrutiny and that health effects can develop over time.”

Regarding specific concerns about GMOs and concerns about ties to allergies, the committee said that “testing for allergenicity before commercialization could miss allergens to which the population had not previously been exposed,” and “post-commercialization allergen testing would be useful in ensuring that consumers are not exposed to allergens,” though the committee said it realized such testing would be difficult to conduct.

NO GMO YIELD GAIN

In another notable finding, the committee’s work countered the credibility of often-repeated industry propaganda that genetically engineered crops are necessary to “feed the world” because they yield so much more than non-GMO crops.

The report found little foundation for the claims of yield benefit, however:

“The committee examined data on overall rates of increase in yields of soybean, cotton, and maize in the U.S. for the decades preceding introduction of GE crops and after their introduction, and there was no evidence that GE crops had changed the rate of increase in yields.”

The committee’s work also addressed another hot-button issue – the safety of the herbicide glyphosate. Though agrichemical interests say the safety of the herbicide is firmly established and accepted by the world’s scientific community, the NAS committee said there “is significant disagreement among expert committees on the potential harm that could be caused by the use of glyphosate on GE crops and in other applications.”

The committee also addressed the dicey new debate over emerging genome editing technologies that are billed by developers as decreasing the risks of unintended changes in the plants. The committee found that this decreased risk should simplify food safety testing. However, the committee also warned that “major changes in metabolic pathways or insertion of multiple resistance genes will complicate the determination of food safety because changes in metabolic pathways are known to have unexpected effects on plant metabolites.”

As part of the study, the committee said it examined almost 900 research and other publications on the development, use, and effects of genetically engineered characteristics in corn, soybean, and cotton, which account for almost all commercial GE crops to date. As well, the committee said it listened to 80 speakers at three public meetings and 15 public webinars, and read more than 700 comments from members of the public.

The committee didn’t provide all the answers, and indeed in many ways, raised new questions. But the committee call for more transparency to a skeptical public was loud and clear. Lawmaker, regulators and crop developers would do well to answer that call.