Chemical giant Bayer last week signed an exclusive licensing agreement with Pairwise, a genetic-based food startup, to develop and market its CRISPR-edited mustard greens.

Pairwise was the first company to bring produce created with the gene-editing technology known as CRISPR to the U.S. market when last year it started selling its mustard greens in some restaurants, hotels and retirement centers in a few U.S. cities.

The mustard greens are engineered to be less bitter than traditional mustard greens so they can be eaten raw in a salad, the company said. Bayer plans to amp up distribution, selling the greens in U.S. grocery stores this year.

CRISPR-edited produce is new and not commonly available, although Bayer said it hopes to change that. Bayer’s agreement with Pairwise isn’t limited to the mustard-turned-salad greens.

“The latest deal creates value beyond just selling a product, as it also comes with rights to use the knowledge, intellectual property, and technology going forward,” JD Rossouw, head of Vegetables Research & Development at Bayer said in a statement.

As part of Bayer’s “open innovation approach,” the agreement gives the company the rights to develop and commercialize 10 varieties of Pairwise-edited greens and to develop new varieties using the company’s proprietary Fulcrum Platform.

Pairwise touts the platform’s ability to make “17 precise edits in a single plant,” as proof of its success.

For its mustard greens, the startup removed several copies of a gene responsible for the bitter flavor. “We think people will really like the taste,” Bayer’s Anne Williams told Wired.

She also said Bayer is in conversation with farms and salad companies about how to grow and package the greens.

But Claire Robinson, managing editor of GMWatch, told The Defender that Bayer’s gene-edited mustard greens have not been examined for health or environmental risks.

“They could contain toxins or allergens,” she said. “We just don’t know.”

Robinson added:

“And why anyone would want to genetically modify mustard greens to make them less, well, mustardy, is a complete mystery to me. The whole point of eating mustard greens is their pungent and bitter taste, and the compounds that make them pungent and bitter also happen to provide the health benefits. People who want their mustard greens to taste like lettuce can eat lettuce.

“In my view, this is yet another example of a ‘solution’ (GM) looking for a pretend ‘problem.’ It’s yet another vanity product of the GMO industry.”

The first CRISPR-edited produce, a tomato, was developed by Tokyo-based startup Sanatch Seed and debuted in Japan in 2021. The tomatoes are engineered to increase gamma-aminobutyric acid or GABA, a neurotransmitter shown to decrease stress.

As with Bayer’s salad greens, the gene-edited tomato also was introduced to the market despite no studies demonstrating that it has the intended health effects or is even safe.

Sanatech’s president Shimpei Takeshita reported last week that the company is planning to bring its gene-edited tomato to the Philippines and the U.S., according to Wired.

Bayer also reported last week that it is working with South Korean biotech company G+FLAS to develop genome-edited tomatoes nutritionally enhanced with vitamin D as part of its mission to achieve “Health for All, Hunger for None.”

Not exactly genetically modified organisms? 

Genetically modified organisms (GMOs) also called genetically engineered (GE) foods have been pushed by food giants like Monsanto — purchased by Bayer in 2018 — as a solution for all types of challenges in agriculture, including promises to “feed the world.”

Proponents say GE foods increase yields, reduce pesticide use and offer more nutritious foods with longer shelf lives. However, studies show GMO crops have performed no better than non-GMO crops and have sometimes introduced new risks into food and exacerbated existing problems.

GMO crops also have faced widespread rejection by consumers, concerned with the health and environmental impacts of the foods, despite efforts by the powerful and well-funded pro-GMO lobby to undermine those concerns.

At first, genetic engineering worked by inserting genes from one species into another. That’s why the products were often called “transgenic.” For example, hybrid Bt (Bacillus thuringiensis) cotton contains genes from a bacterium that acts as a pesticide.

Wired claimed that gene-edited plants are different. “The mustard greens and high GABA tomato aren’t exactly genetically modified organisms,” because rather than introducing foreign DNA, gene editing involves modifying the DNA of the organism itself.

Williams said that CRISPR-editing is simply speeding up plant breeding, allowing scientists to make changes that “could conceivably happen in nature, just must faster.”

Robinson, a co-author of “GMO Myths and Truths: A Citizen’s Guide to the Evidence on the Safety and Efficacy of Genetically Modified Crops and Foods,” said this claim is false.

“Gene editing is unquestionably a GM technique that produces GMOs. It falls under the definition of a GMO in EU law and in the Cartagena Protocol on Biosafety,” she said.

“Also, gene-editing can and does introduce foreign DNA, both intentionally and unintentionally.”

Robinson said the real difference between older-style transgenic GM techniques and gene editing is that in older-style GM, the insertion of the GM gene(s) into the genome of the host organism is random — whereas gene editing begins with the creation of a break across the double strands of the DNA at a particular targeted location in the genome.

“The creation of a double-strand DNA break triggers DNA repair mechanisms which, depending on the gene editing experiment setup, can lead to genetic material being added, removed or altered at this location,” she said.

Claims that this gene-editing is “precise,” she said, stem from the targeted nature of that double-strand DNA break. However, she said, “That is where gene editing’s precision ends.”

The cell’s own repair machinery repairs the DNA break that CRISPR made. That repair process is inherently imprecise, Robinson said, and can result in widespread mutations, or DNA damage, throughout the genome.

“These mutations could result in altered gene function and biochemistry of the plant, which could include the production of novel toxins and allergens and unpredictable effects on the environment and farming,” Robinson said.

That’s why many scientists have called for gene editing to remain strictly regulated, she added.

U.S. has little regulation for gene-edited foods

The EU has strict regulations on GMOs, but that isn’t the case in the U.S.

Under the Coordinated Framework for Regulation of Biotechnology, the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) jointly oversee agricultural products produced with biotechnology.

But U.S. regulatory oversight historically has been lax.

Although GMO foods were first introduced in the U.S. in 1994, it wasn’t until 2022 that the USDA began requiring labels for food with GMO ingredients — although the controversial legislation allows producers to use the word “bioengineered” instead of genetically modified.

In 2018, the agency announced it would not regulate gene-edited crops as genetically modified organisms, because it determined they could have otherwise been produced through traditional breeding techniques.

“With this approach, USDA seeks to allow innovation when there is no risk present,” U.S. Secretary of Agriculture Sonny Perdue said in a statement at the time.

That means that like Bayer, the USDA isn’t categorizing gene-edited foods as GMOs. Not only does that affect how they are regulated, it also means the greens won’t have to be labeled as gene-edited.

Pairwise reported that it obtained approval from USDA in 2020 to take its greens to market.

In February, the FDA issued industry guidance for gene-edited plants that recommended producers engage in a voluntary premarket consultation with the agency.

Pairwise said it is engaged in that process.

And because the EPA regulates only biotech products created for pesticidal purposes, it doesn’t regulate gene-edited projects unless they are developed to have pesticidal traits.

Who is Pairwise?

Pairwise describes itself as a “pioneering food startup.” The biotech firm was founded by researchers from Harvard and MIT’s Broad Institute, including Feng Zhang, Ph.D., who played an integral role in developing CRISPR-Cas systems.

University of Illinois international law professor and bioweapons expert Francis Boyle, J.D., told The Defender last year that the Broad Institute is one of the country’s leading Defense Advanced Research Projects Agency (DARPA)-funded synthetic biology research centers.

Pairwise launched in 2017. In 2018, it raised $25 million in series A funding — a first round of venture capital funding where the company offers stocks in exchange for financing — from Monsanto Growth Ventures, the venture capital arm of Monsanto, Bayer and Deerfield Management, another venture capital firm.

The company also entered into a licensing agreement with Monsanto through which the biotech giant must pay “$100 million to access and develop Pairwise IP” in crop applications.

In 2021 Pairwise raised another $90 million in series B funding from Bayer, which by that time had acquired Monsanto, Deerfield and two other venture capital funds.

The company’s co-founder and CEO Tom Adams, Ph.D., was formerly the vice president of Global Biotechnology at Monsanto.