Recent Actions by the USDA and FDA Should Worry Organic Advocates, More Industry Involvement is Needed

Two announcements out of Washington, D.C. over the past week are blatant signs that more aggressive involvement from the industry is needed in order to protect the long-term interests of organic food.

First, Impossible Foods, the owner of the Impossible Burger, just received its “no questions letter” from the FDA.

Why should this concern us?

The Impossible Burger, a plant-based burger that bleeds, uses a genetically-modified protein that has never been in the human diet before. When submitting its first GRAS (Generally Recognized as Safe) application in 2014, Impossible Foods argued that because the modeled 3D structure of this genetically-modified protein — soy leghemoglobin — was similar to hemoglobin and myoglobin, the FDA should consider it safe.

The FDA did not agree with this premise and said “conformational similarity or functional similarity among proteins is not an indication of the safety among proteins … and just belonging to the globin family does not guarantee that the protein will be safe to consume.”

In its most recent GRAS application, Impossible Foods did not give the amino acid sequence of the genetically-modified soy leghemoglobin and other comparative myoglobins in order to address the FDA’s concerns. Instead, the company reiterated the same argument about structural similarity. This time, however, the FDA appeared to accept the company’s argument — for some inexplicable reason.

Also, despite the fact that Impossible Foods offered to do a 90-day feeding study on animals to prove the safety of this genetically-modified soy leghemoglobin, it never completed one. Rather, Impossible Foods did a 14-day and 28-day study, of which the 14-day study showed toxicity. Problems with this 14-day study were not fully resolved.

Given that Impossible Foods failed to address all of the FDA’s initial concerns but still received a “no questions letter” in this most recent GRAS notification, this has raised a serious red flag with Michael Hansen, PhD and Senior Scientist at Consumers Union.

“Impossible Foods’ 14-day animal study showed adverse effects, and the company never submitted a 90-day study, something it said it would do. The whole concept of GRAS is based on the long history of safe use in the food supply. How can something — soy leghemoglobin — that has never been eaten by humans before get GRAS status? Not only should this genetically-modified protein be treated as a new food additive and be required to go through the new food additive application process, but it shows just how broken the GRAS process has become. The FDA told Impossible Foods what was wrong with the initial GRAS notification, but the company didn’t adequately respond and somehow got approval anyhow. This sets a dangerous precedent that a company can put a new ingredient in a food — one that has never been in the human diet before — without submitting the safety data required for a new food additive, and the FDA will allow that to happen. This raises the question of why a company should do the right thing anymore, e.g., submit the required safety assessments before putting a new ingredient into a food.”

Second, in another troubling measure to placate the biotechnology industry, the USDA responded to last week’s court ruling out of Europe in regards to gene-editing of plants and animals. The EU said that gene-editing, or GMO 2.0, is genetic modification and should be regulated as such, with safety testing and labeling.

In a press release, USDA said, “Innovations in precision biotechnology, such as genome editing, hold great promise. For consumers, potential benefits include healthier, higher-quality foods at affordable prices. For farmers, they include improvements in productivity, plant and animal health, and environmental sustainability.”

According to Michael Hansen, PhD, “There has been absolutely no demonstration that gene editing offers any of these benefits. Indeed, these same arguments were made 30 years ago with the first wave of genetically-engineered crops, and the major traits that were developed on large scale were herbicide-tolerant plants and Bt plants. These crops have led to massive increases in the use of the herbicide glyphosate and the appearance and spread of glyphosate-tolerant weeds to more than 50% of U.S. farms. In turn, this has led to additional plants being engineered to tolerate glyphosate and other dangerous herbicides, such as 2,4-D and dicamba.”

Andrew Kimbrell, Executive Director of the Center for Food Safety, shares a similar view.

“What we have to understand is that gene-editing technology is flawed and is not precise at all,” he said, contrary what the USDA is claiming in its press release. “CRISPR can cause cancer, and every week we are seeing more unintended consequences.

USDA Secretary Sonny Perdue is not only talking biological nonsense but dangerous nonsense. This is technology that can permanently change life forms, and biological pollution does not dilute over time. It reproduces and spreads, and we cannot recall it. This can be very dangerous to human health and the environment.”

As the FDA and USDA give ag-biotech companies a free pass and make statements about unproven benefits of gene-editing technologies, the organic industry remains in harm’s way. Andrew Kimbrell continues,

“This is very dangerous to organic because these gene-edited crops can invade and infest organic fields, which poses a real risk to the integrity of organic. While Nature’s Path and other independent companies have come out strongly against these technologies, the Organic Trade Association (OTA) has been soft on GMOs for a long time. The OTA played a pivotal role in passing the DARK Act and has not been a real player in forcing adequate regulation of biotechnology in agriculture.”

While consumers have been very vocal in opposing GMOs, such as in the pushback against GE-salmon, which garnered approximately 1.5 million comments, Andrew Kimbrell believes that it is critical that organic companies get more involved.

“The industry should be joining with us to reduce or eliminate genetic engineering because of the contamination of organic farms and the existential threat that this technology poses. The anti-organic rhetoric in Congress is unparalleled, and the industry should be with us to defend the integrity of the market. We are not getting the consistent help from companies that we need, and we are certainly not getting it from the OTA.

The organic consumer will not be happy when there is an abundance of GMO contamination in their food.”

Have a great day! Max Goldberg, Founder