Tell EPA Not to Re-Approve a Pesticide that has been Twice Banned already by Federal Courts

Posted on September 5, 2025 by Belinda

Here we go again. The Environmental Protection Agency (EPA) is planning to repeat a mistake it’s already made twice; a mistake seven years of experience and data indicate was disastrous for United States agriculture; a mistake federal courts have twice struck down (in 2020 noting “EPA had failed to examine how “dicamba use would tear the social fabric of farming communities,” and in 2024 outlining massive damage to stakeholders).

For background on this dicamba disaster, I recommend checking out press releases from the Center for Food Safety and the Center for Biological Diversity.

But all hope is not lost yet. EPA is still accepting public comments on use of dicamba on genetically engineered dicamba-tolerant cotten and soybeans, but only through tomorrow, September 6, 2025 (until 11:59PM EDT).

You can submit your own comment directly with EPA here.

Or, you could simply (and quickly) submit a pre-written comment through the Center for Food Safety’s petition, which that organization will then submit to EPA.

Here is the text of the pre-written comment:

“I am a supporter of the Center for Food Safety and am writing to oppose EPA’s proposed re-registration of dicamba pesticide products for use on genetically engineered cotton and soybeans. This decision threatens to perpetuate one of the most damaging pesticides in U.S. agricultural history. 

Federal courts have twice vacated EPA’s dicamba registrations—in 2020 and again in 2024—finding the approvals unlawful. These judicial decisions were based on EPA’s failure to adequately assess dicamba’s environmental and social impacts. Rather than addressing the fundamental problems identified by the courts, EPA is proposing to re-register the same problematic pesticide with even weaker restrictions. 

Since dicamba’s introduction for use on genetically engineered crops in 2016, the pesticide has caused widespread agricultural and environmental destruction. The USDA estimates that up to 15 million acres of soybeans were damaged by dicamba drift in 2018 alone. This represents the worst herbicide damage in U.S. agricultural history. And it’s not just soybeans. Orchards, vegetable farms, home gardens, native plants, and wildlife refuges across the Midwest and South have experienced serious injury. Dicamba damages flowering plants that pollinators require for pollen and nectar, and has contributed to catastrophic honeybee colony losses while also undoubtedly impacting wild pollinators. Small and family farmers are made to bear the brunt of dicamba damage.   

Rather than strengthening protections, EPA’s current proposal actually loosens the already inadequate restrictions. The proposal eliminates application cutoff dates and removes time-of-day restrictions that provided some protection against volatility. EPA’s own 2021 report acknowledged that previous application restrictions had failed and that dicamba continued to cause extensive damage to crops and natural areas. 

I respectfully request that EPA deny the proposed dicamba re-registration and work with farmers to develop truly sustainable approaches to weed management that don’t threaten rural communities and ecosystems. 

Thank you for considering my comments.”

And thank YOU for taking a minute to take this easy action, for the sake of the safety and economic health of US agriculture.

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We Need the Whole Truth to Regulate GMOs

Posted on July 15, 2023 by Belinda

The following is a piece I wrote which was published in the July 15, 2023 edition (online; July 16 in print) of The Davis Enterprise.

A critical detail was omitted from Rich Rifkin’s Forum article published June 28 in The Davis Enterprise. In the interest of reducing the “mountains of misinformation” related to regulation of genetically engineered/modified (hereafter GE) organisms to which he referred in that piece, that omission should be corrected.

Rifkin pointed out that TALENs, the process UC Davis professor Alison Van Eenennaam and colleagues used to edit a gene responsible for the development of horns in cows, is “more precise [at] editing [the genes of] live cells than CRISPR.” But he failed to mention the imprecision of TALENs that led to the bovine offspring resulting from Van Eenennaam’s research containing more than just the edited gene they had intended to insert into those animals.

That’s right. Despite Rifkin’s statement that “Everything else about the offspring [other than the allele the scientists had intended to insert] … was the same as any other Holstein,” in reality those GE bovine offspring also contained bacterial DNA sequences — including a gene conferring antibiotic resistance — that had been inserted during the gene-editing process. Not only did Van Eenennaam and her colleagues not intend to insert that bacterial DNA into those offspring, but they didn’t even know they had inserted them until a scientist at the FDA informed them about it (after FDA scientists had analyzed the genomic data generated and provided to them by Van Eenennaam and her colleagues).

This type of GE-associated imprecision isn’t unique or new. In fact, unintended insertion of “extra” DNA into genetically engineered organisms has been happening for over 30 years. I know because my colleagues and I at Calgene, Inc. found that we had inadvertently inserted bacterial DNA into the Flavr Savr tomatoes we were analyzing and preparing for commercial sales back in the early 1990s.

In the Flavr Savr case, FDA scientists asked us to prove our contention that only the DNA we intended to insert into our tomatoes had been inserted. The fact that our subsequent experiments revealed bacterial DNA had been inserted into 20-30% of our tomatoes shocked me, and we published our results in a peer-reviewed journal soon thereafter so as to let the scientific community know about this imprecision of genetic engineering. The FDA scientists who found the bacterial DNA in Van Eenennaam’s de-horned GE cows published their results as well and cited additional examples of this “extra DNA” problem that had surfaced in the years since my colleagues and I had identified the problem in our tomatoes.

UC Berkeley professor Jennifer Doudna, who was awarded the Nobel Prize in Chemistry in 2020 for her research on CRISPR, is another peer-reviewed scientist who is concerned about imprecision associated with gene-editing. She gave the keynote address at the UC Davis Krebs Symposium held a couple of months ago during which she cited examples from the peer-reviewed literature of large DNA deletions and translocations, chromothripsis and chromosome loss associated with use of CRISPR and referred to this precision problem as a “bottleneck” to “What’s Ahead for Genome Editing” (the title of her talk).

Being concerned about unintended consequences of using new technologies is not — as Rifkin implied in his article — fomenting “unscientific folly.” In order to make the most informed decisions possible about how best to regulate the products of these new technologies we need to admit to their imperfections that we (should) know about, like the “extra DNA” issue that contributed to abandonment of Van Eenennaam’s hornless cow research, not make boldfaced lies of omission regarding them.

We also need to recognize that it is possible there are additional imprecisions associated with the new technologies that we just don’t understand yet (like the possibility of interfering with dynamic genomic processes in organisms, perhaps), and throw a little precaution into the mix.

I’m all for reforming the “archaic regulations used by the FDA” to regulate GE animals. But we should start by admitting that the selective breeding process humans have been using for more than 10,000 years — a process Charles Darwin called “artificial selection” — is substantially different and significantly more “tried and true” than the GE processes humans have been using for the last 30-plus years.

There have been examples of “troublesome” GE products in those three decades (like StarLink Corn, glyphosate-tolerant crops that contributed to build-up of glyphosate-resistant weeds, NK603 corn, etc.) and they should be dealt with as red flags, not denied, downplayed or ignored. We need an honest process for reforming U.S. regulations of GE organisms, one in which the truth, the whole truth, and nothing but the truth prevails. No lies of omission allowed.

— Belinda Martineau is a Davis resident, plant geneticist and former genetic engineer; she reports and comments on biotechnology on her blog: biotechsalon.com and elsewhere.

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Edible Vaccines Against COVID-19? Another Case of Genetic Engineering Déjà vu

Posted on November 2, 2020 by Belinda

Recent reports indicate that plant scientists in Mexico and Canada are working to produce “edible” vaccines against COVID-19. 

But the idea that fruits or veggies could be genetically engineered (GE) to produce edible vaccines that could be easily shipped, stored and administered to people all over the world, especially in developing countries, has already been debunked…by the originator of the edible vaccine idea himself, Charles Arntzen. Dr. Arntzen, once he had overcome his naïveté about how safe and effective vaccines are actually made, came “to regret coining the term” edible vaccine at all.

So why would a new generation of plant scientists plow ahead on a path deemed a dead end by a respected plant scientist who had spent 25 years in the field and ultimately decided that his edible vaccine idea had been a bad one?

Could these young scientists be unaware of Arntzen’s body of work? I certainly hope not since science builds upon previous science and reading the peer-reviewed literature on a subject one plans to conduct their own research into should be the first step one should take in embarking on a scientific career path.

But, just in case these young scientists are not aware of Arntzen, his work on “edible vaccines,” and his subsequent work with the traditional vaccine industry that led to his regret concerning edible vaccines, here (below) is a brief review.  

Origins of the Edible Vaccine Notion  

Back in the 1990s, Charles Arntzen (most recently professor with the Center for Infectious Diseases and Vaccinology, the Biodesign Institute at Arizona State University, now retired) coined the term “edible vaccines” to describe bananas and other produce items genetically engineered (GE) to produce antigens representing specific disease pathogens. Consuming these GE fruits and veggies, Arntzen hypothesized, would induce production of antigen-specific antibodies in those who ate them, antibodies that would immunize those consumers against that particular disease…hence the moniker “edible vaccines.” 

Arntzen’s idea was to leverage the relatively low cost of producing GE proteins in plants to produce low-cost vaccines in fruits like bananas—which would not require the expensive “cold chains” necessary for transporting and storing traditional vaccines nor technically trained health professionals to administer injections—and deliver them to the developing world.

Arntzen spent the better part of the 1990s trying to reduce his idea to practice, bananas serving as a particular focus and one that “attracted extensive interest in the press.”

Arntzen’s Abandonment of the Edible Vaccine Area of Research

Arntzen has since admitted he had been naïve back then, having ignored the “rigorous regulatory requirements that government agencies and the vaccine industry follow to give us today’s highly effective and wonderfully safe vaccines.” He was less naïve by fifteen years ago when he and his colleagues informed edible vaccine enthusiasts at a scientific conference that “[w]hile it was frequently mentioned that plant-based protein production is highly cost effective…production costs may represent only a small part of the cost of a vaccine. GMP (Good Manufacturing Practice) requirements, purification, quality controls for vaccine approval are major cost factors in (human) vaccine production.” 

By five years ago, Arntzen admitted that “plant-to-plant variations will require careful (and expensive) analytical controls to determine exact dosages of antigen….” [And I would extend this requirement to fruit-to-fruit and veggie-to-veggie variation as fruits and veggies continue physiological and biochemical processes after they have been harvested from plants, for example the cell elongation process that can proceed in a cut onion during storage in your refrigerator.]

By 2015 Arntzen noted that the edible vaccine concept “may have attracted attention in the plant biology realm, but it probably has been much more counterproductive in the traditional vaccine industry.” It was by then that he had “come to regret coining the term” edible vaccine in the first place.

The More Recent Scientific Literature

A recent review article in the Journal of Immunology Research (Criscuolo et al. 2019) still lists the “lack of a proper dosing strategy” as one of the major problems with the “edible vaccine” concept. Other cons that Criscuolo et al. mention in relation to edible vaccines include “improper glycosylation, low antigen expression yields, unstable antigen expression.”

So Why the Resurgence of the Edible Vaccine Concept Now?

So why is Cornell’s Alliance for Science now asking if “we could eat a GM [AKA GE] fruit that directly confers immunity” to COVID-19? And why are young plant biologists, like Daniel Garza Garcia (Institute of Biotechnology of the Autonomous University of Nuevo Leon, Mexico) and Allyson MacLean (University of Ottawa, Canada) now touting edible vaccines against COVID-19?

Post-harvest plant physiology and the “lack of a proper dosing strategy” still pose very real problems that need to be solved before this edible vaccine “notion” can be reduced to practice. Arntzen had given up on this notion by at least 5 years ago, and had moved on to another strategy: producing high levels of antigens in GE plants but then—instead of eating the fruit or veggies directly from those GE plants—purifying the antigens from their GE plant factories and using those purified antigens to “follow the regulatory pathways now well established for subunit vaccines….” Arntzen and his collaborators, as well as others, have had success utilizing this “plant-made pharmaceuticals” strategy in developing Ebola therapeutics, for example.

Based on the accounts I’ve read about current research being conducted with the goal of developing edible vaccines against COVID-19, I’d say (IMHO) that these projects are at the naïve stage Arntzen was at back in the early 1990s.

Naïve is Not What We Need in Response to the COVID-19 Pandemic

We don’t have time for young scientists to rediscover the various problems with delivering an “edible COVID-19 vaccine” to a real and desperate world. Instead, our scientific focus should be on supporting efficient, effective work—based on less naïve strategies—toward producing COVID-19 vaccines.    

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In Light of Big Mistakes Made by Developers of “Poster Child” GMO Products like Hornless Cattle and Golden Rice, FDA is Justified in Requiring Regulation

Posted on February 17, 2020 by Belinda

Earlier this month, the United States Food and Drug Administration (FDA) published its analysis of what has been touted as the “Poster Child” of gene-edited animals: cattle genetically engineered (GE) to prevent them from developing horns. As mentioned in an FDA press announcement released the same day as the article, FDA scientists detected “previously unreported, unintended alterations in [the] genome-edited bulls.” Steven M. Solomon, DVM, MPH, director of the FDA’s Center for Veterinary Medicine, went on to say that while “existence of [the] unintended alteration does not necessarily mean that the genome edit is unsafe to animals or consumers, it does show that both scientists and regulators need to be alert to the potential for such unintended alterations to take place.”

But both scientists and regulators should be well aware by now that unintended alterations can take place when using lab-based biotechnological processes to insert genes into, or otherwise alter existing genes in, living organisms. For decades scientists have known that these biotech processes can cause unintended insertional mutations in recipient organisms, unintended scrambling of recipient DNA at insertion sites, unintended rearrangements of and mutations in the inserted DNA itself, and even (in one case at least, NK603 maize) creation of an unintended combination of inserted and recipient DNA that is transcribed into a chimeric mRNA.

Granted, because the gene-editing processes are newer, we know less about unintended consequences that are specifically associated with these techniques. But even for gene-editing processes we’ve already known for years that unintended “off-target effects” can accompany use of these techniques as well.

The Nature of the Hornless Cow Mistake

This case of the GE hornless cattle illustrates a situation worse than simply not being “alert to the potential” for the gene-editing process to result in unintended consequences, however. The developers of these GE cattle had proclaimed that only the DNA sequences they intended to insert—DNA isolated from cattle—had in fact been inserted into their GE product; they claimed that their GE cattle were therefore “100% cow” and contained no DNA from any other organism or source. And they used this claim to seek FDA’s permission to have humans consume their GE cattle.

But the developers of these GE cattle had never verified this claim of theirs that the genomes of their GE cattle were 100% cow. So in essence, their claim was only a hypothesis; they hypothesized that their gene-editing process had worked exactly as they had hoped it would and that, as a result, only the DNA they’d isolated from cattle and intended to insert into their GE cattle “products” had in fact been inserted.

Is that a big mistake?

Yes, I believe that is a big mistake for any scientist to make. And it’s an especially big mistake if one aims to demonstrate the “precision” of a new technology to a regulatory agency and thereby hopes to influence regulatory policy regarding that new technology. 

It’s a big mistake because, as every scientist knows (or should), a hypothesis is only the start of the scientific process of fact-finding. The next step is to gather and analyze data that will prove or disprove the hypothesis.

And the developers of these GE cattle actually had the necessary data in hand that would have disproved their “100% cow” hypothesis. They had the data in hand and yet they did not use it to verify (or not) their hypothesis; instead they went to FDA with only an untested hypothesis, asking the agency for permission to feed their incompletely analyzed experiment to humans.

Special Care Should be Taken in Developing “Poster Child” GE Products

I would have expected the developers of the GE hornless cattle to be especially careful in producing and analyzing what had been expected to be the world’s first commercially available gene-edited animal. And yet they didn’t even use data they had readily available to verify a claim they hoped would convince FDA that there is no need to regulate GE products like theirs.

Thankfully, FDA scientists used the DNA sequence data that the developers had in hand to test and ultimately disprove the “100% cow” hypothesis themselves.

Similarly, I would have expected the developers of Golden Rice to be especially careful in producing that “poster child” for GE products produced for humanitarian reasons. And yet, the developers of Golden Rice also failed to use DNA sequencing data they had in hand to avoid unintended mistakes attributable to the genetic engineering process itself. They failed to screen their potential GE products for those “events” in which insertional mutations had been created by the genetic engineering process; as a result of this mistake development of Golden Rice was delayed by at least half a decade.

Implications for Other GMO Products

Such big mistakes made during the development of these “poster children” GMOs make one wonder how carefully other, more run-of-the-mill GMOs have been developed over the last 25 years as well.

They also justify—in my mind at least—FDA’s intention to “carry out mandatory premarket review of all gene-edited livestock” and thereby regulate these GE products based on the fact that they were created using genetic engineering. (I also think FDA should require premarket review of all GE crops as well.) We know the genetic engineering process itself can result in certain types of unintended consequences; we also know that (at least some) developers of GMOs are not being sufficiently careful about analyzing their putative GE products to identify the known types of unintended alterations; therefore, FDA’s decision to require premarket review of all gene-edited livestock to ensure that developers are conducting careful, thorough analyses of their potential GE products prior to commercializing them is a logical and science-based conclusion for the agency to have reached.    

Nevertheless, the editorial staff at Nature Biotechnology published their own piece in the same February 7, 2020 issue of the journal as FDA’s analysis of the GE hornless cattle which encourages FDA to regulate gene-edited livestock based only on risks associated with the trait introduced into the GE animal (e.g. “hornlessness”) as opposed to regulation based on the process through which those traits were introduced.

The Nature Biotechnology editorial staff related some of the same old arguments I’ve heard for 25 years, like: the public doesn’t have a problem supporting GE drugs so why shouldn’t they support gene-edited animals as well? My response has been the same for 25 years: sick people are willing to take more risks to regain their health than healthy people are willing to take with the food they feed themselves and their families.

The editorial also brought up a new, but disingenuous, argument: “In over 30 years, there has yet to be a single compelling case where genetic engineering posed a safety problem in a food animal.” It’s disingenuous because…GE food animals have not been around for 30 years; in fact, as stated later in the Nature Biotechnology editorial, the “world’s first genetically engineered animal…still has not reached US consumers.”

The Bottom Line For Me Is: 

Scientists still have a lot to learn about unintended consequences associated with all methods currently used to genetically engineer organisms, especially newer methods like gene-editing;

(At least some) developers of GMOs aren’t being careful enough in checking their GE products for the unintended consequences of GE processes/methods that we already know about—even when those products serve as “poster children” for gene-edited animals or humanitarian uses for GE crops;   

Therefore, all organisms produced using these GE processes/methods should be regulated by federal agencies on a case-by-case basis to ensure that developers are being scientifically rigorous in their analyses of their products and that possible risks to the US food supply are identified prior to product commercialization.

And the FDA is on the correct course…at least for gene-edited animals…in spite of the Course correction published by the editorial staff at Nature Biotechnology.

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Gene Editing’s Extra DNA Problem: Déjà Vu All Over Again

Posted on September 6, 2019 by Belinda

UC Davis researcher Alison Van Eenennaam described the experience of learning that the “poster animals for the gene-editing revolution” do not, after all, comprise the “same outcome [that] could be achieved by breeding in the farmyard,” like she and her collaborators at Recombinetics had been claiming for years, to Antonio Regalado of the MIT Technology Review by saying simply that “We were surprised, but when you get new information, you proceed ahead, that is what science does.”

My reaction back in the early 1990’s to hearing similar news about extra, unintended DNA being inserted into Flavr Savr™ tomatoes, the poster GMOs for the first generation of genetic engineering technology, was somewhat more intense. My boss at Calgene, Inc. at the time, Bill Hiatt, gave me the news as we were traveling on the subterranean moving walkway system that connects the United Airlines terminals at Chicago’s O’Hare airport. I stopped in my tracks (although I kept moving). It just couldn’t be true, I said to myself; the flashing lights and recurrent United theme song intensifying the surrealism I felt at that moment. (Thinking about it now still gives me a queasy stomach.) I remember asking myself whether genetically engineered (GE; my definition covers gene-editing as well) products were really ready to bring to market when we, evidently, still had a lot to learn about how the technology worked and what unintended changes it could produce.

Like Van Eenennaam’s Recombinetics collaborators, we at Calgene had also initially informed US regulators at FDA and USDA that the changes we had engineered into our tomatoes were very precise, and that we knew exactly what DNA sequences we had inserted into them. And like Van Eenennaam and her animal scientist collaborators, we plant scientists only learned the truth about plasmid vector “backbone” DNA sequences getting unintentionally inserted into our GE products–in addition to the genes we intended to insert–through our interactions with scientists at FDA.

In our case, FDA had asked Calgene to provide experimental evidence to prove our claim that only our genes of interest would be inserted into our GE products, a claim which had been based on 10 years of published reports. It was the results of those experiments that Hiatt had conveyed to me at O’Hare airport. I, with a couple of Calgene colleagues, then published our findings in the Plant Cell in 1994. (Our paper might have been published in a more widely read, general science journal had it not been for the fact that one of its anonymous peer-reviewers seemed not to believe our results.)

In the case of Recombinetics’ GE cows, which had been engineered using one of the new gene-editing methods (TALENs) to prevent them from growing horns, FDA scientists were the ones who conducted the experiments that provided the incriminating evidence. FDA then informed Van Eenennaam and Recombinetics, as well as the Comissão Técnica Nacional de Biossegurança (CTNBio) in Brazil. (CTNBio had been planning–in conjunction with Recombinetics–to create a herd of gene-edited, hornless dairy cows; FDA’s results put an end to those plans.) FDA scientists are now in the process of publishing their results; a preprint describing them was posted online on July 28, 2019.

Will Publishing “Contradictory Results” Help?

It’s important that scientists publish findings like these so that developers of other GE products are aware of them and can, as mentioned by FDA scientists Norris et al. in their paper describing this latest GE “surprise,” employ “screening methods suited to reliably detect the unintended integration of plasmids and multiple template copies.” Because only then, after developers identify engineered/edited organisms that contain DNA they did not intend to insert, can informed decisions be made about whether or how to commercialize those products; for example, in cases like Recombinetics’ cows, in which the unintended DNA contains genes that convey resistance to antibiotics like ampicillin and neomycin/kanamycin, I believe the decision should be to not commercialize.

But publishing is apparently not enough. Some 20 years after we at Calgene published our paper about the “extra DNA problem” associated with the Agrobacterium method of inserting genes into plants, a former Calgene colleague of mine informed me that the scientists at the ag biotech company she was then working for had not been checking their potential products for vector “backbone” DNA that could have been unintentionally inserted during the genetic engineering process…until she brought them up to speed on the issue.

Similarly, papers documenting “unwanted” insertion of plasmid/vector DNA sequences when using zinc-finger nucleases to modify genomic DNA targets in recipient cells had been in the scientific literature for half a decade by the time scientists at Recombinetics published their results on gene-edited cows (see references cited in Norris et al.). Yet those published papers describing unintended insertion of DNA, as well as our paper describing the phenomenon in plants, were apparently not read or otherwise taken into account by the authors of the Recombinetics paper.

The preprint posted by FDA scientists Norris et al. cites additional, more recently published papers that also document unintended integrations of foreign DNA, as well as scrambled DNA at target sites and off-target effects, in various GE organisms that have occurred via use of various gene-editing/engineering techniques, including the CRISPR/Cas9 system.

And so I ask again the question I asked myself in the tunnel between United terminals at O’Hare airport back in 1993: are we really ready to bring gene-edited/engineered products to market when, as described by Norris et al., “our understanding of the unintended alterations” produced via these technologies is still evolving?

Regulation of all GE products–including those that have been gene-edited–should be based on the fact that they were produced using lab-based techniques that we still don’t understand very well

Norris et al. make recommendations for technical ways genetic engineers might rectify what these authors refer to as a “blind spot” in GE product development that was highlighted by their discovery of unintended insertion of vector/plasmid DNA into Recombinetics’ cows.

But FDA should go further. I hope that Recombinetics’ blunder will also convince US regulators that the agricultural biotechnology industry–including developers using the new gene-editing techniques–requires more regulating, not less (as opposed to claims made previously by Recombinetics). Developers of GE products should be required to adequately screen their potential products for these newly discovered failures of precision in the processes of genetic engineering/gene-editing.

For one thing, requiring that all GE products be regulated in this way will ensure that all developers of GE products become aware of this lack of precision in their methods.

For another, regulatory requirements for all GE products could save the ag biotech industry from itself since these kinds of mistakes reflect badly on the entire sector as noted in this August 26th Tweet by Chris Thompson @centrekicker82: “Between Theranos, and now this mess, the impending biotech revolution sure seems a bit… incompetent?”

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U.S. Grain Industry Believes USDA APHIS’s “New Proposed Rule [for regulating GMOs] Is Fundamentally Flawed”

Posted on August 17, 2019 by Belinda

I’ve got to give credit to the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) for persistence. USDA APHIS has proposed new rules for regulating genetically engineered (GE) crop plants (AKA genetically modified organisms: GMOs) on three different occasions over the last decade: in October of 2008, January of 2017 and again a couple of months ago.

There is no doubt that USDA APHIS needs new regulations for GMOs. Rather than based on science or risk assessment, the current rules are based on whether a GMO was engineered using a vector, vector agent, or DNA from an organism on USDA’s plant pest list. Consequently, the rules don’t apply to all GMOs and GMOs that likely don’t pose a “plant pest” or “noxious weed” risk are being regulated while others that could pose such risks are not being regulated at all.

But despite the agency’s efforts to update its regulations, the 2008 and 2017 proposals were withdrawn and–based on public comments it received on its most recent proposal–I expect (or at least hope) that the newly proposed regulations will be withdrawn as well.

Most of the comments on the new regulations proposed in the June 6, 2019 Federal Register (I estimate greater than 90% of them) were from individual citizens who were understandably unhappy that APHIS was planning to let developers of new GMOs determine for themselves whether their products required regulatory review or not. But citizen consumers were not the only ones worried about foxes guarding the henhouse…a group of U.S. grain and oilseed organizations submitted a pretty harsh critique of the new proposed rules as well.

Leaders of the National Grain and Feed, Corn Refiners, National Oilseed Processors, North American Export Grain, and North American Millers’ associations all believe that “APHIS’s largely deregulatory approach” would not only “undermine consumer confidence in the U.S. regulatory system” but also “create further impediments” to their industry’s ability to market grains and oilseeds in global markets because it “directly contradicts the well-established international norms of case-by-case risk-assessment” and is thus “largely out of step with key international markets and governments.” They also noted (as an aside) the aviation industry’s current “significant turmoil and scrutiny over the safety certification process where the federal government leaned heavily on self-determination by an aircraft manufacturer.”

They additionally called out APHIS for exempting some engineered crops from the new regulations “because they could be produced through traditional plant breeding techniques and thus are unlikely to pose a greater plant pest risk than traditionally bred crops, which APHIS has historically not regulated.” [Emphasis added by the grain industry leaders.]  This statement by APHIS, these industry leaders believe, provides “insufficient scientific justification for granting broad exemptions.” (As an aside, I note that assumptions about pilots being able to handle any failures or misfires associated with the new technology on board the Boeing 737 MAX, and about the technology’s failure being “unlikely to result in death or the loss of the plane” [my emphasis], contributed to the aviation industry’s current turmoil referred to above.)

The grain industry leaders also noted that “APHIS would be ill-advised to issue a final rule” until USDA had coordinated its efforts on “rules and guidance on genome editing and other forms of plant breeding innovation” with FDA and EPA. After all, the U.S. approach to regulating GMOs is supposed to comprise a “Coordinated Framework for Regulation of Biotechnology;” therefore, these grain industry leaders recommend that the efforts of USDA APHIS, FDA and EPA “should all be compatible with each other and be coordinated through the White House Office of Science and Technology Policy.”

In summary, the leaders of these U.S. grain associations “believe that APHIS’s new proposed rule is fundamentally flawed.” Two years ago they “jointly urged APHIS to go back to the drawing board in response to its 2017 proposed rule to modernize its biotechnology regulations….” Now they “strongly urge APHIS to amend” its newly proposed rule to “require all technology providers to notify the agency in advance before introducing gene-edited or other plant breeding innovation traits for commercialization–even those within APHIS’s expressly exempted categories–so that the agency can issue an official letter for all traits attesting that they do not present a plant pest risk.” [Emphases added by the grain industry leaders.]

I agree whole-heartedly with these agricultural industry leaders. It’s time for USDA APHIS (together with FDA and EPA) to go back to the drawing board and try again to craft effective regulations for GMOs.

Let’s hope APHIS has the persistence to get these regs right on the fourth try.

 

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Disappointment in the First 25 Years of GMO Foods

Posted on May 21, 2019 by Belinda

The world’s first, commercially available GMO (genetically modified organism) created for human or animal food was first sold in U.S. grocery stores twenty-five years ago today.

I can still remember the excitement my colleagues and I at Calgene, Inc. felt as we ushered into the marketplace that first genetically engineered (GE) whole food (AKA GMO) available to consumers. We told each other it was something we’d tell our grandchildren about.

Granted, I’d gone into the agbiotech industry with hopes of helping solve the world’s problems by contributing to projects like engineering maize (corn) to fix its own nitrogen, and the Flavr SavrTM tomato had not been created with that lofty ideal in mind. Instead, these tomatoes had been genetically engineered so that they softened more slowly, an attempt to allow them to remain on the vine longer, to let them develop their true tomato flavor as they would in one’s own garden, yet remain firm enough to truck them, en masse, to market.

Still, I rationalized back then, this tomato would open the door for the technology that produced it, allowing others to solve more important agricultural problems. And so at Calgene, in May of 1994, we celebrated what we considered to be a huge, important milestone in agricultural history.

Now, 25 years later, I certainly don’t feel the same excitement or satisfaction about that achievement.

In fact, my principal emotion now is one of disappointment. Profound disappointment.

Not only are we still not able to engineer corn or any other non-leguminous crop plant to fix its own nitrogen (which could reduce use of nitrogen fertilizers which would, in turn, benefit smallholder farmers and reduce the fertilizer run-off into rivers that creates “dead zones” in the world’s oceans), but the agbiotech industry hasn’t produced much of anything else that might help solve significant agricultural problems either.

GE Golden Rice still isn’t available, for example, due to both project-specific technical difficulties and agbiotechnology-induced mutations in potential products. And even when it finally becomes available to those it was designed to help, it will remain to be determined how effective it may be at reducing vitamin A deficiency. (An initial study with children in China was retracted due to inappropriate collection of participant consent information, among other issues.)

The introduction into Burkina Faso of cotton varieties genetically engineered to produce their own insecticide turned into another disappointment recently. Instead of overall farmer savings associated with reducing the number of pesticide applications yet protecting the crop and thereby increasing yields, the poor quality of the cotton fiber from those GE varieties has contributed to economic problems for the smallholder farmers there. (A Google search today indicates that perhaps the GE cotton situation in Burkina Faso may be improving; I hope so.)

And the Republic of South Africa apparently refused to approve a GE “drought-tolerant” (DT) maize/corn for production and sales in that country recently. The government’s regulatory authorities indicated that the available data didn’t demonstrate that DT GE corn was significantly different from conventional, non-DT varieties in terms of drought-tolerance…and they weren’t pleased with the DT GE crop’s grain yield either.

Overall, most of the GE crops grown around the world today have been engineered to produce their own pesticide (usually in every part of the plant—including the edible parts), or to be tolerant of herbicides (predominantly glyphosate, which was classified an animal carcinogen and a probable human carcinogen in March 2015), or both. Perhaps as a consequence, most of the GE crops grown anywhere on our planet today are fed to animals.

Anywhere, that is, except in the United States. Here it has been estimated that 70 to 80% of processed foods in grocery stores contain GE ingredients, and some varieties of sweet corn and crookneck squash are GE as well.

Why this difference between the U.S. and other countries? As opposed to more than 60 other countries throughout the world, the U.S. has not—for the past 25 years since GE food products first entered the marketplace—required GE foods or ingredients to be labelled as such (although producers will have to comply with a recently enacted federal labelling statute in the near future). The likely difference, therefore, is that Americans simply haven’t been given a choice in the matter.

As a scientist, I’m sorely disappointed that this powerful technology hasn’t been used more carefully and judiciously and to better the human condition, instead of for purposes like selling herbicides/poisons and supporting unsustainable industrial agricultural systems.

As a U.S. citizen, I’m sorely disappointed that—after the initial introduction of Calgene’s GE tomato—the biotech industry chose to deny the American people their right to know what is in their food.

And as a citizen of Planet Earth, I am appalled at the tactics, both alleged and exposed (see here and here), that have been used by Monsanto, until recently the largest producer of GE crop products in the world, to promote (what I consider) disappointing products.

Nowadays, I wonder what I’d tell my grandchildren about bringing the first GE whole food to market. I guess I’d tell them that Calgene was commendably transparent during the process, that we told the FDA and USDA about the technology’s positives as well as its negatives. And that we labelled our GE tomatoes—at least initially.

But then I’d have to admit to them that Calgene failed as a company. Monsanto purchased it and, soon thereafter, the world’s first GE whole food was eliminated from Monsanto’s Roundup Ready-prevalent product line.

Perhaps I’ll go on to tell my (currently hypothetical) grandkids that I made an effort, at least virtually with this blog, to fill in some of the gaps in transparency about agricultural genetic engineering and its products —the things not expressed by the agbiotech industry and academic scientists who support it—for consumers shopping for food for themselves and their families.

In any case, whatever I tell them, the story won’t have the worldwide, problem-solving ending I was hoping for 25 years ago—unless things drastically change for the better in the near future.

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UC Professors Weigh in on Glyphosate (AKA Roundup) and Carcinogenicity

Posted on April 16, 2019 by Belinda

Glyphosate, the “most widely used herbicide in the world,” is in the news a lot lately, largely because the first of thousands of lawsuits, filed by folks who used Monsanto’s Roundup (or other glyphosate-based herbicide products) for decades–who assumed it was as safe as the company claimed it was–and then developed cancer, are now coming to trial.

To those of you who might be interested in learning the lengths to which Monsanto apparently went in defending its glyphosate-based product(s), I highly recommend that you follow the Courthouse News Service articles on these trials.

The opening statement in the third case to go to trial, for example, by the attorney for a California couple who were both diagnosed with non-Hodgkin lymphoma within four years of one another after having sprayed Roundup on their residential properties for 35 years, could serve as the basis for a great movie plot (IMHO).

As described in Roundup Trial: Monsanto Used Fake Data to Win Over Regulators, Monsanto “seemingly planted one of its employees at a contract lab…in the 1970s to fake negative mouse carcinogenicity data for…glyphosate that were to be used to win regulatory approval for the weed killer in 1975; planned an attack to discredit the World Health Organization’s (WHO) cancer research agency, anticipating the agency would classify glyphosate as a probable human carcinogen in 2015 [which, nevertheless, the agency did]; and exploited ‘deep connections’ within the U.S. Environmental Protection Agency to classify glyphosate as non-carcinogenic.”

You may have heard some of these allegations before. Bloomberg reported on the Monsanto-EPA connection in “EPA Official Accused of Helping Monsanto ‘Kill’ Cancer Study” (published in March of 2017), for example.

But maybe not others, like the much older scandal at the now defunct contract lab. (This 1983 article in the Washington Post provides some general information regarding inadequate or falsified data on over 200 pesticides–including Roundup–tested by the specific contract lab mentioned in the current trial.)

Jurors serving on the current trial are also learning about a new study, published in Mutation Research in February 2019, that found “a compelling link between exposure to glyphosate-based herbicides and an increased risk of non-Hodgkin lymphoma.” The first author of this new scientific paper, which comprises a meta-analysis of multiple previously published studies that were designed to determine whether glyphosate exposure increases cancer risk, is an adjunct professor of toxicology with the School of Public Health at the University of California (UC) in Berkeley named Luoping Zhang.

Dr. Zhang, along with two of her co-authors on the Mutation Research paper, had been members of EPA’s 2016 scientific advisory panel on glyphosate. But “Zhang was ‘so outraged’ by the EPA’s failure to follow its own herbicide-assessment guidelines” that she resigned from the advisory panel to carry out the meta-analysis herself. The resulting study is focused on the evidence pertaining to groups of people most highly exposed to glyphosate, and also takes into account the most recent publication on the Agricultural Health Study, a large and long-term study of the effects of pesticides on U.S. farmers that was initiated in 1993. One of Monsanto’s complaints about the WHO’s 2015 determination that glyphosate is a probable human carcinogen had been that the agency hadn’t taken the most recent results from the Agricultural Health Study (AHS) into consideration. (WHO hadn’t taken them into consideration because those results hadn’t been published yet.) But after considering all the available published data–including the latest data from the AHS–Zhang et al.‘s results still indicated that high exposure to glyphosate increased a person’s risk of developing non-Hodgkin lymphoma.

Another UC Berkeley professor, Elena Conis of the Graduate School of Journalism and Center for Science, Technology, Medicine and Society, recently wrote an overview of the history of how pesticides have been regulated in the U.S. that sheds some light on how we got to this point where pesticides “are innocent and on the market until…enough independent science has produced evidence of harm….” In her Perspective piece in the Washington Post, Dr. Conis mentions that the EPA classified glyphosate as a carcinogen in 1985 but “reversed course after six years of correspondence with Monsanto executives;” that since then Monsanto has asked EPA to base its decisions on Monsanto-commissioned science; and that “[i]n one instance, the EPA ceded to industry requests to remove a certain scientist from a glyphosate safety review panel.”

On the other hand, I, for one, am grateful to Dr. Zhang for removing herself from the 2016 glyphosate review panel so that she could conduct the kind of independent science that is so desperately needed to protect humans from capitalists who put their bottom lines ahead of our collective health. U.S. regulatory agencies need to correspond more with scientists who are not working for, or otherwise aligned with, the companies which make money by developing poisons (which is what pesticides were called until after WWII) to spray on our food crops.

In the meantime, while the safety of glyphosate is being debated in the courts, there are steps you can take to limit your exposure to it from the food you eat.

Traditional crops die if glyphosate is applied to them, but crops genetically engineered (GE) to tolerate glyphosate do not. So avoiding GE fruits, vegetables and grains (AKA GMOs) should reduce your intake of glyphosate.

However, some non-GMO crops, like wheat and oats, are now sprayed with glyphosate just prior to harvest to speed up their desiccation–and the regulatory agencies have responded to this new farming practice by increasing the legally permissible levels of glyphosate residues on those crops (see Zhang et al. and references therein for more information on exposure to glyphosate). Consequently, the best way to avoid glyphosate in these crops is to buy products from crops that have been organically grown; glyphosate use is not allowed in organic farming per the current USDA organic standards.

 

 

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“Modified” the Film: Upcoming Screenings

Posted on February 22, 2019 by Belinda

A new film dubbed “A Food Lover’s Journey Into GMOs” was released recently and I highly recommend it…both as an interesting, beautiful and poignant story of its own and also as a means toward filling in gaps in the GMO story as told, for example, in the film Food Evolution (which has been called propaganda by many).

It’s called Modified. Thus far, it’s received 13 film festival awards (including four Audience Choice awards) and well known chef Jacques Pépin calls it “a very personal, tender, touching tribute and a well-researched, enlightening and powerful documentary.”

Canadian Aube Giroux, who wrote, directed, edited and produced Modified, tells me that “audiences respond very strongly and favourably to the film.” I can see why. As described on its website, Modified intimately portrays a “mother-daughter quest for answers” about GMOs, interweaving a “visual celebration of food”, cooking, gardening and family legacy with an investigation into the “extent to which the agribusiness industry controls our food policies.” Modified makes a “strong case for a more transparent and sustainable food system.”

Check out the 2019 schedule for screenings of Modified. It’s being shown in Nevada City on Feb. 24 at Nevada Theatre, for example. And it will be screened during the San Luis Obispo International Film Festival March 12-17 and during the Phoenix Film Festival April 4-14.

IMHO, Modified does a much better job of laying the groundwork for a more civil and productive societal debate about GMOs than efforts like Food Evolution. But view it for yourself and see if you agree.

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New Salk Institute Study Reveals More Detailed Picture of “Scrambled Nature” of Gene Insertions in GMOs

Posted on February 4, 2019 by Belinda

Plant molecular biologists have known for decades that the techniques they use to genetically engineer plants are error prone and can result in GMOs with unintended:

  • mutations in host plant genes,
  • insertion of vector backbone DNA sequences,
  • small duplications or deletions of inserted or host DNA, and/or
  • large rearrangements of host plant chromosomes.

Other unintended changes are also possible; for example, Monsanto’s commercially available NK603 corn unintentionally produces a hybrid RNA molecule derived from sequences of the foreign DNA inserted into that product and sequences from the recipient corn variety’s DNA adjacent to the insertion site.

But, according to the new study published by Jupe et al., “detailed understanding of structure and epigenomic status of insertion events [had been] limited” by the technologies available to researchers; “plant scientists didn’t have the molecular tools” that could enable them to “see” the multiple effects that inserting pieces of foreign DNA into a host plant’s genome have had on those genetically engineered (GE) genomes in a single “picture” until recently.

For this new study, conducted under the supervision of Joseph R. Ecker, a highly respected academic plant molecular biologist at the Salk Institute for Biological Studies, researchers used “state-of-the-art long-range sequencing technologies…to provide new insights into the structural impact of inserting foreign [DNA] fragments into plant genomes….”

These authors, primarily associated with the Salk Institute but including a scientist from the Donald Danforth Plant Science Center and two others from the J. Craig Venter Institute, utilized the state-of-the-art techniques to elucidate unintended changes in the genomes and epigenomes of Arabidopsis thaliana plants that had been genetically engineered using the Agrobacterium-based method. [Arabidopsis is a model plant organism used by many academic researchers. The Agrobacterium-based method of genetic engineering involves the intended transfer of a specific piece of DNA (the transferred DNA or “T-DNA”); this method is good enough at mutating host plant genes that it was used by plant scientists in an effort to mutate every gene in the Arabidopsis genome. Many commercially available GMOs were created using the Agrobacterium-based method of genetic engineering.]

The new study revealed the “scrambled nature of T-DNA and vector backbone insertions and rearrangements in high detail” and “uncovered various effects of T-DNA insertions on the adjacent chromatin landscape.” Unintended “intra- and interchromosomal rearrangements” were discovered, for example, as well as unintended “alterations of chromatin and thus chromatin structure and functionality.” With “unprecedented detail” this study reveals “novel insights into the impact of these events on plant genome/epigenome integrity.”

The authors point out that this kind of “Knowledge of structure variations induced by transgene insertions…as well as evidence for epigenetic changes to the host genome is crucial from scientific as well as regulatory perspectives.”

I agree. We just don’t know enough about genomes and epigenomes, and how randomly inserting foreign pieces of DNA into them and scrambling them will affect them. Therefore, I think U.S. regulators should take a more precautionary approach to regulating GMOs, and require developers of GMOs to provide information about the integrity of the genomes and epigenomes of their products prior to commercializing them.

But the FDA has never required developers of GMOs to provide the kind of crucial information about structure variations induced in their products by transgene insertions that Jupe et al. addresses…even though older techniques for revealing most of them have been available for decades. And some who have provided information about the “scrambled” genomes in their GMOs to the FDA voluntarily–like Monsanto did for NK603–have gone ahead and commercialized those scrambled products anyway.

Jupe et al. conclude the Discussion of their results by stating that “Our findings pave the way for structural genomic studies of transgenic crop plants….”

Maybe. But will developers of GMO crops follow this newly paved path? Will FDA make them?

Or will GMOs with scrambled genomes and epigenomes continue to be commercialized?

 

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