Steven Druker is a public-interest attorney and the founder and executive director of the nonprofit Alliance for Bio-Integrity, which focuses on advancing human and environmental health with safe and sustainable technology. As executive director of the nonprofit, Druker brought a lawsuit against the U.S. Food and Drug Administration (FDA) in an effort to mandate safety testing and labeling of genetically engineered (GE) foods. The lawsuit resulted in the release of the FDA’s files on GE foods, revealing numerous violations of federal food safety law.
Druker also speaks often about the risks of GE foods. He has been a guest on numerous nationally broadcast radio and television programs, served on food safety panels globally, and met with government officials in various countries to talk about food safety and environmental health concerns. He is the author of Altered Genes, Twisted Truth: How the Venture to Genetically Engineer Our Food Has Subverted Science, Corrupted Government, and Systematically Deceived the Public; Jane Goodall’s foreword hailed it as “without doubt one of the most important books of the last 50 years.” He is also the recipient of the 2017 Luxembourg Peace Prize for Outstanding Environmental Peace.
Druker studied philosophy at the University of California at Berkeley and received his law degree from the same institution.
Food Policy Center (FPC): What sparked your interest in environmental health and food safety? How did your background in philosophy and law shape the founding of the Alliance for Bio-Integrity?
Steven Druker (SD): I became interested in human and environmental health when I was a law student at Berkeley. As my own health and energy improved through regular exercise (especially running) and transcendental meditation, I grew increasingly aware of the effects of food on physical and psychological health. That led to positive change in my choices of food — and eventually led to an interest in food safety issues. Further, as I became more cognizant of the value of holistic health on the individual level, I gained greater appreciation for the need to preserve the overall health of our environment.
My law degree played a major role in the founding of the Alliance for Bio-Integrity, because a primary goal was for the organization to serve as the lead plaintiff in a lawsuit against the FDA’s policy on genetically engineered foods. My philosophy background, with its training in rigorous logical analysis, contributed significantly to my success in law school and was very helpful during the lawsuit. Moreover, it played a key role in the writing of my book, Altered Genes, Twisted Truth — especially the sections exposing the fact that reports from the National Academy of Sciences asserting the safety of GE foods rely on flawed logic and the surreptitious alteration of the technical definition of risk.
FPC: You were the driving force behind the 1998 lawsuit that required the FDA to open its files on genetically engineered foods, ultimately revealing that these foods were allowed to be sold without undergoing the testing mandated by the federal food safety law. How did you decide to focus on that specific topic?
SD: The FDA’s policy on GE foods has always rested on a flimsy foundation, so it was a ripe target for a legal challenge. It is based on the agency’s claim that these products are Generally Recognized as Safe (GRAS) and do not need to be subjected to safety testing, a claim that was not merely false but fraudulent when first announced in 1992 — and that continues to be fraudulent today. In reality, none of the foods has ever met the qualifications for GRAS standing, and the FDA has always possessed conclusive information demonstrating that fact. Nonetheless, as I’ll explain, the FDA’s unethical and illegal policy has been permitted to persist.
According to explicit provisions of federal food safety law, no food product can be deemed GRAS unless it meets two strict criteria: (1) it must be recognized as safe by an overwhelming consensus of experts, and (2) that consensus must be based on technical evidence of safety.
GE foods fail both requirements, and the lawsuit clearly exposed this failure. Indeed, the exposure occurred on the day it was filed, because nine well-credentialed scientists took the unprecedented step of joining as plaintiffs to emphasize their concerns about the abnormal risks — more than enough experts, according to legal precedent, to refute the FDA’s claim of consensus. They additionally asserted that they weren’t aware of any reliable scientific studies demonstrating safety.
In her written opinion, the judge acknowledged the strength of this showing and stated that “significant disagreements among scientific experts” had been demonstrated. However, she stated that because the key issue was whether the FDA policy decision of May 1992 was arbitrary, she would only consider the information the FDA had before it at that time. But that information was itself sufficient to defeat the GRAS claim — a fact discovered when the FDA was compelled to hand over copies of its internal files on GE foods. Within those files were a number of memos from the agency’s scientists cautioning about the abnormal risks and calling for rigorous safety testing. The files also contained admissions that there was no technical evidence of safety and that there was not a consensus about safety in the general scientific community. (Copies of key FDA memos are posted at https://biointegrity.org/24-fda-documents )
Nevertheless, the judge not only disregarded these critical admissions, she even said that the FDA administrators had been entitled to disregard the warnings of their scientists. And she herself failed to take the significance of those warnings into account, because she ignored the fact that the FDA’s policy statement was based on the blatant lie that the agency “was not aware of any information” showing that GE foods differ from other foods “in any meaningful way.” Although our submissions to her had highlighted this falsehood and emphasized its importance, she made no mention of it. Only by excluding all this crucial evidence from consideration could she rule in the FDA’s favor — and argue that its administrators had not acted arbitrarily when, in May 1992, they made the presumption that GE foods were GRAS.
The judge’s ruling was very narrow. She never asserted that GE foods had been shown to be safe. Nor did she determine that there ever had been a general recognition of safety among experts. She did not even say that the FDA could justifiably continue to presume that GE foods are safe. Her decision was limited to the particular exercise of discretion made by the FDA in May of 1992, and it asserted, that at that point in time, the FDA had some rational basis to presume there was a general recognition of safety among experts. But she also indicated that as of May 1998, such general recognition did not exist — which entails that GE foods were not GRAS at that time.
Unfortunately, considerable confusion has been created about the lawsuit, and proponents of GE foods have imparted the false impression that the judge confirmed both the soundness of the FDA’s current policy and the safety of GE foods. Further, because the key details of her opinion are inimical to the FDA’s position, they avoid discussing them and simply emphasize that the judge dismissed the suit, thereby implying that the action was without legal merit and was rejected without the need for substantial legal proceedings. And the media have largely done the same, amplifying the confusion. In fact, extensive proceedings occurred before the judge issued her ruling in a multi-page written opinion. That ruling was not rendered until more than two years after the lawsuit was filed, and only then did the court dismiss our suit, which is the standard result in such situations.
Regrettably, because hardly anyone in the mainstream media has read the judge’s opinion and studied the evidence submitted in the case, the public is largely unaware of the astonishing extent to which the opinion was illogical and counterfactual — and to which FDA policy has been fraudulent.
FPC: The lawsuit was ultimately dismissed by a federal judge in 2000. What changes, if any, have been made in the U.S. regarding the production and sale of genetically engineered foods in the past 20 years? What would the regulations on genetically engineered foods look like if you had the power to rewrite the law yourself?
SD: Over the last 20 years, the FDA has maintained its delinquent policy, continued to falsely declare that GE foods qualify as GRAS, and refused to require them to undergo even a smidgen of safety testing. Further, it has rebuffed increasing demands from the public for labeling these foods. And although citizen-induced ballot initiatives to require labeling at the state level arose in California and a few other states, they were defeated by massively funded campaigns that substantially relied on misinformation. Moreover, although Vermont enacted legislation that required labeling of GE foods within its borders, shortly after the requirement went into effect on July 1, 2016, the US Congress passed a law that quashed it — and prevents any other state from doing the same.
Instead, as of January 2022, the federal government will require some forms of labeling, but the measures will be weak. Labels won’t be required on the packaging, and manufacturers can instead provide a phone number, a website address, or a QR code that can be scanned on a smartphone for people who want information. Further, even when manufacturers elect to use one of the two approved (but optional) labels, because of the wording many consumers will not be adequately informed that the product contains GMO ingredients. Accordingly, for these and other reasons, many public-interest organizations maintain that all GMO-containing food products in the US will be mislabeled.
If I could establish the safety assessments for GE foods, I would institute the series of tests prescribed by the molecular biologists John Fagan and Michael Antoniou (described in the tenth chapter of my book). First, there should be assessment via the full range of available molecular profiling techniques (genomics, transcriptomics, proteomics, and metabolomics). Next, long-term feeding studies on laboratory animals that not only follow the animals throughout their lifetime but also monitor their offspring and the subsequent generation as well. Those tests would include comprehensive anatomical, histological, physiological, and biochemical analyses of organs, blood, and urine. There would also be tests to monitor effects on gene expression, proteins, and metabolites. Similar testing of farm animals would be next, followed by long-term human clinical trials.
The need for such testing is clearly explained in my book’s eleventh chapter — “Overlooked Lessons from Computer Science: The Inescapable Risks of Altering Complex Information Systems” — which scrutinizes so-called genetic engineering from the perspective of software engineering. Such an analysis establishes that the tests on each GE food should be at least as rigorous as the testing required any time a life-critical software program is revised, especially because the latter revisions are performed by experts who understand the systems they’re revising far better than do the people altering the far more complex bioinformation systems. Such rigor, applied to assessing the safety GE foods, would at minimum entail the series of tests previously summarized.
Yet, most such tests are not currently required, and even though some regions require some animal testing, it’s inadequate in several respects. For instance, only medium-term testing is mandated, a duration that’s been demonstrated to be too short.
FPC: There is an ongoing public debate on the pros and cons of GE foods. What are the greatest perils posed by genetically engineered foods? What about promises?
SD: As my book explains, when the issue is food safety, the potential benefits of GE foods are irrelevant, and, according to US law, it’s illicit to employ them to offset risks. This is different from the case of prescription drugs, where it is legitimate to assess safety via risk/benefit analysis. But US law dictates that in the case of a new food product, there must be a “reasonable certainty” that it will not cause harm, regardless of the benefits it may promise.
Further, the proponents of GE foods routinely exaggerate their benefits. For instance, they claim the foods are needed to adequately feed the world’s growing population, even though numerous experts have concluded this is not the case. For instance, in 2008 the World Bank and four United Nations agencies completed a four-year study on the future of farming: the International Assessment of Agricultural Knowledge, Science and Technology for Development (IAASTD). This massive study was conducted by more than 400 experts from 80 countries, and 58 governments have endorsed it. It concluded that GE foods are not needed for solving the problem of hunger. What’s more, it noted that yields of GE crops were “highly variable” and that in some cases there had been “yield declines.”
Instead, the IAASTD endorsed agroecological methods of production (which are organic or near organic), methods that require fewer inputs, conserve resources, and preserve the soil. Not only are such methods better suited to the developing world, they’ve been highly successful at increasing yields. For instance, the UN special rapporteur on the right to food has stated: “Yields went up 214% in 44 projects in 20 countries in sub-Saharan Africa using agroecological farming techniques over a period of 3 to 10 years.” And he pointed out that this accomplishment is “far more than any GM crop has ever done.”
While GMO proponents overhype their benefits, they routinely understate their risks, even though the risks are substantial. For instance, the first ingestible product of genetic engineering caused an epidemic that killed dozens of Americans and seriously sickened thousands, permanently disabling many of them. It was a food supplement of the essential amino acid L-tryptophan that had been derived from genetically altered bacteria. Although it met the standards for pharmacological purity, it contained at least one novel contaminant that was highly toxic even at extremely low levels. Further, the evidence strongly implicates the gene-altering technology as the key cause in the creation of the lethal contaminant. Moreover, this catastrophe has serious implications for all the technology’s edible products, because the toxic chemical was almost surely created through a general aspect of the technology. Thus, in other GE foods, that problematic factor could have been creating other toxins that do not induce acute, readily noticeable damage but rather incremental long-term harm that’s difficult to detect, harm that could have been accumulating in millions of people over many years.
Additionally, a number of studies of GE foods published in peer-reviewed journals have reported significant adverse effects on lab animals, including serious injury to the livers and kidneys, disturbed immune systems, and increased mortality. And when independent scientists have scrutinized the research done by the foods’ manufacturers, they’ve determined not only that it tends to be of lower quality than the studies reporting harm, but also that in several cases the data that were declared to support safety actually raise serious doubts. At least as ominous, the tests reporting an absence of harm have been rendered even more dubious by a solid study demonstrating that almost all of them were too short to sufficiently screen for problems.
Furthermore, besides the substantial damage it has inflicted on the bodies of humans and animals, the GE food venture has caused immense damage to science. As my book documents, in their efforts to defend the image of GE foods, many eminent scientists and scientific institutions (including the US National Academy of Sciences and the UK Royal Society) have repeatedly dispensed misinformation and subverted other scientific standards as well — in marked contrast to the measured and responsible manner in which they’ve behaved regarding the issue of climate change. In an era when the scientific endeavor has come under increasing attack from hostile and powerful external forces, it’s especially injurious for science to be so seriously and surreptitiously assaulted from within, by agents who purport to be acting under its banner.
FPC: In 2018 and 2019, there was a lot of talk, concern, and confusion about the presence of the pesticide glyphosate in various cereals and granola bars and its potential long-term health effects, even though the Environmental Protection Agency (EPA) declared that there was no public health risk posed by the pesticide. What was your take on this case? Do you agree or disagree that the health risks are negligible?
SD: Unfortunately, this is another instance in which the EPA allowed itself to be swayed by the pesticide’s manufacturer and has ignored the more valid input from independent experts. And despite the EPA’s claim, when the evidence is objectively assessed, it’s clear that glyphosate is unacceptably risky to public health, especially when delivered in the form of Roundup®: the chemical concoction that’s sprayed on plants and contains the adjuvants that enable the glyphosate to be most penetrative and effective. Some of the strongest evidence of Roundup’s risks was generated by a well-conducted long-term toxicological study that demonstrated it caused significant harm to the livers and kidneys of rats when consumed at a dose equivalent to the amount delivered in a typical serving of sprayed corn. Although Monsanto and other GMO proponents have disparaged that study, its toxicological findings are solid, it has passed rigorous peer review, and it is published in a scientific journal. (Chapter 10 of my book describes the unjustness of the attacks that the study has endured.)
FPC: Norwegian historian, Christian Lous Lange, said “technology is a useful servant but a dangerous master.” How can advances and innovations in technology be harmful to food production? In what ways can new technology benefit food systems and environmental health?
SD: Lange is certainly correct. Moreover, the way in which GE technology has been employed to alter the complex information systems of food-yielding organisms is especially dangerous because the biotechnicians have been operating under the illusion that they are significantly mastering nature when in reality, they have been significantly disrupting it (as elucidated in my book). Thus, to a substantial degree, they have been mastered by their own illusions.
As the FDA’s scientific staff warned in 1991, as an expert panel of the Royal Society of Canada similarly cautioned in 2001, and as many other experts have likewise warned during succeeding years, producing new foods via GE technology without extensive, rigorous testing the likes of which have never been required anywhere, can give rise to novel toxins, allergens, or otherwise harmful substances that could be difficult to detect. Agricultural biotechnology has also caused substantial harm to the environment — and has the potential to cause a lot more.
Luckily, there are also technological advances that can have positive effects on food systems and the environment. For instance, Marker Assisted Selection (MAS) has enabled the development of plants with important complex traits that bioengineering cannot produce — but without the risks it does engender. And small robots are being developed that have the potential to replace a substantial amount of farm machinery and substantially reduce energy consumption, the volume of pesticides applied, and the amount of human labor required.
FPC: What does the future of GE foods look like in terms of both public debate and new technologies that continue to innovate food production? How can we ensure ethics are not compromised by the drive for progress and profits?
SD: I’ll start with the question about ethics. As previous answers indicate, and as my book thoroughly establishes, the most consequential transgressions of ethics in connection with GE food have not been perpetrated by major corporations but by government agencies and key components of the scientific establishment. Further, the transgressions of the latter have been paramount, because they have enabled those of the government officials and the corporate executives. After all, if every scientist and scientific institution had openly and honestly communicated the facts about GE foods — without suppressing so many of the key ones and distorting so many others — the officials and the executives could not have maintained their misrepresentations. Indeed, scientists had begun to twist the truth about genetic engineering even before there was a substantial biotech industry, and their misrepresentations were instrumental in shaping government policies and inducing officials to subsequently disfigure the facts.
Accordingly, it will remain difficult to have a meaningful public debate on the issue until the basic facts are cleared up and widely illuminated. At present, the mainstream media in North America and Europe largely project the distorted version of reality conveyed by the scientist-proponents of GE foods– an ostensibly authoritative narrative in which the products’ safety has been proven, they’re responsibly regulated, and the only people raising concerns are ill-informed nonscientists who, through their opposition to the foods, are opposing science. Unless the falsity of this narrative is thoroughly exposed, government policies and public discourse will remain significantly misaligned with the facts.
Moreover, like the first generation of gene-altering techniques, the newest ones, such as CRISPR, are also being overhyped, and their risks are likewise being unduly downplayed. For instance, they’re described as “genome editing” techniques and are claimed to operate with profound precision, but they’re imprecise in significant ways and are far more erratic than any genuine forms of editing. Based on these distorted depictions, biotech advocates have been pressuring government regulators to permit foods produced through the new techniques to enter the market without safety testing. But the European Court of Justice has ruled that any crops the techniques produce must be regulated according to the existing standards for GMOs, which mandate testing and labeling. And in a further blow to the biotech industry, the US Food and Drug Administration has ruled that animals produced through these new techniques must be carefully regulated before they can be marketed as food. The agency made this decision after determining that a manufacturer’s claims about its hornless cows were inaccurate. Although the manufacturer had intended to enhance the genome with only a single gene from a hornless variety of cattle — and had asserted (and believed) that nothing but that gene had been added — FDA scientists discovered that the purported precision of the “editing” was fictional. In reality, the genomes had been inadvertently endowed with an additional gene from a foreign source.
Yet, oddly enough, the FDA has not extended its concern to plants that are altered via these new methods, even though they also have substantial potential for unintended effects. Instead, the agency apparently plans to give such organisms the same unrestricted access to the market that it has been affording crops produced via the earlier means of gene-alteration.
Predictably, in both the EU and the US, intense efforts are being made by pro-GMO forces to alter the policies and laws so that all the new products will be exempt from regulations. Therefore, it’s vital for the facts to be clarified and the fictions refuted so that the health of hundreds of millions of people will not be subjected to unwarranted risks.
FPC: What’s one food item we won’t ever find in your kitchen or on your plate?
SD: I’d like to say GMOs, but although I go to great lengths to avoid them, I cannot confidently assert that there will never be any GMO ingredients in my kitchen or on my plate, especially when I’m at a restaurant. Due to the significant extent to which contamination occurs, even certified organic foods may not be fully free of GMO content, and foods that have earned Non-GMO Project verification could still contain up to 0.9 percent GMO ingredients. Therefore, in order to answer with the greatest degree of certainty, I’ll say meat. I became a vegetarian when I was in law school.
FPC: You have done significant work with food safety panels and government officials across the world. How do food safety regulations differ in other parts of the world? Are there any countries you believe adhere to the “gold standard” in food safety laws?
SD: I’ve addressed this question to some degree in previous replies. Regrettably, in the case of GMOs, no nation comes close to upholding what could be termed the “gold standard,” and it’s fair to say that none of the standards even deserves to be called “bronze” — and that the one in the United States can be classified as “lead.”
FPC: What is the one food policy change at the federal level that would have the biggest impact regarding food safety, environmental health, and/or human health?
SD: If the FDA, USDA, and EPA were to institute a policy to acknowledge — and retract — all the false or otherwise misleading statements they’ve made; were to henceforth openly and honestly communicate the facts; and were to base their decisions on solid scientific evidence and the advice of experts who are independent from the agri-food and chemical industries.
FACT SHEET
Grew up in: Des Moines, Iowa
City or town you call home: Fairfield, Iowa
Job title: Executive Director, Alliance for Bio-Integrity
Background and education: Majored in philosophy at UC Berkeley. Received a special award for “outstanding accomplishment” in that field; elected to Phi Beta Kappa in junior year; graduated with “Great Distinction in General Scholarship.”
Juris Doctor from the UC Berkeley Law School. Elected to the California Law Review and the Order of the Coif (the legal honor society).
One word you would use to describe our food system: Misguided
Your food policy hero: I have several heroes. One is the Rodale Institute.
Your breakfast this morning: Cooked cereal of kamut flakes and ground buckwheat with almonds, walnuts, and hemp seeds; baked apple with cranberry and pomegranate sauce. (all ingredients were organic)
Favorite food: I have several favorites. Among them are avocados, artichokes, and asparagus.
A favorite recent meal: A stew of quinoa, collard greens, sweet potato, zucchini, daikon, and celery. Hummus on whole-grain rye bread. Date/nut balls for dessert. (all organic)
