Pursuing Truth and Transparency in America's Food System

The FDA does not test whether GMOs are safe

[Excerpt from Seedy Business, chapter 2]

In recent testimony before Congress, the FDA stated that it is “confident that the GE foods in the U.S. marketplace today are as safe as their conventional counterparts.”[1]

However, FDA does not itself test whether genetically engineered foods are safe. The FDA has repeatedly made this clear. As Jason Dietz, a policy analyst at FDA explains about genetically engineered food: “It’s the manufacturer’s responsibility to insure that the product is safe.”[2] Or, as FDA spokesperson Theresa Eisenman said, “it is the manufacturer’s responsibility to ensure that the [GMO] food products it offers for sale are safe…”[3]

Nor does the FDA require independent pre-market safety testing for genetically engineered food. As a matter of practice, the agrichemical companies submit their own studies to the FDA as part of a voluntary “consultation.” Moreover, the FDA does not require the companies to submit full and complete information about these studies. Rather, as the FDA has testified, “After the studies are completed, a summary of the data and information on the safety and nutritional assessment are provided to the FDA for review.”[4]

That the FDA does not see the complete data and studies is a problem, according to a Biotechnology and Genetic Engineering Reviews article by William Freese and David Schubert:

the FDA never sees the methodological details, but rather only limited data and the conclusions the company has drawn from its own research….the FDA does not require the submission of data. And, in fact, companies have failed to comply with FDA requests for data beyond that which they submitted initially. Without test protocols or other important data, the FDA is unable to identify unintentional mistakes, errors in data interpretation, or intentional deception…[5]

At the end of the consultation, the FDA issues a letter ending the consultation. Here is a typical response from FDA, in its letter to Monsanto about its MON 810 Bt corn:

Based on the safety and nutritional assessment you have conducted, it is our understanding that Monsanto has concluded that corn products derived from this new variety are not materially different in composition, safety, and other relevant parameters from corn currently on the market, and that the genetically modified corn does not raise issues that would require premarket review or approval by FDA…. as you are aware, it is Monsanto’s responsibility to ensure that foods marketed by the firm are safe, wholesome [emphasis ours] and in compliance with all applicable legal and regulatory requirements.[6]

This testing regime is insufficient for several other reasons.

Most of the animal safety testing prepared for the FDA is merely short-term. A study in the International Journal of Biological Sciences summarizes the typical testing regime: “The most detailed regulatory tests on the GMOs are three-month long feeding trials of laboratory rats, which are biochemically assessed.” Such tests may well be too brief in duration to uncover pathologies that develop more slowly, such as many types of organ damage, endocrine disturbances and cancer.[7]

There are too few peer-reviewed studies on the health risks of genetically engineered food. In their 2004 article in Biotechnology and Genetic Engineering Reviews, William Freese and David Schubert wrote that, “Published, peer-reviewed studies, particularly in the area of potential human health impacts, are rare. For instance, the EPA’s human health assessment of Bt crops cites 22 unpublished corporate studies, with initially only one ancillary literature citation.”[8] Similarly, a 2014 review in Environment International of 21 studies of the effects of genetically engineered foods on the digestive tracts of rats found an “incomplete picture” regarding “the toxicity (and safety) of GM products consumed by humans and animals.”[9] In other words, it concludes that there is not enough evidence to say that genetically engineered foods are safe to eat.

The FDA permits companies to submit their own safety studies, but does not require independent ones. However, the evidence regarding pharmaceutical studies strongly suggests that industry-funded studies are more likely than independent ones to be favorable to industry. Here’s Ben Goldacre’s review of this evidence:

in 2010, three researchers from Harvard and Toronto found all the trials looking at five major classes of drug—antidepressants, ulcer drugs and so on—then measured two key features: were they positive, and were they funded by industry? They found over five hundred trials in total: 85 per cent of the industry-funded studies were positive, but only 50 per cent of the government funded trials were. That’s a very significant difference.

In 2007, researchers looked at every published trial that set out to explore the benefit of a statin….This study found 192 trials in total, either comparing one statin against another, or comparing a statin against a different kind of treatment. Once the researchers controlled for other factors…they found that industry-funded trials were twenty times more likely to give results favoring the test drug. Again, that’s a very big difference.

We’ll do one more. In 2006, researchers looked into every trial of psychiatric drugs in four academic journals over a ten-year period, finding 542 trial outcomes in total. Industry sponsors got favorable outcomes for their own drug 78 per cent of the time, while independently funded trials only gave a positive result in 48 per cent of cases.[10]

These results present a compelling argument for FDA to require independent pre-market safety testing for genetically engineered food, but the FDA fails to do so.

Perhaps more importantly, the agrichemical industry is under no obligation to report the results of all their studies. How do we know that they are not suppressing evidence of health risks of genetically engineered food? It is well-known that in other industries “publication bias” and the suppression of studies is commonplace. That is certainly true in the pharmaceutical industry. Here, for example, is Ben Goldacre’s description of missing evidence in trials on antidepressants:

researchers found seventy-four studies in total, representing 12,500 patients’ worth of data. Thirty-eight of these trials had positive results, and found that the new drug worked; thirty-six were negative. The results were therefore an even split between success and failure for the drugs, in reality. Then the researchers set about looking for these trials in the published academic literature, the material available to doctors and patients. This provided a very different picture. Thirty-seven of the positive trials—all but one—were published in full, often with much fanfare. But the trials with negative results had a very different fate: only three were published. Twenty-two were simply lost to history, never appearing anywhere other than in those dusty, disorganized, thin FDA files. The remaining eleven which had negative results in the FDA summaries did appear in the academic literature, but were written up as if the drug was a success….

This was a remarkable piece of work, spread over twelve drugs from all the major manufacturers, with no stand-out bad guy. It very clearly exposed a broken system: in reality we have thirty-eight positive trials and thirty-seven negative ones; in the academic literature we have forty-eight positive trials and three negative ones.[11]

Why shouldn’t we expect the agrichemical industry to follow the pharmaceutical industry’s pattern of suppressing negative results? This question seems especially relevant, given the agrichemical industry’s history of suppressing evidence of health risks of their other products and operations. It makes no sense for the FDA to trust an industry with such a record.

It is also worth remembering that in the U.S. there is a history of fraud in toxicological testing. As Dan Fagin and Marianne Lavelle explain in their book Toxic Deception, “The U.S. regulatory system for chemical products is tailor-made for fraud. The subjects are arcane, the results subjective, the regulators overmatched, and the real work conducted by – or for – the manufacturers themselves.”[12] Regarding Monsanto’s role in such frauds, they write that:

Paul Wright had been a research chemist at Monsanto before he went to work for IBT [then the nation’s largest toxicology lab] in 1971 as its chief rat toxicologist. Wright stayed at the lab for only 18 months before he returned to Monsanto….But it was long enough, the [federal] government investigators concluded, for him to be in the middle of a series of apparently fraudulent studies that benefitted Monsanto products…In all three cases [regarding an herbicide and a chlorinator], the [federal government] investigators wrote in an internal memo, there was evidence that Monsanto executives knew that the studies were faked but sent them to the FDA and the EPA anyway.[13]

Finally, how can we assess the health risks of genetically engineered foods that are currently on the market? At this time, we can’t. The FDA does not require any post-market studies of health risks of genetically engineered food. As a 2010 study in the International Journal of Biological Sciences points out, “although some stakeholders claim that a history of safe use of GMOs can be upheld, there are no human or animal epidemiological studies to support such a claim as yet, in particular because of the lack of labeling and traceability in GMO-producing countries.”[14] Without such epidemiological studies on genetically engineered food, we can’t know whether GMOs are safe or not, and if they cause illnesses, what they are, who is afflicted, and with what frequency.

Perhaps not coincidentally, there is a similar problem with testing of pesticide levels on the fruits and vegetables eaten by American consumers. A November 2014 report by the U.S. Government Accountability Office found that the FDA only tests the pesticide levels of less than one per thousand imported fruits and vegetables, and one per hundred of those grown domestically. GAO concluded that the FDA’s testing program is not “statistically valid.”[15] The Washington Post explains the GAO’s conclusion: “The U.S. Food and Drug Administration does not perform enough pesticide residue tests — on either imported or domestic foods – to say whether the American food supply is safe…”[16]

Of course, the agrichemical companies say their genetically engineered foods are safe. What’s curious about this is that they have enough money to carry out independent pre-market and post-market testing of the health risks of their products. Such testing would be an easy way to put to rest any questions about health risks. But they don’t. Why not? Also, the agrichemical industry could lobby for federal laws or rules requiring pre-market and post-market safety testing for genetically engineered foods. And they would likely prevail. They haven’t done that either. Why not? It suggests they don’t want to know the answers, or they don’t want us to know the answers. Or both. This doesn’t inspire trust.

Even at the outset, some FDA scientists had concerns about the health risks of genetically engineered food. According to the New York Times,

Among them was Dr. Louis J. Pribyl, one of 17 government scientists working on a policy for genetically engineered food. Dr. Pribyl knew from studies that toxins could be unintentionally created when new genes were introduced into a plant’s cells. But under the new edict, the government was dismissing that risk and any other possible risk as no different from those of conventionally derived food. That meant biotechnology companies would not need government approval to sell the foods they were developing.

“This is the industry’s pet idea, namely that there are no unintended effects that will raise the F.D.A.’s level of concern,” Dr. Pribyl wrote in a fiery memo to the F.D.A. scientist overseeing the policy’s development. “But time and time again, there is no data to back up their contention.”

Dr. Pribyl, a microbiologist, was not alone at the agency. Dr. Gerald Guest, director of the center of veterinary medicine, wrote that he and other scientists at the center had concluded there was “ample scientific justification” to require tests and a government review of each genetically engineered food before it was sold.

Three toxicologists wrote, “The possibility of unexpected, accidental changes in genetically engineered plants justifies a limited traditional toxicological study.”[17]

The federal government’s premise for lax regulation of GMOs was the notion of “substantial equivalence” – that new genetically engineered foods were substantially equivalent to regular foods, so there was no need for regulation. As the FDA’s 1992 “guidance to industry” stated, “FDA believes that the new techniques are extensions at the molecular level of traditional methods and will be used to achieve the same goals as pursued with traditional plant breeding.”[18] It was with this idea that the agrichemical industry evaded rigorous safety testing.

But the premise of “substantial equivalence” was dubious from the start. It was an a priori political concept – adopted without studies or evidence – to treat genetically engineered food as GRAS (Generally Regarded As Safe). It was claimed by the agrichemical industry, not proven by independent study. For this reason, some FDA staff opposed the idea of “substantial equivalence.” For example, Dr. Linda Kahl, an FDA compliance officer, was concerned about unpredictable or unknown safety risks from genetically engineered food. She wrote:

“The process of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks,” Dr. Kahl wrote. “There is no data that addresses the relative magnitude of risk — for all we know, the risks may be lower for genetically engineered foods than for foods produced by traditional breeding. But the acknowledgment that the risks are different is lost in the attempt to hold to the doctrine that the product and not the process is regulated.”[19]

Along the same lines, E. J. Matthews of the FDA’s Toxicology Group warned that “genetically modified plants could…contain unexpected high concentrations of plant toxicants” and that these could be “uniquely different chemicals that are usually expressed in unrelated plants.”[20]
“Substantial equivalence is a pseudo-scientific concept,” explained a commentary by Erik Millstone, Eric Brunner and Sue Mayer in Nature, “because it is a commercial and political judgment masquerading as if it were scientific. It is, moreover, inherently anti-scientific because it was created primarily to provide an excuse for not requiring biochemical or toxicological tests.”[21]

As Consumers Union senior staff scientist Michael Hansen points out, even the FDA itself has explicitly rejected its own premise of “substantial equivalence.” It did so in its 2001 proposed rule on pre-market notice of genetically engineered food. The FDA wrote:

Because some rDNA-induced unintended changes are specific to a transformational event (e.g., those resulting from insertional mutagenesis), FDA believes that it needs to be provided with information about foods from all separate transformational events, even when the agency has been provided with information about foods from rDNA-modified plants with the same intended new trait and has had no questions about such foods…. In contrast, the agency does not believe that it needs to receive information about foods from plants derived through narrow crosses [such as traditional plant breeding][22]

Yet, even though the FDA has acknowledged the flaws in its own premise of “substantial equivalence,” the underlying policy lives on – now without any justification at all.

So, the FDA states that it is “confident” about the safety of GMOs currently in the marketplace. But it does not itself conduct safety testing on GMOs. It does not sponsor independent safety testing. It does not require independent safety testing. It does not require long-term safety testing, to uncover ill effects that have delayed onset. It does not have access to the full data and content of all industry safety testing. And it does not require post-market epidemiological testing. Without such testing, and full access to industry data, the FDA cannot credibly decree, declare or certify that GMOs are safe.

Footnotes

[1] Statement of Michael M. Landa, J.D., Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration, Department of Health and Human Services, Before the Subcommittee on Health, Committee on Energy and Commerce, U.S. House of Representatives. December 10, 2014.

[2] Nathaniel Johnson, “The GM Safety Dance: What’s Rule and What’s Real.” Grist, July 10, 2013.

[3] Rachel Pomerance, “GMOs: A Breakthrough or Breakdown in U.S. Agriculture?” U.S. News & World Report, April 25, 2013.

[4] Statement of Michael M. Landa, J.D., Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration, Department of Health and Human Services, Before the Subcommittee on Health, Committee on Energy and Commerce, U.S. House of Representatives. December 10, 2014.

[5] William Freese and David Schubert, “Safety Testing of Genetically Engineered Food.” Biotechnology and Genetic Engineering Reviews, November 2004, 21:299-324.

[6] Correspondence from Alan M. Rulis Ph.D., Director, Office of Premarket Approval, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, to Dr. Kent Croon, Regulatory Affairs Manager, Monsanto Company, September 25, 1996.

[7] Joël Spiroux de Vendômois, et al., “Debate on GMOs Health Risks after Statistical Findings in Regulatory Tests.” International Journal of Biological Sciences, 2010; 6(6):590-598. doi:10.7150/ijbs.6.590.

[8] William Freese and David Schubert, “Safety Testing of Genetically Engineered Food.” Biotechnology and Genetic Engineering Reviews, November 2004, 21:299-324.

[9] I.M. Zdziarski, J.W. Edwards, J.A. Carman and J.I. Haynes, “GM Crops and the Rat Digestive Tract: A Critical Review.” Environment International, December 2014. 73:423-433. doi: 10.1016/j.envint.2014.08.018.

[10] Ben Goldacre, “Trial Sans Error: How Pharma-Funded Research Cherry-Picks Positive Results.” Scientific American, February 13, 2013. Ben Goldacre, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients. (New York: Faber and Faber, 2012), pp. 1-2.

[11] Ben Goldacre, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients. (New York: Faber and Faber, 2012), p. 20. See also Erick H. Turner, Annette M. Matthews, Eftihia Linardatos, Robert A. Tell, and Robert Rosenthal, “Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy.” New England Journal of Medicine, January 17, 2008. 2008; 358:252-260. DOI: 10.1056/NEJMsa065779. Benedict Carey, “Researchers Find a Bias Toward Upbeat Findings on Antidepressants.” New York Times, January 17, 2008.

[12] Dan Fagin, Marianne Lavelle and the Center for Public Integrity, Toxic Deception: How the Chemical Industry Manipulates Science, Bends the Law and Endangers Your Health. (Secaucus, NJ: Carol Publishing Group, 1996), p. 33.

[13] Dan Fagin, Marianne Lavelle and the Center for Public Integrity, Toxic Deception: How the Chemical Industry Manipulates Science, Bends the Law and Endangers Your Health. (Secaucus, NJ: Carol Publishing Group, 1996), p. 34.

[14] Joël Spiroux de Vendômois et al., “Debate on GMOs Health Risks after Statistical Findings in Regulatory Tests.” International Journal of Biological Sciences, 2010; 6(6):590-598. doi:10.7150/ijbs.6.590.

[15]Food Safety: FDA and USDA Should Strengthen Pesticide Residue Monitoring Programs and Further Disclose Monitoring Limitations.” U.S. Government Accountability Office, November 6, 2014. GAO-15-38.

[16] Kimberly Kindy, “Pesticide Levels On Food Unknown Due to Poor Government Testing.” Washington Post, November 7, 2014.

[17] Kurt Eichenwald, Gina Kolata and Melody Petersen, “Biotechnology Food: From the Lab to a Debacle.” New York Times, January 25, 2001.

[18]Statement of Policy: Foods Derived From New Plant Varieties.” U.S. Food and Drug Administration, May 29, 1992. 57 FR 22984.

[19] Marian Burros, “Documents Show Officials Disagreed On Altered Food.” New York Times, December 1, 1999.

[20] Helena Paul and Ricarda Steinbrecher, Hungry Corporations: Transnational Biotech Companies Colonise the Food Chain. (London: Zed Books, 2003), p. 170.

[21] Erik Millstone, Eric Brunner and Sue Mayer, “Beyond ‘Substantial Equivalence.’” Nature 401, 525-526, October 7, 1999. doi:10.1038/44006.

[22]Premarket Notice Concerning Bioengineered Foods.” US Food and Drug Administration, January 18, 2001. 66 FR 4706, at 4711. Memorandum from Michael Hansen, Senior Scientist, Consumer Reports, to AMA Council on Science and Public Health, “Reasons for Labeling of Genetically Engineered Foods.” March 19, 2012.