Why aren’t GMOs tested on humans?

A very common question or criticism of GMOs is that they are not properly tested, particularly on humans. Some individuals believe that GMOs should be tested the same way drugs are tested. I’ve read comments such as “I won’t believe GMOs are safe until they’re tested for 5 years on humans and we examine long-term impact”. In this post, we’ll explore these ideas.

Substantial Equivalence

The regulation of GMOs is based on the principle of “substantial equivalence”. This means that the nutritional content of the GE crop and the non-GE crop that it originated from is the same. In the past, I’ve reviewed papers that have done comparisons between crops generated by transgenesis (the method used to make GMOs) vs crops generated by traditional cross breeding. The transgenic crops had fewer unintended consequences than the crops generated by traditional breeding methods. What remains to be demonstrated is that the protein introduced poses no risk to human health, which is why studies on allergenicity and animal feeding studies are performed.

Testing GMOs vs Testing Drugs

Frank and the Ibuprofin don't have very much in common
Frank and the Ibuprofin don’t have very much in common

I’ve often been asked: “why don’t we do clinical trials on GMOs the same way we do for drugs?” Drugs are designed to cause a change in the human body: that’s the whole point behind them. Since drugs are altering something in humans, it’s important to know the side-effects that they may cause and whether or not they’re causing the anticipated effect (i.e. is it better than placebo). In contrast, GMOs are designed to be equivalent to their non-GE counterparts: they aren’t drugs or nutritional supplements. GE crops which ARE designed to impact human health, such as vitamin-A enriched rice, should be tested in humans to determine if the desired outcome is achieved (i.e that the rice actually delivers vitamin-A to the body). But such studies are not the same as looking for unknown long-term effects.

Another reason why GMOs aren’t tested on humans is that there’s no plausible mechanism for harm. In the past, I’ve explained how nothing can truly ever be proven to be 100% safe, whether it’s water, a computer, or a car. Researchers examine safety when there’s a plausible mechanism whereby harm can occur. For example, a cholesterol lowering drug may act by interfering with cholesterol synthesis in the liver. Consequently, it may make sense to examine the drug’s impact on other metabolic functions in the liver. But when it comes to the traits that are introduced into GE crops, there isn’t really a mechanism of harm. For example, the Arctic Apple is engineered to have a gene turned off, but the gene doesn’t exist in humans. How could the silencing of a plant gene harm us?

These are why most scientists wouldn’t want to spend years trying to secure grants for a long term feeding study when the likelihood of having an important discovery or contribution to the field is very low. Safety is relative, and there have been many long-term feeding studies in animals which haven’t observed any harm, suggesting that follow-up testing of engineered crops in humans is unnecessary.

The Difficulty of Experimental Design When There’s No Mechanism For Harm

An additional issue is that the experimental design would be incredibly difficult. Unlike animal feeding studies, you cannot control for other dietary factors or for lifestyle of the humans in the study. In animal feeding studies, all the animals are inbred so there’s very little genetic variability. All the animals live in the same type of cage, get the same amount of food, sleep, water, etc, but none of this applies to humans. As a mental exercise, let’s imagine that we’re going to embark on a study examining the long term effects of GM crops. We’ll narrow it down to a single GM crop: Bt-Corn. Here are some of the factors that we have to consider:

  • Since corn derivatives are found in many processed foods, we’d have to eliminate other sources of Bt by making all the participants adhere to a non-GMO diet.
    • Since we don’t know the mechanism of harm, would the data be confounded by Bt used as a pesticide in organic food production? What about Bt-corn consumed by dairy cows and other animals? Would the participants have to remove these from their diet, too? Let’s continue, but keep in mind that these are important experimental design consideration that will be unanswered.
  • Most sweet corn in the US is not of the Bt-variety. However, since we want to be able to keep track of how much GE corn our participants are ingesting, we’ll have to use this type. If we were to use Bt-corn that is used commonly in food-production, then our results might be confounded by the different ways this corn can be processed.
  • We have to figure out the duration of our experiment: how long will these people have to eat Bt-corn to get this unknown effect? 1 year? 2 years? 5? 10? Let’s keep it simple and say one year (although I doubt that one year will be long enough for individuals who are skeptical of GMO safety).
  • We have to figure out who we will be feeding: will we focus on individuals of a single genetic background to eliminate other variables? Will we include children? Pregnant women? (I mention these specific categories because there’s no end to anti-GMO blog posts about the dangers of GMOs for these individuals).
  • We’d have to grow all the corn in the same place: studies have shown that geographic and seasonal variability changes the nutritional content of crops more than whether the crop is a GMO or not (see here and here). Since we want all the participants to get the same corn for the entire duration of the study, we’d have to grow it all in a single place, process it, and all the participants would need a deep freezer to store their 1 year’s worth of sweet corn.
  • We have to decide how much corn they’d need to eat in order to observe this unknown effect. One ear a week? A day? Who would sign up to eat an ear of corn every day for a year?
  • Who is going to pay for this 1 year study on many people who are adhering to a non-GMO diet plus GE-corn? If Monsanto or other seed developers pay for it, will anyone trust the data?

There are FDA guidelines for examining the impact of food additives in humans. It has several important points including this one (emphasis is added): “A food or food additive generally will be considered suitable for clinical testing if the substance is unlikely to produce significant toxic effects at the levels to which the subjects of the clinical study will be exposed. This usually is determined from the results of toxicity studies in animals or by examining existing data on population exposure. However, in cases where the type of toxic response associated with the consumption of a food or food additive by experimental animals is judged to be severe, exposure of subjects in clinical studies to the additive may need to be significantly below the level found to produce no toxic effects in an appropriate species.” If the individuals who want to do long-term feeding studies in humans are looking for evidence of harm due to “long term toxic effects”, then based on the statement above from the FDA, such studies would never be cleared by an ethics panel. Other important points from the document include the fact that such studies should have different dosages and the language used for long-term studies is weeks/months, not years.

Conclusion

This isn’t a cop-out. If we’re looking for a harmful effect but don’t know what it is because we don’t have a reasonable mechanism whereby harm may occur, how can you design the experiment? What variables will you measure? As this document from the FDA outlines, clinical trials for drugs go through very specific phases and can be variable in duration and size. However the thing they all have in common is that they’re looking for a very specific effect (improvement of the disease or its symptoms in the patient). Doctors know what to measure and look for any possible side-effects. These side-effects end up getting listed in the package insert for the drug, even if they are not causal.

My final point is this: what is exclusive or unique about GMOs that merits such rigorous testing, yet excludes other crop modification techniques? If your argument is that GMOs are made by scientists in a lab and are consequently riskier, so are seedless watermelons. If your argument is that GMOs have genes from other species and are consequently riskier, so do sweet potatoes which have genes from bacteria naturally introduced thousands of years ago. If your argument is that we’ve had thousands of years to co-evolve with other crops but not to GMOs, then how it is that I, an individual of Iranian descent, have a passion fruit vine, which is native to South America, growing in my backyard in California? I’m pretty sure that the passion fruit and I didn’t co-evolve and adapt to one another throughout our evolutionary history. The passion fruit, the sweet potato, and the seedless watermelon did not undergo any testing, animal or human, yet many continue arguing that all GMOs regardless of trait should undergo animal and human testing.

Follow Layla Katiraee:

Layla Parker-Katiraee holds a PhD in Molecular Genetics from the University of Toronto and a Bachelors degree in biochemistry from the University of Western Ontario. She is currently a Staff Scientist in DNA Sequencing Product Development. All views and opinions expressed are her own.

  • Rickinreallife

    Are you able to clarify what I believe is a common misrepresentation of the concept of substatial equivalence repeated a lot on comment threads. You often see the claim something like “in (year), FDA declared all gmo’s are substatially eqivalent. ” I don’t believe that is the case. Rather, it is my understanding that substantial equivalence, or more accurately, how substantially equivalent, is something that is determined one by one early in the evaluation process. If a non gmo tomato for example, is considered safe to eat, if a developer can show that the genetic intervention via biotech methods ha not altered the composition of the food product beyond the variability naturally occurring in non ge cultivars or otherwise any change in composition is insignificant, only then is it considered substantially equivalent.

    • Yes: my understanding is that the basis for the testing that is performed and the documents that are submitted to the FDA are to demonstrate that the crop is substantially equivalent. I think that if substantial equivalence were a given, then GMOs would be very easy to make! But a lot of effort is put in to ensure that the inserted transgene hasn’t disrupted any genes or non-coding elements, the content of minerals and nutrients are examined to ensure that there are no significant changes, and nowadays, the genome of the crop is often sequenced to ensure that there aren’t any unforeseen changes.

      • Rickinreallife

        Right, FDA did not at some point in the past make a blanket declaration that foodstuffs derived from ge traited varieties are automatically considered substantially equivalent.

        • Chris Preston

          No they did not. Perhaps there is some confusion with the FDA declaring some long standing food items as GRAS (generally recognised as safe). One of those items was canola oil and people tend to conflate this with GM crops.

          Under the Coordinated Framework for Regulation of Biotechnology in the US, it is the USDA’s role to regulate plants. The USDA has a requirement that the proponents demonstrate that the crops are as safe for human health and the environment as conventional versions of the crops. This is where substantial equivalence comes in. Tests of composition are conducted to determine whether any known toxins are elevated, and whether the nutritional composition is similar (other than for deliberate changes). If they are, the product is declared to be substantially equivalent with respect to existing products on the market.

      • lazylarry

        i don’t believe that for a minute, of course your job ensures you will do everything to promote this false technology, it is not wanted nor needed, food the way nature intended is all we need

        • Eric Bjerregaard

          lazy, your phony name appears to represent you well. Your comment starts with a version of the shill gambit. Then descends into unexplainable nonsense “false technology?” And then veers into the foolishness of the naturalistic fallacy. So, Perhaps more schooling is in order.

      • lazylarry

        you have no idea what the manipulation of genes will cause because the science is lacking, science does not understand the whole genetic system it is far too complex even for you

        • Jim Gordon

          No that’s just your poorly educated mind talking. You are genetically illiterate, a treatable condition.

          • John C. ‘Buck’ Field

            We are all poorly educated relative to experts in particular disciplines. Identification of knowledge limits of genetics is clearly very closely related to genetics, but is a dramatically different field, much like architecture is related to construction.

            The ability to make a logical argument, such as criticism. is a separate skill from either.

            Regardless of our qualifications, a respectful tone at least can earn us a seat at the table where our ideas might be taken seriously.

            • Jim Gordon

              Respect is earned. When a comment starts out with a nonsensical volley based in conspiracy theory, posted anonymously, it does not dignify a friendly reply.

              • John C. ‘Buck’ Field

                Do we agree risk assessment of possible consequences of utilizing a technology is a skill which is distinct and very different from expertise and skills within that technology?

                • Jim Gordon

                  It is not new. No proof that any random mutation is safer than a lab mutation. DNA is DNA. Just a code. Either it lives and grows into food or it does not. The senses evolution gifted us with are all the testing required.

                  • John C. ‘Buck’ Field

                    I just left the Northern Atacama Desert. Our senses certainly don’t distinguishing safe from poisonous levels of arsenic in the water there. Mushrooms, polar bear liver, and a host of other natural born killers come to mind…although they would pass “substantial equivalence” criteria for nutritional value and many other tests of similarity to safe, common foods.

                    • Still not a problem. Tribal knowledge quickly makes up for what our senses miss. Arsenic is not a GMO trait, nor is polar bear liver.

                    • John C. ‘Buck’ Field

                      Tribal knowledge may do as you claim, but that is a very different position than Jim Gordon’s. One could even argue that my testing recommendations are merely application of modern tribal knowledge regarding risk management of public health decision systems.

                    • No, what I am seeing you do here is silver tongued anti-science activism thinly veiled with an insincere courtesy tone. We never tested any organic developed mutations or new breeds created before the age of GE science. No need to start now. A mutation is a mutation is a mutation.
                      The testing that is done now is voluntary and a preemptive defense against activists.

              • John C. ‘Buck’ Field

                For some, respect is earned. For others, it is something we can give to those who have not had the advantages we have. Without an attitude of respect, we cripple our ability to listen and learn what others believe, even when they are terribly misguided, biased, or simply ignorant of crucial information.

                • Not good enough for the disinformation wars on the web. Anonymous liars and shills spread lies like apple seeds. We have to get tough, flag and even prosecute them.

                • Red Beard

                  Jim Gordon and Solar Surfer are the same person (sock puppet accounts). He is a GMO industry shill and consummate troll. His sole purpose on these threads is to promulgate misinformation, and disrupt any civil debate by dragging it down to name calling and infantile behavior. He is actually very good at that. However, he is scientifically and genetically illiterate (which he projects onto others, to deflect from his own obvious ignorance.)

      • lazylarry

        Defamation case

        The latest ruling marks a second court victory for Séralini’s team.

        In September 2012, an article written by Jean-Claude Jaillette in Marianne magazine said that “researchers around the world” had voiced “harsh words” about the research of Séralini and his team on the toxic effects of a GMO and Roundup over a long term period – research that was supported by the independent organisation CRIIGEN. The journalist wrote of a “scientific fraud in which the methodology served to reinforce pre-determined results”.

        Séralini, his team, and CRIIGEN challenged this allegation in a defamation lawsuit. They were assisted by the notaries Bernard Dartevelle and Cindy Gay.

        On 6 November 2015, after a criminal investigation lasting three years, the 17th Criminal Chamber of the High Court of Paris passed sentence. Marianne magazine and its journalist were fined for public defamation of a public official and public defamation of the researchers and of CRIIGEN, which is chaired by Dr Joel Spiroux de Vendômois.

        The trial demonstrated that the original author of the fraud accusation, prior to Marianne, was the American lobbyist Henry I. Miller in Forbes magazine.

        Miller had previously lobbied to discredit research linking tobacco to cancer and heart disease on behalf of the tobacco industry. Since then he has tried to do the same in support of GMOs and pesticides, through defamation.

        The long-term toxicity study by Séralini’s team was republished after the journal Food and Chemical Toxicology retracted it under pressure from lobbyists. Séralini’s team has just published a summary of the toxic effects of Roundup below regulatory thresholds.
        http://www.globalresearch.ca/toxicity-of-gmos-and-pesticides-seralinis-team-wins-defamation-and-forgery-court-cases/5492480

        • Jim Gordon

          That is a lying fraud page authored by the original lying quack fraud himself. You don’t fool us, you don’t fool anyone.

  • Eric Bjerregaard

    Thanks, This will be of no influence on the ideological diehards. But for the undecided may well be useful.

  • mem_somerville

    The varieties of crops are changing all the time, too. There’s no way to keep up with the changes in the conventional genetics because those are not standing still.

  • lazylarry
    • Eric Bjerregaard

      More nonsense, There is no research in that article.

    • Jim Gordon

      Quack fraud site.

  • John C. ‘Buck’ Field

    Selection of the criterion: “whether or not something was designed for a particular purpose” seems like it could use justification. While cars are designed for safe travel and not “to cause a change in the human body”, even though we lack any hint (much less evidence) a particular model is dangerous, we still rightly expect they be safety tested, including via catastrophic crashes. That GMO’s are not “designed to cause a change in the human body” seems immaterial, and remains unjustified in this article. Support via fallacy doesn’t make the claim wrong, but doesn’t inspire confidence in it.

    Similarly, the idea that a mechanism must be proposed prior to looking for phenomena runs counter to centuries of scientific practice, including many decades when “gene” was a reification placeholder for unknowns. Were we to apply such a rule, genetics should be considered a pseudoscience.

    You may be a fantastic geneticist, but prior to holding forth on this topic, one might want to at least speak with experts in risk management, decision theory, and philosophy of science, or obtain some grounding oneself. I recommend Jeffrey Kasser’s course from The Teaching Company – great for commuting!

    • Hi John,

      You misconstrued this article as a defense against any form of testing. GMOs are extensively tested for regulatory purposes, including animal testing. Their substantial equivalence has to be demonstrated. This article is specifically as to why there’s no additional testing in humans.

      As to “Crop Modification Techniques” being inconsistent categorization, you’re right: there’s a lot of overlap between the various techniques, which is why I think that a crop’s risk should not be assessed based on the method used to generate the trait.

      • John C. ‘Buck’ Field

        My opinion is that testing *commensurate* with – and appropriate to – known risk
        indicators appears to lacking; And I suggest drug trial protocols as a very plausible solution.

        These risk indicators include
        investment in restricting best-practice science, including licensing for seeds, inconsistent legal categorization of GMOs as both “equivalent” and
        “unique inventions” depending on venue, and the unique potential of this new technology.

        At no point have I interpreted the article as a defense against *any form* of testing. Please share anything in my comment that warrants criticism the article was “misconstrued”?

        • Let’s back up a bit. Do you think that new genetically modified crops should undergo human testing or all new crops in general, and why?

          • John C. ‘Buck’ Field

            I’m happy to back up, and suggest we back up even further to establish expectations for productive discussion. This includes my answering your question – something I’m eager to do.

            However, it is important participants agree to answer reasonable questions. Currently unanswered is: What justifies the criticism I misconstrued your article?

            If the justification depends on me having a set position on appropriate scope for human testing, I’ll be happy to address that.

            • Hi John, in your first paragraph when you spoke of testing car seats, I understood that to mean that you wanted GMOs to be tested in a similar fashion. Consequently, I thought that you had understood my post to be *against* testing. If this wasn’t what you meant, then I apologize for the assumption on my part.

              • John C. ‘Buck’ Field

                Hi Layla, very nice to meet you. 🙂

                Technically, the illustration used referred to a new model of car rather than car seats generally, but the point was not about whether we test them or not, but about the procedures used which ensure decisions we reach are reliable.

                This deals with the normative (‘oughts’) of a good decision making process regarding safety. This is not conerned so much about what opinion we reach as much as how certain we can be about whatever conclusion results.

                Without evidence, I asserted we “properly” expect new models of cars to be safety tested – assuming that we share the expectation new cars *should* be tested, as I think most people do. I also think it worth noting that in the past, such tests were ridiculed as absurd. The change in opinion results from a new procedure being used for making what was considered a more reliable decision incorporating more information.

                Decisions are good or bad not because of *what* they claim, but rather *how* they are reached. If we decide to endorse vaccines because we believe they “balance chi” or a tarot card turned up favorably, the endorsement is a bad decision. During the first day of decision theory, we teach students the need to distinguish decision processes from outcomes.

                To make a scientific claim, we must reach it via certain rules for science. In your lab, you certainly have analogous protocols. For less mature sciences, these are the crux of something called “the demarcation problem”. I’ve most recently had some online discussion with Paul Hoyningen-Huene regarding his (at times overly conservative) assessment models, and these may be of interest to you. If so, you could do worse than his book “Systematicity”.

                You asked about my “position” on GMO testing on humans, which is: I’m perfectly happy to have GMOs tested or not, so long as the decision is based on a good process…and what I’ve found on both pro/anti GMO sides so far does not appear to merit high confidence. To improve confidence, we can calculate things like expected value of perfect information. Available data from industry does not seem in line with this metric.

                Granted, this is an initial impression and I would love to have that changed by good evidence. Since I take you to be a top advocate for the pro-GMO camp, it is troubling to see very little in the way of solid support and much that indicates lack of basic analytical training.

                Indicators of problems include “too expensive” argument, the lack of plausible explanation for corporate investment in propaganda and lawyers to resist testing, endemic use of strawman and other fallacies, etc. seems to justify a precautionary approach, but again: I’d love to have my preliminary opinion changed by learning something relevant that properly *should* persuade a change of opinion in a good decision making process.

                • What about the testing of new crops that aren’t transgenic?

                  • John C. ‘Buck’ Field

                    The first thing we might want to answer is whether research on the transgenic is restricted.

                    The goal is a system to produce reliable information for good decisions. This would seem to entail the system be sufficiently robust to handle any molecular source, such as traditional, transgenic, and future sources we’ve yet to create.

                    Evaluation system design here requires we examine whether restrictions on scientific study exist for especially non-scientific reasons. When possible, our system rules would be neutral regarding source inputs (transgenic), processes used for creation, intent of the developer, etc. We want to account for risks, and I envision the documented assumptions will include drug (or other protocols) *are* possible to adapt to this application area.

                    With “traditional food”, scientists and anyone else are largely free to study anything they want with some restrictions on effects like cruelty. In contrast, private entities (such as a government-created, private-profit corporation) often seek even more government privileges to artificially increase profits, via licensing and patent restrictions which hobble science. In such cases, it doesn’t seem unreasonable IMO that the private entity should demonstrate safety prior to preferential government interference in the market, increased profits, and restrictions on scientific freedom.

                    Does this seem fair?

                    • But private entities make or commercialize most new traits these days, including “traditionally bred” hybrids. Whatever motivations private entities have for the creation of GMOs also exist for the creation of traits using other methods. See: http://www.wired.com/2014/01/new-monsanto-vegetables/ for examples.

                    • John C. ‘Buck’ Field

                      I agree both of your claims regarding means and motives on trait commercialization.

                      How do these relate to my currently proposed criteria?

                    • The reason why it’s important to determine your position with respect to non-transgenics is because it determines exactly what it is that needs to be tested.

                      Alright, so we’ve determined that all crops, regardless of method used to generate the new trait in the crop needs to be tested in humans. Even after all the laboratory testing that demonstrate that the new variety is equivalent to the variety it originated from. So, if we don’t know what needs to be measured in our subject, what do you propose we measure (keeping in mind that the more things we measure the more likely the odds of finding a spurious measurement that is statistically different between “treated” and “non-treated” subjects)?

                    • John C. ‘Buck’ Field

                      It seems inappropriate to use someone’s opinion to determine “what needs to be tested”, even that person is me ;).

                      I do not agree that “all crops” ought to require pre-market human testing. Rather, my claim is that new, patentable crops for which our best scientific research is restricted should have safety testing prior to market release.

                      Your post raises the additional question of whether we can scientifically justify different standards that assess a plant as “equivalent to the original variety” on one hand, and “a new variety” on the other.

                      Before that and your question above however – I still don’t know what is the problem you perceive with the criteria I proposed relative to the Wired piece. Can you help?

                    • If I understand correctly, you want the extent of testing to be based on the amount of scientific research that is publicly available on the trait, and are using private vs public development as a proxy for the amount of scientific research that is available?

                      I encourage you to visit tthe cera-gmc.org database or isaaa.org and compare the available regulatory information between a privately and publicly developed crop to see if there’s a difference. To date, I haven’t had much difficulty finding information on a privately developed GM variety.

                      With respect to substantial equivalence, it is based on the nutritional content. It is named a new variety for regulatory and commercial purposes.

                    • John C. ‘Buck’ Field

                      Hi Layla,

                      It seems you may have misread “research” in most of my statements to mean the not-uncommon: “results of research activities” rather than the activity of research itself. This misinterpretation could lead one to think I would advocate that the “extent of testing to be based on the amount of scientific research that is publicly available on the trait, etc.”

                      On the other hand, I don’t think I’ve ever represented that developing organization type should be a factor, i.e.: “private vs public development as a proxy…” If that could be shown worth considering, I’d be interested in that story. As it stands now, I’ve no certainty that’s appropriate and would therefore not endorse that based on what I currently know at this moment.

                      What does seem a better statement of my position is the following:

                      If we use the best known techniques for scientific decision making and assess likely outcomes according to their probability and impact, the following assertion can be defended: “Market products expected to interact with the human body, (physically, chemically, radiologically, mechanically, etc.) should undergo appropriate safety testing prior to market availability.”

                      I hope this makes my position more clear, but if not, ask.

                      Thank you for addressing the change of criteria from “new variety” to “equivalent”. Do we agree that selecting criteria to achieve “regulatory and commercial purposes” is a responsibility in industry, yet not valid justification within the constraints of good practices of science?

                    • Farmer with a Dell

                      Please answer Layla’s question ‘Buck”:

                      “So, if we don’t know what needs to be measured in our subject, what do you propose we measure”

                      Until you address this issue all the rest of your didactic parsing, pigeon holing and goal post moving is pointless (not to mention tedious and sophomoric).

              • Rickinreallife

                Mr. Field’s advocacy of “testing” is a vaguely defined objective. He has given the appearance of suggesting a specific testing protocol by suggesting that food products derived from crops that have acquired a portion of their genetic endowment via biotech methodology be subject to the same testing regimen for new drugs. I think it would be difficult, and I think your article makes this point, to translate a testing protocol for drugs, which are a delivery mechanism to introduce a known quantity of a known substance that is intended to induce a desired physiological response in the body, with foodstuffs for which we have very little reason to believe the mechanism for transferring the genetic information in and of itself results in any meaningful difference in composition to a conventional variety of that food product (unless the trait were for example a biofortification to provide a nutrient not normally associated with that food product –e.g. golden rice).
                Mr. Field’s suggestion presumes one of two things: 1) that food from a ge traited variety is something of wholly novel composition or characteristic (i.e. an artic apple is not really an apple, it is only a synthetic replica of an apple, or at lest in essence is something other than an apple), or 2) that the process of introducing genetic information (in this case, human directed horizontal transfer) somehow scrambles the genetic orchestra of the receiving organism in chaotic ways so that the plant might inadvertently be instructed to produce high amounts of a toxin or other detrimental substance, perhaps some previously unknown substance. The first is a cultural construct, not a biological reality in any sense that is amenable to detecting some effect on the human body via drug testing protocol.
                The second is the more likely scenario and presents somewhat of a thesis to work with to design safety analysis around. But probably the most useful and meaningful safety evaluation protocol is to evaluate and characterize any alterations in the resulting composition of the food product. NAS has advocated more exhaustive compositional analysis, and omics evaluation protocols. Of course, NAS advocated that that same evaluation should be applied regardless of the breeding method, including conventionally bred varieties, as there was no evidence that the process of ge itself was any more likely to result in the type of dangerous genetic change or functioning that some imagine. If that compositional analysis were to detect some substance within the composition or metabolism, then we could have a starting point to more directly evaluate effects on human health. We could determine how concentrated the substance is, calculate the amount that humans would likely be exposed to in normal patterns of consumption of the product, test concentrated amounts of the detected substance to rats to determine at what amount any potential health effects occur, and then determine whether there is any safety concern in the amounts that appear. But even in human clinical trials, just eating a food that contains small amounts of a substance wouldn’t tell you anything. We know for instance that tomatoes contain solanine which is very toxic to humans if you get enough of it. But if we had a clinical trial where we asked human subjects to eat a couple tomatoes a day, they wouldn’t consume enough solanine to have any effect.
                The emerging evidence from omics and other compositional analysis thus far is that there is very little to support a theory that the process of ge is scrambling genetics inherently any way more concerning or likely than any other method. We are learning that a ge variety differs in its composition from non ge isolenes less than various non ge varieties differ from each other, or differences resulting from climate, cultivation factors, growing season stresses, etc.. In other words, a ge traited crop variety is nothing more, nothing less than another variety of that crop. So, absent some reason to believe that the genetic intervention had altered the composition of a product, a human clinical trial of say the artic apple would in effect only be studying the effects of eating apples.

                • John C. ‘Buck’ Field

                  Hello Rick, Nice to meet you.

                  Since it is not something I believe, would you cite any comments I’ve made which suggest I would agree with or presume “that food from a ge traited variety is something of wholly novel composition”?

                  Thanks in advance.

                  • Rickinreallife

                    I don’t claim you specifically said those words or harbour that concept . I probably could have said it better, but i intended the assertion generically that the call for human clinical trials of the effects of eating foodstuffs derived from ge traited varities of food crops presumes one of those lines of perception about what we mean by gmo to justify human clinical trials according to drug testing protocols or for those protocols to have any utiliy for arriving at some conclusion of “safety”.

                    I would add a third — if the trait itself were intended or expected to alter composition. For example, adding the bt trait, i.e. the gene instrcting for production of cry proteins. Perhaps some clinical trial could conceivably be designed to detect whether bt had some detrimental effect, but the issue would be the trait itself, not the method by which the trait were acquired. If ingesting cry proteins were unsafe, it would be unsafe whether the trait resulted from ge, mutations breeding, crossbreeding, or any other method to incorporate that particular genetic code.

                    I think the chaotic genetic rearrangement that somehow distorts the evolved orchestration of processes regulated by genetics as a potential collateral consequence of the ge process is at least a plausible theory. But I also perceive that the mounting evidence from omics measurements and compositional analysis fails to find any meaningful compositional difference or any signal that supports the theory that the process of genetic engineering is any more prone to that effect than non ge methods. Additionally, I don’the recall offhand the name of a recent publicly funded project in Europe that examined the utility of feeding trials for purposes of evaluating safety of ge sourced food items, but it concluded that feeding trial do not detect affects on monitored physiological endpoints that differed from what we could predict by compositional analysis alone. In other words, feeding trials are not detecting that some ge effect toxin is lurking there that compositional ana lysis overlooked, thus calling into question the utility of feeding trials absent finding something of concern in the compositional analysis.

                    I suspect that the author doesn’t disagree that regulatory requirements for compositional analysis is a prudent step. I would also venture that the author would support feeding trials if the compositional analysis detectecd compositional change that merited further investigation. Perhaps the author might even see a justification for human clinical trials in principle if there was some signal in the compositional analysis, although I suspect she would question whether even a human clinical trial where subjects consumed some amount of a ge food product for a period (i.e. eat an arctic apple a day, and after 6 months , let us perform tests and observations to see if we can detect something detrimental happening to you) could provide useful information.

                    • John C. ‘Buck’ Field

                      PMI Best Practice Standards specify documenting “assumptions” rather than “presumptions”. While both mean “to take as true”, “presume” indicates greater certainty and implies a stronger, evidenced-based support for a statement. Good risk management requires we remain alert to indications our assumptions were not true. This is assisted by employing systemic doubt – a virtue of science.

                      I’m curious to learn your take on the approach and evaluation presented to Layla.

                    • Rickinreallife

                      You are laying out an argument for why products of ge traited varieties should be subject to premarket safety verification. Your argument as far as I can tell, essentially boils down to that corporations can’t be trusted. You further assert that companies have suppressed independent evaluation as providing further justification for imposing some type of regulatory imposed testing regimen. You then make a legal argument that government has the right to do so because we grant corporations legal existemce and bestow other privileges and therefore we can insist that they provide verification of safety of products they produce.

                      I don’t dispute government has that prerogative. That is not the issue I was responding to in your first post. For sake of argument, let’s suppose that I agree 100% with that. OK then, what is the testing we should impose? I was disputing your suggestion, and agreeing with the author, that clinical trials of the type that are utilized to test drugs are for a purpose that does not translate to whole foods, especially when they are biologically just another variety of the food crop. My argument is not that we don’t have the right to, my argument is that it would be nonsensical to do so, that it wouldn’t tell us anything of value about “safety”. I am suggesting what would be more useful for getting at the question of safety is thorough compositional analysis. If compositional analysis indicated elevated toxins or novel substances from what is normal for that crop, then we isolate that substance and feed it in large enuff doses to study it clinically. Unless there is something unusual or concerning that turns up in composition analysis, then your clinical trials of say the Arctic apple would just be a study of the effects of eating apples.

                      I then added that compositional analysis

                    • John C. ‘Buck’ Field

                      Hi Rick,

                      You raise a number of good points here, at least a couple of which were raised last night in discussion with a medical expert. It is true that the analysis Presented could be “boiled down to” (summarized as): “corporations can’t be trusted”. Depending on what we use that summary for, we could expect some problems. I think we agree your selection of this is for your reply, a criticism that claim “products of ge traited varieties should be subject to premarket safety verification”. Do I understand this objection correctly?

                      If so, I would clarify that my claim is that with particular assumptions, use of the best known techniques for scientific decision making, and assessment of plausible outcomes according to their probabiliby and impact, the following assertion can be defended: “Market products expected to interact with the human body, (physically, chemically, radiologically, mechanically, etc.) should undergo safety testing prior to market availability.”

                      By general use of “interact” this rule would keep in cars and patented GMO’s, but exclude home-made meals, for example.

                      Any thoughts on where we should expect application of such a rule to produce harm?

        • Jason

          They are the same testing protocols as drug trials. So, now what hurdles would you suggest be surpassed?

    • Nobody spends more on propaganda than the organic foods cartel:
      http://www.agdaily.com/features/farm-babe-fat-lies-fatter-wallets-anti-gmo-lobbyists/

      • Red Beard

        Except the agro-chemical companies, who spend hundreds of millions of dollars to fight against GMO labels.