Regulator rejects scientists' GM concerns

It has taken nearly two months, but Food Standards Australia and New Zealand has finally responded to criticisms of its regulation of GM foods after it was accused of “systemic neglect” in its regulatory regime by Canterbury University’s Professor Jack Heinemann.

Screen Shot 2013-05-22 at 10.12.07 AMThe response is well worth a read for Sciblogs regulars who have followed the debate Heinemann and colleagues have led of late about dsRNA and the potential of dsRNA molecules present in genetically modified food to interfere with the genes of humans who consume it.

Last year, Heinemann teamed up with Dr Judy Carman and the Australian anti-GM activist group Safe Food Foundation to release a paper suggesting that GM wheat being developed by the CSIRO could cause liver damage in humans or as the foundation alarmingly put it “devastating consequences causing serious illness or death”.

The paper was criticised by scientists as it had not been through peer review by a major journal. Robust debate ensued here on Sciblogs, with Prof Heinemann contributing this guest post. Sciblogger Prof Peter Dearden chipped in with some typically insightful analysis here.

In March, Prof Heinemann, Dr Carman and Sarah Agapito-Tenfen of the Federal University of Santa Catarina, Brazil, authored a paper that appeared in the journal Environment International and suggested regulators in Australia, New Zealand and Brazil were failing to properly test genetically modified food that could could pose a risk to humans. The Press newspaper carried the story on its front page and more scientific argument generated some heat, it not much light on the subject.

In that respect, the decision by the FSANZ to step back and let the dust settle was a wise one. It’s extensive report is well laid-out and gives a good overview on the state of the scientific literature concerning the dsRNA issues that these researchers have sought to highlight.

Overall FSANZ concludes: “The weight of scientific evidence published to date does not support the view that small dsRNAs in foods are likely to have adverse consequences for humans.”

It elaborates:

– In formulating their hypothesis, the authors have not taken into account the fact that small dsRNAs are ubiquitous in the environment and in the diverse range of organisms we consume as food, including plants and animals. This establishes a long history of safe human consumption which pre-dates the use of such techniques in GM plants.

– The authors failed to adequately acknowledge that developing oral therapies based on small dsRNAs targeted against human viruses and other diseases such as cancer has so far been unsuccessful because of the barriers that exist to their uptake, distribution and targeting within the body.

– The authors have also underestimated the strengths of the GM food safety assessment to detect possible unintended effects, including those that could arise from the use of gene silencing.

– There is no scientific basis for suggesting that small dsRNAs present in some GM foods have different properties or pose a greater risk than those already naturally abundant in conventional foods.

– The current case-by-case approach to GM food safety assessment is sufficiently broad and flexible to address the safety of GM foods developed using gene silencing techniques. This approach enables additional studies to be requested should that be necessary to further inform the safety assessment of a particular GM food.

– FSANZ will continue to monitor the scientific literature for any new developments which may be relevant to GM food safety assessment.

It particular, FSANZ points out that the researchers have relied heavily on a single paper (Zhang et al.):

The core of the argument presented in the Heinemann et al. (2013) paper is based on the research findings published by L. Zhang and others (Zhang et al., 2012a) in which certain plant miRNAs derived from common food crops were reportedly found in the bloodstream of humans. Further, one miRNA, which is highly enriched in rice, was reported to inhibit the expression of a protein in human liver, leading the authors to suggest that miRNAs can influence gene expression across phylogenetic kingdoms. This paper lead to speculation (e.g. Jiang et al., 2012) that small duplex RNAs (eg siRNAs and miRNAs) present in foods could be taken up by epithelial cells lining the human gastrointestinal tract, be packaged into microvesicles, secreted into the bloodstream and subsequently make their way to target organs where they would enter cells and exert some effect on the expression of endogenous genes. No other evidence for this as a biological phenomenon in humans currently exists however.

While there have been several commentaries on the implications of these findings (Hirschi, 2012; Vaucheret and Chupeau, 2011; Zhang et al., 2012b), it is notable that there have been no other publications which corroborate the transmissibility of gene silencing effects from foods to humans.

Over at the Science Media Centre we will later today be posting reaction to the report from FSANZ – including hopefully from Prof. Heinemann, who today via The Press, expressed his disappointment on an initial look at the paper, that FSANZ had not supplied data on testing of dsRNA in GM foods.

The FSANZ response, arguably, is no surprise.But Prof Heinemann and colleagues, even their critics agree, have raised some issues worthy of discussion.

The view however, from the regulator responsible for assessing the safety of our food, genetically modified or not, suggests there is scant evidence to back up the bold claims that in effect suggested a public health disaster was waiting to happen.


  1. Grant Jacobs

    Some science blogs are reporting that (an apparently, large) survey of the safety of genetically engineered plants has been published. It turns out that the article is subscriber-only, but you can read accounts of it on-line, for example this ArsTechnica article.

    The abstract (the authors’ summary of their article) reads:

    The technology to produce genetically engineered (GE) plants is celebrating its 30th anniversary and one of the major achievements has been the development of GE crops. The safety of GE crops is crucial for their adoption and has been the object of intense research work often ignored in the public debate. We have reviewed the scientific literature on GE crop safety during the last 10 years, built a classified and manageable list of scientific papers, and analyzed the distribution and composition of the published literature. We selected original research papers, reviews, relevant opinions and reports addressing all the major issues that emerged in the debate on GE crops, trying to catch the scientific consensus that has matured since GE plants became widely cultivated worldwide. The scientific research conducted so far has not detected any significant hazards directly connected with the use of GE crops; however, the debate is still intense. An improvement in the efficacy of scientific communication could have a significant impact on the future of agricultural GE. Our collection of scientific records is available to researchers, communicators and teachers at all levels to help create an informed, balanced public perception on the important issue of GE use in agriculture.

    Just dropping this in here in case those with subscription access might like to check it out. I have to say, though, that it’s hard to see how they can fulfill their aim of assisting “researchers, communicators and teachers at all levels” if the article is not open access! Perhaps they mean that they have deposited their tables, etc., elsewhere, where anyone can access them.

  2. Grant Jacobs


    Just a thought: when the subject matter is factual and/or scientific I find it unhelpful when people focus on slighting others (e.g. by calling them names as you’re doing) – better to focus on substantive material.

    On that note, you wrote: “We have not always been consuming novel engineered/unintended dsRNA.”

    The fact that dsRNAs are ‘engineered’ in and of itself wouldn’t make them dangerous (or not) – they’d just be dsRNAs like those we are already exposed to.

    It’s very unlikely that we have not be exposed to ‘new’ dsRNAs. It’s very likely—a certainly I would think—that all new foods (plants, animals), bred by whatever means, introduce us to some molecules (of all kinds) that we haven’t eaten before – including whatever dsRNAs these plants or animals have in them.

    ‘unintended’ seems a odd word here – I presume you mean ‘unintended effect” – the dsRNA is intended and everyone knows it is present or we wouldn’t be having this discussion.

    What is more relevant is if a molecule (‘new’ or otherwise) might be interact with molecules in our bodies in a way that had an adverse effect.

    I haven’t yet had time to read the full report, but it seems clear from the summary that a key point they are saying is that there are apparently no clear examples of any other dsRNA causing the sort of risk proposed, so why should people suspect this one might?

  3. madeleinelove

    @PeterGriffin So you are a sledging journalist and you have an interest in making your blogs look popular? Might leave you to it. Back to something real….

  4. Peter Griffin

    @madeleinelove What Grant said. Next time, don’t just randomly cut and paste some links from Google you’ve found. It might help to read the articles, watch the videos before you post them…

  5. Grant Jacobs

    Madeleine Love,

    All our blogs here have ‘About’ pages (see the banner for each blog), where the person says who they are and so on. It’s the usual in blogs – would have been worth researching there first. (Same for my blog here.)

    If you’re asking for others’ interests, you could declare your own too – ? A quick search suggests you are a member of ‘MADGE’ (Mothers are Demystifying Genetic Engineering) naming you as a ‘researcher’ for that group;* that Fran Murrell, also writing here, is the spokesperson of the same group and thus a colleague; that your group acts as lobby group (and thus has a vested interest in the topic); and so on.

    (* Nothing I’ve seen from a very brief visit to the MADGE site indicates what training, if any, you might have.)

  6. madeleinelove

    @PeterGriffin I am shocked by your response, and feel I need to place you so I can understand it. What is your interest in this subject – are you able to fully declare any conflicts of interest, as a publishing scientist would?

  7. chriskelly

    I am almost feeling sorry for Madeline love and Fran Murrell from MADGEAustralia who are Australia’s equivalent of Meryl Dorey of anti-vax group the Australian Vaccination Network. They have invested as much hope in Heinemann as Doney has in Wakefield.

  8. Peter Griffin

    @franmurrell and with the ABC story you’re wrong as well. They don’t know why some batches of seeds haven’t worked. As the reporter points out “is it the plant, is it the genetics, is it the fertiliser – all sorts of things need to be opened up and looked at.”

    Thankfully Australia’s public broadcasters and its reporters are a bit more open to examining the scientific evidence before jumping to conclusions driven by ideology.

  9. Peter Griffin

    @franmurrell – that SBS piece from Moree doesn’t even mention genetic modification. The residents have anecdotal information about increases in autism, cancers and “dead fish floating” in the river. What evidence is there to suggest these things are down to genetic modification?

  10. franmurrell

    As is typical FSANZ has decided not to look for problems with a newly emerging technology on which the science is by no means certain.

    There is no need for GM crops. The existing GM crops are a dud. Roundup Ready canola in WA is either not germinating or if it does it is deformed or weak and subject to insect attack.

    Also residents in Moree are asking for an investigation into the apparent toxic effects of the local cotton industry. This is extremely likely to be GM as over 90% of Australia’s cotton is GM.

    It is depressing to see that the need for science to investigate new technologies to ascertain if they are safe is being brushed aside again. FSANZ is a rubber stamp for industry and is failing in its legislative objective to protect public health and safety.

    This decision to use unfounded assumptions of safety instead of scientific investigation of the new area of rnai technology is bringing FSANZ, science and food in Australia into disrepute.

  11. Grant Jacobs


    You wrote “And this from Heinemann’s colleague at the University of Canterbury, Professor Ian Shaw, a toxicologist”

    With the greatest of respect for what Shaw knows of toxicology, I think his straying away from core issues into epigenetics is a bit populist (epigenetics has been a glamour topic over recent years), and unhelpful in this situation. His potted summary is too simplistic and overplays the hand, as it were.

  12. Peter Griffin

    @madeleine What is more irresponsible – looking at the abundant evidence and informing the public based on the balance of evidence, or taking scant evidence and extrapolating what MIGHT happen i.e: a public health disaster? Who is irresponsible here?

  13. Peter Griffin

    Note – Ian Shaw isn’t commenting on the FSANZ response (he didn’t have the time to respond) – but gave us an earlier assessment of the concerns raised by Heinemann et al.

  14. madeleinelove

    In its reply FSANZ seems to have rejected the possibility of risks associated with novel engineered/unintended dsRNA molecules on the grounds that we have always been consuming dsRNA molecules in food. Such an argument from FSANZ is insulting to the public and irresponsible. We have always been consuming proteins in food, yet we do know that some proteins kill us or make us ill. We have always been consuming bacteria but we do know that some can kill us or make us ill. When we have done more research into dsRNA (more than two studies), we may find that some of these have direct or complex effects that result in death, decline or illness. We have not always been consuming novel engineered/unintended dsRNA. I resent my taxes going to FSANZ for this quality of response.

  15. kjhvm

    I wanted to add a note about caution and professional responsibility. The Heinemann-Carman report from the Safe Food Foundation based its speculations about human disease on the wrong DNA sequence information, and when the right information was used, the basis of their whole claim that it could cause human disease evaporated. We published an analysis of it on the Biofortified Blog (by MaryM above) which readers interested in these claims should read:
    Now for the professional responsibility part. An extraordinary claim was made, using the professional titles of the scientists who made the claim, that we now know to be false. What they need to do is retract it and apologize, and try to track down all the places where their false claim was echoed to set the record straight.
    Critics of genetic engineering often talk about the “precautionary principle” – to investigate every possible harm before releasing a genetically engineered crop. The same goes for making statements about them, and once a false fact is promoted around the world, the cat is out of the bag, so to speak, and recalling it is not an easy task. Perhaps they should exercise more caution before making such wild claims again? Who does the risk assessment for the claims of GMO opponents?

  16. marym

    I’m pleased to have this response too. But the damage is done, the myth is out there, and it will persist in the minds of the fearful for years. It will poison the discussion on every future project. And I’m sure that’s what the goal was, unfortunately.

  17. Peter Griffin

    marym: I agree about the stuff in the Safe Food Foundation statements around the GM wheat paper – it was irresponsible and the backlash from the scientific community was justified. This time, the authors have gone through peer review (thought its a review of risk assessment rather than introducing new scientific research). After being in the thick of this argument, I’m personally quite glad to have the FSANZ response because it has laid out better than anything else I’ve read the current state of the literature on dsRNA and gene silencing issues.

  18. marym

    I disagree that the Heinemann and Carman claims were worthy of discussion. It was fully irresponsible to drop the implication of dead babies as they did in the Safe Food Foundation reports. The misinformation and fear they launched was shameful. They actually made people think that it would change their genome. There should be consequences for that kind of behavior–but there’s no mechanism for retraction like there would be if it was a legitimate publication, or for striking from the MD rolls like Andrew Wakefield.

    It probably is worthy to discuss how such unhinged reports get taken seriously by the press and the crankosphere though.

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