Editor’s note: See an update at the bottom about GM Watch’s response to this post.
In a discussion about the scientific literature on genetically engineered crops, Claire Robinson of GM Watch has previously said: “I am, as you say, unaware of your GENERA project. A comprehensive list of studies on all aspects of GMOs is badly needed but beyond our means to gather together.” Biology Fortified, Inc., with our limited resources and volunteer staff, have come to the rescue and created this “badly needed” resource. Happily, GM Watch is now aware that GENERA is in beta testing, with more to come.
In response to our recent press release about the beta test of GENERA, Claire Robinson tried the resource out, and found it useful. She was able to use GENERA to search for literature, find the information she wanted, and she agreed with our evaluation of the scientific literature in at least two cases, as discussed in a post published on GM Watch* in response to our press release about GENERA. Although she thought it both needed and useful, the GM Watch post took an odd tone in the form of a criticism – claiming that we were misrepresenting the research contained in GENERA and leaving out important information. There were so many misunderstandings in Ms. Robinson’s post that I wanted to help her organization understand what it all means and clear up their confusion.
GM Watch agrees with assessment in GENERA of at least 2 studies
While GM Watch is criticizing our conclusions, they have indicated that they found GENERA to be both useful and accurate. They mention two studies and show that they agree with how we have classified the results.
These include Pusztai’s study on GM potatoes, which the GENERA authors correctly note had a “negative” conclusion for food safety. To be specific, the GM-fed rats showed gut cell proliferation that was similar to a pre-cancerous condition.
The GENERA authors also include the multi-generational study by Kilic and colleagues, which they note had “mixed” results. These consisted of damage to liver and kidneys and alterations in blood biochemistry in rats fed GM Bt maize over three generations, though other measured parameters showed no effect.
GM Watch picks out these two studies, but they seem to misunderstand science. Science is done not by cherry-picking single studies or data points within a single study to make conclusions that are at odds with the rest of the literature. Biology research is messy and data is often hard to interpret.
The Kiliç et al study is a perfect example of this. They fed rats three different diets (standard diet, control maize, and transgenic maize) for three generations, as part of a masters thesis project. The data was highly variable and confusing, thus it was classified as mixed results, but there were some strange issues with the health status of these rats. One of the control groups fed non-GMO corn had an average liver size that was 1/5 the normal relative size! What is going on with these rats? This shows the perils of cherry-picking data points from individual studies to claim that GMOs are “toxic,” when if you took their approach, this table on the right would be interpreted to mean that non-GMO corn is “toxic” to female rats. The Pusztai study on GMO potatoes suffers from many other similar problems that have been discussed elsewhere.
Scientists have to take all of the evidence into account, and now GENERA gives everyone the ability to step back and see the bigger picture. While it may seem ironic to be using GENERA to dig up individual studies to argue that GENERA is “misleading” while also confirming its accuracy, GM Watch is showing us that they are finding GENERA to be a useful resource for them. In addition, based on previous comments, Claire Robinson of GM Watch has said that it is badly needed. Hence the title of this post.
Conflicts and interests
GM watch mentioned a 2011 paper by Diels et al. That paper found that studies conducted by authors classified as “industry-affiliated” were more likely to show a favorable result for genetic engineering (being safer than or as safe as conventional, or effective at achieving the desired outcome). However, the authors only considered 94 studies which is a small subset of the total research available, and they had some strange definitions for how they classified the studies. For instance, some government agencies were classified as industry-affiliated while others were not, and without seeing the actual data, there’s no way to tell if this classification system makes sense. In addition, there was no consideration in the paper of funding or affiliation to competing industries or NGOs (or agencies for that matter) that are affiliated with these industries. There was also a “one drop rule” for industry affiliation – if only one author or funding source was considered “affiliated” with industry, it was classified with studies done entirely by the industry. These issues may introduce a bias into the data analysis, which is amplified when it is done on such a small subset of the research. Even so, they found no association between funding sources and outcomes, only between outcomes and their novel “one drop rule” classification system. For another view about industry funding, including analysis of the Diels et al paper, see this post by Marc Brazeau.
When we planned GENERA we wanted to avoid these kinds of pitfalls. We included an array of classifications for funding sources that includes governments, individuals, and different kinds of industries and NGOs. Most importantly, everyone can see how we have classified each study in the Atlas – the data is entirely public and transparent. GM Watch’s comments about taking our conclusions “on faith” just don’t make any sense considering that our data is public and the data for the study they refer to is not. In fact, we encourage people to do searches, make charts, and check individual studies and tell us if they find any problems! (That’s how a beta test works!) Finally, our tentative conclusion that the clear majority of studies in the literature indicate safety is based off of 197 studies, which is more than twice the number of studies that was included in Diels, et al. And when GENERA reaches its full release, it will have many, many more.
Additionally, GM Watch claims that the Diels review study already found that half of the research was independent, however, that is not the case. They found that 39% of the 94 studies they examined were independent by their classification system, which is not half. In fact, 39% is closer to the 1/3 estimate that we made early on before we began work on the Atlas itself. We highlighted this result because it disconfirms our previous rough estimate as well as many of the claims that are made on the internet, including in articles republished by GM Watch and the Diels et al. study. There is a perception that nearly all of the research is conducted by the biotech industry, and we wanted people to know that the GENERA beta version shows that approximately half of the research on the safety of GMOs for consumption is funded by government agencies and independent nonprofit organizations.
So how do the results of studies funded by these different sources compare? As an infographic produced by the Genetic Literacy Project shows, we have found that industry funded studies have more favorable results for genetic engineering (4 safer than, 35 as safe as, and 1 less safe) (at least with our randomly selected 400 papers from the literature). We also found that independent (non-industry) government funded studies also overwhelmingly show a favorable result for genetic engineering (7 safer than, 62 as safe as, 7 inconclusive, and 6 less safe). We hypothesize that this trend will hold as we add more studies to GENERA. Either the industry results confirm the government results because they are based on the same science and genetic engineering is indeed a generally safe technology, or there is a massive global conspiracy among scientists working for governments around the world. In my years as a scientist, I have not yet found evidence of such a conspiracy, so if GM Watch has such evidence I hope they share with the rest of us.
Just a misunderstanding
In our press release, I was quoted as saying “Systematic reviews have concluded that genetically engineered crops are safe to eat, and when you look at the results collected in GENERA, it agrees with that conclusion.” but the press release didn’t include specific citations to reviews. GM Watch took issue with that, claiming that I had an “avoidance of specific citations”. Perhaps they think that the press release was a scientific journal article. I’m not sure why they think that, but that’s okay, it’s obviously just a misunderstanding. Press releases, as a form of prose, generally don’t have citations. Blog posts usually don’t have citations either, however at the Biofortified Blog, our blog posts often have scientific citations, so if GM Watch thought that this was a blog post then maybe that would explain their confusion?
Claire Robinson has also said that her organization purposefully didn’t provide citations in a report they published, so you’d think GM Watch would understand not including citations in a press release. Ms. Robinson said: “The reason is that such a list would be boring in a report for the public.” Of course, the citations simply weren’t included in our press release because it’s a press release. Biology Fortified, Inc. doesn’t believe the citations are boring for the public, in fact the entire goal of GENERA is to make the citations more accessible to the public.
So where are the systematic reviews?
In the case of this press release, I was thinking more of the statements produced by various organizations around the world in favor of genetic engineering as a safe technology. For example: the American Association for the Advancement of Science (AAAS) and the World Health Organization (WHO). See statements from well-respected scientific organizations by clicking on the image to the right (image by Axis Mundi).
There have, of course, been systematic reviews in the literature as well as these consensus statements from well-respected scientific organizations. One of the largest is Nicolia et al in 2014 (PDF). This review included 1784 studies about various aspects of safety of genetically engineered crops for the environment and human/animal health. They conclude:
“We have reviewed the scientific literature on GE crop safety for the last 10 years that catches the scientific consensus matured since GE plants became widely cultivated worldwide, and we can conclude that the scientific research conducted so far has not detected any significant hazard directly connected with the use of GM crops.”
Each consensus statement and review has its own focus. Once GENERA is complete, people will be able to do their own reviews of the literature and report their findings with our helpful graphs!
Perhaps GM Watch wants to help
As we say in the press release, there are only 400 randomly selected studies in GENERA right now. Surely there are other studies that GM Watch and similar organizations would like to see represented in GENERA. And we say that’s just fine! We fully acknowledge that there are many more studies than just these 400 randomly selected ones in our beta test, and we fully acknowledge that the format and function of the database still need some tweaking. Check out GENERA and take our survey to let us know if you spot any errors, and let us know if we are missing any studies (but first check our page about what is included in GENERA).
* An earlier version of this post indicated that the GM Watch post was not attributed to any author, as is usually the case for GM Watch. The author of the post was Claire Robinson, as identified in italicized text in the post.
Editor’s Note: Karl Haro von Mogel contributed to this post.
Update 9-30-2014: GM Watch now asks Questions
We were delighted to see that Claire Robinson of GM Watch responded to our post with questions about GENERA, and confirmed several of our statements while disputing others. Unfortunately, she chose to spend a great deal of the post engaging in personal attacks and name-calling, however, we do believe that there are some important and worthwhile points that she brought up in her post which we will address.
Ms. Robinson correctly noted our error that the post was indeed signed to her name, in italicized text. This is a welcome change from the historical policies of GM Watch, which usually posts unsigned criticisms. We encourage GM Watch to take it to the next level and allow comments on their site so that a true discussion can take place.
Ms. Robinson also addresses the issue of how many studies are independent, and appears to be making some creative assumptions about studies that have no funding data. If you recall, we announced that just over 50% of the studies in our beta release for GENERA are independently-funded. Ms Robinson, however said:
We didn’t need BFI or GENERA to tell us that half of GMO research is independent of the industry. That is old news…
As we point out, Diels et al only stated that 39% of the 94 studies they surveyed were known to be independent, and our result dis-confirms this number and elevates it to over 50%. But in her response, Ms. Robinson appears to be counting studies with no funding information as independent:
In other words, somewhere between 39% and 53% (just over half) of GMO studies were independent at the time of Diels’ investigation.
While it may be possible that as many as 53% of the 94 studies examined by Diels were independently funded, we don’t actually know that. It would be wrong to assume what the funding sources are, and we find it curious that GM Watch is assuming that these unknown funding sources are independent in order to create a criticism out of confirming the findings of other researchers. This is a very odd argument to make. But if you were to add the 21% of studies in GENERA that do not have funding information to our total, then that means that the independent studies are between 50% and almost 75%. This is very different from the results of Diels et al.
Biofortified accuses me of “cherry-picking” data points from the Kilic et al study, which found mixed results.
From the KQED discusssion:
Our report, GMO Myths and Truths, nowhere claims to present the entirety of the literature on GMOs (as I’ve said, that’s way beyond our means), but to present some studies that show risks and hazards of GMOs that have not been properly addressed – and which are often claimed not to exist!
Our goal is to be comprehensive, while Ms. Robinson has stated that her goal has been to present only a select subset which meet a particular conclusion. That is what it means to “cherry-pick.” This is a correct description of choosing only results you agree with in one study or from a group of studies and ignoring data that undermines it, or that calls into question the validity of the study in question. Ms. Robinson does not provide a counter-argument that negates this description so it still stands as uncontested and it seems that she is justifying it rather than negating the description.
With these errors and misunderstandings out of the way, we can now help Ms. Robinson understand what is contained in GENERA. In fact, we are glad that she is asking questions!
We’re told the chart is based on 197 studies “out of 400 randomly selected”, but no further information is given about the questions these studies addressed or which methodologies they used.
These 197 studies are the studies that made conclusions specifically about the relative risks of genetic engineering on the safety of foods for consumption. In fact, we gave quite extensive information about the kinds of studies that have been included in GENERA, and what has been excluded. This information was posted on the GENERA site since before the announcement of the beta release. This can only mean that we either 1. did not post the menu link to the “What is in GENERA” page clearly enough under the “About” tab, in which case it would be our error, or 2. Ms. Robinson instead did not find out what was actually in the Atlas before claiming that we had misrepresented its contents. We will leave it up to the reader to decide which is more likely.
Ms. Robinson also asks about how many studies are reviews, original research articles, and perspectives/opinions. There are zero perspectives/opinions included in the graphics being discussed, and there are some reviews that have been included. Again, it is easy to find out how many reviews there are, as GENERA has a full range of search and exclusion features, so anyone could repeat the same search and include only reviews, exclude them, etc. Since Ms. Robinson is asking this question after-the-fact, we can only assume that she has not taken the time to understand what is contained in GENERA before making broad-sweeping claims about it.
Ms. Robinson has similar questions about what the different outcomes mean, which we explain on the Glossary of Terms page, and what species these studies have been done on. This information is contained within the Atlas and she has had the ability to search and chart these details herself. Since she is asking this question after having declared that we are misrepresenting our Atlas, we can only assume that she has not taken advantage of this public information and was again making broad sweeping claims without first learning the facts.
Biofortified should also identify each GMO for which they are claiming safety, since GMOs are evaluated on a case-by-case basis and a finding that one GMO is toxic or safe cannot be assumed to apply to any other GMO.
Until now, no resource has existed which could allow an analysis of what they are requesting here. Indeed, on a future version of GENERA we intend to have “event-specific” features that would allow users to search for studies only conducted on specific genetically engineered crops. However, we would like to note a contradiction evident in the list of questions posted on GM Watch. Ms. Robinson both states that the control animals should not have been “fed non-GM feed,” but that no two GMOs are the same. This is a point of confusion which we note that GM Watch tends to make. If the GMOs are all different, then it doesn’t matter if the control and experimental diets both contain a GMO-derived ingredient from a crop that is not being tested in the experiment. As long as the variable that is different is the trait being tested, that is fine. If all GMOs were the same, then it would be correct to require excluding them. You can’t have it both ways.
This leads us to the final answer to her questions. We did not make judgements about the completeness or incompleteness of the individual studies. Our goal is to include every relevant study – warts and all – so that people can have greater access to them. A case in point is the inclusion of the retracted Seralini 2012 feeding study, which was criticized around the world for inadequate sample sizes for the duration of the experiment, and did not ensure that non-GM feed was fed to the control rats prior to the beginning of the experiment – both of which are criteria that Ms. Robinson identifies as study flaws. If we were to exclude studies that contain these flaws then we would be forced to exclude this study as well. We may in the future incorporate a feeding study completeness rating based on published critical reviews – which might help people gauge the overall study quality – but that is beyond the scope of our Atlas’s capabilities at this time.
It is a pity that Claire Robinson freely and readily casts aspersions when engaging in discussion and debate about genetically engineered crops, and attacks individual people with ad-hominem attacks rather than spending the time it takes to understand the science and the resource she is criticizing in the first place. We hope that these answers will help clarify her confusion and that she will be able to engage in meaningful and civil dialog and help us to improve this public resource for everyone. We are happy to clarify these and other details so that people can better understand what is in GENERA, how to use it, and what conclusions may be drawn from it. We look forward to constructive criticisms, and are thankful that Ms. Robinson has agreed with the results for what individual studies she has indicated that she has examined in the Atlas thus far.
The Diels argument is so flimsy. If someone funded my lab to test to verify their findings that gravity is present, my results would likely support their hypothesis. Industry funding goes to answer questions, not to manufacture results. Why would they pay for independent verification or testing of something that they know is unlikely or wrong? What researcher would take on a project like that?
Any claim of bias by an activist organization that has an agenda clearly defined is invalid. To pick two studies out of 400 that mildly support their views and dismiss the rest as bias reveals their cherry picking confirmation bias.
It would help if some of these people actually knew some real scientists.
I know many scientists who genuinely would be happy to help, myself included. If only they could find us… oh wait, they obviously know we are here, they wrote an article about us 😉
GM Watch finds GENERA useful, “badly needed” – Biofortified
That comes up when I search for info about this. You’ve written the title and first paragraph of this piece to purposefully misrepresent the GM watch’s position. They don’t find GENERA useful or badly needed.
Personally, I couldn’t care less about this, but it doesn’t reflect well on biofortified,
In fact, now that I’ve read GM watch’s page on this – I find that the above article completely misrepresents what they’re saying about GENERA. People should click on the link to the GM watch page and read it.
The first two paragraphs show exactly how GM Watch said GENERA (or at least a resource like it) is “badly needed” (direct quote from Claire Robinson) and how they found it useful because they used it to find the info they wanted. I’m not sure how that could be made more clear.
I’m wondering if there’s a language barrier here… Perhaps English isn’t your first language? That’s totally ok, we welcome everyone here at the Biofortified Blog. But sometimes that can be a barrier to understanding and it can help to recognize that up front to reduce misunderstandings and make communication more effective.
Sure, people should read their article, that’s why we included the link. If anyone has specific examples of any mischaracterization they are welcome to provide details. Any such mischaracterization, if it exists, was unintentional, and we can address any misunderstandings if we get them out into the open.
Mlema, you seem to be missing the point of the point of the tone of our post. GM Watch went on a negative rant (that highly misrepresented our press release, GENERA, and the science itself. We decided to see the good in it while correcting their misunderstandings. Also, as you can see Ms. Robinson did in fact say that GENERA was badly needed.
You seem to throw a lot of non-specific negativity our direction for someone who says that they don’t care much about such things.
That’s so great that GMWatch was able to find the papers they are looking for. Can you imagine if they weren’t in there? The accusations about cherry-picking would be pretty funny from them.
I’m sure it disappointed them that papers they support are in there.
I’m glad you think it’s ok for people for whom English isn’t a first language to visit biofortified. That’s very enlightened of you and I’m sure they’ll feel very welcome with comments like that. (If they recognize their barrier up front of course)
Naturally, they hold themselves to a different standard than they do everyone else.
It’s not “their” barrier. When two people have different languages, that can be a barrier to communication, and once recognized, can be addressed.
You are claiming that I purposefully misrepresented something (in other words you are calling me a liar) while the proof behind my claims is in black and white at the top of this page. Clearly you didn’t read the article, have an agenda preventing you from clear thinking, you have some issues with reading comprehension (such as having a different primary language), or there is some other issue here. Others have read the article and understood it just fine.
I agree with Karl: “You seem to throw a lot of non-specific negativity our direction for someone who says that they don’t care much about such things.” The negativity isn’t useful at all.
You wrote: “GM Watch finds GENERA useful, “badly needed””
and GM Watch wrote in referring to GENERA: “Biology Fortified misleads the public on GMO safety”
There’s nowhere that GM Watch said that GENERA was useful and badly needed. You’ve disingenuously portrayed GM watch as endorsing your new service for usefulness and accuracy.
this comment was supposed to be in reply to Anastasia. But Karl – Claire Robinson never said GENERA was badly needed. I don’t know if Anastasia and you are just misunderstanding what Ms Robinson and GM watch said, or if you’re misrepresenting it on purpose. Either way – this reporting is inaccurate and reflects badly on biofortified (if anyone takes the time to look at all this ridiculousness as I foolishly have)
C’mon. How can you read the GM watch page and think that what you’re saying here about what GM watch thinks of GENERA is true? But what you’re saying is what comes up in searches. So, since you guys are smart, I’m assuming you know what you’re doing with this.
And again with the misleading infographics with all those quotes? OK, I’ll leave you all alone for a while and then maybe we’ll eventually look at each of those someday and find out who’s saying what.
Thanks y’all
Mlema,
We do not pretend to know what they ‘think’ per se nor speak for them on that matter. While they have obviously taken a critical position on our press release, we wanted to highlight what they said about the contents of the atlas and what the same author (now confirmed by another source) said about the need for our project. Call it looking on the bright side. Then we addressed many of their mistakes. We didn’t even address them all. If you have any actual misrepresentations of anything they said to point out please let us know.
I think everyone who reads this is intelligent enough to understand what has been said and by whom.
Those are actual statements.
Very good concept and project. One of the frustrations I have of writings by authors like Samsel and Seneff and Jeffrey Smith is that they massage a lot of theory and speculation out of the sources they use as evidence, “such and such study found this association between A & B, and since that’s true, C might very well be true as well”. Then, their speculation is represented as something either overlooked or purposely swept under the rug. In many cases, in critiques of these writings, you find out either, 1) the association between A&B claimed was not accurate, or, the study wasn’t even relevant to the question of any association between A&B and a claim of association between A&B vastly oversteps the evidence, or 2) while the particular study may be accurately represented as finding an association between A&B, there have been many other studies not mentioned by the author that have reached contradictory conclusions and that A&B association can hardly be considered unbreachable truth, or 3) even if the representation that the study finds an association between A&B, and perhaps other studies agree with these findings, there are serious weaknesses in the theory that C is true making it understandable why no one would have wasted resources to study the theory, or 4) and even if the speculation that C might also be true is a legitimate one, the authors omit any mention of actual existing research that has looked precisely at that question.
I have no problem with any author, even Jeffrey Smith and Samsel and Seneff, Earth Open Source, etc developing theories out of the existing literature. Well reasoned, well researched meta analysis, perhaps even by laypersons in the field and gmo skeptics, could contribute guidance for future useful research. However, it is at least customary to be thorough in incorporating all existing research evidence relevant to your theory, if there is any, and to address contradictory results in work already done, i.e.. “There has been some research relevant to the question whether C is true. Research A seems to contradict this finding, however, the methodology failed to consider this factor, Research B design was deficient in this manner, In research C, there was apparent measurement error, in research D, its duration was not long enough to detect or rule out evidence of C, etc. A layperson friendly database would be helpful in performing independent skeptical analysis.
My comment from Sept 2 seems to be remaining in moderation. I just wanted to point out that some of the organizations quoted on the “consensus” graphic are funded by the industry. As an independent source of information, biofortified may want to re-examine that particular graphic. There are still plenty of quotes without the industry ones.
I don’t think Diels was making an argument. He was merely analyzing the literature for trends (kinda like GENERA analyzes how hundreds of studies reflect on GMOs altogether).
Your comparison of results in gmo studies to ‘gravity being present’ shows that you believe certain findings are a foregone conclusion (as indisputable as gravity). It’s not about finding something unlikely or wrong – it’s about interpretation (for example) – like dismissing data as not meaningful where the math actually finds it significant.
Honest scientists like yourself are often blind to the bias because it doesn’t occur to them that anyone would do something that they wouldn’t do. But, bias is there whether you want to believe it or not.
“What researcher would take on a project like that?”
One who needs money. And since private industry is where the money is, there’s lots of motivation. Diels didn’t show that this was clear cut and absolute. He just showed that bias very likely exists in some cases. i wouldn’t take it personally. I’ve seen this sort of thing happen in many areas. It’s just something to be aware of imo.
I think it would be educational for biofortified to do a post on the full statements from each organization represented in the graphic with quotes from organizations. We could consider what’s actually being said, and how those statements reflect on what members of those organizations believe. If we’re deciding the science by consensus (for those who are unable to approach the science itself) we ought to go ahead and figure out what consensus of scientific opinion exists out there. I think it’s rather more comprehensive than the quotes extracted in the poster, which are somewhat misleading in their simplicity and non-committal wording. For example, the AMA supports mandatory testing. Also, some of the groups on the chart are funded by the biotech industry, which detracts from what they’re saying as an independent opinion. I’ve seen these lists of quotes circulating around the blogosphere for a while. They’re mainly used in an effort to convince people who can’t otherwise analyze individual facts about GMOs, that GMOs are safe to eat. As Karl has said elsewhere – biofortified is NOT saying that “it’s basically ok to eat any GM food.” So, I would say the list isn’t a scientifically valid vote for GM food safety. And it’s certainly not a systematic review of the literature, as Anastasia seems to be thinking.
The noble goal of GENERA is not only to provide an exhaustive collection of studies relating to GMOs, but to further give people a way to sort them based on species, author, funding, etc. – truly an impressive and valuable development in bringing GMO science to the masses. But by overlaying subjective analysis of what the studies say about GMOs in general and as a whole, GENERA subtracts from its own scientific validity. Mistakes in identifying objective characteristics of individual articles will eventually be sorted out as knowledgeable people review the details (if knowledgeable people take the time and effort to do that). But the fact that the Genetic Literacy Project found 197 studies out of 400 to reflect on safety for human consumption means there’s something fundamentally wrong with the subjective labeling of GENERA content with regard to the broad characterization of what are actually diverse and specific things that are being studied.
http://i0.wp.com/biofortified.org/wp-content/uploads//2014/08/GENERA-Safety.jpg
This poster is wrong. There aren’t 197 peer-reviewed studies that address the safety of genetically engineered foods out of 400 randomly selected, and GENERA isn’t a “risk atlas”.
Scientists aren’t going to be using GENERA for research because it’s not an official database. And people who aren’t scientists won’t necessarily be able to discern these charts and so forth as being either accurate or inaccurate. I think GENERA needs to remove the labels that sort studies into “equivalence” “safety for consumption”, etc along with the additional labels of “positive” ” negative” ” mixed” etc. until such time as other professionals with backgrounds in medicine, toxicology, epidemiology, etc. can add their analysis to the labeling of all these studies.
Or, if the blog participants want to get together and develop their own study of this collected literature as being “positive” or “negative” in relationship to things like safety for consumption – and submit it for peer-review as Diels did with his analysis – well – who could then condemn their results? Peer-review is what it’s all about in giving validity to these sorts of analysis (even if they end up having faults – as Anastasia has pointed out)
I think the way the studies in GENERA are being used and portrayed to reflect on GMOs as a homogeneous group of organisms is a negative development in what has been a so far positive endeavor. There’s untold value in a resource like GENERA, but there’s no value in subjective analysis of these studies as a monolithic group outside of consideration of objective characteristics like authors, species, trait, funding, etc.
(PS – The link to enlarge the graphic which contains quotes extracted from statements about GMOs is broken.)
I’d like to point out that I already addressed most of your concerns in previous comments. I’m not sure why you’re ignoring my previous comments but it makes me not want to waste time replying to you.
Case in point. You say here “But by overlaying subjective analysis of what the studies say about GMOs… Mistakes in identifying objective characteristics of individual articles”
I already said that we are not doing any subjective analysis. We are simply pulling out the authors’ own conclusion without any interpretation on our part. If you see that a study has a conclusion other than what is listed then by all means use the feedback methods provided. It is possible that a mistake or two could be made out of 400 but to characterize this as bias is flat out wrong.
I already said that anti gmo groups group all gmos into a category together and say the entire class is unsafe. The scientific literature (both what’s in GENERA and elsewhere) clearly says that there’s no particular risks of gmos as a group. That’s all. This is what those consensus statements speak to. Reviewing the literature results in a general consensus that gmos as a group do not pose any particular risk, that gmos as a group are safe. This does not mean that one couldn’t engineer an unsafe gmo but that’s why we have to look at each trait individually – and you can use GENERA to look at each trait individually. This is not complicated.
“I already said that we are not doing any subjective analysis. We are simply pulling out the authors’ own conclusion without any interpretation on our part.”
Perhaps you’re just not aware that you’re interpreting these studies with respect to how you’re categorizing them. You’re overlaying subjective analysis by making qualitative decisions on how to classify and characterize these studies. There’s no other way to explain how you could come up with:
“197 peer-reviewed scientific studies that address the safety of genetically engineered foods out of 400 randomly selected”
This is not “a mistake or two”, it’s a systemic error.
Let me try to explain a little further with another example. This isn’t cherry-picking. I can search in almost any way and find an example, but this one comes up when I search with “safety”. Actually, if I’m the one that’s off here, maybe this is an example for you to explain to me how I’m wrong:
I searched with “safety” and I get 96 results. The second study on the list catches my eye:
http://genera.biofortified.org/view/Batista2008
Biofortified has categorized this study under “equivalence”, and has characterized it as “positive”.
Perhaps if you can explain the rational behind these labels it will be a beginning in understanding how you can justify saying “197 peer-reviewed scientific studies that address the safety of genetically engineered foods out of 400 randomly selected”.
A further problem with GENERA in attempting to draw conclusions on all these GMO studies is the same problem that anti-GMO groups have. There are varying techniques used to develop transgenics. And varying purposes in doing so. They don’t all carry the same risks for the environment or for human safety. If there’s a study on growing human proteins in rice and it’s labeled along with a study on engineering disease resistance from two closely related species – it’s misleading to oversimplify these comparisons. This problem has only been addressed as: they do it, and others do it – so why shouldn’t we do it?
No one can prevent you from going forward on this track with regards to GENERA, but I think it’s important to acknowledge these flaws, which invalidate the broad generalizations you and others (GLP) seem to want to make about GMOs.
It’s ridiculous to say GMOs are unsafe. It’s also ridiculous to say they’re safe. The whole debate is ridiculous because this is a science that has numerous applications, technologies and effects. If the purpose is to educate the public on the science, either of these extremes is counter-productive. I understand the drive to portray “another side” to transgenics – one the public might not hear as much about. But misrepresenting the nature of the science is not the way to go.
Mlema, there are several problems with your argument here. Perhaps I will deal first with the study you identified and indicate how I see the author’s conclusion of that study. I should note at the beginning that I am in no way associated with Biofortified. They did ask me to write a blog post for them once, but I had insufficient time to write it at that time, so declined. This means that I am not going to second guess what Karl, Anastasia and others have done, but just give you my impression.
So to Batista et al. http://genera.biofortified.org/view/Batista2008 What this study proposed was to address the hypothesis that genetic modification as a tool was unsafe because it would result in large numbers of unintended changes that are not tested for. What the study did was compared mutagenesis with genetic modification. What they found was far more unintended changes with mutagenesis (a procedure that is generally agreed to be safe) than with genetic modification.
So in characterising this study, I would conclude that it is addressing an issue with food safety (because that is what the authors state in their hypothesis), it addressed equivalence by comparing the effects of two procedures, and concluded that genetic modification as a technique is unlikely to be less safe than mutagenesis.
Now to some of the other issues you are raising. I think part of the problem is that you are using safety in a different way to others. This is always likely to cause problems in interpretation. However, unless you can show that you usage is the only correct one, you cannot use that to conclude another usage is wrong.
Secondly, as the safety of genetic modification depends on the trait included that is what most regulators focus on. No-one I know is claiming that all genetic modifications are safe. However, there are many people claiming the exact opposite. Genetic modification as a technique is no less safe than other forms of plant breeding. Whether the individual product is safe (as with other forms of plant breeding) depends entirely on the trait. However, what we have at the moment, Canada excluded, is a regulatory process and political process that is triggered by technique rather than safety.
Thanks, Chris. This is exactly how we intended the results to be interpreted. it’s gratifying to hear that at least someone is able to understand what’s in the database. Hopefully people will fill out the survey that we have set up and that will give us more information as to whether or not most people are understanding what is intended by the categories of studies.
Chris, the study didn’t “address the hypothesis that genetic modification as a tool was unsafe because it would result in large numbers of unintended changes that are not tested for.” There’s no mention at all of any relationship between numbers of unintended changes and safety. In fact, mutations aren’t necessarily relevant to safety.
The study is about whether or not transgenics should be treated differently from mutagenics. In other words: why are transgenics considered GM where mutagenics aren’t?
“We found that the improvement of a plant variety through the acquisition of a new desired trait, using either mutagenesis or transgenesis, may cause stress and thus lead to an altered expression of untargeted genes. In all of the cases studied, the observed alteration was more extensive in mutagenized than in transgenic plants.”
So, BOTH the transgenic and mutagenic plants experienced an altered expression of untargeted genes, and therefore both had a NEGATIVE effect on equivalence. So yes, this study is rightly categorized under equivalence, but wrongly characterized as positive UNLESS: GENERA includes disclaimers to say that its characterization of “equivalence” is irrelevant with regard to comparisons to the parent plant.
“We propose that the safety assessment of improved plant varieties should be carried out on a case-by-case basis and not simply restricted to foods obtained through genetic engineering.”
This indicates to me that safety assessment should INCLUDE mutagenics because they’re even more mutagenic than transgenics. The study says “should be carried out on a case-by-case basis and not RESTRICTED to foods obtained through genetic engineering.” (my emphasis) The only way you can make this study say that transgenics are “positive” in “equivalence” to conventionally bred is to push hard on the idea that mutagenics are “conventionally bred”. This would be misleading to most people outside plant breeding. And no one considers positive equivalence of GMOs to mean ‘less altered expression of untargeted genes than mutagenesis’.
plus – please note that GENERA didn’t categorize the study as reflecting on safety. My complaint is that the categorizations given to these studies don’t reflect what the studies are actually saying. The issue of safety was highlighted due to claims made by GLP’s graphic above in article) which says there are “197 peer-reviewed scientific studies that address the safety of genetically engineered foods” in GENERA.
Anastasia, please see my response to Chris above.
The general understanding of equivalence with regards to GMOs is: how do they compare to the isogenic parent (the “non-GMO” version)?
The aforementioned study has been categorized as reflecting positively on equivalence even though this equivalence is only by comparison of GMOs to mutagenics (the most highly mutagenic technique of plant breeding). Typically, a person asking whether or not GMOs are equivalent to the plants the GMOs were created from are asking about a number of things. They may indeed be wondering about whether there are changes in gene expression. More typically they’re interested in the equivalence of nutrition, toxicity, etc. But, if the study doesn’t deal with nutrition, but does measure some aspects of equivalence, then whatever equivalence it deals with has to be characterized (based on GENERA’s current set-up) This study shows that the transgenic plants were NOT equivalent to their parent. Instead, there were unintended changes in gene expression.
What does it mean to your audience that mutagenic plants have more unintended changes in gene expression than transgenics? Do you think your audience would agree that the fact that mutagenics have more unintended changes than transgenics means that GMOs are equivalent to non-GMOs? (hence – the “positive” characterization of GMOs, because they’re “more equivalent” than mutagenics are?)
Is this GENERA’s intended meaning of “equivalence” (more equivalent than something else, less inequivalent than mutagenics)?
And, are there:
“197 peer-reviewed scientific studies that address the safety of genetically engineered foods” in GENERA?
The vast majority of GMOs so far developed are for animal feed, biofuel, food extracts, etc.. The subjective categorizations of these hundreds of studies, along with the qualitative characterizations as they supposedly reflect on each category, bring systemic problems to GENERA. These become obvious with the kind of charting and interpretation done by GLP, which created the above quote about GENERA. And GENERA isn’t a “risk atlas”.
After looking at the study mentioned above, it becomes more clear how this confusion has arisen. Perhaps you simply haven’t fully considered the problematic nature of presenting these studies in this way. I hope you will do so at this time to fix what’s otherwise a valuable asset for your site and for those who wish to look at what studies have been done on GMOs, and who’s done them, and what they’ve studied, etc..
Mlema,
First point. What the paper was addressing.
From the Introduction “Contrasting with the readily acceptance of food products obtained through conventional plant breeding, the potential benefits of this new technology have been held largely at bay because of the enormous controversy regarding the food safety of the resulting products (5).” which sets the scene for the work.
So the issue they are addressing is food safety, but only one bit of it. Going to reference 5, you will find “The commonly raised concerns about possible implications for human health are: inherent toxicity of the novel gene and their products, the potential to express novel antigenic proteins or alter levels of existing protein allergens, the potential for unintended effects resulting from alterations of host metabolic pathways or over expression of inherently toxic or pharmacologically active substances and the potential for nutrient composition in the new food occur differing significantly from a conventional counterpart.”
Then the hypothesis section at the end of the introduction “In this study, we used expression microarray analyses to monitor the extension of unexpected transcriptome modifications obtained in rice by conventional plant breeding by γ-irradiation as compared with the ones obtained through genetic engineering.”
This is why I stated the paper was addressing “the hypothesis that genetic modification as a tool was unsafe because it would result in large numbers of unintended changes that are not tested for.”
They were my words, not the authors, but were based on the three quotes above. One reason for controversy is potential unintended effects. The potential unintended effects addressed in the paper were unexpected transcriptome modifications.
Second point “The study is about whether or not transgenics should be treated differently from mutagenics. In other words: why are transgenics considered GM where mutagenics aren’t?”
This is one conclusion the authors came to, not a reason for undertaking the work.
Third point “So, BOTH the transgenic and mutagenic plants experienced an altered expression of untargeted genes, and therefore both had a NEGATIVE effect on equivalence. So yes, this study is rightly categorized under equivalence, but wrongly characterized as positive UNLESS: GENERA includes disclaimers to say that its characterization of “equivalence” is irrelevant with regard to comparisons to the parent plant.”
You will have to ask Anastasia or Karl about how they characterise studies as positive or negative. My assumption is that a study showing no difference to conventional practice would be neutral, one showing greater risk of harm would be negative and one showing lower risk of harm would be positive. Mutagenesis is a well-accepted plant breeding technique. Almost all crop varieties grown in developed countries and many in developing countries will have mutagenesis in their background. It is an appropriate breeding method to test against. The other breeding technique would be cross-breeding, but there would be massive numbers of changes to the transcriptome in cross breeding.
On that basis, I would conclude that this study would come out on the positive ledger. It would also come out as a ‘safety’ study, because it is addressing a specific claim about safety viz. : “The commonly raised concerns about possible implications for human health are … the potential for unintended effects resulting from alterations of host metabolic pathways …”
Chris, thanks for your thorough response and explanation of why you would categorize and characterize the study as you said you would. Your viewpoint makes sense. But GENERA didn’t categorize the study as reflecting on safety, only on equivalence. So, right from the start, I think you can see that it’s possible to disagree on how the study should be categorized in GENERA’s analysis. I happen to agree with GENERA that the study reflects on equivalence. I don’t think it reflects on safety because there was no evaluation of how the plants actually compared to each other with regard to those issues which are pertinent to safety (toxicity, allergenicity, etc.). But, of course, equivalence can in turn reflect on safety. Because if there’s no equivalence, that may or may not mean we might have allergenic proteins, unexpected toxins, etc.
Let’s face it – the topic of GMOs is a big one and issues like equivalence and safety overlap, depending on the particular GMO and what it’s purpose and environment will be. Pharmaceutical plants would raise more issues of consideration and debate than a disease-resistance crop for animal consumption.
The point of all this is: can we justify these various subjective judgements about how any one study reflects on GMOs as a whole? I don’t think it’s justifiable. Not without extensive explanations of how a category like “equivalence” is defined. This study illustrates that problem by considering a transgenic plant which has fewer changes in gene expression compared to a mutagene plant to be positively equivalent to conventional. Now, the irony here is, if the “positive” attribute is due to the fact that mutagenic plants are considered conventional, then even the transgenic isn’t equivalent because it has FEWER changes. This becomes a convoluted overlay of subjective interpretations which are unnecessarily unclear for anyone who doesn’t understand the science. And for anyone who does understand the science, they’re superfluous. What is the point of these qualitative labels? We’re told they allow people to bypass a reading of the studies – they can just read the labels, charts, etc. that GENERA has provided. “We read the studies so you don’t have to”. But if it turns out that the labels don’t reflect accurately upon what the study is saying then GENERA is misrepresenting the literature.
If only the creators of GENERA had…. I don’t know, somehow explained what they meant by equivalence, and how it was defined… Oh wait, they did.
http://genera.biofortified.org/wp/how-to-use-genera/glossary-of-terms
from the glossary:
“The equivalence category includes studies that assess whether or not genetic engineering (GE) significantly alters the characteristics of the plant or the food it produces in way that was not intended.”
As I said to Chris just above, I agree with GENERA that the study reflects on equivalence. So, apparently we agree on that and hopefully others more qualified than you or I would also agree. The study compares changes in gene expression between conventional, transgenic and mutagenic rice.
from the glossary:
“Positive effect
For equivalence studies, a positive effect means that the researchers concluded that the GE approach caused fewer changes than other methods of genetic modification (applies to comparisons).”
So, how did the study show that the GE approach caused fewer changes than other methods? Trangenics were found to have fewer changes than only the most mutagenic breeding method known. Is this the standard to which these GMO “comparisons” are made? The most mutagenic method of genetic modification causes more changes than the GMO, but the transgenically method of genetic modification caused more changes than all the other methods it was compared to – therefore the study reflects positively on the equivalence of GMOs? How so?
my reply ended up below – don’t know why that happens sometimes. Must be carelessness on my part. My reply begins with “from the glossary…”
“Pharmaceutical plants would raise more issues of consideration and debate than a disease-resistance crop for animal consumption.”
Well, exactly. It is all about the trait.
“Trangenics were found to have fewer changes than only the most mutagenic breeding method known. Is this the standard to which these GMO “comparisons” are made? The most mutagenic method of genetic modification causes more changes than the GMO, but the transgenically method of genetic modification caused more changes than all the other methods it was compared to – therefore the study reflects positively on the equivalence of GMOs? How so?”
I explained above why mutagenesis was an appropriate standard to compare with. We already know that mutagenesis will produce fewer changes in gene expression than will cross-breeding.
Chris, again, my complaint is that it’s inappropriate to characterize this study as reflecting positively on equivalence of GMOs. The authors found that both mutagenesis and transgenesis led to altered expression of untargeted genes. They further said “We propose that the safety assessment of improved plant varieties should be carried out on a case-by-case basis and not simply restricted to foods obtained through genetic engineering.”
Batista et al., 2008., should not be characterized as reflecting positively on the equivalence of GMOs.
And this is just the first study I looked at under a search of “safety”. Is it one of the “197 peer-reviewed scientific studies that address the safety of genetically engineered foods” in GENERA? What about the rest of the supposed 197 studies that reflect on safety for human consumption? I’ve looked at a number of studies now, and there are many of them that have similar problems when it comes to these qualitative labels.
Do you want me to try to go through these hundreds of studies to see whether or not there really are 197 peer-reviewed studies that address the safety for human consumption of genetically engineered foods?
Where do you want the notes/corrections for each one? in the forum area as a list?
There seems to be a lot of unnecessary arguing going on here.
When Mlema claimed that GM Watch’s intent was not to endorse GENERA as being useful, couldn’t you just simply have said, “Yes, we know, we were being sarcastic.”
In the other comment thread Mlema must have asked some variation on the same question 20 times:
“Where are the feeding studies done on appropriate species that examine parameters important to human health with the same GM food that people will actually be consuming?”
That seems like a pretty simple and straightforward question for people who created the database, but I don’t believe a straightforward answer was ever given.
Lastly, I was sort of taken aback by the condescending tone of some the replies to Mlema’s posts. Anastasia suggesting that perhaps English was not their first language, when clearly it is, came off as rude and immature. And, sorry, but I don’t buy for second that you actually believed there was a language barrier.
If the purpose of this site is to inform the public, perhaps you should try not to get so obviously annoyed with people who are actually interested in analyzing what you have to say.
Mlema, I think we have reached an impasse on the opinion of what should be called positive. You disagree with my assessment and I think your opinion that this study should not be called positive is wrong.
I will just finish by commenting on the following:
“We propose that the safety assessment of improved plant varieties should be carried out on a case-by-case basis and not simply restricted to foods obtained through genetic engineering.”
The current situation is that new traits introduced by genetically engineered have safety assessments as mandatory. New traits introduced by mutagenesis have no requirement for any safety assessments. Clearly, a result showing fewer unintended differences with genetic engineering compared to mutagenesis raises a question as to why safety assessments are required for only one of these breeding techniques.
“The current situation is that new traits introduced by genetically engineered have safety assessments as mandatory.”
FDA safety consultations are voluntary, not mandatory. When GMOs appeared on the scene years ago, there was no regulatory mechanism to oversee their safety to people or the environment. We now have a mish-mosh of rules put together between the FDA, USDA and EPA (because they are foods, plants and pesticides.) But the fact remains, safety tests for human consumption (which would involve a species appropriate to compare to human physiology) are still rather rare, since most of these crops are for animal feed, biofuels, food extracts, etc.
What seems to be happening now is that the industry is pushing, through the court of public opinion, to change the practices that are currently in plance. With the advent of nutritionally-enhanced plants, or pharmaceutical plants, or any host of other plants altered in a more complex way than pesticide-related crops, it would be unwise to lessen the safety testing typically done for commercialization. In fact, the AMA says it supports mandatory safety testing. Often, universities are part of the development and study of these crops in co-operation with the industry.
“New traits introduced by mutagenesis have no requirement for any safety assessments. Clearly, a result showing fewer unintended differences with genetic engineering compared to mutagenesis raises a question as to why safety assessments are required for only one of these breeding techniques.”
But that wasn’t what the study said. The study said ““We propose that the safety assessment of improved plant varieties should be carried out on a case-by-case basis and not simply restricted to foods obtained through genetic engineering.”
This is an area of contention on both sides of the GMO debate. Proponents say: “see? transgenics have fewer changes in gene expression than mutagenesis and they don’t have to be tested?” Opponents say “see? we’ve got all kinds of unintended changes going on here that aren’t being fully evaluated!”
Some people would like to do away with the testing currently practiced by convention. As far as I can see, there’s nothing to prevent that from happening now. But it would be a public relations nightmare. There needs to be a sea change in public opinion before GMOs start going straight to market. Is that what biofortified is working to effect?
Personally, I think it would be unwise to do away with the current practice of safety assessment. I think it ought to be strengthened and become mandatory for any food plant that shows the kind of changes exhibited in SOME transgenics and possibly mutagens. I don’t know too much about mutagenic breeding. But this is a different mechanism and as GMO proponents continually assert: the technology is irrelevant, it’s the final product that’s important. What we know is that mutagenic breeding is likely to cause the greatest number of unintended changes. GMOs of one kind are next highest in likelihood. BUT, some GMOs are LESS likely to have unintended changes than conventionally bred. That’s why this entire enterprise of characterizing GMOs as ONE THING is nothing more than an exercise in confusion. The GMOs that tend to be more problematic are those where crosses occur between distantly related species, and are executed by specific means which in themselves are mutagenic. But the thing is, it’s not the NUMBER of changes in gene expression that’s important, it’s the actual change in the cell. It’s overly simplistic to contend that since GMOs have only a few genes inserted that they’re actually safer than conventionally developed plants. And the general habit of equating all these different technologies and organisms and then trying to make blanket statements about them, as GENERA does, has little value in advancing public understanding of safety for humans and the environment. I think it has a negative effect on public acceptance of this technology. By equating all GMOs – you risk the rejection of all when you attempt to gain the acceptance of all. If there’s one thing that’s apparent from looking at all these studies, it’s that GMOs are not all the same.
Anyway, I would say it remains an erroneous interpretation of the study to say: it reflects positively on the equivalence between GMOs and conventionally-bred plants. And this is just one study out of hundreds. Look at the debate we’re having over ONE study that I picked out after searching under “safety” (there were 96 results) and looking at the second study that came up. Wouldn’t it be an improvement in GENERA to remove these qualitative labels? What would be lost? The only thing that would be lost would be the subjective overlay of some individuals interpretation of these hundreds of studies. The real value of GENERA – the objective sorting of authors, funding, species, traits, etc,. would only be enhanced.
Chris, please see my response below. For some reason when I’ve replied here it has ended up in moderation. Hope this one posts! (thanks)
When I wrote this article I was not being sarcastic. You can see from the quotes at the beginning of the article that GM Watch thinks GENERA (or at least a resource like it) is badly needed, and that they were able to use it to find the info they wanted, hence useful.
I provided a comprehensive link to a discussion of why humans are not used for feeding studies. Then, I carefully wrote a long comment about feeding studies to address the comment.
I was asking about language in good faith. With the misunderstanding happening here I honestly thought perhaps there was a translation issue happening. Someone can speak perfectly in a language yet still not have 100% comprehension. There was absolutely zero slight intended.
I’m sorry if you are getting annoyed but I for one am trying really hard not to, despite being asked the same question so many times and myself and others answering again and again. I did let out a little frustration when I pointed to the glossary, but IMHO it’s not really fair for someone to claim that we are trying to hide information when we have it there in black and white.
You’re welcome to post a list if you wish, and we will duly review it. But Batista has been characterized according to the publicly available definition found in the glossary, which we believe is a fair definition. Batista et al considered unintended changes of genetic engineering compared a widely used alternative method of genetic tinkering – mutagenesis. Mutagenesis, while it does cause a lot of unintended changes, is widely considered safe and requires zero regulation in most countries. This clearly fits the bill for “positive” in the equivalence category. However, this is the Beta test. If you believe the definitions used for categorization are a problem then please provide evidence that they should be changed.
In the Beta test of GENERA, there are 5 studies with positive effect for equivalence. http://genera.biofortified.org/search_results.php?query=%5Bequivalence=positive%20effect%5D These all show that the GE version of the plant they were testing had fewer unintended changes than the comparator. There are 6 with a negative effect. http://genera.biofortified.org/search_results.php?query=%5Bequivalence=negative%20effect%5D These show that there was more unintended changes in the GE version. There are also 151 that show no effect, and 15 mixed. The whole body of data on the subject shows that in general, GE does not cause unintended changes. The few studies that show more or less unintended changes than the comparator are outliers, which are to be expected when we are talking about a diverse group of experiments on diverse organisms with diverse GE traits. This says to me that while GE in general does not cause unintended changes, it can cause these changes so we should consider them on a case by case basis as part of the evaluation process.
Now, keep in mind that we are NOT interpreting the results provided by the authors. We are taking their conclusion at face value here. If you disagree with the conclusion in the paper that is another issue. We plan to include links to critiques of articles so if you find any useful science-based critiques please let us know.
So in the first paragraph when you say this:
“Biology Fortified, Inc., with our limited resources and volunteer staff, have come to the rescue and created this “badly needed” resource.”
There’s no sarcasm there? Your motivation to create GENERA was literally to come to Claire’s rescue?
I believe Claire’s statement was sarcastic given what we all know she thinks about Biofortified and I think your use of her sarcastic statement was also sarcastic. And to clarify, there is absolutely nothing wrong with employing sarcasm to get your point across, so I don’t really see what the problem is.
“Where are the feeding studies done on appropriate species that examine parameters important to human health with the same GM food that people will actually be consuming?”
There is Mlema’s question again, you’ll notice it asks nothing about human trials, but let me rephrase it for clarity:
“Are there any feeding studies DONE ON ANIMALS using THE SAME GM FOODS THAT HUMANS WILL BE CONSUMING?”
“Someone can speak perfectly in a language yet still not have 100% comprehension.”
That’s obviously not the case here and, again, I think you know that.
I didn’t suggest that I was getting annoyed, I suggested that you were. See how easy it is to miss things? Perhaps the comprehension issue is not Mlema’s alone.
Mlema, there is nothing voluntary about the requirement for the proponent of a new GM plant to get a declaration of non regulated status from the USDA. It is illegal to commercialise a product otherwise. http://www.usda.gov/wps/portal/usda/usdahome?contentidonly=true&contentid=biotech-plants.xml The USDA is required to consult with the EPA and FDA over appropriate issues.
I am sure this has been explained to you before, but the rules around safety to humans have been developed internationally and are based on a series of hypotheses that have to be explored. These are: Is the novel protein potentially toxic or allergenic? Are there changes to any known toxins or allergens in the new crop? Are food products from the new plant substantially equivalent to existing food products, except for the desired change? The answers to these questions are developed through toxicity testing, testing for known compounds, and in silico testing for potential allergenicity. The regulator can require additional test to be carried out if there remain queries for safety. The EU requires in addition whole food feeding studies.
For toxicity purposes, the rat and mouse are considered species of biological relevance to humans.
I think I have previously pointed out that the trait is what is important. As someone involved in developing new cultivars through mutagenesis, I fully see the irony that any cultivar I develop has no requirement for any regulation (except in Canada) whereas developing the same trait through genetic engineering would result in a $80 million regulation program.
“…there is nothing voluntary about the requirement for the proponent of a new GM plant to get a declaration of non regulated status from the USDA. It is illegal to commercialise a product otherwise.”
Yeah. I know. But that’s not what you said. You said:
“The current situation is that new traits introduced by genetically engineered have safety assessments as mandatory.”
Safety consultations with the FDA are voluntary.
http://www.fda.gov/food/foodscienceresearch/biotechnology/ucm346030.htm
Are you suggesting that, as part of the deregulation process, toxicity studies are done on rats and mice to ensure the safety of GMOs for human consumption? They’re not. And with some transgenics posing a greater risk of unintended, unwanted effects, it would seem that any GMO destined to be consumed as whole food by humans should undergo feeding trials in appropriate species. Why? Because the other evaluations you’ve enumerated (more or less accurately) provide no way to know whether there will be unanticipated problems. Every GMO is different. And one trait in 2 different plants, even of the same variety, can create many different characteristics. It’s not all about the trait.
The bulk of “lists” of studies claiming to show safety for human consumption, or equivalence, don’t reflect on safety for human consumption. The bulk of feeding trials has been on animals for which the new crop will be a major part of their diet. Most are short-term and examine only gross appearance of organs, feed conversion, litter size, etc. (Wrong species, wrong parameters.)
“$80 million regulation program”
It doesn’t cost 80$ million dollars to get a transgenic through deregulation.
It’s interesting that you work with mutagenics. What food plants have you helped to breed with mutagenesis and what are the valuable traits you’ve helped develop?
PS – I’ve always wondered: how alike do two plants have to be to consider them “substantially equivalent”? Based on some GMOs that have been commercialized and later showed notable pleiotropic changes, not very.
I saw no indication that Claire’s statement about a comprehensive resource was sarcastic.
Yes. Any trait commercialized in maize will be consumed by humans in various forms (corn chips, masa flour, corn syrup, corn meal, etc), and any traits commercialized in soy will also be eaten by humans, often in the form of soy-based products but sometimes in other forms such as soybean oil. Canola is pressed into oil and consumed by humans, as are cotton seeds (My BBQ Grill spray contains cottonseed oil – likely genetically engineered). That’s the big 4. Experiments on rice are for crops intended for human consumption. Wheat, tomatoes, potatoes – all human consumption, broccoli, cucumbers, peas, papaya… You get the picture. It is easy to search and see what kinds of crops and traits are studied, and what animals they are fed to in the case of feeding studies. Statements that such information is not in there without having checked in the first place can doubtless be an impediment to dialog.
I think (although am not utterly certain) that *all* field corn in the US would be considered substantially equivalent. So a hybrid that performs well in Northern states (probably an RM80 or 75) would be considered substantially equivalent to a hybrid which performs in Mississippi (probably an RM120).
Equally a goss’ wilt resistant variety of corn would be considered substantially equivalent to a susceptible variety, a 1970’s hybrid equivalent to a 2014 hybrid.
At least in so far as I understand it.
Ewan, substantial equivalence isn’t about crop performance or any corn being corn.
OECD definition of substantial equivalence (it’s not too specific)
http://stats.oecd.org/glossary/detail.asp?ID=2604
“… an assessment of a novel food, in particular one that is genetically modified, should demonstrate that the food is as safe as its traditional counterpart.”
It may be that all corn now growing is substantially equivalent. But “substantial equivalence” is about the composition of the food. It shouldn’t have anything in it that other corn doesn’t (except a GM trait of course) and it should have everything in it that other corn does. But there are no percentages of difference to show how equivalent these varieties are.
Testing the safety of a trait isn’t the same as testing the safety of consuming the engineered whole food. The fruits and vegetables you’ve listed as being tested for human consumption are all differently engineered. There’s more than one technique used, and each technique has it’s own level of risk for unintended alterations. Also, the trait introduced carries a varying level of risk depending on how closely it’s related to the engineered plant and how it incorporates in the plant.
I don’t think it’s inaccurate to say that many of these studies reflect on the safety of consumption – but not for humans. Many are on the safety of consumption for broiler chickens, pigs and cows – as that relates to feed conversion, milk production and reproduction rate. Some are more detailed. And some of the more detailed ones indicate problems. And of course those problems would reflect only on that GMO in that animal and would indicate that further research is needed. It certainly doesn’t indicate that it’s safe to eat any old GMO. And the fact remains that we don’t really know whether or not eating a bt plant (for instance) as a staple in our diets will be unhealthful. Even if it’s less healthful than eating a non-bt plant, we ought to know. Because there is that possibility. We just can’t know unless we do the research in some form other than by proxy of trait and animal. And perhaps roundup resistant crops with roundup residue is more harmful than bt. Who knows? The research seems to indicate that there may be health problems associated with consuming RR foods with roundup residues. That’s not the same as saying GMOs are unsafe to eat, but it does mean that we ought to look more closely before saying they’re safe, since RR crops will inevitably have Roundup residue.
The fact that humans are eating GE plant products in various forms isn’t a scientific claim of safety. And there seems to be an implication that GMOs are safe to eat. Which is a blanket statement. But when pressed, biofortified says they’re NOT saying that “it’s basically ok to eat any GM food.”
“Statements that such information is not in there without having checked in the first place can doubtless be an impediment to dialog.”
As is the implication that there are 197 studies that address the safety of genetically engineered foods for human consumption. Are GMOs safe to eat? Maybe they are, maybe they aren’t. Maybe some are, maybe some aren’t. The point is, if we’re approaching this scientifically, we have to be objective about the research and not make blanket statements (or graphics). Each GM plant is unique. Blanket statements about the products of this technology are unscientific.
also, the question was: “Where are the feeding studies done on appropriate species that examine parameters important to human health with the same GM food that people will actually be consuming?”
I don’t know that this doesn’t match what I said above – however it would allow for a traited version to fit entirely into the spectrum of all observed corn, rather than isogenic lines, thus small variations in phenotype which may be observed would still fall within substantial equivalence. (given that there is qutie stark variation within corn in general, and indeed, within beans in general, as to their composition)
As has been pointed out before, please direct questions about the contents of GENERA to the appropriate place in the forum, or through the contact page on the GENERA site. These questions are off-topic for this post, so please direct them to the appropriate places.
You are twisting my words:
I will explain your error in plain logic. We are saying that the majority of the research in GENERA agrees with the review studies that conclude that GE crops are not inherently risky, and that GE crops currently grown are in general no different from non-GE crops in terms of safety for consumption. You took that to mean “it’s basically ok to eat any GM food.” This does not logically follow. “Any GM food” is a blanket statement that we have not said. “Any” includes all instances of GE crops, including those that could be dangerous, which is why I said that we have not said that. You are setting up a straw man to knock down.
You are twisting our words to mean something they do not.
Sorry Karl. So you’re just saying that the GM foods being grown now, like bt eggplant, are safe to eat?
“Your comparison of results in gmo studies to ‘gravity being present’ shows that you believe certain findings are a foregone conclusion (as indisputable as gravity). It’s not about finding something unlikely or wrong – it’s about interpretation (for example) – like dismissing data as not meaningful where the math actually finds it significant.”
No gravity was just used as an example of who funds the research not making a difference in the outcome for most scientists. Diels makes a value judgement when he categorizes a study having one scientist with industry “connections” as being industry affiliated. This at a time when granting agencies are pushing more and more for collaboration between universities, industry, and stakeholders. I wonder what the results of the study would have been if there had been a “mixed” category? I guess we will never know, because the “list of papers had been lost and was unrecoverable, and there was no way of regenerating it”.
As for dismissing data as not meaningful, here is an example. There is a difference in mathematical or statistical significance and practical “significance”. Say you run an experiment to see if a treatment results in more residue of a particular chemical. The maximum allowed residue in food is 50μg/Kg. We find that the control results in a residue of 0.1μg/Kg and the treatment results in 0.2μg/Kg. Statistics show that this is a significant difference at P=.05. Sure you have found a significant statistical difference, but since the maximum allowable amount based on safety studies is 50μg?Kg, there is no PRACTICAL significance. But this gets reported by critics as “treatment found to increase chemical residues by 100%!!! That is misleading, even though factually correct, because this 0.2μg/Kg is 250 times less that the allowable limit!
For another example, suppose you have a GM gene for insect resistance in soft wheat. You grow and compare the nutritional content of the GM variety and its non-GM isoline. The GM line has protein content of 8.5 percent and the isoline has 10 percent protein. This is found to be significantly different. But is it biologically significant? For this you have to know your crop. Stress often causes higher protein levels in wheat. Insect feeding on the non-GM isoline could have caused the higher protein, while the resistance of the GM wheat resulted in higher yield and lower protein content. One way to get a better idea of the real difference in protein content would have been to treat both varieties with an insecticide. This would remove the effect of the insect feeding if the insecticide was effective.
Another way to deal with this would be to grow a number of other varieties along with the GM variety and the isoline. Suppose their proteins came in at 8.0 and 11.5. This shows that the protein percentages of the two test varieties are well within the range of other similar varieties. The normal range of soft wheat happens to be from around 8% – 12% protein. Knowing that, we knew from the start that the two values we got for our test varieties were within the normal range for protein in soft wheat. But having the 2 additional varieties helps to confirm that. This shows that while the difference in protein content between the GM wheat and its isoline is statistically significant, it is still not biologically significant. FYI, in soft wheat, lower percent protein is actually desirable.
This is why Monsanto uses additional varieties in its safety tests, to establish and compare to the normal biological variability that occurs between varieties. Ideally, tests would use crop samples over multiple years and locations, but every additional factor you add costs more. It doesn’t, as Seralini claims, serve to dilute unwelcome results. Having more samples and replication helps to improve the precision of a test, especially if the test is well run in the first place.
I was thinking of the Monsanto feeding trial on MON863, where the number of lesions in the liver and kidney seen in the raw data were thought to be significant by other scientists, but not according to the results given in the study. When Monsanto got called on this, it sought to then compare the test results to historical data outside the controls of the investigation. But I agree with your comments. I think in the kind of cases you’re talking about, it’s just important to look for trends: if the new varieties consistently show lower protein (for example), even if within acceptable range, then you’d want to take a look at that.
“I was thinking of the Monsanto feeding trial on MON863, where the number of lesions in the liver and kidney seen in the raw data were thought to be significant by other scientists”
Let’s be very clear, this is the re-analysis that was done by Seralini, and which was criticized by almost every other scientist that looked at it, and rejected by every regulatory agency that looked at is as well – it was a statistical fishing trip.
Seralini looked at the raw data, which is available online. There are obvious notable differences in liver and kidney histology. Also, I believe Germany commissioned an independent review and likewise found problems – and also found problems with Monsanto’s attempts to justify their conclusions after the fact. The regulatory agencies are typically disposed to granting approval – for economic reasons. The fact that the developers do the safety testing would ordinarily be considered conflict of interest. I think wikileaks revealed that Monsanto holds sway in European regulation through the US State Department.
I for one am encouraged to see the effort in the GENERA project to bring studies on the health & environmental effects of GMO into public domain. That is indeed much needed. What I’d like to see more of is open-minded discussion rather than using information to support a POV. I’m impressed with BFI for informed & researched articles, although remaining skeptical at this point. The health debate is not over.