Barriers to GE Hort Crop Commercialization

Written by Kevin Folta

Last week a workshop at the International Horticultural Congress in Lisbon, Portugal featured a series of speakers known for their work in transgenic  technology.  I’ll summarize these in the next few posts.  Today’s post addresses an important question- why are there few horticultural (basically non-agronomic fruits and vegetables) transgenic crops available, at least relative to corn, soy and other huge agronomic crops?  These are the capsules of flavor and nutrition truly necessary in a diverse diet, yet they suffer tremendous challenges to production and distribution.  Transgenic technologies could deliver great benefits.
The issue was approached by Dr. Ralph Scorza from the USDA Appalachian Fruit Research Station. I’ve known of Dr. Scorza’s outstanding work for almost two decades.  Years ago he sought a solution to the plum pox virus (PPV), the causative agent of a devastating disease called Sharka. The disease affects stone fruits (peaches, apricots, others) and can destroy whole orchards and decimate natural populations.  While breeding solutions are being pursued with timelines measured in decades, PPV can now be mitigated with Scorza’s solution by grafting a stonefruit scion to the transgenic rootstock.  Works like a charm, and the fruit are not transgenic.
The solution was introduction of a gene encoding the coat protein of PPV.  When overexpressed in plums (because they are routinely transformed in the Scorza Lab), the plant became immune to the disease, almost like a vaccination.  While this was interesting science it was not viewed as an application, that is until PPV was identified in the United States.  While the disease was successfully controlled with quarantine, the development of PPV-resistant plums (a cultivar known as “Honeysweet”) was initiated as a solution in future outbreaks.
Years later in 2010, the Honeysweet cultivar has found approval.  It is a true minority, as very few horticultural crops are ever approved, reserving much of the focus for major agronomical crops like soy and corn.  To date, only 6% of de-regulated crops are horticultural and only 1% had viable commercial potential.  Of that, 0.2 were crops other than tomato and potato. Therein lies the question, why are transgenic technologies not approved (or even pursued) in fruits and vegetables?
A mere 127 horticultural crop lines have sought deregulation, but the vast majority of these did not complete the process to commercialization.  Dr. Scorza indicates that the costs of pursuing deregulation and testing are incredibly expensive, leading companies or universities to abandon the process in mid-stream, even if promising.
He goes on to describe other potential reasons for the waning desire to deregulate.  First, there is a relatively small market for any given horticultural crop, so the likelihood of  substantial profit is low, an important consideration when the costs of R&D and deregulation are concerned.  Universities and small companies do not have the funds, infrastructure or intellectual property resources required to hustle the process along.  Horticultural companies and universities may understand the potentially negative perception that the public has on safe transgenic technology, so they stay away from attempting to commercializing transgenic plant lines that while scientifically proven, may not be tremendously profitable.
The other key reason while these crops do not navigate the maze to deregulation is because there is no incentive for the scientist.  Inventing a solution to a horticultural problem does not bring in grant money, does not generate publications, and requires a tremendous investment of time in meetings and paperwork that may never be rewarded.  Ask anyone working in the public science sector– we didn’t get into it for the love of beaurocracy.  Additionally, there are steep consequences of not following the approval process to the letter, with substantial fines and/or regulatory action. Together these barriers frame a formidable disincentive. To date the effect shows, as private concerns have deregulated many achievements in tomato, potato, squash and tobacco, whereas public entities have only released (the amazingly successful) papaya and now plum.
The other problem is the aforementioned maze of regulatory hassle.  There are three major levels of approval for a GM food crop.  The first is through USDA-APHIS, an agency that regulates the growing of GM foods.  “Honeysweet” cleared this barrier quickly.  Next the FDA has to approve safety.  For ‘Honeysweet’ that took 2.5 years.  Finally, the EPA must approve the new organism, a process that took almost 3 years in the case of ‘Honeysweet’.
After all of the regulatory hurdles the product still may not be commercialized, mostly based on public perception. For instance, it cost nearly half a million dollars to build raspberry plants resistant to the Raspberry Bushy Dwarf Virus, a devastating disease.  While the plants work brilliantly, the industry suggested they not be commercialized due to public fears.
The other problems are from coordinated attacks by anti-GE groups.  In 2007, while ‘Honeysweet’ was in the process of deregulation, instructions on gmofreetrees.com provided details to cut-and-paste complaints into websites of federal agencies. Of the 1725 notes provided, 1708 were negative to ‘Honeysweet’ deregulation, but all followed the cut-and-paste format.
Dr. Scorza completed his discussion by noting that transgenic plant acceptance will be disaster driven.  When farmers and consumers have no choice, then the new technologies will be accepted.  Problems such as PPV in stonefruits, Pierce’s disease in grapes, and citrus greening may all soon benefit from transgenic technology with existing tools that may save an industry.  Even crusty old Europe is considering ‘Honeysweet’ and weighing real risks in the face of losing tremendous stonefruit populations to a viral outbreak.  Just as a major outbreak of polio will send anti-vaccination parents scurrying for a jab, the adoption of GE technology will be found quite acceptable when scenarios dictate no other choice.
I agree with Dr. Scorza’s assessment.  Anti-GE interests don’t trust big, private agribusiness, but then simultaneously support a regulatory system where only it can thrive.  Public scientists that have a mission of societal contribution lack the funds and infrastructure to obtain approval have trouble competing in the disincentivized process.
Dr. Scorza concluded that he remains optimistic.  Consumers have accepted GM soy and corn.  The acceptance of horticultural crops will happen eventually, but the barriers to application will make the process slow, impeding potential benefits to the consumer, the farmer and the environment.

Written by Guest Expert

Kevin Folta has studied biology and agricultural biotechnology for over thirty years. His research examines the role of light in controlling plant traits, especially those relevant to agriculture. His group is known for using innovative genomics approaches to identify genes associated with fruit quality, especially flavors and aromas.

18 comments

  1. The other problem is the aforementioned maze of regulatory hassle. There are three major levels of approval for a GM food crop. The first is through USDA-APHIS, an agency that regulates the growing of GM foods. “Honeysweet” cleared this barrier quickly. Next the FDA has to approve safety. For ‘Honeysweet’ that took 2.5 years. Finally, the EPA must approve the new organism, a process that took almost 3 years in the case of ‘Honeysweet’.

    This is only the start of things – for anything grown for export you also need to get seperate regulatory approval from every market which has the potential to be an importer of the product – obviosuly for anything that was internal use only then Aphis, FDA, EPA is all you’d need to clear – but as soon as it leaves the US then there are more regulatory hurdles to jump before you have a commercially viable product – as soon as segregation of GM from non-GM is required the premium for the GM product will drop as it requires special treatment – fast making it pointless to utilize the technology.
    All another reason why it tends to only be major cash crops which are GM’d – getting clearance in every market is helluva expensive and requires different expertise for different markets – how many small research groups can afford to have a whole team of regulatory experts to push the regulatory process in all markets?
    Meaning that the regulatory framework is even more biased towards big agri-business than portrayed above – which is a tremendous shame, both for small researchers and, imo, for big-agribusiness – as it is my belief that only when non-big agri GMOs become widely available will hearts and minds truly be won over (as GMOs tend to be viewed through anti-corporate lenses)

  2. I think the anti-public GE bias is an important issue to consider, and I am glad that Kevin brought it up. It seems that the anti-GE folks have decided that the best way to stop the corporate dominance of this technology is to demand so high of regulations (and strict liability for even cross-pollination of non-GE crops) that it would limit the financial and practical feasibility of bringing those products to market. But this has the side-effect of making it so that only gigantic corporations can even afford to do it in the first place – thus concentrating corporate power. What if Greenpeace and FoE were really working for Monsanto all along? 🙂
    Even the Union of Concerned Scientists has taken this particular tack. Doug Gurian-Sherman in particular seems to be anti-public-funding of GE crop research.
    http://www.scienceprogress.org/2009/06/ag-biotech-gurian-sherman/
    For instance when it comes to the Global Food Security Act, he argues that GE is a waste of public money. If he got his way, only companies would fund it, and only companies would own it, at least until the patents run out and it becomes public domain.

  3. Last time I saw Gonsalves talk about his GM papaya he emphasized that scientists really had to be willing to make deregulation of their crop their calling and be willing to do whatever it takes. It’s pretty admirable to do that to save a small community, but I doubt anyone will do the same for a new rose variety…

  4. I remember hearing the same thing myself about that whole process. I really admire the folks in the Golden Rice project who, despite all the corporate and governmental and greenpeacial hurdles thrown in their way, are still working hard at getting it to people. That doesn’t mean that some, like Potrykus, don’t get angry about it – it would be hard not to.

  5. Very interesting article! I love hearing about the state of GE horticultural crops. I hope that in the future we really see more of them, and not just out of necessity!
    I once spoke with a pomologist here at my university about this topic with respect to fruit. According to him, one of the reasons you see less of it was that the growers were wary of GE fruit crops, the nature of fruits being more long term than agronomic or vege crops, I think he said it was because no one wants to topwork a bunch of trees, spend a few years waiting for them to come into production, just to emerge into some sort of backlash against the GE fruits. He didn’t mention the growers being worried about the GE fruits themselves, but about people worrying about the GE fruits. He also told me of one person who did research for a certain crop, but the industry did not even want him to publish it out of fear of it stirring up consumer backlash!
    I asked him if there was any future mixing the two things I find fascinating, genetic engineering, and undercultivated crops (I love all the ‘new’ stuff; fruit like service tree, zabala, cassabanana, or muntries, veges like chaya or oca, nuts like yellowhorn or hodgsonia, spices like rosita de cacao or dorrigo pepper, ect. ect. ect., but mostly fruits). He said no one really even wants to fund the conventional breeding of those potential, underutilized crops (weird risky things that they are) to begin with, let alone going through all that hassle to get a GE variety to market. The things that are the most economically important are, naturally, going to get the funding, and fruits aren’t that horribly important (relatively), and the biodiverse ones I find fascinating aren’t important at all. Basically, he kinda told me that, regrettably, because these ways things are now, about the research and the regulation and the funding, it might not be such a bad idea to keep horticulture something of a hobby and keep doing my finance degree, as there is very little geared to my interest that’s really happening. Oh well.
    Hopefully, things will improve in the area of GE fruits, nuts, veges, and spices sooner rather than later. I’ll be very sad if in my lifetime I don’t see some GE ‘tropical’ fruit somehow surviving outside & in the ground here in Pennsylvania.

  6. I tried explaining that to people once, said ‘Monsanto couldn’t pay for better friends’ or something to that effect, about how opposing all GE crops means only ones with corporate strength behind them are likely to make it thorough regulation (which I’m not too sure they even believe truly exists, keeping in line with their belief that GMOs receive no serious testing), and that it must be nice to bump out the little guys like that. I don’t think I really got anything through though, but it is a good point.

  7. Greg, my lab was told by a large berry company that they didn’t want to contribute to sequencing the strawberry genome because they were afraid of the perception that they were making transgenics. Of course, they’d be the first ones mining the heck out of it for markers etc. Again, tail wags dog.

  8. Now that’s important….

    they didn’t want to contribute to sequencing the strawberry genome because they were afraid of the perception that they were making transgenics

    I’ve sometimes wondered why I haven’t seen more support from those types of companies around this. So that means that the anti-GMO forces are, in fact, creating additional barriers to basic research this way. This doesn’t surprise me, but it’s the first evidence I can point to specifically on that.
    Very interesting.

  9. That strawberry account is interesting anecdotal anti-anti-GE rhetoric, but I think only represents a fringe anti-science attitude and not the attitude of many who are concerned about GE, but are pro-science and pro-organic (as it is, without GE).
    The truth, aside from anecdote, is that Molly Jahn (then at Cornell, now Karl’s Dean) sequenced the pepper genome as part of a federal grant that also included organic farmers growing out and documenting varieties in NPGS collection. The truth, aside from anecdote, is organic wheat breeders like WSU’s Dr. Steve Jones (who has been an outspoken opponent of GE wheat and GE technology in general) use MAS in their programs and while he might not prioritize gene mapping over classical skills, knows it can be useful. These are organic researchers, working with organic advocates and farmers. None of them are anti-science, none of them are anti-genomics, even if not pro-GE. I know I can give all sorts of anecdotal stories about university researchers I know who are much more afraid of patent barriers (“legal land mines” as one plant breeder I know calls them) than they are regulatory barriers and blame patents for slowing – and at times halting – public research. You can’t analyze or discuss wat is slowing or blocking ag innovation without a critical look at IP restrictions.
    MaryM goes so far into dreamland with her statement that antiGE forces are impeding basic research. Karl’s suggestion that anti-GE folks are even remotely responsible for concentration of corporate ag power is not even worth responding to.
    Greg almost points to the much bigger elephant in the room with research on horticultural crops – there is no money for classical breeding in even the larger minor crops, much less more expensive genomics tools. Our public research systems have been systematically stripped of funding since the passage of Bayh-Dole and decline in Hatch Funds and push towards public researchers depending on royalties. To suggest, as several commentaries on here have, that the the anti-GE crowd is the biggest friend to big ag by creating hurdles of small companies and public researchers is a massive obfuscation of the facts on the ground regarding the history of public funding for research. Karl, ask your professor Bill Tracy for his take on why hort programs are struggling with funding. Ask him for his powerpoint from Seeds and Breeds for 21st Century Agriculture. I don’t know a single university breeder (and I know just about as many as anyone on this board) who believes that activists are at fault for the shrinking budgets they face. And please, before you make a radically whacky statement about the causes of concentrated ag read some agricultural socio-economic history books.
    The same goes for the regulatory system. None of the anti-GE folks LIKE the regulatory system for GE crops, and agree that it is broken. Who do you think set up the regulatory system for these crops, divvying it up amongst the FDA, EPA and APHIS? The activists? Reread your histories of Coordinated Framework. (Look at 51 Fed. Reg. 23302 – June 26, 1986). The Framework, begun in the 70s and finalized in 1986, was not at all what those concerned about GE technology asked for, and if anything was founded on the biotech industry’s desire for USDA to regulate GE crops under the old FPPA and PQA of 1957 and 1912, respectively – which were intended to regulate the introduction of non-native plant species. Even with the PPA of 2000 the USDA is still guided by these ancient regulatory docs (www.usda.gov/oig/webdocs/50601-08-TE.pdf).
    Who had the most power in creating this broken regulatory system? Wasn’t Union of Concerned Scientists or Center for Food Safety (who weren’t even around when the Coordinated Framework was being developed).
    And did you know the anti-GE folks also fund Glen Beck’s underwriter’s seed saving campaign (http://www.survivalseedbank.com)??? Spread the word, Beck is working with Greenpeace!!
    Please, this blog used to have reasonable discussion, but blaming folks concerned about GE (and not all who are concerned are anti-GE, I include myself in this category) for everything wrong with ag, research, and world hunger doesn’t really serve a productive intellectual discussion. Just like there are those anti-GE paranoid folks out there spreading misinformation on Morganellas Disease (being caused by GMOs), there are those anti-anti-GE paranoid folks who want to reduce and blame. Oh the American political culture – lovely, isn’t it?

  10. I have noticed that whenever a genome sequence comes out for a crop, some of the anti-GE folks get worked up with worries about GMO frankencrops following soon after. It seems like some things which sound like advanced genetics get all lumped together sometimes.

  11. What part of the fact is in “dreamland” Matthew?
    Fact: Large berry company avoids funding basic research because of the perception of involvement in GE.
    What part of that do you dispute? I’m not sure I understand.

  12. Matt, you make an excellent point about the funding problems that horticultural research has, and breeding in general. But I was not talking about how we got to this point, I was talking about the place that some anti-GE organizations want to get us to. This is what I said:
    “It seems that the anti-GE folks have decided that the best way to stop the corporate dominance of this technology is to demand so high of regulations (and strict liability for even cross-pollination of non-GE crops) that it would limit the financial and practical feasibility of bringing those products to market. But this has the side-effect of making it so that only gigantic corporations can even afford to do it in the first place – thus concentrating corporate power.”
    I said nothing of what you accused me of saying. This is American politics, alright.
    I do think that we need a better organized regulatory system, but I don’t know enough to come up with any concrete suggestions, apart from making it a single-agency system. I have heard that that is really cumbersome. We’ve tossed around some ideas about using microarrays in the regulatory process, but those have pitfalls as well.
    The Golden Rice project is a good example also of how patents can get in the way of public projects. Potrykus has credited the need for good PR on the part of the seed companies for why they allowed the project to use their patents without royalties, and I think we can have a good discussion on the pros and cons of patenting. My view is that it should always be about the benefits and drawbacks, not about whether it is intrinsically right or wrong.
    There are other examples of extreme anti-GE groups trying to halt basic research. When I was at UC Davis, I covered a protest of the Dendrome Project, which is a genbank for tree genome research. They thought it was a nefarious scheme to plant the world over with GE trees. Luckily they didn’t decide to damage anything like the fire of 1999 where an anti-GE group destroyed a graduate student’s non-GE tree research and a field building in protest of genetic engineering. While I don’t think these anecdotes demonstrate that all those who are against GE crops feel that way, they are still examples of how certain lines of thinking can (but not necessarily) lead to extreme and undesirable outcomes that everyone should be ashamed of. Are they a problem with the science? With the communicators of the science? Or also with the critics?

  13. Matt, thanks for the thoughtful reply. The strawberry example is an interesting one because it is not the anti-GE folks directly causing the problem. It is the companies that are so worried about perception (and the lies that anti-GE types perpetuate; to be posted next week) because it can affect bottom line.
    I do disagree with your assessment that the organic types that are not “pro-GE” are not anti-science. There are facts and non-facts. To oppose the technology is like being against stem cell technology. Some people don’t like it, they think it is not necessary, they want it stopped.
    However, the potential of serving everyone warrants continued study and implementation. To oppose this progress is absolutely working against science, as long as there is no evidence of harm.

  14. In my experience, it is sometimes very difficult to apply the anti-science label to different groups of people. I tend not to use it myself because it can be polarizing. I prefer to talk about attitudes and ideas as being anti-science rather than people, as some people are pro-science in some areas and anti-science in others. For example, many anti-GE people are probably pro-stem cells.

  15. Very true. However, such tags are absolutely meant to be polarizing. There is science, supported by evidence, and there are other opinions and interpretations that are inconsistent with the facts as we know them. You know me, I point out anti-scientific rhetoric as a starting point. It is one thing to help people understand and educate them, but at the same time sometimes we have to disengage them from non-scientific thinking.
    I adore evidence and the scientific method. Solves a lot of problems. I’d really like to help everyone understand it and use that as a base to make their assertions.

  16. Matthew,
    Interesting that you mention gene sequencing and peppers.
    Even though there are no GMO peppers, there’s a lot of protest against them! There’s even an ‘award-winning’ movie complaining about them! Trailer of Genetic Chile – The Movie:

  17. Matthew,
    Anti-GE activists have played a large role in limiting public research. Such as more than 70 acts of vandalism against academic or governmental GMO research — including threats of violence. [1]
    In Britain, the cost of security for guarding university-sponsored field trials against vandals has become prohibitive. [2]
    Whether or not the anti-GE people were in on the original construction of the ‘broken’ regulations, it is nonetheless clear that they are clamoring for more stringent regulations. And they managed to block the first field trial of a GMO — ice-minus bacteria which could prevent frost damage on crops. [3]
    These are not nice people, and are willing to do nearly anything at all.
    ——–
    1. http://ddata.over-blog.com/xxxyyy/1/39/38/37/public-research-vandalized.pdf
    2. http://www.timeshighereducation.co.uk/story.asp?storyCode=403088
    3. http://en.wikipedia.org/wiki/Ice-minus_bacteria

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