








But I’m getting ahead of myself….

Timeline of the Development of Golden Rice

















What can this history of Golden Rice teach us?









10 Responses to Golden Rice: Of Good Intentions, Insertional Mutants, Human Error, and the Need for Better Regulation of GMOs

  1. Ed says:

    In a piece published in 2010 on the lessons learned from his work on Golden Rice, Ingo Potrykus argued that it was precisely over regulation that caused a 10-year delay in the product’s development. The Abstract says:

    Compared to a non-Genetically Engineered (GE) variety, the deployment of Golden Rice has suffered from a delay of at least ten years. The cause of this delay is exclusively GE-regulation. Considering the potential impact of Golden Rice on the reduction in vitamin A-malnutrition, this delay is responsible for an unjustifiable loss of millions of lives, mostly children and women. GE-regulation is also responsible for the fact that no public institution can deliver a public good GE-product and that thus we have a de facto monopoly in favour of a few potent industries. Considering the forgone benefits from prevented public good GE-products, GE-regulation is responsible for hundreds of millions of lives, all of them, of course, in developing countries. As there is no scientific justification for present GE-regulation, and as it has, so far, not prevented any harm, our society has the urgent responsibility to reconsider present regulation, which is based on an extreme interpretation of the precautionary principle, and change it to science-based regulation on the basis of traits instead of technology. GE-technology has an unprecedented safety record and is far more precise and predictable than any other ‘traditional’ and unregulated breeding technology. Not to change GE-regulation to a scientific basis is considered by the author ‘a crime against humanity’.

    The paper may be found at:

    Click to access sv113-potrykus2.pdf

    Ed Regis

    • Belinda says:

      Well, first of all, Dr. Potrykus’ estimate that “Golden Rice should have reached the farmers’ fields in Asia by 2002” (stated in the paper you cite) is ridiculous. Developers were still working (in labs) on ways to deliver higher levels of beta-carotene (pro-vitamin A) in rice endosperm that year, and the Humanitarian Board was asking researchers to create thousands of new genetically engineered rice “events” from which they hoped to select the one event that would be eventually bred into farmer-preferred rice varieties; i.e. they didn’t even have GE rice plants to choose a top candidate from yet in 2002.

      Second, Dr. Potrykus states repeatedly in his paper that there was “no experience in the public domain with deregulation of a GMO-product” but that is not true; the GE papaya that saved the Hawaiian papaya industry was developed in the public sector.

      Third, while the AMA, WHO and others have asked developers of GE foods to avoid having genes that confer antibiotic resistance in their products, it is still (to my knowledge) not a requirement of regulatory authorities. In fact, many commercialized GE food crops contain a gene that confers resistance to kanamycin. And if the Humanitarian Board decided to remove the selectable marker gene from Golden Rice as a means to increasing public acceptance of it (or for any other non-regulatory reason)…blame is not with the regulatory agencies.

      Similarly, screening for “regulatory clean events” has not been a requirement of regulatory agencies in many countries (although I believe it always should have been); in fact, there are multiple commercialized GE crops out there that contain various “alterations of the [foreign gene] construct.” One of the most egregious examples I know of is NK603, the GE corn fed to the rats in Seralini’s study (which was so viciously attacked and subsequently retracted for merely being “inconclusive”). The developer of that GE food crop, Monsanto, identified not only an extra piece of DNA that had been inserted into that product unintentionally, but also two point mutations in one of the genes conferring resistance to glyphosate; Monsanto also found that RNA transcribed from the DNA inserted into NK603 contains not just the information contained in the inserted DNA but, unintentionally, some from the adjacent corn DNA as well. (See my post from 2/9/18 for more details.) And NK603, this GE crop/food that contains these various, multiple “alterations of the gene construct,” is currently in the same queue waiting for regulatory approval in the Philippines as Golden Rice, another indication that Monsanto/Bayer (at least) doesn’t believe that “regulatory clean events” are necessary for gaining regulatory approval.

      So it’s not the case that regulatory agencies require a “clean event;” and, again, if the Golden Rice Humanitarian Board decided that a “clean event” was necessary (for public acceptance or whatever), the regulatory requirements are not to blame.

      The main problem as I see it is that the “naïve public sector scientists” Dr. Potrykus mentions in his paper, who followed their “idealistic concept,” didn’t fully realize how inefficient and imprecise the current methods for genetically engineering crop plants actually are.

      Worse yet is that, despite Dr. Potrykus’ claim made in 2009 (in the paper you cite), that “all final Golden Rice varieties are based on such ‘regulatory clean’ events” (as I believe they should be), neither of the top two events of Golden Rice chosen for their product development pipeline in 2009 were such clean events; instead, they were both mutants created by the genetic engineering process itself, even though the developers of Golden Rice had possessed data indicating that they were both mutants since 2006. Clearly, not enough care was used in selecting those top GE Golden Rice events.

      In my opinion, more time in 2009 (and before) should have been spent carefully examining the molecular data on Golden Rice events, and less time spent writing papers disparaging the regulatory process for bringing a GE food crop to market. Regulation of GE crops may well have “prevented any harm” in the case of StarLinkTM corn, for example, since U.S. regulatory agencies were so concerned about that GE crop that they monitored levels of it in the U.S. corn crop for 7 years AFTER that product had been taken off the market. And, if peer-reviewed studies of other GE crops that indicate possible evidence of harm weren’t attacked by plant molecular biologists, but followed up on with additional scientific studies instead, we might now have an even more “science-based” process(es) for regulating new GE food crops.

      In sum, lack of taking appropriate care in utilizing what is currently an inefficient, expensive and imprecise (in its own ways) genetic engineering technology to develop food products for humans is not a reason to change regulation so as to be based on “traits instead of technology;” in fact, it is reason for strengthening regulation of GE food crops, not weakening it. For regulation of GE crops to be truly “science-based,” it is appropriate for developers to be required to screen for “regulatory clean events.”

  2. Ed REGIS says:

    Belinda says: “But it’s been 18 years since then [Time magazine Golden Rice cover story, 2000] and Golden Rice is still not available to the world’s poor who might benefit from it. Why is it taking so long to deliver this humanitarian product?”

    Part of the answer is: Because of the regulatory hurdles facing the development of any GM plant variety.

    In 2011, a private British consulting firm, Phillips McDougal, was hired to produce a study of the cost and time involved in the discovery, development, and authorization of new plant varieties created through biotechnology. The project was carried out by collecting data from six of the world’s major crop biotechnology companies, including BASF Corporation, Bayer CropScience, Dow AgroScience, and Syngenta.

    The total amount of time required for a developer to move from initial trait discovery to final authorization and release into the marketplace was an average of 13.1 years. “However, there was considerable variation in the responses between companies and between crop species,” according to the study report. “Overall variability in the responses received varied from a low value of seven years to the comparatively high value of 24 years.”

    Further, according to the study report: “Regulatory science, registration and regulatory affairs is the longest single phase in product development and is estimated to account for 25.8% and 36.7% of total cost and time involved respectively.”

    Given these figures, the 18 years between the invention of the Golden Rice prototype in 1999 and the first government approval, issued by Food Standards Australia New Zealand (FSANZ) in December 2017, is well within the normal range found by the study.

    Click to access Getting-a-Biotech-Crop-to-Market-Phillips-McDougall-Study.pdf

    • Belinda says:

      Have you informed Ingo Potrykus and Adrian Dubock of this study?

      • Ed REGIS says:

        No, because it only reinforces what they have maintained for years, namely that regulatory matters constitute a large share of the time and expense burden of developing any GM food. Nothing new in that for them.

      • Belinda says:

        The bottom line is that the development of Golden Rice would have been both faster and cheaper if its developers had utilized the molecular data at hand immediately and thrown all the putative “product” events that were mutants caused by the genetic engineering process away.

  3. Mary Darragh says:

    Great article. You clearly presented a complicated issue that was easy for this lay person to understand.

  4. JAN says:

    Really excellent article – very helpful explanation of the various roadblocks that have slowed up the deployment of GR. I wasn’t aware of the 2014 Dubock paper, good cite. Your point about weeding out problematic intentional mutants is well-made, particularly relevant for diploid species like rice,

  5. Pingback: Disappointment in the First 25 Years of GMO Foods | Biotech Salon

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