What Did Monsanto’s Robb Fraley Really Learn From Bill Nye?

Posted on May 31, 2017 by

I read a piece by Robb Fraley, Monsanto’s Executive Vice President and Chief Technology Officer, called “What I’ve Learned From Bill Nye” in the Huffington Post a few weeks ago. In it, Fraley wrote that he had Bill to thank for teaching him important lessons, the first of which is:

“When you’re not sure if you fully understand a topic you feel strongly about – and are able to recognize that you may be basing your opinion on ideology rather than data – it’s important to push yourself out of your comfort zone to research and learn more.”

Fred Gould, the chairman of the committee that put together the most recent National Academy of Sciences report on GMOs, is shown in the photo accompanying that HuffPost.

I therefore submitted a comment to Fraley’s post, on a topic I hypothesized he probably feels strongly about…Fred Gould’s opinion regarding a safety study on one of Monsanto’s genetically engineered (GE) crop/food products.

It’s been 2 1/2 weeks since I submitted my comment and, as I write this, it has still not been posted. Therefore, I am posting it herein below.

Comment submitted May 14, 2017, in response to “What I’ve Leaned from Bill Nye:”

Since you mention “retracted scientific studies regarding GMOs,” and Fred Gould, the chairman of the committee that put together the most recent National Academy of Sciences report on GMOs, is shown in the photo accompanying this post, I think you should know that Fred Gould believes that Eric Séralini’s study of the long-term effects on rats of eating your company’s genetically engineered (GE) NK603 corn and herbicide glyphosate should never have been retracted.

For those who may not know, that study, which was peer-reviewed and originally published in the respected international journal Food and Chemical Toxicology, was in print for more than a year when it—very unusually—underwent a thorough review by the journal’s editor-in-chief; he reviewed not only the submitted manuscript and all the reviewers’ comments, but also the raw scientific data from Séralini’s lab. That editor “unequivocally…found no evidence of fraud or intentional misrepresentation of the data” and deemed Séralini’s results “not incorrect” but “inconclusive.” And yet, despite the fact that inconclusiveness is not a benchmark for retraction of a scientific paper, he retracted the paper.

Fred Gould told me that Séralini’s paper should never have been retracted during an NSF-sponsored workshop on “Scientific Uncertainty and Professional Ethics: Getting from Strong Public Science to Sound Public Policy” held last December in Washington, D.C. Other scientists, environmental lawyers and journalists participating in the workshop agreed.

A lot of people feel strongly about this study. Unintended/off-target changes to crop plants can occur as a result of the genetic engineering process and it’s to look for such changes that GE crops/foods are fed to animals in these kinds of studies. In fact, scientists at your company have conducted very similar (although not as long-term) studies, with GE NK603 corn as well as other GE crop products.

Since Séralini’s results have been deemed inconclusive, we obviously don’t fully understand what may, or may not, be unintendedly going on with GE NK603 corn and glyphosate. So Séralini’s data suggest that you and your company may not “fully understand a topic you feel strongly about.”

Therefore, based on your Important Lesson #1, it is now “important to push yourself out of your comfort zone to research and learn more.” The proper scientific response to this situation is to repeat Séralini’s study, with additional control rats, in an effort to conclusively, one way or the other, establish the safety status of GE NK603 corn.

Choosing instead to declare the issue “debunked for years” not only would be unscientific but also could indicate that you are not “able to recognize that you may be basing your opinion on ideology rather than data.”

 

Posted in Biotechnology | Tagged , , , , , | 6 Comments

Scientific Uncertainty and Professional Ethics as Related to GMOs

Posted on April 22, 2017 by

Fred Gould, the chairman of the committee that produced the most recent National Academies report on GMOs, and I were invited to speak at the third and final NSF-funded workshop on the topic of “Scientific Uncertainty and Professional Ethics: Getting from Strong Public Science to Sound Public Policy,” which I mentioned in my last post: Pew Research Center Finds “Americans have Limited Trust in Scientists Connected with Genetically Modified Foods.” The workshop was held the Monday following the release of that Pew Research Center report. Dan Charles, a journalist who published a piece on the Pew report for NPR and authored a book on GMOs titled Lords of the Harvest: Biotech, Big Money and the Future of Food (Perseus Publishing, 2001), moderated our session of the workshop.

Workshop participants, comprised of scientists, journalists and environmental attorneys, were using crop genetic engineering as a case study of how scientific uncertainty is communicated, to the public and otherwise. The entire workshop was “on the record.”

In his presentation Dr. Gould reiterated a point made in his NAS report [emphasis mine]:

“With regard to the issue of uncertainty, it is useful to note that many of the favorable institutional statements about safety of foods from GE crops [such as those mentioned in Box 5-1 of the report] contain caveats, for example: ‘no overt consequences,’ ‘no effects on human health have been shown,’ ‘are not per se more risky,’ and ‘are not likely to present risks for human health.'[see * below] Scientific research can answer many questions, but absolute safety of eating specific foods and the safety of other human activities is uncertain.”

Dr. Gould also mentioned that the media often fail to mention these caveats.

(I would add that many crop genetic engineers and other vocal GMO proponents often fail to mention them as well. See, for example, The Absurdity of Claiming that “All GMOs are Safe.”)

I then briefly explained some sources of the uncertainty associated with crop genetic engineering that necessitate—for the sake of abject truthfulness—mention of such caveats.

I described how introducing DNA into an organism via genetic engineering involves biological processes that are very different from traditional cross-breeding (see my post on this topic here), and that plant scientists know that mutation of recipient plant genes and/or insertion of large chunks of vector DNA not meant to be inserted into genetically engineered (GE) crops (when using the Agrobacterium-based method) can occur at what I consider to be relatively high rates (20% to greater than 60%). (For more details about these uncertainties that we know something about please see Crop Genetic Engineering, Warts and All.)

I also mentioned our current lack of knowledge (i.e. ignorance) about the genomes of plants (and other organisms), how we don’t know the function of most of the DNA that comprises them beyond the small amount (~2-3%) that codes for proteins but that it has become clear that at least some of the oft-called “junk” DNA is actually important for proper gene expression and function. And because scientists have no control over where in a crop plant’s genome their foreign genes will be inserted (when using the genetic engineering techniques used over the last 30 years anyway), insertions could disrupt protein-coding genes (causing mutations) or non-coding regions of DNA with unknown but possibly important functions.

I then explained that the reason animal-feeding studies are carried out with GE crops is to look for possible unintended consequences–AKA pleiotropic effects–that might have occurred as a result of such scientific uncertainties. I went on to say that if such studies suggest possible negative consequences—as was the case with the peer-reviewed 2012 study of NK603 corn conducted by Séralini and colleagues, for example—the proper scientific response is to repeat the study; instead, that 2012 study was retracted for being “inconclusive” more than a year after it had been in print. (For more information on various safety-related issues with GE crops, and the controversy over the Séralini publication, see A Dearth of Life-Long Animal Studies of GE Foods and Science-based Regulation of GE Crops Requires More Long-Term Rat Feeding Studies with NK603 Corn.)

I also mentioned that, in my opinion, plant scientists have not done a good job at being abjectly honest and transparent about the scientific uncertainties associated with genetic engineering; instead many have made general statements about its precise aspects, about all GE food/crops being safe, about genetic engineering being just an extension of traditional breeding…statements that gloss over the scientific uncertainties that I believe it is the responsibility of scientists to provide to society so that society, as a whole, can make good decisions, based on all the available information, about how to use and control a technology.

I additionally mentioned that the physicist Richard Feynman expressed this same philosophy of science and technology.

After some Q&A, Dr. Gould and other workshop participants agreed that the NK603 paper by Séralini and colleagues should never have been retracted.

Dr. Gould also agreed that the technology of crop genetic engineering had been “over sold.” He additionally said, and his report indicates as well, that use of new scientific techniques, including the various “omics” technologies, should help in evaluating the safety of GE crop products.

But in response to the final question asked during our workshop session, “Do you believe that all GE crop products currently on the market are safe?” Dr. Gould answered “yes” even after I reminded him specifically about NK603.

I said that I feel the jury is still out on NK603 GE corn.

Just a couple of weeks later, more evidence (along with some controversy) came to light. “An integrated multi-omics analysis of the NK603 Roundup-tolerant GM maize reveals metabolism disturbances caused by the transformation process” was published in Scientific Reports.

I’d say the jury remains out on NK603 GE corn.

 

* More caveats, as well as means of dealing with them, are mentioned in this last example when the entire quote from the World Health Organization is referenced (rather than the partial quote cited in the NAS report):

“Different GM organisms include different genes inserted in different ways. This means that individual GM foods and their safety should be assessed on a case-by-case basis and that it is not possible to make general statements on the safety of all GM foods.

GM foods currently available on the international market have passed safety assessments and are not likely to present risks for human health. In addition, no effects on human health have been shown as a result of the consumption of such foods by the general population in the countries where they have been approved. Continuous application of safety assessments based on the Codex Alimentarius principles and, where appropriate, adequate post market monitoring, should form the basis for ensuring the safety of GM foods.”

 

 

Posted in Biotechnology | Tagged , , , , , , , , | 5 Comments

Pew Research Center Finds “Americans have Limited Trust in Scientists Connected with Genetically Modified Foods”

Posted on December 30, 2016 by

I started this blog because I strongly believe that when a technology is heading out of scientific laboratories and into the public marketplace, it is the job of scientists who use it to provide the public and its government with full and accurate information about how that technology works and what its potential pitfalls might be. Only with all of the information available about the technology, including any uncertainties or aspects about it that could be cause for concern, can societies make the best possible decisions about whether or how best to use and regulate that technology.

I am not the only scientist who feels this way.

Great scientists like Richard Feynman encouraged scientists to be abjectly honest in explaining their science to lay people (see quotes on the “About” page of this blog). More recently, participants in a workshop on “Scientific Uncertainty and Professional Ethics,” conducted by the Environmental Law Institute and sponsored by the National Science Foundation (NSF), concluded that scientists should aim to “provide all the information needed to help others judge the value of their work, rather than to steer that judgment in a particular direction.”

My aim has been “to provide all the information needed to help others judge” genetic engineering of crops and other organisms for human and animal food.

But I also started this blog because I felt other scientists were—by neglecting to mention the imprecise aspects of crop genetic engineering technology and/or evidence of problems associated with specific genetically engineered (GE, AKA genetically modified, or GM) products—steering judgment of GE crops/foods in a particular direction. I worried that scientists steering judgment in this way would some day undermine the public’s trust in scientists.

And now, according to a recent report from the Pew Research Center, that day has apparently arrived.

The authors of that report, based on a nationally representative survey of 1,480 adults conducted in May and June of this year and released on December 1st, concluded that “in general people’s views of scientists connected with genetically modified foods…are largely skeptical, or at best, tepid.” They also found that there is “considerable skepticism about scientific understanding, consensus and influences on research about genetically modified foods” with fully 80% of the Americans surveyed indicating that “scientists’ desire to help connected industries influences the research findings,” either most of the time (30%) or some of the time (50%).

I cannot say that I am surprised.

For more than 20 years now, scientists who promote the use of genetic engineering for producing food crops have largely neglected to mention the scientific uncertainties that accompany it, or even the fact that there have been commercialized GE crops that were found to be problematic and then pulled off the market. (See “Crop Genetic Engineering, Warts and All” for more information on these subjects.) Some have also neglected to mention, or have otherwise misled the public about, their ties—financial and otherwise—to the ag biotech industry, as reported in The New York Times.

Rather than providing all the information needed to help others judge this technology, a number of plant scientists have instead participated in efforts to suppress reports on specific GE products that suggest there could be cause for concern—the most egregious instance being the ruckus raised by plant scientists over a peer-reviewed animal-feeding study of NK603 GE corn and the herbicide glyphosate which led to the paper being retracted, more than a year after it was published, because it was deemed “inconclusive” by the journal’s editor-in-chief. And nearly all scientists (see my response to one here) who speak publicly in support of agricultural genetic engineering have made sweeping generalizations about the “safety” of all GE foods/crops.

To me, these actions seem meant to steer judgment in a particular direction.

Rather than the standards of abject honesty that Feynman encouraged scientists to meet, they bring to mind the advice of another Nobel laureate, André Gide, who said: “Believe those who are seeking the truth. Doubt those who find it.”

Based on the Pew Research Center report, the American public has taken Gide’s advice in regard to scientists connected with genetically engineered foods.

Hopefully, those scientists will take the report’s findings seriously, reevaluate and incorporate more abject honesty into their current “outreach” efforts, and start the long, hard process of (re)building trust with the public.

Posted in Biotechnology | 6 Comments

Would Nobel Laureate Richard Feynman Have Signed that GMO Letter?

Posted on August 9, 2016 by

From what I have read about him, I am pretty sure that Richard Feynman would not have signed the recent letter in which a large percentage of our living Nobel laureates urged Greenpeace to end its opposition to genetically modified organisms (GMOs).

Feynman was awarded the Nobel Prize for Physics in 1965 for his basic research in quantum electrodynamics. He also knew and thought a lot about technology–i.e. the application of basic science–because of his work on the Manhattan Project during World War II. (He was also the guy who famously dropped a Shuttle o-ring into a glass of ice water to demonstrate a deadly flaw after the Challenger tragedy.)

In his book The Meaning of It All: Thoughts of a Citizen-Scientist, Feynman described the role he believed scientists should play when science moves out of the lab and into real world applications such as–in the case of genetically engineered (GE) foods–onto people’s dinner plates. Feynman said that scientists should explain the science behind the technology to the public, and in doing so they should not “only tell what’s true but…make clear all the information that is required for somebody else who is intelligent to make up their mind” about the technology. He was very adamant that scientists should be abjectly honest when carrying out this duty for the public, i.e. they should not just tell the truth, but the whole truth and nothing but the truth when explaining their science.

He also said that technology “carries with it no instructions on how to use it…[and that how to control technology] is something not so scientific and is not something that the scientist knows so much about.”

So, based on these thoughts of Citizen-Scientist Feynman, I don’t think he would have signed that GMO-promoting “Laureate Letter” for at least two reasons.

1) The letter is not an attempt to explain the science of genetic engineering to the public, but rather a collection of general statements that does not convey the whole truth about (among other things): the technology’s possible risks, who is currently responsible for declaring them “safe” and the results of animal-feeding studies. (For a more thorough review of these issues please see “Statement: No scientific consensus on GMO safety,” signed by another group of scientists.)

2) The letter delves instead into the realm of control/regulation of the technology, the realm Feynman described as one “not so scientific” and “not something that the scientist knows so much about.”

Granted, even though the Laureate Letter-signers are not (at least to my knowledge) experts in crop genetic engineering, they are certainly entitled to their opinions as citizens on how this powerful technology could and should be applied to our global food systems.

But I wonder if they know that over the decades that we have been debating how to control/regulate this technology, most of the scientists who are experts in crop genetic engineering have not been telling the public the whole truth about it. The consequent dearth of abject honesty about the science behind the technology of genetic engineering has, in my opinion, confounded people who are intelligent in making up their minds about GMOs.

Take the title, “Laureates Letter Supporting Precision Agriculture (GMOs),” as exhibit A. The letter organizers are obviously equating GMOs with “Precision Agriculture,” consistent with the fact that most proponents of GE crops over the last 25 years have touted the “precision” of crop genetic engineering.

But the whole truth includes the fact that there are many imprecise aspects of this technology as well; it’s just that most GMO proponents never mention them, at least not in public.

For example, with both of the methods that have been used to insert foreign genes into the GE crops we in the U.S. have been eating since the mid 1990s, genetic engineers have no control over where in the plant’s genome the foreign genes will be inserted and, it turns out, those foreign genes can land in and insertionally mutate protein-coding genes in recipient plants at rates of 27-63%. These mutation rates are high enough that the Agrobacterium-mediated method of genetic engineering was used by plant scientists in a largely successful effort to mutate (and tag) every protein-coding gene in the Arabidopsis thaliana genome.

Somaclonal variation, inadvertent insertion of “extra” vector DNA and unintended changes in the types and numbers of endogenous sRNAs expressed in GE plants are other examples of the “imprecision” inherent in the technology of crop genetic engineering as it has been practiced over the last 25 years.

Adverse consequences of some of these imprecisions, like inserted vector DNA sequences or mutations in endogenous protein-coding genes (at least in crops for which complete genome sequences are available), can be identified in crop plants that have been genetically engineered and give genetic engineers the option to eliminate such material from their product pipelines. But, because we just don’t know enough yet about plant genomes, physiology, biochemisty, etc., we can’t do the same for others. In fact, it is because of the imprecision inherent in the technology of crop genetic engineering, and the unexpected, unintended consequences that might occur as a result of them, that GE food crops are fed to rats…to check for possible negative consequences that cannot be anticipated.

Additionally, and despite the claim in the Laureate Letter that “There has never been a single confirmed case of a negative health outcome for humans or animals from [the] consumption” of a GE food, there are actually a few peer-reviewed scientific articles that have described negative health outcomes in animals fed some GE crop-derived foods. (See, for example, articles in The Lancet and Archives of Environmental Contamination and Toxicology. Also of interest, the U.S. corn crop was monitored for seven years after StarLink™ corn was removed from the market until levels of the GE protein in it, which posed concerns related to human allergenicity, were deemed below levels of concern/detection.)

But, instead of following up on these studies to confirm or refute their results–as the scientific method I was taught dictates (and, it seems to me, the government agencies responsible for “regulating” these products should require)–plant molecular biologists and others with similar conflicts of interest in relation to GE crops have instead called for retractions and vilified study authors. In one infamous case of a “negative” study involving Monsanto’s NK603 corn variety, a peer-reviewed paper in print for over a year in a respected international journal was retracted for mere “inconclusiveness.” (NK603 is a good example of the imprecision of genetic engineering at the molecular level, as described in an earlier post on this blog.)

One could conclude that crop/plant scientists who call for retractions instead of experiments to confirm/negate initially published “negative” results are trying to prevent others from being abjectly honest in explaining the science behind genetic engineering to the public.

And I just don’t think that Richard Feynman would have been okay with that.

Technology is a very different thing than basic science. Technology, as Feynman described it, “carries with it no instructions on how to use it, whether to use it for good or for evil.” And that, along with the imprecisions inherent in the technology of crop genetic engineering, is why each GE food crop should be regulated on a case-by-case basis.

The World Heath Organization agrees: “Different GM organisms include different genes inserted in different ways. This means that individual GM foods and their safety should be assessed on a case-by-case basis and that it is not possible to make general statements on the safety of all GM foods.” (See my post on this subject, and references cited therein.)

Golden Rice? It’s developers have not even submitted it to regulatory agencies for safety assessment yet. And the hold-up has not been Greenpeace but the fact that the GE rice varieties developed thus far have yields deemed too low for farmer acceptance.

So what is needed now is higher yielding GE Golden Rice varieties, and abjectly honest scientific data assessing their safety, to submit to regulatory agencies in the Philippines, Pakistan, etc.

Not the general views or opinions of superlative basic scientists about what is still a hypothetical product of the technology of genetic engineering…

Not cherry-picked pieces of pro-GMO information…

And certainly not the emotion-packed suggestion about a “crime against humanity” that was used to close the Laureate Letter.

I can only imagine what Richard Feynman would have had to say about that!

Posted in Biotechnology | Tagged , , , , , , , , , , , , , | 2 Comments

The 2016 NAS Report on GE Crops (GMOs)

Posted on May 22, 2016 by

The National Academy of Sciences, Engineering and Medicine (NAS) report, called Genetically Engineered [GE] Crops: Experiences and Prospects was released on Tuesday. The report is “intended to provide an independent, objective examination of what has been learned since the introduction of GE crops, based on current evidence.”

My first response to this report is to commend the Chairperson of the 20-person committee that compiled it, Dr. Fred Gould, professor of entomology at North Carolina State University, for making this statement in its preface: “We received impassioned requests to give the public a simple, general, authoritative answer about GE crops. Given the complexity of GE issues, we did not see that as appropriate.”

I agree. Simple, general answers about GE crops, even (especially?) when given by persons considered authoritative on the complex subject of genetic engineering, have certainly contributed to the polarization of the public debate over this technology. That’s because, as with any complex issue, the devil is in the details and generalizations without the devilish details–particularly when they support only one end of a polarized spectrum like the one encompassing this debate–can seem more like propaganda than like anything the public would want to hear from a group of scientific experts.

What we want to hear from an NAS committee like Dr. Gould’s is conclusions based on well-designed studies, well-executed by researchers who have no conflicts of interest that might affect the interpretation of their results.

And yet, despite Dr. Gould’s statement, this NAS report contains statements about GE crops like this one: “Although the design and analysis of many animal-feeding studies were not optimal, the committee’s examination of the large group of experimental studies available provided sufficient evidence that animals were not harmed by eating food derived from GE crops.” (pg 9, pre-publication copy)

That doesn’t sound like a ringing endorsement of the safety of GE crops for animals to me. In fact, it sounds like a simple, general, authoritative answer…and one which appears to be based (at least in part) on many sub-optimally designed and analyzed studies to boot!

And the reason animal-feeding studies are carried out with GE crops in the first place is to look for unintended, unexpected changes that can occur as a result of the process of genetic engineering. That is why the products of genetic engineering should be assessed on a case-by-case basis…and another reason to question the usefulness of general statements about the safety of GE crops generally.

And in spite of its simple, general, authoritative statement about animal-feeding studies, the committee was obviously concerned with “equivocal results” as evidenced by the following Recommendations on Human Health Effects included in the report’s Summary:

“In cases in which early published studies produce equivocal results regarding health effects of a GE crop, follow-up experimentation using trusted research protocols, personnel, and publication outlets should be used to decrease uncertainty and increase the legitimacy of regulatory decisions. 

Public funding in the United States should be provided for independent follow-up studies when equivocal results are found in reasonably designed initial or preliminary experimental tests.” (pg 11, pre-publication copy)

Now I obviously cannot speak for the NAS committee…but the “equivocal results” that immediately came to my mind as I read the committee’s recommendations are those associated with a paper published by Dr. Gilles Eric Séralini and colleagues and originally published in Food and Chemical Toxicology, a respected, peer-reviewed international journal; those results suggested that rats fed Monsanto’s NK603 GE corn “long-term” (over the course of their lives) had experienced various negative effects.

More than a year after that paper had been in print, Séralini’s manuscript and raw data were scrutinized by the Editor-in-Chief of Food and Chemical Toxicology who “unequivocally…found no evidence of fraud or intentional misrepresentation of the data.” The journal deemed Séralini’s results “not incorrect” but “inconclusive” because “the number of animals in each study group and the particular strain” of rat used posed “cause for concern;” the paper was subsequently (and very controversially) retracted.

I believe that this study by Séralini of NK603 GE corn warrants “follow-up experimentation using trusted research protocols, personnel, and publication outlets.”

Perhaps the NAS committee (in consensus) thinks so too?

 

Posted in Biotechnology | 3 Comments

US Food Standard: Reasonable Certainty of No Harm

Posted on April 13, 2016 by

There seems to be some confusion among people I have interacted with recently as to whether the standard for food safety in the United States is one of “relative safety,” i.e. one that permits foods, food additives or foods with pesticide chemical residues to be marketed as long as their benefits have been deemed to exceed their risks, or one that focuses on “safety” (without regard to benefits or regulatory costs) and requires a “reasonable certainty of no harm” for all products in the American food supply.

So I asked a representative from the US Environmental Protection Agency (EPA) during the public engagement session on how the products of agricultural biotechnology are regulated in the US (held at UC Davis on March 30 in response to a White House request for a review of the US “Coordinated Framework” for regulating GMOs):

What is the US standard? “Relative safety” or  “safety”?

His answer (not a direct quote): According to the US federal Food, Drug, and Cosmetic Act (the Act), the primary food safety statute in the United States, the standard for food safety is “reasonable certainty of no harm,” not relative safety.

And this standard applies to all foods in the US, whether GE, organic and/or produced using industrialized agriculture.

In researching this topic, however, I can see how it could be seen as confusing.

For one thing, the 1906 federal Food, Drug and Cosmetic act (345 pages long and amended multiple times, starting in 1958) doesn’t provide much of a definition of “safety.” This is how “safety” is defined in it: The term ‘‘safe,’’ as used in paragraph (s) of this section and in sections 409, 512, and 721, has reference to the health of man or animal.

That’s it.

It also appears, according to an article in the Ecology Law Quarterly by Daryl M. Freedman, that the US Food and Drug Administration (FDA) and various US courts do not necessarily adhere well to this standard of “reasonable certainly of no harm” (at least not back in the 1970s!).

But I think Freedman’s article is still amazingly relevant to not only regulation of GMOs but to other food-related issues being debated today as well.

For example, the author quotes members of Congress from back in the times various amendments to the Act were being considered, shedding light on the concerns expressed by congressional members about regulatory costs, the limits of science, etc.

Despite these concerns, however, Congress still supported the strict standard of safety: “reasonable certainly of no harm.”

For anyone interested in the safety of the American food supply and how we regulate foods, produced using new biotechnologies or otherwise, I highly recommend this article…because we should know where we have come from so that we can more wisely decide where we should be heading.
Posted in Biotechnology | Tagged , , , , , | 2 Comments

Preparing for Regulating Future Products of Biotechnology by Learning from the Past

Posted on March 30, 2016 by

In response to a memorandum issued by the Executive Office of the President last July, representatives of the agencies that regulate the products of biotechnology in the United States–FDA, EPA and USDA–participated in a meeting at UC Davis today titled “Modernizing the Regulatory System for Biotechnology Products.”

The meeting was well attended, mostly by folks in the biotech industry. But there were a few of us who were more concerned with transparency and protecting health and the environment than with reducing regulatory burdens and inhibiting innovation. I count among the former Professor Albert C. Lin of the UC Davis School of Law.

Here is the text of the public comment I delivered at the meeting:

My name is Belinda Martineau. My Ph.D. is in plant molecular genetics and 25 years ago I spent 4 years interacting with FDA scientists as the agency was first learning 1) how crop genetic engineering worked, 2) what risks it might pose, and 3) how best to regulate these new food and feed products. These interactions were part of gaining regulatory approval of the first whole GE food to be commercialized, the Flavr SavrTM tomato, developed at Calgene where I was working at the time.

This tomato still serves as a good example for how to modernize the regulatory system for biotechnology products.

We knew from the get-go that the GE process could result in unintended, unexpected changes in GE plants via insertional mutations or somaclonal variation, and informed FDA accordingly. That’s why animal feeding studies are conducted with GE foods, and why FDA should require follow-up of the feeding studies carried out with NK603 corn.

We were still dialoging with FDA after the 1992 policy was published when FDA scientists asked us to make sure only the DNA we intended to insert in our tomatoes had been inserted. To our surprise we found that 20% of the time our entire minimally characterized “vector backbone” sequences had been inserted too. This is still a problem when using the agro-based method—although I learned recently of a GE developer who was not initially aware of this problem—and its a reason why regulation of GE products should be required by FDA.

We also didn’t understand exactly how the gene inserted into Flavr Savr tomatoes worked in 1994 when it was commercialized. It turned out to be RNA silencing, discovered years later.

We now know that alterations in endogenous versions of these small regulatory RNAs can be another source of unintended changes in GE crops, and even the new CRISPR-Cas9 process can have off-target effects.

Genetic engineers currently cannot prevent these unintended processes from occurring; but they can look afterward for unintended, unexpected changes in a GE crop, such as an unapproved food additive (as is mentioned in footnotes to many of [the hypothetical case studies that were reviewed during this meeting today]).

FDA should not just “strongly encourage” developers to voluntarily consult with the agency about these and other issues; because of the possibility of these unintended changes, the fact that a food or feed crop has undergone GE should trigger mandatory pre-market federal regulation.

As mentioned earlier, FDA regulated the antibiotic-resistance protein produced in Flavr SavrTM tomatoes as a Food Additive. Why hasn’t the FDA considered other foreign proteins expressed in other GE crops—insecticidal proteins, for example—as food additives as well?

Calgene voluntarily labeled the Flavr SavrTM tomato in 1994 and it sold like hot cakes. I am happy to see that more and more food companies are now, finally, doing the same. But for the Administration to attain its goal of ensuring public confidence in the regulatory system and improving its transparency, it should require mandatory labeling of all GE foods.

And here is the text of the part of my comment I could not fit into the 3 minutes allotted for each comment:

I also hope the federal agencies have learned from actual (as opposed to hypothetical) commercialized GE products that have been problematic during the last 20 years, like StarLink™ corn, Bt176 corn, and NK603 corn.

But if so, why wasn’t human allergenicity mentioned in the case studies after concern about StarLink corn led to monitoring US corn crops for 7 years after that product was removed from the market?

Will pollen from new Bt crops be tested for their toxicity to Monarch butterfly larvae prior to commercial release, in light of the toxicity of Bt176 pollen to those non-pest insects?

Is regulation of GE crops no longer based solely on “intended use” as a result of the case of avidin-producing corn?

And again, hopefully, FDA will require additional animal feeding studies with NK603 corn in an effort to provide conclusive evidence, one way or another, about the safety of that GE product.

Posted in Biotechnology | Tagged , , , , , , , | 1 Comment