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!

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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?

 

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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.
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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.

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The Good News About the Bad Effort in Congress to Thwart GMO Labeling by States

Posted on February 29, 2016 by

The Editorial Board of The New York Times declared a few days ago that it “is a bad idea” for the United States Senate to join the United States House of Representatives in trying “to make it harder for consumers to know what is in their food by prohibiting state governments from requiring the labeling of genetically modified foods.” The NYT EB went on to say that “lawmakers and the Obama administration should oppose” this bill and that “[t]here is no harm in providing consumers more information about their food.”

I agree.

And I would add that, as reported earlier in The NYT, the CEO of Campbell Soup Company has stated that “…establishment of a national mandatory labeling standard to take effect over a period of time would allow companies to work the changes into their business operations with little cost [emphasis added].” Consumers Union has also concluded that the cost of labeling genetically engineered (GE) foods would be minimal.

The NYT EB also cited the numerous polls–some two dozen–on this general subject of GE labeling that have been conducted in the United States since 1992 (two years before the first GE crop was commercialized); and in all of them the vast majority of Americans (~70-96%) indicated that they want GE foods and GE ingredients labeled as such.

That is the good news…The New York Times is in favor of labeling GE foods and food ingredients.

My question is why has it taken so long for a major U.S. newspaper to take a stand in favor of what the vast majority of Americans have indicated they wanted for some two dozen years?

My short answer is that having a member of “Big Food” like Campbell Soup not only support mandatory GE/GMO labeling but also state that companies could label GMO ingredients “with little cost” is likely a big factor in turning this two-decades-old tide.

But what made Campbell Soup change its stance? After all, according to The NYT, “Campbell joined other major food companies in fighting efforts to impose mandatory labeling in California and Washington State, spending more than $1 million, according to the Environmental Working Group. It is also a member of the Grocery Manufacturers Association, a trade group that has spent millions trying to get a bill passed in Congress that would make labeling voluntary and pre-empt state labeling efforts.”

My guess is that the delay of the U.S. media and U.S. food companies in coming to what I believe is the “right” decision for a democratic, capitalist society like the United States has something to do with “the forces that cause scientists and other experts to mislead us,” a subject explored by David H. Freedman is his book appropriately titled Wrong. Freedman has been “covering science, business and technology [for Scientific American, for example] for 30 years.”

The bigger subject, of how societies decide whether and how to adopt new technologies, is an important one. For crop genetic engineering, this process has been going on for nearly a quarter century. New “genetic engineering” technologies are now being introduced. It’s time to take stock of what we (might) have learned from the introduction of what, for want of a better term, I shall refer to as “traditional genetic engineering.”

Stay tuned.

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Campbell Soup or Monsanto? Who Do You Trust?

Posted on January 25, 2016 by

How does a company build trust? Campbell Soup and Monsanto appear to be going about it in quite different ways.

As reported in The New York Times, the Monsanto Company filed a lawsuit against California’s Office of Environmental Health Hazard Assessment (OEHHA) last Thursday in an effort to prevent that state agency from listing glyphosate, the active ingredient in Monsanto’s flagship herbicide Roundup, as known to the state to cause cancer.

OEHHA is the government agency in California that implements the Safe Drinking Water and Toxic Enforcement Act of 1986 (AKA Proposition 65). This California state law requires that substances identified as human or animal carcinogens by the International Agency for Research on Cancer (IARC), an agency of the World Health Organization (WHO), be included on the state’s list.

As reported in The Lancet Oncology, the IARC had concluded last March that glyphosate causes cancer in lab animals and is also a probable human carcinogen.

Reuters reported soon thereafter that Monsanto was seeking to have the IARC’s report retracted.

Apparently, however, neither that tactic, nor Monsanto’s effort to convince the OEHHA to withdraw its proposal to list glyphosate as a known carcinogen, worked. Hence, the lawsuit: Monsanto Company v. Office of Environmental Health Hazard Assessment, et al., filed in the Superior Court of the State of California, County of Fresno.

According to Reuters, Monsanto argues that providing a “clear and reasonable warning” to consumers that glyphosate is known to cause cancer (a requirement that would go into effect upon listing) would damage its reputation and violate its First Amendment rights (presumably its right to refuse to “speak” about glyphosate in this manner).

I can’t help but contrast this argument to Campbell Soup Company’s commitment to both transparency and putting its customers first (expressed earlier this month when it called for mandatory federal labeling of foods “that may contain genetically modified organisms”).

“We put the consumer at the center of everything we do. That’s how we’ve built trust for nearly 150 years, explained Campbell’s President and CEO Denise Morrison in a message she delivered to Campbell employees in early January.

In my opinion, the Monsanto Company has a lot to learn about trust. Calling for retractions, refusing to label, and suing the California OEHHA over enforcement of a state law are certainly not going to engender it.

Better to follow in the footsteps of a company that has been around a while longer than Monsanto…the Campbell Soup Company. “For generations, people have trusted Campbell….” It’s time for the rest of “Big Food,” and the agricultural biotechnology industry in general, to put consumers first and start (re)building trust.

That game plan is bound to improve a reputation much more than suing California OEHHA.

 

 

 

 

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Kudos to Campbell Soup for Supporting Mandatory Federal GMO Labeling

Posted on January 10, 2016 by

As announced in a company press release and reported by The New York Times on January 8, Campbell Soup Company is calling for mandatory federal labeling of foods “that may contain genetically modified organisms (GMOs)….“[Such foods/ingredients are also known as genetically engineered, or GE, food/ingredients.]

As explained in the message Campbell’s President and CEO Denise Morrison delivered to Campbell employees, this change of heart is based on the company’s commitments to both transparency and putting its customers first. As Ms. Morrison explained:

“We put the consumer at the center of everything we do. That’s how we’ve built trust for nearly 150 years. We have always believed that consumers have the right to know what’s in their food. GMO has evolved to be a top consumer food issue reaching a critical mass of 92% of consumers in favor of putting it on the label.”

Kudos to Ms. Morrison and Campbell Soup Company for putting customers first!

Ms. Morrison also told The New York Times that “complying with Vermont’s law was expensive but that establishment of a national mandatory labeling standard to take effect over a period of time would allow companies to work the changes into their business operations with little cost. She noted that adoption of the 1990 Nutrition Labeling and Education Act, which required companies to add nutritional information to their labels, did not significantly raise costs.”

The President and CEO of one of the oldest and most successful companies in the US has thus verified that complying with a mandatory label at the federal level would “not significantly raise costs.”

Campbell’s has prepared the following label for SpaghettioO’s in order to comply with Vermont’s labeling law: “Partially produced with genetic engineering. For more information about GMO ingredients, visit WhatsinMyFood.com.”

That’s very similar to how Calgene, Inc. launched the world’s first GE whole food, the Flavr Savr™ tomato, back in 1994. Calgene’s label read: Grown From Genetically Modified Seeds. MacGregor's sticker

Back then, however, we used a 1-800 number (in our Point-of-Purchase brochure) instead of a website to provide consumers with more information .Tomato brochure 1-800-34TOMATO

And that transparency was well received by consumers…those GE tomatoes flew off grocery shelves. A grocer in California limited sales to 2 GE tomatoes/person/day when supplies were limited, and sold gift boxes of GE tomatoes during the holidays.

Granted, the lack of transparency by subsequent developers of GE foods and, worse, the multi-million dollar efforts of the Grocery Manufacturer’s Association (GMA) and Big Food to squash state initiatives to establish mandatory labels for GE foods (initiated due to lack of federal action on the subject) have contributed to a more negative climate for GE foods in the US now than when the Flavr Savr™ was first commercialized.

But transparency is still the best policy. And the only way that the ag biotech industry will ever earn the trust of the American people is by being transparent with them.

Ms. Morrison and the Campbell Soup Company have made a politically brave and ultimately smart business move. Let’s hope Big Food and the GMA follow suite…and that the FDA and USDA take note.

 

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