US Food Standard: Reasonable Certainty of No Harm

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

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

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?

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

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”

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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The Products of GE Technology Must be Assessed for Safety on a Case-By-Case Basis

Mark Lynas was at it again in an opinion piece in The New York Times last week, making claims once more about a so-called “worldwide scientific consensus on the safety of genetic engineering,” and calling those 17 countries in Europe that have announced bans on the cultivation of genetically engineered (GE) crops, the “Coalition of the Ignorant.”

But it is Lynas who appears to be ignorant of the fact that, as I explain in my letter to the editor published in today’s Times, genetic engineering is a technology and technologies are only as safe as they are used, each time they are used.

Therefore, suggesting that there is a scientific consensus “on the safety of genetic engineering” generally, or on “the products of crop genetic engineering technology” en masse is not only not scientific, it is illogical.

All of the products of the technology of genetic engineering should be assessed for safety on a case-by-case basis.

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GMOs: All Facts, No Fiction

I participated in two panel discussions on genetic engineering called “GMOs: All Facts, No Fiction” that were sponsored by the University of California’s Global Food Initiative in 2015.

One was held at UC Davis on November 3rd and the other at UC Riverside on November 4th. You can find a recording of the one on November 4th here (scroll down to: Public Lecture Focuses on “GMOs: All Facts, No Fiction”).

For more information, please see the links below.


UCR GMO-Poster-HighQuality

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Genetic Engineering is Very Different Than Traditional Breeding

The United States National Academies of Sciences, Engineering, and Medicine have established a committee to study the “economic, agronomic, health, safety, or other impacts of genetically engineered (GE) crops and food.” The committee’s results may be used to reassess the way GE crops, animals and foods are regulated in the U.S. and, hopefully, to improve that loophole-filled “regulatory” process. (For more information on the committee’s purpose and history, or for submitting comments, please see the committee’s website.)

Now, while this national review is taking place, is a good time to review the differences between genetic engineering and traditional breeding. The following lists serve to contrast the biological processes that underlie these technologies.

Traditional Breeding (i.e. its biological basis: sexual reproduction):

  • Evolved over eons (along with “checkpoint” mechanisms to eliminate mistakes)
  • Occurs between closely related organisms
  • Genetic exchange occurs in reproductive cells,
  • and occurs between related chromosomes,
  • through homologous recombination
  • Amount of DNA and spacing between genes remain the same


(Traditional) Genetic Engineering (particularly of crop plants):

  • Is human-made, recently (and subject to human and other errors)
  • Involves any gene from any organism (alive or dead) or synthesized in a lab
  • Occurs in somatic cells
  • Insertion into chromosomes occurs “randomly”
  • Causes insertional mutation of recipient’s genes at rates of 27-63%
  • Gene spacing and amount of genomic DNA are altered
  • Involves “selectable marker” genes (e.g. kanamycin-resistance gene)

And because genetically engineered cells–in and of themselves–are of no use to agriculture, they must then be coaxed into becoming whole, fertile plants through another biological process called regeneration. And another form of mutation, called somaclonal variation, can occur during the regeneration process.

And, finally–to be of real use to agriculture–a genetically engineered, regenerated, fertile plant must be traditionally bred into a commercially viable crop variety.

To sum, there are multiple biologically relevant differences between the processes of traditional breeding and genetic engineering of crop plants; and the “process” of genetic engineering actually comprises multiple, different processes.

Therefore, genetic engineering is very different than traditional breeding. And, until proven otherwise, it should be assumed that the risks associated with these technologies must be different as well.

As a scientist trained in biology and genetics, I see no way other way to look at it.

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California EPA to List Glyphosate as Known to the State to Cause Cancer

In case you haven’t already heard…

The California Environmental Protection Agency (EPA) Office of Environmental Health Hazard Assessment (OEHHA) has posted notice of its intent to list glyphosate, the active ingredient in Roundup® and other related herbicides, as “known to the state to cause cancer.”

As stated by the OEHHA: “[California] law requires that certain substances identified by the International Agency for Research on Cancer (IARC) be listed as known to cause cancer under Proposition 65 [AKA California’s Safe Drinking Water and Toxic Enforcement Act of 1986]….OEHHA [has determined that] Tetrachlorvinphos, parathion, malathion, and glyphosate each meet the requirements for listing as known to the state to cause cancer for purposes of Proposition 65.”

The use of glyphosate, and the acreage to which it is applied, has increased dramatically since the first crops genetically engineered (GE) to be resistant to this herbicide were first commercialized in 1996. And new glyphosate-resistant crops continue to be commercialized. The U.S. Department of Agriculture (USDA) recently deregulated new GE corn and GE soybean crops that can survive being sprayed with both glyphosate and another pesticide, 2,4-D, pesticides that would kill their non-engineered relatives…and the U.S. Environmental Protection Agency (EPA) approved the herbicide cocktail, Enlist Duo™, comprised of those two pesticides that can be sprayed on those GE crops with impunity. (For more information, see this previous post of mine.)

So a chemical (soon to be) “known to the state [of California] to cause cancer” is being sprayed on vast acreages of farmland, not only in California, but throughout the United States and in many other parts of the world.

Hopefully, U.S. EPA will similarly take the recent IARC publications into account and take another long, hard look at the widespread use of glyphosate in the United States.

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GMOs and Democracy

The start of a comment made in response to my last post—“Maybe it is undemocratic but in this case…”—still bothers me.

It also worries me when I hear plant molecular biologists say: “I would normally be in favor of labeling, but not when it comes to GMOs.”

Why should anyone suspend democracy, and the capitalist principle of letting the consumer/marketplace decide whether a new product will succeed or not, for the sake of food products of genetic engineering?

Are genetically engineered (GE) food crops such a great innovation that the United States should set aside basic American principles to ensure that they end up on American dinner plates?

GE food products and ingredients have now been commercially available—in the U.S. and elsewhere—for more than two decades. What are the results of this social experiment so far?

According to Colin Macilwain, in an opinion piece published in the scientific journal Nature recently:

“Five-sixths of [the world’s] GM acreage is in the Americas. The rest consists mostly of non-food crops (mainly cotton) grown in India and China. Little of the harvest is in nations that need improved yields to feed themselves. Twenty years in, the GM strains currently under cultivation are still best suited to the needs of large-scale industrial farmers who can afford the seeds and inputs that accompany them.”

That is my take as well…although I would add that much of the yellow GE corn grown in places like China and the Philippines is also fed primarily to animals as opposed to humans.

These “results” appear to indicate that the citizens of the United States, as opposed to those in developing countries with food shortages, comprise many (if not most) of the humans on the planet who are actually eating GE foods. And, as opposed to the citizens of the more than 60 other countries in the world that require foods containing GE ingredients to be labeled, citizens of the United States, one of the most democratic nations on Earth (arguably it seems), don’t have that right…despite the fact that in poll after poll 80-90% of American citizens have indicated they want these foods labeled.

There is something terribly wrong with this picture!

As an American consumer myself, just the fact that genetic engineering has been used primarily in support of unsustainable, industrialized agriculture, combined with the fact that its promoters—including academic scientists, corroborated recently by the New York Times—don’t want me to know whether the foods I buy in my grocery store contain GE ingredients…are reasons enough, in my mind, to vote against such foods with my pocketbook. That I was once a genetic engineer involved in bringing a GE food to market makes me that much more disappointed in the non-tranparent, unsustainable trajectory the ag biotech industry has taken since I left the industry in 1995.

In the United States that I grew up in, these types of reasons–or any others consumers conceived of–were among those that buying decisions were based on. If I didn’t like a product, its packaging, or…whatever, I was free to forego purchasing that product. Back in the day, it was up to the sellers to convince consumers to become their buyers.

And now, after having had two decades to demonstrate the great “potential” of this powerful technology, but without having to take consumer demand into account while doing so, the ag biotech industry has relatively little to show for it…except a public that—for lack of: assurance of long-term safety, GE products that consumers could get excited about, and/or transparency—has only become more and more wary of the whole biotech food endeavor.

It may now be time to pay the piper.

According to Macilwain, there are decisions pending in countries like “Scotland, Germany, France, Italy and others to stand up to corporate pressure and keep GM crop technology out of the European country-side.” And even in the U.S., “John Holdren, science adviser to US President Barack Obama, [has, as of July 2, 2015,] directed regulators to revisit the U.S. framework for regulating agricultural biotechnology.”

Two decades in, it’s time to reassess this technology…why and how it is used, and how it is regulated and marketed.

And at this juncture, the truly democratic nations of the Earth would do well to heed Macilwain’s reminder: “good risk management involves early communication with the public and the careful weighing of many factors, not just scientific risk assessment.”

As for the U.S., being transparent (via labeling, etc.), conducting the long-term studies necessary to reassure the public about GE crops (starting with NK603 GE corn) and having regulatory agencies require case-by-case assessment of new GE products will, in my opinion, all be necessary for there to be any chance of turning public concern around.

And unless public concern is turned around, who knows whether the “potential” of genetic engineering evidenced by projects like Golden Rice (which, if all goes well, may be ready for market in 3-5 more years) will ever be realized?

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