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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Tell the US House of Reps: Defeat HR1599 Because It’s Downright UnAmerican!

I just signed a petition asking members of the U.S. House of Representatives to vote down HR 1599, the deceptively named “Safe and Accurate Food Labeling Act,” which would make it illegal for state governments to pass GMO labeling laws or regulate GMOs in other ways.

The vote is scheduled to occur tomorrow, July 23, 2015.

Here’s the comment I made when I signed the petition:

I am a former genetic engineer, but no matter the subject matter, it is outrageous that the federal government of this great nation is even considering a bill that would negate the will of its people, at the grass roots and state levels, and allow any industry to continue to hide its products from American consumers. It’s supposed to be of, for and by the people…remember?

If you agree that Americans should have the right to know what’s in the food they buy in grocery stores, and when the vast majority of Americans (80-90%, depending on the poll) want to know whether GMOs are in their food labeling those foods should be mandatory, and when the citizens of more than 60 other countries already have this information that Americans should have it too…

then I urge you to let your US representatives know how you feel by signing a petition like the one here.

For more information here’s an article in the Boston Globe supporting the idea that HR 1599 should be defeated and Americans should get to decide for themselves about GMOs via labeling, and another in the Huffington Post by Fedele Bauccio, CEO of Bon Appétit Management Company, indicating that labeling GMOs is just good business.

This is not just about GMOs. This is about our democracy.

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Let USDA APHIS Know that GMOs Should be Regulated

USDA’s Animal and Plant Health Inspection Service (APHIS) has been regulating genetically engineered (GE) crops over the last two decades based on whether development of those products involved use of organisms deemed “plant pests.” (Whether that strategy has been science-based is debatable, in my opinion.)

In light of the fact that more and more GE organisms are now being developed without the use of “plant pests,” the agency is seeking input on how APHIS should regulate the products of biotechnology from here on out. The deadline for submitting comments is Monday, June 22, 11:59PM Eastern Time.

I encourage anyone interested in how GMOs are regulated in the United States to submit comments.

I just submitted mine to the agency; here is a copy of them:

I am a molecular geneticist and former crop genetic engineer. Thank you for seeking input on how APHIS should regulate the products of biotechnology. The following are my comments addressing the four question areas that APHIS is seeking input on.

1. APHIS should regulate biotechnology products based on the fact that they were created using biotechnology processes because any individual biotechnology product (as currently produced) may present potential risks that can not be anticipated based on the product’s intended characteristics; these risks relate to unexpected, unintended changes that could result from insertional mutagenesis, unintentional insertion of vector “backbone” sequences, or off-target effects. The criterion used to determine what APHIS regulates should therefore be the fact that the organism was created using a biotechnology process like genetic engineering, which includes processes that utilize the biolistic gun, Agrobacterium tumefaciens and RNAi technologies, as well as the newer CRISPR-related methods. Until scientists know more about genomic processes governing global gene expression and how those processes might be disrupted by the processes of biotechnology, all biotechnology products should undergo some level of APHIS regulation.
2. Yes, APHIS should add noxious weed provisions to its biotechnology regulations. The intended characteristic of herbicide tolerance that has been genetically engineered (GE) into many biotechnology products grown on vast acreages of U.S. farmland over the last two decades, has, predictably, substantially contributed to the significant noxious weed problem facing many American farmers (and many other farmers around the world). APHIS should therefore require any biotechnology product designed to be tolerant to any herbicide to undergo additional regulatory oversight by APHIS. This oversight should include monitoring herbicide-resistant crop systems for their potential to foster herbicide-resistant weed populations and imposing appropriate control measures if monitoring reveals a problem, as well as regulating direct and indirect harms from these systems to the livelihoods of GE, non-GE and organic farmers, to biodiversity generally and to public health. APHIS should consider protection goals that align with making American agriculture more sustainable, more environmentally friendly and less in need of future “solutions” to GE-produced noxious weed problems that involve additional GE crops engineered to be tolerant of more noxious herbicides.

3. My understanding is that the 2008 Farm Bill gives USDA additional authority to regulate biotechnology, especially with regard to issues of contamination and gene flow to food crops from field trials of GE crops that have not yet been “de-regulated” for commercial release, or from GE crops producing industrial chemicals or drugs. Given the history of contamination and gene flow events from field trials, APHIS should utilize its authority to the fullest extent to regulate GE crop production systems and prevent cases of contamination, such as the pig vaccine-producing GE corn that contaminated a soybean field, and cases of inadequate regulation based on the “intended” use of a GE crop, as was the case for the avidin-producing GE corn product.

4. The history of GE crop contamination events that have occurred in the U.S. in spite of APHIS oversight meant to prevent them is testimony for the need of more federal regulation of GE organisms, not less. The biotechnology industry has not proven that it is capable of regulating itself and yet there are now examples of GE crops ready for commercialization that would not come under APHIS’s “plant pest-based” criteria for regulation of GE organisms. There is certainly no evidence supporting the notion that non-regulatory solutions, i.e. those without the force of law, would be in the best interest of American agriculture, farmers or the public and non-regulatory “solutions” should therefore not be considered as a complement to APHIS’s regulatory program. Increasing regulatory oversight of GE organisms at this time would have the added advantage of instilling more confidence in the U.S. public with regard to products of biotechnology.

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The Absurdity of Claiming that “All GMOs are Safe”

In an op-ed piece in The New York Times, Mark Lynas recently wrote that “There is an equivalent level of scientific consensus on both issues…that climate change is real and genetically modified foods are safe.”

But comparing the issues of climate change and genetically modified (GM; AKA genetically engineered, GE) foods in terms of “scientific consensus” is not a valid comparison.

Climate change is a phenomenon, a phenomenon being studied by many scientists, using many techniques, publishing many studies. Scientific consensus as to whether that particular phenomenon is real may be ascertained based on the resulting body of science.

GE food crops, on the other hand, are not a single phenomenon. They are the products of a technology. And it is not possible to ascertain whether all products–past, present and future–developed using a technology, any technology, are safe. And to make such a general claim is not scientific; it is absurd.

Take nuclear fission technology, for example. Nuclear power plants, built carefully and regulated by a government, may be safe. Nevertheless, the nuclear reactors in Fukashima, Japan–for reasons related to both how the technology was used (the design of the reactors) and how the products of the technology were regulated–were not safe enough when disaster hit in March 2011. (The current Japanese plan for cleaning up Fukashima is expected to take another 30-40 years.)

Each product of any technology will (or at least can) be different…the various products of crop genetic engineering certainly are. And because each GE product is different–not only in the ways genetic engineers design and expect them to be, but also by potentially containing unique unintended and unexpected changes–the safety of each different product of this powerful technology needs to be assessed on a case-by-case basis.

So any all-encompassing statement, or consensus, claiming that “genetically modified foods are safe” is–there is just no better word for it–absurd.

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.”

And we Americans have already experienced examples of commercialized GE food crops of questionable “safety,” the GE corn product that was the subject of the French study Lynas mentioned in his NYT op-ed being one of them. (Please see my post on that subject, including mention that the proper scientific response to a study deemed–after careful scrutiny of not just the paper’s contents but also the study’s raw data–to be merely “inconclusive,” is to repeat the study, in this case with many more control animals.)

Others include a Bt GE corn (Bt176) that a study published in the Proceedings of the National Academy of Sciences USA determined was approximately 100 times more hazardous to Monarch butterfly larvae than other Bt GE corn products, and another Bt GE product (StarLink™ corn) that, after it was removed from the market out of concern that it could prove to be a human allergen (no evidence for that was found in initial CDC studies), the FDA was still concerned enough about its “safety” that the US corn crop was monitored for another seven years until levels of StarLink™ corn were low enough that officials felt comfortable enough to cease monitoring efforts.

As a society, we need to learn from these mistakes in how the technology of genetic engineering has been used to design individual GE food crops and in how the products of this imperfect technology have been imperfectly regulated.

Making general statements claiming “genetically modified foods are safe” is counterproductive to that learning process. It is also illogical and unscientific.

Instead, we need to evaluate the products of this technology on a case-by-case basis, something the regulatory system in the US is not currently doing.

Therefore, in my opinion, a great step toward de-polarizing the debate over “GMOs” would be to develop a new system for regulating the products of this powerful technology.

Wouldn’t it be nice if a scientific consensus on that particular issue, as well as on what that new regulatory system might look like, could be reached?

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What’s up with the Media Response to Chipotle going GMO-Free?

A notice on the side panel of my box of Cheerios™ says “Not made with genetically modified ingredients.” But when General Mills, the company that manufactures this “Toasted Whole Grain Oat Cereal,” decided to make this one product in its product line without ingredients from genetically engineered (GE) organisms (AKA GMOs), I don’t recall it coming under the kind of flak that Chipotle is enduring now.

Chipotle, it seems to me, is being very transparent about what it is doing and why. For example, Chipotle spokesman Chris Arnold told Business Insider:

“Over the years, we have come to believe that the limited number of GMOs that were in our food were not making our food better or providing benefits to the farmers and other suppliers involved in producing our ingredients. We also found that switching to non-GMO alternatives in these cases was less expensive than initially predicted. We started this effort focused on the ingredients we use to make our food [my emphasis] simply because that is where our ability to affect change is most immediate.”

Sounds like a pretty all-American idea to me…affect change via your business practices and, ultimately, your pocketbook. I fully support the right of the owners of Chipotle to do so.

And because it would be downright unreasonable to expect Chipotle to take on Big Soda all by itself, it doesn’t bother me that Chipotle sodas still contain GMO ingredients either. To affect change you have to start somewhere, and Chipotle and General Mills have done just that.

What does bother me is that Dan Charles brought “meat” into this discussion about eliminating GMO ingredients.

As already mentioned, Chipotle’s current effort is focused on the ingredients used to make their food; and at this time there are no GMO “meat” ingredients in any commercialized food products, at Chipotle or anywhere else.

Chipotle couldn’t serve GMO pork or GMO chicken or GMO beef even if it wanted to.

I want to be very clear about this: THERE ARE CURRENTLY NO COMMERCIALLY AVAILABLE GE PIGS or GE CHICKENS or GE COWS anywhere on the planet that could serve as sources of GMO “meat” ingredients. (The GE animal closest to “market” in the AquaBounty salmon.)

So maybe Chipotle will someday expand its focus to include the GMO ingredients fed to the “ingredients” used to make their food. But that’s not the company’s current focus.

You have to start somewhere.

Chipotle has started with an effort to remove GMO ingredients from its food products.

General Mills did the same for Cheerios.

Maybe this is the start of something big.

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Time To Talk “Conflicts of Interest” In Relation to GMOs

Scientific conflicts of interest have been in the news a lot lately.

For example, a federal judge recently ruled that various members of the FDA’s Tobacco Products Scientific Advisory Committee had conflicts of interest and, consequently, the chairman and three other members of that committee resigned.

And then there was the case of the scientist at the Harvard-Smithsonian Center for Astrophysics who failed to disclose, in his scientific papers related to global warming, his conflict of interest over the more than $1.2 million he had received from the fossil-fuel industry; according to the New York Times, Wei-Hock Soon violated, in at least eight cases, the ethical guidelines of the journals that published his work.

In its ethical guidelines for authors submitting manuscripts, Science requires clear disclosures of “…any affiliations, funding sources, or financial holdings that might raise questions about possible sources of bias.” Annual Reviews requires the same but goes into some detail on “factors that might be viewed as biasing a literature review” including:

“Employment, professional affiliations, paid consultancies, membership in related advocacy organizations;

Funding, support, and/or grants received within the past three years;

Significant financial holdings or patents.”

So, according to Annual Reviews, not only scientists who are employed by biotech “life sciences” companies, but also academic scientists who utilize the techniques of genetic engineering to produce genetically engineered (GE) organisms (AKA genetically modified organisms, or GMOs) and who have received any grants or other funding for that research within the past three years, all have potential conflicts of interest on the subject of GE organisms.

In fact, according to Annual Reviews, I myself have potential conflicts of interest when it comes to GE crops because, for one thing, I’ve been granted a few U.S. patents that involve genetic engineering of various plant species.

But having potential conflicts of interest doesn’t necessarily have to be a bad thing. As per Annual Reviews: “A potential bias does not mean that the work presented has been compromised, nor does it disqualify authors from publication….” Rather, the point is to make an “effort to provide readers with information relevant to factors that might be viewed as biasing….”

In other words, conflicts of interest are all about what readers view as bias, i.e. bias is in the eyes of the beholder.

Well, this beholder has viewed many of the “stands” on genetic engineering taken by industrial and academic genetic engineers over the last 20 years as motivated by “conflicts of interest.”

Here are a few:

It’s just an extension of traditional breeding, only more precise.” Without further elaboration, especially of the imprecisions of genetic engineering such as insertional mutagenesis, vector “backbone” integration, rearrangements of inserted DNA as well as “landing site” DNA, etc., this statement not only smacks of conflict of interest but also lacks scientific basis since the biological processes underlying traditional breeding and genetic engineering are very different.

Regulation of GE organisms is onerous in the United States.” In addition to its economic implications, this statement ignores loopholes in the U.S.’s “coordinated” regulatory system so large that tens of GE products are now starting to fall through its cracks (as commendably pointed out recently by Camacho et al.).

Consumers are not well informed about genetic engineering and its potential to solve agricultural problems.”

I find this last example particularly vexing. In my opinion, it represents nothing more than “conflict-of-interest-driven” wishful thinking. These wishful thinkers have had more than 20 years to inform consumers about this technology and its potential and, therefore, if consumers are uninformed (and whether vocal opponents are truly uninformed is certainly debatable) then the promoters of genetic engineering are at least partly to blame. Even worse, genetic engineers have had 20 years to demonstrate the technology’s potential for solving difficult agricultural problems and what have they got to show for those two decades?

With exceptions of minor crops like virus-resistant GE papaya and GE squash, the answer to that question is GE crops that primarily contribute to industrialized, unsustainable agriculture and the very difficult agricultural problem of glyphosate-resistant weeds, a problem undoubtedly made significantly worse as a result of wide-spread cultivation of GE crops.

From my point of view, instead of “feeding the world,” GE foods are being fed primarily to Earth’s non-human animals…except in the U.S., of course, where lack of labeling ensures that people are eating them too.

So I, for one, am tired of hearing about the “potential” of genetic engineering.

Consumers like me want transparency and trustworthiness, not rhetoric and wishful thinking.

Therefore, I suggest that genetic engineers, both industrial and academic 1) admit their potential conflicts of interest and 2) be more mindful of telling the whole truth about it, warts and all. That, together with a re-vamping of the system for regulating GE products in the U.S. and–for the sake of transparency, capitalism and democracy–labeling them, would go a long way toward “depolarizing” the current debate engulfing GE crops, GE animals and GE foods in general.

Commercializing a GE product that consumers could embrace for its benefit(s) to individuals and/or to society as a whole, and promoting it with transparent labeling, wouldn’t hurt either.

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