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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Exposure of Mammals, Birds, Reptiles and Land-Phase Amphibians to Dow Agrosciences’ Pesticide Cocktail?

I’ve already expressed my concern over the fact that U.S. government agencies recently unleashed a ticking bomb with regard to the genetically engineered (GE) “superweed” problem we’re already experiencing in the United States when the U.S. Department of Agriculture (USDA) deregulated GE corn and GE soybeans that can survive being sprayed with two pesticides that would kill their non-engineered relatives, and the Environmental Protection Agency (EPA) approved the herbicide cocktail, Enlist Duo™, comprised of the two pesticides that can be sprayed on those GE crops with impunity. Supporting this “pesticide treadmill” seems the antithesis of “sustainable” agriculture to me.

But after reading EPA’s “Response to Public Comments Received Regarding New Uses of Enlist Duo™ on Corn and Soybeans,” I have an additional concern: the toxicity of 2,4-D, one of the two pesticides comprising Enlist Duo™, to animals.

EPA acknowledges that,“should actual exposures [to 2,4-D] occur, direct effects (risk quotients…above the level of concern) may be possible only [my emphasis] for mammals, birds, reptiles, land-phase amphibians and terrestrial plants.” EPA also noted that “Acute exposure risk concerns were identified for both listed [i.e. endangered or threatened] and non-listed birds in the screening level assessment.”

But, while I find these “concerns” mentioned by EPA, well… concerning–especially since, as reported in the Huffington Post, the USDA predicted that 2,4-D use could now increase by an estimated 200-600 percent by the year 2020–the agency, apparently, does not.

And the difference in our perspectives over 2,4-D toxicity to organisms other than corn and soybean weeds appears to boil down to the issue of “exposure.”

As explained by the agency: “EPA requires a suite of toxicological data on mammals, birds, honeybees, freshwater fish and invertebrates, estuarine/marine fish and invertebrates, aquatic plants, and terrestrial plants. The purpose of the data is to determine the toxicity of the pesticide when direct exposures occur. This is known as “hazard” and is one of two components that make up “risk.” The second consideration is “exposure.” Exposure constitutes how much of the pesticide will come into contact with an organism. “Risk” is a combination of the hazard of the pesticide and the anticipated exposure of the pesticide….The risk assessment for 2,4-D choline salt incorporates both the hazard and exposure components into its conclusions; thus although it may be toxic to some groups of organisms [my emphasis] [but remember, only “mammals, birds, reptiles, land-phase amphibians and terrestrial plants”], the risk varies proportionately with exposure.”

And there’s the rub.

To me, spraying 200-600 percent more 2,4-D on corn and soybean crops, the largest crops grown in the U.S., is bound to “expose” mammals, birds, reptiles, land-phase amphibians and terrestrial plants to 2,4-D. And that exposure to 2,4-D, combined with the toxicity hazard it presents to “some groups of organisms” could constitute substantial “risk” to those organisms.

But EPA seems to believe that restrictions it has mandated for Enlist Duo™ will adequately limit exposure. As the agency put it: “By requiring pesticide application restrictions that limit off-site exposure [my emphasis] to levels below effects thresholds of the most sensitive taxonomic group, the action area (the geographic extent to where effects can reasonably be expected to occur), is limited to the directly treated footprint of the soy or corn field [my emphasis]. Consequently, no direct or indirect effects are expected for threatened and endangered species….” EPA summed up the situation this way: “When these types of information were considered, the endangered species assessment addendum concluded that there were no direct risk concerns for mammals, birds, reptiles, land-phase amphibians, and terrestrial plants.”

In drawing this conclusion, EPA considered “species specific biology, geographic location, and the ability of spray drift mitigation measures to reduce the geographic extent of exposures of concern to a limit of the boundaries of the treatment site [my emphasis].”

But the bottom line is that even if EPA’s restrictions for Enlist Duo™ are followed to the letter, all “treatment site[s],” i.e. potentially all fields of GE corn or GE soybeans in the six states for which EPA has allowed registration of Enlist Duo™–Illinois, Indiana, Iowa, Ohio, South Dakota and Wisconsin, present “exposures of concern” to sensitive mammals, birds, reptiles, land-phase amphibians and terrestrial plants which might wander into those fields.

So unless those “treatment sites” are all fenced and netted (and even if they were), I predict that sensitive mammals, birds, reptiles, land-phase amphibians and terrestrial plants will make their way into those fields of GE corn and GE soybeans and get themselves exposed to 2,4-D.

As I recall, mammals (mainly squirrels) often wandered in and out of “contained” field trials of Flavr Savr™ tomatoes two+ decades ago. GE corn and GE soybean fields could be just as inviting to mammals, birds and other animals today.

The EPA is currently considering whether to register Enlist Duo™ in ten additional states: Arkansas, Kansas, Louisiana, Minnesota, Mississippi, Missouri, Nebraska, North Dakota, Oklahoma and Tennessee. For the sake of the mammals, birds, reptiles and land-phase amphibians in those states that are sensitive to 2,4-D, I hope that registration is denied.

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EPA Expresses Concern Regarding Potential Development of 2,4-D-Resistant Weeds

I am not surprised that the U.S. Environmental Protection Agency (EPA) went ahead and registered Enlist Duo™, Dow Agrosciences’ pesticide cocktail made for spraying on corn and soybean crops genetically engineered (GE) to be tolerant of it.

Disappointed, yes. Surprised? No.

Now, it’s only a matter of time before American farmers will have an even bigger superweed problem than they already have, the current problem in large part the result of previous registration by EPA of glyphosate, the active ingredient in Roundup®, for use on the millions and millions of acres of farms where GE corn, GE soybeans and other GE crops are grown in the United States.

Even the EPA shares my concern.

As it states in its Response to Public Comments Received Regarding New Uses of Enlist DuoTM on corn and soybean:

“The Agency agrees that the registration of Enlist Duo™ for use on Enlist seed presents the potential for growers to over-rely on a single product that contains two herbicidal active ingredients. If it happens, the over-dependence can increase the selection pressure on weeds and lead to resistance.”

EPA goes on to state that “because herbicide use on herbicide-resistant crops presents this increased risk…of the likelihood of the development of resistant weeds and their associated impacts…the Agency is addressing resistance potential in this registration in an unprecedented manner.”

At one point that unprecedented manner included a requirement listed on Enlist Duo™ labels to “scout fields before and after herbicide application, which is consistent with integrated pest management (IPM) and is essential to early identification of lack of herbicide efficacy that could be an early sign of weed resistance. The critical importance of scouting is widely recognized by research and extension specialists in pest control and should be practiced when using Enlist Duo™ or other pesticides.”

However, although the “Agency firmly believes that it is a good best management practice to scout…[it] also recognizes that on-field weed resistance is best managed by the grower who understands his or her specific situation. Therefore, the requirement [emphasis added] to scout fields 7-21 days after application will not be imposed, but the labels will contain recommendations [emphasis added] for field scouting.”

In the end, the “terms of registration for Enlist Duo™ place the responsibility on the registrant [Dow Agrosciences] for reducing the potential for resistance or to significantly delay the onset of resistance.”  The “Agency is requiring that [Dow Agrosciences] have an Herbicide Resistance Management (HRM) Plan in place…[and] is also requiring the registrant to develop education and training programs that will provide growers with the best available information on herbicide resistance management…. The HRM Plan…will involve [Dow Agrosciences] working with growers to help identify early signs of weed resistance and to resolve the problem before it spreads. The HRM Plan also requires education and reporting to the Agency.”

Will putting the onus on the registrant for managing this critical issue do the trick?

History suggests not.

EPA also put the onus for managing the critical issue of keeping GE StarLink™ corn and the potential human allergen it produced out of the human food supply on the registrant of that product. That registrant’s management plan failed in a matter of months when that GE corn showed up in the human food chain in the United States. Not only that, but the wayward StarLink™ corn was detected in human food on grocery shelves only through the efforts of an NGO, not the efforts of the “responsible” registrant. StarLink™ corn remained detectable in US corn crops, at levels of concern to the US Centers for Disease Control and Prevention, for at least another seven years after EPA revoked its registration.

EPA has imposed a 6-year limit on registration of Enlist Duo™, partly to allow it to reassess the “superweed” issue. But, based on both history and biology, the increased selection pressure imposed by using Enlist Duo™ will most certainly result in significantly more 2,4-D-resistant weeds–and more glyphosate-resistant weeds than are already out there as well–and US farmers are bound to have an even bigger superweed problem by the EPA’s 2020 registration deadline.

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