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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Hyper-propagandizing crop genetic engineering in The New Yorker?

I was very disappointed with Michael Specter’s recent piece in The New Yorker called “Seeds of Doubt: An activist’s controversial crusade against genetically modified crops.”

For one thing, Specter didn’t seem to understand the basics of crop genetic engineering (GE) itself, inaccurately describing the process multiple times in the article. For example, GE crops are not created by firing “a bacterium into seeds” (as was stated on p49 of the article). DNA isolated from various organisms (plants, animals, viruses, bacteria) is what is inserted into all GE crops, not an entire organism such as a bacterium. And that inserted (foreign) DNA is present in every cell in the resulting GE crop plant, not just its seeds or any other specific organ or tissue in that plant. We apparently have a long way to go in educating the public about this powerful technology when a staff writer covering “science” for The New Yorker doesn’t get it right.

The article also failed to mention any of the risks of genetic engineering, risks associated with (for example) what the US Food and Agriculture Agency (F.D.A.) has referred to as “unexpected” changes that can occur as a result of utilizing the techniques currently used to genetically engineer crop plants. [For more information on risks specific to genetic engineering (as opposed to traditional breeding) and examples of commercialized GE crops exhibiting “unexpected” changes or “unintended” risks see Crop Genetic Engineering is a Mutagenic Process,  Crop Genetic Engineering, Warts and All, and Science-based Regulation of GE Crops Requires More Long-Term Rat Feeding Studies of NK603 Corn.] Although I’m not formally trained as a journalist, it seems to me that mention of such technological risks, as well as documented failings like StarLink™ corn, should be made in an article casting doubt on an activist’s crusade against that technology.

Consequently, in my opinion, Specter’s piece contributes to the “hyper-propagandizing” of GE products that one of his interviewees, Dr. Deepak Pental, mentioned (p56) was a mistake made by the promoters of this new biotechnology.

I wrote a letter to The New Yorker expressing my disappointment, a drastically shortened version of which was published in the Sept. 15, 2014 issue of the magazine. My entire, original letter (containing quotes, and reference to The New Yorker pages that contain them) follows.

To: themail@newyorker.com

Unfortunately, Michael Specter only contributed to the “gulf between the truth about G.M.O.s and what people say about them” (p57) with his piece about genetically engineered (G.E.) crops and Vandana Shiva (“Seeds of Doubt” August 25th). “Genetic engineering takes the process [of breeding] one step further” (p48) is by no means enough information to enlighten anyone about how this technology works, how it differs from traditional breeding, whether it is safe, or anything else.

As a former genetic engineer who carried out safety studies submitted to the Food and Drug Administration (F.D.A.) to gain commercial approval of the world’s first G.E. whole food, the Flavr Savr™ tomato (in 1994 not 1996 as implied in the article), I know firsthand of the kinds of risks this technology presents…and so does the F.D.A. which has admitted that “unexpected” and “unintended” changes can occur in G.E. crops. [Commercialized examples of unexpected, unintended changes include one Bt corn variety (Bt176) that posed a 100 times greater risk of harming Monarch butterfly larvae than other Bt corn and another (StarLink™) that contained a Bt protein that behaved like a human allergen in multiple tests conducted in conjunction with the Environmental Protection Agency.] For the most part, long term studies to identify any such unexpected, unintended changes in G.E. crops have not been conducted but a few that have been suggest we should proceed more cautiously with this technology.

On the other hand, long term animal studies as well as human clinical trials have been carried out for G.E. insulin (mentioned in the article, p57) and all other commercially available G.E. drugs for humans in the United States. Those drugs are also labeled; patients know they are products of genetic engineering. Patients can therefore make informed decisions regarding any potential risks, risks they are likely more willing to take than a non-patient would be.

When it comes to groceries, people—healthy or not—can’t make the same informed decisions about G.E. foods, at least not in the United States; and most Americans, in poll after poll, indicate they want that opportunity. After all, it’s one thing to need a G.E. medicine, another to wear G.E. cotton, and still another to feed your G.E. yellow corn or G.E. soybean meal to your animals; it’s quite another when you are feeding yourself and your family and the foods in questions haven’t gone through rigorous, long term testing.

I agree with Mr. Specter that we will need many approaches to farming in order to “feed the world” (p57) but, to make informed decisions about the available approaches, we’ll also need more scientifically accurate and thorough descriptions of them than was provided for genetic engineering in his article. Otherwise, “Seeds of Doubt” could be classified as simply more “advertis[ing]” (p49) or “hyper-propagandizing [of] G.M. products” (p56) and that is not what I, for one, expect from The New Yorker.

Belinda Martineau, Ph.D.

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Why test GE Bananas on U.S. citizens?

According to a recent NPR article, “Somewhere in Iowa, volunteers are earning $900 apiece by providing blood samples after eating” bananas that have been genetically engineered (GE) to produce levels of pro-vitamin A some 5-6 times higher than levels in their non-engineered counterparts. Previous U.S. trials of the GE bananas, which used Mongolian gerbils instead of humans, were described as “successful” and this next test, the world’s first human test of a GE banana, is designed “to assess how successful it is in producing higher levels of vitamin A in the body.”

These GE bananas are a fresh fruit version of Golden Rice and have been created to “reduce infant mortality and blindness in children across Africa,” an admirable goal.

But why then are the human trials being conducted in the U.S.?

Will results obtained for U.S. residents with adequate vitamin A be applicable to residents of Uganda, Rwanda, Kenya, Tanzania and parts of the Democratic Republic of Congo where bananas are a staple crop and vitamin A (and other vitamin and mineral) deficiency is a major problem?

Shouldn’t these human trials be conducted in Uganda?

Better yet, wouldn’t a trial conducted with non-GE varieties of bananas like Asupina and Uht en yap, which naturally have ~20 and ~40 times as much pro-vitamin A respectively as found in the more common Cavendish variety, serve as a better proof-of-concept for solving vitamin A deficiency in East Africa? Trials in Uganda with naturally “golden” bananas could also give researchers an idea of how willing Ugandans are to eat orange-fleshed bananas. (Of course, if Ugandans were happy to eat banana varieties that are naturally higher in pro-vitamin A, it might not have been necessary to genetically engineer Cavendish or other banana varieties in the first place.)

Just what is the rationale for conducting trials of the GE bananas on U.S. soil?

Could the relatively lax regulatory environment for GE crops and foods in the United States have influenced this decision?

Legislation paving the way for commercialization of GE crops in Uganda is currently before that country’s parliament but, in the meantime, further development of GE “Golden” bananas must take place elsewhere.

And what better “elsewhere” than the (arguably?) most GMO-friendly nation on the planet?

Here in the U. S., these GE bananas require minimal regulation. They don’t produce a pesticide and so regulation by the U.S. Environmental Protection Agency (EPA) doesn’t come into play. Regulation of GE foods at the U.S. Food and Drug Administration (FDA) is on a voluntary basis so the developers of these GE bananas aren’t required to even consult with that agency either.

And while the U.S. Department of Agriculture (USDA) does consider this GE banana a “regulated” article (due to the fact that it was created using an organism on USDA’s “plant pest” list), it is being regulated by that agency using its less stringent “Notification” procedure as opposed to the usual “Permit” process.

With this “developer-friendly” system for regulating GE crops, it only makes sense that developers of GE foods from other nations will turn to the U.S. to test their prototypes, whether those foods are destined for U.S. dinner tables or not.

So, no matter what the results of the human tests of GE bananas in Iowa end up being, Americans should realize their broader ramifications. The relatively lax regulation of GE crops here in the United States encourages the rest of world to use us as guinea pigs (if not Mongolian gerbils).

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EPA Poised to Repeat Superweed Mistake

Twenty years ago scientists debated whether genetically engineering crops to be resistant to herbicides would lead to “superweeds” tolerant of those herbicides.

That debate is no longer hypothetical.

We now know, based on the rapid development of glyphosate-resistant superweeds, that genetically engineering crops to be resistant to additional herbicides will certainly lead to more superweeds. Creating next-generation herbicide-resistant crops amounts to repeating the same mistake as was made with Roundup Ready® crops…only this time around the herbicides that could be sprayed with abandon on the crops genetically engineered to be resistant to them will not be as relatively benign as Roundup® (active ingredient: glyphosate).  (And let’s all hope that glyphosate is that benign because another consequence of spraying glyphosate on vast acreages of resistant crops is that it’s showing up in human and animal urine samples.)

Nevertheless, the U.S. Environmental Protection Agency (EPA) is likely to allow that same mistake to be made again soon.

The agency is poised to register “Enlist Duo,” an herbicide cocktail containing not only glyphosate, the primary cause of our current superweed crisis, but also “2,4-D for use in controlling weeds in corn and soybeans genetically engineered (GE) to tolerate 2,4-D.”

But before EPA allows registration of Enlist Duo, it is seeking comments from the public about doing so. And the agency recently extended the deadline for submitting comments related to registering Enlist Duo until June 30, 2014.

If you’d like to join me in pointing out to the EPA that allowing the spraying of 2,4-D herbicide on U.S. crops will inevitably result in additional superweeds, weeds resistant 2,4-D, you can submit your comments on the agency’s web site. A copy of the comment I submitted to EPA follows.

[For more information on this issue please see “Going Backwards: Dow’s 2,4-D-Resistant Crops and a More Toxic Future,” a publication of the Center for Food Safety.]

May 29, 2014
Comment to the Environmental Protection Agency RE: EPA’s proposed regulatory decision to register Enlist Duo containing glyphosate and the choline salt of 2,4-D for use on corn and soybeans genetically engineered (GE) to tolerate 2,4-D (Docket ID Number: EPA-HQ-OPP-2014-0195)

To Whom It Concerns:
I am a plant molecular geneticist. I was part of the team at Calgene, Inc. that developed, obtained regulatory approval of, and marketed the first genetically engineered (GE) whole food to enter commerce. I believe that, like any powerful technology, crop genetic engineering and any pesticide use it engenders should be regulated on a case-by-case basis. I thank the EPA for this opportunity to comment on EPA-HQ-OPP-2014-0195 (Docket ID).
The cultivation of genetically engineered crops that are tolerant of the herbicide glyphosate, in combination with the use of glyphosate on multi-millions of acres of farmland in the U.S. over the last couple of decades, is a primary reason why, as EPA has stated, “Weeds are becoming increasingly resistant to glyphosate-based herbicides and are posing a problem for farmers.” Based on the requirements EPA proposes to impose on the manufacturer of Enlist Duo, EPA may already be aware that peer-reviewed scientific evidence has been accumulating since at least 2006 (http://www.bioone.org/doi/pdf/10.1614/WT-04-155R.1) indicating that weed management practices associated with crop plants genetically engineered to be resistant to/tolerant of glyphosate have led to substantial increases in plant pests that are resistant to this important herbicide. Weed scientists blame excessive reliance on glyphosate, and the strong selection pressure resulting from that reliance, for the increases in glyphosate-resistant species of Amaranthus, Commelina, Ipomoea and Cyperus (as examples) that have been documented in at least eleven U.S. states. Other peer-reviewed studies have documented biochemical and genetic processes underlying the acquisition of resistance to glyphosate (http://www.pnas.org/content/107/3/1029.full.pdf+html?sid=2ab7260b-932b-476e-b892-6d35ad6f7925). These results of the Roundup Ready crops/glyphosate “commercial experiment” indicate that plant pests can quickly evolve resistance to the herbicide a crop has been genetically engineered to tolerate.
There is no reason to doubt that the lesson learned from glyphosate-tolerant genetically engineered crops, i.e. that plant weeds can quickly evolve resistance to the herbicide a crop has been genetically engineered to tolerate, will also apply to any crop genetically engineered to tolerate being sprayed by any particular herbicide, including 2,4-D. Commercial availability of corn and soybean varieties that are tolerant of 2,4-D, in combination with EPA allowing registration of Enlist Duo, would therefore inevitably lead to excessive reliance on 2,4-D and, consequently, evolution of weeds resistant to that herbicide. If EPA allowed Enlist Duo registration, the question would not be “if resistance develops” among pest plants to 2,4-D but “when.” Therefore, EPA should not allow registration of Enlist Duo.
And while EPA states that “requirements on the manufacturer including robust monitoring and reporting to EPA, grower education and remediation” would “ensure that Enlist Duo successfully manages weed resistance problems,” similar requirements “imposed” by the agency in order to restrict genetically engineered StarLink™ corn to only animal food sources and thereby keep it out of the human food chain failed soon after that product was commercialized. Additionally, the fact that EPA’s current proposal “would allow EPA to take swift action to impose additional restrictions on the manufacturer and the use of the pesticide if resistance develops” is testimony to the agency’s lack of faith in its own ability to “ensure that Enlist Duo successfully manages weed resistance problems” as opposed to creating more of them. Therefore, based on the agency’s track record, the EPA should not allow registration of Enlist Duo.
Were “additional restrictions on the manufacturer and the use of the pesticide” swiftly imposed once it became clear that excessive reliance on glyphosate, and the strong selection pressure resulting from that reliance, was increasing glyphosate-resistant species of Amaranthus, Commelina, Ipomoea and Cyperus weeds in at least eleven U.S. states? (My understanding is that instead of adding restrictions on the use of glyphosate, EPA has increased the allowable levels of glyphosate on various crops.) Even if restrictions were imposed it appears that they were not very effective since the EPA and USDA are now considering Enlist Duo and corn and soybean plants genetically engineered to be tolerant of it as a “solution” to the problem of weeds “becoming increasingly resistant to glyphosate-based herbicides.” But rather than a “solution,” the evidence to date suggests that Enlist Duo in combination with corn and soybean plants genetically engineered to be tolerant of it will inevitably result in 2,4-D-resistant weeds and thereby pose more problems for farmers. Therefore, the EPA should not allow registration of Enlist Duo.
The excessive reliance on 2,4-D that would be encouraged by allowing registration of Enlist Duo for crops genetically engineered to be tolerant to it is also of environmental concern. Multiple peer-reviewed scientific studies have associated 2,4-D (and/or contamination in commercial formulas of same) with increased rates of soft tissue sarcomas (e.g. Hardell and Sandstrom: http://www.nature.com/bjc/journal/v39/n6/index.html) and non-Hodgkins’s lymphoma (e.g. Zahm et al.: http://journals.lww.com/epidem/toc/1990/09000). The commercial availability of corn and soybean varieties that are tolerant of 2,4-D and the inevitable excessive reliance on 2,4-D that will result will lead to significant increases of this carcinogenic compound (or formulas thereof) in the environment. Therefore, on the basis of risk of contamination of the environment, EPA should not allow registration of Enlist Duo.
In sum, 20 years ago environmental scientists and developers of genetically engineered plants could only hypothesize about the chances that cultivating herbicide-resistant crops would result in “superweeds.” But the debate is no longer hypothetical. We now know, based on the rapid development of glyphosate-resistant super weeds, that genetically engineering crops to be resistant to herbicides, and applying massive amounts of those herbicides on those GE crops, will result in superweeds. Creating 2,4-D-resistant crops amounts to repeating the same mistake as was made with Roundup Ready crops…only this time around the herbicide that could be sprayed with abandon on crops genetically engineered to be resistant to it is 2,4-D, a carcinogenic compound. We should have already learned the lesson: GE herbicide-resistant crops are not only not the way to sustainably manage weeds but a way to create more superweeds instead. Please, don’t allow the same mistake to be made again. Let’s get off this dangerous, unsustainable treadmill now. A more sustainable solution would be to encourage the use of an integrated weed management (IWM) program instead.
Thank you for your careful consideration of this matter.
Belinda Martineau, Ph.D.

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Twenty Years Ago Today Biotech Food was Commercially Launched

Today is the 20th anniversary of the first sales of the world’s first genetically engineered (GE), commercially available, whole food: the Flavr Savr™ tomato. High-end Flavr Savrs, dubbed “MacGregor’s®” tomatoes, available that day at the State Market IGA in Davis, California, were displayed in a beautiful cart with a canvas awning. The tomatoes carried MacGregor’s stickers, complete with farmer, watering can, and “GROWN FROM GENETICALLY MODIFIED SEEDS” spelled out in all caps. Here’s a photo of one:

MacGregor's stickerBright-red, tomato-shaped brochures proclaiming “Summertime Taste…Year-Round!™ on their covers accompanied the real fruit.

Tomato brochure Summertime Taste...Year-Round!In addition to explaining that MacGregor’s Tomatoes soften more slowly

Tomato brochure Extra Days On The Vineand suggesting that MacGregor’s tomatoes not be stored in the refrigerator, the point-of-purchase information briefly explained the genetic engineering process, including the use of the kanamycin-resistance selectable marker gene, to produce Flavr Savr seeds.

Tomato brochure kanamycin resistanceConsumers were also invited to call 1-800-34TOMATO if they wanted still more information.

Tomato brochure 1-800-34TOMATOWouldn’t it be great if developers of GE foods in the U.S. were as transparent about their products today as Calgene, Inc. (Calgene Fresh, Inc.) was twenty years ago?

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Is FDA “Regulation” of GE Foods Legal?

Today marks twenty years–to the day–since the U.S. Food and Drug Administration (FDA) first pronounced a “whole food produced by biotechnology,” Calgene’s Flavr Savr™ tomato, “as safe as tomatoes bred by conventional means.” FDA’s announcement “was accompanied by a new food additive regulation allowing the use of an enzyme encoded by a marker gene called the kanamycin resistance” gene in new varieties of genetically engineered (GE) plants.

And although the original plan in the U.S. was to use the regulatory agencies in place and the laws already on the books to regulate GE crops and foods, the FDA has never used the Food Additive Amendment of the U.S. Food, Drug and Cosmetic Act to regulate any of the other enzymes or proteins that have been added to any of the many other GE foods that have been commercialized since.

Is that legal?

I’m commemorating this anniversary with a guest post by Steven M. Druker, J.D., in which he examines the legal aspects related to how the FDA currently deals with GE foods. Mr. Druker describes himself thusly: “I am a public interest attorney with extensive knowledge of the FDA’s illicit behavior because, as executive director of the Alliance for Bio-Integrity, I initiated a lawsuit that forced it to divulge its files on genetically engineered foods.”

The following is an excerpt from Mr. Druker’s Letter to the California Legislature (dated May 15, 2014) entitled: How the FDA Has Illicitly Allowed the Marketing of GE Foods –and Why State Governments Can Legitimately Require That They Be Labeled.

1. The Food Additive Amendment of the U.S. Food, Drug and Cosmetic Act institutes a precautionary approach and requires that new additives to food must be demonstrated safe before they are marketed. (21 U.S.C. Sec. 321)

2. An official Senate report described the intent of the amendment as follows: “While Congress did not want to unnecessarily stifle technological advances, it nevertheless intended that additives created through new technologies be proven safe before they
go to market.” (S. Rep. 2422, 1958 U.S.C.C.A.N. 5301- 2)

3. Although the FDA admits that the various genetic materials implanted in bioengineered organisms are within the amendment’s purview, it claims they are exempt from testing because they are generally recognized as safe (GRAS). (Statement of Policy: Foods Derived From New Plant Varieties, May 29, 1992, Federal Register vol. 57, No. 104 at 22991)

4. However, the FDA’s regulations state that substances added to food that were not in use prior to 1958 cannot qualify as GRAS unless they meet two requirements. Not only must they be acknowledged as safe by an overwhelming consensus of experts, but this consensus must be based on “scientific procedures” – which ordinarily entail studies published in peer-reviewed journals. (21 CFR Sec. 170.30 (a-b))

5. FDA regulations further stipulate that these scientific procedures must provide a demonstration of safety and that GRAS substances “…require the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a
food additive.” (21 CFR Sec. 170.30(b)) Thus, it’s clear that the GRAS exemption is not supposed to reduce the degree of testing but rather to relieve a producer from performing new tests for substances already known to be safe on the basis of previous ones.

6. Genetically engineered (GE) foods fail both requirements. There is substantial dispute among experts about their safety; and none has been confirmed safe through adequate testing.

7. As the FDA was developing its policy on GE foods during 1991-92, there was not even consensus about safety among its own experts. The predominant opinion was (a) that these new foods entail unique risks, especially the potential for unintended harmful side effects that are difficult to detect and (b) that none can be considered safe unless it has passed rigorous tests capable of screening for such effects. These scientists expressed their concerns in numerous memos to superiors – memos that only came to light in 1998 when the lawsuit led by the Alliance for Bio-Integrity forced the FDA to divulge its files. [Copies of these FDA memos are posted on www.biointegrity.org]

8. For example, microbiologist Dr. Louis Pribyl stated: “There is a profound difference between the types of unexpected effects from traditional breeding and genetic engineering ….” He added that several aspects of gene- splicing “. . . may be more hazardous . . .” (FDA Document 4 posted on http://www.biointegrity.org) Similarly, Dr. E.J. Matthews of the FDA’s Toxicology Group warned that “. . . genetically modified plants could … contain unexpected high concentrations of plant toxicants…,” and he cautioned that some of these toxicants could be unexpected and could “…be uniquely different chemicals that are usually expressed in unrelated plants.” (FDA Document 2 posted on http://www.biointegrity.org) Citing the potential for such unintended dangers, the Director of FDA’s Center for Veterinary Medicine (CVM) called for bioengineered products to be demonstrated safe prior to marketing. He stated: “… CVM believes that animal feeds derived from genetically modified plants present unique [emphasis added] animal and food safety concerns.” (FDA Document 10 posted on http://www.biointegrity.org) He explained that residues of unexpected substances could make meat and milk products harmful to humans.

9. In light of these unique risks, agency scientists advised that GE foods should undergo special testing, including toxicological tests. (see e.g. FDA Documents 2 and 6 posted on http://www.biointegrity.org)

10. The pervasiveness of the concerns within the scientific staff is attested by a memo from an FDA official who protested the agency was “… trying to fit a square peg into a round hole . . . [by] trying to force an ultimate conclusion that there is no difference between foods modified by genetic engineering and foods modified by traditional breeding practices.” She declared: “The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks.” (FDA Document 1 posted on http://www.biointegrity.org)

11. Moreover, FDA officials knew there was not a consensus about the safety of GE foods among scientists outside the agency either. For instance, FDA’s Biotechnology Coordinator acknowledged in a letter to a Canadian health official that there was no such consensus in the scientific community at large. He also admitted, “I think the question of the potential for some substances to cause allergenic reactions is particularly difficult to predict.” (FDA Document 8 posted on http://www.biointegrity.org)

12. This lack of consensus in itself disqualifies GE foods from GRAS status. But even if consensus did exist, no GE food would qualify as GRAS because none has satisfactorily passed the level of testing that the law requires – and that the FDA experts stated is necessary. The agency’s files demonstrate that as of 1992, there was virtually no evidence to support safety, with one official’s memo to the Biotechnology Coordinator querying: ” … are we asking the scientific experts to generate the basis for this policy statement in the absence of any data?” (FDA Document 1 posted on http://www.biointegrity.org) And the evidentiary base is still deficient because the FDA does not require any testing; and the tests relied on by the EU, Canada, and others do not adequately screen for the unexpected side effects about which the FDA scientists warned. The inadequacy of current testing has been pointed out by numerous experts, including the Royal Society of Canada and the Public Health Association of Australia. (See also #27 below.)

13. Despite the ample evidence indicating a lack of consensus about safety, as well as the lack of requisite evidence to confirm it, the FDA’s decision-makers (who acknowledge they’ve been operating under a policy “to foster” the U.S. biotechnology industry; see “Genetically Engineered Foods,” FDA Consumer, Jan.-Feb. 1993, p.14) declared that as long as a GE food does not introduce a known toxin or allergen, they would presume that it’s GRAS – and can therefore be marketed without any testing. In doing so, they professed themselves “not aware of any information” showing that GE foods differ from others “in any meaningful way,” even though they had received extensive input from their scientists pointing out the significant differences and their serious implications. (Statement of Policy: Foods Derived From New Plant Varieties, May 29, 1992, Federal Register vol. 57, No. 104 at 22991)

14. Although many people have been led to believe that the U.S. district court in Alliance for Bio-Integrity v. Shalala determined that GE foods are on the market legally, its decision actually highlights the extent to which their presence is contrary to the law. (Alliance for Bio-Integrity v. Shalala. 116 F. Supp. 2d 166 (D.D.C. 2000) at p. 179)

15. In her written opinion, the judge stated: “Plaintiffs have produced several documents showing significant disagreements among scientific experts.” (116 F.Supp.2d 166 (D.D.C. 2000) at 177) However, she ruled that the crucial issue was not whether GE foods were in fact GRAS at the time of the lawsuit (or were actually GRAS when the FDA issued its policy statement on GE foods in May 1992) but whether FDA administrators had acted arbitrarily in 1992 in presuming that they were GRAS. Therefore, because she held that the case hinged on this narrow procedural issue of whether there had been adequate rational basis for the FDA’s presumption, she said that any evidence showing lack of expert consensus at the time of the lawsuit was irrelevant, since it was not within the administrators’ purview when they formed their policy in 1992.

16. As for the evidence that had been within the FDA’s own files in 1992, she ruled that the administrators were free to disregard the opinions of subordinates when setting policy. (116 F.Supp.2d 166 (D.D.C. 2000) p.178) This conclusion seems odd, since the written opinions of the agency’s scientists represented far more than mere policy preferences. They constituted solid evidence that a significant number of experts did not recognize GE foods as safe. Further, the judge failed to mention the fact that the FDA’s biotechnology coordinator had admitted there was not a consensus within the scientific community, even though plaintiffs’ briefs had emphasized the relevant document.

17. Moreover, the judge also disregarded the fact (repeatedly pointed out to her) that the FDA’s files demonstrated there was insufficient technical evidence about safety to support a presumption that GE foods are GRAS. Although her opinion initially acknowledged that such technical evidence is legally required, she never returned to the issue – a highly irregular outcome.

18. Thus, the judge did not determine that GE foods are (or ever were) truly GRAS. Nor did she determine that any has been demonstrated safe. She merely held that, given the evidence before them in 1992, FDA officials had not acted arbitrarily in presuming that the foods were GRAS. Further, she emphasized that their presumption is, as a matter of law, “rebuttable.” (116 F.Supp.2d 166 (D.D.C. 2000) pg.172)

19. Regardless of whether one agrees that the FDA administrators had reasonable basis in 1992 to presume that all GE foods are GRAS, it’s obvious that this presumption has been clearly and continually rebutted, both by the ever-growing dispute among experts and the ongoing lack of adequate testing.

20. And the lack of consensus and the lack of evidence are both glaring, as the following examples amply demonstrate.

21. In the Alliance for Bio-Integrity lawsuit, nine of the plaintiffs were well-credentialed life scientists (including tenured professors at UC Berkeley, Rutgers, the University of Minnesota, and the NYU School of Medicine) who asserted they did not regard GE foods as safe. After acknowledging we had introduced many statements from experts explaining that genetic engineering is “inherently risky,” the judge then stated: “Plaintiffs have produced several documents showing significant disagreements among scientific experts.” (116 F.Supp.2d 166 (D.D.C. 2000) pg.177) This in itself established that as of May 1998, GE foods could not be considered GRAS.

22. The following year, the respected medical journal The Lancet strongly criticized the presumption that GE foods entail no greater risks of unexpected effects than conventional foods, stating that there are “good reasons to believe that specific risks may exist” and that “governments should never have allowed these products into the food chain without insisting on rigorous testing for effects on health.” (The Lancet, Volume 353, Issue 9167, Page 1811, 29 May 1999)

23. In 2001, an expert panel of the Royal Society of Canada issued a report declaring (a) that it is “scientifically unjustifiable” to presume that GE foods are safe and (b) that the “default presumption” for every GE food should be that the genetic alteration has
induced unintended and potentially hazardous side effects. (“Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada; An Expert Panel Report on the Future of Food Biotechnology prepared by The Royal Society of Canada at the request of Health Canada Canadian Food Inspection Agency and Environment Canada” The Royal Society of Canada, January 2001) In describing the report’s criticism of the current approach to regulating GE foods, the Toronto Star stated: “The experts say this approach is fatally flawed … and exposes Canadians to several potential health risks, including toxicity and allergic reactions.” (Calamai, P., “Ottawa Rapped, Expert Study Considered Major Setback for Biotech Industry,” Toronto Star , February 5, 2001)

24. The British Medical Association has also expressed reservations about the safety of these novel products. As described in the British Medical Journal, the Association released a 2004 report stating that “more research is needed to show that genetically modified (GM) food crops and ingredients are safe for people and the environment and that they offer real benefits over traditionally grown foods.” (Kmietowicz, Z. “GM Foods Should Be Submitted to Further Studies, says BMA,” British Medical Journal, 2004 March 13; 328(7440): 602)

25. In October 2013, a large number of well-qualified experts signed a statement asserting that there is not a consensus about the safety of GE foods and that their safety has not been adequately demonstrated. As of December 10 of that year, the statement had 297 signatories. (http://www.ensser.org/increasing-public-information/no-scientific-consensus-on-gmo-safety/)

26. Thus, the absence of requisite consensus is irrefutable, especially in light of the fact that the FDA has, in court, established that an additive was not GRAS merely by producing testimony from two experts who did not regard it as safe. (United States v. Seven Cartons . . . Ferro-Lac, 293 F. Supp. 660, 664 (N.D. Il. 1968)

27. Further, not only has there never been a genuine consensus about the safety of GE foods, the evidentiary base on which such a consensus is legally required to rest has never existed either – and is still absent. This is well-attested by David Schubert, a professor at the Salk Institute for Biological Studies, who recently asserted: “As a medical research scientist who published a comprehensive, peer-reviewed critique of genetically modified food safety testing, I can state confidently that it is false to say such foods and the toxic chemicals they require are extensively tested and proved safe. No producer-independent safety testing, long-term or multigenerational rodent studies or epidemiological studies have been done to support the hypothesis that these foods are safe.” (Letter to the LA Times, October 28, 2012)

Consequently, the marketing of GE foods in the U.S. is illegal because none of them is GRAS and none has undergone formal food additive approval. And it’s high time that the American people were informed of this fact.

Copyright © 2014 Steven M. Druker

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