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.
Sincerely,
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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Senate Bill 1381: Establishing Choice With Regard To GE Foods

An op-ed piece against SB1381, a bill in the California legislature that would require labeling of genetically engineered (GE) foods, was published in The Davis Enterprise, April 20, 2014.

Here’s my response to that piece, published in the same newspaper:

I have great respect for the science that Kent Bradford and many other plant scientists at UC Davis have dedicated their lives to, including use of the tool of genetic engineering in efforts to understand and improve crop plants.

Genetic engineering is a very powerful biotechnology that is being used to further our understanding of how genes and biochemical pathways work and how plants and other creatures develop and respond to their environments. We still have much to learn about these processes and I support utilizing genetic engineering to help us do so.
Not only a supporter of genetic engineering for research, I was also an early adopter of commercially available genetically engineered foods. I fed GE Flavr Savr™ tomatoes to my child back when they first hit the market in May of 1994. I and other early adopters purchased so many of those tomatoes, despite (because of?) the fact that they were clearly labeled “GROWN FROM GENETICALLY MODIFIED SEEDS,” that the company producing them—Davis’ own Calgene, Inc.— couldn’t keep up with demand.

But not everybody is an early adopter. And some people just don’t like the idea of eating the insecticides produced in some GE foods, no matter how safe they may be for humans. Other people don’t like the fact that vastly more glyphosate is being sprayed on vastly more (tens of millions of acres) of this country because some GE crops—and now many “super” weeds—are impervious to it; nor do they like the ag biotech industry’s solution to this superweed problem…engineering crops to be impervious to additional pesticides that are more noxious than glyphosate.

Still others, for their various other reasons, are simply not as enthusiastic about GE foods as scientists like Dr. Bradford who are using genetic engineering in their own labs.

And this is America. Shouldn’t we all have the right to make our own decisions, based on whatever information we find compelling, about the food we purchase in grocery stores to feed to our families?

I think we should. That’s why I support SB 1381, the bill introduced by Senator Noreen Evans (D-Santa Rosa) which states that “California consumers have the right to know through labeling, whether the foods they purchase were produced with genetic engineering, so they can make informed purchasing decisions.”

What SB 1381 addresses is the downright un-American status quo that denies American citizens the choice to decide for themselves whether to purchase foods produced using a new, powerful but imperfect technology. Consumers in 64 other countries can already make that decision; the food industries in those countries (and in the U.S. when preparing foods for export) already handle the logistics required to label GE foods; doing the same for foods sold in the good ‘ol U. S. of A., should be a slam dunk.

SB 1381 calls for foods sold in California retail stores to carry simple labels, “Genetically Engineered” or “Produced Using Genetic Engineering” or “Partially Produced Using Genetic Engineering”—not very different from the one used on Flavr Savr tomatoes, starting in 2016. There is absolutely nothing “misleading” about such labels; and just as the label on Calgene’s GE tomato wasn’t “scary-sounding” or a “de facto warning” these need not be either.

SB 1381 does not call for “forcing products to be repackaged or remade with higher priced ingredients” as suggested by Dr. Bradford and, therefore, the purported increase to the yearly food bill of the average California family is an obfuscation of this issue (just as it was with regard to Proposition 37 in 2012).

Nor is “scientific justification” a prerequisite for food labeling in this country. The U.S. Food and Drug Administration currently requires food producers to include “water” among the ingredients on a food label if water was, in fact, added to the food. Science is also not the issue with Country Of Origin Labels (COOL) now in use in the United States. These labels provide information, not scientific justification, and the labels required by SB 1381 would do the same.

SB 1381 is simply about giving California consumers more information about their potential food purchases and, as Senator Lois Wolk said about this bill at the State Senate Health Committee meeting last month, there is “nothing wrong with labelling.”

Senator Wolk went on to make it clear that she does not support “incentives” that could lead to “mischief” (frivolous lawsuits) and has discussed with Senator Evans ways to limit anyone taking advantage of SB 1381 to cause such mischief. When it came time to vote on the bill, Senator Wolk commended the language that limits incentives (e.g. “The court shall not award monetary damages” only “reasonable attorneys’ fees and costs” to a prevailing plaintiff) and provides an opportunity for “cure” prior to a lawsuit being filed in the first place; thus reassured, Senator Wolk voted “aye” on SB 1381. I’m therefore confident that any putative litigious “mischief” associated with this labeling law is being duly anticipated and mitigated by our fine state senators.

The fact that Dr. Bradford defends genetic engineering is certainly understandable. He has dedicated his “entire career to agricultural biotechnology and plant science….” But his defense is misplaced. The evidence does not support his claim that mandating labels on GE foods “would greatly impede the cutting-edge research [he and others] are conducting here at UC Davis….” Cutting-edge research using genetic engineering, like that being done at UC Davis, is still being carried out in many (I dare say most) of those 64 countries that now require GE foods to be labeled.

And Calgene’s Flavr Savr tomato, the only example we have of a GE food labeled as such in the U.S., doesn’t support Dr. Bradford’s claim that “SB 1381 would effectively ban the sale” of GE foods either. Those tomatoes sold like hotcakes; Bert Gee, the owner of Davis’ State Market, resorted to limiting customers to the purchase of two Flavr Savr tomatoes per day back in 1994.

Perhaps most inventors and scientists are early adopters. But that doesn’t give them the right to force the rest of us to buy their inventions. This is America. The market, comprised of individual consumers, is supposed to decide whether a new product is successful or not. In poll after poll, a majority of American consumers indicates they want GE foods labeled, they want to have a choice about whether to purchase these new inventions or not.

Kudos to Senator Evans for introducing SB 1381 so that Californians might, after the nearly two decades since the GE Flavr Savr tomato was first introduced into commerce, again have that choice.

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Rebuttal to Statements Against SB 1381, The California GE Labeling Bill

Senator Noreen Evans (D-Santa Rosa) has introduced a bill, SB 1381, which would require genetically engineered (GE) foods in California’s retail grocery stores to be labeled starting in 2016. I’m in favor of this bill because, as stated in its text, “California consumers have the right to know, through labeling, whether the foods they purchase were produced with genetic engineering, so they can make informed purchasing decisions.” Consumers in 64 other countries can already make such informed purchasing decisions; the food industries in those countries (and in the U.S. when preparing foods for export) already handle the logistics required to label GE foods; doing the same for foods sold in the good ‘ole U. S. of A. should be a slam dunk.

But proponents of GE foods are still fighting against labeling anyway.

Statements made against SB 1381 prior to the bill being approved by the Health Committee of the California State Senate late last month amounted to a defense of genetic engineering technology comprised of definitive-sounding claims of “overwhelming scientific evidence” that GE food products “are completely safe” and mention of multiple, highly regarded scientific organizations “none of which have found any evidence” of problems with these foods [emphases added]. A plant scientist at UC Davis also said claims that the United States Food and Drug Administration (FDA) “does not properly regulate” GE foods are “not true” and that these foods are “fully vetted.”

But, as I’ve been pointing out on this blog, the state of the science and regulation of GE agricultural products is not nearly as black and white as these statements made in opposition to SB 1381 indicate. And for anyone to make truly informed decisions—about GE food purchases or GE labeling or anything else—mention should be made of the shades of grey.

For example, as mentioned in the text of SB 1381, the FDA “does not require safety studies of GE foods. Instead, any consultations are voluntary….” While every GE food on the market today may have gone through this voluntary consultation process with FDA, that need not necessarily be the case for future GE foods and feeds. There have already been cases in which developers of GE crops have refused to provide answers to additional questions asked by FDA; there was also the case of Bt10, a GE corn variety that was accidentally commercialized without having gone through the voluntary consultation process with FDA.

The current system of regulating GE crops and foods in the U.S. uses agencies and laws designed with “traditional” agricultural products in mind; loopholes exist in it through which some GE crops could escape regulation altogether. While others (obviously) disagree, I do not consider the current system in the U.S. to be the “proper” way to regulate the powerful technology of genetic engineering.

As also mentioned in SB 1381:
“Genetic engineering of plants and animals can cause unintended consequences. It has been demonstrated that manipulating genes through genetic engineering and inserting them into organisms is an imprecise process. The results are not always predictable or controllable. United States government scientists have stated that the artificial insertion of genetic material into plants via genetic engineering can increase the levels of known toxicants or allergens in foods and create new toxicants or allergens with consequent health concerns.”

These statements are all true. And in the less than 20 years since GE crops have been commercialized, we’ve already had examples which raised heath concerns. One was StarLink™ corn. Although it has never been established that the Bt protein in StarLink corn—which behaved like a human allergen in multiple pre-market tests—actually caused allergies in humans, the U.S. corn crop was nevertheless monitored for the presence of StarLink’s GE protein for seven years after it was discovered in human food products and taken off the market. (The StarLink incident also gives an idea of how long GE crops can persist in the environment.) Even with no concrete evidence of harm, regulators did not deal with that particular GE corn product as if it was “completely safe.”

Such is the concern over unintended consequences that a “Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health” was established by the Institute of Medicine and the National Research Council of the U.S. National Academies. The committee’s report promotes “postmarketing studies to further assess both intended and unintended effects” and suggests that “epidemiological studies may be helpful in the postmarketing phase….”

SB 1381 also notes that “mandatory identification of foods produced with genetic engineering can provide a method for detecting, at a large epidemiological scale, the potential health effects of consuming those foods.”

Yet an opponent of SB 1381 stated (in the Health Committee meeting on March 26th) that epidemiological studies would not be helped by “general” labeling of GE ingredients.

I am not an epidemiologist and so will not comment on that claim except to opine that even general labels should make the task of tracking down unintended health effects somewhat easier than no GE labels at all. (I invite any epidemiologists reading this to chime in on this topic.) Instead I’ll ask: what is the alternative? Identifying the specific GE protein or other active GE component that has been added to a food, as was done for the protein conferring kanamycin-resistance in the Flavr Savr™ tomato nearly 20 years ago?

That is apparently no longer a viable option at this juncture. After the FDA treated the GE protein in Flavr Savr tomatoes as a food additive, following the laws on the books for regulating food additives, the agency announced that no other GE protein added to a food need go through that process. The food additive door was shut and replaced with the voluntary consultation process.

The bottom line is that the federal government has let Americans down on this issue. That’s why grass roots initiatives and individual state legislatures are taking it up.

Unintended consequences can, and have, happened as a result of using genetic engineering technology to alter crop plants. Until very recently, there had been no long-term studies of individual GE foods and those that have been published have been attacked…and yet not repeated, the usual hallmark of scientific response to technical disagreement. As a scientist, I find that very disappointing.

And yet I am a supporter of the use of genetic engineering for basic science. I was also an early adopter of GE foods, feeding GE Flavr Savr tomatoes to my child back when they first hit the market in 1994; I and other early adopters purchased so many of those tomatoes, despite (because of?) the fact that they were clearly labeled as having been “Grown From Genetically Modified Seeds,” that the company producing them couldn’t keep up with demand.

Based on the Flavr Savr tomato, the only example we have in the U.S. of a labeled GE food, the labels SB 1381 would require will not necessarily “stigmatize” GE foods. Nor is SB 1381 about forgoing the powerful technology of genetic engineering; agricultural problems like citrus greening are still being addressed using genetic engineering despite concerns about the public’s wariness.

What SB 1381 addresses is the downright un-American status quo that denies American citizens the choice to decide for themselves whether to adopt a powerful new technology being applied to their food. That’s it.

In poll after poll, the majority of Americans indicate they want that choice, a choice citizens of 64 other countries already have.

Kudos to Senator Evans for introducing SB 1381 so that Californians might, after the nearly two decades since the GE Flavr Savr tomato was first introduced into commerce, again have that choice.

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A Dearth of Life-Long Animal Studies of GE Foods

I’ve been corresponding with individual email-writers and I’ll occasionally post versions of my responses here because they tend to touch upon multiple issues related to genetically engineered (GE) crops in one piece (whereas I usually focus on fewer issues in my posts otherwise) and because I hope to open up the conversation to more participants.

Here’s my response to a reader who wants to know whether the fact that he could not “at this time find any long-term health test data, that is test results in advance of FDA approval/certification, …mean[s that] the [GE] product was perhaps released with minimal, if any long-term health testing…”:

I’m afraid that the only long-term safety information in which chronic effects of any GE food or feed product were looked for over the lifetime of the animals (that I’m aware of) are contained in the paper by Séralini et al. (“Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize” in Food and Chemical Toxicology 50:4221-4231) originally published in Sept 2012 but retracted by the journal, after a huge outcry from practitioners of crop genetic engineering, more than a year later and another by Carman et al. (“A long-term toxicology study on pigs fed a combined genetically modified (GM) soy and  GM maize diet” in the Journal of Organic Systems 8 (1): 38-54; Open access full text: http://www.organic-systems.org/journal/81/8106.pdf) published last year.

(I am not an expert on animal feeding studies, however, and Monsanto has, for example, looked at production type variables (weight at slaughter? e.g.) in long-term studies of chickens, etc.; scientists who conduct animal-feeding studies themselves would be much better judges of the value of these chicken (etc.) studies than I would.)

There was also a paper published in The Lancet [Ewen SW, Pusztai A (October 1999) "Effect of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine" Lancet 354 (9187): 1353–4. doi:10.1016/S0140-6736(98)05860-7. PMID 10533866] that documented effects (I’m not sure how “long-term” they were) on rats of a GE potato that had not yet been commercialized.

Unfortunately, all three of these studies that suggested there could be adverse effects associated with the GE crops under investigation were attacked by scientists utilizing genetic engineering themselves and, worse, follow-up studies have not been carried out.

As I’ve pointed out recently on my blog, the proper scientific response to these papers is follow-up science but I’ve contacted Monsanto scientists about Séralini’s data, for example, and I’ve been informed that they have no plans to carry out any long-term (chronic) studies of the GE corn, NK603, in question.

And, apparently, they don’t have to. The FDA does not officially “approve” or “certify” genetically engineered (GE) foods or feeds; in fact, interaction with that agency prior to commercialization of a new GE food or feed is on a voluntary basis (with very few exceptions such as if the foreign gene in question was isolated from an organism known to cause human allergens). Developers of these GE products are responsible for ensuring that their products are safe and wholesome, however, (or so the letter developers receive from the FDA after completion of a voluntary consultation states) so it seems to me that the FDA should now follow-up with Monsanto, for one, regarding some of these published data.

And in regard to regulation of these GE products, I don’t think you are “missing” anything. “Substantial equivalence” is not, in my opinion, a science-based concept. The FDA may think sweet corn that produces multiple insecticides in all of its cells is “substantially equivalent” to non-GE sweet corn, for example, but I do not.

Originally, the FDA did officially approve at least the foreign protein produced in the world’s first GE food, the Flavr Savr™ tomato. But in an illogical, unscientific move, the FDA found that GE tomato so safe it decided that subsequent GE foods/feeds need not go through the Food Additive Petition process like the developer of that tomato, Calgene, Inc. (subsequently purchased by Monsanto), did.

Back in the 1980’s, before GE foods were ready for the marketplace, the U.S. government decided to use the agencies already in place and the laws already on the books to deal with GE products, hence the idea to use the food additive laws to regulate foreign proteins produced in GE foods. But, as I’ve described above, use of the food additive laws on the books was discarded after the approval of the first GE protein in a GE food. And, because of loopholes in our cobbled together “coordinated framework” for regulating GE crops in the U.S., we now have a situation in which a developer of a GE product can avoid pre-market regulation completely depending on the design/composition of the foreign gene/DNA it inserts into its crop of choice.

All that said, the word on the street is that all developers of GE foods have voluntarily consulted with the FDA prior to commercializing their products in the U.S. (although this claim would be difficult to substantiate). And if the GE food produces pesticide, like all the Bt corn varieties do, then the EPA must approve it. And if the GE food was produced using a pest on the USDA’s “plant pest” list (most GE foods are produced using DNA from the cauliflower mosaic virus (CaMV) and many using an organism associated with crown gall disease), then the USDA must “deregulate” it. But, to reiterate, GE crops can be engineered without CaMV or A. tumefaciens and to produce proteins that are not pesticides; and such GE crops would not be required to undergo pre-market regulation based on the current system for “regulating” them in the U.S.

As far as I know, developers of GE crops do not have to submit risk plans with FDA but I’m not sure about requirements at USDA or EPA. “Recalls” (if that is a proper way to refer to them) of GE crops in the U.S. have occurred, however. One was over a Bt corn variety developed by Syngenta, Bt10, which was inadvertently released by that company (http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/Submissions/ucm121416.htm); Bt10 contained a gene that confers resistance to ampicillin and other related antibiotics used frequently for human therapy and FDA essentially “approved” the release of that gene’s protein product “post-commercialization”. Another was a joint effort between the EPA and FDA over StarLink™, another Bt corn variety; the Bt protein in StarLink failed tests related to human allergenicity so EPA approved it only for animal consumption; corn being wind-pollinated, StarLink inevitably contaminated the human food supply anyway and the CDC spent 7 years monitoring the U.S. corn crop before it decided the levels of StarLink Bt in it were low enough that they could stop worrying about it. (I wrote about StarLink not too long ago on my blog: http://biotechsalon.com/2013/08/14/how-slate-com-botched-a-story-about-genetically-modified-food/.)

Perhaps developers have to have risk plans in place when their GE crops produce industrial chemicals or drugs…. There have also been “issues” related to these types of GE crops in the recent past.

The bottom line for me is that 1) unintended, unexpected changes are not just theoretically possible as a result of the genetic engineering process as currently employed, GE crops with unintended, unexpected “problems” (like StarLink and Bt10 corn) have been commercialized and, therefore, 2) we need to get to the scientific bottom of any putative adverse effects that are identified in such crops, one way or the other, and 3) we certainly need to make it mandatory for every product of this agricultural biotechnology to go through a pre-market regulatory process.

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