GeneWatch Vol. 29 No. 1

Volume 29 Number 1 | Jan-May 2016

ISSN 0740-9737

GeneWatch January-May 2016 Volume 29 Number 1

Editor and Designer: Samuel Anderson Editorial Committee: Sheldon Krimsky, Martin Levin Special Thanks: Martin Levin

GeneWatch is published by the Council for Responsible Genetics (CRG). Founded in 1983, CRG’s mission is to foster public debate on the social, ethical, and environmental implications of new genetic technologies. The views expressed herein do not necessarily represent the views of the CRG or ICTA staff or Board of Directors.

The Council for Responsible Genetics is now a project of the International Council for Technology Assessment.

660 Pennsylvania Ave Suite 302 Washington, DC 20003 Phone: 202-733-4094 CRG also has a Post Office box address in Cambridge, Massachusetts: Council for Responsible Genetics PO Box 400559 Cambridge, MA 02140 Correspondence can be sent to: CRG@gene-watch.org www.councilforresponsiblegenetics.org

Editor’s Note

Samuel Anderson

People get fired up about GMOs. As a GeneWatch reader, you may already know that our contributors tend to be quite critical of GMOs, and there’s a decent chance that you are reading this to reinforce your skepticism of GMOs. Or maybe you’re a proponent of GMOs reading this to get a better sense of the other side’s arguments, or even to get a sort of anger fix, like a Democrat watching Fox News. (We are pleased to report that GeneWatch will spare you from the comment sections.)

But in case you aren’t coming in with preconceived notions, given the often heated nature of the topic and the admitted onesidedness of the articles on the following pages, I think a disclaimer is warranted: The opinions contained in this issue will, for the most part, lean heavily in favor of mandatory GMO labeling. Quite heavily, in some cases.

But here’s the other thing: Plenty of reasonable, intelligent, and very well-intentioned people fall on the other side of the debate. It’s not just Monsanto employees and shareholders, whatever some of the more impassioned anti-GMO folks may tell you.

One of the most common arguments against GMO labeling relates to concerns about increased food prices for consumers, including those who already have trouble making ends meet.

Bruce Chassy and Jon Entine emphasize this in their three-part Huffington Post series arguing against mandatory GMO labeling, including the argument that it wouldn’t just impact genetically modified ingredients: “Without a doubt, if mandatory labeling is adopted the cost of GM-free ingredients would go up.”1 Robert Paarlberg wrote in The Wall Street Journal that adoption of mandatory GMO labeling may not change much for consumers in rich countries like the U.S., but that by obstructing the adoption of genetically modified crops such as Golden Rice and Bt brinjal, such anti-GMO campaigns negatively impact “the world’s poorest and hungriest people.”2 Pamela Ronald makes a similar case – an impassioned plea, really – in her 2015 continued on page 9

staff

comments and submissions

Sheldon Krimsky, Executive Director, Ad Interim Samuel Anderson, Editor of GeneWatch Martin Levin, Senior Fellow Elizabeth Small, Fellow

GeneWatch welcomes article submissions, comments and letters to the editor. Please email editor.genewatch@gmail.com if you would like to submit a letter or any other comments or queries, including proposals for article submissions.

Student submissions welcome!

Cover Design Samuel Anderson

founding members of the council for responsible genetics

Unless otherwise noted, all material in this publication is protected by copyright by the Council for Responsible Genetics. All rights reserved. GeneWatch 29,1 0740-973

Ruth Hubbard • Jonathan King • Sheldon Krimsky Philip Bereano • Stuart Newman • Claire Nader • Liebe Cavalieri Barbara Rosenberg • Anthony Mazzocchi • Susan Wright Colin Gracey • Martha Herbert • Terri Goldberg

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GeneWatch Vol. 29 No. 1

4 Point/Counterpoint on GMO Labeling A walk-through of the arguments for and against mandatory labeling. By Sheldon Krimsky 6 Science Supports the Need for GM Food Labeling Evidence is mounting that some GM foods – and definitely the herbicides associated with them – pose human health hazards. By David Schubert 10 The Public Policy Imperative for GM Food Labeling FDA’s abdication of independent pre- and post-market safety assessment and surveillance of GE foods must be remedied by mandatory labeling. By Martin E. Levin 13 Scrapping the Coordinated Framework The public should urge Congress to pass new legislation giving federal agencies effective and adaptive authority to regulate genetic engineering. By Alison Peck 16 The Future of Food: A View From the Farm A farmer’s perspective on GMO labeling. By Dave Bishop 19 A Business Perspective on GMO Labeling and Transparency Why Ben & Jerry’s advocates in favor of GMO labeling. By Andy Barker 21 The Status of GMO Labeling in the Laboratories of Democracy The state-led movement for food labeling transparency is a historical test of our democracy. By Martin Dagoberto Image: Google Earth

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Point/Counterpoint on GMO Labeling A walk-through of the arguments for and against mandatory labeling.

By Sheldon Krimsky

The U.S. government established its labeling policy in the 1990s just as the first food products of biotechnology entered the market. Its policy was based on the principle of material equivalence, sometimes also referred to as “substantial equivalence.”

It is also based on the concept that labeling a food product should not be based on the process of breeding the crop (such as genetic engineering), but rather on the properties of the product resulting from any form of breeding. With respect to foods produced from GMOs, whose parental crops are already consumed as food, the FDA has asserted that foods containing such GMOs are the substantial equivalent of the unmodified and unlabeled foods. Therefore, FDA does not require labeling of such GMO foods.

U.S. policy on labeling is strikingly at odds with that of the European Union. The European Parliament adopted a regulation in 1997 requiring that foods derived from GMOs be labeled as such, and the following year added similar regulation targeting GM maize and soybeans. The European Parliament later strengthened the rules to require labeling whenever

genetically modified organisms make up at least one percent of a product.

Japan also went on to institute mandatory GMO labeling.1 The current debate over whether labeling of GMO foods should be legally mandated has generated a host of arguments, pro and con, based on scientific, legal, economic, commercial, religious, and policy considerations. The purpose of this article is to summarize the way this debate has played out.

Point: Under current U.S. policy, labeling of food can only be mandated for a crop or processed food derived from it if that crop is materially different from a parental variety in nutritional quality or food safety. In Alliance for Bio-Integrity et al. v. Shalala, the US District Court found that FDA had no basis under federal law for requiring labeling, because FDA had determined that crops produced with genetic engineering posed no different or greater food safety concerns than crops produced through traditional plant breeding methods.

Counterpoint: There are many labels on food that are based on factors

other than nutrition or risk. We have labels for “dolphin-free tuna” or Kosher food, or trans fats. We even have a label for organic food that is not produced by genetic engineering, ionizing radiation, or use of sewage sludge, and which must be produced using allowable substances listed by USDA. To receive such a label we do not have to prove that the composition of the organic product is substantially different from the nonorganic product.

Point: The labeling for “dolphinfree” and Kosher are not mandated labels but voluntary. In July 2003, the U.S. Food and Drug Administration (FDA) announced that it would require mandatory trans fat labeling effective January 2006. The reason justifying this was that trans fats are unhealthy and represent a risk to consumers. GMO labeling can be done by manufacturers on a voluntary basis, but it cannot be mandatory because the food product is not materially different from the nonGMO counterpart. The organic label is not required for food producers.

Moreover, popular opinion for labeling does not change the legal authority of FDA to require labeling.

Counterpoint: Maize with a genetically engineered protein from the bacterium bacillus thuringiensis, which is toxic to some insects, makes the GMO maize materially different than the non-GMO variety.

Point: It is different by the criteria that it has a new protein, which the parental plant does not have. But

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it is nutritionally equivalent to the non-GMO and does not present any unacceptable risk to the consumer.

Unless there are risks in the Bt corn product, such as possessing allergenic properties not found in the nonGMO counterpart, labels cannot be mandated.

democratic processes, should be able to allow their citizenry to make their own choices on whether they prefer to buy GMOs. Based on public referenda, California requires labeling on products for toxic chemicals that are not required by the federal government or by other states.

Counterpoint: But the U.S. does not have required testing to evaluate whether there is nutritional equivalence or whether there are long term risks from consuming the GMOs. Without required comprehensive pre-market testing, how would the consumer know whether the criteria for material equivalence and safety are met?

Point: There are no federal laws preempting states from passing labeling statutes for GMOs, although there is still a labeling preemption bill pending in Congress. While states have enacted labeling for certain products that list toxic substances, which is not federally mandated, it often drives up the price of products. Companies often include the state-mandated labels for all their products regardless of where they are shipped rather than operating with a patchwork of labeling requirements.

Point: Many professional groups including the National Academy of Sciences do not believe there is prima facie evidence of material difference between GMOs and non-GMOs or that there are risks to consumers.

Until such evidence can be presented, the U.S. policy will maintain that mandatory labeling by the federal government is not justified.

Counterpoint: GMOs are made with antibiotic resistant markers.

These are proteins, which, if they entered our gut bacteria, could make them resistant to antibiotics. This is especially concerning if the bacteria in our gut happens to be pathogenic.

Point: Antibiotic resistant markers used in the molecular breeding of crops is considered a processing aid.

FDA’s labeling regulations exempt processing aids like the antibiotic resistance enzyme from the labeling requirements.

Counterpoint: What about states requiring labels on GMOs? Why shouldn’t states adopt their own criteria on questions of material equivalence, risk and the precautionary principle? States, through their Volume 29 Number 1

Counterpoint: When states have attempted to create labeling laws for GMOs they are usually sued by the food industry. Some courts have ruled against some labeling requirements, based on claims that corporations have a First Amendment right not to be compelled to state things about what is in their food that is not justified by legally valid government interests.

Point: Every state GMO labeling initiative put to a popular vote has lost at the ballot box. This was likely due, at least in part, to voters’ concerns that labeling would cause an increase in food prices. Anyway, just labeling a food “GMO” or “GMO ingredients” doesn’t tell consumers what, if anything, is new about the food constituents.

Counterpoint: Many ballot initiatives have failed by the slimmest of margins, and only after the commercial interests opposing labeling have overwhelmed the voting public with millions of dollars in anti-labeling

advertisements. The forecasted effects of labeling on food prices vary significantly depending on which economic analysis one reads. Meanwhile, in national polls, the majority of consumers believe they should have a right to know if the food was produced by genetic engineering.

How food is produced is becoming increasingly important for consumers, such as whether the food is organically grown, whether food animals are grass fed, or whether chickens are “free range.” Consumers should have a right to the information they consider relevant to such a highly personal decision as the purchase of the food they eat and serve their families.

Point: The USDA has developed a new government certification program for labeling foods that are free of GMOs. This should satisfy those consumers who wish to make choices based on GMO content in food.

Counterpoint: This certification program is not mandatory. If companies feel that putting a GMO label on their product will reduce sales, they will prefer no label of any kind.

People may oppose GMOs for any number of reasons including sustainability, seed patents, corporate contracts restricting the use of seeds, religious principles, and unknown risks. Whatever their reason, it is their right as consumers to make a choice.

nnn Sheldon Krimsky, PhD, is Director and a co-founder of the Council for Responsible Genetics.

Endnotes 1. Karen A. Goldman, Labeling of Genetically Modified Foods: Legal and Scientific Issues, Georgetown International Environmental Law Review 2:721 (2000).

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Science Supports the Need for GM Food Labeling Evidence is mounting that some GM foods – and definitely the herbicides associated with them – pose human health hazards.

By David Schubert Most people would prefer to have foods containing genetically modified products labeled as such. The simple right of people to know what they are eating is certainly valid, but the major reason for having this information should be personal health.

In the rhetoric surrounding the benefits and hazards of genetically modified (GM) foods, anyone who claims that the technology is proven to be safe should be immediately dismissed as either naĂŻve or dishonest for a few very simple reasons: (1) All existing plants produced by GM technology are different from each other and all pose different levels of risk to health; (2) Because most anything is possible in the world of genetic engineering, we have no way of knowing what will be introduced into our food chain in the future, and; (3) Finally, this is all made more problematic because there is no required Food and Drug Administration (FDA) safety testing of any GM product, and in fact to date none has been tested for toxicity.1,2 Therefore, in the context of GM foods, the American food system essentially offers a carte blanche for the producers if they can sell their product, and they assume that it will be easier to sell without a GMO label.

Clearly, this is not in the best interest of the consumer.

An example of point 1 is a simple comparison between three existing crops (herbicide resistant soybeans, Bt-expressing corn, and GM papaya). The production of GM soy requires large amounts of herbicides 6 GeneWatch

containing the chemical glyphosate, declared a probable carcinogen by the World Health Organization (WHO).3,4 Glyphosate, along with the many unknown and likely toxic chemicals in the herbicide spray formulation that uses glyphosate, are found in high enough concentrations to be a health hazard in the beans. In contrast, Bt-corn makes a bacterial insecticide that binds to and damages cells of the gut of insects and likely does the same in humans.5 Finally, the GM papaya was engineered to resist a plant virus and may be perfectly safe to eat.6 But until some comprehensive safety testing protocols are mandated, at a minimum similar to those required for all other food additives, the buyer should be given the option of whether to take the risk or not.

Second, new GM food products are being commercialized rapidly, and from my view as a medical research scientist, some of these may lead to the biggest GM food-related public health disaster of all. Rather than have the plants make an enzyme for herbicide resistance, a bacterial toxin, or an antiviral protein, the next generation will include nutritionally enhanced plants (NEPs) that are engineered to make molecules that are biologically active in humans. Examples are plants that overproduce certain fatty acids or vitamins. The insertion of genes leading to new synthetic pathways can lead to the production of toxic by-products. Golden rice and yellow

bananas are engineered to produce large amounts of beta-carotene, the precursor to vitamin A. In both, the likelihood of accidentally producing retinoic acid or related compounds, that are toxic at extremely low doses, is very high.7 In fact, such a product was associated with the death of dozens of people when bacteria were engineered to produce higher levels of a tryptophan dietary supplement.8 This case would have been much harder to trace to the source without the required labeling of the supplement. A label stating that the bright yellow banana is made by GM would serve as a warning if the buyer had concerns about the lack of safety testing for this novel food. Pregnant women should be particularly concerned, because retinoids cause birth defects.

Finally, presented with the fact that there is no required safety testing for any of these novel food products, most people simply do not believe that the FDA, mandated to protect our food supply, could be so uninterested. The reason is very simple. The laws that dictate the approval of GM foods were written by Monsanto, the company that developed the first GM plants.9 Despite the objections of many FDA scientists at the time, it was ruled that GM plants were substantially equivalent to their safe relatives in the food supply at the time and, therefore, generally recognized as safe. This is clearly an incorrect conclusion since each and every GM plant is distinct from Jan-May 2016

the conventional cultivar from which it was derived. Nonetheless, the assumption of “substantial equivalence” remains the law of the land and is exploited daily by industry.

In addition to the generic arguments outlined above for GM food labeling, it is important to discuss a few invalid claims continuously made by the commercial and academic interests that oppose GM food labeling. In order to debunk these statements, each will be discussed briefly with references to more thoroughly documented material.

“There is a scientific consensus that GM foods are safe.” Many other scientists and I can assure you that this claim is logically flawed because there is absolutely no evidence for human safety, all GMOs are different, and we do not know about future GMOs. Most importantly, there is increasing evidence within the scientific and medical communities that GM food crops and the agricultural chemicals required for their production are potentially dangerous.10,11 Within the U.S., the scientific discussion of health hazards associated with GM crops is muted because it is largely controlled by industry and pro-industry plant scientists within the major scientific organizations such as the American Association for the Advancement of Science (AAAS), and company-sponsored bureaucrats and scientists within the government regulatory agencies such as the FDA and the Environmental Protection Agency (EPA).12,13 Academic scientists are frequently financially involved with companies in the GM crop pipeline whose products ultimately must be sold to the big seed companies like Monsanto and Dow for commercial development. These scientists clearly have a vested interest in claiming universal safety and preventing labeling. In Volume 29 Number 1

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sharp contrast, a significant part of the world scientific community expresses concern about the rapid and largely uncontrolled introduction of GM foods and their associated pesticides, and supports labeling. These scientists are routinely attacked and vilified by the GM producers, and because of this other scientists are either intimidated or extorted to prevent them from expressing their concerns.14,15 The agricultural chemical and seed industries do not have the same political power in most countries as they do in the US; therefore GM food labeling is required in the majority of countries around the world. There is, in fact, no scientific consensus that GM foods are safe.16 “GM is just like traditional breeding, but more precise.” The production of GM crops has absolutely no relationship to standard plant breeding.17 The statement about precision is not true with the current GM crops, where gene insertion has been random. It is also not a reflection of reality in terms of the consequences of using newer technologies where genes can be inserted into the genome more accurately. This is because being more precise does not mean there is a greater ability to either understand or predict the outcome. You can precisely cut and rearrange a Chinese text without a clue about meaning unless you understand the language. At this point we clearly do not understand the details of how genes are regulated, and one currently cannot predict all of the downstream consequences of any genetic manipulation, regardless of how precisely it was done. In contrast, traditional breeding moves large blocks of genes around where the loss of regulatory controls is less likely to occur. Therefore, GM foods are very different from traditional crops and should be labeled as such.

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“There is no evidence that GM crops are harmful.” There are three aspects to this statement that at this time are difficult to separate. First, because there is no safety testing, no epidemiology and no clinical trials, no one can say that GM crops are safe to eat. The second involves the GM crop itself, and the third the agricultural chemicals required for their production. The toxicity of the chemicals is unambiguous, while the direct toxicity of the plants themselves is less well studied and varies with the modification.

GM soy and corn make up the vast majority of GM crops and most of these are engineered to be resistant to herbicides containing glyphosate such as Roundup. Glyphosate from the herbicide spray gets into the cells of all plants and remains there for extended periods of time. But the glyphosate resistant GM crops do not die, while the surrounding weeds are killed. There are a number of studies showing that glyphosate is an endocrine disrupter and toxic to humans.18,19 For these reasons, the WHO declared that it is a probable carcinogen. Since the introduction of GM plants, herbicide use has increased twenty-fold or more, and now there are very high levels in most soy and many corn products. Glyphosate is now found in extensive ecosystems, drinking water and in humans.

However, perhaps the highest human exposure to glyphosate is from nonGM grains. Most grain crops (wheat, oats, barley) are sprayed with herbicide directly before harvest to speed up their death and make them dry faster. Because the chemicals must be inside the plants in order to kill them, they are inside the grains, and we eat and drink them. In the case of beer, frequently produced with crops that are “dried” with a herbicide, the concentration of glyphosate has been

documented to be over 300 times the European limit allowed in drinking water.20 Therefore, a product can be labeled non-GMO yet contain very high levels of toxic agricultural chemicals.

Food, water, and beverages should be tested for qlyphosate by the FDA or EPA. However, this is not done, probably for the same reason that there is no GM food safety testing required by the FDA. The only way to reduce exposure is to buy organic products, and these may not be herbicide-free if they are farmed with manure from GM-fed animals, a practice currently allowed under organic standards. Herbicides accumulate in this material and can be taken up by plants through their roots.

Unlike the chemicals used in their production, the direct toxicity of GM crops themselves is more difficult to study. Although there is no required safety testing, both industry in the U.S. and a few academic labs outside of the U.S. do carry out studies and make claims about safety. As may be expected, the industry sponsored studies claim that there are no health problems associated with GM soy and grain consumption, while many of the studies from academic labs continue to find serious toxicities that would typically stop the FDA allowance of any medicine or food additive. These issues are too complex to discuss here,21 but it is quite clear that there are sufficient data to raise serious concerns about the safety of some of the current GM food crops, particularly those that are herbicide resistant and are likely to contain glyphosate and the other chemicals that are in the herbicide. An important caveat is that only a few of the many existing crops have been studied at all, so no claims about the global safety of the technology are valid.

In summary, there are no data to Jan-May 2016

support the claim that GM products are universally safe. In contrast, there is increasing evidence from the scientific community that some GM crops and definitely the herbicides that are required to produce the major GM crops are toxic. To limit exposure, currently the best alternative is to require GM food labeling allowing people to avoid purchasing these products. The drying of grains with herbicides must be halted, and all food crops, beverages and drinking water should be monitored for herbicides, and indeed all chemical pesticides. Their allowance should be set to scientifically validated safe limits that are determined independently of the producer. nnn David Schubert, PhD, is a Professor and head of the Cellular Neurobiology Lab at the Salk Institute for Biological Studies.

Endnotes 1. Druker, S. (2015). Altered Genes, Twisted Truth: How the Venture to Genetically Engineer Our Food Has Subverted Science, Corrupted Government, and Systematically Deceived the Public, 1st edn (Salt Lake City, UT, 513 pp.: Clear River Press).

2. Freese, W., and Schubert, D. (2004).

Safety testing of genetically engineered food. Biotechnology and Genetic Engineering Reviews 21:299-325.

3. Guyton, K.Z., Loomis, D., Grosse, Y., El Ghissassi, F., Benbrahim-Tallaa, L., Guha, N., Scoccianti, C., Mattock, H., Straif, K., and International Agency for Research on Cancer Monograph Working Group, I.L.F. (2015).

Carcinogenicity of tetrachlorvinphos, parathion, malathion, diazinon, and glyphosate. Lancet Oncol 16:490-491.

4. Myers, J.P., Antoniou, M.N., Blumberg, B., Carroll, L., Colborn, T., Everett, L.G., Hansen, M., Landrigan, P.J., Lanphear, B.P., Mesnage, R., et al.

(2016). Concerns over use of glyphosate-based herbicides and risks associated with exposures: a consensus

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statement. Environ Health 15:19.

5. Mesnage, R., Clair, E., Gress, S., Then, C., Szekacs, A., and Seralini, G.E. (2013). Cytotoxicity on human cells of Cry1Ab and Cry1Ac Bt insecticidal toxins alone or with a glyphosate-based herbicide. J Appl Toxicol 33:695-699.

6. Tripathi, S., Suzuki, J., and Gonsalves, D. (2007). Development of genetically engineered resistant papaya for papaya ringspot virus in a timely manner: a comprehensive and successful approach. Methods Mol Biol 354:197-240.

7. Schubert, 2008 8. Druker, 2015 9. Druker, 2015; Freese and Schubert, 2004 10. Druker, 2015; Myers et al., 2016 11. Landrigan, P.J., and Benbrook, C. (2015). GMOs, Herbicides, and Public Health. N Engl J Med 373:693-695.

12. Druker, 2015 13. Vallianatos, E.G., and Jenkins, M. (2015). Poison Spring: The Secret History of Pollution and the EPA, 1st edn (London, 304 pp: Bloomsbury Press).

14. Aviv, R. (February 10 2014). A valuable reputation. In The New Yorker: Annals of Science (New York, NY).

15. Johnson, R. (May 20 2014). Monsanto silences scientist who explores risks of gene modification. (http:// guardianlv.com/2014/05/monsantosilences-scientist-who-explores-risksof-gene-modification-video/).

16. Krimsky, S. (2015). An illusory consensus behind GMO health assessment. Sci Technol Human Values (STHV) 40:883914 doi: 810.1177/0162243915598381.

17. Druker, 2015 18. Summarized by Landrigan and Benbrook, 2015 19. Myers et al., 2016 20. Pesce, N.L. (NY Daily Times Thursday, February 25 2016). Popular German beers contain weed-killer linked dto cancer, study finds. http://www. nydailynews.com/life-style/eats/ popular-german-beers-weed-killerlinked-cancer-article-1.2543770.

21. For details, see Druker, 2015 and: Robinson, C., Antoniou, M.N., and Fagan, J. (2015). GMO Myths and truths: A citizen’s guide to the evidence on the safety and efficacy of genetically modified crops and foods, 3rd edn (London, Great Britain, 164 pp: EarthOpenSource).

Editor’s Note continued from page 2

TED Talk.3 And despite all the shouting from both sides, there are still GMO moderates out there. Grist put together a comprehensive series called “Panicfree GMOs” in order to present a balanced, “level-headed assessment of the evidence in plain English.”4 By the end of the series, writer Nathanael Johnson wound up a sort of GMO moderate, settling in the “this isn’t that important” camp. Rachel Ehrenberg wrote a boldly moderate article for Science News in January that includes this wonderfully blunt sentence: “The loudest voices on the proponent side are typically cast as shills for Big Agriculture (some of them are), while the loudest on the anti-GMO side are typically cast as fear-mongering luddites (some of them are).”5 This is all to say: There is a debate to be had. The articles in this issue mostly present one side of that debate, and of course there’s a reason for that. However, if you don’t feel up to speed on the arguments for and against GMO labeling, my own recommendation is this: Read this issue, of course. But also look up some articles making the case against mandatory GMO labeling, and if you can manage to find them, some “moderate” articles too.

May the best (democratically determined) argument win.

Just avoid the comment sections.

nnn Links: 1. http://huff.to/1Iqkc7H 2. http://on.wsj.com/23xkUob 3. https://www.ted.com/talks/ pamela_ronald_the_case_for_engineering_our_food#t-848011 4. http://grist.org/series/panic-free-gmos/ 5. http://bit.ly/1QroQQb

GeneWatch 9

The Public Policy Imperative for GM Food Labeling FDA’s abdication of independent pre- and post-market safety assessment and surveillance of GE foods must be remedied by mandatory labeling.

By Martin E. Levin

In 1992, the FDA blew a hole in the U.S. food safety law through which genetically engineered foods have been permitted to pass for the last twenty years. FDA adopted a policy approach toward this new form of agricultural technology that relied primarily on food suppliers’ voluntary compliance with their legal duty to ensure the safety of products offered to consumers. FDA largely limited the government’s authority to actions that might be taken if foods already on the market were discovered to be unsafe (i.e., “postmarket” legal action). In so doing, FDA essentially stripped itself of its additional authority to require producers to prove that foods containing genetically engineered (GE) ingredients could be safely offered to consumers in the first place (i.e., “premarket” proof of safety). Instead, FDA expressly presumed GE foods to be safe. That presumption, and the FDA’s accompanying determination that GE foods therefore did not have to be labeled as such, set the U.S. on a course of voluntary self-regulation by the producers of GE foods.

The flaw in this model of food safety regulation is self-evident.

Profit-motivated businesses engaged in GE food production determine whether their newly engineered products are safe enough to be offered to consumers. Health problems will only be detected upon consumption, but, because the foods are 10 GeneWatch

unlabeled, consumers have no practical way of knowing they are eating the products. And we did not arrive at this place as a result of rigorous independent scientific study of the GE ingredients now in much of the food found on grocery store shelves, but as the result of a legal presumption.

It didn’t have to be this way. When FDA was considering whether and how to regulate GE food crops, the then-current GE methods involved insertion of genetic material from one organism into the genome of a different organism (the plant), in a manner that could not be normally accomplished in nature. Such genetic modification produced traits in the plant that it did not naturally possess nor could naturally express.

Indeed, it is only because the new form of the plant did not already exist in nature that it could be patented under U.S. law. One common sense application of the U.S. Food, Drug & Cosmetic Act (“FDCA”), America’s food nutrition and safety law, would have been to conclude that the artificially added genetic material, as well as any new trait caused by its addition, constituted “food additives” as defined by the statute. Had FDA taken this common sense approach, GE food producers would have been required to prove the safety of such additives for consumption through FDA’s food additive petition process. Such proof would have been required before foods containing GE

additives could be brought to market (i.e., premarket). Each petition would have to be accompanied by supporting data generated by scientifically accepted methods, and FDA could require submittal of all safety studies, both positive and negative, during the petition process. Based on such data, FDA would have made its own finding whether the additive is sufficiently safe for consumption, and the conditions under which it could be safely consumed. FDA would have given public notice of its safety review in the Federal Register.

The public would have had an opportunity to comment, and FDA would have had to consider and respond to such comments. FDA would have published its final findings in rule form, and court review of FDA’s action would have been available pursuant to well established legal rights and rules of judicial restraint applicable to the agency’s administrative decisions. Inclusion of the additive in a food product would have to be labeled, unless certain exceptions applied.

Had FDA adopted this approach, a quarter century later there would be a public record of what GE products it found safe or unsafe for human consumption and under what conditions, along with detailed chemical, toxicological, allergenicity, nutritional, and other pertinent analyses considered by FDA in reaching its findings. Instead of adopting this Jan-May 2016

transparent approach to the new products of GE technology, FDA announced as “policy” that it would presume that such products fall into a statutory exception to the food additive requirements. This is the exception that applies to foods and additives that are “generally recognized as safe” (“GRAS”). The policy and its underlying presumption were based on FDA’s rationale that moving genetic material from one organism to another through genetic engineering amounts to no more than moving around the very ingredients of life itself, “...genetic material (nucleic acids)...,” [which] “...are present in the cells of every living organism, including every plant and animal used for food by humans or animals, and do not raise a safety concern as a component of food.”1 Assuming that both the newly introduced genetic material and the new trait(s) produced in the recipient plant would not substantially differ from the material and trait(s) present in foods already on the market, FDA made the policy judgment that GE products should Volume 29 Number 1

be considered GRAS and need not be labeled.2 The 1992 FDA policy did establish a voluntary private consultation process through which GE food producers can submit to FDA a summary of the results of the producer’s own research in support of the producer’s conclusion that the plant or food is safe. FDA is relegated to review of the summary, and expression of any questions or reservations concerning the developer’s conclusion of safety.

The producer is not required to submit all research conducted, in its complete form, including the underlying data. FDA does not publish any determination of its own whether the food is safe or unsafe.

In other words, there is no legally required, independent safety assessment of GE products before they reach the U.S. food market.3 The policy adopted by FDA had important procedural consequences. Determination of safety could be made exclusively by private sector scientists, such as scientists working for the GE food producer, rather than the FDA. The

producer decides what, if anything, it submits to FDA review. There is no right to public notice and comment on the producer’s determination, and no readily available avenue to challenge the safety determination made by the producer. And, except in a few cases in which GE products that were not intended for use as human foods found their way into the American food supply, FDA has conducted no post-market monitoring of GE products in the food supply nor surveillance for potential health impacts caused by those products. Nonetheless, the FDA has essentially advised Americans “not to worry”— because GE foods marketed in the U.S. “are as safe as comparable, non-GE foods.”4 But now many Americans are worried. They are worried because as GE food consumption has increased, various reports have documented the increasing incidence of health problems associated with diet. These include a growing prevalence of food allergies in children, as well as a number of digestive disorders.5 Such dietrelated concerns are heightened by GeneWatch 11

recent developments suggesting the importance of the gut microbiome to human health, and scientists’ acknowledgment of how little is known about dietary impacts. Americans have also become worried as reputable, independent nonprofits and academic researchers have, over the course of the past decade, published reports calling into question a number of the health and environment claims made to promote GE products and the pesticides they have been primarily engineered to deliver.6 Correlation does not equate to causation. Neither does shortage of conclusive evidence equate to lack of causation, when premarket safety assessments are made exclusively by industry permitted to cherry-pick which, if any, of its research and resulting data is submitted to the government or published in the scientific literature. Nor has the consuming public been readily able to associate any ill health effects to GE foods, since GE foods have not been labeled as such.

Those who support the current self-regulatory regime for GE foods have nonetheless made broad assertions as to the scientifically established safety of GE foods. They have taken to denigrating proponents of GE food labeling as “science deniers,” analogous to those who still deny the existence of global climate change or humankind’s contribution to it. Science should, of course, inform public policy when it comes to public health. But the present state of GE food science is like climate science virtually stripped of geological and atmospheric observation as well as the past 165 years of temperature data. The scientific understanding of the effects of genomic modification of complex organisms, and of dietary exposures to such organisms, is like climate science virtually stripped of 12 GeneWatch

its knowledge of the effects of greenhouse gases on the atmosphere.

Moreover, much of the GE food science conducted to date is like global climate science carried out and/or paid for by the fossil fuel industry.

When it comes to whether GE foods are safe to eat, current science may not compel a particular public policy outcome, but the current state of the law does. Since American consumers are unable to impose independent and transparent safety assessments on GE food producers, they are left with three fundamental choices: accept the producers’ own opaque assessments, and don’t worry about eating GE foods; accept those producers’ assessments sufficiently to try eating GE foods, but conduct their own monitoring for possible health effects; or reject the producers’ assessments, and avoid GE foods.

Those in the first group can and will proceed as they wish regardless of whether GE foods are labeled. For the many remaining Americans who choose to be more careful about what they eat and feed their families, their choice is difficult to impossible when GE foods are identical in appearance to non-GE foods, and the GE foods are not labeled as such. They are stuck in the hole created by the FDA’s policy to presume rather than assess safety before allowing GE foods to be served up to the American public, and FDA’s failure to look for evidence of the potential effects of GE foods in the American diet. That hole in our food safety law needs to be patched, and mandatory labeling is clearly the quickest way to do it.7

nnn Martin Levin, J.D., practices law in Framingham, Massachusetts, and is a Senior Fellow with the Council for Responsible Genetics.

Endnotes 1. 57 Fed.Reg. at 22,990.

2. The 1992 policy successfully withstood a legal challenge at the trial court level.

Alliance for Bio-Integrity v. Shalala, 116 F.Supp. 2d 166 (D.D.C. 2000). That lower court decision was never reviewed by a higher court, so still stands.

3. The 1992 policy only applied to GE crops.

However, its underlying rationale—that GE only involved moving around genetic material already present in every living organism and GE products could therefore be presumed safe—was so broad that it placed FDA in a regulatory corner when it comes to food safety of GE animals. FDA has attempted to escape this corner by applying its “New Animal Drug” authority to GE animals even though the FDCA expressly defines the term “drug” as an article “other than food.” 21 U.S.C. §321(g)(1)(C).

4. Consumer Info About Food from Genetically Engineered Plants, FDA, http://www.fda.gov/Food/ FoodScienceResearch/GEPlants/ ucm461805.htm (visited Apr. 7, 2016).

5. See, e.g., Jackson et al., Trends in Allergic Conditions Among Children: United States, 1997–2011, NCHS data brief, no. 121. Hyattsville, MD: National Center for Health Statistics. 2013; Samsel & Seneff, Glyphosate, pathways to modern diseases II: Celiac sprue and gluten intolerance, Interdisciplinary Toxicology (2013) 6(4): 159-184; Peery et al., Burden of Gastrointestinal, Liver, and Pancreatic Diseases in the United States, Gastroenterology (2015) 149(7): 1731-1741.

6. See, e.g., Schubert, Science Supports the Need for GM Food Labeling, GeneWatch (2016) 29(1): 6-9, and references cited therein.

7. This is not to suggest that changes to FDA’s approach to premarket food safety assessment and post-market surveillance need not also occur. Indeed, after 1992, the FDA extended to a wide range of additives the laissez-faire approach taken with respect to GE foods, to such an extent that its use of the GRAS exception could be said to have almost entirely swallowed the FDA’s food additive safety authority. See, e.g., Kindy, “Food additives on the rise as FDA scrutiny wanes,” The Washington Post, Aug. 17, 2014, https:// www.washingtonpost.com/national/foodadditives-on-the-rise-as-fda-scrutinywanes/2014/08/17/828e9bf8-1cb2-11e4ab7b-696c295ddfd1_story.html.

Jan-May 2016

Scrapping the Coordinated Framework The public should urge Congress to pass new legislation giving federal agencies effective and adaptive authority to regulate genetic engineering.

By Alison Peck

The contemporary movement to mandate labeling of foods containing genetically modified (GM) ingredients presents an opportunity to bring the issue of regulation of GM products into the public arena for debate.

That debate is important because current federal regulation is based on statutes that pre-dated the technology and were a poor fit for the technology even in the beginning.

As the technology has evolved, those statutes don’t cover many of the new techniques at all, leaving wide gaps in federal oversight of genetic engineering. A process is now underway to plug those gaps, and citizens should get involved to ensure that the new approach is comprehensive, forwardlooking, and responsive to public concerns.

The labeling movement arose out of public dissatisfaction with the stealthy entry of GM ingredients into the food supply. In the 1980s, the executive branch quickly put in place a regulatory framework to govern federal oversight of GM products based on old statutes. Only after GM seed varieties constituted the vast majority of soy, cotton, corn, and sugar beets grown in the United States (94 percent, 90 percent, 90 percent, and 95 percent respectively, according to 2013 estimates) did consumers become aware that nearly all processed foods they were consuming contained GM ingredients. While the labeling movement is useful to focus more public attention on an old Volume 29 Number 1

problem, the greatest harm resulting from the historic lack of public awareness and discussion of genetic engineering is not to the consumer who wishes to avoid consuming GM foods. Those consumers may already

do so by purchasing USDA Organic certified foods, which are not permitted to contain GM ingredients, and by purchasing nearly all varieties of fresh produce and fish, and all varieties of meat, poultry, and eggs, GeneWatch 13

which (at least at present) are not genetically modified.

Instead, the greatest harm from the lack of public awareness of GM regulation is to the consumer who does want to purchase GM foods, but wants to know that they are safe, and to the citizen who wants assurance that GM products will not disrupt the environment. The quick-fix regulatory solution of the 1980s was so poorly suited to the technology that many new GM products using modern genetic engineering techniques now escape important aspects of federal oversight – oversight meant to ensure safety of GM products for health and the environment.

To prevent the technology from continually outgrowing federal regulatory authority, the current framework should be scrapped and replaced with a new statute that directly addresses and regulates the unique risks of genetic engineering.

Some history may help to understand the poor fit between federal regulatory authority and the current state of genetic engineering. When the biotechnology industry was nascent in the 1980s, the Reagan Administration charged its Office of Science and Technology Policy (OSTP) with developing a regulatory framework that would be operational immediately, allowing the industry to bring products to market without the delays associated with drafting, debating, passing and implementing new legislation. The deputy director of the OSTP at that time, Dr. Bernadine Healy, testified at a congressional hearing in 1984 that “one of our major concerns in designing [the regulatory regime] is something that we think would be

operational almost immediately.” To avoid delay, the Reagan Administration announced the regulatory structure that would govern federal oversight of biotechnology in 1986. The Coordinated Framework for Regulation of Biotechnology divided oversight between three agencies. The FDA’s authority is based primarily on the Federal Food, Drug and Cosmetic Act, a 1938 act that authorizes FDA to regulate food additives and misbranding. The USDA’s authority stems primarily from a law that dates back to the Federal Plant Pest Act of 1957, which gave the USDA jurisdiction over bacteria and viruses in plants. The EPA derives its authority from the relatively modern pesticide and toxics control laws of the 1970s, including the Federal Insecticide, Fungicide and Rodenticide Act and

regulatory hook for these statutes is, at best, a rough analogy to those core concerns. FDA’s authority, for example, was based on its oversight of adulterated foods and food additives – substance (both natural and artificial) added to foods to improve their taste or appearance, such as colorings, emulsifiers, sweeteners and thickeners. Because addition of DNA to an organism didn’t seem much like these past examples, it was easier for FDA to enact a presumption that these new components were subject to a statutory exemption for substances that are generally recognized as safe. Moreover, since genetic engineering increasingly involves editing or deleting genes rather than adding new ones, it is unclear that FDA has jurisdiction over these new types of products at all. Similarly, USDA’s authority to oversee plant pests gave it jurisdiction over early genetic engineering techniques, which relied on viruses to insert new DNA into an organism.

But the virus was never really the problem, and modern genetic engineering increasingly doesn’t rely on viruses to do the job at all.

USDA has already announced that it has no jurisdiction over products created with new technologies. In July 2011, USDA informed Scotts Miracle-Gro Co. that USDA had no authority to regulate Scotts’ new GM bluegrass. That product was created using biolistics, or a “gene gun,” to insert genes, rather than the older method of using a viral vector. In May 2015, USDA acknowledged that it had no jurisdiction over five types of rice developed by researchers at Iowa State University using a new

The decision to avoid a legislative solution in favor of a cobbled-together regulatory framework based on old statutes need not be preserved out of lethargy or loyalty.

14 GeneWatch

the Toxic Substances Control Act. The trouble with these statutes is that they do not address the core concerns of genetic engineering: unintended and unidentified consequences to the DNA of the modified plant or animal; potential adverse effects of those unintended consequences on people or animals who consume them; environmental impacts of creating plants or animals that are hard to kill or have a genetic advantage over their wild cousins; and secondary effects on health or the environment from the overuse of pesticides that most GM seeds are designed to withstand. Instead, the

Jan-May 2016

technology called TALEN, which allows developers to edit an organism’s DNA rather than inserting anything at all. An even newer technology called CRISPR allows scientists to quickly and cheaply edit genomes, promising an explosion of new GM products in the near future that do not insert DNA, thus evading plant pest and food additive oversight authority by USDA and FDA. The best way to ensure that federal agencies retain jurisdiction to regulate genetic engineering as the technology continues to evolve is to pass a new law that gives federal agencies jurisdiction to regulate genetic engineering. The decision to avoid a legislative solution in favor of a cobbled-together regulatory framework based on old statutes was not a foregone conclusion in the 1980s and need not be preserved out of lethargy or loyalty. Between 1983 and 1987, at least eight congressional hearings were held investigating the need for new legislation. The Biotechnology Science Coordination Act of 1986 would have amended the Toxic Substances Control Act to provide for a three-level regulatory review of field testing and commercial use of GM products by USDA and EPA. A companion bill was introduced in the Senate. The Omnibus Biotechnology Act of 1990 would have set aside the 1986 Coordinated Framework and given agencies authority to regulate genetic engineering specifically.

Despite the labeling movement, public awareness of GM foods remains low. A 2013 survey by researchers at Rutgers University showed that 54 percent said they know very little or nothing at all about GM foods, and 25 percent still say they have never heard of them. Because most consumers are not aware of GM foods, only seven percent mentioned genetic modification when asked what Volume 29 Number 1

information they would like to see on food labels. Minimally-informed consumers, however, express concern about GM foods. When asked to rate how important it would be to them to have various kinds of information on food labels, 59 percent said that it was very or extremely important to have information about GM ingredients. Moreover, responses suggest that consumers would be unhappy if they understood their current lack of awareness: Only 26 percent of respondents believed that they had ever eaten any food containing GM ingredients, but 63 percent said they would be upset if they were served GM food in a restaurant without knowing it. Fifty-four percent said they would be willing to pay more for food that was not genetically modified.

Fortunately, and perhaps in part due to the GM labeling movement, the Obama Administration has begun an effort to reconsider the Coordinated Framework. On July 2, 2015, President Obama created an interagency task force among USDA, FDA, and EPA to update the Coordinated Framework and develop a strategy to prepare for changes in biotechnology. But tinkering with a framework based on statutes that didn’t contemplate genetic engineering or its core concerns will inevitably be inefficient and off-target. Instead, the task force should request new legislative authority that authorizes agencies to regulate genetic engineering and the risks it presents, and concerned citizens should push Congress to enact such legislation.

nnn Alison Peck, J.D., LL.M., is Professor of Law at West Virginia University College of Law.

Stem Cell Dialogues

A Philosophical and Scientific Inquiry Into Medical Frontiers

By Sheldon Krimsky “Stem cells” have become linked with both new frontiers in medical science and political and ethical controversy.

Addressing the moral and ethical issues of stem cell research while also educating readers about the biological function and medical applications of these cells, this book features fictional characters engaging in compelling inquiry and debate. Educational, entertaining, and rigorously researched, Stem Cell Dialogues should be included in any effort to help the public understand the science, ethics, and policy concerns of this promising field.

“Krimsky’s use of the dialogue method identifies, sharpens and advances both key points of debate and the breadth of issues being addressed.”

— Ronald M. Green, Dartmouth College AVAILABLE NOW from Columbia University Press

GeneWatch 15

The Future of Food: A View From the Farm A farmer’s perspective on GMO labeling.

By Dave Bishop

“Hi, I’m calling to ask if you give farm tours?”

The caller typically continues with a list of concerns about the food their family is eating and how that food is being produced. “Do you use antibiotics if an animal gets sick? Do grass fed cattle get any grain? Can pesticides be washed off? You’re organic, so you don’t use GMOs, right?”

Each year over 2,000 visitors come to PrairiErth Farm to see for themselves how food can be grown without being drenched with toxins or confining animals into tiny spaces.

16 GeneWatch

We walk through the hoop houses and vegetable fields, then into the pastures where they can get a closeup look at the animals. Finally we’ll collect a few samples of what’s in season, talk with the interns about what life is like on an organic farm, and finish the nearly mile-long trek back to their car. Many will become regular customers.

A recent afternoon visit by a young physician and his family was typical. On the long walk back to the car he described the health issues his patients were experiencing and why

he felt that many, if not most, were related to the foods they were eating.

He observed that “food labels don’t tell you anything about the pesticides that are used to grow something, or if GMO ingredients were used, so it’s hard to hard to figure out what effects these things are having on human health.” Americans are frustrated with a food system they no longer trust. Farmers are dependent on government subsidies to produce huge quantities of crops that large corporations use to make cheap “foodlike” products for big profits. We’ve

Jan-May 2016

become disconnected from our food.

Our food system has become disconnected from our health care system.

The industrial scale monocultures that produce those products depend on non-renewable resources – mined fertilizers and chemical pesticides – and genetically engineered organisms that produce more pesticides (Bt corn) or facilitate the use of pesticides (“RoundUp Ready”).

Pesticides and pollen from the fields where these crops are cultivated drift onto neighboring farms and contaminate non-GMO and organic crops, reducing their value dramatically.

At today’s prices, the value of a truckload (about 850 bushels) of organic corn is reduced from about $7,000 to less than $3,000 if GMO contamination is detected at the point of sale. A single load of soybeans instantly depreciates $10,000.

For the industrial producer of GMO crops in 2016, the profit margin has become too thin to be detected by bankers. In fact, it’s in the red. At current prices and production costs, corn will lose fifty cents a bushel (or about $100 an acre) and soybeans may come in at a $2 per bushel loss (again, about $100 per acre). A typical 5,000 acre corn/soybean farm could end the year a half million in the red.

If that’s not enough, the technology is failing as well. Weeds once killed by RoundUp, like Waterhemp or Marestail, have developed resistance to glyphosate. Sometimes called “superweeds,” such resistant weeds now require more applications of more potent chemicals. Insects like corn rootworms, once controlled by genetically modified Bt corn, are also developing resistance, meaning – yes – more applications of more insecticides. Farmers are led to believe the answer is to use even more toxic Volume 29 Number 1

The PrairiErth Farm crew. (photo previously published in ACRES -USA magazine, October 2015 issue. Rights retained)

combinations of pesticides and novel genetics in order to defeat the enemy: nature. Meanwhile, the government props up this farming system with its subsidies, while environmental costs – such as pest resistance, crosscontamination, and pollution from chemical inputs and agricultural runoff – are borne by others.

Of course there are alternative ways to grow abundant, healthy and profitable crops. Techniques like crop diversity, the use of cover crops, and extended crop rotations – working with nature – continue to be effective at managing weed and pests, but are much harder for biotech and chemical companies to market. For farmers, it means questioning some long held assumptions and changing the way we’ve been thinking and operating over the past few decades.

Moving away from GMOs isn’t about rejecting technology, it’s about selecting technologies that help us build soil and provide the ecosystem services – soil fertility, pest and disease

control – that all crops require without the need for toxic chemicals. By reintegrating livestock and increasing crop diversity we can improve agronomic sustainability while offering a more diverse product line to our customers.

Suppliers and buyers of the farms’ raw materials have convinced farmers that success means higher yields at any cost. It’s necessary to feed the world, which they would have us believe is entirely the responsibility of the American farmer. But if you look closely at the causes of hunger in the world, it’s not about producing enough food.

The world produces enough food to feed everyone . . . The principal problem is that many people in the world still do not have sufficient income to purchase (or land to grow) enough food.

World Hunger Education Service, UN, “2015 World Hunger and Poverty Facts and Statistics”

GeneWatch 17

Hunger is mostly about poverty and accessibility. In some parts of the world it’s caused by war, ineffective governance, environmental despoliation, and human displacement (e.g.

Iraq and Syria). Sometimes transportation and refrigeration problems keep food from getting to where it’s needed. At least one third of the food produced globally simply goes to waste. One example of hunger not being what it seems is the Irish Potato Famine, 1845 to 1847, when nearly half of Ireland starved or emigrated when the potato crop failed. Sure seems like a food problem!

But in fact during that time Ireland exported meats and grains to England in quantities at least large enough to feed everyone in Ireland. So why did so many starve? Meats and grains were expensive; what most people could afford to buy were potatoes.

So how did GMOs get a pass on the label? Why should someone have to seek out a “non-GMO verified” or organic product just to get an accurately labeled food product?

The silence on GMOs makes consumer confidence in the food system even harder to swallow. If GMOs are so safe, what’s the big secret about what’s in our food?

Consumers are paying attention.

The biotech industries’ persistent and expensive opposition to laws requiring labeling of their products has kept the issue on the public’s radar.

Shoppers are looking for identity preserved and organic foods and they’re willing to pay for them. With their legal and political efforts to stop Vermont’s GMO labeling law so far failing, food companies are beginning to respond to consumer demands and

labeling their products nationwide whether required by law to do so or not.

I guess it’s really no mystery why the biotech industry has been so derided for so long. In most of the 64 or so countries where GMO labeling is required, consumers have rejected those products. It’s all about industry profit. Why agencies like the FDA and the USDA have been so eager to promote the interests biotech crop companies over those of others needs some explaining.

produce healthy, profitable, and affordable crops without GMOs and their attendant pesticides. Efforts like the Open Source Seed Initiative, begun at the University of Wisconsin, Madison, are making non-GMO seed available to farmers without patent restrictions, so farmers can save the seeds grown on their farms and develop local ecotypes. Small seed companies are forming to breed and supply modern versions of old heritage grains with superior taste and nutrition for local chefs, bakers, and cooperative grocery stores.

Farms like ours are growing food for local markets and inviting customers to visit the farm, where they (and their kids) can participate in planting and harvesting the foods they share at their table. No transparency issues here. nnn

“In farming, like in every other business, informed consumer choices drive change. ”

18 GeneWatch

In farming, like in every other business, informed consumer choices drive change. If American consumers reject products with GMO on the label, farmers will produce the kind of foods they demand and are willing to pay for. What consumers are demanding is nothing less than a new food paradigm. This paradigm is one of emerging local food systems, and will define the way Americans and people globally will feed ourselves in the 21st century. Sustainable farming systems will have no need for industrial scale monocultures hiding behind “ag-gag” laws, right-to-farm legislation, or secrecy about the farming technology itself. Local food systems will produce culturally appropriate foods close to home using many independent farmers, processors, and sellers who maintain close personal relationships with those they serve.

At PrairiErth Farm we’re working with university researchers to develop diverse farming systems that improve the quality of our soils and

Dave Bishop is owner of the PrairiErth Farm in Atlanta, Illinois, is President of the Illinois Food, Farms, and Jobs Council, and a member of the Illinois Dept. of Agriculture’s Sustainable Ag Committee.

PrairiErth Farm in central Illinois is a multigenerational 400-acre diversified organic farm producing corn, soybeans, wheat, oats, alfalfa, vegetable crops, beef, pork, eggs and honey. The farm provides the sole support for two families, three full time employees, numerous part time helpers from around the community and offers four full time internships from March through November.

Jan-May 2016

A Business Perspective on GMO Labeling and Transparency Why Ben & Jerry’s advocates in favor of GMO labeling.

By Andy Barker Jerry Greenfield, co-founder of Ben & Jerry’s, has a knack for getting to the heart of things. “Every company should be proud to tell consumers what is in their products,” he testified in front of Vermont’s legislature back in 2014. It’s a statement he has made in support of mandatory GMO labeling at rallies around the country, in conversation with members of Congress and in dozens of media interviews.

It’s not just a talking point. It is an attitude about transparency that Ben & Jerry’s has embraced since the days of the original ice cream scoop shop, when our co-founders proudly advertised such disastrous flavors as Honey Apple Raisin Oreo and Lemon Peppermint Carob Chip. In the 1990s, our company fought (unsuccessfully) for mandatory labeling of dairy products produced with rBGH, an artificial hormone given to dairy cows to increase milk production. In the last several years, we have advocated for mandatory GMO labeling, supporting efforts in Washington DC and nearly a dozen US states to pass new laws on this issue. It’s clear to us that the vast majority of Ben & Jerry’s fans support labeling. And numerous surveys have measured overall public support for mandatory GMO labeling at around 90%.

Still, despite the logic behind our company’s position on labeling, there are real world implications for our Volume 29 Number 1

business, and for the whole food industry. What are those implications?

Why do we continue to see mandatory labeling as the right path forward, for our company and for the United States?

The fundamental reality Beneath all of the furor around GMOs and GMO labeling, a few basic trends are driving the evolution of the food industry today. One is a growing consumer interest in socalled ‘clean label’ foods, those with ingredients perceived to be pure, natural, and simple. This interest has been fueled by decades of marketing from the food industry itself, pitching consumers relentlessly on the idea that ‘natural’ means ‘better’; the emergence of the millennial consumer, with higher expectations around food purity and corporate social responsibility; and a new focus on the connections between food quality and health outcomes driven by the rise of chronic disease rates around the world and the growth of the alternative health care sector.

Supporting this trend is growing consumer interest in transparency, which has been accelerated by the expansion of digital and social media.

There are few places for companies to hide anymore when their activities – and their supply chains – are out of line with the expectations of some segment of the population. And it is

easier than ever for companies to discover what their consumers want so they can bring products to market to meet that demand.

GMO labeling aligns with the trend In most consumers’ minds, genetically modified foods do not qualify as pure, natural, and simple. Indeed, whatever one might say about GMOs, it is hard to make the case that they are ‘natural’ foods, by any reasonable definition. (Though that question, too, is currently under consideration by the Food and Drug Administration.) In this light, the push among the public for mandatory GMO labeling is not purely about the ‘right to know.’ It is also about consumers’ right to choose, or said another way, their ability to avoid GMO foods in their diet.

And consumers are already choosing on the basis of voluntary GMO labeling. The Hartman Group reports that 40% of consumers are avoiding or reducing GMOs in their diet, with concerns ranging from potential negative health effects to environmental concerns. ‘Non-GMO’ has now become a ‘purity marker,’ and sales of foods with this claim are growing at 14% annually. This makes Non-GMO one of the fastest growing segments in the supermarket, according to Packaged Facts. Consumers want more of these products – and they want choice in the GeneWatch 19

marketplace, which mandatory labeling promises to deliver.

Is the cost and complexity of labeling really the problem?

Some have argued against mandatory GMO labeling on the grounds that the expense of changing labels will raise the cost of food. This has not been Ben & Jerry’s experience.

On the contrary, label changes are a frequent and ordinary part of doing business. Every year, we make changes to between 25% and 50% of our packaging. Over the last 7 years, we’ve gone through three full packaging redesign projects. In other words, we have changed the packaging on every single pint in our product line as a matter of normal business. Lots of things impact the cost a consumer pays for a pint of Ben & Jerry’s ice cream. Changing labels is not one of them.

What is really driving industry opposition is the fear that transparency will prompt some consumers to choose not to buy foods made with GMO ingredients. Today, many consumers are unaware that GMO ingredients are used in most processed foods on supermarket shelves. Mandatory labeling will certainly raise awareness. And given the underlying trends favoring ‘clean’ labels, this is likely to further erode demand for conventionally sourced foods.

Some food companies with conventional supply chains are responding to the prospect of mandatory labeling by reformulating their products to avoid GMOs. This is likely to add some measure of complexity and cost into food company supply chains - in the short run. Depending on the ingredients being transitioned, there are typically cost premiums for NonGMO ingredients compared to conventional ingredients once segregation, testing, and verification costs 20 GeneWatch

are included. However, Ben & Jerry’s experience shows that transitioning products to Non-GMO ingredients can be achieved without raising prices to consumers, even for complex products. (And with all of the chunks and swirls, Ben & Jerry’s ice cream is one of the more complex consumer food products available.) In the longer run, as the size of the Non-GMO marketplace grows to respond to consumer demand, it is likely that scale efficiencies will reduce cost premiums on Non-GMO inputs.

The specter of a state-by-state GMO labeling ‘patchwork’ The reality is that neither the Food and Drug Administration nor Congress has shown any inclination to create mandatory GMO labeling at the national level, despite more than a million public comments demanding it. The only viable path to national labeling leads through the states, where legislatures have been more responsive to public opinion and where ballot initiatives allow voters in some states to consider legislation directly. Ben & Jerry’s home state of Vermont is the first and, so far, only state to pass mandatory GMO labeling without a ‘trigger’ that would rely on action by other states to take effect. Although a court challenge to Vermont’s Act 120 is still pending, and the threat of Congress pre-empting Vermont’s law still remains, this law has put tremendous pressure on policymakers – and on national food companies – to respond. As of the time of this writing, several national companies had made announcements of their plans to voluntarily label their products everywhere in the United States, to comply with Vermont’s law. In effect, one small state has set a de facto national standard on GMO labeling. Ironically, this state’s legislature has responded

to American consumers’ desire for labeling more effectively than Congress. In any case, a mandatory, national, on-package GMO labeling requirement remains the ultimate goal of most advocates, including Ben & Jerry’s. In the meantime, our company will continue to support efforts in other states to pass labeling laws similar to Vermont, thereby reinforcing the existing de facto national standard.

The path ahead The debate over mandatory GMO labeling is far from over. Yet it seems safe to conclude that the underlying trends will continue to grow: consumers will increasingly seek out clean label products; responsive food companies will be rewarded in the marketplace; the supply of NonGMO ingredients will grow to meet demand; and the pressure will continue to build for mandatory GMO labeling. Whether or not this goal is achieved nationally in the near future, the desire among the public for transparency about the food supply will not go away. The real question for food companies is how they want to respond to the trend. At the leading edge, some companies have embraced transparency as a North Star, from hundreds of start-up natural food companies to national brand owners like Campbell’s. For these players, transparency is not an obstacle but a path to growth and profitability in a highly competitive landscape. nnn Andy Barker is Social Mission Strategy and Policy Manager at Ben & Jerry’s.

Jan-May 2016

The Status of GMO Labeling in the Laboratories of Democracy The state-led movement for food labeling transparency is a historical test of our democracy.

By Martin Dagoberto If GMO Labeling is any indication, the “Laboratory of the States” is alive and well. Despite federal inaction, food packages bearing the words “produced with genetic engineering” are beginning to arrive on shelves across the United States as this article goes to print. Major manufacturers are choosing to label nationwide in response to the GMO labeling law slated to go into effect in Vermont on July 1, 2016. Vermont has effectively set the standard for mandatory labeling of genetically engineered food ingredients and several other states are poised to join them at this critical moment in time.

Laws passed in Connecticut and Maine in 2013 set the stage for the 2014 passage of Vermont’s law, but contained “trigger clauses” that delay their operation until several other states pass similar labeling requirements. Regardless of the different effective dates of the various laws, each of them contains substantially similar labeling standards and definitions .In fact, advocates in these states, as well as dozens of organizations across the country, have coordinated their efforts over the past four years with the goal of a uniform national mandatory GMO labeling standard. These groups have successfully avoided the predictions of a “patchwork quilt” of regulations frequently raised by opponents of state GMO labeling laws.

Despite this state level success, special interest forces continue to Volume 29 Number 1

work overtime in Washington, DC to pre-empt state laws and implement a meaningless, voluntary federal standard. Fortunately, their efforts have been met by a vibrant nationwide grassroots movement of consumer advocates working together to set the expectation for labeling transparency.

Consumers have no shortage of legitimate reasons why they need to know what they’re buying. As demonstrated by the recent (albeit temporary) defeat of a U.S. Senate attempt to nullify Vermont’s law, the public will settle for nothing less than clear,

conspicuous on-pack labeling of genetically engineered ingredients.

The standard set by Vermont states that food for human consumption offered for retail sale that is entirely or partially produced with genetic engineering (as defined by the internationally-recognized “Codex” definition) must be labeled to indicate this fact. Raw and bulk commodities will be labeled on the bin or shelf as applicable. Animal products would be labeled only if the animal itself is engineered. Also in accordance with international standards, the labeling threshold is 0.9% total weight. Due GeneWatch 21

to the limitations of state legislation, current laws and proposed bills don’t cover alcoholic beverages, food offered for immediate consumption, or meat and poultry products under the purview of the USDA. The responsibility for labeling will be on the manufacturer (not the retailer), who will be subject to a $1,000 per day per product penalty in Vermont.

On the same day that Vermont’s Governor Shumlin signed the GMO labeling law, industry groups headed by the Grocery Manufacturers Association announced (as expected) that they would sue to stop the law. Their lawsuit relies in large part on a First Amendment challenge, alleging that the labeling requirement “imposes burdensome new speech requirements on food manufacturers and retailers.” However, a preliminary injunction to delay implementation of the law was denied in federal district court in April 2015. In its decision, the court said the plaintiffs’ claim of irreparable harm lacked merit and found that the “safety of food products, the protection of the environment, and the accommodation of religious belief and practices are all quintessential government interests,” as is the “desire to promote informed consumer decision-making.” The court also dismissed claims that Vermont’s law was preempted by federal law and that it violated the Dormant Commerce Clause. The Grocery Manufacturers Association appealed the district court’s decision based on the First Amendment. The appellate court’s decision is pending, and the lawsuit itself could take years. Given manufacturers’ recent moves to comply with Vermont’s law, they do not appear confident that they will resolve it in courts before the law goes into effect in July.

GMO labeling advocates will continue to work for progress at the 22 GeneWatch

state level until a federal mandatory GMO labeling standard which meets or exceeds the Vermont standard is adopted .In Massachusetts, a recordbreaking bipartisan coalition of state legislators has cosponsored a GMO labeling bill (155 of 200 total legislators as cosponsors). Nearly 500 local farms, businesses and organizations across the state have joined the coalition in support of the legislation.

Tens of thousands of residents have made their voices heard through petitions, hearings, lobby days and call/ email campaigns, and legislators are listening. The bill was passed unanimously out of its first committee in March 2016 and is awaiting a vote on the House floor before the legislative session ends in July. In Rhode Island, a GMO labeling bill has the support of nearly the entire House of Representatives and a majority of the Senate. New York, Minnesota and other states are expected to follow shortly.

Labeling advocates in Connecticut are also working to remove the trigger clause that has prevented implementation up to this point. Discussions are under way in Maine about a possible ballot initiative to strip the trigger clause from the Maine law as well.

Most reforms start closest to those who are in need of them. Important reforms, demanded by citizens, are often debated, vetted, and passed on the state level where lawmakers are closer to their constituents and less influenced by industry giants and their armies of lobbyists. Only after being faced with the prospect of negotiating different laws in different states and wasting millions of dollars in uphill battles are powerful moneyed interests willing to come to the table on the national level to adopt simple reforms for the whole country. State GMO labeling campaigns have been successful for this reason:

a coordinated network of grassroots activists have mobilized a diverse, passionate and vocal constituency, overwhelming the influence and reach of industry lobbyists.

Not surprisingly, transparency opponents have focused their attention on the gatekeepers who have the greatest influence on the priorities and operations of the legislature.

Rank and file lawmakers may be completely on board, but if a small number of powerful legislators can prevent or delay a bill from coming up for a vote, then a majority of support doesn’t count for anything.

Grassroots campaigns have and will overcome such roadblocks by making inaction an undeniable political liability.

Transparency opponents will continue to cry wolf and muddy the waters, saying that “GMO labeling is meaningless and unnecessary” and even that it will somehow “destroy the food system.” At the end of the day, however, consumers have demonstrated that this information is important to them, and the issue is clearly not going away. Whether or not the old adage “the customer is always right” holds water any more, the populist tenor of today’s political climate is undeniable and growing.

If anything, this state-led movement for food labeling transparency is a historical test of our democracy, and the more perceptive manufacturers have already begun to move in the direction the winds are blowing. nnn Martin Dagoberto is the Massachusetts GMO Labeling Campaign Coordinator with Citizens for GMO Labeling.

Jan-May 2016

From the Council for Responsible Genetics

The GMO DecepTiOn What You Need to Know about the Food, Corporations, and Government Agencies Putting Our Families and Our Environment at Risk

edited by Sheldon Krimsky and Jeremy Gruber Foreword by Ralph nader

“If you do not understand why there is so much opposition to GMOs, nationally and internationally, this book is the place to start.”

—Marion Nestle, professor of nutrition, food studies, and public health at New York University and author of Eat Drink Vote: An Illustrated Guide to Food Politics “The GMO Deception is the most comprehensive resource covering all areas of this complex topic.”

—Ken Roseboro, editor and publisher, The Organic & Non-GMO Report

ON SALE NOW Volume 29 Number 1

GeneWatch 23

Council for Responsible Genetics www.councilforresponsiblegenetics.org

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