Genetically Modified Food: No Labeling
The FDA has declared that genetically modified foods or food ingredients need not be labeled. Why not? The FDA holds that genetically modified foods (GM-foods) are essentially the same as traditional foods -- there is "substantial equivalence", in the language of food scientists. For example, Monsanto scientists performed a detailed nutritional analysis of traditionally bred soybeans and also of "Roundup Ready" soybeans, which were genetically modified to be resistant to Monsanto's "Roundup" herbicide. The scientists compared nutrient content (protein, fat, carbohydrates, fiber, etc.), even analyzing the amounts of the different kinds of amino acid that make up proteins. They also compared so-called antinutrients (such as lectins), undesirable substances that occur in small amounts in many foods. In all cases they found no substantial differences in composition or amount and therefore concluded that conventional and genetically engineered soybeans are substantially equivalent (7).
Utilizing such studies from the companies that produce genetically engineered products (the FDA does no testing of its own and does not require third-party testing) the FDA formulated its policy on genetically modified foods in 1992:
The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding. For this reason, the agency does not believe that the method of development of a new plant variety is normally material information ... and would not usually be required to be disclosed in labeling for the food (8).
This policy narrowly couples labeling of GM-foods with safety, leaving out all the other criteria for labels we described above. The idea is: if there is no safety issue, there is no reason to label. And, according to the FDA, there is no safety issue, because GM-food and traditional food is substantially equivalent, and since traditional food is safe, GM-food must also be safe.
Remaining within this tidy argument, the FDA does not hold the method of production to be "material information". This is a telling conclusion that rests on a very specific interpretation of what "material infor- mation" means. Normally the term refers to something relevant or pertinent to the matter at hand. But here the FDA has chosen to restrict the meaning, equating "material" with "physical substance". Since "genetic engineering", as a method of production, is not a physical substance within the plant, it is deemed irrelevant.
This logic restricts the regulation and labeling of genetically modified foods to the narrowest terms possible. The FDA is applying a very different standard than it does for other foods. I called the FDA and asked why it demands labeling of orange juice from concentrate. Surely, I said, it is not a safety issue, and just as surely the agency is not raising a question about "substantial equivalence" with fresh- squeezed orange juice. The answer was, "no, of course not; it's a matter of truthfulness". A simple and clear answer (from an FDA employee who did not work on GM issues).
Substantial Equivalence Doesn't Tell it All
Two foods are defined as substantially equivalent if the investigation of certain substances in the foods shows the foods to be "the same". The scientists investigate only a select number of known nutrients and antinutrients. Other substances ("nonnutrients") that are produced, expectedly or unexpectedly, through genetic engineering are not taken into account. For example, the fact that each cell of a genetically engineered soybean contains a novel protein -- the enzyme that prevents the herbicide from killing the plant -- is not included in the data used to determine substantial equivalence. Nor is the fact that genetically engineered plants usually contain five or more genes (DNA sequences) that come from other organisms -- other plants, bacteria, and viruses (see Table below). No traditionally bred plant contains such an array of foreign genes, which include, for example, a bacterial gene that gives the plant resistance to a specific antibiotic.
The concept of substantial equivalence is, by virtue of its narrowness, misleading (9). The term itself suggests that all the substances in the foods are the same, but in reality only a specific subset of substances has been investigated and taken into account in the designation "safe".
What A Genetically Engineered Plant Contains
Plants are never modified by adding just one foreign gene. A whole "DNA construct" made up of DNA from different sources is shot into the plant. In the case of Monsanto's "Roundup Ready" soybeans that are genetically modified to become resistant to the herbicide glyphosate, the gene construct consists at least of the following (10):
DNA originally from the bacterium Agrobacterium, now synthetically produced, for herbicide resistance.
DNA from the cauliflower mosaic virus that regulates the expression of the herbicide-resistance gene.
DNA from the petunia to move the gene product to the chloroplasts (so that the herbicide-resistance gene will be adequately expressed in the leaves, which are the main target of the herbicide).
DNA from a bacterium (Agrobacterium tumefaciens) to regulate the production of the enzyme needed for herbicide-resistance.
DNA from a fecal Streptococcus bacterium to make the plant antibiotic resistance. It is used as a "marker" gene to help scientists identify which plants have been genetically transformed in an experiment.
A circular strand of DNA (called a plasmid) from a bacterium.
All the other ingredients are biochemically inserted into the plasmid, which carries the DNA into the plant's cells. When the experiment goes according to plan, every cell of the organism contains at least one copy of the complete construct. Through the gene construct the metabolism of the cells is altered and the plant is obliged to produce novel proteins:
a target protein -- for example, the enzyme to convey resistance to herbicide in "Roundup Ready" soybeans or the toxin to kill insect larvae in "Bt" crops;
enzymes affording antibiotic resistance.
These proteins are produced continually, in every cell in the plant. By contrast, in normal protein metabolism, proteins are specific to particular tissues and functions.
Foreign Gene Products as Additives
In the early 1990s Calgene was developing its "flavrsavr" tomato, the first GM-food to enter the market. This tomato was genetically engineered to turn red on the vine but remain hard for shipping. (The idea was that it would taste better, but in the end Calgene's $95,000,000 investment didn't pan out, and the company -- on the verge of bankruptcy -- was bought by Monsanto.) The FDA at that time was still in the process of formulating its policy on GM-foods. According to Belinda Martineau, a scientist who worked on Calgene's tomato project, "the FDA did not have a specific process in place for dealing with genetically engineered whole foods. It was up to us, therefore, to decide just how to submit to the agency whatever safety data we would produce" (p. 64) (12).
The company had to decide how to deal with the new tomato's novel proteins. The fruit contained, like other genetically engineered crops, an antibiotic-resistance gene and the protein (enzyme) produced through it. The scientists involved came to the conclusion that the enzyme would fit into the category of food additives, and the tomato would then carry a label specifying the additive. Since food additives are strictly regulated, the process of approval might have taken three years. Calgene's management wanted to get around this problem by calling the antibiotic-resistance enzyme a "processing aid". Receiving approval for a processing aid was likely to be quicker, the company wouldn't have to publish safety data, and processing aids don't need to appear on labels. This seemed an ideal strategy.
In the end, the FDA did require that Calgene submit a food-additive petition, since this was considered the approach that would cause the least problems for approval (See reference 11, p. 161). The main issues considered were whether the tomatoes were safe for human consumption (the company did some animal tests), whether the enzyme might cause resistance to antibiotics in humans, and whether the gene might be transferred to bacteria in the intestines. Based on all the evidence Calgene presented, the FDA declared the enzyme to be a safe food additive (12).
But it did not require labeling. Normally, as I described at the beginning of this paper, the FDA requires any added ingredients to be indicated on a food's label. But in the case of the antibiotic- resistance enzyme, the FDA reasoned:
FDA considers an "ingredient" to be a substance used to fabricate (i.e., manufacture or produce) a food. FDA does not consider those substances that are inherent components of food to be ingredients that must be disclosed in the food label. A genetic substance introduced into a plant by breeding becomes an inherent part of the plant as well as of all foods derived from the plant. Consistent with FDA's general approach on ingredient labeling, the agency has not treated as an ingredient a new constituent of a plant introduced by breeding, regardless of the method used to develop the new plant variety.... Accordingly, [the antibiotic-resistance enzyme is not] an ingredient that must be individually identified on the labels of foods containing them. (See reference 12.)
In other words, after declaring the antibiotic-resistance enzyme to be an additive (which means it is an ingredient), the FDA immediately turned around and, for purposes of labeling, denied the additive-ingredient status, calling the enzyme an inherent part of the plant. The FDA went on to "solidify" this position by stating that even if the enzyme were an ingredient, it would treat it as a "processing aid" rather than an additive, so it wouldn't require labeling anyway. These logical flip-flops seem inexplicable except as efforts to prevent labeling at all costs.
We'll see why later. But now we need to look at how genetic engineering differs from traditional breeding.
A Long Way from Traditional Breeding
It is not only the genetic and biochemical composition that makes GM-crops different from conventional crops. The whole way in which they are produced differs radically from traditional breeding, and these differences bring new kinds of uncertainty. First, scientists must isolate the various genes used in the genetic manipulation. This is an involved biochemical and technical procedure, yielding products for which companies (and universities) seek patents. You can't help feeling the wool is being pulled over your eyes when the same companies that receive patents for their products, which according to the patent office must be "man- made", argue that genetic engineering is as natural as traditional breeding.
Then genetic engineers make the novel gene construct, consisting of DNA from different sources (plants, bacteria, and viruses; sometimes animal DNA). This product of biochemical analysis and synthesis is used to alter the plant, a far cry from a breeder taking pollen from one plant variety and using it to fertilize another plant of the same species in the hope of producing plants with a new combination of characteristics.
Once the laboratory-produced DNA construct has been made in the lab, the task is to get it into the plant. The most prevalent method is to use a "gene gun" (13). Tiny pellets of tungsten or gold are coated with the transgenic plasmids and then shot into embryonic plants. These plants are then grown in a medium with antibiotics. Only a small percentage of plants survive -- those that have the antibiotic-resistance gene. These plants and their progeny are investigated further to see if they also express the desired trait (herbicide resistance, toxin production, and so on). Usually a few plants are chosen to be the parent stock of the future crop. At this point traditional breeding methods set in. Breeders select and perhaps cross the transgenic plants with other known varieties with desirable traits. Finally, a new transgenic crop line emerges.
When a company has a transgenic crop line, it can carry out a detailed genetic analysis to discover how the DNA has been incorporated into the plant. Often the DNA-construct is broken, the desired genes are separated from each other, and the individual genes themselves split into fragments. These genes and fragments may be incorporated into different places into one or more chromosomes. The foreign DNA may also be inserted into the chromosome in such a way that it breaks up one of the plant's genes. Some of the DNA may be broken down altogether.
All of this can be detected only after the fact. And sometimes long after the fact. Monsanto originally declared that each cell of Roundup Ready soybeans did not contain the entire DNA construct (see Table above), but rather a single copy of two of the genes and partial copies of two others. Nonetheless the plant "worked" the way the scientists wanted it to (with high resistance to the glyphosate herbicide). Four years after the Roundup Ready soybeans had been on the market, Monsanto reported that each cell also contained two additional partial segments of the herbicide-resistance gene as well as another copy of one of the other genes of the construct.
Genetic engineering is usually hailed as a precise new technique to make exact modifications. In reality, precision stops when the DNA leaves the laboratory and enters the plant. The scientists have to wait and see what the organism has made of their attempted manipulation.
By now you can see why there are good grounds to expect unintended effects arising from any genetic manipulation. The plant may be producing new substances that it hadn't produced before, or its normal production of substances may have been repressed.
There are countless examples of such changes: transgenic potatoes that were supposed to make more starch and less sugar, made less starch and less sugar; transgenic tomatoes that were made to produce excess carotene did so, but the more carotene they produced, the smaller they got; a normally self-fertilizing weed that was made herbicide-resistant (as intended) also unexpectedly began cross-pollinating with other specimens -- a radical change in reproduction (14). Many such undesired and unexpected effects are weeded out in the process of selecting plants for further breeding. But there is no reason to believe that the only changes are the more obviously detectable ones. Also, some changes may become apparent only in the field, and there are various environmental concerns (15).
Let me give one example. Some farmers in Georgia complained about the poor performance of their transgenic herbicide- resistant soybeans under conditions of drought and heat. Scientists then carried out a comparative laboratory study of transgenic and conventional soybeans (16). They found that the transgenic plants were shorter, had a lower fresh weight, had less chlorophyll content and, at high temperature, suffered from stem splitting. They were clearly different from their conventional counterparts in ways other than being herbicide- resistant. This is one of many examples showing how a genetic modification intended to change a specific and clearly circumscribed characteristic of the plant, ends up affecting the whole organism. Some of the unintended effects may be induced by environmental conditions. No one can foretell the kind or degree of such changes.
Why A Double Standard?
All these examples make one wonder how the FDA can claim it "is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way". This view has a glimmer of credibility only as long as the FDA views GM-food through the monocle of substantial equivalence, while wearing blinders to all other considerations. The broader view shows that genetic engineering is a radically new way of altering the plants we utilize for food. Traditional food processing and use of additives begins after the plants have been harvested and reach the factory. With genetic engineering, processing and adding new substances begins already in the growing plant.
Even apart from safety issues, shouldn't the FDA, as a consumer protection agency, inform consumers via labels about genetic engineering as a new method of adding substances to and processing food? Isn't this at least as important as knowing that your orange juice is from concentrate? Surely the criteria of truthfulness and honest disclosure remain the same in both cases. Why has the FDA chosen to establish such a crass double standard?
At the time the FDA was formulating its policy regarding genetically modified foods, scientists within the FDA itself were critical of the new policy. These dissenting voices were made public only much later. Early in 1992, Linda Kahl, an FDA scientist and compliance officer, complained to James Marianski, the FDA's biotechnology coordinator, about how the agency was "trying to force an ultimate conclusion that there is no difference between foods modified by genetic engineering and foods modified by traditional breeding practices". This was like "trying to fit a square peg into a round hole" (17). Another FDA scientist, Louis Pribyl, writes in his comments on the draft document:
What has happened to scientific elements of this document? Without a sound scientific base to rest on, this becomes a broad, general, "What do I have to do to avoid trouble"-type document .... This document reads like a biotech REDBOOK!! .... It reads very pro-industry, especially in the area of unintended effects, but contains very little input from consumers and only a few answers for their concerns (18).
In other words, the FDA took the perspective of the biotech industry in formulating its policy. The pro-biotech bias has not been restricted to the FDA. James Glickmann, reflecting on his tenure as Clinton's Secretary of Agriculture, stated in the summer of 2001:
Regulators even viewed themselves as cheerleaders for biotechnology. It was viewed as science marching forward, and anyone who wasn't marching forward was a Luddite. (Los Angeles Times, July 1, 2001)
The interviewer goes on to write that Glickman expressed his regrets "that industry was allowed to take the lead, as regulators ceded their watchdog role".
This pro-biotech bias makes clear why the FDA policy regarding GM-foods differs in spirit and in content so radically from its policies regarding other foods. Otherwise it is impossible to understand the tortuous and often disingenuous argumentation that FDA uses in its attempts, as Kahl put it, to fit square pegs into round holes. The policy was crafted around a foregone conclusion that is also the biotech industry's view -- GM-food should not be labeled. So the FDA had to find ways to narrow the context (safety as the only reason to label) and to "demonstrate" that GM-food and food from traditionally bred plants is the same. Along the way it left out all the factually existing differences in content and process, while also ignoring the consumer.
The Consumer's Right to Know? - Contrasting Views
When I participated in a panel discussion with representatives from the biotech industry and the government earlier this year, the representative from the FDA opined that "consumers have a right to know -- but not to know everything". This echoes a sentiment expressed on the FDA's website, where we can read that law "does not require disclosure of information solely on the basis of consumers' desire to know" (19). This is a very strange reading of its mission as a consumer protection agency, which is (according to the Food, Drug, and Cosmetic Act) to "promote honesty and fair dealing with consumers".
The Europeans have taken a very different stance on labeling genetically modified food. David Byrne, European Commissioner for Health and Consumer Protection, spoke to the National Press Club on October 9, 2001:
Let me be very frank. Unless we can give EU consumers confidence in this new technology then GM is dead in Europe. Let me assure you that this is not a scare tactic on my part. I am not prone to exaggeration.... As part of the new approval process, GM food and feed will have to be labeled as such.... Europe is perfectly entitled to impose the labeling rules proposed. Our consumers are demanding this. They are entitled to choice and full information is now a right since the Amsterdam Treaty has become part of the constitutional arrangements of the European Union.... Labels that cover all GM-derived products ensure that our consumers are able to choose a GM product or a non-GM product.
This is a very clear position statement. It leaves no doubt that the main reason to label GM-foods is the consumer's right to know and to choose. Britain's premier scientific society, The Royal Society, states in its essentially pro-genetic engineering position paper that nonetheless "public debate must take account of wider issues than science alone" (20).
In contrast, U.S. regulations (or rather, the lack thereof) concerning GM-food are based solely on a partial examination of the end-product. This is called a "science-based" approach. Biotech advocate Henry Miller (Hoover Institution, Stanford University) echoes the FDA's view when he states that regulations focusing on process are unscientific and therefore the only "rational approach" is not to label genetically modified food (21). It is "rational" to ignore process and to ignore the consumer. What a sad view -- one might even call it insane, inasmuch as insanity entails losing touch with reality. Following this approach the food label would reveal nothing more and nothing less than what passed through the filter of an extremely narrow view, so-called "sound science". The authority of "science" (represented by the government and the biotech industry) chooses what is fit for the people to know. This does not sound like a healthy democracy to me.
Food Labels -- A Window to Food's Story
During the course of the twentieth century, farming and food production and processing became increasingly detached from the lives of most people in the Western world. Children who are told, to their surprise, that milk comes from cows and eggs from chickens often find the facts "gross". More broadly, most of us have next to no idea where the food we eat comes from or what's involved in its processing. Food additives labeled on packages are just names. And in many instances we would not be enthralled if we knew more about the food we're eating.
Recently Michael Pollan wrote an exemplary piece on the life of a beef steer (22). His detailed "biography" brings home how the food we eat is connected with a whole world of social, economic, political, and ecological connections. When we buy food we're supporting that particular world -- a world about which we usually know nothing. In a sense we're sleepwalking. This is one of the consequences of the technologization of our culture -- it distances us from concrete processes and we end up living in a world peopled with end-products whose life stories we don't know.
Food labels are one (and only one) small window into the world of food. Many labels restrict themselves to end-product information -- contents, nutritional value, etc. The more they tell you about processing and method of production, the more you as a consumer can see into the world connected to that particular product. Some producers want you to have this knowledge, especially in the natural foods industry where the label might tell you the contents of salsa are organically grown (and therefore genetic engineering was not involved in the food's production). Or the milk you buy might state that the cattle were not treated with hormones and did have access to pasture grazing. All this labeling is voluntary. What you don't find (although it is allowed) is voluntary labeling that states "genetically engineered" or "factory farmed". Evidently the producers are not interested in any window being open to those worlds.
The more the window to a food's story is open and the larger that window is, the greater the opportunity for consumers to make informed decisions. In respect to genetically engineered foods (and to many practices of modern agriculture and animal husbandry) the government keeps the window closed. It does not go all the way to promote "honest and fair dealing with consumers".
I doubt that the impetus for making labels transparent will come from the government. The pro-biotech stance is very firm. But if American consumers become more active -- as they have in Europe -- then things can change. This activity can have at least two complementary directions.
First, we can inform the government that we do believe in the significance of our choices as consumers and in the obligation of the federal regulatory agencies to protect these choices. We can demand more open and consistent practices instead of double standards. We can demand that labels be more comprehensive and include information about process and production as well as content. The cynic in us will counter that we don't have any power to confront the government-biotech complex. But the consumer does still have power. When the Agriculture Department was adopting new "organic" standards, public protest brought about changes so that, for example, a product cannot be called organic if it has been genetically engineered. The standards on organic agriculture are far from perfect, but they are much better than they would have been had citizens not made their opinions known (23).
Second, we can purchase selectively. We can choose to buy food that does open the window to food's story. In this way we influence the way food is produced and labeled. The more consumers buy products with transparent labeling practices, the more such labeling -- and the type of farming and animal husbandry the labels stand for -- will take hold. Consumers are a primary force in the rapid expansion of the organic foods market, as well as in the burgeoning growth of local and regional food networks, such as Community Supported Agriculture (CSA), where there is direct contact between consumers and farmers who produce the food.
Surveys consistently show a majority of Americans in favor of labeling GM-foods (24). While the FDA has, for now, set itself against full disclosure, surely it cannot remain wholly immune to consumer pressure. After all, if the FDA does not exist to protect the declared interests of consumers, particularly with respect to truthfulness and transparency, then what is its mission?
Section 401 of the Food, Drug and Cosmetic Act.
Code of Federal Regulations, Title 21, Chapter 1, especially parts 101 and 102. See http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=3D200121.
See reference 2.
Padgette, S. et al. 1996. "The Composition of Glyphosate- Tolerant Soybean Seeds Is Equivalent to That of Conventional Soybeans", Journal of Nutrition vol. 126: 702-716.
Federal Register vol. 54, No. 104 (1992), p. 22991.
For a succinct overview of the problematic concept of substantial equivalence, including links to other articles, see the discussion on the website of Physicians and Scientists for Responsible Action of Science and Technology (http://www.psrast.org/subeqow.htm).
http://www.genewatch.org. (Click successively on "Database", "Search", and "Search by crop line". Then, under "Select a crop line", click on "GTS 40-3-2".)
Martineau, B. (2001). First Fruit. New York: McGraw-Hill.
Federal Register vol. 59, No. 98 (1994), pp. 26700-26711.
For a good description of the "gene gun", see: http://www.hawkhill.com/926s.html.
Trethewey, R.N. et al. (1998). "Combined Expression of Glucokinase and Invertase in Potato Tubers Leads to a Dramatic Reduction in Starch Accumulation and a Stimulation of Glycolysis", Plant Journal vol. 15, pp. 109-118; Fray, R. et al. (1995). "Constitutive Expression of a Fruit Phytoene Synthase Gene in Transgenic Tomatoes Causes Dwarfism by Redirecting Metabolites from the Gibberellin Pathway", The Plant Journal vol. 8, pp. 693-701; Bergelson, J. et al. (1998). "Promiscuity in Transgenic Plants", Nature vol. 395, p. 25.
Holdrege, C. and S. Talbott (2001). "Sowing Technology", Sierra (July/August), pp. 34 ff.; for an online version of this article, see http://www.netfuture.org/2001/Oct0901_123.html.
Gertz, J.M. et al. (1999). "Tolerance of Transgenic Soybean (Glycine max) to Heat Stress", The Brighton Conference: Weeds. Surrey, U.K.: The Council, pp. 835-840.
http://www.royalsoc.ac.uk (see "GM Plants" under "Issues"; report from February 2002).
Miller, H. (1999). "A Rational Approach to Labeling Biotech- Derived Foods". Science vol. 284, pp. 1471-1472.
Pollan, M. (2002). "Power Steer", New York Times Magazine (March 31), pp. 44ff.
For information about how you can make your opinion known, see the Center for Food Safety website - http://www.centerforfoodsafety.org.
For a summary of public opinion polls see http://www.centerforfoodsafety.org/.
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