“GM Foods in the U.S. Marketplace: Untested? Unlabelled?”
New Zealand Biotechnology Conference
March 2002

Situation in the U.S.

Unrest over genetically modified foods began to erupt in Europe about four years ago. The reasons for this are very complex, but it led to consumer unrest so strong that supermarkets were forced to rid their shelves of products containing GMOs and governments to enact moratoria and strict labeling laws.
I watched these events unfold, confident in the fact that U.S. citizens had been through their "uncomfortable phase” with GM foods in the late 1980's and early 1990's. SLIDE 2 For example, in 1992 newspapers spoke of the "Food Frankensteins" and there had been heated debate and anti-GM legislation enacted over the ice-minus bacterium and later over milk from BGH-injected cows.

This “uncomfortable phase” passed and in 1995, I found myself no longer being asked to defend the technology, but to work with groups to determine how best to apply the new technology to their particular problem. Progress was being made toward creating more new genetically engineered crops, mainly in large acreage crops and primarily by the agrochemical giants. SLIDE 3 Acreage of engineered cotton, soybean, corn and potatoes was rising. In 1998, 26.5% of the corn planted in the U.S. was genetically engineered; 27% of the soybeans; 44% of the cotton and 3% of potatoes. U.S. consumers did not seem concerned about these new crops and actually knew little about them.

Situation in Europe differed from U.S.

Regardless of why US consumers ignored the appearance of these new GM foods or didn’t know, concerned voices were heard in Europe. SLIDE 4

“Why are there GM ingredients in our foods and we didn’t know it?”

“Why should we believe that our government is able to judge the safety of these products when they didn’t warn us of mad cow disease and dioxin contamination?”

In my opinion, the furor in Europe came about because of some fundamental differences in issues between Europe and the US. These included one important, and I believe critical issue, trust in governmental regulatory authorities. This confidence is crucial in addressing consumer safety issues and Europeans simply didn’t have that trust. SLIDE 5 Europeans had been “burned” by two food safety scares in the mid 90’s: mad cow disease and dioxin contamination of foods and beverages. On average, Americans trusted their government regulators and still do. The situation was quite different in Europe. This was largely due to the fact that there was a lack of trust in governmental oversight of GM foods and, perhaps as importantly, these foods were being foisted upon them by US multinational corporations. This undermined consumers' confidence in the government and led to more open minds for alarmists' claims. SLIDE 6
Despite the concerns in Europe and later Asia, acreage planted to GM crops continued to rise in the U.S. during the 1999 through 2001 period, albeit at a lower rate. Figures for 2001 from the U.S. Department of Agriculture were that approximately 68% of the acreage of soyben, 69% of cotton and 26% of corn was GM.

Consumer attitudes in the U.S.

Vast numbers of products streamed into the marketplace in the US and in Europe, containing corn starch and soy flour and soy, corn and cottonseed oil made from G.M. corn, soybeans and cotton. SLIDE 7 Despite this influx into the market, it took place quietly with most consumers unaware. An SLIDE 8 International Food Information Council (IFIC) poll, conducted in October 1999, indicated that only 38% of U.S. consumers thought there were any foods produced by biotechnology in the marketplace. In fact that awareness has changed little because in September 2001, even fewer consumers, 33%, believed this to be true. Is it because consumers just aren't aware or is it possible that U.S. consumers simply choose to ignore this information because they did not view the process of genetic engineering as being inherently risky? It is probably a bit of both.

The majority of Americans have confidence in the federal regulatory system that monitors the safety of the foods we eat. SLIDE 9 In a September 1999 Gallup poll, 76% of Americans polled had a lot or a fair amount of confidence in the federal government to assure safety in our food supply. And do Americans view GM foods as one of the food safety risks that they are concerned about? In January 2001, U.S. consumers were asked to identify the nature of the concerns they had with regard to food safety. SLIDE 10 Only 2% of consumers named “altered or engineered food” as something they were concerned about, despite extensive media coverage in fall 2000 about “Starlink” corn contamination. SLIDE 11 And in fact only 5% of individuals polled indicated that they had taken any action as a result of concerns over food safety. Looking at a particular question that has been asked repeatedly in IFIC polls shows that concern over GM foods has not changed from 1997 to 2001. SLIDE 12 Consumers were asked if they would be willing to buy a GM food if it were modified to be protected against insecticides and required fewer pesticides. The response has been consistently high from 1997 to 2001 with approximately 60-70% willing to buy and consume it.

Labeling of GM foods
What about labeling of GM foods? In the September 2001 IFIC survey, consumers were asked to indicate what information, not currently on food labels, they would like to see. SLIDE 13 Only 1% of individuals surveyed responded that “genetically altered” was something they wanted to see on labels. Seventy-eight % couldn’t think of any information they wanted to see on labels that was not already there. Many polls, however, have shown that, when asked specifically if they would like GM foods labeled, many U.S. respondents say yes. SLIDE 14 For example in a June 2001 poll by ABC news, 35% of those polled said yes; 52% said no. SLIDE 15 While only 2% of consumers wanted to see “genetically altered” on labels in a January 2001 IFIC survey, when presented with the fact that critics wanted to label all foods produced through biotechnology, greater than 50% of consumers indicated that they wanted labels. Perhaps consistent with this kind of thinking, in a March 2001 poll conducted by the Center for Science in the Public Interest, consumers were asked if they wanted foods labeled under the following circumstances. SLIDE 16 If they were (1) sprayed with pesticides – 76% said yes; (2) genetically engineered – 70%; (3) treated with plant hormones – 65% or (4) made with crossbred corn – 40%! So, when given the choice, consumers want information about everything, even if they don’t understand what information they are asking for!

That there is not an outright demand for labeling in the U.S. maybe be due to the fact that most American trust the federal regulatory system. SLIDE 17 When specifically asked, in the September 2001 IFIC poll, 57% supported the policy of the U.S. Food and Drug Administration to label foods derived from biotechnology, only when they differed substantially in their nutritional content or when an allergen or toxin was introduced. This number has dropped significantly, however, over the last five years, down almost 20% from numbers obtained in 1997 and 10% from numbers obtained in October 1999 and January 2001.

Importance of the regulatory structure in the U.S.

SLIDE 18 In a report about a study conducted by the U.S. National Research Council, they state that, while scientific evaluations of GM crops support their safety, public acceptance of these foods ultimately depends upon the credibility of the testing and regulatory process. This is especially true since the average citizen does not have access to the safety testing data and, even if it were available, would likely lack the ability to evaluate it. So at the core of safety issues in the US lies the federal system that regulates the new GM crops and foods. These plants - and the many food products made from them - will never win public acceptance unless the public perceives that the government is making both public health and environmental protection top priorities.

What is the regulatory structure in the U.S.?
As the technology was being developed, scientists, regulators and policy makers in the U.S. agreed that plants bred with the new technologies should be rigorously evaluated, perhaps in many cases not so much as a safety issue but as a means to win public acceptance. It has also been argued by some that certain large companies lobbied for extensive regulations, perhaps not strictly for safety or consumer acceptance reasons, but to decrease competition. If the hurdles were high, it would be much harder for other entities, e.g., small companies and academics, to clear the hurdles.

To enact the regulatory oversight, the White House Office of Science and Technology Policy in 1986 created a Coordinated Framework for Regulation of Biotechnology. Responsibility for implementing the framework fell to three lead agencies: SLIDE 19

U.S. Department of Agriculture (USDA)

Food and Drug Administration (FDA)

Environmental Protection Agency (EPA)

Under this Coordinated Framework every new GM food or feed product created by modern biotechnology is subject to pre-market safety assessment by at least one federal agency; all products released so far have been subject to assessment by several agencies. That this has occurred is due to the fact that plants per se are under the jurisdiction of the USDA, while pesticidal products in plants, like Bt, are subject to the regulations of the EPA. The FDA assesses food and feed safety. The environmental and food safety of each product is judged in a case-by-case situation, judged on the basis that these foods are to be as safe as their conventional counterparts.

How are foods from conventional breeding regulated?

SLIDE 20 That leads us to ask question about how foods are regulated that are derived from “conventional crops”, which might be the result of classical breeding, wide species crosses, mutation, or in vitro culture. Generally these foods are considered safe because of decades or centuries of widespread use and consumption and even new varieties undergo little, if any, federal scrutiny. However, most contemporary varieties are evaluated for many years by public or private sector breeders who look at both agronomic characteristics, such as phenotype, yield, and pest resistance, and quality characteristics, like nutrient content, digestibility, taste and appearance.

Historically these procedures have provided reliable, safe foods and crops. A few crop species, like potato and celery, have compounds, i.e., glycoalkaloids and psoralens, respectively, which can cause adverse human reactions and are monitored by breeders for their levels in commercial releases. Occasionally varieties are produced which contain unacceptable levels of the toxic compounds and these varieties are not developed further. But evaluation of these varieties is not federally mandated or monitored. The ruler used to judge these conventionally produced foods is one based on the probability for adverse effects, not one based on the process by which they are produced.

How are GM foods regulated?

SLIDE 21 Crops developed through biotechnology have specific traits mediated by the introduction of specific genes. Current testing and evaluation procedures focus on the specific gene and protein introduced and whether this trait raises safety questions beyond those of the parental varieties and whether the new variety is essentially the same as the parental variety, e.g., the principle of substantial equivalence. So, in general, process guides regulation, not product. Fundamentally this is due to the fact that it is a new technology with no track record of safety.

What do agencies look for before GM products are on the market?

SLIDE 22 USDA: USDA is responsible for assessing the environmental safety of the GM crops; they are also responsible for overseeing the movement, import and release of the plants. Between 1987 and 2001, 7,300 small-scale field tests were conducted under USDA regulation by the Animal and Plant Health Inspection Service (APHIS). SLIDE 23 Data on such tests, indicating the crop, trait and location is available at a website maintained by Virginia Polytechnic University (http://www.isb.vt.edu/cfdocs/biocharts1.cfm). During and after the field testing, data is to be gathered on the food, feed and environmental safety of the product, along with information on the genetic makeup of the plant.

By early 2001, 49 USDA-approved plant products had completed the voluntary FDA pre-market review process. EPA also reviewed nineteen of the 49, which were either insect- or virus-resistant. Once sufficient data is accumulated regarding potential environmental impact, e.g. several years of field testing, developers of the plant can request non-regulated status. This request is published in the Federal Register and the public is given 60 days to respond. As of today 52 of 73 petitions for non-regulated status were approved.

SLIDE 24 EPA: The EPA gains its regulatory oversight of GM crops based on its responsibility to evaluate and regulate plant pesticides. Therefore, if a plant is engineered with a gene that expresses a protein, like Bt, that protects it from attack by a pest, it comes under EPA jurisdiction. In the 1990’s the EPA proposed that a plant genetically engineered to contain a pesticidal gene would have to be labeled as a “pesticide”. Members of the scientific community felt that this was not scientifically defensible, since it would be possible for biochemically identical plants, created either by classical breeding or biotechnology, to be treated differently. The GM food would have to be labeled “pesticide”, while the conventional food would require no labeling. SLIDE 25

The compromise reached after over 7 years of discussions was that some proteins would be exempt from the ruling. EPA is still taking comments on whether coat proteins from viruses will be in this category. Proteins not exempt would be termed “plant-incorporated protectants” or PIPs, rather than pesticides. The genes themselves are now exempt from EPA regulations, only the protein is regulated.

Under EPA rules, a pesticide, or in this case a PIP, must not cause “unreasonable adverse effects on the environment”, which by definition encompasses ecological concerns as well as human health risks. The EPA therefore requests detailed information on the toxicology, impacts on nontarget organisms, wildlife and endangered species and the environmental fate of PIPs. None of this is examined with conventional crops, even though they contain many such proteins. Part of the rationale for this difference is the scale of use of these new GM crops. No conventional varieties containing high levels of PIPs are grown on 70% of crop acreage.

Companies provide data to the EPA relating to the food and environmental safety of the crops, including nutritional equivalence, SLIDE 26 toxicology, effects on nontarget organisms and soil residues. SLIDE 27 To evaluate the benefits and risks, it is necessary to make a judgement on a case-by-case basis that weighs potential adverse environmental effects, like Bt residues in the soil, with potential benefits, like reducing applications of other perhaps more risky chemicals.

Then the question becomes what is more important and to whom? To what do you compare GM crops? A mythical, no-impact agricultural system? Crops grown under “organic standards”? Or crops grown with current conventional technologies? The answer regarding the comparison might be different among different countries, where agricultural impacts and biodiversity issues are different.

SLIDE 28 FDA: The FDA has primary responsibility for the safety of the food and feed supply; foods must not contain any substances that render them injurious to health. Of course this, in its absolute sense, would be impossible to achieve since plants and foods do contain substances that can cause harm when consumed in sufficient quantities, compounds like the glycoalkaloids in green potatoes and cyanide in apple seeds. Therefore “zero risk” or “absolute safety” is not possible and the FDA has adopted a standard for food safety based on a reasonable certainty of no harm.

Food Safety Evaluation by FDA and EPA

The FDA and EPA use similar strategies to evaluate the safety of foods. Certain analyses are performed on all new GM food products, like compositional and nutritional analyses, and food allergy and toxicity testing. But foods are different in their composition and use, and evaluations are carried out based on a decision tree. SLIDE 29

1) Evaluate safety of source organism of gene/protein

2) Assess safety of genes and expression products from new inserted genetic material

3) Establish safety of consumed food

1) Safety of source organism SLIDE 30

If the gene is from a source that is considered to adversely affect the health of human consumers, like using a peanut gene, when some individuals suffer life-threatening allergies due to peanuts, the food containing the new gene must be thoroughly tested and so-labeled.

2) Safety of consumed DNA and product of introduced trait SLIDE 31

FDA has established that consumption of DNA is “generally regarded as safe” or “GRAS”, independent of its source. They rather look at what would happen if the introduced gene were transferred to its consumer, which explains their focus on antibiotic resistance genes. They have released nonmandatory guidelines for the use of genes that encode resistance to antibiotics and have recommended that the use of such genes be phased out over the next five years. The kanamycin gene, because it received FDA Food Additive Status, does not have to be phased out; it is not in significant clinical use as an antibiotic.

In terms of safety of the consumed product of the introduced gene, this evaluation considers the history of consumption and the relatedness of the new product to other proteins that have consumption records and to known toxicants or allergens. An important consideration in these evaluations is the expected dietary intake of such a protein. If the new product is placed in an infrequently consumed food, this is a different situation from its incorporation into soy or corn. Safety evaluations also include stability of the protein during digestion and processing to determine whether the product would actually be presented to the consumer in the form in which it exists in the food.
Allergenicity is probably the most troublesome of the human safety issues to evaluate, given the vagaries of human allergies. Proteins in GM foods are evaluated on several fronts, including comparisons to known allergens in terms of protein sequence, size, digestibility and resistance to heat. The use of animal models is the final step in evaluation, but there are no animal models that have yet been validated for this use.

3) Safety of remaining edible portion of food

SLIDE 32 For this evaluation, when applied to a whole food, the comparison that is made is between the GM food and its conventional counterpart. This includes comparison of composition and nutritional value as well as comprehensive macro- and micronutrients. This includes generally 50 or more different key nutrients and antinutrients in either the whole food or in processed foods containing the GM ingredient. Equivalence of composition, or substantial equivalence, is taken as evidence that substantive changes did not occur in the food and it is as “safe” as its conventional counterpart. Companies marketing GM foods today voluntarily conduct such safety testing and undergo voluntary pre-market review. Due to public hearings in December 1999, proposed new FDA regulations will make pre-market review mandatory and the data presented in the review will be made public.


SLIDE 33 Consistent with FDA policies for foods developed by other methods, labeling of foods derived from GM crops is only required when the crop differs significantly in composition, nutritional value or health effects from the conventional counterpart. Only two products in the market today require such special labeling; these are high laurate canola and high oleic acid soybean; all other labeling in the U.S. is voluntary.

The issue of labeling in the U.S. appears not to be a food safety issue to most people, since in many cases the GM ingredient (DNA or protein) would not even be present in the consumed food, e.g.. oils, meat. It is rather a consumer-choice issue. A consumer wants to be able to make an informed choice about the foods they eat. That sounds reasonable enough. But what would be involved in a GMO-free labeling scheme? Can’t you just slap a label on a food? If you are talking about a whole food, this is not a difficult thing. After all, they put small labels on many of our fresh fruits and vegetables so the checkout clerks know what to charge us for a particular piece of fruit.
The problem comes with processed foods. This would involve complicated tracking streams and testing to satisfy labeling specification and to determine liability should GM ingredients inadvertently get mixed in where they were not supposed to be. Economists have estimated that this might raise the price of some foods 20-30%. SLIDE 34 In the U.S. consumers pay that much more for organically produced foods, but this is by choice. If individuals think it is either not worth the extra cost or can’t afford the extra cost, they still have the option of not buying organic food. If labeling of GM food were mandated, consumers who didn’t care or who didn’t want GM-free food might still be forced to pay the additional costs of tracking and labeling.

What is in the biotechnology pipeline?

While it might not seem a “big deal” to the consumer to lose Roundup Ready Soybean or Bollgard Cotton (although farmers might disagree!), it might be of interest to look into the pipeline of products that could come to market in the next decade. Many will still focus on farmer and environmental concerns, including alternatives for pest control. SLIDE 35 Like natural host resistance genes that can protect tomato roots from nematodes or a gene that protects rice from blast disease. SLIDE 36 Efforts are also being taken to protect plants against environmental insults, like frost or salt, or to increase yields. In the latter case, a single gene was taken from corn and moved into rice to increase yield by 30%.

Some of the efforts with the new technologies are focused on changing the nutritional quality of the crop. For example, in some cases an antinutrient, like an allergen, is removed from the food. SLIDE 37 In other cases the nutritional content of foods is changed, such as an increase in the amount and quality of protein in potato, the b-carotene content of rice or oil or the iron content of cereal grains. SLIDE 38 Using foods to improve human health can be taken a step further, where foods can be modified to provide vaccines or cancer treatments for humans or animals. SLIDE 39 Other uses of plants in the fields of the future might be to remediate soils and lakes, removing metal and radioactive contaminants, or their use to do biomining, SLIDE 40 concentrating precious metals like gold and platinum in their tissues to be smelted and recovered. Plants can also serve as sources of biofuels or plastics to supplement those currently made from nonrenewable resources.


SLIDE 41 But each of these products must be scrutinized, requiring a strong and flexible regulatory system that can address the needs and concerns of users and consumers. The regulatory system applied to GM crops in the US involves several agencies, which is viewed as strength by some and a weakness by others. The case-by-case approach to evaluation of GM crops is also viewed differently, as strength by some, a weakness by others.

There have been some issues raised regarding GM crops and foods, such as the Monarch butterfly study, the presence of Starlink corn in the human food supply and the more recent reported detection of transgenes in Mexican landraces of corn. But few, if any, federal systems in any country are perfect and the hallmark of an acceptable one is its ability to change over time to address emerging issues. I believe that the U.S. system has shown its ability to take on new technological challenges in the past and will continue to do so in the future. Does this mean that our food supply will be 100% safe? No, such assurances would be impossible. But I do believe that the U.S. system will be the basis for the safest food supply in the world and one that can include GM foods!